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Filed pursuant to Rule 424(b)(3)
Registration No. 333-227547

LOGO   LOGO

PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT

To the Stockholders of OvaScience, Inc. and Millendo Therapeutics, Inc.:

          OvaScience, Inc. ("OvaScience") and Millendo Therapeutics, Inc. ("Millendo") have entered into an Agreement and Plan of Merger and Reorganization, as may be amended from time to time (the "Merger Agreement"), pursuant to which a wholly owned subsidiary of OvaScience will merge with and into Millendo, with Millendo surviving as a wholly owned subsidiary of OvaScience (the "Merger"). OvaScience and Millendo believe that the Merger will result in a specialty biopharmaceutical company focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient.

          At the closing of the Merger (the "Effective Time"), each share of Millendo's common stock, par value $0.001 per share ("Millendo Common Stock") (excluding certain shares to be cancelled pursuant to the Merger Agreement, and shares held by stockholders who have exercised and perfected appraisal rights or dissenters' rights as more fully described in the section of this proxy statement/prospectus/information statement titled "The Merger—Appraisal Rights and Dissenters' Rights"), outstanding immediately prior to the Effective Time will be converted into the right to receive shares of OvaScience's common stock, par value $0.001 per share ("OvaScience Common Stock") equal to an exchange ratio, as further discussed in the Merger Agreement and in this proxy statement/prospectus/information statement (the "Exchange Ratio"). OvaScience will assume outstanding and unexercised options and warrants to purchase shares of Millendo Common Stock, which will be converted into options or warrants to purchase shares of OvaScience Common Stock, with the number of shares of OvaScience Common Stock subject to such option or warrant and the exercise price being appropriately adjusted to reflect the Exchange Ratio. OvaScience Stockholders will continue to own and hold their existing shares of OvaScience Common Stock. Each existing unexpired and unexercised option to purchase OvaScience Common Stock (an "OvaScience Option"), whether vested or unvested, will be accelerated in full pursuant to the Merger Agreement subject to and effective as of immediately prior to the Effective Time.

          As of the date of the execution of the Merger Agreement, it was estimated that immediately after the consummation of the Merger, based solely on the sample Exchange Ratio of 0.1173 set forth below, existing Millendo Stockholders, Millendo Optionholders and persons holding securities and other rights directly or indirectly convertible, exercisable or exchangeable for Millendo Common Stock (collectively, "Millendo Securityholders") would own approximately 82% of the Fully Diluted Closing OvaScience Common Stock, and OvaScience Stockholders, OvaScience Optionholders and persons holding securities convertible, exercisable or exchangeable for OvaScience Common Stock (collectively, "OvaScience Securityholders") would own approximately 18% of the Fully Diluted Closing OvaScience Common Stock, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement. "Fully Diluted Closing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan).The initial estimate of the Exchange Ratio set forth below assumed the following:

    that OvaScience would have between $40 million and $42 million in net cash immediately prior to the closing of the Merger (the "Closing"),

    a Pre-Closing Financing amount of $30.0 million,

    OvaScience outstanding shares and options as of the Closing would be equal to 3,721,460 (on a post reverse stock split basis),

    Millendo shares as of the Closing on a fully diluted and as-converted basis would be equal to 148,171,273, and

    a reverse stock split in which every 10 shares of outstanding OvaScience Common Stock will be combined and reclassified into one share of OvaScience Common Stock.

          The Exchange Ratio is calculated using a formula intended to allocate a percentage of the combined organization to existing Millendo Securityholders. The Exchange Ratio is subject to change based on the amount of OvaScience net cash, changes in the capitalization of OvaScience or Millendo prior to the Closing and the actual amount raised by Millendo in its pre-closing private placement of Millendo Common Stock (the "Pre-Closing Financing"). Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock. The initial Exchange Ratio was originally based on a negotiated value of $47.5 million for OvaScience (assuming OvaScience would have net cash of $41 million at closing). After the initial signing of the Merger Agreement, the valuations for Millendo and OvaScience were reduced, as further described in this proxy statement/prospectus/information statement. In addition, OvaScience currently estimates, assuming for this purpose a closing date of November 30, 2018, that (i) it will have approximately $37.6 million in net cash immediately prior to Closing, (ii) the Pre-Closing Financing amount will be approximately $29.5 million, (iii) OvaScience outstanding shares and options as of the Closing will be equal to 3,727,669 (on a post reverse stock split basis) and (iv) the Millendo shares as of the Closing on a fully diluted and as-converted basis will be equal to 152,629,595. Accordingly, it is currently estimated that the Exchange Ratio at Closing will be approximately 0.1070 and, based solely on such Exchange Ratio, at Closing: (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 67.1% of the Fully Diluted Closing OvaScience Common Stock, (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 13.1% of the Fully Diluted Closing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 18.6% of the Fully Diluted Closing OvaScience Common Stock, and (d) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.2% of the Fully Diluted Closing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. Additionally, it is anticipated that the Post-Closing Financing (as defined below) will close shortly after the Closing, which would dilute, and thereby reduce, each then existing OvaScience Securityholder's proportionate holdings. Assuming that the Post-Closing Financing closes immediately after the Merger as well as the other aforementioned assumptions, it is expected that (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 61.7% of the Fully Diluted Post-Financing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 12.0% of the Fully Diluted Post-Financing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 17.1% of the Fully Diluted Post-Financing OvaScience Common Stock, (d) the shares issued in the Post-Closing Financing to the Post-Closing Financing Investor (as defined below) will represent approximately 8.1% of the Fully Diluted Post-Financing OvaScience Common Stock, and (e) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.1% of the Fully Diluted Post-Financing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. "Fully Diluted Post-Financing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan) plus (z) the Post-Closing Financing shares.


          Shares of OvaScience Common Stock are listed on The Nasdaq Capital Market under the symbol "OVAS". OvaScience has filed an initial listing application with The Nasdaq Capital Market pursuant to Nasdaq's rules for companies conducting a business combination that results in a change of control. After completion of the Merger, OvaScience will be renamed "Millendo Therapeutics, Inc." and expects to trade on The Nasdaq Capital Market under the symbol "MLND." On November 2, 2018, the last trading day before the date of this proxy statement/prospectus/information statement, the closing sale price of OvaScience Common Stock was $0.79 per share.

          OvaScience is holding a special meeting of stockholders (the "Special Meeting") in order to obtain the stockholder approvals necessary to complete the Merger and related matters. At the Special Meeting, which will be held at 10:00 a.m., local time, on December 4, 2018, at the Westin Waltham Boston Hotel, 70 Third Avenue, Waltham, Massachusetts 02451, unless postponed or adjourned to a later date, OvaScience will ask its stockholders to:

    1.
    adopt the Merger Agreement, thereby approving the Merger and the issuance of OvaScience Common Stock pursuant to the Merger Agreement, including shares of OvaScience Common Stock to be issued in exchange for all shares of Millendo Common Stock that are sold in the Pre-Closing Financing;

    2.
    approve an amendment to OvaScience's restated certificate of incorporation effecting a reverse stock split of OvaScience Common Stock at a ratio mutually agreed to between OvaScience and Millendo in the range of one new share for every 5 to 15 shares outstanding (or any number in between) (the "Reverse Stock Split");

    3.
    approve an amendment to OvaScience's restated certificate of incorporation changing OvaScience's corporate name from "OvaScience, Inc." to "Millendo Therapeutics, Inc.";

    4.
    approve an amendment to the OvaScience 2012 Stock Incentive Plan (the "2012 Plan") to increase the total number of shares of OvaScience Common Stock currently available for issuance under the 2012 Plan by 671,000 shares, which amendment reflects the Reverse Stock Split at an assumed ratio of 1:10;

    5.
    approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to OvaScience's named executive officers as a result of the Merger;

    6.
    approve the issuance of shares of OvaScience Common Stock in the Post-Closing Financing (as defined below) in accordance with Nasdaq Listing Rule 5635(a);

    7.
    consider and vote upon an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 6; and

    8.
    consider such other business as may properly come before the stockholders at the Special Meeting or any adjournment or postponement thereof.

          As described in the accompanying proxy statement/prospectus/information statement, certain of Millendo's stockholders who in the aggregate own approximately 73% of the outstanding shares of Millendo Common Stock, Millendo's Class-1 Common Stock, par value $0.001 per share ("Millendo's Class-1 Common Stock") and Millendo's preferred stock, par value $0.001 per share ("Millendo Preferred Stock," and together with Millendo's Class-1 Common Stock and Millendo Common Stock, the "Millendo Capital Stock") on an as converted to common stock basis, and certain OvaScience stockholders who in the aggregate own approximately 5% of the outstanding shares of OvaScience Common Stock, are parties to voting agreements with OvaScience and Millendo, respectively, whereby such stockholders have agreed to vote in favor of the adoption or approval of the Merger Agreement, as applicable, and the approval of the transactions contemplated therein, including the Merger and the issuance of OvaScience Common Stock in the Merger pursuant to the Merger Agreement, respectively, subject to the terms of the voting agreements. In addition, following the registration statement on Form S-4, of which this proxy statement/prospectus/information statement is a part, being declared effective by the U.S. Securities and Exchange Commission and pursuant to the conditions of the Merger Agreement, Millendo's stockholders who are party to the voting agreements will each execute an action by written consent of Millendo's stockholders, referred to herein as the written consent, adopting the Merger Agreement, thereby approving the Merger and related transactions. Therefore, holders of a sufficient number of shares of Millendo Capital Stock required to adopt the Merger Agreement will adopt the Merger Agreement, and no meeting of Millendo stockholders is required to adopt the Merger Agreement and approve the Merger and related transactions and no meeting of Millendo's stockholders will be held. Nevertheless, all of Millendo's stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions, by signing and returning to Millendo a written consent.

          After careful consideration, the respective boards of directors of OvaScience and Millendo have (i) determined that the transactions contemplated by the Merger Agreement are fair to, advisable and in the best interests of OvaScience or Millendo, as applicable, and their respective stockholders, (ii) approved and declared advisable the Merger Agreement and the transactions contemplated thereby and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that its stockholders vote to adopt or approve, as applicable, the Merger Agreement and, therefore, approve the transactions contemplated therein. OvaScience's board of directors recommends that its stockholders vote "FOR" the proposals described in this proxy statement/prospectus/information statement, and Millendo's board of directors recommends that its stockholders sign and return to Millendo the written consent indicating their approval of the Merger and adoption of the Merger Agreement and related transactions.

          More information about OvaScience, Millendo and the proposed transaction is contained in this proxy statement/prospectus/information statement. OvaScience and Millendo urge you to read this proxy statement/prospectus/information statement carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER THE SECTION TITLED "RISK FACTORS" IN THIS PROXY STATEMENT/PROSPECTUS/INFORMATION STATEMENT.

          OvaScience and Millendo are excited about the opportunities the Merger brings to both OvaScience's and Millendo's respective stockholders, and thank you for your consideration and continued support.


Christopher A. Kroeger, M.D., M.B.A.

 

Julia C. Owens, Ph.D.
President and Chief Executive Officer   President and Chief Executive Officer
OvaScience, Inc.   Millendo Therapeutics, Inc.

          Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this proxy statement/prospectus/information statement. Any representation to the contrary is a criminal offense.

          This proxy statement/prospectus/information statement is dated November 5, 2018, and is first being mailed to OvaScience's and Millendo's respective stockholders on or about November 5, 2018.


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LOGO

OVASCIENCE, INC.
9 Fourth Avenue
Waltham, Massachusetts
(617) 500-2802

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD ON DECEMBER 4, 2018

Dear Stockholders of OvaScience:

        On behalf of the board of directors of OvaScience, Inc., a Delaware corporation ("OvaScience"), we are pleased to deliver this proxy statement/prospectus/information statement for the proposed merger between OvaScience and Millendo Therapeutics, Inc., a Delaware corporation ("Millendo"), pursuant to which Orion Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of OvaScience, will merge with and into Millendo, with Millendo surviving as a wholly owned subsidiary of OvaScience (the "Merger"). The special meeting of stockholders of OvaScience (the "Special Meeting") will be held on December 4, 2018, at 10:00 a.m., local time, at the Westin Waltham Boston Hotel, 70 Third Avenue, Waltham, Massachusetts 02451, for the following purposes:

    1.
    To consider and vote upon a proposal to approve the Agreement and Plan of Merger and Reorganization, dated as of August 8, 2018, by and among OvaScience, Orion Merger Sub, Inc. and Millendo, as may be amended from time to time, a copy of which is attached as Annex A to this proxy statement/prospectus/information statement (the "Merger Agreement"), and the transactions contemplated thereby, including the Merger and the issuance of shares of OvaScience's common stock to Millendo's stockholders pursuant to the terms of the Merger Agreement.

    2.
    To approve an amendment to the restated certificate of incorporation of OvaScience to effect a reverse stock split (the "Reverse Stock Split") of OvaScience's common stock, at a ratio mutually agreed to by OvaScience and Millendo in the range of one new share for every 5 to 15 shares outstanding (or any number in between), in the form attached as Annex D to this proxy statement/prospectus/information statement.

    3.
    To approve an amendment to the restated certificate of incorporation of OvaScience to change the corporate name of OvaScience from "OvaScience, Inc." to "Millendo Therapeutics, Inc." in the form attached as Annex E to this proxy statement/prospectus/information statement.

    4.
    To approve an amendment to the OvaScience 2012 Stock Incentive Plan (the "2012 Plan") to increase the total number of shares of OvaScience Common Stock currently available for issuance under the 2012 Plan by 671,000 shares, in the form attached as Annex F to this proxy statement/prospectus/information statement, which amendment reflects the Reverse Stock Split at an assumed ratio of 1:10.

    5.
    To approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to OvaScience's named executive officers as a result of the Merger.

    6.
    To approve the issuance of shares of OvaScience Common Stock in the Post-Closing Financing (as defined below) in accordance with Nasdaq Listing Rule 5635(a).

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    7.
    To consider and vote upon an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1, 2 or 6.

    8.
    To transact such other business as may properly come before the stockholders at the Special Meeting or any adjournment or postponement thereof.

        OvaScience's board of directors has fixed October 26, 2018, as the record date (the "Record Date") for the determination of stockholders entitled to notice of, and to vote at, the Special Meeting and any adjournment or postponement thereof. Only holders of record of shares of OvaScience's common stock at the close of business on the Record Date are entitled to notice of, and to vote at, the Special Meeting. At the close of business on the Record Date, there were 35,826,429 shares of OvaScience's common stock outstanding and entitled to vote.

        Your vote is important. The affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter is required for approval of Proposal Nos. 1, 4, 5, 6, and 7. The affirmative vote of the holders of a majority of shares of OvaScience's common stock having voting power outstanding on the Record Date for the Special Meeting is required for approval of Proposal Nos. 2 and 3. The approval of Proposal No. 1 is a closing condition of the Merger. Therefore, the Merger cannot be consummated without the approval of Proposal No. 1. Proposal Nos. 3 and 4 are conditioned upon the consummation of the Merger. If the Merger is not completed, Proposal Nos. 3 and 4 will not be implemented, and OvaScience's name will not be changed pursuant to this proposal and the amendment to the 2012 Plan will not become effective. If the Merger is completed, but OvaScience's stockholders do not approve Proposal No. 3 or Proposal No. 4, then whichever of such proposals is approved will be implemented and the proposal(s) not approved will not be implemented. Even if you plan to attend the Special Meeting in person, OvaScience requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the Special Meeting if you are unable to attend.

By Order of OvaScience's board of directors,

Christopher A. Kroeger, M.D., M.B.A.
OvaScience, Inc.
Waltham, Massachusetts
November 5, 2018

        OVASCIENCE'S BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, OVASCIENCE AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. OVASCIENCE'S BOARD OF DIRECTORS RECOMMENDS THAT OVASCIENCE STOCKHOLDERS VOTE "FOR" EACH SUCH PROPOSAL.


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REFERENCES TO ADDITIONAL INFORMATION

        This proxy statement/prospectus/information statement incorporates important business and financial information about OvaScience that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission ("SEC") website (www.sec.gov) or upon your written or oral request by contacting OvaScience's Investor Relations department at OvaScience, Inc., 9 4th Avenue, Waltham, MA 02451 or by calling (617) 500-2808.

        To ensure timely delivery of these documents, any request should be made no later than November 27, 2018, to receive them before the special meeting of OvaScience stockholders.

        For additional details about where you can find information about OvaScience, please see the section titled "Where You Can Find More Information" in this proxy statement/prospectus/information statement.


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TABLE OF CONTENTS

 
  Page  

QUESTIONS AND ANSWERS ABOUT THE MERGER

    1  

PROSPECTUS SUMMARY

   
13
 

The Companies

   
13
 

The Merger

    14  

Reasons for the Merger

    16  

Opinion of the OvaScience Financial Advisor

    18  

Overview of the Merger Agreement

    18  

Voting Agreements

    21  

Lock-up Agreements

    21  

Management Following the Merger

    22  

Interests of Certain Directors, Officers and Affiliates of OvaScience and Millendo

    22  

Material U.S. Federal Income Tax Consequences of the Merger

    23  

Risk Factors

    23  

Regulatory Approvals

    24  

Nasdaq Capital Market Listing

    24  

Anticipated Accounting Treatment

    24  

Appraisal Rights and Dissenters' Rights

    25  

Comparison of Stockholder Rights

    25  

SELECTED HISTORICAL AND UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA

   
26
 

Selected Historical Financial Data of OvaScience

   
26
 

Selected Historical Financial Data of Millendo

    27  

Selected Unaudited Pro Forma Condensed Combined Financial Data of OvaScience and Millendo

    29  

Comparative Historical and Unaudited Pro Forma Per Share Data

    31  

MARKET PRICE AND DIVIDEND INFORMATION

   
32
 

OvaScience Common Stock

   
32
 

Dividends

    32  

RISK FACTORS

   
34
 

Risks Related to the Merger

   
34
 

Risks Related to the Proposed Reverse Stock Split

    40  

Risks Related to OvaScience

    41  

Risks Related to the Proposed Merger with Millendo

    41  

Risks Related to OvaScience's Financial Position and Need for Additional Capital

    41  

Risks Related to Research, Development and Commercialization of OvaScience's Potential Fertility Treatments

    45  

Risks Related to Regulation of OvaScience's Potential Fertility Treatments and Other Regulatory Matters

    51  

Risks Related to the Manufacturing of OvaScience's Potential Fertility Treatments

    64  

Risks Related to OvaScience's Dependence on Third Parties

    65  

Risks Related to OvaScience's Intellectual Property

    68  

Risks Related to Employee Matters and Managing Growth

    72  

Risks Associated with OvaScience's Capital Stock

    73  

Risks Related to Millendo

    77  

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  Page  

Risks Related to Millendo's Financial Position and Need for Additional Capital

    77  

Risks Related to Development and Commercialization

    81  

Risks Related to Regulatory Compliance

    96  

Risks Related to Millendo's Intellectual Property

    101  

Risks Related to Millendo's Dependence on Third Parties

    110  

Risks Related to Millendo's Business Operations, Employee Matters and Managing Growth

    115  

Risks Related to the Combined Organization

    119  

FORWARD-LOOKING STATEMENTS

   
125
 

THE SPECIAL MEETING OF OVASCIENCE STOCKHOLDERS

   
126
 

Date, Time and Place

   
126
 

Purposes of the Special Meeting

    126  

Recommendation of the OvaScience Board of Directors

    126  

Record Date and Voting Power

    127  

Voting and Revocation of Proxies

    128  

Required Vote

    129  

Solicitation of Proxies

    130  

Other Matters

    130  

THE MERGER

   
131
 

Background of the Merger

   
131
 

OvaScience Reasons for the Merger

    138  

Millendo Reasons for the Merger

    142  

Opinion of the OvaScience Financial Advisor as of August 8, 2018

    143  

Discounted Cash Flow Analysis as of the Date of the August Opinion

    150  

Opinion of the OvaScience Financial Advisor as of October 26, 2018

    154  

Analysis of Selected Publicly Traded Companies as of the Date of the October Opinion

    159  

Discounted Cash Flow Analysis as of the Date of the October Opinion

    161  

Financial Projections

    163  

Interests of the OvaScience Directors and Executive Officers in the Merger

    165  

Golden Parachute Compensation

    179  

Interests of the Millendo Directors and Executive Officers in the Merger

    182  

Limitations of Liability and Indemnification

    185  

Form of the Merger

    185  

Merger Consideration and Adjustment

    185  

Determination of OvaScience's Net Cash

    189  

Procedures for Exchanging Millendo Stock Certificates

    191  

Effective Time of the Merger

    192  

Regulatory Approvals

    192  

Tax Treatment of the Merger

    192  

Material U.S. Federal Income Tax Consequences of the Merger

    192  

Nasdaq Capital Market Listing

    195  

Anticipated Accounting Treatment

    196  

Appraisal Rights and Dissenters' Rights

    196  

THE MERGER AGREEMENT

   
200
 

Structure

   
200
 

Completion and Effectiveness of the Merger

    200  

Merger Consideration

    200  

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  Page  

Treatment of OvaScience Options

    201  

Treatment of Millendo Options

    201  

Treatment of Millendo Warrants

    201  

Procedures for Exchanging Millendo Stock Certificates

    202  

Fractional Shares

    202  

Representations and Warranties

    202  

Covenants; Conduct of Business Pending the Merger

    206  

No Solicitation

    209  

Disclosure Documents

    212  

Meeting of OvaScience's Stockholders; Consent from Millendo's Stockholders

    212  

Regulatory Approvals

    213  

Indemnification of Officers and Directors

    213  

Additional Agreements

    214  

Nasdaq Stock Market Listing

    215  

Directors and Officers of OvaScience Following the Merger

    215  

Conditions to Completion of the Merger

    215  

Termination

    220  

Termination Fee

    222  

Amendment

    223  

Expenses

    224  

AGREEMENTS RELATED TO THE MERGER

   
225
 

Voting Agreements

   
225
 

Lock-up Agreements

    226  

Pre-Closing Financing

    226  

Post-Closing Financing

    227  

MATTERS BEING SUBMITTED TO A VOTE OF OVASCIENCE STOCKHOLDERS

   
228
 

Proposal No. 1: Approval of the Merger and the Issuance of Common Stock in the Merger

   
228
 

Proposal No. 2: Approval of an Amendment to the Restated Certificate of Incorporation of OvaScience Effecting the Reverse Stock Split

    230  

Proposal No. 3: Approval of an Amendment to the Restated Certificate of Incorporation of OvaScience Effecting the OvaScience Name Change

    236  

Proposal No. 4: Approval of an Amendment to the OvaScience 2012 Stock Incentive Plan

    237  

Proposal No. 5: Advisory Vote on Golden Parachute Compensation

    244  

Proposal No. 6: Approval of the Issuance of OvaScience Common Stock in accordance with Nasdaq Listing Rule 5635(a)

    245  

Proposal No. 7: Approval of Possible Adjournment of the Special Meeting

    247  

OVASCIENCE BUSINESS

   
248
 

Overview

   
248
 

OvaScience's Historical Business and Programs

    248  

OvaPrime

    250  

OvaTure

    252  

Collaboration with Intrexon to Accelerate Development of OvaTure

    252  

OvaXon Joint Venture with Intrexon

    253  

AUGMENT

    253  

The Role of Mitochondria in Egg Health

    254  

Research and Development Spending

    256  

Manufacturing

    256  

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  Page  

Marketing and Sales

    256  

Foreign Subsidiaries

    256  

Intellectual Property

    256  

Competition

    260  

Government Regulation

    261  

European Union Requirements

    262  

United States Requirements

    265  

Employees

    269  

OvaScience's Corporate Information

    269  

Available Information

    270  

Properties

    270  

Legal Proceedings

    270  

MILLENDO BUSINESS

   
273
 

Strategy

   
275
 

Product Candidates

    276  

Sales and Marketing

    286  

Research and Development

    287  

License Agreement with The University of Michigan

    287  

Assignment Agreement with Erasmus University Medical Center and The University of Turin

    288  

Competition

    288  

Intellectual Property

    289  

Manufacturing

    290  

Government Regulation and Approval

    290  

Employees

    304  

Facilities

    304  

Legal Proceedings

    304  

OVASCIENCE MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   
305
 

Overview

   
305
 

Financial Operations Overview

    309  

Critical Accounting Policies and Significant Judgments and Estimates

    312  

Results of Operations

    313  

Liquidity and Capital Resources

    318  

Off-Balance Sheet Arrangements

    321  

Contractual Obligations as of June 30, 2018

    321  

Recent Accounting Pronouncements

    321  

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT THE MARKET RISK OF OVASCIENCE

   
323
 

MILLENDO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   
324
 

Overview

   
324
 

Recent Events

    325  

Components of Results of Operations

    327  

Liquidity and Capital Resources

    331  

Contractual Obligations and Commitments

    335  

Off-Balance Sheet Arrangements

    336  

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  Page  

Critical Accounting Policies

    336  

Recent Accounting Pronouncements

    340  

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT THE MARKET RISK OF MILLENDO

   
341
 

MANAGEMENT FOLLOWING THE MERGER

   
342
 

Executive Officers and Directors

   
342
 

Composition of the Board of Directors

    345  

Committees of the Board of Directors

    346  

Director Compensation

    349  

Millendo Executive Compensation

    350  

Equity Incentive Plans

    355  

401(k) Plan

    356  

Health and Welfare Benefits

    356  

RELATED PARTY TRANSACTIONS OF DIRECTORS AND EXECUTIVE OFFICERS OF THE COMBINED ORGANIZATION

   
357
 

OvaScience Transactions

   
357
 

Millendo Transactions

    363  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

   
370
 

NOTES TO UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

   
375
 

DESCRIPTION OF OVASCIENCE CAPITAL STOCK

   
383
 

Description of Common Stock

   
383
 

Description of Preferred Stock

    383  

Anti-Takeover Provisions

    384  

COMPARISON OF RIGHTS OF HOLDERS OF OVASCIENCE STOCK AND MILLENDO STOCK

   
386
 

Current Millendo Rights Versus OvaScience Rights Post-Merger

   
387
 

PRINCIPAL STOCKHOLDERS OF OVASCIENCE

   
405
 

PRINCIPAL STOCKHOLDERS OF MILLENDO

   
409
 

PRINCIPAL STOCKHOLDERS OF THE COMBINED ORGANIZATION

   
413
 

LEGAL MATTERS

   
418
 

EXPERTS

   
418
 

WHERE YOU CAN FIND MORE INFORMATION

   
418
 

OTHER MATTERS

   
420
 

Section 16(a) Beneficial Ownership Reporting Compliance

   
420
 

Stockholder Proposals

    420  

Stockholder Communications with the OvaScience Board of Directors

    420  

Householding of Proxy Materials

    420  

FINANCIAL STATEMENTS

   
F-1
 

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QUESTIONS AND ANSWERS ABOUT THE MERGER

        Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus/information statement does not give effect to the proposed reverse stock split described in Proposal No. 2, beginning on page 230 in this proxy statement/prospectus/information statement (the "Reverse Stock Split").

        The following section provides answers to frequently asked questions about the Merger. This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.

Q:
What is the Merger?

A:
OvaScience, Inc. ("OvaScience") and Millendo Therapeutics, Inc. ("Millendo") have entered into an Agreement and Plan of Merger and Reorganization, dated as of August 8, 2018, as may be amended from time to time (the "Merger Agreement"). The Merger Agreement contains the terms and conditions of the proposed business combination of OvaScience and Millendo. Under the Merger Agreement, Orion Merger Sub, Inc., a wholly owned subsidiary of OvaScience ("Merger Sub") will merge with and into Millendo, with Millendo surviving as a wholly owned subsidiary of OvaScience (the "Merger").

    At the effective time of the Merger (the "Effective Time"), each share of Millendo's common stock, par value $0.001 per share ("Millendo Common Stock") outstanding immediately prior to the Effective Time (excluding certain shares to be canceled pursuant to the Merger Agreement and shares held by stockholders who have exercised and perfected appraisal rights or dissenters' rights as more fully described in the section of this proxy statement/prospectus/information statement titled "The Merger—Appraisal Rights and Dissenters' Rights", but including shares of Millendo Common Stock that will be issued pursuant to the Pre-Closing Financing as more fully described below under "Questions and Answers About the Merger—What is the Pre-Closing Financing?") will be converted into the right to receive shares of OvaScience's common stock, par value $0.001 per share ("OvaScience Common Stock") (the "Exchange Ratio"), which Exchange Ratio was initially estimated (as of the date of the execution of the Merger Agreement) to be 0.1173 shares and is currently estimated to be 0.1070 shares of OvaScience Common Stock for each share of Millendo Common Stock and is subject to change to account, among other things, for OvaScience's net cash immediately prior to the closing of the Merger (the "Closing"). Because OvaScience's net cash balance will not be determined until the Closing, and because, among other things, the number of shares of OvaScience Common Stock issuable to Millendo is determined based on OvaScience's net cash balance and the capitalization of Millendo and OvaScience at the Closing, OvaScience Securityholders cannot be certain of the exact number of shares that will be issued to Millendo's stockholders when OvaScience's stockholders vote on the proposals at the special meeting of OvaScience stockholders (the "Special Meeting"). The Exchange Ratios referenced above are estimates only and the final Exchange Ratio will be determined pursuant to a formula described in more detail in the Merger Agreement and in this proxy statement/prospectus/information statement.

    As of the date of the execution of the Merger Agreement, it was estimated that as a result of the Merger and based solely on the sample Exchange Ratio of 0.1173 set forth above, current holders of shares of Millendo Common Stock (the "Millendo Stockholders") and holders of options to purchase shares of Millendo Common Stock (each a "Millendo Option" and each holder of a Millendo Option a "Millendo Optionholder") and other persons holding securities and rights directly or indirectly convertible, exercisable or exchangeable for Millendo Common Stock (collectively, "Millendo Securityholders") would own, or hold rights to acquire, in the aggregate approximately 82% of the Fully Diluted Closing OvaScience Common Stock and current

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    stockholders of OvaScience ("OvaScience Stockholders"), OvaScience Optionholders and other persons holding securities convertible, exercisable or exchangeable for OvaScience Common Stock (collectively, "OvaScience Securityholders") would own in the aggregate approximately 18% of the Fully Diluted OvaScience Closing Common Stock and, in each case, following the Effective Time and subject to adjustment of the Exchange Ratio, assuming a Pre-Closing Financing of $30.0 million. "Fully Diluted Closing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan). Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock. After the consummation of the Merger, and assuming OvaScience Stockholders approve Proposal No. 3, OvaScience will change its corporate name to "Millendo Therapeutics, Inc." as required by the Merger Agreement (the "OvaScience Name Change"). It is currently expected that the Pre-Closing Financing amount will be approximately $29.5 million.

Q:
What will happen to OvaScience if, for any reason, the Merger does not close?

A:
If, for any reason, the Merger does not close, the board of directors of OvaScience (the "OvaScience Board of Directors") may elect to, among other things, attempt to complete another strategic transaction like the Merger, attempt to sell or otherwise dispose of the various assets of OvaScience or continue to operate the business of OvaScience. If the OvaScience Board of Directors decides to dissolve and liquidate OvaScience's assets, OvaScience would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims. This would be a lengthy and uncertain process, and there can be no assurances as to the amount or timing of available cash, if any, that would be left to distribute to OvaScience Stockholders after paying the debts and other obligations of OvaScience and setting aside funds for reserves.

    If OvaScience were to continue its business, OvaScience's management would need to identify, acquire and develop other products or product candidates, and OvaScience's management and the OvaScience Board of Directors does not believe it is in the best interest of OvaScience to pursue development of OvaScience's current product candidates. In addition, as of September 1, 2018, the OvaScience workforce was comprised of eight employees, four of whom are involved in financial and administrative roles. OvaScience has ceased most of its research activities and completed most activity related to ongoing clinical trials and commercial development of its products. If the OvaScience Board of Directors decides to reestablish OvaScience's business and/or pursue development of other products or product candidates, OvaScience will need to rebuild its senior management team and hire managerial and other personnel to lead and staff all of its necessary functions, especially its research, development and commercialization areas.

Q:
Why are the two companies proposing to merge?

A:
Millendo and OvaScience believe that the Merger will result in a specialty biopharmaceutical company focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. For a discussion of OvaScience's and Millendo's reasons for the Merger, please see the section titled "The Merger—OvaScience Reasons for the Merger" and "The Merger—Millendo Reasons for the Merger" in this proxy statement/prospectus/information statement.

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Q:
Why am I receiving this proxy statement/prospectus/information statement?

A:
You are receiving this proxy statement/prospectus/information statement because you have been identified as an OvaScience Stockholder or a Millendo Stockholder as of the applicable Record Date, and you are entitled, as applicable, to (i) vote at the Special Meeting to approve the Merger Agreement and the transactions contemplated thereby, including the Merger and the issuance of shares of OvaScience Common Stock pursuant to the Merger Agreement, or (ii) sign and return the Millendo written consent to adopt the Merger Agreement and approve the transactions contemplated thereby, including the Merger. This document serves as:

a proxy statement of OvaScience used to solicit proxies for the Special Meeting;

a prospectus of OvaScience used to offer shares of OvaScience Common Stock in exchange for shares of Millendo Capital Stock in the Merger and issuable upon exercise of options to purchase OvaScience Common Stock, as applicable; and

an information statement of Millendo used to solicit the written consent of Millendo Stockholders for the adoption of the Merger Agreement and the approval of the Merger and related transactions.

Q:
What is required to consummate the Merger?

A:
To consummate the Merger, OvaScience Stockholders must adopt the Merger Agreement, thereby approving the Merger and the issuance of OvaScience Common Stock pursuant to the Merger Agreement, including with respect to shares of Millendo Common Stock that are issued pursuant to the Pre-Closing Financing (Proposal No. 1), and Millendo Stockholders must adopt the Merger Agreement, thereby approving the Merger and the other transactions contemplated by the Merger Agreement.

    The approval of the Merger and the issuance of OvaScience Common Stock pursuant to the Merger Agreement by the OvaScience Stockholders requires the affirmative vote of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter. The approval of the amendments to the restated certificate of incorporation of OvaScience to effect the Reverse Stock Split and the OvaScience Name Change require the affirmative vote of the holders of a majority of shares of OvaScience Common Stock having voting power outstanding on October 26, 2018 (the "Record Date"). The approval of the Reverse Stock Split (Proposal No. 2) is required in order to allow the issuance of the shares of OvaScience Common Stock pursuant to the Merger Agreement and to avoid a delisting of OvaScience Common Stock from The Nasdaq Capital Market. Consequently, if the requisite OvaScience Stockholders approve the Merger and the issuance of OvaScience Common Stock pursuant to the Merger Agreement but do not approve the Reverse Stock Split, the Merger will not be consummated.

    Proposal Nos. 3 and 4 are conditioned upon the consummation of the Merger. If the Merger is not completed, Proposal Nos. 3 and 4 will not be implemented, and OvaScience's name will not be changed pursuant to this proposal and the amendment to the 2012 Plan will not become effective. If the Merger is completed, but the OvaScience Stockholders do not approve Proposal No. 3 or Proposal No. 4, then whichever of such proposals is approved will be implemented and the proposal(s) not approved will not be implemented. Proposal No. 2, regarding the Reverse Stock Split, is not conditioned upon the consummation of the Merger, and as such the Reverse Stock Split may be implemented by the OvaScience Board of Directors even if the Merger does not take place.

    The presence, in person or represented by proxy, at the Special Meeting of the holders of a majority in voting power of the shares of OvaScience Common Stock issued and outstanding and

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    entitled to vote at the Special Meeting is necessary to constitute a quorum at the meeting. Abstentions and broker non-votes will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Special Meeting.

    Votes will be counted by the inspector of election appointed for the Special Meeting, who will separately count "FOR" and "AGAINST" votes, abstentions and broker non-votes. Abstentions and broker non-votes will not be considered votes cast by the holders of all the shares of OvaScience Common Stock present in person or by proxy at the Special Meeting and voting affirmatively or negatively, and will therefore not have any effect with respect to Proposal Nos. 1, 4, 5, 6 or 7. Abstentions and broker non-votes will have the same effect as a vote "AGAINST" Proposal Nos. 2 and 3.

    The adoption of the Merger Agreement and the approval of the Merger and related transactions by the Millendo Stockholders requires the affirmative vote (or written consent) of the holders of a majority of (a) the outstanding shares of Millendo Common Stock and Millendo Preferred Stock, voting together as one class and (b) the holders of a majority of the outstanding shares of Millendo Preferred Stock voting as a separate class. In addition to the requirement of obtaining such stockholder approvals and appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

    As of September 1, 2018, certain Millendo Stockholders who in the aggregate own approximately 73% of the outstanding shares of Millendo Capital Stock on an as converted to common stock basis, and certain OvaScience Stockholders who in the aggregate own approximately 5% of the outstanding shares of OvaScience Common Stock, are parties to voting agreements with OvaScience and Millendo, respectively, whereby such stockholders have agreed to vote their shares in favor of the adoption or approval, as applicable, of the Merger Agreement and the transactions contemplated therein, including the Merger and the issuance of OvaScience Common Stock to Millendo Stockholders pursuant to the Merger Agreement, subject to the terms of the voting agreements. In addition, following the registration statement on Form S-4, of which this proxy statement/prospectus/information statement is a part, being declared effective by the U.S. Securities and Exchange Commission (the "SEC") and pursuant to the conditions of the Merger Agreement and the voting agreements, Millendo Stockholders who are party to the voting agreements will each execute written consents approving the Merger and related transactions. Therefore, holders of a sufficient number of shares of Millendo Capital Stock required to adopt the Merger Agreement, thereby approving the Merger, have agreed to adopt the Merger Agreement via written consent. Millendo Stockholders, including those who are parties to voting agreements, are being requested to execute written consents providing such approvals.

    For a more complete description of the closing conditions under the Merger Agreement, OvaScience urges you to read the section titled "The Merger Agreement—Conditions to Completion of the Merger" in this proxy statement/prospectus/information statement.

Q:
What will Millendo Securityholders receive in the Merger?

A:
As of the date of the execution of the Merger Agreement, it was estimated that immediately after the consummation of the Merger, based solely on the sample Exchange Ratio of 0.1173 set forth below, existing Millendo Stockholders, Millendo Optionholders and persons holding securities and other rights directly or indirectly convertible, exercisable or exchangeable for Millendo Common Stock (collectively, "Millendo Securityholders") would own approximately 82% of the Fully Diluted Closing OvaScience Common Stock, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement.

    Following the Closing, Millendo Optionholders will have their Millendo Options converted into options to purchase shares of OvaScience Common Stock, with the number of shares of

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    OvaScience Common Stock subject to such option and the exercise price being appropriately adjusted to reflect the Exchange Ratio between OvaScience Common Stock and Millendo Common Stock determined in accordance with the Merger Agreement and Millendo warrantholders will have their Millendo warrants converted into warrants to purchase shares of OvaScience Common Stock, with the number of shares of OvaScience Common Stock subject to such warrants and the exercise price being appropriately adjusted to reflect the Exchange Ratio between OvaScience Common Stock and Millendo Common Stock determined in accordance with the Merger Agreement. The initial estimate of the Exchange Ratio set forth below assumed (i) that OvaScience would have between $40 million and $42 million in net cash immediately prior to Closing, (ii) a Pre-Closing Financing amount of $30.0 million, (iii) OvaScience outstanding shares and options as of the Closing would be equal to 3,721,460 (on a post reverse stock split basis), (iv) Millendo shares as of the Closing would be equal to 148,171,273 (on a fully-diluted, as-converted basis) and (v) a reverse stock split of every 10 shares of outstanding OvaScience Common Stock being combined and reclassified into one share of OvaScience Common Stock).

