As filed with the Securities and Exchange Commission on December 1, 2022

No. 333-267276

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Amendment No. 4

to

FORM S-4

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

GEMINI THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	6770	85-1612845
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification No.)

297 Boston Post Road #248, Wayland, MA 01778¹

(617) 401-4400

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Georges Gemayel, Ph.D.

Interim President and Chief Executive Officer

297 Boston Post Road #248, Wayland, MA 01778¹

(617) 401-4400

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies of all communications, including communications sent to agent for service, should be sent to:

Christopher D. Barnstable-Brown, Esq.
Stuart M. Falber, Esq.
Mark Nylen, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP
7 World Trade Center
250 Greenwich Street
New York, NY 10007
Tel: (212) 230-8800 William D. Collins, Esq.
Stephanie Richards, Esq.
Alicia M. Tschirhart, Esq.
Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
(617) 570-1000

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after the effective date of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box  ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  ☐	Accelerated filer  ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer)  ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)  ☐

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

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The Company does not currently maintain a physical headquarters but maintains a mailing address at 297 Boston Post Road #248, Wayland, MA 01778.

The information in this proxy statement/prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus is not an offer to sell and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED DECEMBER 1, 2022

 
 

PROPOSED MERGER

 

YOUR VOTE IS VERY IMPORTANT

To the Stockholders of Gemini Therapeutics, Inc. and Disc Medicine, Inc.,

Gemini Therapeutics, Inc., a Delaware corporation, or Gemini, and Disc Medicine, Inc., a Delaware corporation, or Disc, entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, on August 9, 2022, pursuant to which, among other matters, a direct, wholly owned subsidiary of Gemini, Gemstone Merger Sub, Inc., or Merger Sub, will merge with and into Disc, with Disc surviving as a wholly owned subsidiary of Gemini, and the surviving corporation of the merger, which transaction is referred to herein as the merger. The surviving corporation following the merger is referred to herein as the combined company.

At the effective time of the merger each share of Disc common stock (after giving effect to the conversion of each share of Disc’s preferred stock into Disc common stock and including all such shares that are converted into Disc common stock) will be converted into the right to receive a number of shares of Gemini common stock equal to the exchange ratio described in more detail in the section titled “The Merger Agreement—Exchange Ratio” beginning on page 181 of the accompanying proxy statement/prospectus. The final exchange ratio is subject to adjustment prior to closing of the merger based upon Gemini’s net cash at closing and the aggregate proceeds from the sale of Disc common stock in the Disc pre-closing financing and as a result, Gemini securityholders could own more, and Disc securityholders (including, for this purpose, investors in the pre-closing financing) could own less, or vice versa, of the combined company. Based on Gemini’s and Disc’s capitalization as of August 9, 2022, the date the Merger Agreement was executed, the exchange ratio was estimated to be equal to approximately 1.1052 shares of Gemini common stock for each share of Disc capital stock, which estimated exchange ratio did not give effect to the expected Gemini reverse stock split. The following table illustrates a range of exchange ratios (including a high and a low range) at various figures of Gemini net cash (which is the sole material variable in determining the exchange ratio) after giving effect to the anticipated 1:10 reverse stock split:

Gemini Net Cash at Closing ($ in millions)	Exchange Ratio
$100 (high range)	0.1069
$97.6	0.1094
$92.5	0.1105
$86.4	0.1116
$80 (low range)	0.1194

Gemini management continues to anticipate that Gemini net cash at the closing will be between $87.4 million and $96.6 million, and, as further described below and in connection with the Merger Agreement, within such range there would be no adjustment to the exchange ratio.

In connection with the merger, each outstanding and unexercised option to purchase shares of Disc common stock that, following assumption by Gemini at the effective time, will be eligible to be registered on Form S-8, will be assumed by Gemini and will be converted into an option to purchase shares of Gemini’s common stock, with necessary adjustments to reflect the exchange ratio. All other Disc equity awards will be cancelled immediately prior to the closing of the merger.

Certain investors have agreed to purchase shares of Disc common stock at a purchase price of $2.51 per share, for an aggregate purchase price of approximately $53.5 million, referred to as the Disc pre-closing financing, immediately prior to the closing of the merger. The closing of the Disc pre-closing financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the merger as well as certain other conditions. The shares of Disc common stock that are issued in the Disc pre-closing financing will be converted into the right to receive a number of shares of Gemini common stock equal to the exchange ratio described in more detail in the section titled “The Merger Agreement—Exchange Ratio” beginning on page 181 of the accompanying proxy statement/prospectus.

Each share of Gemini common stock, each option to purchase Gemini common stock and each award of restricted stock units over Gemini common stock that is issued and outstanding at the effective time of the merger will remain issued and outstanding in accordance with its terms and such shares, options and restricted stock units, subject to the proposed reverse stock split and any acceleration provided for in connection with the merger, will be unaffected by the merger. Immediately after the merger, Gemini securityholders as of immediately prior to the merger are expected to own approximately 24% of the outstanding shares of the combined company, former Disc securityholders, excluding shares purchased in the Disc pre-closing financing, are expected to own approximately 63% of the outstanding shares of the combined company and shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of capital stock of the combined company, subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million to $96.6 million.

Shares of Gemini common stock are currently listed on The Nasdaq Global Market, or Nasdaq, under the symbol “GMTX.” Gemini has filed an initial listing application for the combined company with Nasdaq. After completion of the merger, Gemini will be renamed “Disc Medicine, Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “IRON.” On November 30, 2022, the last trading day before the date of the accompanying proxy statement/prospectus, the closing sale price of Gemini common stock was $1.72 per share.

The closing of the Disc pre-closing financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the merger as well as certain other conditions. The Disc pre-closing financing is more fully described in the accompanying proxy statement/prospectus.

Gemini stockholders are cordially invited to attend the special meeting of Gemini stockholders. Gemini is holding its special meeting of stockholders, or the Gemini special meeting, on December 28, 2022, at 10:00 a.m. Eastern Time, unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the merger and related matters. The Gemini special meeting will be held entirely online. Gemini stockholders will be able to attend and participate in the Gemini special meeting online by visiting www.virtualshareholdermeeting.com/GMTX2022SM where they will be able to listen to the meeting live, submit questions and vote. At the Gemini special meeting, Gemini will ask its stockholders to:

1.
Approve (i) the issuance of shares of common stock of Gemini, which will represent more than 20% of the shares of Gemini common stock outstanding immediately prior to the merger, to stockholders of Disc, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A to the accompanying proxy statement/prospectus, and (ii) the change of control resulting from the merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively;

2.
Approve an amendment to the amended and restated certificate of incorporation of Gemini to (a) effect a reverse stock split of Gemini’s issued and outstanding common stock at a ratio of one new share of Gemini common stock for every ten shares of outstanding Gemini common stock, and (b) implement a reduction in the number of authorized shares of Gemini common stock to 100,000,000, in the form attached as Annex G to the accompanying proxy statement/prospectus;

3.
Approve, on a nonbinding, advisory basis, the compensation that will or may become payable by Gemini to its named executive officers in connection with the merger;

4.
Approve amendments to Gemini’s 2021 Stock Option and Incentive Plan and Gemini’s 2021 Employee Stock Purchase Plan to (i) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Stock Option and Incentive Plan to a number of shares representing approximately 9% of the fully diluted capitalization of Gemini, determined as of immediately following the merger and (ii) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Employee Stock Purchase Plan to a number of shares representing approximately 0.84% of the fully diluted capitalization of Gemini, determined as of immediately following the merger;

5.
Approve an adjournment of the Gemini special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1 and 2; and

6.
Transact such other business as may properly come before the stockholders at the Gemini special meeting or any adjournment or postponement thereof.

As described in the accompanying proxy statement/prospectus, certain Gemini stockholders who in the aggregate owned approximately 36% of the outstanding shares of Gemini as of August 9, 2022, and certain Disc stockholders who in the aggregate owned approximately 90% of the outstanding shares of Disc capital stock as of August 9, 2022, are parties to stockholder support agreements with Gemini and Disc, respectively, whereby such stockholders have agreed to vote in favor of the approval of the transactions contemplated therein, including, with respect to Disc stockholders, adoption of the Merger Agreement and approval of the merger and, with respect to such Gemini stockholders, the issuance of Gemini common stock in the merger pursuant to the Merger Agreement, subject to the terms of the support agreements. Following the effectiveness of the registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part and pursuant to the Merger Agreement, Disc stockholders holding a sufficient number of shares of Disc capital stock to adopt the Merger Agreement and approve the merger and related transactions will be asked to execute written consents providing for such adoption and approval.

After careful consideration, each of the Gemini and Disc boards of directors have approved the Merger Agreement and have determined that it is advisable to consummate the merger. Gemini’s board of directors has approved the proposals described in the accompanying proxy statement/prospectus and unanimously recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.

More information about Gemini, Disc, the Merger Agreement and transactions contemplated thereby and the foregoing proposals is contained in the accompanying proxy statement/prospectus. Gemini urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 22 OF THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS.

Gemini and Disc are excited about the opportunities the merger brings to Gemini’s and Disc’s stockholders and thank you for your consideration and continued support. Sincerely,

Georges Gemayel, Ph.D.	John Quisel, J.D., Ph.D.
Interim President and Chief Executive Officer	President and Chief Executive Officer
Gemini Therapeutics, Inc.	Disc Medicine, 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 the accompanying proxy statement/prospectus. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus is dated   , 2022, and is first being mailed to Gemini’s stockholders on or about   , 2022.

GEMINI THERAPEUTICS, INC.

297 Boston Post Road #248, Wayland, MA 01778

(617) 401-4400

 

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

To the stockholders of Gemini Therapeutics, Inc.:

NOTICE IS HEREBY GIVEN that a virtual special meeting of stockholders, or the Gemini special meeting, will be held on December 28, 2022, at 10:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The Gemini special meeting will be held entirely online. You will be able to attend and participate in the Gemini special meeting online by visiting www.virtualshareholdermeeting.com/GMTX2022SM where you will be able to listen to the meeting live, submit questions and vote.

The Gemini special meeting will be held for the following purposes:

1.
To approve (i) the issuance of shares of common stock of Gemini Therapeutics, Inc., or Gemini, which will represent more than 20% of the shares of Gemini common stock outstanding immediately prior to the merger, to stockholders of Disc Medicine, Inc., or Disc, pursuant to the terms of the Agreement and Plan of Merger and Reorganization among Gemini, Disc and Gemstone Merger Sub, Inc., or Merger Sub, dated as of August 9, 2022, a copy of which is attached as Annex A to the accompanying proxy statement/prospectus, which is referred to in this Notice as the Merger Agreement, and (ii) the change of control resulting from the merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively;

2.
To approve an amendment to the amended and restated certificate of incorporation of Gemini to (a) effect a reverse stock split of Gemini’s issued and outstanding common stock at a ratio of one new share of Gemini common stock for every ten shares of outstanding Gemini common stock, and (b) implement a reduction in the number of authorized shares of Gemini common stock to 100,000,000, in the form attached as Annex G to the accompanying proxy statement/prospectus;

3.
To approve, on a nonbinding, advisory basis, the compensation that will or may become payable by Gemini to its named executive officers in connection with the merger;

4.
To approve amendments to Gemini’s 2021 Stock Option and Incentive Plan and Gemini’s 2021 Employee Stock Purchase Plan to (i) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Stock Option and Incentive Plan to a number of shares representing approximately 9% of the fully diluted capitalization of Gemini, determined as of immediately following the merger and (ii) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Employee Stock Purchase Plan to a number of shares representing approximately 0.84% of the fully diluted capitalization of Gemini, determined as of immediately following the merger;

5.
To approve an adjournment of the Gemini special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1 and 2; and

6.
To transact such other business as may properly come before the stockholders at the Gemini special meeting or any adjournment or postponement thereof.