    The Exchange Ratio is calculated using a formula intended to allocate a percentage of the combined organization to existing Millendo Securityholders. Based on the assumptions described above, the Exchange Ratio would have been equal to approximately 0.1173 post-reverse split shares of OvaScience Common Stock for each share of Millendo Common Stock, which Exchange Ratio is subject to change based on the amount of OvaScience net cash, changes in the capitalization of OvaScience or Millendo prior to the Closing and the amount raised by Millendo in the Pre-Closing Financing (and as a result, OvaScience Securityholders and Millendo Securityholders could own more or less of the combined organization). Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock. After the initial signing of the Merger Agreement, the valuations for Millendo and OvaScience were reduced, as further described in this proxy statement/prospectus/information statement. In addition, OvaScience currently estimates, assuming for this purpose a closing date of November 30, 2018, that (i) it will have approximately $37.6 million in net cash immediately prior to Closing, (ii) the Pre-Closing Financing amount will be approximately $29.5 million, (iii) OvaScience outstanding shares and options as of the Closing will be equal to 3,727,669 (on a post reverse stock split basis) and (iv) the Millendo shares as of the Closing on a fully diluted and as-converted basis will be equal to 152,629,595. Accordingly, it is currently estimated that the Exchange Ratio at Closing will be approximately 0.1070 and, based solely on such Exchange Ratio, at Closing: (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 67.1% of the Fully Diluted Closing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 13.1% of the Fully Diluted Closing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 18.6% of the Fully Diluted Closing OvaScience Common Stock, and (d) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.2% of the Fully Diluted Closing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. Additionally, it is anticipated that the Post-Closing Financing (as defined below) will close shortly after the Closing, which would dilute, and thereby reduce, each then existing OvaScience Securityholder's proportionate holdings. Assuming that the Post-Closing Financing closes immediately after the Merger as well as the other aforementioned assumptions, it is expected that (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 61.7% of the Fully Diluted Post-Financing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing

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    to Millendo Securityholders as of immediately prior to the Merger will represent approximately 12.0% of the Fully Diluted Post- Financing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 17.1% of the Fully Diluted Post-Financing OvaScience Common Stock, (d) the shares issued in the Post-Closing Financing to the Post-Closing Financing Investor (as defined below) will represent approximately 8.1% of the Fully Diluted Post-Financing OvaScience Common Stock, and (e) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.1% of the Fully Diluted Post-Financing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. "Fully Diluted Closing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan). "Fully Diluted Post-Financing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan) plus (z) the Post-Closing Financing shares.

    For a more complete description of what Millendo Stockholders, Millendo Optionholders and Millendo warrantholders will receive in the Merger, please see the sections titled "The Merger Agreement—Merger Consideration" in this proxy statement/prospectus/information statement.

Q:
Who will be the directors of OvaScience following the Merger?

A:
Following the consummation of the Merger, the size of the OvaScience Board of Directors will be increased to include a total of eight directors. Pursuant to the terms of the Merger Agreement, the OvaScience Board of Directors will be reconstituted such that seven of the initial post-Closing directors will be designated by Millendo, and one initial post-Closing director will be designated by OvaScience. It is anticipated that, following the Closing, the OvaScience Board of Directors will be constituted as follows:
Name
  Current Principal Affiliation
John Howe, III, M.D.    OvaScience, Inc., Director
Carol G. Gallagher, Pharm.D.    Millendo Therapeutics, Inc., Director
Carole L. Nuechterlein, J.D.    Millendo Therapeutics, Inc., Director
Julia C. Owens, Ph.D.    Millendo Therapeutics, Inc., President and Chief Executive Officer
James M. Hindman   Millendo Therapeutics, Inc., Director
Randall W. Whitcomb, M.D.    Millendo Therapeutics, Inc., Director
Habib J. Dable   Millendo Therapeutics, Inc., Director
Mary Lynne Hedley, Ph.D.    Millendo Therapeutics, Inc., Director

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Q:
Who will be the executive officers of OvaScience immediately following the Merger?

A:
Immediately following the consummation of the Merger, the executive management team of OvaScience is expected to be composed solely of the members of Millendo's executive management team prior to the Merger, as follows:
Name
  Title
Julia C. Owens, Ph.D.    President and Chief Executive Officer
Pharis Mohideen, M.D.    Chief Medical Officer
Jeffery M. Brinza, J.D.    Secretary, Chief Administrative Officer and General Counsel
Q:
What are the material U.S. federal income tax consequences of the Reverse Stock Split?

A:
The Reverse Stock Split should constitute a "recapitalization" for U.S. federal income tax purposes. As a result, a U.S. Holder (as defined in the section of this proxy statement/prospectus/information statement titled "Matters Being Submitted to a Vote of OvaScience Stockholders—Proposal No. 2: Approval of an Amendment to the Restated Certificate of Incorporation of OvaScience Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split") of OvaScience Common Stock generally should not recognize gain or loss upon the Reverse Stock Split, except with respect to cash received in lieu of a fractional share of OvaScience Common Stock, as discussed in the section of this proxy statement/prospectus/information statement titled "Matters Being Submitted to a Vote of OvaScience Stockholders—Proposal No. 2: Approval of an Amendment to the Restated Certificate of Incorporation of OvaScience Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split." A U.S. Holder's aggregate tax basis in the shares of OvaScience Common Stock received pursuant to the Reverse Stock Split should equal the aggregate tax basis of the shares of the OvaScience Common Stock surrendered (excluding any portion of such basis that is allocated to any fractional share of OvaScience Common Stock), and such U.S. Holder's holding period in the shares of OvaScience Common Stock received should include the holding period in the shares of OvaScience Common Stock surrendered. Treasury Regulations provide detailed rules for allocating the tax basis and holding period of the shares of OvaScience Common Stock surrendered to the shares of OvaScience Common Stock received in a recapitalization pursuant to the Reverse Stock Split. U.S. Holders of shares of OvaScience Common Stock acquired on different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares. For more information, please see the section of this proxy statement/prospectus/information statement titled "Matters Being Submitted to a Vote of OvaScience Stockholders—Proposal No. 2: Approval of an Amendment to the Restated Certificate of Incorporation of OvaScience Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split."

Q:
What are the material U.S. federal income tax consequences of the Merger?

A:
OvaScience and Millendo intend the Merger to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the "Code"), as described in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement. Assuming the Merger constitutes a reorganization, subject to the limitations and qualifications described in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement, Millendo Stockholders generally should not recognize gain or loss for U.S. federal income tax purposes on the receipt of shares of OvaScience Common Stock issued in connection with the Merger (other than in respect of cash received in lieu of fractional shares). Each Millendo Stockholder who receives cash in lieu of a fractional share of OvaScience

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    Common Stock should generally recognize capital gain or loss in an amount equal to the difference between the amount of cash received in lieu of such fractional share and the stockholder's tax basis allocable to such fractional share.

    If the Merger is not treated as a reorganization under Section 368(a) of the Code, then, subject to the limitations and qualifications described in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement, each Millendo Stockholder will generally recognize capital gain or loss, for U.S. federal income tax purposes, on the receipt of shares of OvaScience Common Stock issued to such Millendo Stockholder and on any cash received in lieu of fractional shares in connection with the Merger. The tax consequences to each Millendo Stockholder will depend on that stockholder's particular circumstances. Each Millendo Stockholder should consult with his, her or its tax advisor for a full understanding of the tax consequences of the Merger to that stockholder.

Q:
What is the Pre-Closing Financing?

A:
Prior to the Closing, Millendo intends to complete a private placement financing (the "Pre-Closing Financing") of the Millendo Common Stock. The securities issued in the Pre-Closing Financing will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended, and the resale of the OvaScience securities into which such securities will be exchanged and converted are not registered on this registration statement and will not be registered for resale. An investor syndicate that includes New Enterprise Associates, Frazier Healthcare Partners, Roche Venture Fund, Fonds Innobio managed by Bpifrance, Osage University Partners, Altitude Life Science Ventures, Adams Street Partners, and Longwood Fund has committed to invest $25.0 million plus €4.0 million or its USD equivalent of the amount to be sold in the Pre-Closing Financing, $8.0 million of which has already been funded via the issuance of interest-bearing convertible promissory notes (as amended). Neither the OvaScience Stockholders nor the Millendo Stockholders are being asked to vote on the Pre-Closing Financing. Shares of Millendo Common Stock that are issued in the Pre-Closing Financing will be converted into shares of OvaScience Common Stock in the Merger. Accordingly, by approving Proposal No. 1 relating to the Merger, OvaScience Stockholders will also be approving the issuance of shares of OvaScience Common Stock to be issued in exchange for all shares of Millendo Common Stock that are sold in the Pre-Closing Financing.

Q:
What is the Post-Closing Financing?

A:
After the Closing, OvaScience intends to complete a private placement financing (the "Post-Closing Financing") with an investor (the "Post-Closing Financing Investor") involving the sale of approximately $20 million of OvaScience Common Stock. OvaScience has entered into a stock purchase agreement with the Post-Closing Financing Investor pursuant to which these shares will be issued following the closing of the Merger. Further, OvaScience has entered into a registration rights agreement with the Post-Closing Financing Investor providing for the registration of the resale by such investors of these shares. The stock purchase agreement may be terminated as follows: (i) at any time prior to the closing of the Post-Closing Financing and prior to termination of the Merger Agreement by mutual written consent of OvaScience, Millendo and the Post-Closing Financing Investor, (ii) at any time prior to the closing of the Post-Closing Financing and following termination of the Merger Agreement by either OvaScience, Millendo or the Post-Closing Financing Investor, (iii) by the Post-Closing Financing Investor if the closing of the Post-Closing Financing has not been consummated by February 8, 2019, (iv) by Millendo or OvaScience if the closing of the Post-Closing Financing has not been consummated by February 8, 2020 or (v) by Millendo, OvaScience, or the Post-Closing Financing Investor if the Post-Closing Financing would violate any nonappealable order, degree or judgment of any governmental authority having

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    competent jurisdiction. If the Merger does not close because either OvaScience or Millendo terminates the Merger Agreement in order to accept a superior offer, the Post-Closing Financing Investor will be entitled to receive a termination fee of $1 million from the party that owes a termination fee pursuant to the Merger Agreement. The securities issued in the Post-Closing Financing will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended, and the resale of the OvaScience Common Stock issued in the Post-Closing Financing will be registered pursuant to a resale registration statement on Form S-3. These shares would be issued at a price per share equal to (i) $1.2096 divided by (ii) the Exchange Ratio. The Post-Closing Financing will not occur until the completion of the Merger and the effectiveness of such Form S-3, unless such conditions are waived by the Post-Closing Financing Investor. In the event that the Merger has closed, but the Form S-3 has not gone effective, the Post- Closing Financing Investor will have the right, subject to the terms of the stock purchase agreement, to make the investment at any time prior to at least February 8, 2020 if it does not terminate the agreement sooner.

Q:
As an OvaScience Stockholder, how does the OvaScience Board of Directors recommend that I vote?

A:
After careful consideration, the OvaScience Board of Directors recommends that OvaScience Stockholders vote "FOR" all of the proposals.

Q:
As a Millendo Stockholder, how does the Millendo Board of Directors recommend that I vote?

A:
After careful consideration, the board of directors of Millendo (the "Millendo Board of Directors") recommends that Millendo Stockholders execute the written consent to approve the Merger, the Merger Agreement, and the transactions contemplated therein, substantially in accordance with the terms of the Merger Agreement and the other agreements contemplated by the Merger Agreement.

Q:
What risks should I consider in deciding whether to vote in favor of the Merger or to execute and return the written consent, as applicable?

A:
You should carefully review the section of this proxy statement/prospectus/information statement titled "Risk Factors," which sets forth certain risks and uncertainties related to the Merger, risks and uncertainties to which the combined organization's business will be subject, and risks and uncertainties to which each of OvaScience and Millendo, as independent companies, are subject.

Q:
What is "golden parachute" compensation and why I am being asked to vote on it?

A:
The SEC has adopted rules that require OvaScience to seek an advisory (non-binding) vote on "golden parachute" compensation. "Golden parachute" compensation is compensation that is tied to or based on the Merger and that will or may be paid by OvaScience to its named executive officers in connection with the Merger.

Q:
Who can vote at the Special Meeting?

A:
Only OvaScience Stockholders of record at the close of business on the Record Date, October 26, 2018, will be entitled to vote at the Special Meeting. As of October 26, 2018, there were 35,826,429 shares of OvaScience Common Stock outstanding and entitled to vote.

    Stockholder of Record: Shares Registered in Your Name

    If, at the close of business on the Record Date, your shares of OvaScience Common Stock were registered directly in your name with OvaScience's transfer agent, Computershare Trust Company,

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    N.A., then you are an OvaScience Stockholder of record. As an OvaScience Stockholder of record, you may vote in person at the Special Meeting or vote by proxy. Whether or not you plan to attend the Special Meeting, please vote as soon as possible by completing and returning the enclosed proxy card or vote by proxy over the telephone or on the internet as instructed below to ensure your vote is counted.

    Beneficial Owner: Shares Registered in the Name of a Broker or Bank

    If, at the close of business on the Record Date, your shares of OvaScience Common Stock were not held in your name, but rather in an account at a brokerage firm, bank, dealer or other similar organization, then you are the beneficial owner of shares held in "street name" and these proxy materials are being forwarded to you by that organization. The organization holding your account is considered to be the stockholder of record for purposes of voting at the Special Meeting. As a beneficial owner, you have the right to direct your broker or other agent how to vote the shares in your account. You are also invited to attend the Special Meeting. However, because you are not the stockholder of record, you may not vote your shares in person at the Special Meeting unless you request and obtain a valid legal proxy from your broker or other agent, giving you the right to vote the shares at the meeting.

Q:
How many votes do I have?

A:
On each matter to be voted upon, you have one vote for each share of OvaScience Common Stock you own as of the Record Date.

Q:
What is the quorum requirement?

A:
A quorum of stockholders is necessary to hold a valid meeting. A quorum will be present if stockholders holding at least a majority in voting power of the shares of OvaScience issued and outstanding and entitled to vote at the Special Meeting, present in person or represented by proxy, are present at the Special Meeting. On October 26, 2018, the Record Date, there were 35,826,429 shares of OvaScience Common Stock outstanding and entitled to vote. Accordingly, OvaScience expects that the holders of at least 17,913,215 shares of OvaScience Common Stock must be present at the Special Meeting for a quorum to exist. Your shares of OvaScience Common Stock will be counted toward the quorum at the Special Meeting only if you attend the Special Meeting in person or are represented at the Special Meeting by proxy.

    Abstentions and broker non-votes (as described below) will be counted towards the quorum requirement. If there is no quorum, the holders of a majority of shares present and entitled to vote at the meeting in person or represented by proxy may adjourn the Special Meeting to another date.

Q:
What are "broker non-votes"?

A:
If you hold shares beneficially in street name and do not provide your broker or other agent with voting instructions, your shares may constitute "broker non-votes." Broker non-votes occur on a matter when banks, brokers and other nominees are not permitted to vote on certain non-discretionary matters without instructions from the beneficial owner and instructions are not given. These matters are referred to as "non-routine" matters. All of the proposals to be acted on at the Special Meeting, other than Proposal No. 2 regarding the Reverse Stock Split, are anticipated to be non-routine matters. Broker non-votes will be counted toward the vote total for Proposals 2 and 3 and will have the same effect as a vote "AGAINST" such proposals. Broker non-votes will not, however, be considered votes cast by the holders of all of the shares of OvaScience Common Stock present in person or by proxy at the Special Meeting and voting

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    affirmatively or negatively, and will therefore not have any effect with respect to Proposal Nos. 1, 4, 5, 6 or 7.

Q:
When do you expect the Merger to be consummated?

A:
OvaScience and Millendo anticipate that the Merger will occur sometime soon after the OvaScience Special Meeting to be held on December 4, 2018, but the companies cannot predict the exact timing. For more information, please see the section titled "The Merger Agreement—Conditions to Completion of the Merger" in this proxy statement/prospectus/information statement.

Q:
What do I need to do now?

A:
OvaScience and Millendo urge you to read this proxy statement/prospectus/information statement carefully, including its annexes, and to consider how the Merger affects you.

    If you are an OvaScience Stockholder of record, you may provide your proxy instructions in one of two different ways. First, you can mail your signed proxy card in the enclosed return envelope. You may also provide your proxy instructions via telephone or via the Internet by following the instructions on your proxy card or voting instruction form. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the OvaScience Special Meeting.

    If you are a Millendo Stockholder, you may execute and return your written consent to Millendo in accordance with the instructions provided.

Q:
What happens if I do not return a proxy card or otherwise provide proxy instructions, as applicable?

A:
If you are an OvaScience Stockholder, the failure to return your proxy card or otherwise provide proxy instructions will reduce the aggregate number of votes required to approve Proposal Nos. 1, 4, 5, 6 and 7 and will have the same effect as a vote "AGAINST" Proposal Nos. 2 and 3.

Q:
When and where is the Special Meeting of OvaScience Stockholders?

A:
The OvaScience Special Meeting will be held at the Westin Waltham Boston Hotel, 70 Third Avenue, Waltham, Massachusetts 02451, at 10:00 a.m., local time, on December 4, 2018. Subject to space availability, all OvaScience Stockholders as of the Record Date, or their duly appointed proxies, may attend the OvaScience Special Meeting. Since seating is limited, admission to the OvaScience Special Meeting will be on a first-come, first-served basis. Registration and seating will begin at 9:30 a.m., local time.

Q:
If my OvaScience shares are held in "street name" by my broker, will my broker vote my shares for me?

A:
Unless your broker has discretionary authority to vote on certain matters, your broker will not be able to vote your shares of OvaScience Common Stock without instructions from you. Brokers are not expected to have discretionary authority to vote for any of the proposals other than Proposal No. 2, regarding the Reverse Stock Split. To make sure that your vote is counted, you should instruct your broker to vote your shares, following the procedures provided by your broker.

Q:
May I change my vote after I have submitted a proxy or provided proxy instructions?

A:
OvaScience Stockholders of record, other than those OvaScience Stockholders who are parties to voting agreements, may change their vote at any time before their proxy is voted at the OvaScience Special Meeting in one of three ways. First, an OvaScience Stockholder of record can

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    send a written notice to the Secretary of OvaScience stating that it would like to revoke its proxy. Second, an OvaScience Stockholder of record can submit new proxy instructions either on a new proxy card via telephone or the Internet. Third, an OvaScience Stockholder of record can attend the OvaScience Special Meeting and vote in person. Attendance alone will not revoke a proxy. If an OvaScience Stockholder who owns shares of OvaScience Common Stock in "street name" has instructed a broker to vote its shares of OvaScience Common Stock, the stockholder must follow directions received from its broker to change those instructions.

Q:
Who is paying for this proxy solicitation?

A:
OvaScience and Millendo will share equally the cost of printing and filing this proxy statement/prospectus/information statement and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of OvaScience Common Stock for the forwarding of solicitation materials to the beneficial owners of OvaScience Common Stock. OvaScience will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials.

Q:
Who can help answer my questions?

A:
If you are an OvaScience Stockholder and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:

    OvaScience, Inc.
    9 Fourth Avenue
    Waltham, MA 02451
    (617) 500-2802
    Attn: Jonathan Gillis

    If you are a Millendo Stockholder, and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:

    Millendo Therapeutics, Inc.
    301 N. Main Street, Suite 100
    Ann Arbor, MI 48104
    (734) 845-9000
    Attn: Jeffery M. Brinza

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PROSPECTUS SUMMARY

        This summary highlights selected information from this proxy statement/prospectus/information statement and may not contain all of the information that is important to you. To better understand the Merger, the proposals being considered at the Special Meeting and Millendo Stockholder actions that are the subject of the written consent, you should read this entire proxy statement/prospectus/information statement carefully, including the Merger Agreement, as amended, attached as Annex A, the opinions of Ladenburg Thalmann & Co. Inc. ("Ladenburg Thalmann") attached as Annex B-1 and B-2, and the other annexes to which you are referred herein. For more information, please see the section titled "Where You Can Find More Information" in this proxy statement/prospectus/information statement.

The Companies

OvaScience, Inc.

    OvaScience, Inc.
    9 Fourth Avenue
    Waltham, MA 02451
    (617) 500-2802

        OvaScience is a company focused on the discovery and development of new treatment options for women and families struggling with infertility. To date OvaScience has been leveraging the breakthrough discovery of egg precursor, or EggPCSM, cells to transform the treatment landscape for women's fertility. OvaScience's operations to date have been limited to organizing and staffing the company, business planning, raising capital, acquiring and developing our technology, identifying potential fertility treatments, developing the OvaPrimeSM treatment, the OvaTureSM treatment and the AUGMENTSM treatment, introducing AUGMENT in select international in vitro fertilization ("IVF") clinics and determining the regulatory and development path for OvaScience's fertility treatments. OvaScience has generated limited revenues to date, and does not anticipate significant revenues in the near term. In June 2017, OvaScience announced that it would continue to focus on advancing OvaPrime in clinical development and OvaTure in preclinical development and would discontinue ongoing efforts related to the AUGMENT treatment outside of North America. To better align its organization with these strategic priorities, OvaScience restructured its workforce and reduced its workforce by approximately 50%. On January 3, 2018, OvaScience announced a further restructuring of its organization and a workforce reduction of approximately 50%. On May 3, 2018, OvaScience announced that its Board of Directors had approved a corporate restructuring plan furthering its on-going efforts to effectively align its resources. On August 9, 2018, OvaScience announced that it had entered into a definitive agreement with Millendo under which Millendo will merge with OvaScience in an all-stock transaction.

Millendo Therapeutics, Inc.

    Millendo Therapeutics, Inc.
    301 N. Main Street
    Suite 100
    Ann Arbor, MI 48104
    (734) 845-9000

        Millendo is a late-stage biopharmaceutical company focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. The endocrine system is a collection of glands that secrete hormones into the blood stream to regulate a number of functions, including appetite, metabolism, growth, development and reproduction. Diseases of the endocrine system can cause multiple and varied symptoms, including appetite dysregulation, metabolic

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dysfunction, obesity, cardiovascular disease, menstrual irregularity, excessive facial and body hair growth, and infertility.

        Millendo is currently advancing two product candidates to treat three indications. Millendo's most advanced product candidate, livoletide (AZP-531), is a potential treatment for Prader-Willi syndrome, or PWS, a rare and complex genetic endocrine disease characterized by hyperphagia, or insatiable hunger, that contributes to serious complications, a significant burden on patients and caregivers and early mortality. In a randomized, double-blind, placebo-controlled Phase 2 clinical trial in 47 patients with PWS, Millendo observed that administration of livoletide once daily was associated with a clinically meaningful improvement in hyperphagia, as well as a reduction in appetite. In a pre-specified analysis of 38 home-resident PWS patients from the Phase 2 trial, Millendo observed a larger and statistically significant decrease in hyperphagia following administration of livoletide as compared to placebo. Millendo expects to initiate a pivotal Phase 2b/3 clinical trial of livoletide in home-resident PWS patients in the first quarter of 2019, with results expected in the first half of 2020. Millendo is also developing nevanimibe (ATR-101) with a primary focus on treating patients with classic congenital adrenal hyperplasia, or CAH, a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems. When on suboptimal doses of cortisol, female CAH patients can experience male-pattern hair growth, male physical characteristics, infertility and menstrual irregularity, and male CAH patients can experience testicular atrophy, infertility and testicular tumors, making it difficult for physicians to appropriately treat CAH without causing adverse consequences. Millendo recently reported results from its Phase 2 clinical trial of nevanimibe in patients with CAH and initiated a Phase 2b trial in the third quarter of 2018, with results expected in the first half of 2020. Millendo is also investigating nevanimibe in a Phase 2 clinical trial for the treatment of patients with endogenous Cushing's syndrome, or CS, a rare endocrine disease characterized by excessive cortisol production from the adrenal glands.

Orion Merger Sub, Inc.

        Merger Sub is a wholly owned subsidiary of OvaScience, and was formed solely for the purposes of carrying out the Merger.

The Merger (see page 131)

        If the Merger is completed, Merger Sub will merge with and into Millendo, with Millendo surviving as a wholly owned subsidiary of OvaScience.

        At the Effective Time, each share of Millendo Common Stock outstanding immediately prior to the Effective Time (excluding shares held by stockholders who have exercised and perfected appraisal rights or dissenters' rights as more fully described in the section titled "The Merger—Appraisal Rights and Dissenters' Rights" in this proxy statement/prospectus/information statement, but including shares of Millendo Common Stock that will be issued pursuant to the Pre-Closing Financing as more fully described above under "Questions and Answers About the Merger—What is the Pre-Closing Financing?") will be converted into the right to receive a number of shares of OvaScience Common Stock. The final Exchange Ratio will be determined pursuant to a formula described in more detail in the Merger Agreement and in this proxy statement/prospectus/information statement. As of the date of the execution of the Merger Agreement, it was estimated that immediately after the consummation of the Merger, based solely on the sample Exchange Ratio of 0.1173 set forth below, Millendo Securityholders would own approximately 82% of Fully Diluted Closing OvaScience Common Stock, and OvaScience Securityholders would own approximately 18% of Fully Diluted Closing OvaScience Common Stock, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement.

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        OvaScience will assume all outstanding and unexercised Millendo Options and warrants to purchase Millendo Common Stock, and each such Millendo Options and warrants will be converted into an option or warrant, respectively, to purchase shares of OvaScience Common Stock, with the number of shares of OvaScience Common Stock subject to such option or warrant and the exercise price being appropriately adjusted to reflect the Exchange Ratio. The percentages set forth above assume that the initial estimate of the Exchange Ratio is not changed; however, the Exchange Ratio is subject to change as described in the section titled "The Merger Agreement—Merger Consideration" in this proxy statement/prospectus/information statement. The initial estimate of the Exchange Ratio set forth below assumed (i) that OvaScience would have between $40 million and $42 million in net cash immediately prior to Closing, (ii) a Pre-Closing Financing amount of $30.0 million, (iii) OvaScience outstanding shares and options as of the Closing would be equal to 3,721,460 (on a post reverse stock split basis), (iv) Millendo shares as of the Closing would be equal to 148,171,273 (on a fully-diluted, as-converted basis) and (v) a reverse stock split of every 10 shares of outstanding OvaScience Common Stock being combined and reclassified into one share of OvaScience Common Stock. Shares of Millendo Common Stock that are issued in the Pre-Closing Financing will be converted into shares of OvaScience Common Stock in the Merger. Accordingly, by approving Proposal No. 1 relating to the Merger, OvaScience Stockholders will also be approving the issuance of shares of OvaScience Common Stock to be issued in exchange for all shares of Millendo Common Stock that are sold in the Pre-Closing Financing.

        The Exchange Ratio is calculated using a formula intended to allocate a percentage of the combined organization to existing Millendo Securityholders. Based on the assumptions described above, the Exchange Ratio would have been equal to approximately 0.1173 post-reverse split shares of OvaScience Common Stock for each share of Millendo Common Stock, which Exchange Ratio is subject to change based on the amount of OvaScience net cash, changes in the capitalization of OvaScience or Millendo prior to the Closing and the amount raised by Millendo in the Pre-Closing Financing (and as a result, OvaScience Securityholders and Millendo Securityholders could own more or less of the combined organization).

        After the initial signing of the Merger Agreement, the valuations for Millendo and OvaScience were reduced, as further described in this proxy statement/prospectus/information statement. In addition, OvaScience currently estimates that, assuming for this purpose a closing date of November 30, 2018, (i) it will have approximately $37.6 million in net cash immediately prior to Closing, (ii) the Pre-Closing Financing amount will be approximately $29.5 million, (iii) OvaScience outstanding shares and options as of the Closing will be equal to 3,727,669 (on a post reverse stock split basis) and (iv) the Millendo shares as of the Closing on a fully diluted and as-converted basis will be equal to 152,629,595. Accordingly, it is currently estimated that the Exchange Ratio at Closing will be approximately 0.1070 and, based solely on such Exchange Ratio, at Closing: (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 67.1% of the Fully Diluted Closing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 13.1% of the Fully Diluted Closing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 18.6% of the Fully Diluted Closing OvaScience Common Stock, and (d) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.2% of the Fully Diluted Closing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. Additionally, it is anticipated that the Post-Closing Financing (as defined below) will close shortly after the Closing, which would dilute, and thereby reduce, each then existing OvaScience Securityholder's proportionate holdings. Assuming that the Post-Closing Financing closes immediately after the Merger as well as the other aforementioned assumptions, it is expected that (a) Millendo Securityholders as of immediately prior to the Merger

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(not including the shares issued in the Pre-Closing Financing) will own approximately 61.7% of the Fully Diluted Post-Financing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 12.0% of the Fully Diluted Post-Financing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 17.1% of the Fully Diluted Post-Financing OvaScience Common Stock, (d) the shares issued in the Post-Closing Financing to the Post-Closing Financing Investor (as defined below) will represent approximately 8.1% of the Fully Diluted Post-Financing OvaScience Common Stock, and (e) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.1% of the Fully Diluted Post-Financing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. "Fully Diluted Closing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan). "Fully Diluted Post-Financing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan) plus (z) the Post-Closing Financing shares.

        Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock. For a more complete description of the Merger and the Exchange Ratio please see the section titled "The Merger Agreement" in this proxy statement/prospectus/information statement.

        The Closing will occur no later than the second business day after the last of the conditions to the Merger has been satisfied or waived (other than those conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of each such conditions), or at such other time as OvaScience and Millendo agree. OvaScience and Millendo anticipate that the consummation of the Merger will occur in the fourth quarter of 2018. However, because the Merger is subject to a number of conditions, neither OvaScience nor Millendo can predict exactly when the Closing will occur or if it will occur at all. After completion of the Merger, assuming that OvaScience receives the required stockholder approval of Proposal No. 3, OvaScience will be renamed "Millendo Therapeutics, Inc."

Reasons for the Merger

        Following the Merger, the combined organization will be a late-stage biopharmaceutical company focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. OvaScience and Millendo believe that the combined organization will have the following potential advantages:

    Late-Stage Specialty Biopharmaceutical Company.  Millendo is focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. Millendo is currently advancing two product candidates for three indications: livoletide for the treatment of Prader-Willi syndrome and nevanimibe for the treatment of classic congenital adrenal hyperplasia and Cushing's syndrome.

    Management Team.  It is expected that the combined organization will be led by the experienced senior management from Millendo and a board of directors with representation from each of OvaScience and Millendo.

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    Cash Resources.  The combined organization is expected to have approximately $81.1 million in cash, cash equivalents and short-term investments at the Closing, which OvaScience and Millendo believe is sufficient to enable Millendo to implement its near-term business plans. The cash, cash equivalents and short-term investments amount assumes that OvaScience's transaction costs and other obligations will be paid at Closing, other than certain severance payment amounts, which may be paid out up to one year after Closing.

        Each of the boards of directors of OvaScience and Millendo also considered other reasons for the Merger, as described herein. For example, the OvaScience Board of Directors considered, among other things:

    the strategic alternatives to the Merger available to OvaScience, including the discussions that OvaScience's management and the OvaScience Board of Directors previously conducted with other potential merger partners;

    the risks and delays associated with, and uncertain value and costs to OvaScience Stockholders of, liquidating OvaScience, including the uncertainties of continuing cash burn while contingent liabilities are resolved, uncertainty of timing of release of cash until contingent liabilities are resolved, and the risks associated with being a shell company prior to cash distribution, including the risks associated with delisting;

    the risks of continuing to operate OvaScience on a stand-alone basis, including the need to rebuild infrastructure and management to continue its operations; and

    the opportunity as a result of the Merger for OvaScience Stockholders to participate in the potential value of Millendo's product candidate portfolio and the potential growth of the combined organization following the Merger.

        In addition, the Millendo Board of Directors approved the Merger based on a number of factors, including the following:

    the process undertaken by the Millendo Board of Directors and management to ascertain actionable alternatives, including partnering transactions and including possibly the sale of the company and whether this was an appropriate juncture, in light of the progress achieved and additional challenges faced by Millendo, to undertake such a process;

    the possible alternatives to the Merger, the range of possible benefits to the Millendo Stockholders of such alternatives and the timing and the likelihood of accomplishing the goal of any of such alternatives;

    the financial condition, historical results of operations and business and strategic objectives Millendo, as well as the risks involved in achieving those objectives;

    the amount and form of consideration to be received by the Millendo Stockholders in the Merger pursuant to the Merger Agreement taking into account the relative interests of the various classes of stock of Millendo and the contractual rights afforded to holders of the Preferred Stock of the Company (including as to whether any alternatives to the Merger would reasonably likely be achievable and derive more value across such classes of stock);

    the expectation that the Merger will be treated as a tax-deferred reorganization for U.S. federal income tax purposes; and

    the proposed timing of the interim period between the signing of the Merger Agreement and the expected Closing and whether it is advisable to proceed given current economic, industry and market conditions.

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Opinions of the OvaScience Financial Advisor as of August 8, 2018 (see page 143)

        The OvaScience Board of Directors engaged Ladenburg Thalmann to provide strategic advisory and investment banking services in connection with evaluating and considering various strategic alternatives, and ultimately requested that Ladenburg Thalmann render an opinion as to whether the Exchange Ratio was fair, from a financial point of view, to the OvaScience Stockholders. At the August 8, 2018 meeting of the OvaScience Board of Directors, Ladenburg Thalmann rendered its oral opinion, subsequently confirmed by delivery of its written opinion dated August 8, 2018, to the OvaScience Board of Directors. On October 26, 2018, at the request of the OvaScience Board of Directors and in light of the changes proposed to the valuation of Millendo and OvaScience as set forth in the Second Amendment to the Merger Agreement, Ladenburg Thalmann rendered a revised oral opinion, subsequently confirmed by delivery of the written opinion dated October 26, 2018, to the OvaScience Board of Directors, that the Exchange Ratio was fair, from a financial point of view, to the OvaScience Stockholders as of the date of such opinion and based upon the various assumptions, qualifications and limitations set forth therein.

        The full texts of Ladenburg Thalmann's written opinions, which set forth the procedures followed, assumptions made, matters considered, and qualifications and limitations of the review undertaken in connection with the opinions, are attached to this proxy statement/prospectus/information statement as Annex B-1 and B-2 and are incorporated by reference in their entirety to this proxy statement/prospectus/information statement. Ladenburg Thalmann's opinions were intended solely for the benefit and use of the OvaScience Board of Directors (in its capacity as such) in connection with its consideration of the Merger. Ladenburg Thalmann's opinions were not intended to be used for any other purpose without Ladenburg Thalmann's prior written consent in each instance, except as expressly provided for in the engagement letter between OvaScience and Ladenburg Thalmann. Ladenburg Thalmann has consented to the use of Ladenburg Thalmann's opinions in this proxy statement/prospectus/information statement. Ladenburg Thalmann's opinions did not address OvaScience's underlying business decision to enter into the Merger Agreement or complete the Merger or the merits of the Merger as compared to any alternative transactions that were or may be available to OvaScience, and did not constitute a recommendation to the OvaScience Board of Directors or to any OvaScience Stockholder or Millendo Stockholder as to how such stockholder should vote with respect to the Merger or otherwise.

Overview of the Merger Agreement

Merger Consideration (see page 200)

        At the Effective Time, each outstanding share of common stock of Millendo will be converted into the right to receive a number of shares of OvaScience Common Stock.

        The Merger Agreement does not provide for an adjustment to the total number of shares of OvaScience Common Stock that Millendo Stockholders will be entitled to receive for changes in the market price of OvaScience Common Stock. Accordingly, the market value of the shares of OvaScience Common Stock issued pursuant to the Merger will depend on the market value of the shares of OvaScience Common Stock at the time the Merger closes, and could vary significantly from the market value on the date of this proxy statement/prospectus/information statement.

Treatment of Millendo Options (see page 201)

        Pursuant to the Merger Agreement, at the Effective Time, each option to purchase shares of Millendo Common Stock (a "Millendo Option") that is outstanding and unexercised immediately prior to the Effective Time granted under the Millendo 2012 Equity Incentive Plan (the "Millendo Plan") or otherwise, whether or not vested, will be, along with the Millendo Plan, assumed by OvaScience and will become an option to purchase solely that number of shares of OvaScience Common Stock equal to

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the product obtained by multiplying (i) the number of shares of Millendo Common Stock that were subject to such Millendo Option immediately prior to the Effective Time by (ii) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of OvaScience Common Stock. The per share exercise price for OvaScience Common Stock issuable upon exercise of each Millendo Option assumed by OvaScience shall be determined by dividing (a) the per share exercise price of Millendo Common Stock subject to such Millendo Option, as in effect immediately prior to the Effective Time, by (b) the Exchange Ratio, and rounding the resulting exercise price up to the nearest whole cent. Any restriction on the exercise of any Millendo Option assumed by OvaScience will continue in full force and effect and the term, exercisability, vesting schedule and other provisions of such Millendo Option shall otherwise remain unchanged.

Treatment of Millendo Warrants (see page 201)

        Pursuant to the Merger Agreement, at the Effective Time, each warrant to purchase shares of Millendo Common Stock (a "Millendo Warrant") that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into and become a warrant to purchase (and OvaScience shall assume each such Millendo Warrant in accordance with its terms) solely that number of shares of OvaScience Common Stock equal to the product obtained by multiplying (i) the number of shares of Millendo Common Stock that were subject to such Millendo Warrant immediately prior to the Effective Time by (ii) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of OvaScience Common Stock. The per share exercise price for OvaScience Common Stock issuable upon exercise of each Millendo Warrant assumed by OvaScience shall be determined by dividing (a) the per share exercise price of Millendo Common Stock subject to such Millendo Warrant, as in effect immediately prior to the Effective Time, by (b) the Exchange Ratio, and rounding the resulting exercise price up to the nearest whole cent. Any restriction on the exercise of any Millendo Warrant assumed by OvaScience will continue in full force and effect and the term, exercisability, vesting schedule and other provisions of such Millendo Warrant shall otherwise remain unchanged. Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock.

Treatment of OvaScience Options (see page 201)

        Prior to the Closing, OvaScience's board of directors will adopt appropriate resolutions and take all other actions necessary and appropriate to provide that the vesting of each unexpired and unexercised option to purchase shares of OvaScience Common Stock, whether vested or unvested, will be accelerated in full effective as of immediately prior to the Effective Time, and each such option will survive the Closing and remain outstanding in accordance with its terms. The number of shares of OvaScience Common Stock underlying such options and the exercise prices for such options will be appropriately adjusted to reflect the proposed Reverse Stock Split to be implemented prior to the Closing.

Conditions to Completion of the Merger (see page 215)

        To consummate the Merger, OvaScience Stockholders must approve (a) the Merger Agreement and the transactions contemplated thereby, including the Merger and the issuance of shares of OvaScience Common Stock to Millendo Stockholders in the Merger, and (b) an amendment to the restated certificate of incorporation of OvaScience effecting the Reverse Stock Split. Additionally, Millendo Stockholders must adopt the Merger Agreement thereby approving the Merger and the other transactions contemplated by the Merger Agreement. In addition to obtaining such stockholder approvals and obtaining appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

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No Solicitation (see page 209)

        Each of OvaScience and Millendo have agreed that, except as described below, OvaScience and Millendo and any of their respective subsidiaries will not, nor will either party or any of its subsidiaries authorize any of the officers, directors, employees, representatives, affiliates, advisors or agents, directly or indirectly:

    initiate, solicit, seek or knowingly encourage or support any inquiries, proposals or offers that constitute or may reasonably be expected to lead to any competing proposal;

    engage or participate in, or knowingly facilitate, any discussions or negotiations regarding, or furnish any nonpublic information to any person in connection with, any inquiries, proposals or offers that constitute, or may reasonably be expected to lead to, a competing proposal;

    enter into any letter of intent, agreement in principle or other similar type of agreement relating to a competing proposal, or enter into any agreement or agreement in principle requiring either OvaScience or Millendo, as the case may be, to abandon, terminate or fail to complete the Merger; or

    resolve, propose or agree to do any of the foregoing.

        However, prior to the approval of the proposals relating to the Merger set forth in this proxy statement at the meeting of the OvaScience Stockholders or by written consent of Millendo Stockholders (unless, in either case, the Merger Agreement is earlier terminated), as the case may be, either OvaScience or Millendo may, after providing written notice to the other party, furnish nonpublic information to and engage in discussions or negotiations with any third-party that makes an unsolicited bona fide written competing proposal (as described in the Merger Agreement) that its board of directors in good faith, after consultation with its outside legal counsel and financial advisors, has determined constitutes or would reasonably be expected to lead to a superior competing proposal, only if:

    such party receives from such third-party an executed confidentiality agreement the terms of which are not less restrictive to the third-party than those contained in the confidentiality agreement between OvaScience and Millendo;

    such party receiving the competing proposal contemporaneously supplies to the other party (OvaScience or Millendo, as the case may be) any nonpublic information or access to any such nonpublic information granted to such third-party to the extent it had not been previously provided or made available;

    such party has not breached the no solicitation provisions of the Merger Agreement; and

    the board of directors of OvaScience or Millendo, as the case may be, determines in good faith, after consultation with its outside legal counsel and its financial advisors that taking such actions would be required to comply with the fiduciary duties of the board of directors under applicable laws.

Termination of the Merger Agreement (see page 220)

        Either OvaScience or Millendo can terminate the Merger Agreement under certain circumstances, which would prevent the Merger from being consummated.

Termination Fee (see page 222)

        The Merger Agreement contains certain termination rights for both OvaScience and Millendo, and further provides that, upon termination of the Merger Agreement under specified circumstances, either party may be required to pay the other party a termination fee of $3.0 million, or in some

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circumstances reimburse the other party's expenses up to a maximum of $1.0 million. In addition, in certain specified circumstances, Millendo may be required to pay OvaScience a termination fee of $15.0 million.

Voting Agreements (see page 225)

        Certain Millendo Stockholders are party to a voting agreement with OvaScience and Millendo pursuant to which, among other things, each of these stockholders agreed, solely in his, her or its capacity as a Millendo Stockholder, to vote all of his, her or its shares of Millendo Capital Stock in favor of the adoption of the Merger Agreement and the approval of any transaction proposed under the Merger Agreement and any other proposal included in the written consent presented to Millendo's Stockholders in connection with, or related to, the consummation of the Merger for which the Board of Directors of Millendo has recommended that Millendo's Stockholders vote in favor.

        As of September 1, 2018, the Millendo Stockholders that are party to a voting agreement with OvaScience owned approximately 73% of the outstanding shares of Millendo Capital Stock. Following the effectiveness of the registration statement of which this proxy statement/prospectus/information statement is a part, Millendo Stockholders holding a sufficient number of shares of Millendo Capital Stock to adopt the Merger Agreement and thereby approve the Merger will, pursuant to their voting agreements, execute written consents providing for such adoption and approval.

        Certain OvaScience Stockholders are party to a voting agreement with Millendo pursuant to which, among other things, each of these stockholders agreed, solely in his, her or its capacity as a OvaScience Stockholder, to vote all of his, her or its shares of OvaScience Common Stock in favor of approval of (i) the Merger Agreement and the transactions contemplated thereby, including the Merger and the issuance of shares of OvaScience Common Stock to Millendo Stockholders, (ii) an amendment to the restated certificate of incorporation of OvaScience to effect the Reverse Stock Split, (iii) an amendment to the restated certificate of incorporation of OvaScience to effect the OvaScience Name Change, (iv) any proposal to adjourn or postpone the meeting to a later date, if there are not sufficient votes for the approval of the Merger and other matters to be approved on date of the Special Meeting, and (v) any other proposal included in this proxy statement/prospectus/information statement in connection with, or related to, the consummation of the Merger for which the Board of Directors of OvaScience has recommended that the stockholders of OvaScience vote in favor.

        The OvaScience Stockholders that are party to a voting agreement with Millendo beneficially owned approximately 5% of the outstanding shares of OvaScience Common Stock as of September 1, 2018. The parties to the voting agreements with Millendo include the executive officers and directors of OvaScience and certain OvaScience Stockholders.

        The voting agreements are discussed in greater detail in the section titled "Agreements Related to the Merger—Voting Agreements" in this proxy statement/prospectus/information statement.

Lock-up Agreements (see page 226)

        As a condition to the Closing, certain OvaScience Stockholders and Millendo Stockholders have entered into lock-up agreements, pursuant to which such parties have agreed not to, except in limited circumstances, sell or transfer, or engage in swap or similar transactions with respect to, shares of OvaScience Common Stock, including, as applicable, shares received in the Merger and issuable upon exercise of certain options, in each case from the Closing until the date that is 180 days from the Closing.

        As of September 1, 2018, OvaScience Stockholders who have executed lock-up agreements beneficially owned in the aggregate approximately 3% of the outstanding shares of OvaScience Common Stock.

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        Millendo Stockholders who have executed lock-up agreements as of September 1, 2018 owned in the aggregate approximately 97% of the outstanding shares of Millendo Capital Stock on an as converted into common stock basis.

Management Following the Merger (see page 342)

        Effective as of the Closing, OvaScience's officers are expected to include:

Name
  Title
Julia C. Owens, Ph.D.    President and Chief Executive Officer
Pharis Mohideen, M.D.    Chief Medical Officer
Jeffery M. Brinza, J.D.    Secretary, Chief Administrative Officer and General Counsel

Interests of Certain Directors, Officers and Affiliates of OvaScience and Millendo (see pages 165 and 182)

        In considering the recommendation of the OvaScience Board of Directors with respect to issuing shares of OvaScience Common Stock pursuant to the Merger Agreement and the other matters to be acted upon by OvaScience Stockholders at the Special Meeting, OvaScience Stockholders should be aware that certain members of the OvaScience Board of Directors and executive officers of OvaScience have interests in the Merger that may be different from, or in addition to, interests they have as OvaScience Stockholders. For example, OvaScience has entered into certain retention agreements with its current executive officers that may result in the receipt by such executive officers of cash severance payments and other benefits with a total value of approximately $2.3 million (collectively, not individually, and excluding the value of any accelerated vesting of OvaScience Options) and the accelerated vesting of OvaScience Options held by those officers, based on data available as of September 1, 2018 and assuming a covered termination of employment of each executive officer's employment as of such date.

        As of September 1, 2018, the directors and executive officers of OvaScience beneficially owned, in the aggregate, approximately 8.0% of the outstanding shares of OvaScience Common Stock. Each of OvaScience's officers and directors, as well as an affiliate of one of OvaScience's directors, have entered into voting agreements in connection with the Merger. The voting agreements are discussed in greater detail in the section titled "Agreements Related to the Merger—Voting Agreements" in this proxy statement/prospectus/information statement.

        In considering the recommendation of the Millendo Board of Directors with respect to approving the Merger and related transactions, Millendo Stockholders should be aware that certain members of the Millendo Board of Directors and certain executive officers of Millendo have interests in the Merger that may be different from, or in addition to, interests they have as Millendo Stockholders. For example, Millendo's executive officers have options, subject to vesting, to purchase shares of Millendo Common Stock, which will convert into options to purchase a number of shares of OvaScience Common Stock determined by the Exchange Ratio, rounding any resulting fractional shares down to the nearest whole share, certain of Millendo's directors and executive officers are expected to become directors and executive officers of the combined organization upon the Closing and all of Millendo's directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. For more information, please see the section titled "The Merger—Interests of the Millendo Directors and Executive Officers in the Merger."

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Material U.S. Federal Income Tax Consequences of the Merger (see page 192)

        As discussed in detail in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement, OvaScience and Millendo intend the Merger to qualify as a reorganization within the meaning of Section 368(a) of the Code. In general, and subject to the qualifications and limitations set forth in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement, if the Merger qualifies as a "reorganization" within the meaning of Section 368(a) of the Code, the material tax consequences to a U.S. holder of Millendo Capital Stock should be as follows:

    such Millendo Stockholder will not recognize gain or loss upon the exchange of Millendo Capital Stock for OvaScience Common Stock pursuant to the Merger, except to the extent of cash received in lieu of a fractional share of OvaScience Common Stock as described below;

    such Millendo Stockholder who receives cash in lieu of a fractional share of OvaScience Common Stock in the Merger will recognize capital gain or loss in an amount equal to the difference between the amount of cash received in lieu of a fractional share and the stockholder's tax basis allocable to such fractional share;

    such Millendo Stockholder's aggregate tax basis for the shares of OvaScience Common Stock received in the Merger (including any fractional share interest for which cash is received) will equal the stockholder's aggregate tax basis in the shares of Millendo Capital Stock surrendered in the Merger; and

    the holding period of the shares of OvaScience Common Stock received by such Millendo Stockholder in the Merger will include the holding period of the shares of Millendo Capital Stock surrendered in exchange therefor.

        If the Merger is not treated as a reorganization within the meaning of Section 368(a) of the Code, then each U.S. holder generally will be treated as exchanging its shares of Millendo Capital Stock in a fully-taxable transaction in exchange for shares of OvaScience Common Stock. Millendo Stockholders will generally recognize gain or loss in such exchange equal to the amount that such Millendo Stockholder's adjusted tax basis in the shares of Millendo Capital Stock surrendered is less or more than the fair market value of the shares of OvaScience Common Stock (and cash in lieu of a fractional share) received in exchange therefor. Determining the actual tax consequences of the Merger to you may be complex and will depend on the facts of your own situation. You should consult your tax advisors to fully understand the tax consequences to you of the Merger, including estate, gift, state, local or non-U.S. tax consequences of the Merger.

Risk Factors (see page 34)

        Both OvaScience and Millendo are subject to various risks associated with their businesses and their industries. In addition, the Merger poses a number of risks to each company and its respective stockholders, including the possibility that the Merger may not be completed and the following risks:

    the Exchange Ratio is not adjustable based on the market price of OvaScience Common Stock, so the merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed;

    failure to complete the Merger may result in OvaScience or Millendo paying a termination fee or expenses to the other and could harm the per share price of OvaScience Common Stock and future business and operations of each company;

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    the Merger may be completed even though material adverse changes may result solely from the announcement of the Merger, general economic or political conditions or conditions generally affecting the industries in which OvaScience and Millendo operate and other causes;

    some OvaScience and Millendo officers and directors have interests that are different from or in addition to those considered by stockholders of OvaScience and Millendo and which may influence them to support or approve the Merger;

    the market price of OvaScience Common Stock may decline as a result of the Merger;

    OvaScience Stockholders and Millendo Stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger;

    during the pendency of the Merger, OvaScience and Millendo may not be able to enter into a business combination with another party under certain circumstances because of restrictions in the Merger Agreement, which could adversely affect their respective businesses;

    certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement;

    because the lack of a public market for shares of Millendo Capital Stock makes it difficult to evaluate the fairness of the Merger, the Millendo Stockholders may receive consideration in the Merger that is less than the fair market value of the shares of Millendo Capital Stock and/or OvaScience may pay more than the fair market value of the shares of Millendo Capital Stock; and

    if the conditions to the Merger are not met, the Merger will not occur.

        These risks and other risks are discussed in greater detail under the section titled "Risk Factors" in this proxy statement/prospectus/information statement. OvaScience and Millendo both encourage you to read and consider all of these risks carefully.

Regulatory Approvals (see page 192)

        In the United States, OvaScience must comply with applicable federal and state securities laws and the rules and regulations of The Nasdaq Stock Market LLC ("Nasdaq") in connection with the issuance of shares of OvaScience Common Stock and the filing of this proxy statement/prospectus/information statement with the SEC.

Nasdaq Capital Market Listing (see page 195)

        Prior to consummation of the Merger, OvaScience has filed an initial listing application with The Nasdaq Capital Market pursuant to Nasdaq's rules for companies conducting a business combination that results in a change of control. If such application is accepted, OvaScience anticipates that shares of OvaScience Common Stock will be listed on The Nasdaq Capital Market following the Closing under OvaScience's new name, "Millendo Therapeutics, Inc.," with the trading symbol "MLND."

Anticipated Accounting Treatment (see page 196)

        The Merger is expected be treated by OvaScience as a reverse merger and accounted for as a reverse recapitalization in accordance with U.S. generally accepted accounting principles ("U.S. GAAP"). For accounting purposes, Millendo is considered to be acquiring OvaScience in the Merger.

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Appraisal Rights and Dissenters' Rights (see page 196)

        Holders of shares of OvaScience Common Stock are not entitled to appraisal rights in connection with the Merger. Millendo Stockholders are entitled to appraisal rights in connection with the Merger under Delaware law. For more information about such rights, see the provisions of Section 262 of the General Corporation Law of the State of Delaware (the "DGCL") attached hereto as Annex C, and the section titled "The Merger—Appraisal Rights and Dissenters' Rights" in this proxy statement/prospectus/information statement.

Comparison of Stockholder Rights (see page 386)

        Both OvaScience and Millendo are incorporated under the laws of the State of Delaware and, accordingly, the rights of the stockholders of each are currently, and will continue to be, governed by the DGCL. If the Merger is completed, Millendo Stockholders will become OvaScience Stockholders, and their rights will be governed by the DGCL, the amended and restated bylaws of OvaScience and, assuming Proposals No. 2 and 3 are approved by OvaScience Stockholders at the Special Meeting, the restated certificate of incorporation of OvaScience. The rights of OvaScience Stockholders contained in the restated certificate of incorporation and amended and restated bylaws of OvaScience differ from the rights of Millendo Stockholders under the amended and restated certificate of incorporation and amended bylaws of Millendo, as more fully described under the section titled "Comparison of Rights of Holders of OvaScience Stock and Millendo Stock" in this proxy statement/prospectus/information statement.

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SELECTED HISTORICAL AND UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL DATA

        The following tables present summary historical financial data for OvaScience and Millendo, summary unaudited pro forma condensed combined financial data for OvaScience and Millendo, and comparative historical and unaudited pro forma per share data for OvaScience and Millendo.

Selected Historical Financial Data of OvaScience

        The selected statement of operations data for the years ended December 31, 2017, 2016 and 2015 and the selected balance sheet data as of December 31, 2017 and 2016 are derived from OvaScience's audited financial statements prepared using accounting principles generally accepted in the United States ("U.S. GAAP"), which are included in this proxy statement/prospectus/information statement. The selected statement of operations data for the years ended December 31, 2014 and 2013 and the selected balance sheet data as of December 31, 2015, 2014 and 2013 are derived from OvaScience's audited financial statements, which are not included in this proxy statement/prospectus/information statement. The selected financial data for the six months ended June 30, 2018 and 2017, are derived from OvaScience's unaudited condensed financial statements included in this proxy statement/prospectus/information statement. The financial data should be read in conjunction with "OvaScience Management's Discussion and Analysis of Financial Condition and Results of Operations" and OvaScience's condensed financial statements and related notes appearing elsewhere in this proxy statement/prospectus/information statement. The historical results are not necessarily indicative of results to be expected in any future period.

 
  Years Ended December 31,   Six Months Ended
June 30,
 
 
  2017   2016   2015   2014   2013   2018   2017  
 
   
   
   
   
   
  (unaudited)
 
 
  (in thousands, except per share data)
 

Consolidated Statements of Operations Data:

                                           

Revenues:

  $ 295   $ 653   $ 277           $ 148   $ 147  

Total costs and expenses (excluding restructuring)

  $ 46,871   $ 76,265   $ 72,276   $ 47,993   $ 29,134   $ 12,050   $ 29,184  

Restructuring

    4,030     5,400                 3,584     3,480  

Loss from operations

    (50,606 )   (81,012 )   (71,999 )   (47,993 )   (29,134 )   (15,486 )   (32,517 )

Net loss

  $ (50,975 ) $ (82,260 ) $ (73,219 ) $ (49,520 ) $ (29,044 ) $ (15,073 ) $ (33,081 )

Net loss per share applicable to common stockholders—basic and diluted

  $ (1.43 ) $ (2.56 ) $ (2.70 ) $ (2.19 ) $ (1.80 ) $ (0.42 ) $ (0.93 )

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    35,675     32,148     27,085     22,647     16,160     35,743     35,653  

 

 
  At December 31,   At June 30,  
 
  2017   2016   2015   2014   2013   2018  
 
   
   
   
   
   
  (unaudited)
 
 
  (in thousands)
 

Consolidated Balance Sheet Data:

                                     

Cash, cash equivalents, and short-term investments

  $ 67,203   $ 114,388   $ 126,662   $ 60,231   $ 44,427   $ 53,628  

Total assets

    72,853     122,543     138,613     65,572     47,545     55,533  

Total current liabilities

    7,804     13,209     11,243     10,174     5,774     4,747  

Total long-term liabilities

    751     1,116     520     73     70     576  

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Selected Historical Financial Data of Millendo

        The selected statement of operations data for the years ended December 31, 2017 and 2016 and the selected balance sheet data as of December 31, 2017 and 2016 are derived from Millendo's audited financial statements prepared using accounting principles generally accepted in the United States ("U.S. GAAP"), which are included in this proxy statement/prospectus/information statement. The selected financial data for the six months ended June 30, 2018 and 2017 are derived from Millendo's unaudited condensed financial statements included in this proxy statement/prospectus/information statement. The financial data should be read in conjunction with "Millendo Management's Discussion and Analysis of Financial Condition and Results of Operations" and Millendo's condensed financial statements and related notes appearing elsewhere in this proxy statement/prospectus/information

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statement. The historical results are not necessarily indicative of results to be expected in any future period.

 
  Years Ended
December 31,
  Six Months Ended
June 30,
 
 
  2017   2016   2018   2017  
 
  (in thousands, except share and per share amounts)
 
 
   
   
  (unaudited)
 

Operating expenses:

                         

Research and development(1)

  $ 14,526   $ 14,097   $ 5,969   $ 9,883  

Acquired in-process research and development(2)

    63,844              

General and administrative(1)

    5,956     4,543     3,405     3,848  

Loss from operations

    84,326     18,640     9,374     13,731  

Other expenses:

                         

Interest expense (income), net

    288     177     (15 )   184  

Change in fair value of preferred stock warrant liability

    (28 )   30          

Other loss

            69      

Net loss

  $ (84,586 ) $ (18,847 ) $ (9,428 ) $ (13,915 )

Net loss attributable to noncontrolling interest

  $ 8   $   $ 321   $  

Net loss per share attributable to common stockholders

  $ (84,578 ) $ (18,847 ) $ (9,107 ) $ (13,915 )

Net loss per share of common stock, basic and diluted(3)

  $ (23.94 ) $ (6.41 ) $ (0.95 ) $ (4.20 )

Weighted-average shares of common stock outstanding, basic and diluted(3)

    3,532,566     2,942,250     9,548,254     3,309,714  

Other comprehensive income:

                         

Foreign currency translation adjustment

  $ 10   $   $ 47   $  

Comprehensive loss

  $ (84,568 ) $ (18,847 ) $ (9,060 ) $ (13,915 )

Comprehensive income attributable to noncontrolling interest

  $ 2   $   $ 7   $  

Comprehensive loss attributable to Millendo Therapeutics, Inc. 

  $ (84,570 ) $ (18,847 ) $ (9,067 ) $ (13,915 )

(1)
Includes stock-based compensation expense as follows:
 
  Year Ended
December 31,
  Six Months
Ended
June 30,
 
 
  2017   2016   2018   2017  
 
  (in thousands)
 
 
   
   
  (unaudited)
 

Stock-based compensation expense:

                         

Research and development expense

  $ 315   $ 223   $ 138   $ 168  

General and administrative expense

    447     339     198     233  

Total stock-based compensation expense

  $ 762   $ 562   $ 336   $ 401  
(2)
Millendo's acquired and in-process research and development expense was incurred in connection with its acquisition of Alizé Pharma SAS in December 2017.

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(3)
See note 2 to Millendo's consolidated financial statements appearing elsewhere in this proxy statement/prospectus/information statement for further details on the calculation of basic and diluted net loss per share of common stock.
 
  As of December 31,   As of
June 30,
 
 
  2017   2016   2018  
 
   
  (in thousands)
   
 
 
   
   
  (unaudited)
 

Consolidated balance sheet data:

                   

Cash

  $ 17,578   $ 41,904   $ 6,779  

Working capital(1)

    15,647     38,595     5,861  

Total assets

    19,812     44,851     10,357  

Total debt

    773     3,880     672  

Preferred stock warrant liability

    139     167     139  

Preferred stock

    132,922     86,998     132,922  

Additional paid-in capital

    6,183     1,111     6,519  

Accumulated deficit

    (136,894 )   (52,316 )   (146,001 )

Total stockholders' deficit

    (128,523 )   (51,202 )   (137,254 )

(1)
Millendo defines working capital as current assets less current liabilities. See Millendo's consolidated financial statements included elsewhere in this proxy statement/prospectus/information statement for further details regarding Millendo's current assets and current liabilities.

Selected Unaudited Pro Forma Condensed Combined Financial Data of OvaScience and Millendo

        The following selected unaudited pro forma condensed combined financial data gives effect to: (i) the Merger, (ii) the Reverse Stock Split of OvaScience Common Stock, (iii) the Pre-Closing Financing, which includes the automatic conversion of Millendo's convertible promissory notes that were issued in August 2018 in exchange for $8.0 million cash proceeds, (iv) the Post-Closing Financing and (v) Millendo's acquisition of Alizé on December 19, 2017. The Merger is accounted for as a reverse recapitalization under U.S. GAAP because the primary assets of OvaScience are cash and short-term investments. Millendo was determined to be the accounting acquirer based upon the terms of the Merger and other factors including: (i) Millendo Securityholders are expected to own at least 82% of the Fully Diluted Closing OvaScience Common Stock immediately following the Effective Time (subject to adjustment as described herein), (ii) Millendo will hold the majority (seven of eight) of board seats of the combined company and (iii) Millendo's management will hold all key positions in the management of the combined company.

        The OvaScience and Millendo unaudited pro forma combined balance sheet data assume that the Merger took place on June 30, 2018, and combines the OvaScience and Millendo historical balance sheets at June 30, 2018. The OvaScience and Millendo unaudited pro forma condensed combined statements of operations data assume that the Merger took place as of January 1, 2017, and combines the historical results of OvaScience and Millendo for the six months ended June 30, 2018 and the year ended December 31, 2017. For the year ended December 31, 2017, the unaudited pro forma condensed combined statements of operations data also assume Millendo's acquisition of Alizé took place as of January 1, 2017.

        The selected unaudited pro forma condensed combined financial data are presented for illustrative purposes only and are not necessarily indicative of the combined financial position or results of operations of future periods or the results that actually would have been realized had the entities been a single entity during these periods. The selected unaudited pro forma condensed combined financial data as of and for the six months ended June 30, 2018 and for the year ended December 31, 2017 are derived from the unaudited pro forma condensed combined financial information and should be read in

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conjunction with that information. For more information, please see the section titled "Unaudited Pro Forma Condensed Combined Financial Statements" in this proxy statement/prospectus/information statement.

        The unaudited pro forma condensed combined financial information assumes that, at the Effective Time, each share of Millendo Capital Stock will be converted into the right to receive shares of OvaScience Common Stock such that, immediately after the Merger, and assuming that the Post-Closing Financing closes immediately after the Merger and based on aforementioned assumptions, it is expected that (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 61.7% of the Fully Diluted Post-Financing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 12.0% of the Fully Diluted Post-Financing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 17.1% of the Fully Diluted Post-Financing OvaScience Common Stock, (d) the shares issued in the Post-Closing Financing to the Post-Closing Financing Investor (as defined below) will represent approximately 8.1% of the Fully Diluted Post-Financing OvaScience Common Stock, and (e) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.1% of the Fully Diluted Post-Financing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. "Fully Diluted Post-Financing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan) plus (z) the Post-Closing Financing shares.

Unaudited Pro Forma Condensed Combined Statements of Operations Data

 
  For the
Six Months
Ended
June 30, 2018
  For the
Year Ended
December 31, 2017
 
 
  (in thousands, except per share data)
 

Revenue

  $ 148   $ 295  

Research and development expenses

    10,931     36,203  

Acquired in-process research and development

        63,844  

General and administrative expenses

    9,782     34,327  

Restructuring expenses

    3,584     4,030  

Loss from operations

    (24,315 )   (138,899 )

Net loss attributable to common stockholders

    (23,635 )   (138,095 )

Net loss per share, basic and diluted

  $ (1.26 ) $ (7.38 )

Unaudited Pro Forma Condensed Combined Balance Sheet Data

 
  As of
June 30, 2018
 
 
  (in thousands)
 

Cash and cash equivalents

  $ 71,430  

Working capital, net

    95,339  

Total assets

    105,940  

Accumulated deficit

    (153,228 )

Total stockholders' equity

    86,598  

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Comparative Historical and Unaudited Pro Forma Per Share Data

        The information below reflects the historical net loss and book value per share of OvaScience Common Stock and the historical net loss and book value per unit of Millendo Common Stock in comparison with the unaudited pro forma net loss and book value per share after giving effect to the Merger on a purchase basis.

        You should read the tables below in conjunction with the audited and unaudited consolidated financial statements of OvaScience included in this proxy statement/prospectus/information statement and the audited and unaudited financial statements of Millendo included in this proxy statement/prospectus/information statement and the related notes and the unaudited pro forma condensed combined financial information and notes related to such financial statements included elsewhere in this proxy statement/prospectus/information statement.

OvaScience

 
  Six Months
Ended
June 30, 2018
  Year Ended
December 31, 2017
 

Historical Per Common Share Data:

             

Basic and diluted net loss per share

  $ (0.42 ) $ (1.43 )

Book value per share

    1.40     1.80  

Millendo

 
  Six Months
Ended
June 30, 2018
  Year Ended
December 31, 2017
 

Historical Per Common Stock Data:

             

Basic and diluted net loss per share

  $ (0.95 ) $ (23.94 )

Book value per share

    (14.38 )   (13.46 )

Combined company

 
  Six Months
Ended
June 30, 2018
  Year Ended
December 31, 2017
 

Pro Forma Per Common Share Data:

             

Basic and diluted net loss per share

  $ (1.26 ) $ (7.38 )

Book value per share

    4.63     N/A  

Millendo unaudited pro forma equivalent per share data

 
  Six Months
Ended
June 30, 2018
  Year Ended
December 31, 2017
 

Pro Forma Per Common Share Data:

             

Basic and diluted net loss per share

  $ (1.77 ) $ (10.33 )

Book value per share

    6.48     N/A  

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MARKET PRICE AND DIVIDEND INFORMATION

        The OvaScience Common Stock is currently listed on The Nasdaq Capital Market under the symbol "OVAS." The following table presents the range of high and low per share sales prices for the OvaScience Common Stock as reported on The Nasdaq Stock Market for each of the periods set forth below. Millendo is a private company and the Millendo Common Stock and Millendo Preferred Stock are not publicly traded. These per share sales prices do not give effect to the Reverse Stock Split.

OvaScience Common Stock

 
  High   Low  

Year Ended December 31, 2018

             

First Quarter

  $ 1.52   $ 0.79  

Second Quarter

  $ 1.01   $ 0.71  

Third Quarter

  $ 0.97   $ 0.66  

Fourth Quarter (through November 2, 2018)

  $ 0.82   $ 0.66  

Year Ended December 31, 2017

             

First Quarter

  $ 2.05   $ 1.35  

Second Quarter

  $ 1.96   $ 1.25  

Third Quarter

  $ 1.73   $ 1.27  

Fourth Quarter

  $ 1.65   $ 1.33  

Year Ended December 31, 2016

             

First Quarter

  $ 11.50   $ 4.53  

Second Quarter

  $ 11.66   $ 4.59  

Third Quarter

  $ 8.98   $ 4.93  

Fourth Quarter

  $ 7.92   $ 1.30  

        The closing price of the OvaScience Common Stock on November 2, 2018, as reported on The Nasdaq Capital Market, was $0.79 per share.

        Because the market price of the OvaScience Common Stock is subject to fluctuation, the market value of the shares of the OvaScience Common Stock that Millendo Stockholders will be entitled to receive in the Merger may increase or decrease.

        Assuming approval of Proposal Nos. 1, 2 and 3 and successful application for initial listing with The Nasdaq Capital Market, following the consummation of the Merger, the OvaScience Common Stock will trade on The Nasdaq Capital Market under OvaScience's new name, "Millendo Therapeutics, Inc.," and new trading symbol "MLND."

        As of October 26, 2018, the Record Date for the Special Meeting, there were approximately 71 holders of record of the OvaScience Common Stock. As of October 26, 2018, Millendo had 12 holders of record of Millendo Common Stock and 30 holders of record of Millendo Preferred Stock. For detailed information regarding the beneficial ownership of certain OvaScience Stockholders upon consummation of the Merger, see the section titled "Principal Stockholders of the Combined Organization" in this proxy statement/prospectus/information statement.

Dividends

        OvaScience has never declared or paid any cash dividends on the OvaScience Common Stock and does not anticipate paying cash dividends on the OvaScience Common Stock for the foreseeable future. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Merger will be at the discretion of the combined organization's then-current board of directors and will depend upon a number of factors, including the combined organization's results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other

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factors the then-current board of directors deems relevant. Millendo has never paid or declared any cash dividends on the Millendo Capital Stock. If the Merger does not occur, Millendo does not anticipate paying any cash dividends on the Millendo Capital Stock in the foreseeable future, and Millendo intends to retain all available funds and any future earnings to fund the development and expansion of its business. Any future determination to pay dividends will be at the discretion of the Millendo Board of Directors and will depend upon a number of factors, including its results of operations, financial condition, future prospects, contractual restrictions, and restrictions imposed by applicable laws and other factors the Millendo Board of Directors deems relevant.

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RISK FACTORS

        The combined organization will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/information statement, you should carefully consider the material risks described below and those described in the section of this proxy statement/prospectus/information statement titled "Forward-Looking Statements" before deciding how to vote your shares of stock. In addition, you should read and consider the risks associated with the business of OvaScience because these risks may also affect the combined organization—these risks can be found in OvaScience's Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC and incorporated by reference into this proxy statement/prospectus/information statement. You should also read and consider the other information in this proxy statement/prospectus/information statement and the other documents incorporated by reference into this proxy statement/prospectus/information statement. Please see the section titled "Where You Can Find More Information" in this proxy statement/prospectus/information statement.

Risks Related to the Merger

The Exchange Ratio is not adjustable based on the market price of OvaScience Common Stock, so the Merger Consideration at Closing may have a greater or lesser value than the market price at the time the Merger Agreement was signed.

        The Merger Agreement has set the Exchange Ratio formula for Millendo Capital Stock, and the Exchange Ratio is adjustable upward or downward based on OvaScience's net cash at the Closing, changes in the outstanding Millendo Capital Stock, in connection with any additional financing consummated by Millendo at or before the Closing and changes in the outstanding OvaScience Common Stock, including in connection with the proposed Reverse Stock Split prior to completion of the Merger as described in the section titled "The Merger—Merger Consideration and Adjustment" in this proxy statement/prospectus/information statement. Any changes in the market price of OvaScience Common Stock before the completion of the Merger will not affect the number of shares Millendo Stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger, the market price of OvaScience Common Stock declines from the market price on the date of the Merger Agreement, then Millendo Stockholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the Merger, the market price of OvaScience Common Stock increases from the market price on the date of the Merger Agreement, then Millendo Stockholders could receive merger consideration with substantially more value for their shares of Millendo Capital Stock than the parties had negotiated in the establishment of the Exchange Ratio. The Merger Agreement does not include a price-based termination right. Because the Exchange Ratio does not adjust as a result of changes in the value of OvaScience Common Stock, for each one percentage point that the market value of OvaScience Common Stock rises or declines, there is a corresponding one percentage point rise or decline, respectively, in the value of the total merger consideration issued to Millendo Stockholders.

OvaScience's net cash may be less than $35.0 million at the Closing, which would result in OvaScience Stockholders owning a smaller percentage of the combined organization and could even result in the termination of the Merger Agreement.

        For purposes of the Merger Agreement, net cash is subject to certain reductions, including, without limitation, accounts payable, accrued expenses (except those related to the Merger), current liabilities payable in cash, unpaid expenses related to the Merger and certain other unpaid obligations, including outstanding lease obligations. In the event the amount of OvaScience's cash is smaller or such reductions are greater than anticipated, OvaScience Stockholders could hold a significantly smaller portion of the combined organization.

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Failure to complete the Merger may result in OvaScience and Millendo paying a termination fee or expenses to the other party, and could harm the price of OvaScience Common Stock and the future business and operations of each company.

        If the Merger is not completed, OvaScience and Millendo are subject to the following risks:

    if Merger Agreement is terminated under certain circumstances, either party may be required to pay the other party a termination fee of $3.0 million;

    if Merger Agreement is terminated in certain specified circumstances, Millendo may be required to pay OvaScience a termination fee of $15.0 million;

    if the Merger Agreement is terminated under certain circumstances, OvaScience or Millendo will be required to pay certain transaction expenses of the other party, up to a maximum of $1.0 million;

    the price of OvaScience Common Stock may decline and remain volatile; and

    substantial costs related to the Merger, such as legal and accounting fees, which must be paid even if the Merger is not completed.

        In addition, if the Merger Agreement is terminated and the OvaScience Board of Directors or the Millendo Board of Directors determines to seek another business combination, there can be no assurance that either OvaScience or Millendo will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the Merger.

The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes and other causes.

        In general, either OvaScience or Millendo can refuse to complete the Merger if there is a material adverse change affecting the other party between the date of the Merger Agreement, and the Closing. However, certain types of changes do not permit either party to refuse to complete the Merger, even if such change could be said to have a material adverse effect on OvaScience or Millendo, including:

    any rejection or non-acceptance by a governmental body of a registration or filing by OvaScience or Millendo relating to certain intellectual property rights of OvaScience or Millendo;

    the taking of any action, or the failure to take any action, by either OvaScience or Millendo required to comply with the terms of the Merger Agreement;

    changes in or affecting the industries in which either OvaScience or Millendo operate to the extent they do not disproportionately affect OvaScience or Millendo, respectively, taken as a whole;

    any change, effect or circumstance resulting from the announcement or pendency of the Merger or any related transactions;

    changes in general economic or political conditions or the securities market in general, whether as a result of acts of terrorism, war, whether or not declared, armed conflicts, natural disaster or otherwise, to the extent they do not disproportionately affect either OvaScience or Millendo, taken as a whole, or the commencement or continuation of war, terrorism or hostilities, or natural disasters or political events;

    any change in accounting requirements or principles of any change in applicable laws, rules or regulations or the interpretation thereof;

    any general economic or political conditions or conditions generally affecting the industries in which OvaScience and Millendo operate;

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    with respect to OvaScience, any change in the stock price or trading volume of OvaScience Common Stock excluding any underlying effect that may have caused such change;

    with respect to OvaScience, any changes in or affecting research and development, clinical trials or other drug development activities conducted by OvaScience or on its behalf in respect of OvaScience's products excluding any underlying liability resulting from those changes;

    with respect to OvaScience, continued losses from operations or decreases in OvaScience's cash balances or those of its subsidiaries; and

    with respect to Millendo, any change in the cash position of Millendo that results from operations in the ordinary course of business.

        If adverse changes occur and OvaScience and Millendo still complete the Merger, the price of OvaScience Common Stock may suffer. This in turn may reduce the value of the Merger to the OvaScience Stockholders, the Millendo Stockholders or both.

Some OvaScience and Millendo officers and directors have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

        Certain officers and directors of OvaScience and Millendo participate in arrangements that provide them with interests in the Merger that are different from yours, including, among others, the continued service as an officer or director of the combined organization, severance benefits, the acceleration of stock option vesting, continued indemnification and the potential ability to sell an increased number of shares of common stock of the combined organization in accordance with Rule 144 under the Securities Act of 1933, as amended (the "Securities Act"). For example, OvaScience has entered into certain employment and severance benefits agreements with each of its executive officers that may result in the receipt by such executive officers of cash severance payments and other benefits with a total value of approximately $2.3 million (collectively, not individually, and excluding the value of any accelerated vesting of stock awards) and the acceleration of stock awards held by those officers, including options to purchase shares of OvaScience Common Stock, based on data available as of September 1, 2018 and assuming a covered termination of employment of each executive officer's employment as of such date. The Closing will also result in the acceleration of vesting of a portion of the stock awards, including options to purchase approximately 2,021,039 shares of OvaScience Common Stock held by the OvaScience executive officers and directors (before giving effect to the proposed Reverse Stock Split), whether or not there is a covered termination of such officer's employment. For more information concerning the treatment of OvaScience options in connection with the Merger, see the section titled "The Merger Agreement—Treatment of OvaScience Options" in this proxy statement/prospectus/information statement. In addition, and for example, certain of Millendo's directors and executive officers have options, subject to vesting, to purchase shares of Millendo Common Stock which, at the Closing, shall be converted into and become options to purchase shares of OvaScience Common Stock; certain of Millendo's directors and executive officers are expected to become directors and executive officers of OvaScience upon the Closing; and all of Millendo's directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. These interests, among others, may influence the officers and directors of OvaScience and Millendo to support or approve the Merger. For more information concerning the interests of OvaScience and Millendo executive officers and directors, see the sections titled "The Merger—Interests of the OvaScience Directors and Executive Officers in the Merger" and "The Merger—Interests of the Millendo Directors and Executive Officers in the Merger" in this proxy statement/prospectus/information statement.

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The market price of OvaScience Common Stock following the Merger may decline as a result of the Merger.

        The market price of OvaScience Common Stock may decline as a result of the Merger for a number of reasons if:

    investors react negatively to the prospects of the combined organization's business and prospects from the Merger;

    the effect of the Merger on the combined organization's business and prospects is not consistent with the expectations of financial or industry analysts; or

    the combined organization does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts.

OvaScience Stockholders and Millendo Stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

        If the combined organization is unable to realize the full strategic and financial benefits currently anticipated from the Merger, OvaScience Stockholders and Millendo Stockholders will have experienced substantial dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined organization is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

OvaScience Stockholders and Millendo Stockholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined organization following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.