Record Date: Gemini’s board of directors has fixed November 29, 2022 as the record date for the determination of stockholders entitled to notice of, and to vote at, the Gemini special meeting and any adjournment or postponement thereof. Only holders of record of shares of Gemini common stock at the close of business on the record date are entitled to notice of, and to vote at, the Gemini special meeting. At the close of business on the record date, Gemini had 43,328,315 shares of common stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of a majority of the votes cast at the Gemini special meeting, assuming a quorum is present, is required for approval of Proposal Nos. 1, 3, 4 and 5. The affirmative vote of a majority of the outstanding shares of Gemini common stock entitled to vote at the Gemini special meeting is required for approval of Proposal No. 2. Approval of each of Proposal No. 1, referred to as the merger proposal, and Proposal No. 2, referred to as the reverse stock split proposal, is a condition to the completion of the merger. Therefore, the merger cannot be consummated without the approval of Proposal Nos. 1 and 2.

Even if you plan to virtually attend the Gemini special meeting, Gemini requests that you sign and return the enclosed proxy or vote by mail or online to ensure that your shares will be represented at the Gemini special meeting if you are unable to virtually attend. You may change or revoke your proxy at any time before it is voted at the Gemini special meeting.

GEMINI’S BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS FAIR TO, IN THE BEST INTERESTS OF, AND ADVISABLE TO GEMINI AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. GEMINI’S BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS THAT GEMINI STOCKHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.

Important Notice Regarding the Availability of Proxy Materials for the Stockholders’ Meeting

to Be Held on December 28, 2022 at 10:00 a.m. Eastern Time via the internet

 

The proxy statement/prospectus and annual report to stockholders are available at www.virtualshareholdermeeting.com/GMTX2022SM

By Order of Gemini’s Board of Directors,

Dr. Georges Gemayel

Interim President and Chief Executive Officer

   , 2022

EXPLANATORY NOTE

The issuance of all shares of Gemini common stock in exchange for each share of Disc common stock (including all shares of Disc preferred stock converted into common stock), other than shares of Gemini common stock issued in exchange for shares of Disc common stock sold in the pre-closing financing, is intended to be covered by this registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part. There is no difference between the Gemini common stock that will be issued in exchange for each share of Disc common stock issued in the pre-closing financing and the Gemini common stock that will be issued in exchange for each other share of Disc common stock, except that the shares of Gemini common stock that will be issued as transaction consideration in exchange for each share of Disc common stock issued in the pre-closing financing will not be registered under the Securities Act and will be subject to restrictions on resale.

REFERENCES TO ADDITIONAL INFORMATION

This proxy statement/prospectus incorporates important business and financial information about Gemini Therapeutics, Inc. that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission website (www.sec.gov) or upon your written or oral request by contacting the Corporate Secretary of Gemini Therapeutics, Inc. by calling (617) 401-4400 or via email to IR@geminitherapeutics.com.

To ensure timely delivery of these documents, any request should be made no later than December 15, 2022 to receive them before the Gemini special meeting.

For additional details about where you can find information about Gemini, please see the section titled “Where You Can Find More Information” beginning on page 385 of this proxy statement/prospectus.

i

TABLE OF CONTENTS

References to Additional Information	i
Questions and Answers about the Merger	1
Prospectus Summary	9
Market Price and Dividend Information	21
Risk Factors	22
Cautionary Note Regarding Forward-Looking Statements	132
The Special Meeting of Gemini Stockholders	133
The Merger	138
The Merger Agreement	181
Holders of Disc Common Stock or Disc Preferred Stock should not send in their Disc Stock Certificates until they receive a Letter of Transmittal from the Exchange Agent with instructions for the surrender of Disc Stock Certificates	185
Agreements Related to the Merger	200
Gemini Directors, Officers and Corporate Governance	209
Gemini Executive Compensation	215
Gemini Director Compensation	222
Equity Compensation Plan Information	224
Disc Executive Compensation	225
Disc Director Compensation	231
Matters Being Submitted to a Vote of Gemini Stockholders	232
Proposal No. 1	232
Approval of (i) The issuance of shares of Gemini Common Stock pursuant to the Merger Agreement, which will represent more than 20% of the shares of Gemini Common Stock Outstanding immediately prior to the Merger and (ii) the Change of Control resulting from the Merger pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively	232
Proposal No. 2	233
Approval of the Amendment to Amended and Restated Certificate of Incorporation of Gemini to effect the Reverse Stock Split	233
Proposal No. 3	239
Advisory, Non-Binding Vote on Merger-Related Executive Compensation Arrangements	239
Proposal No. 4	240
Amendment of Gemini Equity Plans	240
Proposal No. 5	249
Approval of Possible Adjournment of the Special Meeting	249
Gemini’s Business	250
Disc’s Business	265
Gemini Management’s Discussion and Analysis of Financial Condition and Results of Operations	315
Quantitative and Qualitative Disclosures about the Market Risk of Gemini	329
Disc’s Management’s Discussion and Analysis of Financial Condition and Results of Operations	330
Management following the Merger	342
Certain Relationships and Related Party Transactions of the Combined Company Selected Historical and Unaudited Pro Forma Condensed Combined Financial Data	348
Description of Gemini Capital Stock	370
Comparison of Rights of Holders of Gemini Capital Stock and Disc Capital Stock	371
Principal Stockholders of Gemini	379
Principal Stockholders of Disc	381
Principal Stockholders of the Combined Company	383
Legal Matters	385
Experts	385
Where You Can Find More Information	385
Other Matters	387
Index to Disc’s Consolidated Financial Statements	F-1
Annex A—Agreement and Plan of Merger	A-1

ii

Annex B—Opinion of SVB Securities LLC	B-1
Annex C—Form of Disc Support Agreement	C-1
Annex D—Form of Gemini Support Agreement	D-1
Annex E—Form of Lock-Up Agreement	E-1
Annex F—Form of Contingent Value Rights Agreement	F-1
Annex G—Certificate of Amendment for the Reverse Stock Split	G-1
Annex H—Appraisal Rights (Section 262 of the Delaware General Corporation Law)	H-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 does not give effect to the proposed reverse stock split described in Proposal No. 2 of this proxy statement/prospectus.

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:
Gemini Therapeutics, Inc., or Gemini, and Disc Medicine, Inc., or Disc, have entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, dated as of August 9, 2022, a copy of which is attached as Annex A.The Merger Agreement contains the terms and conditions of the proposed merger. Pursuant to the Merger Agreement, Gemstone Merger Sub, Inc., or Merger Sub, a direct, wholly owned subsidiary of Gemini will merge with and into Disc, with Disc surviving as a wholly owned subsidiary of Gemini. This transaction is referred to in this proxy statement/prospectus as the merger. After the completion of the merger, Gemini will change its corporate name to “Disc Medicine, Inc.” Gemini following the merger is referred to herein as the combined company.

At the effective time of the merger each share of Disc common stock (after giving effect to the conversion of each share of Disc’s preferred stock into Disc common stock) will be converted into the right to receive a number of shares of Gemini common stock equal to the exchange ratio described in more detail in the section titled “The Merger Agreement—Exchange Ratio” beginning on page 181 of this proxy statement/prospectus.

In connection with the merger, each outstanding and unexercised option to purchase shares of Disc common stock will be converted into an option to purchase shares of Gemini’s common stock, with necessary adjustments to reflect the exchange ratio.

Each share of Gemini common stock, each option to purchase Gemini common stock and each award of restricted stock units over Gemini common stock that is issued and outstanding at the effective time of the merger will remain issued and outstanding in accordance with its terms and such shares, options and restricted stock units, subject to the proposed reverse stock split and any acceleration provided for in connection with the merger, will be unaffected by the merger. Immediately after the merger, Gemini securityholders as of immediately prior to the merger are expected to own approximately 24% of the outstanding shares of the combined company, former Disc securityholders, excluding shares purchased in the Disc pre-closing financing, are expected to own approximately 63% of the outstanding shares of the combined company and shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of capital stock of the combined company, subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million and $96.6 million.

Q:
Why are the two companies proposing to merge?

A:
Gemini and Disc believe that combining the two companies will result in a company with a robust pipeline, a strong leadership team and substantial capital resources, positioning it to become a pre-eminent biotechnology company focusing on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases. For a more complete description of the reasons for the merger, please see the sections titled “The Merger—Gemini Reasons for the Merger” and “The Merger—Disc Reasons for the Merger” beginning on pages 148 and 152, respectively, of this proxy statement/prospectus.

1

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

A:
You are receiving this proxy statement/prospectus because you have been identified as a stockholder of Gemini and/or Disc as of the applicable record date, and you are entitled to vote to approve the matters set forth herein. This document serves as:

• a proxy statement of Gemini used to solicit proxies for the Gemini special meeting to vote on the matters set forth herein; and

• a prospectus of Gemini used to offer shares of Gemini common stock in exchange for shares of Disc common stock (including shares of Disc common stock issued upon conversion of Disc preferred stock, but excluding shares of Disc common stock issued in the pre-closing financing) in the merger.

Q:
What is the Disc pre-closing financing?

A:
On August 9, 2022, immediately prior to the execution and delivery of the Merger Agreement, Disc entered into a subscription agreement with certain existing investors of Disc named therein, including Access Biotechnology, OrbiMed, Atlas Venture, 5AM Ventures, Novo Holdings A/S, Rock Springs Capital and Janus Henderson Investors, pursuant to which the investors agreed to purchase shares of Disc common stock, at a per share purchase price of $2.51 and an aggregate purchase price of approximately $53.5 million. Immediately after the merger, the shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of capital stock of the combined company. The closing of the Disc pre-closing financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the merger as well as certain other conditions.

Q:
What proposals will be voted on at the Gemini special meeting in connection with the merger?

A:
Pursuant to the terms of the Merger Agreement, the following proposals must be approved by the requisite stockholder vote at the Gemini special meeting in order for the merger to close:

• Proposal No. 1 to approve (i) the issuance of shares of Gemini common stock to the stockholders of Disc pursuant to the Merger Agreement, which shares of Gemini common stock will represent more than 20% of the shares of Gemini common stock outstanding immediately prior to the merger, and (ii) the change of control resulting from the merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively; and

• Proposal No. 2 to approve an amendment to the amended and restated certificate of incorporation of Gemini to (a) effect a reverse stock split of Gemini’s issued and outstanding common stock at a ratio of one new share of Gemini common stock for every ten shares of outstanding Gemini common stock, and (b) implement a reduction in the number of authorized shares   of Gemini common stock to 100,000,000.