        After the completion of the Merger, the current OvaScience Stockholders and Millendo Stockholders will own a smaller percentage of the combined organization than their ownership of their respective companies prior to the Merger. As of the date of the execution of the Merger Agreement, it was determined that immediately after the consummation of the Merger, based solely on the sample Exchange Ratio of 0.1173 set forth below, Millendo Securityholders would own approximately 82% of the Fully Diluted Closing OvaScience Common Stock (as defined below), and OvaScience Securityholders would own approximately 18% of the Fully Diluted Closing OvaScience Common Stock (as defined below), subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement. The initial estimate of the Exchange Ratio set forth below assumed (i) that OvaScience would have between $40 million and $42 million in net cash immediately prior to Closing, (ii) a Pre-Closing Financing amount of $30.0 million, (iii) OvaScience outstanding shares and options as of the Closing would be equal to 3,721,460 (on a post reverse stock split basis), (iv) Millendo shares as of the Closing would be equal to 148,171,273 (on a fully-diluted, as-converted basis) and (v) a reverse stock split of every 10 shares of outstanding OvaScience Common Stock being combined and reclassified into one share of OvaScience Common Stock).

        The Exchange Ratio is calculated using a formula intended to allocate a percentage of the combined organization to existing Millendo Securityholders. Based on the assumptions described above, the Exchange Ratio would have been equal to approximately 0.1173 post-reverse split shares of OvaScience Common Stock for each share of Millendo Common Stock. The Exchange Ratio is subject to change based on the amount of OvaScience net cash, changes in the capitalization of OvaScience or Millendo prior to the Closing and the amount raised by Millendo in the Pre-Closing Financing (and as a result, OvaScience Securityholders and Millendo Securityholders could own more or less of the combined organization). Immediately prior to the Effective Time, each share of Millendo preferred stock and Millendo class-1 common stock will be converted into Millendo Common Stock. After the initial signing of the Merger Agreement, the valuations for Millendo and OvaScience were reduced, as further described in this proxy statement/prospectus/information statement. In addition, OvaScience

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currently estimates, assuming for this purpose a closing date of November 30, 2018 that (i) it will have approximately $37.6 million in net cash immediately prior to Closing, (ii) the Pre-Closing Financing amount will be approximately $29.5 million, (iii) OvaScience outstanding shares and options as of the Closing will be equal to 3,727,669 (on a post reverse stock split basis) and (iv) the Millendo shares as of the Closing on a fully diluted and as-converted basis will be equal to 152,629,595. Accordingly, it is currently estimated that the Exchange Ratio at Closing will be approximately 0.1070 and, based solely on such Exchange Ratio, at Closing: (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 67.1% of the Fully Diluted Closing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 13.1% of the Fully Diluted Closing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 18.6% of the Fully Diluted Closing OvaScience Common Stock, and (d) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.2% of the Fully Diluted Closing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. Additionally, it is anticipated that the Post-Closing Financing (as defined below) will close shortly after the Closing, which would dilute, and thereby reduce, each then existing OvaScience Securityholder's proportionate holdings. Assuming that the Post-Closing Financing closes immediately after the Merger as well as the other aforementioned assumptions, it is expected that (a) Millendo Securityholders as of immediately prior to the Merger (not including the shares issued in the Pre-Closing Financing) will own approximately 61.7% of the Fully Diluted Post-Financing OvaScience Common Stock (as defined below), (b) the shares issued in the Pre-Closing Financing to Millendo Securityholders as of immediately prior to the Merger will represent approximately 12.0% of the Fully Diluted Post-Financing OvaScience Common Stock, (c) the OvaScience Securityholders as of immediately prior to the Merger (excluding for this purpose certain out-of-the-money OvaScience Options) will own approximately 17.1% of the Fully Diluted Post-Financing OvaScience Common Stock, (d) the shares issued in the Post-Closing Financing to the Post-Closing Financing Investor (as defined below) will represent approximately 8.1% of the Fully Diluted Post-Financing OvaScience Common Stock, and (e) the shares available for issuance under the Millendo Plan as of immediately prior to the Merger will represent approximately 1.1% of the Fully Diluted Post-Financing OvaScience Common Stock, in each case, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement and described herein. "Fully Diluted Closing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan). "Fully Diluted Post-Financing OvaScience Common Stock" as used herein means (x) Orion Outstanding Shares (as defined in the Merger Agreement, which figure excludes the shares available for issuance under the 2012 Plan and a portion of the out-of-the-money OvaScience Options) plus (y) Company Outstanding Shares (as defined in the Merger Agreement, which figure includes the shares available for issuance under the Millendo Plan) plus (z) the Post-Closing Financing shares.

During the pendency of the Merger, OvaScience and Millendo may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

        Covenants in the Merger Agreement impede the ability of OvaScience and Millendo to make acquisitions, subject to certain exceptions relating to fiduciary duties, as set forth below, or to complete other transactions that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally

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prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets or other business combination outside the ordinary course of business with any third party, subject to certain exceptions relating to fiduciary duties, as set forth below. Any such transactions could be favorable to such party's stockholders.

Certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.

        The terms of the Merger Agreement prohibit each of OvaScience and Millendo from soliciting alternative takeover proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when such party's board of directors determines in good faith that an unsolicited alternative takeover proposal is or is reasonably likely to be inconsistent with the board's fiduciary duties. Moreover, even if a party receives what the party's board of directors determine is a superior proposal, the Merger Agreement does not permit either party to terminate the Merger Agreement to enter into a superior proposal.

Because the lack of a public market for Millendo Capital Stock makes it difficult to evaluate the value of Millendo Capital Stock, the Millendo Stockholders may receive shares of OvaScience Common Stock in the Merger that have a value that is less than, or greater than, the fair market value of Millendo Capital Stock.

        The outstanding Millendo Capital Stock is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Millendo Capital Stock. Because the percentage of OvaScience equity to be issued to Millendo Stockholders was determined based on negotiations between the parties, it is possible that the value of the OvaScience Common Stock to be received by Millendo Stockholders will be less than the fair market value of Millendo Capital Stock, or OvaScience may pay more than the aggregate fair market value of Millendo Capital Stock.

If the conditions of the Merger are not met, the Merger will not occur.

        Even if the Merger is approved by OvaScience Stockholders and Millendo Stockholders, specified conditions must be satisfied or waived, except for the Pre-Closing Financing, which condition cannot be waived, to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled "The Merger Agreement—Conditions to Completion of the Merger" in this proxy statement/prospectus/information statement. OvaScience and Millendo cannot assure you that all of the conditions will be satisfied or waived. If the conditions are not satisfied or waived, the Merger will not occur or will be delayed, and OvaScience and Millendo each may lose some or all of the intended benefits of the Merger.

The Merger may fail to qualify as a reorganization for U.S. federal income tax purposes, resulting in recognition of taxable gain or loss by Millendo Stockholders in respect of their Millendo Capital Stock.

        OvaScience and Millendo intend for the Merger to qualify as a reorganization within the meaning of Section 368(a) of the Code, as described in the section titled "The Merger—Material U.S. Federal Income Tax Consequences of the Merger" in this proxy statement/prospectus/information statement. In the event that the Merger does not qualify as a reorganization, the Merger would result in taxable gain or loss for each Millendo Stockholder, with the amount of such gain or loss determined by the amount that each Millendo Stockholder's adjusted tax basis in the Millendo Capital Stock surrendered is less or more than the fair market value of the OvaScience Common Stock and any cash in lieu of a fractional share received in exchange therefor. Each holder of Millendo Capital Stock is urged to consult with his, her or its own tax advisor with respect to the tax consequences of the Merger.

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The combined organization may become involved in securities class action litigation that could divert management's attention and harm the combined organization's business and insurance coverage may not be sufficient to cover all costs and damages.

        In the past, securities class action or shareholder derivative litigation often follows certain significant business transactions, such as the sale of a business division or announcement of a Merger. The combined organization may become involved in this type of litigation in the future. Litigation often is expensive and diverts management's attention and resources, which could adversely affect the combined organization's business.

Risks Related to the Proposed Reverse Stock Split

The proposed Reverse Stock Split may not increase the combined organization's stock price over the long-term.

        The principal purpose of the proposed Reverse Stock Split is to increase the per-share market price of OvaScience Common Stock. It cannot be assured, however, that the proposed Reverse Stock Split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of OvaScience Common Stock will proportionally increase the market price of OvaScience Common Stock, it cannot be assured that the proposed Reverse Stock Split will increase the market price of OvaScience Common Stock by a multiple of the proposed Reverse Stock Split ratio, or result in any permanent or sustained increase in the market price of OvaScience Common Stock, which is dependent upon many factors, including the combined organization's business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of the combined organization might meet the continued listing requirements for The Nasdaq Capital Market initially, it cannot be assured that it will continue to do so.

The proposed Reverse Stock Split may decrease the liquidity of the combined organization's common stock.

        Although the OvaScience Board of Directors believes that the anticipated increase in the market price of the combined organization's common stock could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the proposed Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for OvaScience Common Stock.

The proposed Reverse Stock Split may lead to a decrease in the combined organization's overall market capitalization.

        Should the market price of the combined organization's common stock decline after the proposed Reverse Stock Split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the proposed Reverse Stock Split. A reverse stock split may be viewed negatively by the market and, consequently, can lead to a decrease in the combined organization's overall market capitalization. If the per share market price does not increase in proportion to the proposed Reverse Stock Split ratio, then the value of the combined organization, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of OvaScience Common Stock will remain the same after the proposed Reverse Stock Split is effected, or that the proposed Reverse Stock Split will not have an adverse effect on the stock price of OvaScience Common due to the reduced number of shares outstanding after the proposed Reverse Stock Split.

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Risks Related to OvaScience

Risks Related to the Proposed Merger with Millendo

If OvaScience does not successfully consummate the Merger with Millendo or another strategic transaction, the OvaScience Board of Directors may decide to pursue a dissolution and liquidation of OvaScience. In such an event, the amount of cash available for distribution to OvaScience Stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, as to which we can give you no assurance.

        There can be no assurance that the Merger will be completed. If the Merger is not completed, the OvaScience Board of Directors may decide to pursue a dissolution and liquidation of OvaScience. In such an event, the amount of cash available for distribution to OvaScience Stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution continues to decrease as OvaScience funds its operations while pursuing the Merger. In addition, if the OvaScience Board of Directors were to approve and recommend, and the OvaScience Stockholders were to approve, a dissolution and liquidation of OvaScience, OvaScience would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to stockholders. OvaScience's commitments and contingent liabilities may include (i) obligations under its employment and related agreements with certain employees that provide for severance and other payments following a termination of employment occurring for various reasons, including a change in control of OvaScience; (ii) litigation against OvaScience, and other various claims and legal actions arising in the ordinary course of business; and (iii) non-cancelable facility lease obligations. As a result of this requirement, a portion of OvaScience's assets would need to be reserved pending the resolution of such obligations.

        In addition, OvaScience may be subject to litigation or other claims related to a dissolution and liquidation of OvaScience. If a dissolution and liquidation were to be pursued, the OvaScience Board of Directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of OvaScience Common Stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of OvaScience. A liquidation would be a lengthy and uncertain process with no assurance of any value ever being returned to the OvaScience Stockholders.

OvaScience is substantially dependent on its remaining employees to facilitate the consummation of the Merger.

        OvaScience's ability to successfully complete the Merger, or if the Merger is not completed, another potential strategic transaction, depends in large part on OvaScience's ability to retain certain of its remaining personnel, particularly Christopher Kroeger, OvaScience's president and chief executive officer. Despite OvaScience's efforts to retain these employees, one or more may terminate their employment with OvaScience on short notice. The loss of the services of any of these employees could potentially harm OvaScience's ability to evaluate and pursue strategic alternatives, as well as fulfill OvaScience's reporting obligations as a public company.

Risks Related to OvaScience's Financial Position and Need for Additional Capital

OvaScience has incurred significant losses since its inception. OvaScience expects to incur losses for the foreseeable future and may never achieve or maintain profitability.

        Since OvaScience's inception, OvaScience has incurred significant operating losses. OvaScience's net loss was $51.0 million for the year ended December 31, 2017 and $15.1 million for the six months ended June 30, 2018. As of December 31, 2017, OvaScience had an accumulated deficit of $301.5 million. OvaScience has recorded limited revenues to date and has financed its operations

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primarily through equity financings. OvaScience has devoted significant efforts to research and development, acquiring its technology, researching and developing the OvaPrime, OvaTure and AUGMENT treatments and, previously, to building out its international infrastructure.

        OvaScience expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses OvaScience incurs may fluctuate significantly from quarter to quarter. OvaScience anticipates that its expenses will increase if and as OvaScience:

    advances the clinical development of OvaPrime;

    pursues OvaTure maturation and fertilization studies;

    continues advancing the preclinical development of OvaTure, both internally and in collaboration with commercial and academic partners;

    educates physicians and embryologists regarding the use of the OvaPrime and OvaTure treatments;

    in the long term, establishes a domestic and international sales, marketing, manufacturing and distribution infrastructure to commercialize OvaScience's fertility treatments;

    initiates any additional preclinical studies and clinical trials of OvaScience's fertility treatments;

    continues to discuss the future of the OvaXon joint venture with Intrexon;

    seeks any required approvals from the FDA or similar regulatory agencies outside of the United States, which OvaScience refers to as Foreign Regulatory Authorities, for its potential fertility treatments;

    maintains, expands and protects its intellectual property portfolio;

    hires additional scientific, clinical, quality control and management personnel to support its fertility treatment development efforts;

    seeks to identify additional potential fertility treatments; and

    develops, acquires or in-licenses other potential fertility treatments and technologies

        To become and remain profitable, OvaScience must develop and eventually commercialize its potential fertility treatments with significant market potential, including OvaPrime and OvaTure, and determine strategies to scale OvaScience's treatments commercially. This will require OvaScience to be successful in a range of challenging activities, completing preclinical and clinical trials for its treatments, obtaining any necessary regulatory approvals and successfully commercializing, either alone or with partners. OvaScience may never succeed in these activities and, even if it does, may never generate revenues that are significant or large enough to achieve profitability. If OvaScience does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. OvaScience's failure to become and remain profitable would decrease its value and could impair OvaScience's ability to raise capital, maintain its research and development efforts, expand its business or continue its operations.

OvaScience will need substantial additional funding. If OvaScience is unable to raise capital when needed, OvaScience would be forced to delay, reduce or eliminate its fertility treatment development programs.

        OvaScience expects its expenses to increase in connection with its ongoing activities, particularly as OvaScience continues the development of its fertility treatments. OvaScience expects to incur significant expenses with respect to the continued development and clinical trials for its fertility treatments. OvaScience's clinical trials will be costly. Furthermore, OvaScience expects to continue to incur costs associated with operating as a public company. Accordingly, it will need to obtain substantial additional funding in connection with its continuing operations. If OvaScience is unable to raise capital when

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needed or on attractive terms, OvaScience will be forced to delay, reduce or eliminate some or all of its research and development programs.

        OvaScience believes that its cash and cash equivalents and short-term investments of approximately $53.6 million at June 30, 2018, will be sufficient to fund its current operating plan for at least the next 12 months. There can be no assurances, however, that the current operating plan will be achieved or that additional funding, if needed, will be available on terms acceptable to OvaScience, or at all.

        Identifying, developing and commercializing potential fertility treatments is a time consuming, expensive and uncertain process that takes years to complete. OvaScience may fail to achieve sufficient revenues from its fertility treatments to achieve profitability on its expected timelines or at all. OvaScience will need to continue to rely on additional financing to achieve its business objectives. Adequate additional financing may not be available to OvaScience on acceptable terms, or at all.

        Until the time, if ever, that OvaScience can generate sufficient revenues from its potential fertility treatments, OvaScience plans to finance its cash needs through some combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. OvaScience does not have any committed external source of funds. To the extent that OvaScience raises additional capital through the sale of equity or convertible debt securities, the ownership interest of OvaScience's existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of OvaScience's existing stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

        If OvaScience raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, OvaScience may have to relinquish valuable rights to its technologies, future revenue streams, research programs or potential fertility treatments or grant licenses on terms that may not be favorable to OvaScience.

OvaScience has been in the past, and remains, the subject of securities class action lawsuits and shareholder derivative lawsuits, the unfavorable outcomes of which may have a material adverse effect on OvaScience's financial condition, results of operations and cash flows.

        In October 2015, a purported class action lawsuit was filed in the Suffolk County Superior Court in the Commonwealth of Massachusetts, against OvaScience, certain of its executive officers, the members of the OvaScience Board of Directors and certain of the underwriters from OvaScience's January 2015 follow-on public offering of its common stock by investors alleging violations of the Securities Act. The plaintiffs' motion for class certification was denied, and the court entered summary judgment dismissing the claims of all but one of the plaintiffs. Thereafter, the case was voluntarily dismissed. The remaining plaintiff also filed a substantially similar putative class action complaint in the U.S. District Court for the District of Massachusetts (the "Westmoreland Federal Action"). On March 24, 2017, a second purported shareholder class action lawsuit was filed against OvaScience and certain of OvaScience's former officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Dahhan Action"). The Westmoreland Federal Action has been dismissed without prejudice to the plaintiff's ability to pursue damages, if any, only as a member of the putative class in the Dahhan Action.

        On November 9, 2016, a purported shareholder derivative action was filed against certain present and former officers and directors of OvaScience and OvaScience as a nominal defendant, alleging breaches of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement and corporate waste for purported actions related to its January 2015 follow-on public offering. On June 30, 2017, a second purported shareholder derivative action was filed against certain of OvaScience's present and former directors and OvaScience as a nominal defendant, alleging breach of fiduciary duties, waste of corporate assets, unjust enrichment, and violations of Section 14(a) of the Securities Exchange Act of

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1934, alleging that compensation awarded to the director defendants was excessive. The parties have reached a settlement of the action whereby OvaScience agreed to seek shareholder approval for certain changes to non-employee director compensation. OvaScience also has agreed to pay $300,000 in attorney's fees to plaintiff's counsel. Following a hearing held on August 30, 2018, the court issued an order approving the settlement, and the case is now closed.

        On July 27, 2017, a third purported shareholder derivative complaint was filed against certain of OvaScience's present and former directors and OvaScience as a nominal defendant, alleging breach of fiduciary duty, unjust enrichment, and violations of Section 14(a) of the Securities Exchange Act of 1934 alleging that compensation awarded to the director defendants was excessive and seeking redress for purported actions related to OvaScience's January 2015 follow-on public offering and other public statements. On September 26, 2017, the plaintiffs filed an amended complaint, which eliminated all claims regarding allegedly excessive director pay. The court granted the defendants' motion to dismiss the amended complaint for failure to state a claim for relief under Section 14(a). The court also dismissed the plaintiffs' pendent state law claims without prejudice, based on lack of subject matter jurisdiction. On April 25, 2018, the plaintiffs moved for leave to amend the complaint, and to stay this case pending the outcome of the Westmoreland Federal Action and the Dahhan Action. The defendants do not believe that the proposed amended complaint cures the defects in the current complaint, but informed plaintiffs' counsel that, in the interest of judicial economy, the defendants would not oppose the proposed amendment if the court would consider staying the case pending the resolution of the Dahhan Action and a now-dismissed Westmoreland Federal Action. On April 27, 2018, the court granted the plaintiffs' motion for leave to amend the complaint and for a stay. On April 30, 2018, plaintiffs filed their Second Amended Shareholder Derivative Complaint. On May 23, 2018, the court entered an order staying this case pending the resolution of the Dahhan Action and the Westmoreland Federal Action. While OvaScience believes it has substantial legal and factual defenses to these claims in these lawsuits and will vigorously defend the lawsuits, the outcome of litigation is difficult to predict and quantify, and the defense against such claims or actions can be costly and divert management resources. In connection with these lawsuits, OvaScience could incur substantial costs, and such costs and any related settlements or judgments may not be covered by insurance.

        On October 16, 2018, an OvaScience stockholder filed a complaint in the U.S. District Court for the District of Delaware against OvaScience, its chief executive officer, and the members of the OvaScience Board of Directors, alleging violations of Sections 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, and as against the individual defendants, alleging violations of Section 20(a) of the Exchange Act. The plaintiff alleges that the defendants made materially misleading disclosures in the Registration Statement on Form S-4 of which this proxy statement/prospectus/information statement forms a part, in connection with OvaScience's proposed merger with Millendo by allegedly omitting material information concerning the sale process. The plaintiff seeks declaratory and injunctive relief to enjoin the proposed merger with Millendo, rescissory damages against the individual defendants, including pre-judgment and post-judgment interest, costs, and attorneys' fees. OvaScience believes that the complaint is without merit and intends to defend against the litigation. There can be no assurance, however, that OvaScience will be successful. At present, OvaScience is unable to estimate potential losses, if any, related to the lawsuit.

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Risks Related to Research, Development and Commercialization of OvaScience's Potential Fertility Treatments

OvaScience changed its corporate strategy to focus on OvaPrime and OvaTure, each of which is at a substantially earlier stage of development than AUGMENT. As a result, it will take a longer period of time for OvaScience to complete the development of, and to commercialize, any products that will generate meaningful revenues.

        In December 2016, OvaScience announced that it would slow the commercial expansion of AUGMENT, reassess its ongoing and planned clinical studies of AUGMENT, and undertake a corporate restructuring, and in June 2017, OvaScience announced that it would discontinue ongoing efforts related to the AUGMENT treatment outside of North America. In January 2018, OvaScience announced a further corporate restructuring designed to streamline its operations and reduce its cost structure. OvaPrime and OvaTure are at a substantially earlier stage of development than AUGMENT. Accordingly, OvaScience expects that it will take a longer period of time for it to complete the development of, and to generate revenues from the sale of, OvaScience's treatments than it would have had OvaScience continued to pursue the commercial expansion of AUGMENT in accordance with its previous corporate strategy. The process of developing OvaTure and OvaPrime is uncertain and may never yield treatments that allow OvaScience to achieve revenue from their sale, and if OvaScience does succeed in developing treatments for sale, OvaScience may never be able to develop a profitable commercial model.

The science underlying OvaPrime, OvaTure and AUGMENT is based on recent discoveries, and as a result the programs are subject to a higher level of risk than programs based on longer established science. Additionally, the OvaPrime treatment and OvaTure treatment are at early stages of clinical and preclinical development, respectively, and may never yield treatments that can be successfully commercialized.

        OvaPrime, OvaTure and AUGMENT are based on recent scientific discoveries relating to egg precursor cells. As a result, the programs are subject to a higher level of risk than programs based on longer established science.

        With respect to OvaTure, while OvaScience has observed key criteria of developmental competence in EggPC cell-derived eggs in both human and bovine models, OvaScience will not know if it has successfully developed fertilizable, mature eggs until OvaScience has successfully fertilized them, and OvaScience may never succeed in fertilizing human or bovine EggPC cell-derived eggs. OvaScience may find that there are important criteria for developmental competence that OvaScience is not observing, or that elements of the criteria for maturity that OvaScience has observed are inadequately developed for fertilization. To date, OvaScience's efforts to fertilize bovine EggPC cell-derived eggs have failed. Further, OvaScience will require authorization from regulatory bodies outside of the United States to attempt to fertilize a human Egg PC cell-derived egg before OvaScience can test any eggs that it does mature. There are significant aspects of OvaTure that will require additional innovation for OvaScience to continue its development. The recent nature of the scientific discoveries underlying OvaTure, the need for additional innovation and the absence of information about egg precursor cell technology from human clinical trials all increase the risks associated with this potential fertility treatment. In any event, OvaScience believes that it will be costly and time consuming to develop and successfully commercialize OvaTure, and OvaScience may not succeed in doing so.

OvaScience may not be able to successfully develop OvaTure, OvaPrime or other potential fertility treatments.

        In 2016, OvaScience began a clinical trial of OvaPrime in Canada, and in January 2018, OvaScience announced initial clinical data from this trial. The successful enrollment of patients in any future clinical studies and their results, including whether and by how much OvaPrime restores egg production, will impact OvaScience's ability to further introduce the treatment, obtain approval where necessary, and ultimately generate revenues from any sales of OvaPrime. If the results of the clinical

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trials are unfavorable, OvaPrime may not be viable or significant additional time and expense could be required before OvaScience is able to commercialize this potential fertility treatment. OvaScience's OvaTure program is in preclinical development, and OvaScience may not succeed in fertilizing an EggPC cell-derived egg, determining a clinical and regulatory pathway for OvaTure, or developing a viable commercial model for the treatment if OvaScience succeeds in its development efforts. Further, the time it takes to achieve discovery stage goals can is unpredictable.

OvaScience faces significant risks associated with clinical trials.

        Clinical studies are expensive, difficult to design and implement and uncertain as to outcome. Regulatory authorities and IRB or ethics committees regulate clinical trials and can suspend or terminate them for many reasons, or require additional expensive and time consuming preclinical work. Success in animal and preclinical studies does not ensure that studies in humans will be successful, and interim or preliminary findings do not necessarily predict final results. OvaScience's potential fertility treatments rely on new and complex technology that impacts human reproductive systems. Therefore, regulatory authorities and ethics committees may be especially cautious in reviewing and approving its clinical protocols for such potential fertility treatments.

        The timing of results from and completion of the studies will depend, in part, on OvaScience's ability to enroll clinic sites and patients in the studies on the timeline expected. Enrollment in any studies could be delayed for a number of reasons, including the unwillingness of patients to undergo, or physicians to prescribe, an additional surgical procedure in connection with IVF.

        Patient and clinical site enrollment may be affected by other factors, including:

    timing and capacity of tissue processing facilities and third party manufacturers;

    novelty of the potential fertility treatments being tested;

    form of infertility or severity of the condition being treated;

    eligibility criteria for the study in question;

    rates of success of competitive fertility treatments;

    perceived risks and benefits of the potential fertility treatments under study;

    any negative publicity or political or governmental action related to OvaScience's or its competitors' potential fertility treatments or IVF;

    known side effects of the potential fertility treatments under study, if any;

    efforts of IVF clinics to facilitate enrollment in studies or clinical trials;

    patient referral practices of physicians;

    ability to monitor patients adequately during and after treatment; and

    proximity and availability of clinical trial sites for prospective patients.

        OvaScience's inability to enroll a sufficient number of clinic sites or patients for clinical trials for OvaPrime or OvaScience's other fertility treatments would result in significant delays or may require OvaScience to abandon one or more clinical trials altogether. Enrollment delays in OvaScience's clinical trials may result in increased development costs for OvaScience's potential fertility treatments, which would cause the value of OvaScience to decline and limit its ability to obtain additional financing.

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Even if OvaScience is able to commercialize any of its fertility treatments, OvaScience may fail to achieve the degree of market acceptance by physicians, patients and others in the medical community necessary for commercial success.

        Even if OvaScience is able to commercialize any of its fertility treatments, OvaScience may nonetheless fail to gain sufficient market acceptance by physicians, patients and others in the medical community. For example, doctors may continue to rely on current treatments, including fertility drugs and standard IVF, which are well established in the medical community. In addition, the novel nature of, as well as the need for a laparoscopic biopsy to be performed in connection with AUGMENT, OvaPrime and OvaTure may affect market acceptance by physicians and patients, if and when they receive regulatory approval as required. OvaScience's ability to gain market acceptance of OvaScience's treatments will depend on the experience women have with these treatment options over time. If OvaScience's potential fertility treatments do not achieve an adequate level of acceptance, OvaScience may not generate significant treatment revenues and OvaScience may not become profitable. The degree of market acceptance of OvaScience's fertility treatments, after receipt of any necessary licenses or approvals, will depend on a number of factors, including:

    efficacy and potential advantages as compared to standard IVF or other alternative treatments;

    ability to reduce the number of IVF cycles required to achieve a live birth;

    ability to reduce the cost of standard IVF;

    ability to reduce the incidence of multiple births;

    the willingness of the target population to undergo, and of physicians to prescribe, an additional surgical procedure in connection with IVF;

    convenience compared to alternative treatments;

    adverse effects on mothers or on children conceived using OvaScience's potential fertility treatments;

    ability to improve the side effect profile of infertility treatment;

    the willingness of the target population and of physicians to try new therapies based on recent scientific discoveries;

    limitations on the existing infrastructure to support potential fertility treatments, including adequately trained embryologists and the willingness of IVF clinics to incorporate the process into their current treatment regimens;

    the willingness and ability of patients to pay out of pocket for OvaScience's potential fertility treatments, which will be in addition to the price of a standard IVF procedure;

    whether IVF clinics believe OvaScience's treatments will provide them with a competitive and economic advantage;

    any negative publicity or governmental or political action related to fertility treatments or IVF; and

    the strength of marketing and distribution support.

        In addition, OvaScience's ability to successfully commercialize its potential fertility treatments will depend on the continued use and acceptance of IVF, ICSI and fertility treatments generally. To the extent that the medical community or patient population determines that these procedures are unsafe or are otherwise not generally accepted, the market for OvaScience's potential fertility treatments and, therefore, OvaScience's business would be negatively affected.

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If OvaScience is unable to establish sales and marketing capabilities or enter into additional agreements with third parties to sell and market their potential fertility treatments, OvaScience may not be successful in commercializing them.

        To achieve commercial success for any potential fertility treatment, OvaScience must either develop a sales and marketing team or outsource these functions to third parties.

        There are risks involved both with establishing OvaScience's own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay the introduction of any fertility treatment. If the commercial introduction or expansion of OvaScience's treatments for which OvaScience recruits a sales force and establishes marketing capabilities is delayed or does not occur for any reason, OvaScience would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and OvaScience's investment would be lost if OvaScience cannot retain or reposition its sales and marketing personnel. For example, OvaScience incurred restructuring costs in connection with the corporate restructurings that it announced in December 2016, June 2017 and January 2018.

        If OvaScience enters into arrangements with third parties to perform sales, marketing and distribution services, OvaScience's treatment revenues or the profitability of these treatment revenues to OvaScience are likely to be lower than if OvaScience was to market and sell any potential fertility treatment itself. In addition, OvaScience may not be successful in entering into arrangements with third parties to sell and market their potential fertility treatments or may be unable to do so on terms that are favorable to OvaScience. OvaScience likely will have limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market OvaScience's potential fertility treatments effectively and in compliance with applicable laws.

OvaScience may not be successful in obtaining necessary rights to additional technologies or potential fertility treatments, including from OvaScience's scientific founders, for OvaScience's development pipeline through acquisitions and in-licenses.

        OvaScience may be unable to acquire or in-license additional technologies or potential fertility treatments from third parties, including OvaScience's scientific founders, in order to grow OvaScience's business. A number of more established companies may also pursue strategies to license or acquire potential fertility treatments that OvaScience may consider attractive. These established companies may have a competitive advantage over OvaScience due to their size, cash resources and greater clinical development and commercialization capabilities.

        For example, OvaScience's scientific founders continue to be active in the field of infertility and may develop new potential fertility treatments or intellectual property based on their continued research relating to infertility. The rights to new inventions by OvaScience's scientific founders generally belong to the hospitals and academic institutions at which they are employed and are not subject to license or other rights in their favor. In the event that OvaScience's scientific founders, or other third party scientists or entities, develop potential fertility treatments or intellectual property that they wish to acquire or in-license, they may be unable to negotiate such acquisition or in-license. OvaScience's failure to reach an agreement for any applicable potential fertility treatment or intellectual property could result in a third party acquiring the related rights and thereby harm OvaScience's business.

        In addition, companies that perceive OvaScience to be a competitor may be unwilling to assign or license rights to OvaScience. OvaScience also may be unable to license or acquire relevant potential fertility treatments on terms that would allow OvaScience to make an appropriate return on their investment.

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        OvaScience expects that competition for acquiring and in-licensing potential fertility treatments that are attractive to OvaScience may increase in the future, which may mean fewer suitable opportunities for OvaScience as well as higher acquisition or licensing costs. If OvaScience is unable to successfully obtain rights to suitable potential fertility treatments on reasonable terms, or at all, OvaScience's business, financial condition and prospects for growth could suffer.

OvaScience faces substantial competition, including from more established infertility treatments, such as standard IVF, as well as advances in new artificial reproductive technologies, which may result in others discovering, developing or commercializing potential fertility treatments before or more successfully than OvaScience does.

        There are a number of fertility treatments that are generally accepted in the medical and patient communities, including fertility drugs, IUI and IVF. Competition in the infertility market is largely based on pregnancy and live birth rates and side effects of treatment on patients. Accordingly, OvaScience's success is highly dependent on its ability to develop potential fertility treatments that improve pregnancy and live birth rates and reduce risks and side effects, as compared to existing treatments. The ability of any potential fertility treatment that OvaScience successfully develops to reduce the overall costs associated with IVF also will be an important competitive factor.

        Competitors may develop new infertility drugs, assisted reproductive technology, or ART, therapies, devices and techniques that could render obsolete OvaScience's potential fertility treatments. There are a number of pharmaceutical companies, biotechnology companies, universities and research organizations actively engaged in research and development of potential fertility treatments. Like OvaScience's treatments, some of these potential fertility treatments are designed to address the shortcomings of IVF. In particular, OvaScience is aware of a number of companies and laboratories that are currently developing potential fertility treatments intended to identify high quality embryos for use in IVF, a university study of the transfer of granulosa cell mitochondria into eggs, a university study using pronuclear transfer for improvement in IVF success rates and a university study of induced pluripotent stem cells, or iPS, shows that iPS cells can be generated from somatic cells and programmed to become differentiated cells, which can include germ line cells such as oocytes. If successfully developed, these potential fertility treatments could improve outcomes and alleviate some of the other shortcomings of standard IVF, thereby decreasing the need for OvaScience's potential fertility treatments. At this time, OvaScience cannot evaluate how its potential fertility treatments, if successfully developed and commercialized, would compare technologically, clinically or commercially to any other potential fertility treatments being developed or to be marketed by competitors. There can be no assurance that OvaScience will be able to compete effectively.

        OvaScience's competitors may develop and commercialize new technologies before OvaScience does, allowing them to offer potential fertility treatments, services or solutions that are superior to those that they may offer or which establish market positions before the time, if any, at which OvaScience is able to bring potential fertility treatments to the market. Many of OvaScience's competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than they do and significantly greater experience in the discovery and development of potential fertility treatments, obtaining FDA and other regulatory approvals of potential fertility treatments and the commercialization of those treatments. Accordingly, OvaScience's competitors may be more successful than OvaScience in developing, commercializing and achieving widespread market acceptance. OvaScience's competitors' potential fertility treatments may be safer, more effective or more effectively marketed and sold than any treatment OvaScience may commercialize and may render OvaScience's potential fertility treatments obsolete or non-competitive before OvaScience can recover the expenses of developing and commercializing any of OvaScience's potential fertility treatments. OvaScience anticipates that it will face intense and increasing competition as new treatments enter the market and advanced technologies become available.

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OvaScience could be subject to negative publicity, political action and additional regulation because of the nature of OvaScience's potential fertility treatments. These factors could increase OvaScience's development and commercialization costs.

        OvaScience's potential fertility treatments are based on innovative science regarding eggs, embryos and fertilization. These can be controversial subjects and, as a result, OvaScience could be subject to adverse publicity, political reaction and regulation, as well as changes to the laws and regulations affecting OvaScience's potential fertility treatments. This may result in OvaScience incurring costs beyond what OvaScience anticipates in order to develop and commercialize OvaScience's potential fertility treatments or may make it impossible to develop OvaScience's potential fertility treatments at all. Bad publicity could also delay or impede OvaScience's ability to obtain any necessary licenses or authorizations for OvaScience or OvaScience's clinic accounts to introduce or continue to provide OvaScience's treatments in countries where the criticism occurs. In addition, some states are considering adopting legislation defining when personhood begins. To the extent adopted, this legislation could limit, restrict or prohibit the use of IVF, which would have a negative effect on OvaScience's ability to develop and sell OvaScience's potential fertility treatments and, as a result, on OvaScience's business.

Product liability lawsuits against OvaScience could cause OvaScience to incur substantial liabilities and to limit commercialization of any potential fertility treatments that OvaScience may develop.

        OvaScience faces an inherent risk of product liability exposure related to the use of OvaScience's fertility treatments in humans and will face an even greater risk as OvaScience continues the development and commercialization of its potential fertility treatments. Product liability claims involving OvaScience's activities may be brought for significant amounts because OvaScience's potential fertility treatments involve mothers and children. For example, it is possible that OvaScience will be subject to product liability claims that assert that OvaScience's potential fertility treatments have caused birth defects in children or that such defects are inheritable. In light of the nature of OvaScience's planned activities, these claims could be made many years into the future based on effects that were not observed or observable at the time of birth. If OvaScience cannot successfully defend itself against claims that OvaScience's potential fertility treatments caused injuries, OvaScience will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

    decreased demand for any potential fertility treatment that OvaScience may develop;

    injury to OvaScience's reputation and significant negative media attention;

    withdrawal of clinical trial participants;

    significant costs to defend the related litigation;

    substantial monetary awards or payments to trial participants or patients;

    loss of revenue;

    the diversion of management's resources; and

    the inability to commercialize any potential fertility treatments that OvaScience may develop.

        OvaScience obtained product liability insurance coverage when OvaScience initiated its AUGMENT treatment study in the United States and introduced AUGMENT in select IVF centers outside of the United States. OvaScience will need to maintain product liability insurance coverage as OvaScience continues to introduce the OvaPrime and OvaTure treatments, and/or conduct clinical trials for OvaScience's current or potential fertility treatments. Such insurance is increasingly expensive and difficult to procure. In the future, such insurance may not be available to OvaScience at all or may only be available at a very high cost and, if available, may not be adequate to cover all liabilities that OvaScience may incur. In addition, OvaScience may need to increase its insurance coverage in

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connection with the commercialization of OvaScience's current or potential fertility treatments. If OvaScience is not able to obtain and maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise, OvaScience's business could be harmed, possibly materially.

Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are the subject of standards and recommendations by national regulatory authorities and/or non-governmental bodies. Failure to comply with these standards could harm OvaScience's commercial prospects or subject OvaScience to negative media attention or government sanctions.

        Various countries where OvaScience may seek to introduce its fertility treatments have standards set by regulatory authorities and/or non-governmental bodies that govern IVF procedures and the procurement, storage and processing of gametes and embryos for use in IVF procedures. In the UK, for example, the United Kingdom's Human Fertilisation and Embryology Authority (the "HFEA") has adopted a Code of Practice, as well as supplementary guidance documents, with which licensed IVF clinics are obliged to comply. Similarly, the UK's Association of Clinical Embryologists has adopted a series of best practice guidelines for its members. Even where these standards are voluntary, if OvaScience, or third parties that OvaScience works with, including IVF clinics, fail to comply with these standards, OvaScience's commercial prospects could be harmed because patients may prefer to use the services and potential fertility treatments of companies that meet these standards. Similarly, physicians or IVF clinics may be less likely to endorse or use procedures or potential fertility treatments that fail to comply with such standards. In addition, failure to meet the standards could subject OvaScience to negative media attention.

Risks Related to Regulation of OvaScience's Potential Fertility Treatments and Other Regulatory Matters

OvaScience's potential plans to develop and introduce OvaPrime and make AUGMENT available in selected regions outside of the United States depend upon these treatments meeting the requirements of a class of products or a type of practice or treatment exempt from pre-market review and approval of applications for marketing authorizations in such regions. Determinations by regulators in the markets OvaScience targets that these treatments do not meet the requirements for a class of products exempt from pre-market review and approval could significantly delay or prevent commercialization of those products. Failure to obtain marketing approval in international regions, to the extent required, would prevent OvaScience's potential fertility treatments from being marketed in such regions.