Each of Proposal Nos. 1 and 2 is a condition to completion of the merger. Proposal No. 1 is referred to herein as the merger proposal and Proposal No. 2 is referred to herein as the reverse stock split proposal. The issuance of Gemini common stock in connection with the merger and the change of control resulting from the merger, or Proposal No. 1, will not take place unless Proposal No. 1 is approved by Gemini stockholders and the merger is consummated. The amendment to the amended and restated certificate of incorporation of Gemini to effect a reverse stock split of Gemini’s issued and outstanding common stock, or Proposal No. 2, will not take place unless Proposal No. 2 is approved by the requisite Gemini stockholders and the merger is consummated.

In addition to the requirement of obtaining Gemini stockholder approval, the closing of the merger is subject to the satisfaction or waiver of each of the other closing conditions set forth in the Merger Agreement. For a more complete description of the closing conditions under the Merger Agreement, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 194 of this proxy statement/prospectus.

The presence, by accessing online or being represented by proxy, at the Gemini special meeting of the holders of a majority of the shares of Gemini common stock outstanding and entitled to vote at the Gemini special meeting is necessary to constitute a quorum at the meeting for the purpose of approving the merger proposal.

2

Q:
What proposals are to be voted on at the Gemini special meeting, other than the merger proposal and the reverse stock split proposal?

A:
At the Gemini special meeting, the holders of Gemini common stock will also be asked to consider the following proposals:

• Proposal No. 3 to approve on a nonbinding, advisory basis, the compensation that will or may become payable by Gemini to its named executive officers in connection with the merger.

• Proposal No. 4 to approve amendments to Gemini’s 2021 Stock Option and Incentive Plan and Gemini’s 2021 Employee Stock Purchase Plan to (i) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Stock Option and Incentive Plan to a number of shares representing approximately 9% of the fully diluted capitalization of Gemini, determined as of immediately following the merger and (ii) increase the number of shares of common stock reserved for issuance under Gemini’s 2021 Employee Stock Purchase Plan to a number of shares representing approximately 0.84% of the fully diluted capitalization of Gemini, determined as of immediately following the merger.

• Proposal No. 5 to approve an adjournment of the Gemini special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal Nos. 1 and 2.

The approval of Proposal Nos. 3, 4 and 5 are not a condition to the merger. Such proposals, together with Proposal Nos. 1 and 2, are referred to collectively in this proxy statement/prospectus as the proposals.

The presence, by accessing online or being represented by proxy, at the Gemini special meeting of the holders of a majority of the shares of Gemini common stock outstanding and entitled to vote at the Gemini special meeting is necessary to constitute a quorum at the meeting for the purpose of approving the proposals.

Q:
What stockholder votes are required to approve the proposals at the Gemini special meeting?

A:
The affirmative vote of a majority of votes cast at the Gemini special meeting, assuming a quorum is present, is required for approval of Proposal Nos. 1, 3, 4 and 5. The affirmative vote of the holders of a majority of the outstanding shares of Gemini capital stock entitled to vote at the Gemini special meeting is required for approval of Proposal No. 2.

Votes will be counted by the inspector of election appointed for the meeting, who will separately count “FOR” and “AGAINST” votes, abstentions and broker non-votes. Abstentions and broker non-votes will also be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the special meeting. Abstentions will be counted towards the vote totals for each proposal, and will have the same effect as “AGAINST” votes. Broker non-votes will have no effect on Proposal Nos. 1, 3, 4 and 5, and will have the same effect as “AGAINST” votes for Proposal No. 2.

Q:
What are contingent value rights (CVRs)?

A:
The CVRs represent the contractual right to receive payments (in the form of common stock of the combined company) from Gemini upon the actual receipt by Gemini or certain of its affiliates of certain contingent proceeds derived from any consideration that is paid to Gemini as a result of the disposition of any of Gemini’s pre-merger assets, net of any tax, transaction costs and certain other expenses, during the period that is one year after the closing of the merger.

At or prior to the effective time of the merger, Gemini and a rights agent will enter into a Contingent Value Rights Agreement, or the CVR Agreement, pursuant to which Gemini’s stockholders of record as of immediately prior to the effective time of the merger will receive one non-transferable CVR for each outstanding share of Gemini common stock held by such stockholder on such date. A copy of the form of CVR Agreement is included as Annex Fto this proxy statement/prospectus. The contingent payments under the CVR Agreement, if they become payable, will become payable to the rights agent for subsequent distribution to the holders of the CVRs. In the event that no proceeds are received, holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any holders of CVRs will receive payments with respect thereto.

The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and will not be transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be

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evidenced by a certificate or any other instrument and will not be registered with the SEC. The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in Gemini or the combined company or any of its affiliates. No interest will accrue on any amounts payable in respect of the CVRs.

For a more detailed description of the CVRs and the CVR Agreement, see “Agreements Related to the Merger—Contingent Value Rights Agreement” elsewhere in this proxy statement/prospectus.

Q:
What will Disc stockholders and optionholders receive in the merger?

A:
Disc stockholders will receive shares of Gemini common stock, and Disc optionholders’ outstanding and unexercised options to purchase shares of Disc common stock eligible to be registered on Form S-8 will be assumed by Gemini and will be converted into an option to purchase shares of Gemini’s common stock, with necessary adjustments to reflect the exchange ratio. Applying the exchange ratio, the former Disc securityholders immediately before the merger, excluding shares purchased in the Disc pre-closing financing, are expected to own approximately 63% of the aggregate number of shares of the combined company’s common stock following the merger, Gemini securityholders immediately before the merger are expected to own approximately 24% of the aggregate number of shares of the combined company common stock following the merger and shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of capital stock of the combined company following the merger, in each case subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million and $96.6 million.

In connection with the merger, each outstanding and unexercised option to purchase shares of Disc common stock that, following assumption by Gemini at the effective time, will be eligible to be registered on Form S-8, will be converted into an option to purchase Gemini common stock, with the number of shares and exercise price being appropriately adjusted to reflect the exchange ratio between Gemini common stock and Disc common stock or preferred stock, as the case may be, determined in accordance with the Merger Agreement.

For a more complete description of the treatment of Disc common stock and Disc options in the merger, please see the sections titled “The Merger Agreement—Merger Consideration” and“The Merger Agreement—Exchange Ratio” beginning on pages 181 and 181, respectively, of this proxy statement/prospectus. For a description of the effect of the Disc pre-closing financing on Gemini’s and Disc’s current securityholders, please see the section titled “Agreements Related to the Merger—Subscription Agreement” beginning on page 201 of this proxy statement/prospectus.

Q:
Will the common stock of the combined company trade on an exchange?

A:
Shares of Gemini common stock are currently listed on Nasdaq under the symbol “GMTX.” Gemini has filed an initial listing application for the common stock of the combined company with Nasdaq. After completion of the merger, Gemini will be renamed “Disc Medicine, Inc.” and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “IRON.” On November 30, 2022, the last trading day before the date of this proxy statement/prospectus, the closing sale price of Gemini common stock was $1.72 per share.

Q:
Who will be the directors of the combined company following the merger?

A:
Immediately following the merger, the combined company’s board of directors will be composed of nine (9) members, consisting of (i) one (1) current Gemini board member, Georges Gemayel, and (ii) eight (8) current Disc board members, namely Donald Nicholson, Kevin Bitterman, Mark Chin, John Quisel (who is Disc’s Chief Executive Officer and will serve as Chief Executive Officer of the combined company), Liam Ratcliffe, William White, Mona Ashiya and Jay T. Backstrom. The staggered structure of the Gemini board of directors will remain in place for the combined company following the completion of the merger.

Q:
Who will be the executive officers of the combined company immediately following the merger?

A:
Immediately following the merger, the executive management team of the combined company is expected to consist of members of the Disc executive management team prior to the merger, including:

Name	Title
John Quisel	Chief Executive Officer and Director
Joanne Bryce	Chief Financial Officer

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Name	Title
Jonathan Yu	Chief Business Officer
Will Savage	Chief Medical Officer
Brian MacDonald	Chief Innovation Officer
Rahul Khara	General Counsel

Q:
As a Gemini stockholder, how does Gemini’s board of directors recommend that I vote?

A:
After careful consideration, Gemini’s board of directors unanimously recommends that Gemini stockholders vote “FOR” all of the proposals.

Q:
What risks should I consider in deciding whether to vote in favor of the merger?

A:
You should carefully review the section titled “Risk Factors” beginning on page22 of this proxy statement/prospectus and the documents incorporated by reference herein, which set forth certain risks and uncertainties related to the merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of Gemini and Disc, as independent companies, are subject.

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

A:
The merger is anticipated to close in the fourth quarter of 2022, but the exact timing cannot be predicted. For more information, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page194 of this proxy statement/prospectus.

Q:
What do I need to do now?

A:
Gemini urges you to read this proxy statement/prospectus carefully, including the annexes and the documents incorporated by reference, and to consider how the merger affects you.

If you are a Gemini stockholder of record, you may provide your proxy instructions in one of four different ways:

• You can vote using the proxy card, simply complete, sign and date the accompanying proxy card and return it promptly in the envelope provided. If you return your signed proxy card before the Gemini special meeting, Gemini will vote your shares in accordance with the proxy card.

• You can vote by proxy over the internet, follow the instructions provided on the Notice of Internet Availability.

• You can vote by telephone by calling the toll free number found on the Notice of Internet Availability.

Your signed proxy card, telephonic proxy instructions, or internet proxy instructions must be received by December 27 , 2022, 11:59 p.m. Eastern Time to be counted.

If you hold your shares in “street name” (as described below), you may provide your proxy instructions via telephone or the internet by following the instructions on your vote instruction form provided by your broker. 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 Gemini special meeting.

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

A:
If you are a Gemini stockholder, the failure to return your proxy card or otherwise vote or provide proxy instructions will reduce the aggregate number of votes required to approve Proposal Nos. 1, 3, 4 and 5 and will have the same effect as a vote “AGAINST” Proposal No. 2.

Q:
May I attend the Gemini special meeting and vote in person?

A:
Stockholders of record as of November 29, 2022 will be able to attend and participate in the Gemini special meeting online by accessing www.virtualshareholdermeeting.com/GMTX2022SM. To join the Gemini special

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meeting, you will need to have your 16-digit control number which is included on your Notice of Internet Availability of Proxy Materials and your proxy card. If your shares are held in “street name,” you should contact your bank, broker or other nominee if you did not receive a 16 digit control number.

Q:
Who counts the votes?

A:
Broadridge Financial Solutions, Inc., or Broadridge, has been engaged as Gemini’s independent agent to tabulate stockholder votes, which Gemini refers to as the inspector of election. If you are a stockholder of record, your executed proxy card is returned directly to Broadridge for tabulation. If you hold your shares through a broker, your broker returns one proxy card to Broadridge on behalf of all its clients.

Q:
If my Gemini shares are held in “street name” by my broker, will my broker vote my shares for me?