        OvaScience's potential plans to introduce OvaPrime and make AUGMENT available in select regions outside of the United States depend upon the treatments meeting the requirements of a class of products or a type of practice or treatment exempt from pre-market review and approval of applications for marketing authorizations in such regions. There can be no assurance that this will be the case in any particular jurisdiction, or that applicable Foreign Regulatory Authorities will agree with OvaScience's determinations that OvaScience's treatments meet these requirements. If the Foreign Regulatory Authorities in a given country disagree with OvaScience's determination that OvaScience's treatments are exempt from pre-market review and approval of applications for marketing authorizations required for drugs, biologics, medicinal products and medical devices, then OvaScience likely will be required to cease commercial marketing of that fertility treatment in that country, and may not be able to resume commercial marketing without first demonstrating safety and efficacy through clinical trials, submitting an application for marketing authorization, and receiving approval from the relevant regulatory authorities. In these circumstances, OvaScience is likely to be significantly delayed in its ability to commercialize its fertility treatments in such country, or OvaScience may elect to cease its commercialization activities in that country altogether. In 2012, OvaScience commenced a clinical study of AUGMENT in the United States relying on OvaScience's conclusion that AUGMENT

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met the requirements for a section 361 HCT/P, and therefore did not require an IND. In September 2013, however, OvaScience received an "untitled" letter from the FDA questioning the status of AUGMENT as a section 361 HCT/P and advising OvaScience to file an IND for AUGMENT. As a result, OvaScience chose to suspend enrollment in its AUGMENT study in the United States. In March 2018, Health Canada informed OvaScience that performing AUGMENT violates Canada's Assisted Human Reproduction Act, and requested that OvaScience cease offering AUGMENT in Canada. Accordingly, OvaScience is no longer making AUGMENT available in Canada.

        OvaScience will be unable to complete the development of OvaTure if OvaScience does not obtain authorization to fertilize an Egg PC cell-derived egg. From time to time, OvaScience has engaged in discussions regarding its fertility treatments with Foreign Regulatory Authorities in certain of the countries in which OvaScience has introduced such fertility treatment or potential fertility treatment. If any of OvaScience's fertility treatments were subject to pre-market approval in a particular region, failure to obtain such required marketing approval in international regions would prevent OvaScience from marketing such fertility treatment in such regions, which could have a material adverse effect on OvaScience's business, results of operations or financial condition.

        Further, if Foreign Regulatory Authorities in a particular region determine that OvaScience's fertility treatments do not meet the requirements of a class of products that is exempt from pre-market approval of applications for marketing authorization, then in order to market and sell its potential fertility treatments in that region, OvaScience or its third party collaborators may need to obtain separate marketing approvals and will need to comply with numerous and varying regulatory requirements, as described above. Additionally, study or license requirements vary among countries and may cause delays of or suspension of the approval process and can involve additional testing. The time required to obtain approval in foreign regions can be lengthy, and may differ substantially from region to region. The regulatory approval process outside the United States may be subject to risks like those associated with obtaining FDA approval. In addition, in many countries, a treatment must be approved for reimbursement before the treatment can be approved for sale in that country. Furthermore, some countries have restrictions particular to IVF and/or other fertility treatments, which may impose additional regulatory barriers for market entry for OvaScience's potential fertility treatments. If required, OvaScience may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA for marketing in the United States does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

        By way of example, regulators could determine that OvaPrime, OvaTure or AUGMENT, and/or any other potential fertility treatments, do not meet the requirements for a class of products exempt from pre-market review and approval. In that case, they could be regulated as medicinal products (including advanced therapy medicinal products), as medical devices or as human tissues and cells intended for human applications. For example, products regulated as advanced therapy medicinal products may only be placed on the market in the EU once they have been granted a marketing authorization by the European Commission. Securing a marketing authorization from the European Commission requires the submission of extensive preclinical and clinical data and supporting information, including information about the manufacturing process, to the EMA to establish the potential fertility treatment's safety, efficacy and quality. Following review of the marketing authorization application the EMA will issue an opinion, which the European Commission will take into account when deciding whether or not to grant a marketing authorization. If OvaScience is required to follow this regulatory pathway for OvaPrime, OvaTure treatment or their potential fertility treatments, this may significantly delay or preclude commercialization of these treatments. Similar determinations in other markets outside of the United States could have the same impact.

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        Even if regulators in regions outside of the United States, such as the EU, deem OvaScience's treatments to be exempt from pre-market review and approval of an application for marketing authorization as required of drugs, biologics, medicinal products and medical devices, other regulatory requirements may nevertheless be applicable. For example, medical treatments and processes, such as IVF, may be regulated at the national level, which is the case in the EU. Such national regulations may restrict the extent to which the eggs used in IVF treatments may be manipulated and so may prevent OvaScience from commercializing its treatments in that country. Alternatively, such regulations may require the IVF facilities to be licensed by the national regulatory authority to perform specific IVF procedures or require OvaScience or OvaScience's clinic accounts to obtain special approval of or licenses from national regulatory bodies to introduce OvaScience's treatments in that country. For example, there are specific fertility regulatory authorities, such as the United Kingdom's HFEA, which license IVF facilities and determine what procedures such establishments may perform. In other countries, the national health authority may delegate the review of a fertility treatment to an industry self-regulatory body, an institutional review board, or other body. For example, the approval of OvaScience's clinic account's application to use AUGMENT in Japan was made by the JSOG. However, in some countries, there are no clear guidelines on what standards may apply to OvaScience's treatments or what licenses or approvals may be required. If OvaScience is unable to obtain any required licenses or approvals in a particular country, if the application process takes longer than expected, or if additional licenses or approvals are required to commercialize the treatment on a large scale, then OvaScience's introduction of its fertility treatments in such countries may be delayed, OvaScience may incur additional expenses, and OvaScience may determine not to provide the treatment in such countries.

It is unclear what regulatory pathway FDA will ultimately require for OvaPrime, OvaTure and AUGMENT or any other potential fertility treatments OvaScience may develop.

        In 2012, OvaScience commenced a clinical study of AUGMENT in the United States. OvaScience did so without an IND on the basis of their conclusion that FDA would regulate AUGMENT as a section 361 HCT/P.

        In September 2013, OvaScience received an "untitled" letter from the FDA advising OvaScience to file an IND application for AUGMENT. Following the receipt of the FDA letter, OvaScience chose to suspend the availability of AUGMENT in the United States. OvaScience believes that AUGMENT meets the regulatory definition of a section 361 HCT/P or is a procedure that can be performed as part of the practice of medicine—and in either case, is exempt from pre-market approval. AUGMENT involves isolation of mitochondria from egg precursor cells, and injection of those mitochondria into the same woman's egg, which OvaScience believes constitutes minimal manipulation of both the mitochondria and the egg. OvaScience believes AUGMENT involves only homologous use, does not combine the oocyte with an article that raises new safety concerns, and involves tissues for reproductive use. OvaScience therefore believes that AUGMENT meets all four of the criteria for a section 361 HCT/P set forth in FDA's regulation. If the FDA ultimately agrees with OvaScience's conclusions, AUGMENT would not be required to be the subject of clinical trials pursuant to an IND, nor will it be required to seek FDA pre-market review and approval of an NDA or BLA. However, both AUGMENT, OvaPrime and OvaScience's potential fertility treatments constitute new technologies, the proper regulatory characterization of which likely constitute matters of first impression for FDA. Particularly because AUGMENT, OvaPrime and OvaScience's potential fertility treatments are intended to result in the creation of human life, there can be no assurance that FDA will agree with OvaScience's views as to the proper regulatory characterization of AUGMENT, OvaPrime or any of OvaScience's potential fertility treatments. FDA may conclude that AUGMENT, OvaPrime and/or potential fertility treatments constitute drugs, biologics, or medical devices. If FDA makes such a determination for AUGMENT, OvaPrime or any of OvaScience's potential fertility treatments, OvaScience may be required to conduct clinical trials under an IND (or investigational device

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exemption for a medical device) and seek FDA pre-market review and approval of an NDA or BLA (or premarket approval for a medical device). In that event, OvaScience's may abandon pursuing that potential fertility treatment in the United States, or suffer significant delays and expense seeking to obtain any necessary approval.

Even if the FDA regulates AUGMENT as a section 361 HCT/P, adequate substantiation must still be generated for any claims made in the marketing of AUGMENT before it is commercialized in the United States. Failure to establish such adequate substantiation in the opinion of federal or state authorities or equivalent Foreign Regulatory Authorities could substantially impair the ability to generate revenue with respect to AUGMENT.

        If AUGMENT does not ultimately need to be submitted to the FDA for preapproval due to the FDA regulating the treatment as a section 361 HCT/P, adequate substantiation must still be generated for claims made in any marketing materials for the treatment. Both the U.S. Federal Trade Commission (FTC) and the states retain jurisdiction over the marketing of products for which advertising and promotion are not regulated by the FDA, and require certain standards of evidence to support claims made in marketing materials. Many countries outside of the United States have similar regulatory authorities that regulate the marketing of products. The ultimate marketer of AUGMENT will need to generate such adequate substantiation for any claims made about AUGMENT. If, however, after marketing commences of AUGMENT in the United States, the FTC or one or more states or foreign authorities conclude that adequate substantiation does not exist for any claims, the marketer may be subject to significant penalties or may be forced to alter or cease marketing of AUGMENT in one or more jurisdictions. In addition, if the promotion of AUGMENT suggests that AUGMENT is intended for uses that are not consistent with a section 361 HCT/P, the FDA or equivalent Foreign Regulatory Authorities might consider the potential fertility treatment to be a new drug or biologic. The marketer of AUGMENT will therefore be limited in the promotional claims that it could make about AUGMENT.

Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are the subject of standards and recommendations by national non-governmental bodies. Failure to comply with these standards could harm OvaScience's commercial prospects or subject OvaScience to government sanctions.

        Various countries where OvaScience may seek to introduce its fertility treatments have standards set by regulatory authorities and/or non-governmental bodies that govern IVF procedures and the procurement, storage and processing of gametes and embryos for use in IVF procedures. In the UK, for example, the HFEA has adopted a Code of Practice with which licensed IVF clinics are obliged to comply, as well as supplementary guidance documents. Similarly, the UK's Association of Clinical Embryologists has adopted a series of best practice guidelines for its members. Even where these standards are voluntary, if OvaScience, or third parties that OvaScience works with, including IVF clinics, fail to comply with these standards, OvaScience's commercial prospects could be harmed because patients may prefer to use the services and potential fertility treatments of companies that meet these standards. Similarly, physicians or IVF clinics may be less likely to endorse or use procedures or potential fertility treatments that fail to comply with such standards.

Numerous states place restrictions on the operation of facilities and laboratories that recover, test, process, manufacture, store or dispose of certain cells and tissues. If OvaScience does not comply with such state regulations, as well as potential local regulations, OvaScience could be subject to significant sanctions.

        Various states, including New York, California, Florida, Illinois, Maryland, Texas, Massachusetts and others, impose requirements on facilities and laboratories that recover, test, process, manufacture, store or dispose of certain cells and tissues. These requirements can have significant geographic reach. In Maryland, for example, the permit requirements applicable to tissue banks, including reproductive

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tissue banks, apply not only to tissue banks located in Maryland, but also those tissue banks located outside of the state that are represented or serviced in Maryland. In some cases, the requirements imposed by states, such as record keeping and testing requirements, may be more stringent than those imposed by the FDA. If OvaScience begins commercialization of its fertility treatments in the United States, OvaScience will have to comply with these state requirements. Failure to comply with these state requirements could subject OvaScience to significant sanctions.

OvaScience will not be able to sell any potential fertility treatment that is regulated as a medical device without obtaining and maintaining necessary regulatory clearances or approvals.

        Some regions or countries may determine that certain of OvaScience's potential fertility treatments, or certain aspects of such treatments, such as the innovative culture media solution that OvaScience is planning to develop, should be regulated as medical devices. In such cases, OvaScience will need to seek approval or clearance from the appropriate regulatory authorities in such countries.

        In the EU, for example, OvaScience will need to complete a conformity assessment procedure, to demonstrate that OvaScience's fertility treatments conform to the essential requirements set out in EU law, and only then may OvaScience apply the CE mark to the products, which would allow the products to be marketed throughout the EU. In other countries, such products may be subject to pre-market review and approval by regulatory authorities or some other form of regulatory clearance. OvaScience cannot guarantee that it will be able to complete the necessary conformity assessment procedures or obtain the necessary regulatory clearances of pre-market approvals of these medical devices. In addition, any modifications to medical devices that OvaScience successfully brings to market, if any, may require new conformity assessment procedures, regulatory clearances or pre-market approvals. Marketing a medical device without the necessary CE mark, clearance or approval could result in a warning letter, fines, injunctions, product seizures or other civil or criminal penalties. Delays in OvaScience's receipt of CE marking, regulatory clearance or pre-market approval will cause delays in OvaScience's ability to sell OvaScience's potential fertility treatments, which will have a negative effect on OvaScience's ability to generate and grow revenues.

In addition to the challenges associated with obtaining any necessary marketing approvals in international jurisdictions, economic, political and other risks associated with foreign operations could adversely affect OvaScience's international sales.

        If OvaScience succeeds in commercializing any products internationally, then OvaScience's business will be subject to additional risks associated with doing business internationally. For example, OvaScience's future results of operations could be harmed by a variety of factors, including:

    changes in foreign currency exchange rates;

    changes in a country's or region's political or economic conditions, particularly in developing or emerging markets;

    trade protection measures and import or export licensing requirements;

    differing business practices associated with foreign operations;

    difficulty in staffing and managing widespread operations, including compliance with labor laws and changes in those laws;

    differing protection of intellectual property and changes in that protection; and

    differing regulatory requirements and changes in those requirements.

        OvaScience currently has a limited international infrastructure including, without limitation, sales, manufacturing and distribution capabilities. Establishing and expanding commercial activities and complying with laws in foreign jurisdictions may be costly and could disrupt OvaScience's operations.

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Even if OvaScience's fertility treatments are not subject to pre-market review and approval, OvaScience may be subject to certain ongoing regulation in some regions. OvaScience could be subject to significant civil or criminal penalties if OvaScience fails to comply with these requirements, and OvaScience may be unable to commercialize its potential fertility treatments.

        If regulatory authorities allow OvaScience's fertility treatments to be offered to patients in any of the countries OvaScience seeks to access, OvaScience will still be subject to numerous post-market requirements. Post-marketing requirements applicable to such products vary by region and by country. For example, in the United States, section 361 HCT/Ps are subject to several regulatory requirements, including those related to registration and listing, record keeping, labeling, cGTPs, donor eligibility and other activities. HCT/Ps that do not meet the definition of a section 361 HCT/P and, therefore, are approved via an NDA or BLA, are also subject to these and additional ongoing obligations. If OvaScience fails to comply with these requirements, or similar requirements in foreign jurisdictions, OvaScience could be subject to warning letters, product seizures, injunctions or civil and criminal penalties.

        Moreover, even if the FDA or equivalent Foreign Regulatory Authorities allow OvaScience's fertility treatments to be marketed without pre-market approval, the regulatory authorities could still seek to take enforcement action, which could include serving a written order that an HCT/P be recalled or destroyed, taking possession of the HCT/P, requiring cessation of manufacturing, or otherwise seeking to withdraw the potential fertility treatment from the market for a variety of reasons, including if the regulatory authority develops concerns regarding the safety of the potential fertility treatment or its manufacturing process.

Any fertility treatment for which OvaScience is required to obtain marketing approval, and for which OvaScience obtains such marketing approval, will be subject to continuing regulation after approval. OvaScience may be subject to significant penalties if it fails to comply with these requirements.

        Any potential fertility treatment for which OvaScience obtains approval or clearance of an application for marketing authorization, will be subject to continuing regulation by the FDA or equivalent Foreign Regulatory Authorities. Specific requirements will vary by country and/or region. In general, however, such requirements will include those relating to, among other things, submission of safety and other post-marketing information and reports, registration and listing, manufacturing, packaging, quality control, storage, distribution, quality assurance and corresponding maintenance of records and documents, labeling, advertising and promotional activities, distribution of samples to physicians and recordkeeping. Even if marketing approval or clearance of a potential fertility treatment is granted, the approval or clearance may be subject to limitations on the uses for which the potential fertility treatment may be marketed, be subject to restrictions on distribution or use, or contain requirements for costly post-marketing testing to further evaluate the safety or efficacy of the potential fertility treatment. The FDA and equivalent Foreign Regulatory Authorities closely regulate the post-approval marketing and promotion of drugs, biologics and medical devices to ensure such products are marketed only for the approved indications or cleared uses and in accordance with the provisions of the approved labeling. The FDA and equivalent Foreign Regulatory Authorities impose stringent restrictions on manufacturers' communications regarding off-label use and if OvaScience markets its potential fertility treatments for uses other than for their approved indications, OvaScience may be subject to enforcement action.

        In addition, later discovery of previously unknown problems with OvaScience's potential fertility treatments, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

    restrictions on the labeling or marketing of potential fertility treatments;

    restrictions on distribution or use of potential fertility treatments;

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    requirements to conduct post-marketing clinical trials;

    warning or untitled letters from the FDA or equivalent Foreign Regulatory Authorities;

    withdrawal of potential fertility treatments from the market;

    refusal to approve pending applications or supplements to approved applications;

    recall of potential fertility treatments;

    fines, restitution or disgorgement of profits or revenue;

    suspension or withdrawal of marketing approvals;

    refusal to permit the import or export of OvaScience's potential fertility treatments;

    product seizure;

    injunctions; or

    the imposition of civil or criminal penalties.

It is unlikely that third party payors will cover or reimburse for OvaPrime, OvaTure or other future potential fertility treatments and services, and many patients may be unable to afford them.

        Many third party payors, both in the United States and foreign countries, including national health services or government funded insurance programs as well as private payors, place significant restrictions on coverage and reimbursement for IVF and other ART procedures. Those restrictions may include limits on the types of procedures covered, limits on the number of procedures covered and overall annual or lifetime dollar limits on reimbursement for IVF and other ART procedures. As a result, OvaScience believes very few third party payors, either in the United States or outside the United States, will reimburse for OvaPrime, OvaTure, or other future potential fertility treatments and services. Thus, it is likely that IVF clinics and physicians will be able to use OvaPrime, OvaTure, and other future potential fertility treatments and services only if the patient can afford and is willing to pay out-of-pocket. The cost of OvaPrime, OvaTure and other future potential fertility treatments and services may be beyond the means of many patients. This may limit the size of the market and prices charged for OvaPrime, OvaTure or other future potential fertility treatments and services and, thereby, limit OvaScience's future revenues.

        Even in those limited situations in which third-party payors may cover the OvaPrime treatment, OvaTure, or other future potential fertility treatments and services, cost containment pressures may later cause these third party payors to adopt strategies designed to limit the amount of reimbursement paid to IVF clinics and physicians, including but not limited to the following:

    reducing reimbursement rates;

    challenging the prices charged for medical potential fertility treatments or services;

    further limiting potential fertility treatments and services covered;

    challenging whether potential fertility treatments or services are medically necessary;

    taking measures to limit utilization of potential fertility treatments and services;

    negotiating prospective or discounted contract pricing;

    adopting capitation strategies; and

    seeking competitive bids.

        Additionally, in those limited situations where ART procedures such as IVF are available to disabled patients of childbearing age enrolled in federal healthcare programs, such as Medicare, the

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covered services and potential fertility treatments may be subject to changes in coverage and reimbursement rules and procedures, including retroactive rate adjustments. These contingencies could even further decrease the range of potential fertility treatments and services covered by such programs or the reimbursement rates paid directly or indirectly for such potential fertility treatments and services. Such changes could further limit OvaScience's ability to sell OvaScience's potential fertility treatments, which may have a material adverse effect on OvaScience's revenues.

        The reimbursement process for products and procedures outside the United States generally is subject to risks, like those associated with reimbursement in the United States, including the risk that it is unlikely that third party payors will cover or reimburse OvaPrime, OvaTure or other future potential fertility treatments and services. Many national health services and third party payors in the EU already place coverage and reimbursement limits on ART procedures, including IVF, and may impose even greater limits in the future. In many EU member states, medicinal products and medical devices are subject to formal pricing and reimbursement approvals before they can be reimbursed by national health services or government-funded insurance schemes. Reimbursement may be conditional on the agreement by the seller not to sell the product above a fixed price in that country, or the national authority may unilaterally establish a reimbursement price in connection with the inclusion of the product on a list of reimbursable products.

        The likelihood that many third party payors will refuse to cover and reimburse for OvaPrime, OvaTure and other future potential fertility treatments and services and that many patients will be unable to afford to pay for them out of pocket may reduce the demand for, or the price of, OvaPrime, OvaTure and other future potential fertility treatments and services, which would have a material adverse effect on OvaScience's revenues. Additional legislation or regulation relating to the healthcare industry or third party coverage and reimbursement may be enacted in the future, and could adversely affect the revenues generated from the sale of OvaScience's potential fertility treatments.

Several states and certain foreign countries have enacted legislation that may hamper the ability of IVF clinics and physicians to pass through the cost of OvaScience's potential fertility treatments to patients or third party payors.

        Several states, including California and New York, and certain foreign countries require direct billing of laboratory or pathology services, prohibit physicians from marking up the cost of laboratory or pathology services when they pass these costs on to patients or other payors or require that physicians disclose to patients what they actually paid to obtain laboratory or pathology services. Additionally, the federal government has enacted regulations limiting the Medicare reimbursement available to physicians who contract out the technical component of certain laboratory and pathology procedures.

        To the extent that OvaTure, OvaPrime or other future potential fertility treatments or services are treated as laboratory or pathology services for purposes of reimbursement, these laws may make it difficult for OvaScience to market those potential fertility treatments and services to IVF clinics and physicians in some states and may also require OvaScience to restructure its business model before OvaScience can expand into certain markets. To the extent that OvaScience's IVF clinic and physician customer base anticipates seeking Medicare reimbursement, these laws may require a comprehensive restructuring of OvaScience's business model, and therefore adversely impact OvaScience's ability to market OvaScience's potential fertility treatments. Any additional legislation or regulation in this area could also adversely affect OvaScience's ability to market OvaScience's potential fertility treatments.

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OvaScience's current and future arrangements with third party payors and IVF clinics and physicians may be subject to foreign, federal and state fraud and abuse laws and regulations, which could expose OvaScience to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

        Even though OvaScience anticipates very limited third party coverage and reimbursement, including from federal healthcare programs, for any of OvaScience's potential fertility treatments and services, OvaScience's current and future arrangements with third party payors and IVF clinics and physicians may expose OvaScience to broadly applicable fraud and abuse laws and regulations that may constrain the business or financial arrangements and relationships through which OvaScience markets, sells and distributes OvaPrime, OvaTure and any other future potential fertility treatments and services for which OvaScience obtains marketing approval. Restrictions under federal and state fraud and abuse laws and regulations that may be applicable to OvaScience's business include the following:

    the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;

    the federal Stark law prohibits physicians from referring patients to hospitals, laboratories, and other types of entities in which they or their immediate family members have a financial interest, if the referral is for a select list of Medicare or Medicaid-covered services, including most clinical laboratory services, and also prohibits entities that furnish the covered services subsequent to a prohibited referral from billing Medicare or Medicaid for the services provided and from receiving payment from a federal healthcare program for those services;

    U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. government;

    the U.S. Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

    HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of HIPAA protected health information;

    the U.S. Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid

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      or the Children's Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other "transfers of value" made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members;

    analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures; state laws and regulations that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; state and local laws requiring the registration of pharmaceutical sales representatives; state and non-U.S. laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and

    analogous foreign laws and regulations, such as anti-bribery laws and laws governing the promotion of medicinal products or medical devices, as well as the Foreign Corrupt Practices Act ("FCPA"), may apply to sales or marketing arrangements and interactions with physicians in countries outside the United States.

        Efforts to ensure that OvaScience's business arrangements with third parties will comply with applicable fraud and abuse laws and regulations will involve substantial costs. Governmental authorities may conclude that OvaScience's business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse laws and regulations. If OvaScience's operations are found to be in violation of any of these laws or any other governmental regulations that may apply to OvaScience, OvaScience may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, contractual damages, integrity oversight and reporting obligations, exclusion from government funded healthcare programs, such as Medicare and Medicaid, reputational harm and the curtailment or restructuring of OvaScience's operations. If any of the IVF clinics or physicians or other providers or entities with whom OvaScience expects to do business are found to be not in compliance with applicable laws, they may be subject to similar criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

        Even the assertion of a violation under any of these provisions could have a material adverse effect on OvaScience's financial condition and results of operations. Any such assertion would likely trigger an investigation of OvaScience's business or executives that could cause OvaScience to incur substantial costs and result in significant liabilities or penalties, as well as damage to OvaScience's reputation.

Healthcare legislative reform measures may have a negative impact on OvaScience's business and results of operations.

        In the United States and foreign jurisdictions, the legislative landscape continues to evolve. There have been and continue to be a number of initiatives at the United States federal and state levels that seek to reform the way in which healthcare is funded and reduce healthcare costs. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2009, or collectively, PPACA, was enacted. The PPACA has substantially changed the way that healthcare is financed by both governmental and private insurers and significantly affected

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the delivery and financing of healthcare in the United States. The PPACA contains provisions that, among other things, govern enrollment in federal healthcare programs, effect reimbursement changes, encourage use of comparative effectiveness research in healthcare decision making and enhance fraud and abuse requirements and enforcement. The PPACA imposes a significant annual fee on companies that manufacture or import branded prescription drug products, which could include OvaScience's potential fertility treatments, if the FDA regulates those treatments as a biologic. The fee, which is not deductible for federal income tax purposes, is based on the manufacturer's market share of sales of branded drugs and biologics, excluding orphan drugs, to, or pursuant to coverage under, specified U.S. government programs. In addition, the law subjects most medical devices to a 2.3 percent excise tax, beginning in 2020.

        Some of the provisions of the PPACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects of the PPACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the PPACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the PPACA or otherwise circumvent some of the requirements for health insurance mandated by the PPACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the PPACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the PPACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate". Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain PPACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, among other things, amends the PPACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole". More recently, in July 2018, the Centers for Medicare and Medicaid Services, or CMS, published a final rule permitting further collections and payments to and from certain PPACA qualified health plans and health insurance issuers under the PPACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment.

        In addition, other health reform measures have been proposed and adopted in the United States since PPACA was enacted. For example, as a result of the Budget Control Act of 2011, as amended, providers are subject to Medicare payment reductions of 2% per fiscal year through 2027 unless additional Congressional action is taken. Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments from providers from three to five years.

        If OvaScience's products are regulated as biologics, the PPACA and other healthcare reform measures that may be passed in the future may have a material adverse effect on OvaScience's results of operations and financial condition. However, it is also possible that the PPACA will be repealed and/or replaced, given the current federal administration in the United States. OvaScience is unable at this time to determine the outcome or impact on OvaScience of this uncertainty.

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The comprehensive federal tax reform bill could adversely affect OvaScience's business and financial condition.

        On December 22, 2017, President Trump signed into law the "Tax Cuts and Jobs Act," or TCJA, which significantly reforms the Code. The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a worldwide system of taxation to a territorial system. OvaScience's net deferred tax assets and liabilities will be revalued at the U.S. corporate rate, and the impact, if any, will be recognized in OvaScience's tax expense in the year of enactment. OvaScience continues to examine the impact this tax reform legislation may have on their business. The overall impact of the TCJA is uncertain and OvaScience's business and financial condition could be adversely affected.

OvaScience's ability to use its net operating loss carryforwards and certain other tax attributes may be limited

        As of December 31, 2017, OvaScience had federal net operating loss carryforwards of $140.7 million to offset future federal taxable income, which begin to expire, if not utilized, beginning in 2031. As of December 31, 2017, OvaScience had net operating loss carryforwards of approximately $137.6 million to offset future state taxable income, which begin to expire, if not utilized, beginning in 2031. These net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. In addition, under Section 382 of the Code, and corresponding provisions of state law, if a corporation undergoes an "ownership change," which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation's ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may subject to an annual limitation. The amount of the annual limitation is determined based on a corporation's value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. During 2015, OvaScience conducted an IRC Section 382 study. The study resulted in an adjustment to OvaScience's NOL carryforward of $0.5 million. During 2017, there is a high likelihood that OvaScience underwent an ownership change. If OvaScience underwent an ownership change during 2017, based on the annual limitation, a substantial majority of OvaScience's NOLs would expire unutilized. OvaScience may experience ownership changes in the future as a result of this Merger and/or subsequent shifts in its stock ownership (some of which are outside its control). Such ownership changes could result in increased limitations on its net operating loss carryforwards and certain other tax attributes. Consequently, even if OvaScience achieves profitability, OvaScience may not be able to utilize a material portion of OvaScience's net operating loss carryforwards and certain other tax attributes, which could have a material adverse effect on cash flow and results of operations. Under the newly enacted federal income tax law, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. It is uncertain if and to what extent various states will conform to the newly enacted federal tax law.

OvaScience may have obligations under OvaScience's contracts with IVF clinics and physicians or other healthcare providers to protect the privacy of patient health information.

        In the course of performing OvaScience's business, OvaScience will obtain, from time to time, confidential patient health information. For example, OvaScience may learn patient names and be exposed to confidential patient health information when OvaScience provides training on OvaPrime, OvaTure and other future potential fertility treatments and services to the staff at IVF clinics and physicians' offices. United States federal and state laws protect the confidentiality of certain patient health information, in particular individually identifiable information, and restrict the use and disclosure of that information. At the federal level, the Department of Health and Human Services promulgated health information and privacy and security rules under HIPAA. At this time, OvaScience is not subject to HIPAA as a HIPAA "covered entity" or "business associate." However, OvaScience's current and

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future confidentiality agreements with covered entities contain commitments to protect the privacy and security of patients' health information and, in some instances, may require OvaScience to indemnify the covered entity for any claim, liability, damage, cost or expense arising out of or in connection with a breach of the agreement by OvaScience. If OvaScience were to violate one of these agreements, OvaScience could lose customers and be exposed to liability or OvaScience's reputation and business could be harmed. In addition, HITECH expands the HIPAA privacy and security rules, including imposing many of the requirements of those rules directly on business associates and making business associates directly subject to HIPAA civil and criminal enforcement provisions and associated penalties. If OvaScience becomes subject to HIPAA as a business associate, it may be required to make costly system modifications to comply with the HIPAA privacy and security requirements. OvaScience's failure to comply may result in government investigations and criminal and civil liability, including substantial monetary penalties and regulatory oversight and reporting obligations.

        Other federal and state laws apply to the use and disclosure of health information, as well as certain financial information, which could affect the manner in which OvaScience conducts its business. Such laws are not necessarily preempted by HIPAA, particularly those laws that afford greater protection to the individual than does HIPAA or cover different subject matter. Such state laws typically have their own penalty provisions, which could be applied in the event of an unlawful action affecting health information.

        In the member states of the EU and many other countries, OvaScience will be subject to similar or more stringent data privacy laws, such as those implementing the European Data Protection Directive 95/46/EC and as of May 2018 the EU General Data Protection Regulation (EU) No. 2016/679, that require OvaScience to protect all individually identifiable information and restrict the use, disclosure and onward transfer of that information. Such national laws typically have their own civil or criminal enforcement provisions and associated penalties. OvaScience may incur costs in complying with the applicable privacy and security requirements, which may include registration with the national data protection authorities.

If OvaScience fails to comply with environmental, health and safety laws and regulations, OvaScience could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of OvaScience's business.

        OvaScience is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. OvaScience's operations involve the use of hazardous and flammable materials, including chemicals and biological materials. OvaScience's operations also produce hazardous waste products. OvaScience generally contracts with third parties for the disposal of these materials and wastes. OvaScience cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from OvaScience's use of hazardous materials, OvaScience could be held liable for any resulting damages, and any liability could exceed OvaScience's resources. OvaScience also could incur significant costs associated with civil or criminal fines and penalties.

        Although OvaScience maintains workers' compensation insurance to cover them for costs and expenses OvaScience may incur due to injuries to OvaScience's employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. OvaScience does not maintain insurance for environmental liability or toxic tort claims that may be asserted against OvaScience in connection with OvaScience's storage or disposal of biological, hazardous or radioactive materials.

        In addition, OvaScience may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair OvaScience's research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

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Risks Related to the Manufacturing of OvaScience's Potential Fertility Treatments

OvaScience may rely on third parties for the manufacture of OvaScience's potential fertility treatments for development and commercialization. This reliance on third parties may increase the risk of failing to provide manufacturing capacity to meet OvaScience's potential fertility treatments at an acceptable cost. Lack of direct control of manufacturing capacity, costs and regulatory compliance could delay, prevent or impair OvaScience's development and commercialization efforts.

        Reliance on third party manufacturers and laboratories entails risks, including:

    reliance on the third party for regulatory compliance and quality assurance;

    reliance on the third party for establishment of and maintenance of its redundancy and disaster recovery plans

    possible changes by third party manufacturers and laboratories of business strategies or operating models that are incongruent with maintaining OvaScience's relationship with such third parties;

    the possible breach of the manufacturing or service agreement by the third party;

    the possible delay in obtaining, interruption of or withdrawal of required licenses;

    the possible delay, disruption or termination of service due to sanctions, regulations, or travel bans imposed by the site of third party manufacturer to patients or clinics outside the region where the manufacture is located;

    the possible disruption or availability of supplies, equipment, or properly qualified and trained staff;

    the possible exposure of trade secrets to unintended parties; and

    the possible interruption, or termination, or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for OvaScience.

        OvaScience may wish to utilize third party manufacturers or third party collaborators for the manufacture of OvaScience's other potential fertility treatments for preclinical testing, clinical trials and for commercial supply. OvaScience may be unable to establish any agreements with third party manufacturers or to do so on acceptable terms.

        While OvaScience has identified and may continue to identify contractors with suitable regulatory experience and expertise, OvaScience may not be able to comply with cGTP regulations or similar regulatory requirements expected from global regulatory bodies in countries where OvaScience plans to offer OvaScience's fertility treatments. Any performance failure on the part of OvaScience's existing or future manufacturers and service providers could delay clinical development or marketing approval or adversely affect or impede commercial sales. OvaScience's failure, or the failure of OvaScience's third party manufacturers and service providers, to comply with applicable regulations could also result in sanctions being imposed on OvaScience, including fines, injunctions, civil penalties, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of OvaScience's potential fertility treatments and harm OvaScience's business and results of operations.

        OvaScience may compete with other companies for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGTP and cGMP regulations and that might be capable of manufacturing for OvaScience. It is possible that some of these manufacturers have agreements with OvaScience's competitors that limit or restrict their ability to contract with OvaScience, further narrowing the number of manufacturers that are available to OvaScience.

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        OvaScience does not currently have arrangements in place for redundant supply or a second contract manufacturing supplier for OvaPrime. Although OvaScience believes that there are other potential alternative manufacturers who could manufacture OvaScience's potential fertility treatments, OvaScience may incur added costs and delays in identifying and qualifying any such replacement.

        OvaScience's potential future dependence upon others for the manufacture of OvaScience's potential fertility treatments may adversely affect OvaScience's future profit margins and OvaScience's ability to commercialize OvaPrime or any future potential fertility treatments that OvaScience seeks to market on a timely and competitive basis.

OvaScience is reliant on single sourcing of materials and equipment for OvaScience's potential fertility treatments which could put OvaScience at risk for continuity of supply in the event that any of OvaScience suppliers are unable to supply OvaScience in part or in full.

        OvaScience also is reliant on single sourcing for the majority of OvaScience's raw materials, consumables and processing equipment, including but not limited to OvaScience's proprietary antibody and Fluorescence-Activated Cell Sorting equipment. At this point in time OvaScience does not have the capacity or intent to source alternative or secondary suppliers of materials or processing equipment.

        There is a risk that if OvaScience is required to find alternative suppliers, for whatever reason, this could delay supply of OvaScience's fertility treatments for clinical or commercial purposes and could add an additional, unplanned financial burden on the company. Qualification of alternative suppliers could be a costly and timely process that would need to be driven through OvaScience's Quality Management System to confirm and document that all the testing and validation activities are in place to ensure that like-for-like changes do not impact the performance and safety of OvaScience's potential fertility treatments.

Risks Related to OvaScience's Dependence on Third Parties

OvaScience currently relies and will in the future rely on selected international IVF clinics to conduct clinical trials, enroll patients, commercialize, gain experience and generate data on OvaPrime and OvaScience's other treatments. OvaScience will also rely on other third parties to conduct clinical trials for OvaScience's fertility treatments. Such third parties may not perform satisfactorily, including failing to meet volume expectations, quality standards or deadlines for the completion of such studies or trials.

        OvaScience's reliance on these third parties for providing OvaScience's potential fertility treatments and for clinical development activities will reduce OvaScience's control over these activities.

        OvaScience will remain responsible for ensuring that OvaPrime and OvaScience's other treatments are introduced with consistent and high quality standards. Moreover, the FDA and equivalent Foreign Regulatory Authorities will require OvaScience to comply with GCPs with respect to any clinical trials for any of OvaScience's potential fertility treatments conducted in connection with a submission to the FDA or Foreign Regulatory Authorities, including an IND or equivalent application, and will require that OvaScience records and reports clinical trial results to assure that data and reported results are credible and accurate and that the rights and safety of patients are protected. OvaScience will also be required to register ongoing FDA-regulated clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

        OvaScience's reliance on these third parties, including IVF clinics, for providing OvaPrime and OvaScience's other treatments, and conducting clinical development activities, will reduce OvaScience's control over these activities. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, conduct OvaScience's clinical trials in accordance with regulatory requirements or OvaScience's stated protocols or maintain consistent quality standards, OvaScience will not be able to obtain, or may be delayed in obtaining, regulatory approvals for OvaScience's potential

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fertility treatments and will not be able to, or may be delayed in OvaScience's efforts to, successfully commercialize OvaScience's potential fertility treatments. Furthermore, these third parties may also have relationships with other entities, some of which may be OvaScience's competitors, or have their own IVF practices and could devote more of their resources to such other entities or their own business at the expense of expending sufficient resources on OvaScience's clinical development activities.

OvaScience depends on collaborations with third parties, particularly academic partners and contract research organizations, for the development of OvaScience's potential fertility treatments. If those collaborations are not successful, OvaScience may not be able to succeed in developing and ultimately commercializing these potential fertility treatments.

        In December 2013, OvaScience established a collaboration with Intrexon to accelerate development of OvaTure, and entered into the OvaXon joint venture with Intrexon to create new applications to prevent inherited diseases for human and animal health. In 2016 and 2017, the OvaTure Collaboration generated data supporting the characterization and developmental competence of human EggPC cell derived-eggs, and the OvaXon joint venture generated data supporting the characterization and developmental competence of bovine EggPC cell derived-eggs. Starting in August 2017, Intrexon continued bovine EggPC work for OvaScience under the OvaTure Collaboration rather than under the OvaXon joint venture. On February 1, 2018, OvaScience provided Intrexon with written notice of termination of the OvaTure Collaboration, effective 90 days following notice. OvaScience remains in discussions with Intrexon regarding the future of the OvaXon joint venture, and there can be no assurance that OvaScience will reach agreement on how to proceed with the joint venture. Academic partners have also generated data supporting the characterization and developmental competence of human EggPC cell-derived eggs. OvaScience is also seeking authority to attempt to fertilize a human EggPC cell-derived egg with academic partners in Europe. OvaScience's ability to continue their preclinical work on human and bovine OvaTure depend significantly upon OvaScience's relationships with OvaScience's commercial and academic partners, and if OvaScience does not succeed in maintaining successful commercial and academic partnerships, OvaScience's development efforts may be delayed or fail.

        In the future, if OvaScience seeks to commercialize their treatments, their success will depend on their clinic accounts. In addition, OvaScience may seek partners for further development and commercialization of OvaScience's fertility treatments. These collaborations could take the form of license, distribution, sales representative, joint venture, sponsored research, co-promotion or other arrangements with pharmaceutical and biotechnology companies, other commercial entities and academic and other institutions.

        In any such arrangements with third parties, OvaScience will likely have limited control over the amount and timing of resources that such collaborators dedicate to the development or commercialization of OvaScience's potential fertility treatments. Collaboration agreements may not lead to development or commercialization of potential fertility treatments in the most efficient manner, or at all. OvaScience's ability to generate revenues from these arrangements will depend on, among other things, OvaScience's collaborators' successful performance of the functions assigned to them in these arrangements.

        Collaborations involving OvaScience's potential fertility treatments would pose the following risks to OvaScience:

    collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and could devote fewer resources to OvaScience's potential fertility treatments than OvaScience expects them to;

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    a collaborator with marketing and distribution rights to one or more other potential fertility treatments may not commit sufficient resources to the marketing and distribution of OvaScience's potential fertility treatments;

    collaborators may not pursue development and commercialization of OvaScience's potential fertility treatments or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator's strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;

    collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a potential fertility treatment or repeat or conduct new clinical trials;

    collaborators could independently develop, or develop with third parties, potential fertility treatments that compete directly or indirectly with OvaScience's potential fertility treatments;

    collaborators may create intellectual property that OvaScience needs to in-license, may not properly maintain or defend its intellectual property rights or may use its proprietary information in such a way as to invite litigation that could jeopardize or invalidate OvaScience's proprietary information;

    disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of OvaScience's potential fertility treatments or that result in costly litigation or arbitration that diverts management's attention and resources; and

    collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable potential fertility treatments.

If OvaScience is not able to establish collaborations, OvaScience may have to alter its development and commercialization plans.

        OvaScience's potential fertility treatment development programs and the potential commercialization of such treatments will require substantial additional cash to fund expenses. OvaScience may collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of some of OvaScience's potential fertility treatments. For example, OvaScience currently intends to seek to collaborate with third parties to commercialize OvaPrime and other potential fertility treatments OvaScience successfully develops.

        OvaScience faces significant competition in seeking appropriate collaborators. Whether OvaScience reaches a definitive agreement for a collaboration will depend, among other things, upon OvaScience's assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator's evaluation of a number of factors. Those factors may include the design or results of OvaScience's clinical trials, if any, the likelihood of approval by the FDA or similar regulatory authorities outside the United States or the availability of an exemption for the need or pre-marketing review or approval of OvaScience's potential fertility treatment, the potential market for such potential fertility treatment, the costs and complexities of manufacturing and delivering the potential fertility treatment to patients, the potential and relative cost of competing fertility treatments, uncertainty with respect to OvaScience's ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative potential fertility treatments or technologies for similar indications or conditions that may be available to collaborate on and whether such a collaboration could be more attractive than the one with OvaScience for OvaScience's potential

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fertility treatment. OvaScience may also be restricted under existing license agreements from entering into agreements on certain terms with potential collaborators. In addition, there have been a significant number of business combinations among pharmaceutical and biotechnology companies that have resulted in a reduced number of potential future collaborators. Collaborations are complex and time consuming to negotiate, document and manage. OvaScience may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.

        If OvaScience is not able to obtain a collaborator for a particular program, OvaScience may have to curtail the development of such program or of one or more of OvaScience's other development programs, delay the potential commercialization of such program, reduce the scope of any sales or marketing activities for the program or increase OvaScience's expenditures and undertake development or commercialization activities for the program at OvaScience's own expense. If OvaScience elects to increase OvaScience's expenditures to fund development or commercialization activities on their own, OvaScience may need to obtain additional capital, which may not be available to OvaScience on acceptable terms or at all. If OvaScience does not have sufficient funds, OvaScience may not be able to further develop OvaScience's potential fertility treatments or bring these potential fertility treatments to market and generate revenue.

Risks Related to OvaScience's Intellectual Property

If OvaScience fails to comply with its obligations under OvaScience's intellectual property licenses, OvaScience's could lose license rights that are important to its business.

        OvaScience has an exclusive license from MGH with respect to the intellectual property that forms the basis of OvaScience's business. The license under MGH-owned patent rights and know-how is for human female fertility, the treatment or prevention of inherited (including mitochondrial) diseases or defects in all animals, including humans, assisted and/or artificial reproductive technology in all non-human animals, and the artificial creation of food, research animals and/or animal products; and the license under the MGH and Harvard co-owned patent right is for ex-vivo human female fertility treatments. OvaScience's existing MGH license agreement and another agreement granting rights impose, and OvaScience expect that future license agreements will impose, various obligations on us, including diligence, milestone payments, royalty payments, insurance and other obligations. For example, under OvaScience's license agreement with MGH, OvaScience is required to use commercially reasonable efforts to develop and make available to the public licensed fertility treatments and to satisfy specified diligence milestones within specified timeframes. If OvaScience fails to comply with OvaScience's obligations under this or other of OvaScience's license agreements, OvaScience's licensors may have the right to terminate OvaScience's licenses, in which event OvaScience might not be able to market potential fertility treatments that are covered by these agreements, or to convert OvaScience's licenses to non-exclusive licenses, which could materially adversely affect the value of the potential fertility treatments OvaScience developed under the license agreements. Termination of these license agreements or reduction or elimination of OvaScience licensed rights may result in OvaScience having to negotiate new or reinstated licenses with less favorable terms, or to cease commercialization of licensed technology and potential fertility treatments. This could materially adversely affect OvaScience's business, particularly in the case of OvaScience's license from MGH.

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If OvaScience is unable to obtain and maintain patent protection for OvaScience's technology and potential fertility treatments, or if OvaScience's licensors are unable to obtain and maintain patent protection for the technology or potential fertility treatments that OvaScience licenses from them, OvaScience competitors could develop and commercialize technology and potential fertility treatments similar or identical to OvaScience's, and OvaScience's ability to successfully commercialize OvaScience's technology and potential fertility treatments may be adversely affected.

        OvaScience's success depends in large part on OvaScience and OvaScience's licensors' ability to obtain and maintain patent protection in the United States and other countries with respect to OvaScience's proprietary technology and potential fertility treatments. OvaScience and OvaScience's licensors have sought to protect OvaScience's proprietary position by filing patent applications within the United States and abroad related to OvaScience's novel technologies and potential fertility treatments that are important to OvaScience's business. The process of obtaining patent protection is uncertain, and OvaScience and OvaScience's licensors may not succeed in obtaining the patent protection for OvaScience's novel technologies and potential fertility treatments that OvaScience seeks. If OvaScience and OvaScience's licensors are unable to obtain and maintain patent protection of sufficient scope for OvaScience's technology and potential fertility treatments, OvaScience's competitors could develop and commercialize technology and potential fertility treatments similar or identical to OvaScience's, and in that case, OvaScience's ability to successfully commercialize OvaScience's technology and potential fertility treatments may be adversely affected. This risk is greater outside the United States where some aspects of OvaScience's in-licensed intellectual property are not protected by patents. In addition, the laws of foreign countries may not protect OvaScience's rights to the same extent as the laws of the United States.

        Moreover, under OvaScience's license agreement with MGH, OvaScience does not have the right to control the preparation, filing and prosecution of the licensed patent applications, to defend the validity and enforceability of the licensed patents against challenges by third parties, or to maintain the licensed patents covering OvaScience's technology or potential fertility treatments. This could also be the case under any other license agreements OvaScience enters into in the future. Therefore, OvaScience relies on MGH, and may rely on other licensors in the future, to file, defend and maintain patents that are important to OvaScience's business. The failure of MGH or other licensors to successfully prosecute, defend and maintain these patents and patent applications in a manner consistent with the best interests of OvaScience's business could adversely affect OvaScience's ability to successfully commercialize OvaScience's technology and potential fertility treatments.

        The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of OvaScience's and OvaScience's licensors' patent rights are highly uncertain. OvaScience and OvaScience's licensors' pending and future patent applications may not result in patents being issued which protect OvaScience's technology or potential fertility treatments or that effectively prevent others from commercializing competitive technologies and potential fertility treatments. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of OvaScience's patents or narrow the scope of OvaScience's patent protection.

        Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, OvaScience cannot be certain that OvaScience or OvaScience's licensors were the first to make the inventions claimed in OvaScience's owned or licensed patents or pending patent applications, or that OvaScience or OvaScience's licensors were the first to file for patent protection of such inventions.

        Under the America Invents Act enacted in September 2011, the United States moved to a first inventor to file system in March 2013. Outside the United States, the first to file a patent application is

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generally entitled to the patent. OvaScience may become involved in patent litigation or reexamination, post-grant review, opposition, derivation or interference proceedings challenging OvaScience's patent rights or the patent rights of others. An adverse determination in any such litigation or proceeding could reduce the scope of, or invalidate, OvaScience's patent rights, allow third parties to commercialize OvaScience's technology or potential fertility treatments and compete directly with OvaScience, without payment to OvaScience, or result in OvaScience's inability to manufacture or commercialize potential fertility treatments without infringing third party patent rights.

        Moreover, in recent years, the Supreme Court and the U.S. Court of Appeals for the Federal Circuit have rendered decisions in several patent cases such as Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad I), BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., (Myriad II), Mayo Collaborative Services v. Prometheus Laboratories, Inc., and Alice Corporation Pty. Ltd. v. CLS Bank International, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. For example, in the Myriad I case, the U.S. Supreme Court held that certain claims to naturally occurring substances are not patentable. OvaScience cannot predict how future decisions by the courts, the U.S. Congress, or the U.S. Patent and Trademark Office, USPTO, may impact the value of OvaScience's patents. In addition to increasing uncertainty with regard to OvaScience and OvaScience's licensors' or collaborators' ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken OvaScience's ability to obtain new patents or to enforce existing patents and patents that OvaScience may obtain in the future.

If the scope of the patent protection OvaScience or OvaScience's licensors obtain is not sufficiently broad, OvaScience may not be able to prevent others from developing and commercializing technology and potential fertility treatments similar or identical to OvaScience's.

        OvaScience's owned and licensed patents and any owned or licensed patent applications that issue as patents may not provide OvaScience with any meaningful protection, prevent competitors from competing with OvaScience or otherwise provide OvaScience with any competitive advantage. OvaScience's competitors may be able to circumvent OvaScience's owned or licensed patents by developing similar or alternative technologies or potential fertility treatments in a non-infringing manner. The issuance of a patent is not conclusive as to its scope, validity or enforceability, and OvaScience's owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, which could limit OvaScience's ability to use and commercialize, or to stop or prevent others from using or commercializing, similar or identical technology and potential fertility treatments, or limit the duration of the patent protection of OvaScience's technology and potential fertility treatments. Given the amount of time required for the development, testing and regulatory review of new potential fertility treatments, patents protecting such candidates might expire before or shortly after such candidates are commercialized. For example, certain of the U.S. patents and patent applications that OvaScience exclusively licenses from MGH will expire in May 2025. As a result, OvaScience owned and licensed patent portfolio may not provide OvaScience with sufficient rights to exclude others from commercializing potential fertility treatments similar or identical to ours.

OvaScience may be required to initiate lawsuits to protect or enforce OvaScience's patents, which could be expensive, time consuming and unsuccessful.

        Competitors may infringe OvaScience's patents. To counter infringement or unauthorized use, OvaScience may be required to file infringement claims, which can be expensive and time consuming. In addition, in an infringement proceeding, a court may decide that a patent of OvaScience's is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the

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grounds that OvaScience's patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of OvaScience's patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of OvaScience's confidential information could be compromised by disclosure during litigation.

Third parties may initiate legal proceedings alleging that OvaScience is infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of OvaScience's business.

        OvaScience's commercial success depends upon OvaScience's ability and the ability of OvaScience's current and future collaborators to develop, manufacture, market and sell OvaScience's potential fertility treatments and OvaScience's proprietary technologies without infringing the proprietary rights of third parties. OvaScience may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to OvaScience's potential fertility treatments and technology, including interference proceedings before the USPTO. Third parties may assert infringement claims against OvaScience based on existing patents or patents that may be granted in the future. If OvaScience is found to infringe a third party's intellectual property rights, OvaScience could be required to obtain a license from such third party to continue developing and marketing OvaScience's potential fertility treatments and technology. However, OvaScience may not be able to obtain any required license on commercially reasonable terms or at all. Even if OvaScience were able to obtain a license, it could be non-exclusive, thereby giving OvaScience's competitors access to the same technologies licensed to OvaScience. OvaScience could be forced, including by court order, to cease commercializing the infringing technology or treatment. In addition, OvaScience could be found liable for monetary damages. A finding of infringement could prevent OvaScience from commercializing OvaScience's potential fertility treatments or force OvaScience to cease some of OvaScience's business operations, which could materially harm OvaScience's business. Claims that OvaScience has wrongfully appropriated the confidential information or trade secrets of third parties could have a similar negative impact on OvaScience's business.

OvaScience may be subject to claims that OvaScience's employees have wrongfully appropriated, used or disclosed intellectual property of their former employers.

        Some of OvaScience's employees have previously been employed at universities or other biotechnology or pharmaceutical companies. Although OvaScience tries to ensure that its employees do not appropriate or use the proprietary information or know-how of others in their work for OvaScience, OvaScience may be subject to claims that OvaScience or its employees have appropriated, used or disclosed intellectual property, including information forming the basis of patents and patent applications, trade secrets or other proprietary information, of any such employee's former employer. Litigation may be necessary to defend against these claims. If OvaScience fails in defending any such claims, in addition to paying monetary damages, OvaScience may lose valuable intellectual property rights or personnel and OvaScience's reputation may be harmed.

Intellectual property litigation could cause OvaScience to spend substantial resources and distract OvaScience's personnel from their normal responsibilities.

        Even if resolved in OvaScience's favor, litigation or other legal proceedings relating to intellectual property claims may cause OvaScience to incur significant expenses, and could distract OvaScience's technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, such developments could have a substantial adverse effect on the price of OvaScience's common stock. Such litigation or proceedings could substantially increase OvaScience's operating losses, reduce the resources available

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for development activities and adversely affect OvaScience's ability to raise additional funds. OvaScience may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of OvaScience's competitors may be able to sustain the costs of such litigation or proceedings more effectively than OvaScience can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on OvaScience's ability to compete in the marketplace.

If OvaScience is unable to protect the confidentiality of their trade secrets, OvaScience's business and competitive position would be harmed.

        In addition to seeking patents for some of OvaScience's technology and potential fertility treatments, OvaScience also relies on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain OvaScience's competitive position. The protection available for trade secrets is particularly important with respect to OvaScience's process for manufacturing AUGMENT, to OvaTure, OvaPrime and to OvaScience's potential fertility treatments, which will involve significant unpatented know-how. Any appropriation of OvaScience's know-how, by competing contract manufacturers, collaborators or otherwise, could harm OvaScience's business and OvaScience could suffer financial loss. OvaScience seeks to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such trade secrets, such as OvaScience's employees, corporate collaborators, outside scientific collaborators, sponsored researchers, contract manufacturers, consultants, advisors and other third parties. OvaScience also enters into confidentiality and invention or patent assignment agreements with OvaScience's employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose OvaScience's proprietary information, including OvaScience's trade secrets, and OvaScience may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of OvaScience's trade secrets were to be lawfully obtained or independently developed by a competitor, OvaScience would have no right to prevent such competitor from using that technology or information to compete with OvaScience. If any of OvaScience's trade secrets were to be disclosed to or independently developed by a competitor, OvaScience's competitive position would be harmed.

Risks Related to Employee Matters and Managing Growth

OvaScience's future success depends on its ability to retain their chief executive officer, to retain other key executives and to attract, retain and motivate qualified personnel.

        OvaScience is highly dependent on Dr. Kroeger, their chief executive officer, as well as the other principal members of OvaScience's management and scientific teams. Although OvaScience has entered into an employment arrangement with Dr. Kroeger providing for certain benefits, including severance in the event of a termination without cause, this arrangement does not prevent him from terminating his employment with OvaScience at any time. OvaScience does not maintain "key person" insurance for any of OvaScience's executives or other employees. The loss of the services of any of these persons could impede the achievement of OvaScience's research, development and commercialization objectives.

        Recruiting and retaining qualified medical, scientific, clinical and manufacturing personnel will also be critical to OvaScience's success. OvaScience may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. OvaScience also experiences competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, OvaScience relies on consultants and advisors, including scientific and clinical advisors, to assist OvaScience in formulating

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OvaScience's research and development and commercialization strategy. OvaScience's consultants and advisors, including OvaScience's scientific co-founders, may be employed by employers other than OvaScience and may have commitments under consulting or advisory contracts with other entities that may limit their availability to OvaScience.

A breakdown or breach of OvaScience's information technology systems could subject OvaScience to liability or interrupt the operation of OvaScience's business.

        Many of OvaScience's key business processes are facilitated by information technology systems. Information technology systems are potentially vulnerable to breakdown, malicious intrusion and random attack. Likewise, individuals authorized to access OvaScience's information technology systems may pose a risk by exposing private or confidential data to unauthorized persons or to the public. While OvaScience believes it has taken appropriate security measures to minimize these risks to OvaScience's data and information technology systems, there can be no assurance that OvaScience's efforts will prevent breakdowns or breaches in OvaScience's systems that could adversely affect OvaScience's business.

Risks Associated with OvaScience's Capital Stock

As of October 31, 2018, the OvaScience Common Stock is listed on The Nasdaq Capital Market. Should OvaScience fail to meet the continued listing standards of The Nasdaq Capital Market, it could result in the delisting of OvaScience Common Stock, negatively impact the price of OvaScience Common Stock and negatively impact OvaScience's ability to raise additional capital.

        Nasdaq listing rules require OvaScience to maintain certain closing bid price, stockholders equity and other financial metric criteria in order for its stock to continue trading on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. OvaScience's stock has recently and consistently traded below $1.00 per share, including closing bid prices below $1.00 per share.

        On April 27, 2018, OvaScience received a deficiency letter from Nasdaq, which indicated that OvaScience was not in compliance with the minimum bid price requirement set forth in Nasdaq rules for continued listing on The Nasdaq Global Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), OvaScience was granted a grace period of 180 calendar days, or until October 24, 2018, to regain compliance with the minimum bid price requirement. During the compliance period, OvaScience Common Stock continued to be listed and traded on The Nasdaq Global Market. Because OvaScience was unable to regain compliance with the minimum bid price requirement during the compliance period, OvaScience submitted an application to transfer the listing of the OvaScience Common Stock to The Nasdaq Capital Market, which, according to Nasdaq listing rules, affords OvaScience an additional 180-day compliance period to comply with the minimum bid price requirement. The transfer application also requires OvaScience to submit a letter stating its intention to effect the Reverse Stock Split during the second compliance period, which OvaScience has done. The application to transfer the listing of the OvaScience Common Stock was granted on October 29, 2018, effective October 31, 2018. If OvaScience fails to regain compliance with the minimum bid price requirement during the second compliance period, the OvaScience Common Stock could be subject to delisting. Additionally, if OvaScience fails to comply with any other continued listing standards of Nasdaq, OvaScience Common Stock will also be subject to delisting. There can be no assurance that OvaScience will be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.

        In the event that OvaScience is delisted from The Nasdaq Capital Market, OvaScience Common Stock would be subject to rules that impose additional sales practice requirements on broker-dealers

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who sell OvaScience's securities. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in OvaScience Common Stock. This would significantly and negatively affect the ability of investors to trade OvaScience's securities and would significantly and negatively affect the value and liquidity of OvaScience Common Stock. These factors could contribute to lower prices and larger spreads in the bid and ask prices for OvaScience Common Stock. Delisting would prevent OvaScience from satisfying a closing condition for the proposed Merger, and, in such event, Millendo may elect not to consummate the proposed Merger. In addition, the combined organization has submitted an initial listing application on The Nasdaq Capital Market pursuant to the change of control rules, and, as a result, the combined organization will need to meet Nasdaq's initial listing requirements.

If the proposed Merger is not completed, the market price of OvaScience Common Stock may continue to be volatile and may fluctuate in a way that is disproportionate to OvaScience's operating performance.

        OvaScience's stock price may continue to experience substantial volatility as a result of a number of factors, including:

    sales or potential sales of substantial amounts of OvaScience Common Stock;

    the delay or failure to execute OvaScience's plans for OvaPrime, OvaTure or other potential treatments;

    results of preclinical testing or clinical trials of OvaScience's potential fertility treatments, including OvaTure, or those of OvaScience's competitors;

    the cost of OvaScience's development programs;

    the success of competitive potential fertility treatments or technologies;

    the success of OvaScience's relationships with commercial and academic partners;

    announcements about OvaScience or about OvaScience's competitors, including clinical trial results, regulatory approvals, new potential fertility treatment introductions and commercial results;

    the recruitment or departure of key personnel;

    developments concerning OvaScience's licensors or manufacturers;

    the results of OvaScience's efforts to discover, acquire or in-license additional potential fertility treatments;

    litigation and other developments relating to OvaScience's issued patents or patent applications or other proprietary rights or those of OvaScience's competitors or other material litigation;

    developments with the FDA or equivalent Foreign Regulatory Authorities regarding the regulatory pathway applicable to OvaPrime, OvaTure or AUGMENT;

    regulatory or legal developments in the United States or other countries, particularly with respect to IVF procedures;

    conditions in the pharmaceutical or biotechnology industries;

    changes in the structure of healthcare payment systems;

    actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; and

    general economic, industry and market conditions.

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        Many of these factors are beyond OvaScience's control. The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors could reduce the market price of OvaScience Common Stock, regardless of OvaScience's actual operating performance.

OvaScience has never paid and does not intend to pay cash dividends.

        OvaScience has never paid cash dividends on any of OvaScience's capital stock and OvaScience currently intends to retain future earnings, if any, to fund the development and growth of OvaScience's business. As a result, capital appreciation, if any, of OvaScience's common stock will be OvaScience's common stockholders' sole source of gain for the foreseeable future.

Provisions in OvaScience's certificate of incorporation and by-laws and under Delaware law could make an acquisition of OvaScience, which may be beneficial to OvaScience's stockholders, more difficult and may prevent attempts by OvaScience's stockholders to replace or remove OvaScience's current management.

        Provisions in OvaScience's certificate of incorporation and by-laws may discourage, delay or prevent a merger, acquisition or other change in control of OvaScience that stockholders may consider favorable, including transactions in which OvaScience's common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of OvaScience's common stock, thereby depressing the market price of OvaScience's common stock. In addition, because OvaScience's board of directors is responsible for appointing the members of OvaScience's management team, these provisions may frustrate or prevent any attempts by OvaScience's stockholders to replace or remove OvaScience's current management by making it more difficult for stockholders to replace members of OvaScience's board of directors. Among other things, these provisions:

    establish a classified board of directors such that not all members of the board are elected at one time;

    allow the authorized number of OvaScience's directors to be changed only by resolution of OvaScience's board of directors;

    limit the manner in which stockholders can remove directors from the board;

    establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and for nominations to OvaScience's board of directors;

    limit who may call stockholder meetings;

    prohibit actions by OvaScience's stockholders by written consent;

    require that stockholder actions be effected at a duly called stockholders meeting;

    authorize OvaScience's board of directors to issue preferred stock without stockholder approval, which could be used to institute a "poison pill" that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by OvaScience's board of directors; and

    require the approval of the holders of at least 75 percent of the votes that all OvaScience's stockholders would be entitled to cast to amend or repeal certain provisions of OvaScience's certificate of incorporation or by-laws.

        Moreover, because OvaScience is incorporated in Delaware, OvaScience is governed by the provisions of Section 203 of the DGCL, which prohibits a person who owns 15 percent or more of

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OvaScience's outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired 15 percent or more of OvaScience's outstanding voting stock, unless the merger or combination is approved in a manner prescribed by the statute.

If OvaScience fails to maintain an effective system of internal control over financial reporting in the future, OvaScience may not be able to accurately report OvaScience's financial condition, results of operations or cash flows, which may adversely affect investor confidence in OvaScience and, as a result, the value of OvaScience's common stock.

        The Sarbanes-Oxley Act requires, among other things, that OvaScience maintain effective internal controls for financial reporting and disclosure controls and procedures. OvaScience is required, under Section 404, to furnish a report by management on, among other things, the effectiveness of OvaScience's internal control over financial reporting. This assessment must include disclosure of any material weaknesses identified by OvaScience's management in OvaScience's internal control over financial reporting. A material weakness is a control deficiency, or combination of control deficiencies, in internal control over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis. Section 404 also generally requires an attestation from OvaScience's independent registered public accounting firm on the effectiveness of OvaScience's internal control over financial reporting. Now that OvaScience no longer qualifies as an emerging growth company as defined in the JOBS Act, OvaScience is no longer exempted from certain requirements, such as the independent registered public accounting firm attestation.

        OvaScience's compliance with Section 404 requires that OvaScience incur substantial accounting expense and expend significant management efforts. OvaScience currently does not have an internal audit group, and OvaScience may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge, and compile the system and process documentation necessary to perform the evaluation needed to comply with Section 404. OvaScience may not be able to complete their evaluation, testing and any required remediation in a timely fashion. During the evaluation and testing process, if OvaScience identifies one or more material weaknesses in its internal control over financial reporting, OvaScience will be unable to assert that OvaScience's internal control over financial reporting is effective. OvaScience cannot assure you that there will not be material weaknesses or significant deficiencies in OvaScience's internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit OvaScience's ability to accurately report OvaScience's financial condition, results of operations or cash flows. If OvaScience is unable to conclude that OvaScience's internal control over financial reporting is effective, or if OvaScience's independent registered public accounting firm determines OvaScience has a material weakness or significant deficiency in OvaScience's internal control over financial reporting, OvaScience could lose investor confidence in the accuracy and completeness of OvaScience's financial reports, the market price of OvaScience's common stock could decline, and OvaScience could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in OvaScience's internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict OvaScience's future access to the capital markets.

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Risks Related to Millendo

Risks Related to Millendo's Financial Position and Need for Additional Capital

Millendo has incurred significant operating losses since inception and anticipates that it will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.

        Since inception, Millendo has incurred significant operating losses and negative operating cash flows and there is no assurance that Millendo will ever achieve or sustain profitability. Millendo's net loss was $18.8 million, $84.6 million and $9.4 million for the years ended December 31, 2016 and 2017 and the six months ended June 30, 2018, respectively. As of June 30, 2018, Millendo had an accumulated deficit of $146.0 million. Millendo expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. Millendo has devoted substantially all of its efforts to acquisition and preclinical and clinical development of Millendo's product candidates livoletide and nevanimibe, as well as to building Millendo's management team and infrastructure. It could be several years, if ever, before Millendo has a commercialized product and Millendo's commercialized products, if any, may not be profitable. The net losses Millendo incurs may fluctuate significantly from quarter to quarter and year to year. Millendo anticipates that its expenses will increase significantly in connection with its ongoing activities as Millendo:

    continues the ongoing and planned clinical development of livoletide and nevanimibe;

    initiates preclinical studies and clinical trials for any additional diseases for its current product candidates and any future product candidates that Millendo may pursue;

    builds a portfolio of product candidates through the acquisition or in-license of drugs or product candidates and technologies;

    develops, maintains, expands and protects its intellectual property portfolio;

    manufactures, or have manufactured, clinical and commercial supplies of its product candidates;

    seeks marketing approvals for its current and future product candidates that successfully complete clinical trials;

    establishes a sales, marketing and distribution infrastructure to commercialize any product candidate for which Millendo may obtain marketing approval;

    hires additional administrative, clinical, regulatory and scientific personnel; and

    incurs additional costs associated with operating as a public company following the completion of this Merger.

        In order to become and remain profitable, Millendo will need to develop and eventually commercialize, on Millendo's own or with collaborators, one or more product candidates with significant market potential. This will require Millendo to be successful in a range of challenging activities, including completing clinical trials of livoletide and nevanimibe, developing commercial scale manufacturing processes, obtaining marketing approval, manufacturing, marketing and selling any current and future product candidates for which Millendo may obtain marketing approval, and satisfying any post-marketing requirements. Millendo may never succeed in any or all of these activities and, even if Millendo does, Millendo may never generate revenue from product sales or achieve profitability.

        Because of the numerous risks and uncertainties associated with pharmaceutical products and development, Millendo is unable to accurately predict the timing or amount of increased expenses or when, or if, Millendo will be able to achieve profitability. If Millendo is required by the U.S. Food and Drug Administration, or FDA, or other regulatory authorities such as the European Medicines Agency, or EMA, to perform studies and trials in addition to those currently expected, or if there are any

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delays in the development or in the completion of any planned or future preclinical studies or clinical trials of Millendo's current or future product candidates, Millendo's expenses could increase and profitability could be further delayed.

        Even if Millendo does achieve profitability, Millendo may not be able to sustain or increase profitability on a quarterly or annual basis. Millendo's failure to become and remain profitable would decrease the value of Millendo's company and could impair its ability to raise capital, maintain its research and development efforts, expand its business or continue its operations. A decline in the value of Millendo's company also could cause you to lose all or part of your investment.

Millendo has a limited operating history and has never generated any revenue from product sales, which may make it difficult to evaluate the success of Millendo's business to date and to assess Millendo's future viability.

        Millendo is a clinical stage biopharmaceutical company with a limited operating history. Millendo's operations to date, with respect to the development of its product candidates, have been limited to organizing and staffing its company, business planning, raising capital, acquiring its technology and assets and conducting preclinical and clinical development of Millendo's product candidates. Millendo has not yet demonstrated an ability to successfully complete clinical development of a product candidate, obtain marketing approval, manufacture a commercial-scale drug (or arrange for a third-party to do so on Millendo's behalf), or conduct sales and marketing activities necessary for successful commercialization. Consequently, Millendo has no meaningful operations upon which to evaluate Millendo's business, and predictions about Millendo's future success or viability may not be as accurate as they could be if Millendo had more experience developing product candidates.

        Millendo's ability to generate revenue from product sales and achieve profitability depends on Millendo's ability, alone or with any future collaborative partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, livoletide, nevanimibe and any additional product candidates that Millendo may pursue in the future. Millendo does not anticipate generating revenue from product sales for the next several years, if ever. Millendo's ability to generate revenue from product sales depends heavily on Millendo's or any future collaborators' success in:

    timely and successful completion of clinical development of Millendo's current product candidates;

    obtaining and maintaining regulatory and marketing approvals for livoletide, nevanimibe and any future product candidates for which Millendo successfully complete clinical trials;

    launching and commercializing any product candidates for which Millendo obtains regulatory and marketing approval by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner;

    qualifying for coverage and adequate reimbursement by government and third-party payors for Millendo's current or any future product candidates, if approved, both in the United States and internationally, and reaching acceptable agreements with such government and third-party payors on pricing terms;

    developing, validating and maintaining a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for livoletide, nevanimibe or any future product candidates that are compliant with current good manufacturing practices, or cGMP;

    establishing and maintaining supply and manufacturing relationships with third parties that can provide an adequate amount and quality of drugs and services to support Millendo's planned clinical development, as well as the market demand for livoletide, nevanimibe and any future product candidates, if approved;

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    obtaining market acceptance, if and when approved, of livoletide, nevanimibe or any future product candidates as a viable treatment option by physicians, patients, third-party payors and others in the medical community;

    effectively addressing any competing technological and market developments;

    implementing additional internal systems and infrastructure, as needed;

    negotiating favorable terms in any collaboration, licensing or other arrangements into which Millendo may enter, and performing Millendo's obligations pursuant to such arrangements;

    maintaining, protecting and expanding Millendo's portfolio of intellectual property rights, including patents, trade secrets and know-how;

    avoiding and defending against third-party interference or infringement claims; and

    attracting, hiring and retaining qualified personnel.

Millendo will require additional capital to finance its operations, which may not be available on acceptable terms, if at all. Failure to obtain capital when needed may force Millendo to delay, limit or terminate certain of Millendo's development programs, future commercialization efforts or other operations.

        Millendo expects its expenses to increase in connection with its ongoing activities, particularly as Millendo continues to develop and, if approved, commercialize livoletide and nevanimibe. Additionally, if Millendo obtains marketing approval for its product candidates, Millendo expects to incur significant expenses related to manufacturing, marketing, sales and distribution. Furthermore, upon the Closing, Millendo expects to incur additional costs associated with operating as a public company.

        As of June 30, 2018, Millendo's cash was $6.8 million. Millendo expects that its existing cash, including the net proceeds from the contemplated concurrent financing, or the Pre-Closing Financing, will be sufficient to fund Millendo's current operating plans through the three-month efficacy readout of the Phase 2b portion of its pivotal Phase 2b/3 PWS study and completion of its Phase 2b CAH study. However, Millendo's operating plans may change as a result of many factors currently unknown to Millendo, and Millendo may need to seek additional funds sooner than planned, through public or private equity or debt financings, third-party funding, and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or a combination of these approaches. In any event, Millendo will require additional capital to pursue preclinical and clinical activities, regulatory approval and the commercialization of Millendo's current and future product candidates. Even if Millendo believes it has sufficient capital for its current or future operating plans, Millendo may seek additional capital if market conditions are favorable or if Millendo has specific strategic considerations. If Millendo elects to do so, additional capital may not be available to Millendo on acceptable terms, if at all. Millendo's ability to access additional capital, and as a result Millendo's operating results and liquidity needs, could be negatively affected by market fluctuations and economic downturn. Any additional capital raising efforts may divert Millendo's management from its day-to-day activities, which may adversely affect Millendo's ability to develop and commercialize its current and future product candidates.

Raising additional capital by issuing equity or debt securities may cause dilution to existing stockholders of Millendo, and raising funds through lending and licensing arrangements may restrict Millendo's operations or require Millendo to relinquish proprietary rights.

        Until such time as Millendo can generate substantial revenue from product sales, if ever, Millendo expects to finance its cash needs through a combination of equity and debt financings, including the issuance of shares of Millendo Common Stock in its Pre-Closing Financing, strategic alliances and license and development agreements in connection with any future collaborations. Millendo does not

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have any other committed external source of funds. To the extent that Millendo raises additional capital by issuing equity securities, Millendo's existing stockholders' ownership may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Equity and debt financing, if available, may involve agreements that include covenants limiting or restricting Millendo's ability to take specific actions, such as redeeming Millendo's shares, making investments, incurring additional debt, making capital expenditures or declaring dividends.

        The incurrence of indebtedness could result in increased fixed payment obligations and Millendo may be required to agree to certain restrictive covenants therein, such as limitations on Millendo's ability to incur additional debt, limitations on Millendo's ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely affect Millendo's ability to conduct its business.

        If Millendo raises additional capital through collaborations, strategic alliances or third-party licensing arrangements, Millendo may have to relinquish valuable rights to its intellectual property, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to Millendo. If Millendo is unable to raise additional capital through equity or debt financings when needed, Millendo may be required to delay, limit, reduce or terminate its product development or future commercialization efforts, or grant rights to develop and market product candidates that Millendo would otherwise develop and market itself.

Millendo's independent auditors have expressed substantial doubt about Millendo's ability to continue as a going concern.

        Millendo's audited financial statements at December 31, 2016 and 2017 and unaudited financial statements at June 30, 2018 and for the periods then ended were prepared assuming that Millendo will continue as a going concern. However, Millendo does not believe that its current cash will be sufficient to enable it to fund its current operations for longer than 12 months following June 30, 2018, and has therefore concluded that this circumstance causes substantial doubt about Millendo's ability to continue as a going concern. Similarly, the report of Millendo's independent auditors on Millendo's consolidated financial statements as of and for the year ended December 31, 2017 includes an explanatory paragraph indicating that there is substantial doubt about Millendo's ability to continue as a going concern.

        Such an opinion could materially limit Millendo's ability to raise additional funds through the issuance of new debt or equity securities or otherwise. There is no assurance that sufficient financing will be available when needed to allow Millendo to continue as a going concern. The perception that Millendo may not be able to continue as a going concern may also make it more difficult to operate its business due to concerns about Millendo's ability to meet its contractual obligations. Millendo's ability to continue as a going concern is contingent upon, among other factors, the completion of the Merger, the sale of the shares of Millendo's common stock in the Pre-Closing Financing or obtaining alternate financing. Millendo cannot provide any assurance that Millendo will be able to raise additional capital.

        If Millendo is unable to secure additional capital, Millendo may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve Millendo's cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays in Millendo's clinical and regulatory efforts, which are critical to the realization of Millendo's business plan. The accompanying consolidated financial statements do not include any adjustments that may be necessary should Millendo be unable to continue as a going concern. If Millendo cannot continue as a viable entity, you may lose some or all of your investment.

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Millendo may be required to make payments under licenses applicable to nevanimibe and livoletide.

        Millendo acquired worldwide, exclusive rights to nevanimibe pursuant to its license agreement with the Regents of the University of Michigan, or the University of Michigan, entered into in June 2013, or the UM License Agreement. Under the terms of the UM License Agreement, Millendo is obligated to make significant milestone and royalty payments in connection with the attainment of certain development steps and the sale of resulting products with respect to nevanimibe, as well as other material obligations. In addition, pursuant to an assignment agreement for certain patents and patent applications relating to livoletide, Millendo is also required to pay royalties on commercial sales and licensing of livoletide to the assignors. If milestone or other non-royalty obligations become due, Millendo may not have sufficient funds available to meet its obligations, which will materially adversely affect Millendo's business operations and financial condition.

Millendo may expend Millendo's limited resources to pursue a particular product candidate or disease and fail to capitalize on product candidates or diseases that may be more profitable or for which there is a greater likelihood of success.

        Because Millendo has limited financial and managerial resources, Millendo focuses on research programs and product candidates for specific indications. As a result, Millendo may forego or delay pursuit of opportunities with other product candidates or diseases that later prove to have greater commercial potential. Millendo's resource allocation decisions may ultimately not result in successful clinical development programs and may cause Millendo to fail to capitalize on other viable product candidates, commercial products or profitable market opportunities. In addition, Millendo's spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. For example, Millendo expended substantial time and resources on a previous product candidate, MLE4901, which Millendo ceased developing in 2017.

        If Millendo does not accurately evaluate the commercial potential or target market for a particular product candidate, Millendo may relinquish valuable rights to that product candidate through sale, collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for Millendo to retain sole development and commercialization rights.

Risks Related to Development and Commercialization

Millendo's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of livoletide, nevanimibe and any future product candidates. If Millendo is not able to obtain the required regulatory approvals, Millendo will not be able to commercialize its current or future product candidates and Millendo's ability to generate revenue will be adversely affected.