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.” A “broker non-vote” occurs when shares held by a broker are not voted with respect to a particular proposal because the broker does not have or did not exercise discretionary authority to vote on the matter and has not received voting instructions from its clients. These matters are referred to as “non-discretionary” matters. Proposals No. 2 is anticipated to be a discretionary matter. Broker non-votes will not be considered as votes cast by the holders of Gemini common stock present or represented by proxy at the Gemini special meeting, and will therefore not have any effect with respect to Proposal Nos. 1, 3, 4 and 5. Broker non-votes, if any, will have the effect of an “Against” vote with respect to Proposals No. 2. 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:
What are broker non-votes and do they count for determining a quorum?

A:
Generally, a “broker non-vote” occurs when shares held by a broker are not voted with respect to a particular proposal because the broker does not have or did not exercise discretionary authority to vote on the matter and has not received voting instructions from its clients.

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 Gemini special meeting. Broker non-votes will not be treated as votes cast for or against a proposal and accordingly will not have any effect with respect to the outcome of Proposal Nos. 1, 3, 4 and 5, and will have the same effect as “AGAINST” votes for Proposal No. 2.

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

A:
Gemini stockholders of record, unless such stockholder’s vote is subject to a support agreement, may change their vote at any time before their proxy is voted at the Gemini special meeting in one of four ways:

• You may submit another properly completed proxy with a later date by mail or via the internet.

• You can provide your proxy instructions via telephone at a later date.

• You may send a notice that you are revoking your proxy over the internet, following the instructions provided on the Notice of Internet Availability.

• You may attend the Gemini special meeting online and vote by following the instructions at www.virtualshareholdermeeting.com/GMTX2022SM. Simply attending the Gemini special meeting will not, by itself, revoke your proxy.

Your signed proxy card, telephonic proxy instructions, internet proxy instructions, or written notice must be received by December 27, 2022, 11:59 p.m. Eastern Time to be counted.

If a Gemini stockholder who owns Gemini shares in “street name” has instructed a broker to vote its shares of Gemini common stock, the stockholder must follow directions received from its broker to change those instructions.

Q:
Who is paying for this proxy solicitation?

A:
Gemini and Disc will share equally the cost of printing and filing of this proxy statement/prospectus and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Gemini common stock for the forwarding of solicitation materials to the

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beneficial owners of Gemini common stock. Gemini 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. Gemini has retained MacKenzie Partners, Inc., or MacKenzie Partners, to assist it in soliciting proxies using the means referred to above. Gemini will pay the fees of MacKenzie Partners, which Gemini expects to be approximately $12,500, plus reimbursement of out-of-pocket expenses.

Q:
What are the material U.S. federal income tax consequences of the merger to holders of Gemini capital stock?

A:
Gemini stockholders will not sell, exchange or dispose of any shares of Gemini common stock as a result of the merger. Thus, there will be no material U.S. federal income tax consequences to Gemini stockholders as a result of the merger.

Q:
What are the material U.S. federal income tax consequences of the merger to United States holders of Disc capital stock?

A:
Subject to the limitations and qualifications described in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger,” in the opinion of WilmerHale and Goodwin Proctor LLP, the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) and holders of Disc capital stock will not recognize gain or loss for U.S. federal income tax purposes upon the receipt of shares of Gemini common stock in exchange for Disc capital stockinthe merger, except with respect to cash received in lieu of a fractional share of Gemini common stock. For a more detailed discussion of the material U.S. federal income tax consequences of the merger, see “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 174.

Q:
What are the material U.S. federal income tax consequences of the issuance of the CVRs, including any distributions of Gemini common stock under the CVRs?

A:
Although the U.S. federal income tax treatment of the CVRs is uncertain and the matter is not free from doubt, Gemini will treat (i) a holder’s receipt of the CVRs as a non-taxable distribution with respect to the holder’s existing shares of Gemini common stock for U.S. federal income tax purposes, and (ii) a holder’s receipt of shares of Gemini common stock in respect of the CVRs as a non-taxable exercise of the right to receive stock under the CVRs for U.S. federal income tax purposes. This position may be challenged by the Internal Revenue Service, or the IRS, in which case holders of Gemini common stock could be required to recognize taxable income in respect of the receipt of the CVRs or the receipt of Gemini common stock under the CVRs, in each case, without a corresponding receipt of cash. Please review the information in the section titled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Gemini Common Stock” for a discussion of the material U.S. federal income tax consequences of the CVRs to holders of Gemini common stock.

Q:
What are the material U.S. federal income tax consequences of the reverse stock split to holders of Gemini common stock?

A:
A holder of Gemini common stock should not recognize gain or loss upon the reverse stock split, except to the extent such holder receives cash in lieu of a fractional share of Gemini common stock, and subject to the discussion in the section titled “Matters Being Submitted to a Vote of Gemini Stockholders—Proposal No. 2: Approval of the Amendment to Amended and Restated Certificate of Incorporation of Gemini to Effect the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split.” Please review the information in the section titled “Matters Being Submitted to a Vote of Gemini Stockholders—Proposal No. 2: Approval of the Amendment to Amended and Restated Certificate of Incorporation of Gemini to Effect the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” for a more complete description of the material U.S. federal income tax consequences of the reverse stock split to holders of Gemini common stock.

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Q:
Who can help answer my questions?

A:
If you are a Gemini stockholder and would like additional copies of this proxy statement/prospectus without charge or if you have questions about the merger or related matters, including the procedures for voting your shares, you should contact:

Gemini Therapeutics, Inc.

297 Boston Post Road #248

Wayland, MA 01778

Telephone: (617) 401-4400

Attn: Brian Piekos

Email: IR@gemtherapeutics.com

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PROSPECTUS SUMMARY

This summary highlights selected information from this proxy statement/prospectus and may not contain all of the information that is important to you. To better understand the merger and the proposals being considered at the Gemini special meeting, you should read this entire proxy statement/prospectus carefully, including the Merger Agreement and the other annexes to which you are referred in this proxy statement/prospectus, and the documents incorporated by reference therein. For more information, please see the section titled “Where You Can Find More Information” beginning on page 385 of this proxy statement/prospectus. Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed reverse stock split described in Proposal No. 2 of this proxy statement/prospectus.

The Companies

Gemini Therapeutics, Inc.

297 Boston Post Road #248

Wayland, MA 01778

(617) 401-4400

On February 5, 2021, FS Development Corporation, a Delaware corporation (“FSDC”), consummated a business combination (the “business combination”), by and among Gemini Therapeutics, Inc., a Delaware corporation (“old Gemini”), Shareholder Representative Services LLC, a Colorado limited liability company solely in its capacity as the representative, agent and attorney-in-fact of the company securityholders, FSDC and FSG Merger Sub Inc., a Delaware corporation. On the day prior to the closing date, old Gemini changed its name to “Gemini Therapeutics Sub, Inc.” On February 5, 2021, (i) FSDC changed its name to “Gemini Therapeutics, Inc.” and (ii) old Gemini merged with and into FSG Merger Sub Inc., with old Gemini as the surviving company and, after giving effect to such merger, old Gemini becoming a wholly-owned subsidiary of Gemini. Upon the closing of the business combination, the existing shareholders of old Gemini exchanged their interests for shares of common stock of Gemini. Since February 5, 2021, Gemini has operated as an independent publicly traded company.

Gemini is a clinical-stage precision medicine company developing novel therapeutic compounds to treat genetically defined, age-related macular degeneration (“AMD”). Gemini’s lead product candidate, GEM103, is a recombinant form of the human complement factor H protein (“CFH”) and is designed to address complement hyperactivity and overall dysregulation caused by loss of function mutations thus restoring retinal health in patients with AMD. Native CFH serves multiple functions in maintaining retinal health, including regulating lipid metabolism in the retina, protecting the retina against lipid and protein by-products of oxidative stress, and regulating the complement system, which is part of the innate immune system. This multifaceted regulation plays an integral role in engagement and maintenance of complement-mediated immune responses that are involved in pathogen defense and cellular debris clearance.

In January 2022, Gemini announced that it had discontinued both of its Phase 2a clinical trials of GEM103, the ReGAtta study and the GEM103 as an Add-On to Anti-VEGF Therapy for the Treatment of Wet-AMD study.

In February 2022, Gemini announced a corporate restructuring and that it had initiated a process to evaluate strategic alternatives. Gemini is currently focused on completing a strategic alternative and has paused current clinical development.

Since inception in 2015, Gemini has devoted substantially all its efforts and financial resources to organizing and staffing its company, business planning, raising capital, discovering product candidates and securing related intellectual property rights and conducting research and development activities for its product candidates. Gemini does not have any products approved for sale, and has not generated any revenue from product sales. Gemini may never be able to develop or commercialize a marketable product.

Disc Medicine, Inc.

321 Arsenal Street, Suite 101

Watertown, MA 02472

Telephone: (617) 674-9274

Disc is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases. Disc has assembled a portfolio of clinical and preclinical product candidates that aim to modify fundamental biological pathways associated with the formation and function of red blood cells, specifically heme biosynthesis and iron homeostasis. Disc’s current pipeline includes bitopertin

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for the treatment of erythropoietic porphyrias, including erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP); and DISC-0974 for the treatment of anemia of myelofibrosis (MF) and anemia of chronic kidney disease (CKD). In addition, Disc has two programs in preclinical development: DISC-0998 for the treatment of anemia associated with inflammatory diseases; and a Matriptase-2 inhibitor for the treatment of polycythemia vera (PV) and diseases of iron overload. Disc’s approach to product candidate development leverages well understood molecular mechanisms that have been validated in humans. Disc believes that each of its product candidates, if approved, has the potential to improve the lives of patients suffering from hematologic diseases.

Bitopertin is the lead product candidate in Disc’s heme biosynthesis modulation portfolio. Bitopertin was previously evaluated by Roche in a comprehensive clinical program in over 4,000 individuals in other indications which demonstrated the activity of bitopertin as a glycine transporter 1 (GlyT1) inhibitor and its effect on heme biosynthesis. Disc is planning to initially develop bitopertin for the treatment of erythropoietic porphyrias, including EPP and XLP. In July 2022, Disc received clearance of its IND for “A Randomized, Double-blind, Placebo-Controlled Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX (PPIX) Concentrations in Participants with Erythropoietic Protoporphyria (EPP)” from the FDA. In July 2022, Disc initiated BEACON, a Phase 2 open-label, parallel-dose clinical trial of bitopertin in EPP and XLP patients that is being conducted at sites in Australia. Separately, in October 2022 Disc initiated AURORA, a Phase 2, randomized, double-blind, placebo-controlled clinical trial of bitopertin in EPP patients that is being conducted at sites in the United States. Disc expects interim data from these two trials in 2023. Disc is planning additional studies in Diamond-Blackfan Anemia (DBA) and other indications.

DISC-0974 is the lead product candidate in Disc’s iron homeostasis portfolio. DISC-0974 is designed to suppress hepcidin production and increase serum iron levels. Disc submitted an IND for DISC-0974 in June 2021, received clearance in July 2021, and participants completed a Phase 1 clinical trial in healthy volunteers in the U.S. in June 2022 with results showing evidence of target engagement, iron mobilization and erythropoiesis. Disc initiated a Phase 1b/2 clinical trial in June 2022 in patients with anemia of MF, and plans to initiate a separate Phase 1b/2 clinical trial by the end of 2022 in patients with anemia of CKD. Disc expects interim data from these two trials in 2023. In addition, Disc is developing a preclinical anti-hemojuvelin, or HJV, monoclonal antibody, DISC-0998, which also targets hepcidin suppression and was in-licensed from AbbVie. DISC-0998 is designed to increase serum iron levels and has an extended serum half-life as compared to DISC-0974. Disc believes this profile may be desirable in certain subsets of patients with anemia associated with inflammatory diseases.