        Millendo does not have any drugs that have received regulatory approval and may never be able to develop marketable product candidates. Millendo expects that a substantial portion of Millendo's efforts and expenses for the foreseeable future will be devoted to the clinical development of livoletide and nevanimibe, and as a result, Millendo's business currently depends heavily on the successful development, regulatory approval and commercialization of these product candidates. Millendo cannot be certain that livoletide or nevanimibe will receive regulatory approval or be successfully commercialized, even if Millendo receives regulatory approval. The research, testing, manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of Millendo's product candidates are, and will remain, subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and similar foreign regulatory authorities. Failure to obtain regulatory approval for livoletide or nevanimibe in the United States or other jurisdictions will prevent Millendo from commercializing and marketing livoletide or nevanimibe.

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        Even if Millendo were to successfully obtain approval from the FDA and comparable foreign regulatory authorities for its product candidates, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If Millendo is unable to obtain regulatory approval for its product candidates, or any approval contains significant limitations, on its own or with any future collaborators, Millendo may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of any other product candidate that Millendo may in-license, develop or acquire in the future.

        Furthermore, even if Millendo obtains regulatory approval for livoletide or nevanimibe, Millendo will still need to develop a commercial infrastructure, or otherwise develop relationships with collaborators to commercialize, establish a commercially viable pricing structure and obtain approval for adequate reimbursement from third-party and government payors. If Millendo, or Millendo's collaborators, are unable to successfully commercialize livoletide or nevanimibe, Millendo may not be able to generate sufficient revenue to continue Millendo's business.

Preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Millendo's clinical trials may not support Millendo's livoletide or nevanimibe claims.

        Millendo's product candidates, livoletide and nevanimibe, are still in development and will require extensive clinical testing before Millendo is prepared to submit a New Drug Application, or NDA, or other similar application for regulatory approval. Millendo cannot predict with any certainty if or when Millendo might submit an NDA for regulatory approval for livoletide or nevanimibe for the treatment of any indication or whether any such application will be approved by the relevant regulatory authority. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. For instance, the FDA or foreign regulatory authorities may not agree with Millendo's proposed endpoints for any clinical trials of livoletide or nevanimibe, even if validated in prior clinical trials of similar product candidates, which may delay the commencement of Millendo's future clinical trials. The FDA or foreign regulatory authorities may also not agree with Millendo's proposed trial designs or dosing regimens, which may likewise prevent or delay the commencement of Millendo's future clinical trials. The clinical trial process is also time-consuming. Millendo estimates that clinical trials of livoletide and nevanimibe for each of the indications that Millendo is pursuing will take the next several years to complete. Failure can occur at any stage of the trials, and Millendo could encounter problems that cause it to abandon or repeat clinical trials. Further, Millendo may encounter challenges in the clinical development of product candidates for reasons unrelated to the observed safety or efficacy of such product candidates in prior clinical trials. In addition, because Millendo is pursuing the treatment of two different indications with nevanimibe, setbacks or failures in, or termination of, clinical development for one indication may have a negative impact on the clinical development for the treatment of other indications.

        Success in preclinical testing and early clinical trials does not ensure that later and pivotal clinical trials will generate the same results, or otherwise provide adequate data to demonstrate the safety and efficacy of a product candidate. Frequently, product candidates that have shown promising results in early clinical trials have subsequently suffered significant setbacks in later or pivotal clinical trials. Millendo's approach to targeting orphan endocrine diseases where current therapies do not exist or are insufficient, is novel and unproven, and as such, the cost and time needed to develop livoletide and nevanimibe is difficult to predict and Millendo's efforts may not be successful. If Millendo does not observe favorable results in future or planned clinical trials of livoletide and nevanimibe, Millendo may decide to delay or abandon development of livoletide and nevanimibe, which could harm Millendo's business, financial condition and results of operations. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

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Millendo may encounter substantial delays in its clinical trials or Millendo may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

        Before obtaining marketing approval from regulatory authorities for the sale of livoletide, nevanimibe and any future product candidates, Millendo must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate for its intended indications. Millendo cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

    failure to obtain regulatory approval to commence a trial;

    unforeseen safety issues;

    determination of dosing issues;

    lack of effectiveness during clinical trials;

    inability to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;

    slower than expected rates of patient recruitment, failure to recruit adequate numbers of suitable patients to participate in Millendo's clinical trials or failure to maintain participation of recruited patients in clinical trials;

    failure to manufacture sufficient quantities of a product candidate for use in clinical trials;

    inability to monitor patients adequately during or after treatment; and

    inability or unwillingness of medical investigators to follow Millendo's clinical protocols.

        Further, Millendo, the FDA or an institutional review board, or IRB, or other regulatory authority may suspend Millendo's clinical trials at any time if it appears that Millendo or Millendo's collaborators are failing to conduct a trial in accordance with regulatory requirements, including, for example, the FDA's good clinical practice, or GCP, regulations, that Millendo is exposing participants to unacceptable health risks, or if the FDA or other regulatory authority, as the case may be, finds deficiencies in Millendo's investigational new drug, or IND, application or other submissions, or the manner in which the clinical trials are conducted. Therefore, Millendo cannot predict with any certainty the schedule for commencement and completion of future clinical trials. If Millendo experiences delays in the commencement or completion of Millendo's clinical trials, or if Millendo terminates a clinical trial prior to completion, the commercial prospects of Millendo's current and future product candidates could be harmed, and Millendo's ability to generate revenue from its current or future product candidates, once approved, may be delayed or eliminated. In addition, any delays in Millendo's clinical trials could increase its costs, slow down the approval process and jeopardize its ability to commence product sales and generate revenue. Any of these occurrences may harm Millendo's business, financial condition and results of operations. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of Millendo's product candidates.

        Moreover, principal investigators for Millendo's clinical trials may serve as Millendo's scientific advisors or consultants from time to time and receive compensation in connection with such services. Under certain circumstances, Millendo may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between Millendo and a principal investigator has created a conflict of interest or otherwise affected interpretation of the trial results. The FDA or other regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of

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Millendo's marketing applications by the FDA or other regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of its product candidates.

        Further, Millendo had limited involvement with the development of nevanimibe prior to June 2013. Accordingly, Millendo did not control the preclinical and clinical development of nevanimibe prior to June 2013 and Millendo is dependent on the University of Michigan to have conducted such research and development in accordance with the applicable protocol, legal, regulatory and scientific standards, having accurately reported the results of all clinical trials conducted prior to Millendo's acquisition of nevanimibe, and having correctly collected and interpreted the data from these studies and trials. To the extent any of these has not occurred, expected development time and costs may be increased which could adversely affect any future revenue from these product candidates.

Millendo has never obtained marketing approval for a product candidate and Millendo may be unable to obtain, or may be delayed in obtaining, marketing approval for Millendo's current product candidates or any future product candidates that Millendo may develop.

        Millendo has never obtained marketing approval for a product candidate. It is possible that the FDA may refuse to accept for substantive review any NDAs that Millendo submits for its product candidates or may conclude after review of Millendo's data that its application is insufficient to obtain marketing approval of Millendo's product candidates. If the FDA does not accept or approve Millendo's NDAs for any of Millendo's product candidates, it may require that Millendo conduct additional clinical trials, preclinical studies or manufacturing validation studies and submit that data before it will reconsider Millendo's applications, Depending on the extent of these or any other FDA-required trials or studies, approval of any NDA or application that Millendo submits may be delayed by several years, or may require Millendo to expend more resources than it has available. It is also possible that additional trials or studies, if performed and completed, may not be considered sufficient by the FDA to approve Millendo's NDAs.

        Any delay in obtaining, or an inability to obtain, marketing approvals would prevent Millendo from commercializing its product candidates, generating revenues and achieving and sustaining profitability. If any of these outcomes occurs, Millendo may be forced to abandon its development efforts for its product candidates, which could significantly harm Millendo's business, prospects, operating results and financial condition.

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Millendo's control.

        Identifying and qualifying patients to participate in Millendo's clinical trials is critical to Millendo's success. Millendo may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of its clinical trials, and even once enrolled Millendo may be unable to retain a sufficient number of patients to complete any of its trials. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, Millendo's ability to recruit clinical trial investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical trials of competing drugs for the same disease, the proximity of patients to clinical sites and the eligibility criteria for the trials, Millendo's ability to obtain and maintain patient consents and the risk that patients enrolled in clinical trials will drop out of the trials before completion. Millendo's ability to enroll and retain patients in clinical trials of livoletide may be adversely impacted by the fact that livoletide is administered by subcutaneous injection. Furthermore, any negative results Millendo may report in clinical trials of its product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials of those product candidates. Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on Millendo's ability to develop livoletide

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and nevanimibe, or could render further development impossible. In addition, Millendo may rely on CROs and clinical trial sites to ensure proper and timely conduct of Millendo's future clinical trials and, while Millendo intends to enter into agreements governing their services, Millendo will be limited in its ability to compel their actual performance.

Millendo's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.

        During the conduct of clinical trials, clinical investigators monitor changes in patients' health, including illnesses, injuries and discomforts. Often, it is not possible to determine whether or not the product candidate being investigated caused these conditions, and regulatory authorities may draw different conclusions or require additional testing to confirm these determinations if they occur. In addition, it is possible that as Millendo tests livoletide, nevanimibe or any other product candidate in larger, longer and more extensive clinical programs, or as use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be observed or reported by subjects. If clinical testing indicates that livoletide, nevanimibe or any future product candidate has side effects or causes serious or life-threatening side effects, Millendo may need to change the design of ongoing clinical trials or adjust dosing levels in ongoing or future clinical trials, and the development of the product candidate may be delayed or terminated entirely. For example, in recent years clinical trials by other companies evaluating product candidates for treatment of PWS, which employed a different mechanism of action than livoletide, have resulted in serious adverse events, including patient deaths, and the eventual termination of the clinical trial and/or clinical development program. Further, if the product candidate has received regulatory approval, such approval may be revoked, which would materially harm Millendo's business, prospects, operating results and financial condition.

        Moreover, if Millendo elects, or is required, to modify, delay, suspend or terminate any clinical trial for Millendo's product candidates, the commercial prospects of its product candidates may be harmed and Millendo's ability to generate revenue through their sale may be delayed or eliminated. Any of these occurrences may harm Millendo's business, financial condition and prospects significantly.

Millendo faces substantial competition, and Millendo's operating results will suffer if Millendo fails to compete effectively.

        The commercialization of new drugs is competitive, and Millendo may face worldwide competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies and ultimately generic companies. Millendo's competitors may develop or market therapies that are more effective, safer or less costly than any that Millendo is commercializing, or may obtain regulatory or reimbursement approval for their therapies more rapidly than Millendo may obtain approval for theirs.

        Millendo is aware of a number of companies that are working to develop drugs that would compete, directly or indirectly, against livoletide for the treatment of Prader-Willi Syndrome, or PWS, and nevanimibe for the treatment of classic congenital adrenal hyperplasia, or CAH, and endogenous Cushing's syndrome, or CS.

        Soleno Therapeutics, Inc. is currently developing diazoxide choline controlled release, an ATP-sensitive potassium channel agonist, and Levo Therapeutics, Inc. is pursuing development of carbetocin, a long-acting analogue of oxytocin, for the treatment of PWS. Each of Saniona AB, GLWL Research Inc. and Insys Therapeutics, Inc. has also announced or initiated smaller trials in PWS. There are also a number of compounds in preclinical development.

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        Millendo is aware of three other companies developing treatments for patients with CAH: Diurnal Group PLC is developing an exogenous cortisol treatment with a modified release intended to more closely match the physiological release profile of cortisol. Neurocrine Biosciences, Inc. has initiated a Phase 2 clinical trial targeting CRF 1 and Spruce Biosciences, Inc. is developing a CRF 1 antagonist in a Phase 2 clinical trial. Novartis AG is currently marketing Signifor and Corcept Therapeutics Inc. is currently marketing Korlym, both for the treatment of subsets of CS patients. There are several other product candidates currently in clinical development for CS, including by Novartis, Corcept, HRA Pharma, SA and StrongBridge BioPharma plc.

        Many of Millendo's existing or potential competitors may have substantially greater financial, technical and human resources than Millendo does, and significantly greater experience in the discovery and development of product candidates, as well as in obtaining regulatory approvals of those product candidates in the United States and in foreign countries. Millendo's current and potential future competitors may also have significantly more experience commercializing drugs that have been approved for marketing. If Millendo is not able to compete effectively against existing and potential competitors, Millendo's business and financial condition may be harmed.

        Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even more resources being concentrated among a small number of Millendo's competitors. Competition may reduce the number and types of patients available to Millendo to participate in clinical trials, because some patients who might have opted to enroll in Millendo's trials may instead opt to enroll in a trial being conducted by one of Millendo's competitors.

        Competition may further increase as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Millendo's competitors may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that are more effective or less costly than any product candidate that Millendo may develop.

        Any inability to successfully complete clinical development of a product candidate could result in additional costs or impair or eliminate Millendo's ability to generate revenue from future sales of such product candidate, if approved, or from any regulatory and commercialization milestone with respect to such product candidate. In addition, if Millendo makes manufacturing or formulation changes to livoletide or nevanimibe, Millendo may need to conduct additional testing to bridge Millendo's modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which Millendo may have the exclusive right to commercialize livoletide or nevanimibe, or allow Millendo's competitors to bring comparable drugs to market before Millendo does, which could impair Millendo's ability to successfully commercialize livoletide or nevanimibe, and may harm Millendo's business, financial condition and results of operations.

        Established pharmaceutical and biotechnology companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make livoletide or nevanimibe less competitive. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful. Accordingly, Millendo's competitors may succeed in obtaining patent protection, discovering, developing and receiving FDA or other regulatory authority approval, or commercializing drugs before Millendo does, which would have an adverse impact on Millendo's business and results of operations.

        The availability of Millendo's competitors' products could limit the demand and the price Millendo is able to charge for any product candidate it develops. The inability to compete with existing or subsequently introduced drugs would harm Millendo's business, prospects, financial condition and results of operations.

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The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and even if Millendo obtains approval for a product candidate in one country or jurisdiction, Millendo may never obtain approval for, or commercialize, that product candidate in any other jurisdiction, which would limit Millendo's ability to realize its full market potential.

        Prior to obtaining approval to commercialize a product candidate in any jurisdiction, Millendo or Millendo's collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if Millendo's product candidates meet their safety and efficacy endpoints in clinical trials, the FDA or foreign regulatory agencies may believe the clinical trials do not show the appropriate balance of safety and efficacy in the indication being sought or may interpret the data differently than Millendo does, and deem the results insufficient to demonstrate the appropriate balance of safety and efficacy at the level required for product approval. Further, the regulatory authorities may not complete their review processes in a timely manner, or Millendo may otherwise not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, Millendo may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

        Further, in order to market any products in any particular jurisdiction, Millendo must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval by the FDA in the United States does not ensure approval by regulatory authorities in any other country or jurisdiction. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and costs for Millendo and require additional preclinical studies or clinical trials, which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of Millendo's products in those countries. Millendo does not have any product candidates approved for sale in any jurisdiction, including in international markets, and Millendo does not have experience in obtaining regulatory approval in international markets. If Millendo fails to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, Millendo's target market will be reduced and Millendo's ability to realize the full market potential of any product Millendo develops will be unrealized.

        The FDA or any foreign regulatory bodies can delay, limit or deny approval of Millendo's product candidates or require Millendo to conduct additional preclinical or clinical testing or abandon a program for many reasons, including:

    the FDA or the applicable foreign regulatory agency's disagreement with the design or implementation of Millendo's clinical trials;

    negative or ambiguous results from Millendo's clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval;

    serious and unexpected drug-related side effects experienced by participants in Millendo's clinical trials or by individuals using drugs similar to Millendo's product candidates;

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    Millendo's inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that Millendo's product candidates are safe and effective for the proposed indication;

    the FDA's or the applicable foreign regulatory agency's disagreement with the interpretation of data from preclinical studies or clinical trials;

    Millendo's inability to demonstrate the clinical and other benefits of its product candidates outweigh any safety or other perceived risks;

    the FDA's or the applicable foreign regulatory agency's requirement for additional preclinical studies or clinical trials;

    the FDA's or the applicable foreign regulatory agency's disagreement regarding the formulation, labeling or the specifications of Millendo's product candidates;

    the FDA's or the applicable foreign regulatory agency's failure to approve the manufacturing processes or facilities of third-party manufacturers with which Millendo contracts; or

    the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering Millendo's clinical data insufficient for approval.

        Even if Millendo eventually completes clinical testing and receives approval of an NDA or foreign marketing application for Millendo's product candidates, the FDA or the applicable foreign regulatory agency may grant approval contingent on the performance of costly additional clinical trials, including Phase 4 clinical trials, or the implementation of a Risk Evaluation and Mitigation Strategy, or REMS, which may be required to ensure safe use of the drug after approval. The FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or patient population than Millendo originally requested, and the FDA or applicable foreign regulatory agency may not approve the labeling that Millendo believes is necessary or desirable for the successful commercialization of a product candidate. Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that product candidate and would negatively impact Millendo's business and results of operations.

If Millendo is not able to obtain orphan drug designations or exclusivity for any of its current or future product candidates for which Millendo seeks such designation, the potential profitability of any such product candidates could be limited.

        Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if the treatment is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for a disease for which it receives the designation, then the product is entitled to a period of marketing exclusivity that precludes the applicable regulatory authority from approving another marketing application for the same product for the same disease for the exclusivity period except in limited situations. For purposes of small molecule drugs, the FDA defines "same drug" as a drug that contains the same active moiety and is intended for the same use as the drug in question. A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.

        Millendo has received orphan drug designation for livoletide from the FDA and EMA for the treatment of PWS. Nevanimibe has received orphan drug designation from the FDA for the treatment of CAH and CS and the EMA for the treatment of CAH. Millendo may also seek orphan drug

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designation, where applicable, for its current product candidates in additional indications or for its future product candidates. However, obtaining an orphan drug designation can be difficult and Millendo may not be successful in doing so for any of Millendo's current or future product candidates, in any applicable indication. Even if Millendo were to obtain orphan drug designation for a product candidate, Millendo may not obtain orphan exclusivity and that exclusivity may not effectively protect the product candidate from the competition of different products or drugs for the same condition, which could be approved during the exclusivity period. Additionally, after an orphan drug is approved, the FDA could subsequently approve another application for the same product for the same disease if the FDA concludes that the later product is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusive marketing rights in the United States also may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition. The failure to obtain an orphan drug designation for any product candidates Millendo may develop and seek it for, the inability to maintain that designation for the duration of the applicable period, or the inability to obtain or maintain orphan drug exclusivity could reduce Millendo's ability to make sufficient sales of the applicable product candidates to balance its expenses incurred to develop it, which would have a negative impact on Millendo's operational results and financial condition.

If Millendo is not able to obtain required regulatory approvals, Millendo will not be able to commercialize livoletide or nevanimibe, and Millendo's ability to generate revenue will be harmed.

        Livoletide and nevanimibe and the activities associated with their development and commercialization, including their design, research, testing, manufacture, safety, efficacy, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by similar regulatory authorities outside the United States. Failure to obtain marketing approval for livoletide and nevanimibe will prevent Millendo from commercializing them.

        Millendo has not yet received approval from regulatory authorities to market any product candidate in any jurisdiction, and it is possible that none of livoletide, nevanimibe or any future product candidates will ever obtain the appropriate regulatory approvals necessary for Millendo to commence product sales. Neither Millendo nor any future collaborator is permitted to market any of its product candidates in the United States until Millendo receives regulatory approval of an NDA from the FDA.

        The time required to obtain approval of an NDA by the FDA is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. Prior to submitting an NDA to the FDA or an equivalent application to other foreign regulatory authorities for approval of livoletide for the treatment of PWS and for approval of nevanimibe for the treatment of CAH and CS, respectively, Millendo will need to complete its currently planned Phase 2b/3 clinical trials for each, and additional trials that the FDA may require Millendo to complete.

        Additionally, if the results of Millendo's clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with livoletide or nevanimibe, Millendo may:

    be delayed in obtaining marketing approval for livoletide or nevanimibe, if at all;

    obtain approval for indications or patient populations that are not as broad as intended or desired;

    obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

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    be subject to additional post-marketing testing requirements;

    be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

    have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of REMS;

    be subject to the addition of labeling statements, such as warnings or contraindications;

    be sued; or

    experience damage to Millendo's reputation.

        Furthermore, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate's clinical development and may vary among jurisdictions.

        Millendo may rely on third-party CROs and consultants to assist Millendo in filing and supporting the applications necessary to gain marketing approvals. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each disease to establish the safety and efficacy of livoletide, nevanimibe and any future product candidate for that disease. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities.

Even if Millendo obtains regulatory approval for livoletide, nevanimibe or future product candidates, Millendo will remain subject to ongoing regulatory oversight.

        Even if Millendo obtains any regulatory approval for livoletide, nevanimibe or future product candidates, the approved product will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. For example, we must comply with the FDA's advertising and promotion requirements, such as those related to direct-to-consumer advertising and the prohibition on promoting products for uses or in patient populations that are not described in the product's approved labeling. In addition, any regulatory approvals that Millendo receives for livoletide, nevanimibe or future product candidates may also be subject to REMS limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the drug.

        In addition, drug manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application. If Millendo, or a regulatory authority, discover previously unknown problems with a drug, such as adverse events of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the manufacturing facility or Millendo, including requiring recall or withdrawal of the drug from the market or suspension of manufacturing.

        If Millendo fails to comply with applicable regulatory requirements following approval of livoletide, nevanimibe or future product candidates, a regulatory authority may, among other things:

    issue a warning letter asserting that Millendo is in violation of the law;

    seek an injunction or impose administrative, civil or criminal penalties or monetary fines;

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    suspend or withdraw regulatory approval;

    suspend any ongoing clinical trials;

    refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by Millendo or Millendo's strategic partners;

    restrict the marketing or manufacturing of the drug;

    seize or detain the drug or otherwise require the withdrawal of the drug from the market;

    refuse to permit the import or export of product candidates; or

    refuse to allow Millendo to enter into supply contracts, including government contracts.

        Any government investigation of alleged violations of law could require Millendo to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit Millendo's ability to commercialize livoletide and nevanimibe, and harm Millendo's business, financial condition and results of operations.

        In addition, the FDA's policies, and those of equivalent foreign regulatory agencies, may change and additional government regulations may be enacted that could suspend or restrict regulatory approval of livoletide and nevanimibe. Millendo cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Millendo is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Millendo is not able to maintain regulatory compliance, Millendo may lose any marketing approval that Millendo may have obtained and Millendo may not achieve or sustain profitability, which would harm Millendo's business, financial condition and results of operations.

Even if one of Millendo's product candidates receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

        Even if one of Millendo's product candidates receives marketing approval, it may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If any such product candidate does not achieve an adequate level of acceptance, Millendo may not generate significant product revenue and may not become profitable. The degree of market acceptance of a product candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

    the efficacy and potential advantages compared to alternative treatments;

    the success of Millendo's efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of Millendo's products;

    effectiveness of sales and marketing efforts;

    the cost of treatment in relation to alternative treatments, including any similar generic treatments;

    Millendo's ability to offer Millendo's drugs, once approved, for sale at competitive prices

    the convenience and ease of administration compared to alternative treatments;

    the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

    the strength of marketing and distribution support;

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    the availability of third-party coverage and adequate reimbursement, and patients' willingness to pay out-of-pocket in the absence third-party coverage or adequate reimbursement;

    the willingness of patients to pay out of pocket for serlopitant to the extent it is not reimbursed by third-party payors;

    the prevalence and severity of any side effects; and

    any restrictions on the use of Millendo's drugs, once approved, together with other medications

If the market opportunities for Millendo's product candidates are smaller than it believes they are, Millendo's product revenues may be adversely affected and Millendo business may suffer.

        Millendo's efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of Millendo's products, if and when approved, may require significant resources and may never be successful. Further, patient populations suffering from PWS, CAH and CS, and other indications Millendo may target in the future, are small and have not been established with precision. If the actual number of patients is smaller than Millendo estimates for any disease that Millendo is targeting, or if Millendo cannot raise awareness of these diseases and diagnosis is not improved, Millendo's revenue and ability to achieve profitability may be adversely affected. For example, since the patient populations for PWS, CAH and CS are small, the per-patient drug pricing must be high in order to recover Millendo's development and manufacturing costs, fund adequate patient support programs and achieve profitability. For PWS, CAH and CS, then, Millendo may not maintain or obtain sufficient sales volume at a price high enough to justify Millendo's product development efforts and Millendo's sales and marketing and manufacturing expenses. Because Millendo expects sales of livoletide and nevanimibe, if approved, to generate substantially all of Millendo's product revenue for the foreseeable future, the failure of either of these product candidates to find market acceptance would harm Millendo's business.

If Millendo is unable to establish sales, marketing and distribution capabilities, either on Millendo's own or in collaboration with third parties, Millendo may not be successful in commercializing its product candidates, if approved.

        Millendo does not have any infrastructure for the sales, marketing or distribution of Millendo's products, and the cost of establishing and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market any product that may be approved, Millendo must build its sales, distribution, marketing, managerial and other non-technical capabilities, or make arrangements with third parties to perform these services. There can be no assurance Millendo will be able to do so in a cost-effective manner, on terms favorable to Millendo, or at all.

        While Millendo may seek the aid of global or regional collaborators to provide additional resources for larger indications or to co-commercialize Millendo's product candidates in the European Union and certain other territories, Millendo expects to build a focused sales, distribution and marketing infrastructure to market its product candidates in the United States itself, if approved. There are significant expenses and risks involved with establishing Millendo's own sales, marketing and distribution capabilities, including Millendo's ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of Millendo's internal sales, marketing and distribution capabilities could delay any product launch, which would adversely impact its commercialization.

        Factors that may inhibit Millendo's efforts to commercialize its products on its own include:

    Millendo's inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

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    the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe any drugs;

    the inability of reimbursement professionals to negotiate arrangements, for formulary access, reimbursement, and other acceptance by payors;

    restricted or closed distribution channels that make it difficult to distribute Millendo's products to segments of the patient population;

    the lack of complementary medicines to be offered by sales personnel, which may put Millendo at a competitive disadvantage relative to companies with more extensive product lines; and

    unforeseen costs and expenses associated with creating an independent sales and marketing organization.

        Further, Millendo does not anticipate having the resources in the foreseeable future to allocate to the sales and marketing of Millendo's product candidates in certain markets overseas. Therefore, Millendo's future success will depend, in part, on its ability to enter into and maintain collaborative relationships for such capabilities, the collaborator's strategic interest in a product and such collaborator's ability to successfully market and sell the product. Millendo intends to pursue collaborative arrangements regarding the sale and marketing of its product candidates, if approved, for certain markets overseas; however, Millendo cannot assure you that they will be able to establish or maintain such collaborative arrangements, or if able to do so, that they will have effective sales forces. To the extent that Millendo depends on third parties for marketing and distribution, any revenue Millendo receives will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful.

        If Millendo is unable to build its own sales force or negotiate a collaborative relationship for the commercialization of its product candidates, Millendo may be forced to delay its potential commercialization or reduce the scope of its sales or marketing activities for them. If Millendo elects to increase its expenditures to fund commercialization activities itself, Millendo will need to obtain additional capital, which may not be available to Millendo on acceptable terms, or at all. If Millendo does not have sufficient funds, Millendo will not be able to bring its product candidates to market or generate product revenue. Millendo could enter into arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be ideal and Millendo may be required to relinquish rights to its product candidates or otherwise agree to terms unfavorable to Millendo, any of which may have an adverse effect on Millendo's business and results of operations.

        If Millendo is unable to establish adequate sales, marketing and distribution capabilities, either on Millendo's own or in collaboration with third parties, Millendo will not be successful in commercializing its product candidates and may not become profitable. Millendo will be competing with many companies that currently have extensive and well-funded sales and marketing operations. Without an internal team or the support of a third-party to perform sales and marketing functions, Millendo may be unable to compete successfully against these more established companies.

Even if Millendo obtains and maintains approval for its current and future product candidates from the FDA, Millendo may nevertheless be unable to obtain approval for its product candidates outside of the United States, which would limit Millendo's market opportunities and could harm Millendo's business.

        Approval of a product candidate in the United States by the FDA does not ensure approval of such product candidate by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. If approved, sales of livoletide, nevanimibe and any future product candidate outside of the United States will be subject to foreign regulatory requirements governing clinical trials and marketing approval. Even if the FDA grants marketing approval for a product candidate,

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comparable regulatory authorities of foreign countries also must approve the manufacturing and marketing of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and more onerous than, those in the United States, including additional preclinical studies or clinical trials. In many countries outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that Millendo intends to charge for any product candidates, if approved, is also subject to approval. Obtaining approval for livoletide, nevanimibe or any future product candidate in the European Union from the European Commission following the opinion of the EMA, if Millendo chooses to submit a marketing authorization application there, would be a lengthy and expensive process. Even if a product candidate is approved, the FDA or the European Commission, as the case may be, may limit the indications for which the drug may be marketed, require extensive warnings on the drug labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Millendo and could delay or prevent the introduction of livoletide, nevanimibe or any future product candidate in certain countries.

        Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Also, regulatory approval for livoletide, nevanimibe or any future product candidate may be withdrawn. If Millendo fails to comply with the regulatory requirements, Millendo's target market will be reduced and Millendo's ability to realize the full market potential of livoletide, nevanimibe or any future product candidate will be negatively impacted, and Millendo's business, prospects, financial condition and results of operations could be harmed.

Millendo is exposed to a variety of risks associated with its international operations.

        In December 2017, Millendo acquired Alizé, a biopharmaceutical company based in Lyon, France. As of June 30, 2018, Millendo had 18 employees located in the United States and seven employees located in France. Millendo's global operations expose it to numerous and sometimes conflicting legal, tax and regulatory requirements, and violations or unfavorable interpretation by the respective authorities of these regulations could harm Millendo's business. Risks associated with international operations include the following, and these risks may be more pronounced if Millendo seeks to commercialize livoletide, nevanimibe or any future product candidates outside of the United States:

    different regulatory requirements for approval of therapies in foreign countries;

    reduced protection for intellectual property rights;

    unexpected changes in tariffs, trade barriers and regulatory requirements;

    economic weakness, including inflation, or political instability in particular foreign economies and markets;

    compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

    foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

    foreign reimbursement, pricing and insurance regimes;

    workforce uncertainty in countries where labor unrest is more common than in the United States;

    changes in diplomatic and trade relationships;

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    anti-corruption laws, including the FCPA, and its equivalent in foreign jurisdictions, such as the UK Bribery Act;

    production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

    business interruptions resulting from geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires.

In addition, there are complex regulatory, tax, labor, and other legal requirements imposed by both the European Union and many of the individual countries in and outside of Europe, with which Millendo may need to comply. Many biopharmaceutical companies have found the process of marketing their own products in foreign countries to be very challenging.

        Furthermore, in some countries, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after coverage and reimbursement have been obtained. Reference pricing used by various countries and parallel distribution or arbitrage between low-priced and high-priced countries, can further reduce prices. To obtain reimbursement or pricing approval in some countries, Millendo may be required to conduct a clinical trial that compares the cost-effectiveness of Millendo's product candidate to other available therapies, which is time-consuming and costly. If coverage and reimbursement of Millendo's product candidates are unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, Millendo's business could be harmed.

Product liability lawsuits against Millendo could cause Millendo to incur substantial liabilities and could limit commercialization of any product candidate that Millendo may develop.

        Millendo faces an inherent risk of product liability exposure related to the testing of Millendo's current and future product candidates, and may face an even greater risk if Millendo commercializes any product candidate that it may develop. If Millendo cannot successfully defend itself against claims that any such product candidates caused injuries, Millendo could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

    decreased demand for any product candidate that Millendo may develop;

    loss of revenue;

    substantial monetary awards to trial participants or patients;

    significant time and costs to defend the related litigation;

    withdrawal of clinical trial participants;

    the inability to commercialize any product candidate that it may develop;

    injury to Millendo's reputation and significant negative media attention; and

    increased marketing costs to attempt to overcome any injury to Millendo's reputation or negative media attention.

        Although Millendo maintains product liability insurance coverage, such insurance may not be adequate to cover all liabilities that Millendo may incur. Millendo anticipates that it will need to increase its insurance coverage each time Millendo commences a clinical trial and if Millendo successfully commercializes any product candidate. Insurance coverage is increasingly expensive.

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Millendo may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Regulatory Compliance

Millendo's current and future relationships with investigators, health care professionals, consultants, third-party payors and customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If Millendo is unable to comply, or have not fully complied, with such laws, Millendo could face substantial penalties.

        If Millendo obtains FDA approval for livoletide, nevanimibe or any future product candidates, and begins commercializing in the United States, Millendo's operations will be directly, or indirectly through Millendo's prescribers, customers and purchasers, subject to various federal and state fraud and abuse laws and regulations, including, without limitation, the federal Anti-Kickback Statute, the federal civil and criminal false claims laws and Physician Payments Sunshine Act and regulations. These laws may constrain Millendo's current and future business or financial arrangements and relationships through which Millendo conducts its operations, including how Millendo researches, markets, sells and distributes its products for which Millendo obtains marketing approval. In addition, Millendo may be subject to patient privacy laws by both the federal government and the states and other countries in which Millendo conducts its business. The laws that will affect Millendo's operations include, but are not limited to:

    the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, in return for the purchase, recommendation, leasing or furnishing of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers, purchasers and formulary managers on the other. In addition, the PPACA amended the intent requirement of the federal Anti-Kickback Statute, establishing that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it;

    federal civil and criminal false claims laws and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent. PPACA provides, and recent government cases against pharmaceutical and medical device manufacturers support the view, that federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the federal civil False Claims Act;

    HIPAA, which created additional federal criminal statutes that prohibit a person from knowingly and willfully executing a scheme or from making false or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private);

    HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses and certain health care providers and their business associates who create, use or disclose HIPAA protected health information on their behalf;

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    federal transparency laws, including the federal Physician Payments Sunshine Act, that require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to report annually to CMS information related to: (i) payments or other "transfers of value" made to physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and their immediate family members;

    state and foreign law equivalents of each of the above federal laws, such as state anti-kickback, self-referral, and false claims laws which may apply to Millendo's business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical manufacturers to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers; state laws that require pharmaceutical manufacturers to file reports with states regarding marketing information, such as the tracking and reporting of gifts, compensation and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring the registration of pharmaceutical sales representatives; and

    state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

        Efforts to ensure that Millendo's business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. However, because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of Millendo's business activities could be subject to challenge under one or more of such laws. If Millendo's operations are found to be in violation of any of the laws described above or any other government regulations that apply to Millendo, it may be subject to penalties, including civil and criminal penalties, damages, fines, additional reporting requirements and oversight if Millendo becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, exclusion from participation in government health care programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm and the curtailment or restructuring of Millendo's operations, any of which could harm Millendo's ability to operate its business and its results of operations. Similar sanctions and penalties, as well as individual imprisonment, also can be imposed upon executive officers and employees, including criminal sanctions against executive officers under the so-called "responsible corporate officer" doctrine, even in situations where the executive officer did not intend to violate the law and was unaware of any wrongdoing.

        The risk of Millendo being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and its provisions are open to a variety of interpretations. Any action against Millendo for violation of these laws, even if Millendo successfully defends against it, could cause Millendo to incur significant legal expenses and divert its management's attention from the operation of Millendo's business. The shifting compliance environment and the need to build and maintain a robust and expandable system to comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare company such as Millendo may run afoul of one or more of the requirements.

Coverage and adequate reimbursement may not be available for Millendo's current or future product candidates, which could make it difficult for Millendo to sell them profitably, if approved.

        Market acceptance and sales of any product candidates that Millendo commercializes, if approved, will depend in part on the extent to which reimbursement for these drugs and related treatments will

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be available from third-party payors, including government health administration authorities and private health insurers. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidates that Millendo develops will be made on a plan-by-plan basis. As a result, the coverage determination process is often a time-consuming and costly process that may require Millendo to provide scientific and clinical support for the use of Millendo's products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained. One payor's determination to provide coverage for a drug does not assure that other payors will also provide coverage, and adequate reimbursement, for the drug. Additionally, a third-party payor's decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved. Each plan determines whether it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier of its formulary it will be placed. The position on a formulary generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use Millendo's drugs unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of Millendo's drugs.

        A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Millendo cannot be sure that coverage and reimbursement will be available for any drug that Millendo commercializes and, if reimbursement is available, what the level of reimbursement will be. Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug for which Millendo obtains marketing approval. If coverage and reimbursement are not available, or are available only to limited levels, Millendo may not be able to successfully commercialize livoletide, nevanimibe and any future product candidates that Millendo develops.

        Additionally, there have been a number of legislative and regulatory proposals to change the healthcare system in the United States and in some foreign jurisdictions that could affect Millendo's ability to sell any future product candidates profitably. These legislative and regulatory changes may negatively impact the coverage and available reimbursement for livoletide, nevanimibe and any future product candidates Millendo may commercialize, following approval, if obtained.

Healthcare legislative reform measures may have a negative impact on Millendo's business and results of operations.

        In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect Millendo's ability to profitably sell any product candidates for which Millendo obtain marketing approval.

        In March 2010, PPACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. PPACA, among other things: (i) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs; (iv) expands the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; and (v) establishes a new Medicare Part D coverage gap

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discount program, in which manufacturers must agree to offer 50% (and 70% beginning January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D.

        In addition, other legislative changes have been adopted since PPACA was enacted. These changes include aggregate reductions in Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, following passage of the Bipartisan Budget Act of 2018, among other legislative amendments, will remain in effect through 2027 unless additional Congressional action is taken. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on Millendo's customers and, accordingly, Millendo's financial operations.

        Additional changes that may affect Millendo's business include those governing enrollment in federal healthcare programs, reimbursement changes, rules regarding prescription drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of PPACA and the passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiatives, and may impact existing government healthcare programs, such as by improving the physician quality reporting system and feedback program. For each state that does not choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the sales, business and financial condition of manufacturers of branded prescription drugs. Where patients receive insurance coverage under any of the new options made available through PPACA, the possibility exists that manufacturers may be required to pay Medicaid rebates on their resulting drug utilization, a decision that could impact manufacturer revenues.

        Since PPACA was enacted, the U.S. federal government also has announced delays in the implementation of key provisions of PPACA. Additionally, there have been judicial and Congressional challenges to certain aspects of PPACA, as well as efforts by the Trump administration to repeal or replace certain aspects of PPACA. Since January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of PPACA or otherwise circumvent some of the requirements for health insurance mandated by PPACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of PPACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under PPACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate". Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain PPACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, among other things, amends the PPACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole". More recently, in July 2018 CMS published a final rule permitting further collections and payments to and from certain PPACA qualified health plans and health insurance issuers under the PPACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to

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determine this risk adjustment. Millendo continues to evaluate the potential impact of PPACA and its possible repeal or replacement on Millendo business.

        Millendo expects that PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that Millendo is able to charge for any approved drug in the United States. For example, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration's budget proposal for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Further, the Trump administration released a "Blueprint" to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. The Department of Health and Human Services, or HHS, has already started the process of soliciting feedback on some of these measures and, at the same, is immediately implementing others under its existing authority. While some proposed measures will require authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, such measures are designed to encourage importation from other countries and bulk purchasing. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Millendo from being able to generate revenue, attain profitability, or commercialize Millendo's drugs. Millendo expects that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for Millendo's product candidates or additional pricing pressures.

Regulatory, legislative or self-regulatory/standard developments regarding privacy and data security matters could adversely affect Millendo's ability to conduct its business.