Lastly, Disc is developing a Matriptase-2 inhibitor as part of its iron homeostasis portfolio, which is designed to induce hepcidin production and reduce serum iron levels. Preclinical data has demonstrated positive results, and Disc is in the process of identifying and optimizing a development candidate in its Matriptase-2 inhibitor program. If successful, Disc expects to designate a lead candidate and commence IND-enabling studies.

Gemstone Merger Sub, Inc.

297 Boston Post Road #248

Wayland, MA 01778

(617) 401-4400

Merger Sub is a direct, wholly-owned subsidiary of Gemini and was formed solely for the purpose of carrying out the merger.

The Merger (see page 138)

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

At the effective time, except for shares to be canceled pursuant to the Merger Agreement and dissenting shares, each outstanding share of Disc common stock or Disc preferred stock will be automatically converted solely into the right to receive a number of shares of Gemini common stock equal to the exchange ratio. The exchange ratio is calculated using a formula intended to allocate existing Gemini and Disc securityholders a percentage of the combined company. Based on Gemini’s and Disc’s capitalization as of August 9, 2022, the date the Merger Agreement was executed, the exchange ratio is estimated to be equal to approximately 1.1052 shares of Gemini common stock, which has not yet been adjusted to give effect to the expected Gemini reverse stock split because the reverse stock split is not final. This estimate is subject to adjustment prior to closing of the merger for net cash at the cash determination time and the aggregate amount of Disc common stock sold in the Disc pre-closing financing and as a result, Gemini

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securityholders could own more, and Disc securityholders (including, for this purpose, investors in the pre-closing financing) could own less, or vice versa, of the combined company.

In connection with the merger, each option to purchase shares of Disc common stock that is outstanding and unexercised immediately prior to the effective time of the merger under Disc’s 2017 Stock Option and Grant Plan (“Disc’s 2017 Plan”) will be converted into an option to purchase shares of Gemini common stock, and that following assumption by Gemini at the effective time, will be eligible to be registered on Form S-8, whether or not vested, will be converted into an option to purchase shares of Gemini common stock. Gemini will assume Disc’s 2017 Plan, as amended, and each such outstanding option to purchase shares of Disc common stock in accordance with the terms (as in effect as of the date of the Merger Agreement) of Disc’s 2017 Plan and the terms of the stock option agreement by which such option to purchase shares of Disc common stock is evidenced.

Each share of Gemini common stock issued and outstanding at the time of the merger will remain issued and outstanding and such shares will be appropriately adjusted to reflect the proposed reverse stock split. In addition, each option to purchase shares of Gemini common stock and each Gemini restricted stock unit that is outstanding immediately prior to the effective time of the merger, whether vested or unvested, will survive the closing and remain outstanding in accordance with its terms.

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.

In addition, at or prior to the effective time of the merger, Gemini and a rights agent will enter into the CVR Agreement, pursuant to which Gemini’s stockholders of record as of immediately prior to the effective time of the merger will receive one non-transferable CVR for each outstanding share of Gemini common stock held by such stockholder on such date. The contingent payments under the CVR Agreement, if they become payable, will become payable to the rights agent for subsequent distribution to the holders of the CVRs. In the event that no proceeds are received, holders of the CVRs will not receive any payment pursuant to the CVR Agreement.

The merger will be completed as promptly as practicable (and in any event within two business days) after all of the conditions to completion of the merger are satisfied or waived, including the adoption of the Merger Agreement by the Disc stockholders and the approval by the Gemini stockholders of the issuance of Gemini common stock and the other transactions proposed under the Merger Agreement. Gemini and Disc are working to complete the merger as quickly as practicable. The merger is anticipated to close in the fourth quarter of 2022, after the Gemini special meeting. However, Gemini and Disc cannot predict the exact timing of the completion of the merger because it is subject to the satisfaction of various conditions. After completion of the merger, assuming that Gemini receives the required stockholder approval, Gemini will be renamed “Disc Medicine, Inc.”

Reasons for the Merger (see pages 148 and 152)

After consideration and consultation with its senior management and its financial and legal advisors, and after recommendation by the Special Committee of the Gemini board of directors (the “Special Committee”), the Gemini board of directors unanimously determined that the Merger Agreement, the merger and other transactions contemplated thereby are advisable and in the best interests of Gemini and its stockholders. The Special Committee and the Gemini board of directors considered various reasons to reach its determination. For example:

• the financial condition and prospects of Gemini and the risks associated with continuing to operate Gemini on a stand-alone basis, particularly in light of Gemini’s October 2021 decision to discontinue research and non-clinical programs associated with gene therapy and translational research on Complement Factor H and Complement Factor I and reduce its workforce as well as Gemini’s difficulty in obtaining a strategic partner for development of GEM-103;

• the Special Committee and its financial advisor undertook a comprehensive and thorough process of reviewing and analyzing potential strategic alternatives and merger partner candidates and the Special Committee’s and the Gemini Board of Directors’ view that no alternatives to the merger were reasonably likely to create greater value for Gemini’s stockholders;

• the Special Committee’s and the Gemini Board of Directors’ belief, after a thorough review of strategic alternatives and discussions with Gemini’s senior management, financial advisors and legal counsel, that the merger is more favorable to Gemini Stockholders than the potential value that might have resulted from other strategic alternatives available to Gemini, including a liquidation of Gemini and the distribution of any available cash;

11

• the Special Committee’s and the Gemini Board of Directors’ belief that, as a result of arm’s length negotiations with Disc, Gemini and its representatives negotiated the highest exchange ratio to which Disc was willing to agree, and that the other terms of the Merger Agreement include the most favorable terms to Gemini in the aggregate to which Disc was willing to agree;

• the Special Committee’s and the Gemini Board of Directors’ view, based on the scientific, regulatory and technical due diligence conducted by Gemini management and advisors, of the regulatory pathway for, and market opportunity of, Disc’s product candidates; and

• the Special Committee’s and the Gemini Board of Directors’ view, following a review with Gemini’s management and advisors of Disc’s current development and clinical trial plans, of the likelihood that the combined company would possess sufficient cash resources at the closing of the merger to fund development of Disc’s product candidates through upcoming value inflection points.

Interests of Certain Directors, Officers and Affiliates of Gemini and Disc (see pages 164and 170)

In considering the recommendation of the Gemini board of directors with respect to issuing shares of Gemini common stock in the merger and the other matters to be acted upon by the Gemini stockholders at the Gemini special meeting, Gemini stockholders should be aware that Gemini’s directors and executive officers have interests in the merger that are different from, or in addition to, the interests of Gemini’s stockholders generally. Interests of the directors and executive officers may be different from or in addition to the interests of the stockholders for the following reasons, among others:

• Georges Gemayel, the Executive Chairperson of Gemini’s board of directors and Gemini’s interim Chief Executive Officer, will continue as a director of the combined company after the effective time of the merger, and, following the closing of the merger, will be eligible to be compensated as a non-employee director of the combined company pursuant to the non-employee director compensation policy in place following the effective time of the merger.

• Under the Merger Agreement, Gemini’s directors and executive officers are entitled to continued indemnification, expense advancement and insurance coverage.

• In connection with the merger, options to purchase Gemini common stock held by Gemini’s directors (including those held by Mr. Gemayel) will vest in full upon the closing of the merger and, once vested, such options shall be exercisable for a period of six months following the date on which the director ceases to provide services to Gemini (provided that no option will remain exercisable following the expiration of its term).

• In connection with his anticipated termination of employment following the effective time of the merger, Brian Piekos, Gemini’s Chief Financial Officer and Chief Business Officer, would be entitled to receive certain enhanced severance payments and benefits under the terms of his employment agreement with Gemini. In addition, he shall be entitled to receive a retention bonus following the closing of the merger and certain restricted stock units over Gemini common stock (“Gemini RSUs”) granted to him will, in accordance with the terms of the Merger Agreement, accelerate in full at the closing of the merger.

These interests are discussed in more detail in the section titled “The Merger—Interests of Gemini Directors and Executive Officers in the Merger” beginning on page 164 of this proxy statement/prospectus. The members of Gemini’s board of directors were aware of and considered these interests, among other matters, in evaluating and negotiating the Merger Agreement and the merger, and in recommending to the stockholders that the merger proposal be approved.

Certain Gemini stockholders have also entered into a support agreement and a lock-up agreement in connection with the merger. For a more detailed discussion of the support agreements and lock-up agreements, please see the sections titled “Agreements Related to the Merger—Support Agreements” and “Agreements Related to the Merger—Lock-Up Agreements” beginning on page 200 and page 201, respectively, of this proxy statement/prospectus.

In considering the recommendation of the Disc board of directors with respect to approving the merger and related transactions, Disc stockholders should be aware that certain members of the Disc board of directors and certain executive officers of Disc have interests in the merger that may be different from, or in addition to, interests they have as Disc stockholders. For example, Disc’s executive officers have options, subject to vesting, to purchase shares of Disc common stock, which will convert into options to purchase a number of shares of Gemini common stock

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determined by the exchange ratio, rounding any resulting fractional shares down to the nearest whole share, certain of Disc’s directors and executive officers are expected to become directors and executive officers of the combined company upon the closing and all of Disc’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. These interests are discussed in more detail in the section titled “The Merger—Interests of Disc Directors and Executive Officers in the Merger” beginning on page 170 of this proxy statement/prospectus. The board of directors of Disc was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Merger Agreement and the merger, and to recommend that the Disc stockholders approve the merger as contemplated by this proxy statement/prospectus.

Opinion of Gemini’s Financial Advisor (see page 155)

Gemini retained SVB Securities LLC (“SVB Securities”) as its financial advisor in connection with the merger and the other transactions contemplated by the Merger Agreement. On August 9, 2022, SVB Securities rendered to the Gemini board of directors its oral opinion, which was subsequently confirmed by delivery of a written opinion to the Gemini Board of Directors dated August 9, 2022, that, as of such date and based upon and subject to the various assumptions made, and the qualifications and limitations upon the review undertaken by SVB Securities in preparing its opinion, the exchange ratio proposed to be paid by Gemini pursuant to the Merger Agreement was fair, from a financial point of view, to Gemini.

The full text of the written opinion of SVB Securities, dated August 9, 2022, which describes the assumptions made and the qualifications and limitations upon the review undertaken by SVB Securities in preparing its opinion, is attached as Annex B to this proxy statement and is incorporated herein by reference. SVB Securities’ financial advisory services and opinion were provided for the information and assistance of Gemini board of directors (in their capacity as directors and not in any other capacity) in connection with and for purposes of the Gemini board of directors’ consideration of the merger and the opinion of SVB Securities addressed only the fairness, from a financial point of view, as of the date thereof, to Gemini of the exchange ratio proposed to be paid by Gemini pursuant to the terms of the Merger Agreement. The opinion of SVB Securities did not address any other term or aspect of the Merger Agreement or the merger and does not constitute a recommendation to any stockholder of Gemini as to whether or how such holder should vote with respect to the merger or otherwise act with respect to the merger or any other matter.

The full text of the written opinion of SVB Securities should be read carefully in its entirety for a description of the assumptions made and limitations upon the review undertaken by SVB Securities in preparing its opinion

Overview of the Merger Agreement and Agreements Related to the Merger Agreement

Merger Consideration (see page 181)

At the effective time of the merger, upon the terms and subject to the conditions set forth in the Merger Agreement, each outstanding share of Disc common stock (after giving effect to the conversion of each share of Disc’s preferred stock into Disc common stock and including all such shares that are converted into Disc common stock) (excluding shares to be canceled pursuant to the Merger Agreement and excluding dissenting shares) will be automatically converted solely into the right to receive a number of shares of Gemini common stock equal to the exchange ratio described in more detail below. Based on Gemini’s and Disc’s capitalization as of August 9, 2022, the date the Merger Agreement was executed, the exchange ratio is estimated to be equal to approximately 1.1052 shares of Gemini common stock, which has not yet been adjusted to give effect to the expected Gemini reverse stock split because the reverse stock split is not final. This estimate is subject to adjustment prior to closing of the merger for net cash at the cash determination time and the aggregate amount of Disc common stock sold in the Disc pre-closing financing and as a result, Gemini securityholders could own more, and Disc securityholders (including, for this purpose, investors in the pre-closing financing) could own less, or vice versa, of the combined company.

Immediately after the merger, Gemini securityholders as of immediately prior to the merger are expected to own approximately 24% of the outstanding shares of Gemini common stock, subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million and $96.6 million. Disc securityholders, excluding shares purchased in the Disc pre-closing financing, are expected to own approximately 63% of the common stock of the combined company post-merger and shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the capital stock of the combined company post-merger. For information on the impact of the Disc pre-closing financing, please see the section titled “Agreements Related to the Merger—Subscription Agreement” beginning on page 201 of this proxy statement/prospectus.

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Treatment of Disc Options (see page 184)

Under the terms of the Merger Agreement, each option to purchase shares of Disc common stock that is outstanding and unexercised immediately prior to the effective time of the merger and that, following assumption by Gemini at the effective time of the merger, will be eligible to be registered on Form S-8, whether or not vested, will be assumed and converted into an option to purchase shares of Gemini common stock, based on the exchange ratio. Gemini will assume Disc’s 2017 Plan, as amended. All other Disc equity awards will be cancelled immediately prior to the closing of the merger.

Accordingly, from and after the effective time of the merger: (i) each outstanding Disc stock option assumed by Gemini may be exercised solely for shares of Gemini common stock; (ii) the number of shares of Gemini common stock subject to each outstanding Disc stock option assumed by Gemini will be determined by multiplying (A) the number of shares of Disc common stock that were subject to such Disc stock option assumed by Gemini, as in effect immediately prior to the effective time of the merger, by (B) the exchange ratio, and rounding the resulting number down to the nearest whole number of shares of Gemini common stock; and (iii) the per share exercise price of each Disc stock option assumed by Gemini will be determined by dividing (A) the per share exercise price of such Disc stock option, as in effect immediately prior to the effective time of the merger, by (B) the exchange ratio and rounding the resulting exercise price up to the nearest whole cent. Each Disc stock option assumed by Gemini will otherwise continue in full force and effect and the term, exercisability, vesting schedule, acceleration rights and other terms and conditions of such Disc stock option will otherwise remain unchanged.

Each Disc stock option shall, in accordance with its terms, continue to be subject to further adjustment as appropriate to reflect any stock split, division or subdivision of shares, stock dividend, reverse stock split, consolidation of shares, reclassification, recapitalization or other similar transaction with respect to shares of Gemini common stock subsequent to the effective time of the merger. In addition, the Gemini board of directors or a committee thereof will succeed to the authority and responsibility of the Disc board of directors or any committee thereof with respect to each Disc option assumed by Gemini in accordance with the terms of the Merger Agreement.

Treatment of Gemini Common Stock, Gemini Options and Gemini RSUs (see page 184)

Each share of Gemini common stock issued and outstanding at the time of the merger will remain issued and outstanding, and, subject to the proposed reverse stock split and any acceleration provided for in connection with the merger, will be unaffected by the merger. In addition, each option to purchase shares of Gemini common stock and each Gemini RSU that is outstanding immediately prior to the effective time of the merger, whether vested or unvested, will survive the closing and remain outstanding in accordance with its terms. The number of shares of Gemini common stock underlying such options and RSUs and the exercise prices for such stock options will be appropriately adjusted to reflect the proposed reverse stock split.

Conditions to the Completion of the Merger (see page 194)

To complete the merger, Gemini stockholders must approve Proposal Nos. 1 and 2 and Disc stockholders must adopt the Merger Agreement and approve the merger and the additional transactions contemplated thereby. Additionally, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

Non-Solicitation (see page 189)

The Merger Agreement contains non-solicitation provisions prohibiting Gemini and Disc from inquiring about or seeking a competing transaction. Each of Gemini and Disc have agreed that, subject to certain exceptions, Gemini and Disc and any of their respective subsidiaries will not, nor will either party or any of its subsidiaries authorize any of the directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors or representatives retained by it or any of its subsidiaries to, directly or indirectly:

• solicit, seek, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of, any Acquisition Proposal (as defined in the section of this proxy statement/prospectus entitled “The Merger Agreement—Non-Solicitation”) or Acquisition Inquiry (as defined in the section of this proxy statement/prospectus entitled “The Merger Agreement—Non-Solicitation”);

• furnish any non-public information with respect to it to any person in connection with or in response to an Acquisition Proposal or Acquisition Inquiry;

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• engage in discussions or negotiations with any person with respect to any Acquisition Proposal or Acquisition Inquiry;

• approve, endorse or recommend an Acquisition Proposal;

• execute or enter into any letter of intent or any contract contemplating or otherwise relating to an Acquisition Transaction; or

• publicly propose to do any of the foregoing.

Board Recommendation Change (see page 191)

Neither Disc’s board of directors nor Gemini’s board of directors may change its recommendation in favor of the merger, except that prior to receipt by such party of its stockholder approval, such party’s board of directors may effect a change in recommendation with respect to a superior offer that did not result from a material breach of the Merger Agreement if:

• such party’s board of directors shall have determined (after consultation with outside legal counsel) that the failure to effect such change in recommendation would constitute a violation of the board’s fiduciary duties under applicable law;

• such party has provided at least four business days’ prior written notice to the other party that it intends to effect a change in recommendation, and during such period has, and has caused its financial advisors and outside legal counsel to, negotiate with the other party in good faith to make such adjustments to the terms and conditions so that the acquisition proposal ceases to constitute a superior offer;

• if after other party shall have delivered to such party a written offer to alter the terms or conditions of the Merger Agreement during the four-business day period referred to above, such party’s board of directors shall have determined in good faith (based on the advice of its outside legal counsel), that the failure to effect a change in recommendation would constitute a violation of its fiduciary duties under applicable law.

In the event of any material amendment to any superior offer, such party would be required to provide the other party with notice of such material amendment and there would be a new two business day period following such notification during which the parties would be obligated to comply again with the requirements described above.

Termination of the Merger Agreement (see page 197)

Either Gemini or Disc may terminate the Merger Agreement under certain circumstances, which would prevent the merger from being consummated.

Termination Fee (see page 198)

If the Merger Agreement is terminated under certain circumstances, Gemini could be required to pay Disc a termination fee of $3.0 million or Disc could be required to pay Gemini a termination fee of $7.8 million, plus, in each case, up to $750,000 in expense reimbursements, respectively.

Support Agreements (see page 200)

Certain Disc stockholders are parties to support agreements with Gemini and Disc pursuant to which, among other things, each such stockholder, solely in his, her or its capacity as a Disc stockholder, has agreed to vote all of such stockholder’s shares of Disc capital stock in favor of (i) the adoption of the Merger Agreement and (ii) the approval of the merger and related transactions contemplated by the Merger Agreement. These Disc stockholders also agreed to vote against any competing Acquisition Proposal with respect to Disc.

As of August 9, 2022, the Disc stockholders that are party to a support agreement with Disc and Gemini owned approximately 90% of the outstanding shares of Disc capital stock. These stockholders include executive officers and directors of Disc, as well as certain other stockholders owning a significant portion of the outstanding shares of Disc capital stock. Following the effectiveness of the registration statement on Form S-4 of which this proxy statement/prospectus is a part and pursuant to the Merger Agreement, Disc stockholders holding a sufficient number of shares of Disc capital stock to adopt the Merger Agreement and approve the merger and related transactions will execute a written consent providing for such adoption and approval.

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Certain Gemini stockholders are parties to support agreements with Gemini and Disc pursuant to which, among other things, each such stockholder, solely in his, her or its capacity as a Gemini stockholder, has agreed to vote all of such stockholder’s shares of Gemini capital stock in favor of (i) the adoption of the Merger Agreement and (ii) the approval of the merger and related transactions contemplated by the Merger Agreement. These Gemini stockholders also agreed to vote against any competing Acquisition Proposal with respect to Gemini.

As of August 9, 2022, the Gemini stockholders that are party to a support agreement with Gemini and Disc owned approximately 36% of the outstanding shares of Gemini capital stock. These stockholders include executive officers and directors of Gemini, as well as certain other stockholders owning a significant portion of the outstanding shares of Gemini capital stock.

Lock-Up Agreements (see page 201)

Certain of Disc’s executive officers, directors and stockholders have entered into lock-up agreements, pursuant to which such parties have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Gemini’s common stock or any securities convertible into or exercisable or exchangeable for Gemini common stock, currently or thereafter owned, including, as applicable, shares purchased by existing Disc stockholders in the Disc pre-closing financing, until 180 days after the effective time of the merger.

Gemini’s executive officers, directors and certain of its stockholders have entered into lock-up agreements, pursuant to which such stockholders have agreed not to, except in limited circumstances, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Gemini’s common stock or any securities convertible into or exercisable or exchangeable for Gemini common stock, currently or thereafter owned, until 180 days after the effective time of the merger.

Contingent Value Rights Agreement (see page 202)

At or prior to the effective time, Gemini and its designated rights agent, will enter into the CVR Agreement. As provided in the Merger Agreement, Gemini intends to declare a dividend to each person who as of immediately prior to the effective time was a stockholder of record of Gemini or had the right to receive Gemini’s common stock the right to receive one non-transferable CVR for each outstanding share of Gemini common stock held by such person as of such date, each representing the non-transferable contractual right to receive certain contingent payments from Gemini upon the occurrence of certain events within agreed time periods.

Pursuant to the CVR Agreement, each CVR holder is entitled to certain rights to receive shares of the combined company, which are to be issued by Gemini and delivered by the rights agent, after the end of each calendar quarter following the closing. The number of shares to be issued by Gemini in any given calendar quarter will be equal to (i) the CVR Proceeds for such applicable calendar quarter, divided by (ii) the volume weighted average of Gemini common stock’s closing market prices for the five (5) trading days ending the day prior to the date of issuance. These proceeds consist of consideration paid to or received by Gemini or any of its affiliates during the period beginning immediately following the effective time and ending on the tenth anniversary of the closing date in respect of the disposition of Gemini’s potentially transferrable assets. Such proceeds are subject to certain permitted deductions, including for applicable tax payments, certain reasonable and documented out-of-pocket costs and expenses incurred by Gemini or its affiliates, losses incurred or reasonably expected to be incurred by Gemini or its affiliates due to a third party proceeding in connection with a disposition and certain wind-down costs.