        Millendo is subject to and affected by laws, rules, regulations and industry standards related to data privacy and security, and restrictions or technological requirements regarding the collection, use, storage, security, retention or transfer of data. In the United States, the rules and regulations to which Millendo may be subject include federal laws and regulations enforced by the Federal Trade Commission, the Department of Health & Human Services, and state privacy, data security, and breach notification laws, as well as regulator enforcement positions and expectations. Internationally, governments and agencies have adopted and could in the future adopt, modify, apply or enforce additional laws, policies, regulations, and standards covering privacy and data security that may apply to Millendo's business. New regulation or legislative actions regarding data privacy and security (together with applicable industry standards) may increase Millendo's costs of doing business. In addition to privacy and data security regulations currently in force in the jurisdictions where Millendo operates, the European Union General Data Protection Regulation, or GDPR, went into effect in May 2018. The GDPR contains numerous requirements and changes from existing European Union, or EU, law,

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including more robust obligations on data processors and data controllers and heavier documentation requirements for data protection compliance programs. Specifically, the GDPR will introduce numerous privacy-related changes for companies operating in the EU, including greater control over personal data-by-data subjects (e.g., the "right to be forgotten"), increased data portability for EU consumers, data breach notification requirements, and increased fines. In particular, under the GDPR, fines of up to €20 million or up to 4% of the annual global revenue of the noncompliant company, whichever is greater, could be imposed for violations of certain of the GDPR's requirements. The GDPR requirements apply not only to third-party transactions, but also to transfers of information between Millendo and Millendo's subsidiaries, including employee information. However, despite Millendo's ongoing efforts to bring its practices into compliance before the effective date of the GDPR, Millendo may not be successful either due to various factors within Millendo's control, such as limited financial or human resources, or other factors outside Millendo's control. It is also possible that local data protection authorities may have different interpretations of the GDPR, leading to potential inconsistencies amongst various EU member states. Any failure or alleged failure (including as a result of deficiencies in Millendo's policies, procedures, or measures relating to privacy, data security, marketing, or communications) by Millendo to comply with laws, regulations, policies, legal or contractual obligations, industry standards, or regulatory guidance relating to privacy or data security, may result in governmental investigations and enforcement actions, litigation, fines and penalties, additional regulatory oversight and reporting obligations or adverse publicity. Millendo expects that there will continue to be new proposed laws, regulations and industry standards relating to privacy and data protection in the United States, the European Union, and in other jurisdictions, and Millendo cannot determine the impact such future laws, regulations and standards may have on Millendo's business.

        Future laws, regulations, standards and other obligations or any changed interpretation of existing laws or regulations could impair Millendo's ability to operate its business and negatively impact its results of operations.

Risks Related to Millendo's Intellectual Property

Millendo relies on the availability of licenses for intellectual property from third parties and these licenses may not be available to Millendo on commercially reasonable terms, or at all.

        Millendo is heavily reliant upon the UM License Agreement to certain patent rights and proprietary technology from the University of Michigan that are important or necessary to the development of nevanimibe. As of June 30, 2018, with respect to nevanimibe patent rights, Millendo owned one issued U.S. patent, two pending U.S. patent applications, and a number of patent applications in other jurisdictions, and Millendo jointly owned, with the University of Michigan, three issued U.S. patents, one pending U.S. patent application, and a number of patent applications in other jurisdictions. In addition, as of June 30, 2018, with respect to livoletide patent rights, Millendo owned four issued U.S. patents, one pending U.S. patent application, and a number of patents and pending patent applications in other jurisdictions. There is no guarantee that any of the foregoing patent applications will result in issued patents, or that any current patents or patent applications, if issued, will include claims that are sufficiently broad to cover Millendo's product candidates or future products, or to provide meaningful protection from Millendo's competitors in all territories in which Millendo may wish to develop or commercialize Millendo's products in the future. Millendo will be able to protect Millendo's proprietary rights from unauthorized use by third parties only to the extent they are covered by valid and enforceable patents or are effectively maintained as trade secrets within Millendo's organization. If third parties disclose or misappropriate Millendo's proprietary rights, it may have a material adverse effect on Millendo's business.

        The licenses granted under the UM License Agreement are revocable under certain circumstances including if Millendo ceases to do business, fail to make the payments due thereunder, commit a

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material breach of the agreement that is not cured within a certain time period after receiving written notice or fail to meet certain specified development and commercial timelines. In such an event, Millendo's ability to compete in the market may be diminished. Termination of the UM License Agreement may result in Millendo's having to negotiate a new or reinstated agreement, which may not be available to Millendo on equally favorable terms, or at all, which may mean Millendo is unable to develop or commercialize nevanimibe. Additionally, the UM License Agreement and other licenses Millendo may enter into in the future may not provide exclusive rights to use such intellectual property and technology at all, in all relevant fields of use and/or in all territories in which Millendo may wish to develop or commercialize its product candidates in the future. As a result, Millendo may not be able to prevent competitors from developing and commercializing competitive products, including in territories included in the UM License Agreement.

        Licenses to additional third-party patents and materials that may be required for Millendo's development programs may not be available in the future or may not be available on commercially reasonable terms, or at all, which could harm Millendo's business and financial condition.

Millendo's intellectual property licenses and agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of Millendo's rights to the relevant intellectual property or technology or increase Millendo's financial or other obligations to its licensors.

        Millendo currently depends, and will continue to depend, on the UM License Agreement. In addition, pursuant to an assignment agreement for certain patents and patent applications relating to livoletide, Millendo is also required to pay royalties on commercial sales and licensing of livoletide to the assignors. Further, the assignors under this assignment agreement have a right to repurchase the assigned intellectual property at a certain price in the event Millendo does not, upon receiving notice, use reasonable efforts to develop, introduce for sale and promote products derived from the assigned intellectual property. Such reasonable efforts involve spending an annual amount of at least CDN$100,000 in research and development related to livoletide, actively pursuing the registration, licenses and permits necessary to market livoletide and actual commercialization of livoletide, if approved. Further development and commercialization of livoletide and nevanimibe may, and development of any future product candidates may, require Millendo to enter into additional license, assignment or collaboration agreements. The agreements under which Millendo currently holds or licenses intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what Millendo believes to be the scope of its rights to the relevant intellectual property or technology, or increase what Millendo believes to be its financial or other obligations under the relevant agreement, either of which could have a material adverse effect on Millendo's business, financial condition, results of operations and prospects.

        If any of Millendo's current or future licenses or agreements or material relationships or any in-licenses upon which Millendo's current or future licenses and intellectual property are based are terminated or breached, Millendo may:

    lose Millendo's rights to develop and market its current and any future product candidates;

    lose Millendo's rights to patent protection for its current or any future product candidates;

    experience significant delays in the development or commercialization of Millendo's current or any future product candidates;

    not be able to obtain any other licenses on acceptable terms, if at all; or

    incur liability for damages.

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        These risks apply to any agreements that Millendo may enter into in the future for livoletide, nevanimibe or for any future product candidates. If Millendo experiences any of the foregoing, it would have a material adverse effect on Millendo's business, financial condition and results of operations.

        If Millendo fails to comply with its obligations in the agreements under which Millendo holds or licenses intellectual property rights from third parties or otherwise experience disruptions to Millendo's business relationships with its licensors, Millendo could lose license and intellectual property rights that are important to Millendo's business.

        Further, Millendo cannot provide any assurances that third-party patents or other intellectual property rights do not exist, which might be enforced against Millendo's current product candidates, resulting in either an injunction prohibiting Millendo's manufacture or sales, or, with respect to Millendo's sales, an obligation on Millendo's part to pay royalties and/or other forms of compensation to third parties. Moreover, if disputes over intellectual property that Millendo has licensed prevent or impair Millendo's ability to maintain its current licensing arrangements on commercially acceptable terms, Millendo may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on Millendo's business, prospects, financial condition and results of operations.

If Millendo is unable to obtain and maintain patent protection for its technology and products, or if the scope of the patent protection obtained is not sufficiently broad, Millendo may not be able to compete effectively in Millendo's markets.

        Millendo relies upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to Millendo's product candidates. Millendo's success depends in large part on its ability to obtain and maintain patent protection in the United States and other countries with respect to Millendo's current and future product candidates in the United States and other countries in which Millendo plans to develop and commercialize such product candidates. Millendo seeks to protect its proprietary position by filing patent applications in the United States and abroad related to Millendo's development programs and product candidates. The patent prosecution process is expensive and time-consuming, and Millendo may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

        Pursuant to the UM License Agreement, Millendo obtained an exclusive, worldwide license to develop, manufacture and commercialize nevanimibe. However, the UM License Agreement permits the University of Michigan, and other non-profit research institutions which are granted such rights from the University of Michigan, to manufacture and research nevanimibe for internal research, public service and internal educational purposes, all of which could result in new patentable inventions concerning the manufacture or use of nevanimibe. In addition, pursuant to an assignment agreement for certain livoletide patents and patent applications, certain individuals at the Erasmus University Medical Center and the University of Turin were granted non-exclusive rights to use the assigned intellectual property for non-commercial research with Millendo's prior written consent, all of which could result in new patentable inventions concerning the manufacture or use of livoletide.

        It is also possible that Millendo will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. The patent applications that Millendo owns or in-licenses may fail to result in issued patents with claims that cover Millendo's current and future product candidates in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to Millendo's patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue and even if such patents cover Millendo's current and future product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held

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unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to Millendo could deprive Millendo of rights necessary for the successful commercialization of any product candidates that Millendo may develop. Further, if Millendo encounters delays in regulatory approvals, the period of time during which Millendo could market a product candidate and companion diagnostic under patent protection could be reduced.

        If the patent applications Millendo holds or have in-licensed with respect to Millendo's development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for Millendo's current and future product candidates, it could dissuade companies from collaborating with Millendo to develop product candidates, and threaten Millendo's ability to commercialize future drugs. Any such outcome could have a material adverse effect on Millendo's business.

        The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect Millendo's rights to the same extent as the laws of the United States, or vice versa. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Further, Millendo may not be aware of all third-party intellectual property rights potentially relating to Millendo's product candidates. Publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically published 18 months after filing, or in some cases, not at all. Therefore, Millendo cannot know with certainty whether Millendo was the first to make the inventions claimed in Millendo's owned or licensed patents or pending patent applications, or that Millendo was the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of Millendo's patent rights are highly uncertain. Millendo's pending and future patent applications may not result in patents being issued which protect Millendo's technology or product candidates, in whole or in part, or which effectively prevent others from commercializing competitive technologies and drugs. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of Millendo's patents or narrow the scope of Millendo's patent protection.

        Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of Millendo's patent applications and the enforcement or defense of Millendo's issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The United States Patent and Trademark Office, or USPTO, recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of Millendo's business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of Millendo's patent applications and the enforcement or defense of Millendo's issued patents, all of which could have a material adverse effect on Millendo's business and financial condition. Any further changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of Millendo's patents and patent applications or narrow the scope of Millendo's potential patent protection.

        Moreover, Millendo may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging Millendo's patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Millendo's patent rights, allow third parties to commercialize Millendo's technology or

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product candidates and compete directly with Millendo, without payment to Millendo, or result in Millendo's inability to manufacture or commercialize product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by Millendo's patents and patent applications is threatened, it could dissuade companies from collaborating with Millendo to license, develop or commercialize current or future product candidates.

        The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and Millendo's owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit Millendo's ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of Millendo's technology and product candidates. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years from the earliest filing date of a non-provisional patent application. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for Millendo's current or future product candidates, Millendo may be open to competition from generic versions of such drugs. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, Millendo's owned and licensed patent portfolio may not provide it with sufficient rights to exclude others from commercializing drugs similar or identical to that of Millendo's.

Millendo jointly owns patents and patent applications with third parties. Millendo's ability to exploit or enforce these patent rights, or to prevent the third-party from granting licenses to others with respect to these patent rights, may be limited in some circumstances.

        Millendo jointly owns certain patents and patent applications with third parties. In the absence of an agreement with each co-owner of jointly owned patent rights, Millendo will be subject to default rules pertaining to joint ownership. Some countries require the consent of all joint owners to exploit, license or assign jointly owned patents, and if Millendo is unable to obtain that consent from the joint owners, Millendo may be unable to exploit the invention or to license or assign Millendo's rights under these patents and patent applications in those countries. For example, Millendo secured exclusive rights from the University of Michigan for certain patents and patent applications that they jointly own with Millendo related to nevanimibe. Additionally, in the United States, each co-owner may be required to be joined as a party to any claim or action Millendo may wish to bring to enforce these patent rights, which may limit its ability to pursue third-party infringement claims.

Obtaining and maintaining Millendo's patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Millendo's patent protection could be reduced or eliminated for non-compliance with these requirements.

        Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various government patent agencies outside of the United States in several stages over the lifetime of Millendo's owned and licensed patents and/or applications and any patent rights it may own or license in the future. Millendo relies on its outside counsel or its licensing partners to pay these fees due to non-U.S. patent agencies. The USPTO and various non-U.S. government patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. Millendo employs reputable law firms and other professionals to help Millendo comply and Millendo is also dependent on its licensors to take the necessary action to comply with these requirements with respect to Millendo's licensed intellectual property. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.

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There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

        In such an event, potential competitors might be able to enter the market and this circumstance would have a material adverse effect on Millendo's business.

Patent terms may be inadequate to protect Millendo's competitive position on its product candidates for an adequate amount of time.

        Given the amount of time required for the development, testing and regulatory review of new product candidates such as livoletide and nevanimibe, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Millendo expects to seek extensions of patent terms in the United States and, if available, in other countries where Millendo is prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits extension of the term of one U.S. patent that includes at least one claim covering the composition of matter of an FDA-approved drug, an FDA-approved method of treatment using the drug and/or a method of manufacturing the FDA-approved drug. The extended patent term cannot exceed the shorter of five years beyond the non-extended expiration of the patent or 14 years from the date of the FDA approval of the drug. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with Millendo's assessment of whether such extensions are available, and may refuse to grant extensions to Millendo's patents, or may grant more limited extensions than Millendo requests. Further, Millendo may not elect to extend the most beneficial patent to Millendo or the claims underlying the patent that it chooses to extend could be invalidated. If any of the foregoing occurs, Millendo's competitors may be able to take advantage of Millendo's investment in development and clinical trials by referencing its clinical and preclinical data and launch their drug earlier than might otherwise be the case.

Intellectual property rights do not necessarily address all potential threats to Millendo's business.

        The degree of future protection afforded by Millendo's intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect Millendo's business. The following examples are illustrative:

    others may be able to make compounds, or livoletide and nevanimibe formulations that are similar to Millendo's livoletide and nevanimibe formulations but that are not covered by the claims of the patents that Millendo owns or controls;

    Millendo or any strategic partners might not have been the first to make the inventions covered by the issued patents or pending patent applications that Millendo owns or controls;

    Millendo might not have been the first to file patent applications covering certain of Millendo's inventions;

    others may independently develop similar or alternative technologies or duplicate any of Millendo's technologies without infringing Millendo's intellectual property rights;

    it is possible that Millendo's pending patent applications will not lead to issued patents;

    issued patents that Millendo owns or controls may not provide Millendo with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;

    Millendo's competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where Millendo does not have patent

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      rights and then use the information learned from such activities to develop competitive drugs for sale in Millendo's major commercial markets;

    Millendo may not develop additional proprietary technologies that are patentable; and

    the patents of others may have an adverse effect on Millendo's business.

Millendo does not have composition of matter patent protection with respect to nevanimibe.

        Millendo owns certain patents and patent applications with claims directed to specific methods of using nevanimibe and it expects to have marketing exclusivity from the FDA and EMA for a period of seven and ten years, respectively, because nevanimibe has not been approved in these markets. However, Millendo does not have composition of matter protection in the United States and elsewhere covering nevanimibe. Millendo may be limited in its ability to list its patents in the FDA's Orange Book if the use of its product, consistent with its FDA-approved label, would not fall within the scope of Millendo's patent claims. Also, Millendo's competitors may be able to offer and sell products so long as these competitors do not infringe any other patents that Millendo (or third parties) hold, including patents with claims directed to the manufacture of nevanimibe and/or method of use patents. In general, method of use patents are more difficult to enforce than composition of matter patents because, for example, of the risks that the FDA may approve alternative uses of the subject compounds not covered by the method of use patents, and others may engage in off-label sale or use of the subject compounds. Physicians are permitted to prescribe an approved product for uses that are not described in the product's labeling. Although off-label prescriptions may infringe its method of use patents, the practice is common across medical specialties and such infringement is difficult to prevent or prosecute. FDA approval of uses that are not covered by Millendo's patents would limit Millendo's ability to generate revenue from the sale of nevanimibe, if approved for commercial sale. Off-label sales would limit Millendo's ability to generate revenue from the sale of nevanimibe, if approved for commercial sale.

Third parties may initiate legal proceedings, which are expensive and time consuming, alleging that Millendo is infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse impact on the success of Millendo's business.

        Millendo's commercial success depends, in part, upon its ability, and the ability of Millendo's future collaborators, to develop, manufacture, market and sell livoletide, nevanimibe and any future product candidates and use Millendo's proprietary technologies without infringing the proprietary rights and intellectual property of third parties. The biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property rights. Millendo may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to livoletide, nevanimibe and any future product candidates and technology, including interference proceedings, post grant review and inter partes review before the USPTO. Third parties may assert infringement claims against Millendo based on existing patents or patents that may be granted in the future, regardless of their merit. There is a risk that third parties may choose to engage in litigation with Millendo to enforce or to otherwise assert their patent rights against Millendo. Even if Millendo believes such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a material adverse effect on Millendo's ability to commercialize livoletide, nevanimibe and any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, Millendo would need to overcome a presumption of validity. As this burden is a high one requiring Millendo to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If Millendo is found to infringe a third-party's valid and enforceable intellectual property rights, Millendo could be required to obtain a license from such third-

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party to continue developing, manufacturing and marketing Millendo's product candidate and technology. However, Millendo may not be able to obtain any required license on commercially reasonable terms or at all. Even if Millendo were able to obtain a license, it could be non-exclusive, thereby giving Millendo's competitors and other third parties access to the same technologies licensed to Millendo, and it could require Millendo to make substantial licensing and royalty payments. Millendo could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidate. In addition, Millendo could be found liable for monetary damages, including treble damages and attorneys' fees, if Millendo is found to have willfully infringed a patent or other intellectual property right. A finding of infringement could prevent Millendo from manufacturing and commercializing livoletide, nevanimibe or any future product candidates or force Millendo to cease some or all of Millendo's business operations, which would have a material adverse effect on Millendo's business. Claims that Millendo has misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on Millendo's business. Even if Millendo prevails in such infringement claims, patent litigation can be expensive and time consuming, which would harm Millendo's business, financial condition and results of operations.

Millendo may become involved in lawsuits to protect or enforce Millendo's patents, the patents of Millendo's licensors or Millendo's other intellectual property rights, which could be expensive, time consuming and unsuccessful.

        Competitors may infringe or otherwise violate Millendo's patents, the patents of Millendo's licensors or Millendo's other intellectual property rights. To counter infringement or unauthorized use, Millendo may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of Millendo's or Millendo's licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that Millendo's patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of Millendo's patents at risk of being invalidated or interpreted narrowly and could put Millendo's patent applications at risk of not issuing. The initiation of a claim against a third-party may also cause the third-party to bring counter claims against Millendo such as claims asserting that Millendo's patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Millendo cannot be certain that there is no invalidating prior art, of which Millendo and the patent examiner were unaware during prosecution. For the patents and patent applications that Millendo has licensed, Millendo may have limited or no right to participate in the defense of any licensed patents against challenge by a third-party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, Millendo would lose at least part, and perhaps all, of any future patent protection on Millendo's current or future product candidates. Such a loss of patent protection could have material adverse effect on Millendo's business.

        Millendo may not be able to prevent, alone or with its licensors, misappropriation of its intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Millendo's business could be harmed if in litigation the prevailing party does not offer Millendo a license on commercially reasonable terms. Any litigation or other proceedings to enforce

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Millendo's intellectual property rights may fail, and even if successful, may result in substantial costs and distract Millendo's management and other employees. Even if Millendo prevails in such infringement claims, patent litigation can be expensive and time consuming, which would harm Millendo's business, financial condition and results of operations.

        Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Millendo's confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of Millendo's common stock.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing Millendo's ability to protect its product candidates.

        The United States has recently enacted and implemented wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Millendo's ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, federal courts, USPTO, and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken its ability to obtain new patents or to enforce patents that Millendo has licensed or that Millendo might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken Millendo's ability to obtain new patents or to enforce patents that Millendo has licensed or that Millendo may obtain in the future.

Millendo may not be able to protect Millendo's intellectual property rights throughout the world, which could have a material adverse effect on Millendo's business.

        Filing, prosecuting and defending patents covering livoletide, nevanimibe and any future product candidates throughout the world would be prohibitively expensive. Competitors may use Millendo's technologies in jurisdictions where Millendo has not obtained patent protection to develop its own drugs and, further, may export otherwise infringing drugs to territories where Millendo may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These drugs may compete with Millendo's drugs in jurisdictions where Millendo does not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Millendo's reliance on third parties requires Millendo to share Millendo's trade secrets, which increases the possibility that a competitor will discover them or that Millendo's trade secrets will be misappropriated or disclosed.

        If Millendo relies on third parties to manufacture and commercialize livoletide, nevanimibe or any future product candidates, or if Millendo collaborates with third parties for the development of livoletide, nevanimibe or any future product candidates, Millendo must, at times, share trade secrets with them. Millendo may also conduct joint research and development programs that may require Millendo to share trade secrets under the terms of its research and development partnerships or similar agreements. Millendo seeks to protect Millendo's proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with Millendo's advisors, employees, third-party contractors and consultants

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prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose its confidential information, including Millendo's trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by Millendo's competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that Millendo's proprietary position is based, in part, on Millendo's know-how and trade secrets, a competitor's discovery of Millendo's trade secrets or other unauthorized use or disclosure could have an adverse effect on Millendo's business and results of operations.

        In addition, these agreements typically restrict the ability of Millendo's advisors, employees, third-party contractors and consultants to publish data potentially relating to Millendo's trade secrets. Despite Millendo's efforts to protect its trade secrets, Millendo's competitors may discover Millendo's trade secrets, either through breach of Millendo's agreements with third parties, independent development or publication of information by any of third-party collaborators. A competitor's discovery of Millendo's trade secrets would harm Millendo's business.

Millendo may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.

        Certain of Millendo's employees, consultants or advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies, including Millendo's competitors or potential competitors. Although Millendo tries to ensure that its employees, consultants and advisors do not use the proprietary information or know-how of others in their work for Millendo, Millendo may be subject to claims that these individuals or Millendo has used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual's current or former employer. Litigation may be necessary to defend against these claims. If Millendo fails in defending any such claims, in addition to paying monetary damages Millendo may lose valuable intellectual property rights or personnel. Even if Millendo is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

        In addition, while it is Millendo's policy to require its employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Millendo, Millendo may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Millendo regards as its own. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and Millendo may be forced to bring claims against third parties, or defend claims that they may bring against Millendo, to determine the ownership of what Millendo regards as its intellectual property.

Risks Related to Millendo's Dependence on Third Parties

Millendo does not have its own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of livoletide and nevanimibe, and any future product candidate.

        Millendo has no experience in drug formulation or manufacturing and does not own or operate, and Millendo does not expect to own or operate, facilities for product manufacturing, storage and distribution, or testing. In connection with Millendo's acquisition of Alizé, Millendo acquired all of the active pharmaceutical ingredient, or API, for livoletide in Alizé's possession; however, this existing API will not be sufficient for Millendo to complete its planned Phase 2b/3 clinical trials for livoletide, and Millendo will rely on a contract manufacturing organization, or CMO, to produce additional livoletide API for Millendo for clinical use. Millendo also currently relies on CMOs to produce nevanimibe for Millendo's clinical trials. Additionally, Millendo relies on CMOs with respect to the manufacture of

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drug product for Millendo's clinical trials, including for filing and packaging. Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replenish the supply or replace a third-party manufacturer could considerably delay completion of Millendo's clinical trials, product testing and potential regulatory approval of Millendo's product candidates. If Millendo's manufacturers or Millendo is unable to purchase these raw materials after regulatory approval has been obtained for Millendo's product candidates, the commercial launch of Millendo's product candidates would be delayed or there would be a shortage in supply, which would impair Millendo's ability to generate revenue from the sale of its product candidates.

        Millendo will need to rely on third-party manufacturers to supply Millendo with sufficient quantities of livoletide and nevanimibe to be used, if approved, for the commercialization of each. The facilities used by Millendo's contract manufacturers to manufacture Millendo's product candidates must be approved by the FDA pursuant to inspections that will be conducted after Millendo submits its NDA to the FDA. Millendo does not control the manufacturing process of, and are completely dependent on, its contract manufacturing partners for compliance with cGMP requirements for manufacture of drug products. If Millendo's contract manufacturers cannot successfully manufacture material that conforms to Millendo's specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure or maintain regulatory approval for their manufacturing facilities. In addition, Millendo has no control over the ability of Millendo's contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of Millendo's product candidates or if it withdraws any such approval in the future, Millendo may need to find alternative manufacturing facilities, which would significantly impact Millendo's ability to develop, obtain regulatory approval for or market Millendo's product candidates, if approved. Further, Millendo's reliance on third-party manufacturers entails risks, to which it would not be subject if it manufactured product candidates itself, including:

    inability to meet Millendo's product specifications and quality requirements consistently;

    delay or inability to procure or expand sufficient manufacturing capacity;

    issues related to scale-up of manufacturing;

    costs and validation of new equipment and facilities required for scale-up;

    failure to comply with cGMP and similar foreign standards;

    inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

    termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to Millendo;

    reliance on a limited number of sources, and in some cases, single sources for product components;

    lack of qualified backup suppliers for those materials that are currently purchased from a sole or single source supplier;

    operations of Millendo's third-party manufacturers or suppliers could be disrupted by conditions unrelated to Millendo's business or operations, including the bankruptcy of the manufacturer or supplier;

    inability to find replacement manufacturers or suppliers, if necessary, on terms favorable to Millendo, in a timely manner, or at all;

    carrier disruptions or increased costs that are beyond its control; and

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    failure to deliver Millendo's products under specified storage conditions and in a timely manner.

        Any of these events could lead to clinical trial delays, failure to obtain regulatory approval or impact Millendo's ability to successfully commercialize Millendo's products once approved. Some of these events could be the basis for FDA or other regulatory authority action, including injunction, recall, seizure, or total or partial suspension of production.

Millendo may in the future enter into collaborations with third parties to develop its product candidates. If these collaborations are not successful, Millendo's business could be harmed.

        Millendo may enter into collaborations with third parties in the future. Any collaborations Millendo enters into in the future may pose several risks, including the following:

    collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

    collaborators may not perform their obligations as expected;

    the clinical trials conducted as part of these collaborations may not be successful;

    collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results;

    changes in the collaborators' strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

    collaborators may delay clinical trials, provide insufficient funding for clinical trials, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

    Millendo may not have access to, or may be restricted from disclosing, certain information regarding product candidates being developed or commercialized under a collaboration and, consequently, may have limited ability to inform Millendo's stockholders about the status of such product candidates;

    collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with Millendo's product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than that of Millendo's;

    product candidates developed in collaboration with Millendo may be viewed by Millendo's collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote, or limit, resources to the commercialization of Millendo's product candidates;

    a collaborator with marketing and distribution rights to one or more of Millendo's product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any such product candidate;

    disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development of any product candidates, may cause delays or termination of the research, development, or commercialization of such product candidates, may lead to additional responsibilities for Millendo with respect to such product candidates or may result in litigation or arbitration, any of which would be time-consuming and expensive;

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    collaborators may not properly maintain or defend Millendo's intellectual property rights or may use Millendo's proprietary information in such a way as to invite litigation that could jeopardize or invalidate Millendo's intellectual property or proprietary information or expose Millendo to potential litigation;

    disputes may arise with respect to the ownership of intellectual property developed pursuant to Millendo's collaborations;

    collaborators may infringe the intellectual property rights of third parties, which may expose Millendo to litigation and potential liability; and

    collaborations may be terminated for the convenience of the collaborator and, if terminated, Millendo could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

        If any such potential future collaborations do not result in the successful development and commercialization of product candidates, or if one of Millendo's future collaborators terminates its agreement with Millendo, Millendo may not receive any future research funding or milestone or royalty payments under the collaboration. If Millendo does not receive the funding it expects under these agreements, the development of its product candidates could be delayed and it may need additional resources to develop its product candidates. In addition, if one of Millendo's future collaborators terminates its agreement with Millendo, Millendo may find it more difficult to attract new collaborators and the perception of Millendo in the business and financial communities could be adversely affected. All of the risks relating to product development, regulatory approval and commercialization apply to the activities of Millendo's potential future collaborators.

        Millendo may in the future determine to collaborate with other pharmaceutical and biotechnology companies for development and potential commercialization of Millendo's product candidates. These relationships, or those like them, may require Millendo to incur non-recurring and other charges, increase Millendo's near- and long-term expenditures, issue securities that dilute its existing stockholders or disrupt Millendo's management and business. In addition, Millendo could face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Millendo's ability to reach a definitive collaboration agreement will depend, among other things, upon Millendo's assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator's evaluation of several factors. If Millendo licenses rights to its product candidates, Millendo may not be able to realize the benefit of such transactions if it is unable to successfully integrate them with its existing operations and company culture.

Millendo may not be successful in finding strategic collaborators for continuing development of livoletide or nevanimibe, or successfully commercializing or competing in the market for certain diseases.

        Millendo may seek to develop strategic partnerships for developing and commercializing livoletide or nevanimibe, due to capital costs required to develop the product candidate, manufacturing constraints or anticipated commercialization costs. Millendo may not be successful in its efforts to establish such a strategic partnership or other alternative arrangements for livoletide or nevanimibe because Millendo's research and development pipeline may be insufficient or third parties may not view livoletide or nevanimibe as having the requisite potential to demonstrate safety and efficacy. In addition, Millendo may be restricted under an existing collaboration agreement from entering into a future agreement with a potential collaborator. Millendo cannot be certain that, following a strategic transaction or license, Millendo will achieve an economic benefit that justifies such transaction.

        If Millendo is unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms or at all, Millendo may have to curtail the development of its product candidates,

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reduce or delay the development programs, delay potential commercialization, reduce the scope of any sales or marketing activities or increase Millendo's expenditures and undertake development or commercialization activities at Millendo's own expense. If Millendo elects to fund development or commercialization activities on its own, Millendo may need to obtain additional expertise and additional capital, which may not be available to Millendo on acceptable terms or at all. If Millendo fails to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, Millendo may not be able to further develop livoletide or nevanimibe, which could harm Millendo's business, financial condition and results of operations.

Millendo relies on third parties to conduct, supervise and monitor Millendo's clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm Millendo's business.

        Millendo currently does not have the ability to independently conduct preclinical studies and clinical trials that comply with the regulatory requirements known as good laboratory practice, or GLP, or GCP, respectively. Millendo also does not currently have the ability to independently conduct large clinical trials. Millendo intends to rely on CROs and clinical trial sites to ensure the proper and timely conduct of Millendo's clinical trials, and Millendo expects to have limited influence over their actual performance.

        Millendo intends to rely upon CROs to monitor and manage data for Millendo's clinical programs, as well as the execution of future preclinical studies. Millendo expects to control only certain aspects of Millendo's CROs' activities. Nevertheless, Millendo will be responsible for ensuring that each of Millendo's studies or trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and Millendo's reliance on the CROs does not relieve Millendo of its regulatory responsibilities.

        Millendo and its CROs will be required to comply with GLP and GCP, which are regulations and guidelines enforced by the FDA and are also required by the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities in the form of International Conference on Harmonization guidelines for any of Millendo's product candidates that are in preclinical and clinical development, respectively. The regulatory authorities enforce GCP through periodic inspections of trial sponsors, principal investigators and clinical trial sites. Although Millendo relies on CROs to conduct any future GLP-compliant preclinical and preclinical studies and current or planned GCP-compliant clinical trials, Millendo remains responsible for ensuring that each of its GLP preclinical studies and clinical trials is conducted in accordance with its investigational plan and protocol and applicable laws and regulations, and Millendo's reliance on the CROs does not relieve Millendo of its regulatory responsibilities. If Millendo or its CROs fail to comply with GCP, the clinical data generated in Millendo's clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Millendo to perform additional clinical trials before approving Millendo's marketing applications. Accordingly, if Millendo's CROs fail to comply with these regulations or fail to recruit a sufficient number of subjects, Millendo may be required to repeat clinical trials, which would delay the regulatory approval process.

        While Millendo will have agreements governing their activities, Millendo's CROs will not be Millendo's employees, and Millendo will not control whether or not they devote sufficient time and resources to Millendo's future clinical and preclinical programs. These CROs may also have relationships with other commercial entities, including Millendo's competitors, for whom they may also be conducting clinical trials, or other drug development activities which could harm Millendo's business. Millendo faces the risk of potential unauthorized disclosure or misappropriation of Millendo's intellectual property by CROs, which may reduce Millendo's trade secret protection and allow Millendo's potential competitors to access and exploit Millendo's proprietary technology. If Millendo's CROs do not successfully carry out their contractual duties or obligations, fail to meet expected

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deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to its clinical protocols or regulatory requirements or for any other reasons, Millendo's clinical trials may be extended, delayed or terminated, and Millendo may not be able to obtain regulatory approval for, or successfully commercialize any product candidate that Millendo develops. As a result, Millendo's financial results and the commercial prospects for any product candidate that Millendo develops would be harmed, Millendo's costs could increase, and Millendo's ability to generate revenue could be delayed.

        If Millendo's relationships with these CROs terminate, Millendo may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms. Switching or adding additional CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can negatively impact Millendo's ability to meet its desired clinical development timelines. Though Millendo intends to carefully manage Millendo's relationships with its CROs, there can be no assurance that Millendo will not encounter challenges or delays in the future or that these delays or challenges will not have a negative impact on Millendo's business and financial condition. Further, Millendo currently relies on two CROs to conduct its ongoing clinical trials and may engage one of these same CROs to conduct additional clinical trials on Millendo's behalf. To the extent that these CROs fail to comply with GLP or their contractual obligations to Millendo for any reason, the negative impact on Millendo's business and financial condition could be more profound than if Millendo relied on a greater number of CROs.

Risks Related to Millendo's Business Operations, Employee Matters and Managing Growth

Recent acquisitions and potential future acquisitions could prove difficult to integrate, disrupt Millendo's business, dilute stockholder value and strain Millendo's resources.

        Millendo recently completed its acquisition of Alizé through which Millendo acquired its PWS program, including Millendo's livoletide product candidate. In the future, Millendo may acquire additional companies, technologies or product candidates that Millendo believes could complement or expand Millendo's business. Integrating the operations of acquired businesses successfully or otherwise realizing any of the anticipated benefits of acquisitions involves a number of potential challenges. The failure to meet these integration challenges could seriously harm Millendo's financial condition and results of operations. Realizing the benefits of acquisitions depends in part on the integration of operations and personnel. These integration activities are complex and time-consuming, and Millendo may encounter unexpected difficulties or incur unexpected costs, including with respect to:

    diversion of management attention from ongoing business concerns to integration matters;

    coordinating clinical and preclinical development plans;

    consolidating and rationalizing information technology and accounting platforms and administrative infrastructures;

    complexities associated with managing the geographic separation of the combined businesses and consolidating multiple physical locations;

    reconciling different corporate cultures; and

    retaining scientific and other key employees.

        Acquired businesses may have liabilities, adverse operating issues or other matters of concern arise following the acquisition that Millendo fails to discover through due diligence prior to the acquisition. Further, Millendo's acquisition targets may not have as robust internal controls over financial reporting as would be expected of a public company. Acquisitions may also result in the recording of goodwill and other intangible assets that are subject to potential impairment in the future that could harm

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Millendo's financial results. Millendo may also become subject to new regulations as a result of an acquisition, including if Millendo acquires operations in a country in which Millendo does not already operate. If Millendo fails to properly evaluate acquisitions or unanticipated issues arise following the acquisition, Millendo may incur costs in excess of what Millendo anticipates and may not otherwise achieve the anticipated benefits of any such acquisitions.

Millendo is highly dependent on the services of its key executives and personnel, including Julia C. Owens, Ph.D., its chief executive officer, and Pharis Mohideen, MD, its chief medical officer, and if Millendo is not able to retain these members of its management team or recruit and retain additional management, clinical and scientific personnel, Millendo's business will be harmed.

        Millendo is highly dependent on Drs. Owens and Mohideen. The employment agreements Millendo has with these officers do not prevent such persons from terminating their employment with Millendo at any time. The loss of the services of any of these persons could impede the achievement of Millendo's research, development and commercialization objectives.

        In addition, Millendo is dependent on its continued ability to attract, retain and motivate highly qualified additional management, clinical and scientific personnel. If Millendo is not able to retain its management and to attract, on acceptable terms, additional qualified personnel necessary for the continued development of its business, Millendo may not be able to sustain its operations or grow.

        Millendo may not be able to attract or retain qualified personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses. Many of the other pharmaceutical companies that Millendo competes against for qualified personnel and consultants have greater financial and other resources, different risk profiles, are located in geographies with a larger biotechnology industry presence and a longer history in the industry than Millendo does. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates and consultants than what Millendo has to offer. If Millendo is unable to continue to attract, retain and motivate high-quality personnel and consultants to accomplish its business objectives, the rate and success at which Millendo can discover and develop product candidates and Millendo's business will be limited and Millendo may experience constraints on its development objectives.

        Millendo's future performance will also depend, in part, on Millendo's ability to successfully integrate newly hired executive officers into Millendo's management team and Millendo's ability to develop an effective working relationship among senior management. Millendo's failure to integrate these individuals and create effective working relationships among them and other members of management could result in inefficiencies in the development and commercialization of Millendo's product candidates, harming future regulatory approvals, sales of Millendo's product candidates and its results of operations. Additionally, Millendo does not currently maintain "key person" life insurance on the lives of its executives or any of its employees.

Millendo will need to expand its organization, and Millendo may experience difficulties in managing this growth, which could disrupt Millendo's operations.

        As of June 30, 2018, Millendo had 25 employees. As Millendo's development and commercialization plans and strategies develop, Millendo expects to need additional managerial, operational, sales, marketing, financial, legal and other resources. Millendo's management may need to divert a disproportionate amount of its attention away from Millendo's day-to-day activities and devote a substantial amount of time to managing these growth activities. Millendo may not be able to effectively manage the expansion of Millendo's operations, which may result in weaknesses in Millendo's infrastructure, operational inefficiencies, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Millendo's expected growth could require

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significant capital expenditures and may divert financial resources from other projects, such as the development of Millendo's current and future product candidates. If Millendo's management is unable to effectively manage its growth, Millendo's expenses may increase more than expected, its ability to generate and grow revenue could be reduced, and Millendo may not be able to implement its business strategy. Millendo's future financial performance and its ability to commercialize its product candidates, develop a scalable infrastructure and compete effectively will depend, in part, on Millendo's ability to effectively manage any future growth.

Millendo's employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on Millendo's results of operations.

        Millendo is exposed to the risk of fraud or othe