The CVRs may not be transferred, pledged, hypothecated, encumbered, assigned or otherwise disposed of (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), in whole or in part, subject to certain limited exceptions.

The CVRs will not be evidenced by a certificate or any other instrument. The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable in respect of the CVRs. The CVRs will not represent any equity or ownership interest in Gemini, any constituent company to the merger, or any of its respective affiliates.

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Roche Share Issuance

In connection with Disc's May 2021 license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “Roche”) and pursuant to an addendum to that agreement executed in December 2021, Disc has agreed to issue or cause to be issued in a private placement to Roche or its affiliates, immediately following the closing of the merger and for no additional consideration, shares of common stock estimated to be approximately 2.85% of the combined company's issued and outstanding capitalization immediately following the closing of the merger and the Disc pre-closing financing. See “Disc's Business—Collaborations and License Agreement” for more information regarding Disc's license agreement with Roche.

Management Following the Merger (see page 342)

Effective as of the closing of the merger, the combined company’s executive officers are expected to be members of the Disc executive management team prior to the merger, including:

Name	Title
John Quisel	Chief Executive Officer and Director
Joanne Bryce	Chief Financial Officer
Jonathan Yu	Chief Business Officer
Will Savage	Chief Medical Officer
Brian MacDonald	Chief Innovation Officer
Rahul Khara	General Counsel

Material U.S. Federal Income Tax Consequences of the Merger (see page 174)

Subject to the limitations and qualifications described in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger,” in the opinion of WilmerHale and Goodwin Proctor LLP, the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. Since the Gemini stockholders will not sell, exchange or dispose of any shares of Gemini common stock as a result of the merger, there will be no material U.S. federal income tax consequences to Gemini stockholders as a result of the merger.

Subject to the qualifications and limitations set forth in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger,” the material U.S. federal income tax consequences to a U.S. holder of Disc capital stock as a result of the merger will be as follows:

—
such Disc stockholder will not recognize gain or loss upon the exchange of Disc capital stock for Gemini common stock pursuant to the Merger Agreement, except with respect to cash received in lieu of a fractional share of Gemini common stock;

—
such Disc stockholder’s aggregate tax basis for the shares of Gemini common stock received in the merger will equal the stockholder’s aggregate tax basis in the shares of Disc capital stock surrendered in the merger reduced by the basis allocable to any fractional share of Gemini common stock for which cash is received; and

—
the holding period of the shares of Gemini common stock received by such Disc stockholder in the merger will include the holding period of the shares of Disc capital stock surrendered in exchange therefor.

Risk Factors (see page 22)

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

Risks Related to the Merger:

• The exchange ratio will not change or otherwise be adjusted based on the market price of Gemini common stock as the exchange ratio depends on the Gemini net cash at the closing and not the market price of Gemini 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 Gemini or Disc paying a termination fee to the other party and could harm the common stock price of Gemini and the future business and operations of each company;

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• Some Gemini and Disc executive 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;

• Gemini stockholders and Disc stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger, including because the anticipated benefits reflected in the financial projections prepared by Gemini management and used in the financial analyses of Gemini's financial advisor may not be realized, such as because the assumptions underlying such financial projections may prove inaccurate; and

• If the merger is not completed, Gemini’s stock price may decline significantly.

Risks Related to Gemini:

• Failure to complete, or delays in completing, the proposed merger with Disc could materially and adversely affect Gemini’s results of operations, business, financial results and/or stock price;

• Gemini’s stockholders potentially may not receive any payment on the CVRs and the CVRs may otherwise expire valueless;

• If Gemini does not successfully consummate the merger or another strategic transaction, Gemini’s board of directors may decide to pursue a dissolution and liquidation of Gemini;

• Gemini has incurred significant losses since Gemini’s inception and may incur losses for the foreseeable future;

• If the merger is not consummated and Gemini continues to pursue product development, Gemini will require additional capital to finance Gemini’s operations, which may not be available to Gemini on acceptable terms, or at all;

• Gemini’s business has historically been dependent on the success of GEM103, the trials of which have been discontinued;

• Gemini’s success depends, and the combined company's success will depend, upon its ability to obtain and maintain intellectual property protection for its products and technologies. It is difficult and costly to protect Gemini’s proprietary rights and technology, and Gemini, and if the merger is consummated the combined company, may not be able to ensure their protection; and

• There can be no assurance that Gemini will be able to comply with the continued listing standards of Nasdaq.

Risks Related to Disc:

• Disc’s limited operating history may make it difficult for you to evaluate the success of Disc’s business to date and to assess Disc’s future viability;

• Disc has no products approved for commercial sale and has not generated any revenue from product sales;

• Disc has only successfully completed one Phase 1 clinical trial, and may be unable to successfully complete any additional clinical trials for any product candidates it develops. Certain of Disc’s programs are still in preclinical development and may never advance to clinical development;

• Disc’s programs are focused on the development of therapeutics for patients with hematologic diseases, which is a rapidly evolving area of science, and the approach Disc is taking to discover and develop product candidates is novel and may never lead to approved or marketable products;

• Disc may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of its product candidates;

• Disc faces substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than Disc does;

• Disc relies on third parties to conduct its current clinical trials and expects to continue to rely on third parties. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, Disc may not be able to obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed;

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• If Disc is unable to obtain and maintain patent and other intellectual property protection for its technology and product candidates, its competitors could develop and commercialize technology and drugs similar to Disc’s, and Disc may not be able to compete effectively in its market; and

• Obtaining and maintaining regulatory approval of Disc’s product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of its product candidates in other jurisdictions.

Risks Related to the Ownership of the Common Stock of the Combined Company:

• The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the merger;

• The combined company may need to raise additional capital in the future, and such funds may not be available on attractive terms, or at all;

• If the assets subject to the CVR Agreement are not disposed of in a timely manner, the combined company may have to incur time and resources to wind down or dispose of such assets;

• Once the combined company is no longer an emerging growth company, a smaller reporting company or otherwise no longer qualifies for applicable exemptions, the combined company will be subject to additional laws and regulations affecting public companies that will increase the combined company’s costs and the demands on management and could harm the combined company’s operating results;

• Provisions in the combined company’s charter documents and under Delaware law could make an acquisition of the combined company more difficult and may discourage any takeover attempts which stockholders may consider favorable, and may lead to entrenchment of management;

• An active trading market for the combined company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all;

• After completion of the merger, the combined company’s executive officers, directors and principal stockholders will have the ability to control or significantly influence all matters submitted to the combined company’s stockholders for approval; and

• The combined company will have broad discretion in the use of the cash and cash equivalents of the combined company and the proceeds from the Disc pre-closing financing and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

These risks and other risks are discussed in greater detail under the section titled “Risk Factors” beginning on page 22 of this proxy statement/prospectus. Gemini and Disc both encourage you to read and consider all of these risks carefully.

Regulatory Approvals (see page 174)

Each of Gemini and Disc will use commercially reasonable efforts to file or otherwise submit, as soon as practicable after the date of the Merger Agreement, all applications, notices, reports and other documents reasonably required to be filed by such party with or otherwise submitted by such party to any governmental authority with respect to the transactions contemplated by the Merger Agreement, if any, and to submit promptly any additional information requested by any such governmental authority.

Nasdaq Stock Market Listing (see page 177)

Gemini has filed an initial listing application for the combined company common stock with Nasdaq. If such application is accepted, Gemini anticipates that the common stock of the combined company will be listed on Nasdaq following the closing of the merger under the trading symbol “IRON.”

Anticipated Accounting Treatment (see page 177)

The merger is expected to be treated by Gemini as a reverse merger and will be accounted for as a reverse recapitalization in accordance with U.S. GAAP. For accounting purposes, Disc is considered to be acquiring the assets and liabilities of Gemini in this transaction based on the terms of the Merger Agreement and other factors,

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including: (i) Disc’s largest stockholder will retain the largest interest in the combined company; (ii) Disc will designate a majority (eight of nine) of the initial members of the board of directors of the combined company; (iii) Disc’s executive management team will become the management of the combined company; and (iv) the combined company will be named Disc Medicine, Inc. and be headquartered in Watertown, Massachusetts. Accordingly, the merger is expected to be treated as the equivalent of Disc issuing stock to acquire the net assets of Gemini. As a result of the merger, the net assets of Gemini will be recorded at their acquisition-date fair value in the financial statements of Disc and the reported operating results prior to the merger will be those of Disc. See the “Unaudited Pro Forma Condensed Combined Financial Information” elsewhere in this proxy statement/prospectus for additional information.

Appraisal Rights and Dissenters’ Rights (see page 177)

Holders of Gemini common stock are not entitled to appraisal rights in connection with the merger under Delaware law. Holders of Disc capital stock are entitled to appraisal rights in connection with the merger under Delaware law.

Comparison of Stockholder Rights (see page 371)

Both Gemini and Disc 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 Delaware General Corporation Law (“DGCL”). If the merger is completed, Disc stockholders will become Gemini stockholders, and their rights will be governed by the DGCL, the amended and restated by-laws of Gemini and the amended and restated certificate of incorporation of Gemini, as may be further amended by Proposal No. 2 if approved by the Gemini stockholders at the Gemini special meeting. The rights of Gemini stockholders contained in the amended and restated certificate of incorporation, as amended, and amended and restated by-laws, as amended, of Gemini differ from the rights of Disc stockholders under the amended and restated certificate of incorporation and amended and restated bylaws of Disc, as more fully described under the section titled “Comparison of Rights of Holders of Gemini Capital Stock and Disc Capital Stock” beginning on page 371 of this proxy statement/prospectus.

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MARKET PRICE AND DIVIDEND INFORMATION

The Gemini common stock is currently listed on The Nasdaq Global Market under the symbol “GMTX.”

The closing price of the Gemini common stock on August 9, 2022, the last day of trading prior to the announcement of the Merger, as reported on The Nasdaq Global Market, was $1.56 per share.

Because the market price of the Gemini common stock is subject to fluctuation, the market value of the shares of the Gemini common stock that the Disc 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 Global Market, following the consummation of the merger, the Gemini common stock will trade on The Nasdaq Global Market under Gemini’s new name, “Disc Medicine, Inc.,” and new trading symbol “IRON.”

As of November 29, 2022, the Record Date for the Special Meeting, there were approximately 69 registered holders of record of the Gemini common stock. As of November 30, 2022, Disc had 19 holders of record of Disc common stock and 28 holders of record of Disc Preferred Stock. For detailed information regarding the beneficial ownership of certain Gemini and Disc stockholders, see the sections of this proxy statement/prospectus titled “Principal Stockholders of Gemini” and “Principal Stockholders of Disc”.

Dividends

Gemini has never declared or paid any cash dividends on the Gemini common stock and does not anticipate paying cash dividends on the Gemini common stock for the foreseeable future, except pursuant to the CVR Agreement. 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 factors the then-current board of directors deems relevant. Disc has never paid or declared any cash dividends on the Disc capital stock. If the merger does not occur, Disc does not anticipate paying any cash dividends on the Disc capital stock in the foreseeable future, and Disc 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 Disc 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 Disc board of directors deems relevant.

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RISK FACTORS

The combined company 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 or incorporated by reference in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of Gemini common stock. You should also read and consider the other information in this proxy statement/prospectus and additional information about Gemini set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which is filed with the Securities and Exchange Commission, or the SEC, as updated by its Quarterly Reports on Form 10-Q, in each case incorporated by reference into this proxy statement/prospectus. Please see the section titled “Where You Can Find More Information” beginning on page 385 of this proxy statement/prospectus for further information regarding the documents incorporated by reference into this proxy statement/prospectus.

Summary of Risk Factors

Risks Related to the Merger

• The exchange ratio will not change or otherwise be adjusted based on the market price of Gemini common stock as the exchange ratio depends on the Gemini net cash at the closing and not the market price of Gemini 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 Gemini or Disc paying a termination fee to the other party and could harm the common stock price of Gemini and the future business and operations of each company;

• Some Gemini and Disc executive 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;

• Gemini stockholders and Disc stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger, including because the anticipated benefits reflected in the financial projections prepared by Gemini management and used in the financial analyses of Gemini's financial advisor may not be realized, such as because the assumptions underlying such financial projections may prove inaccurate; and

• If the merger is not completed, Gemini’s stock price may decline significantly.

Risks Related to the Proposed Reverse Stock Split

• The reverse stock split may not increase the combined company’s stock price over the long-term.

• The reverse stock split may decrease the liquidity of the combined company’s common stock.

• The reverse stock split may lead to a decrease in the combined company’s overall market capitalization.

Risks Related to Gemini:

• Failure to complete, or delays in completing, the proposed merger with Disc could materially and adversely affect Gemini’s results of operations, business, financial results and/or stock price;

• Gemini’s stockholders potentially may not receive any payment on the CVRs and the CVRs may otherwise expire valueless;

• If Gemini does not successfully consummate the merger or another strategic transaction, Gemini’s board of directors may decide to pursue a dissolution and liquidation of Gemini;

• Gemini has incurred significant losses since Gemini’s inception and may incur losses for the foreseeable future;

• If the merger is not consummated and Gemini continues to pursue product development, Gemini will require additional capital to finance Gemini’s operations, which may not be available to Gemini on acceptable terms, or at all;

• Gemini’s business has historically been dependent on the success of GEM103, the trials of which have been discontinued;

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• Gemini’s success depends, and the combined company's success will depend, upon its ability to obtain and maintain intellectual property protection for its products and technologies. It is difficult and costly to protect Gemini’s proprietary rights and technology, and Gemini, and if the merger is consummated the combined company, may not be able to ensure their protection; and

• There can be no assurance that Gemini will be able to comply with the continued listing standards of Nasdaq.

Risks Related to Disc:

• Disc’s limited operating history may make it difficult for you to evaluate the success of Disc’s business to date and to assess Disc’s future viability;

• Disc has no products approved for commercial sale and has not generated any revenue from product sales;

• Disc has only successfully completed one Phase 1 clinical trial, and may be unable to successfully complete any additional clinical trials for any product candidates it develops. Certain of Disc’s programs are still in preclinical development and may never advance to clinical development;

• Disc’s programs are focused on the development of therapeutics for patients with hematologic diseases, which is a rapidly evolving area of science, and the approach Disc is taking to discover and develop product candidates is novel and may never lead to approved or marketable products;

• Disc may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of its product candidates;

• Disc faces substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than Disc does;

• Disc relies on third parties to conduct its current clinical trials and expects to continue to rely on third parties. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, Disc may not be able to obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed;

• If Disc is unable to obtain and maintain patent and other intellectual property protection for its technology and product candidates, its competitors could develop and commercialize technology and drugs similar to Disc’s, and Disc may not be able to compete effectively in its market; and

• Obtaining and maintaining regulatory approval of Disc’s product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of its product candidates in other jurisdictions.

Risks Related to the Ownership of the Common Stock of the Combined Company:

• The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the merger;

• The combined company may need to raise additional capital in the future, and such funds may not be available on attractive terms, or at all;

• If the assets subject to the CVR Agreement are not disposed of in a timely manner, the combined company may have to incur time and resources to wind down or dispose of such assets;

• Once the combined company is no longer an emerging growth company, a smaller reporting company or otherwise no longer qualifies for applicable exemptions, the combined company will be subject to additional laws and regulations affecting public companies that will increase the combined company’s costs and the demands on management and could harm the combined company’s operating results;

• Provisions in the combined company’s charter documents and under Delaware law could make an acquisition of the combined company more difficult and may discourage any takeover attempts which stockholders may consider favorable, and may lead to entrenchment of management;

• An active trading market for the combined company’s common stock may not develop and its stockholders may not be able to resell their shares of common stock for a profit, if at all;

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• After completion of the merger, the combined company’s executive officers, directors and principal stockholders will have the ability to control or significantly influence all matters submitted to the combined company’s stockholders for approval; and

• The combined company will have broad discretion in the use of the cash and cash equivalents of the combined company and the proceeds from the Disc pre-closing financing and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

Risks related to the Merger

The exchange ratio will not change or otherwise be adjusted based on the market price of Gemini common stock as the exchange ratio depends on the Gemini net cash at the closing and not the market price of Gemini 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.

At the effective time of the merger, outstanding shares of Disc capital stock will be converted into shares of Gemini common stock. Applying the exchange ratio, the former Disc securityholders immediately before the merger, excluding shares purchased in the Disc pre-closing financing, are expected to own approximately 63% of the aggregate number of shares of Gemini common stock, shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of Gemini common stock and Gemini securityholders immediately before the merger are expected to own approximately 24% of the aggregate number of shares of Gemini common stock, subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million and $96.9 million. In the event Gemini’s net cash is below $87.4 million, the exchange ratio will be adjusted such that the number of shares issued to Disc’s pre-closing securityholders will be increased, and Gemini stockholders will own a smaller percentage of the combined company following the merger.

Any changes in the market price of Gemini stock before the completion of the merger will not affect the number of shares Disc stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the merger, the market price of Gemini common stock increases from the market price on the date of the Merger Agreement, then Disc stockholders could receive merger consideration with substantially more value for their shares of Disc capital stock than the parties had negotiated when they established the exchange ratio. Similarly, if before the completion of the merger the market price of Gemini common stock declines from the market price on the date of the Merger Agreement, then Disc stockholders could receive merger consideration with substantially lower value. The Merger Agreement does not include a price-based termination right.

Failure to complete the merger may result in either Gemini or Disc paying a termination fee to the other party, and could harm the common stock price of Gemini and future business and operations of each company.

If the merger is not completed, Gemini and Disc are subject to the following risks:

• if the Merger Agreement is terminated under specified circumstances, Gemini could be required to pay Disc a termination fee of $3.0 million, or Disc could be required to pay Gemini a termination fee of $7.8 million, plus, in each case, up to $750,000 in expense reimbursements;

• the price of Gemini common stock may decline and could fluctuate significantly; and

• costs related to the merger, such as financial advisor, legal and accounting fees, a majority of which must be paid even if the merger is not completed.

If the Merger Agreement is terminated and the board of directors of Gemini or Disc determines to seek another business combination, there can be no assurance that either Gemini or Disc will be able to find another third party to transact a business combination with, yielding comparable or greater benefits.

If the conditions to the merger are not satisfied or waived, the merger may not occur.

Even if the merger is approved by the stockholders of Disc and Proposal Nos. 1 and 2 as described in this proxy statement/prospectus are approved by the Gemini stockholders, specified conditions must be satisfied or, to the extent permitted by applicable law, waived to complete the merger. These conditions are set forth in the Merger Agreement and each material condition to the completion of the merger is described in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 194 of this proxy statement/prospectus. Gemini and Disc cannot assure you that all of the conditions to the consummation of the merger will be satisfied or waived. If the conditions are not satisfied or waived, the merger may not occur or the closing may be delayed.

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The merger may be completed even though a material adverse effect may result from the announcement of the merger, industry-wide changes or other causes.

In general, neither Gemini nor Disc is obligated to complete the merger if there is a material adverse effect affecting the other party between August 9, 2022, the date of the Merger Agreement, and the closing of the merger. However, certain types of causes are excluded from the concept of a “material adverse effect.” Such exclusions include but are not limited to changes in general economic or political conditions, industry wide changes, changes resulting from the announcement of the merger, natural disasters, pandemics (including the COVID-19 pandemic), other public health events and changes in GAAP. Therefore, if any of these events were to occur and adversely affect Gemini or Disc, the other party would still be obliged to consummate the closing of the merger notwithstanding such material adverse effect. If any such adverse effects occur and Gemini and Disc consummate the closing of the merger, the stock price of the combined company may suffer. This in turn may reduce the value of the merger to the stockholders of Gemini, Disc or both. For a more complete discussion of what constitutes a material adverse effect on Gemini or Disc, see the section titled “The Merger Agreement—Representations and Warranties” beginning on page 181 of this proxy statement/prospectus.

If Gemini and Disc complete the merger, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations.

In August 2022, Disc entered into a subscription agreement with certain investors, including existing investors of Disc, pursuant to which the investors agreed to purchase, in the aggregate, $53.5 million in shares of common stock of Disc immediately prior to the closing of the merger, referred to as the Disc pre-closing financing. The closing of the Disc pre-closing financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the merger as well as certain other conditions. The shares of Disc common stock issued in the Disc pre-closing financing will result in dilution to all securityholders of the combined company (i.e., both the pre-merger Gemini securityholders and former Disc securityholders). The Disc pre-closing financing is more fully described under the section titled “Agreements Related to the Merger—Subscription Agreement” beginning on page 200 of this proxy statement/prospectus.

Additional financing may not be available to the combined company when it is needed or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of the combined company, including Gemini’s pre-merger securityholders and Disc’s former securityholders. It is also possible that the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company.

Some Gemini and Disc directors and executive officers 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.

Directors and executive officers of Gemini and Disc may have interests in the merger that are different from, or in addition to, the interests of other Gemini stockholders generally. These interests with respect to Gemini’s directors and executive officers may include, among others, acceleration of stock option or restricted stock unit vesting, retention bonus payments, extension of exercisability periods of previously issued stock option grants, severance payments if employment is terminated in a qualifying termination in connection with the merger and rights to continued indemnification, expense advancement and insurance coverage. One member of the Gemini board of directors will continue as directors of the combined company after the effective time of the merger, and, following the closing of the merger, will be eligible to be compensated as non-employee directors of the combined company. These interests with respect to Disc’s directors and executive officers may include, among others, certain of Disc’s directors and executive officers have options, subject to vesting, to purchase shares of Disc common stock which, after the effective time of the merger, will be converted into and become options to purchase shares of the common stock of the combined company; Disc’s executive officers are expected to continue as executive officers of the combined company after the effective time of the merger; and all of Disc’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.

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In addition, certain of Gemini’s directors and Disc’s directors are affiliated with investment funds which hold an interest in the other party, and are participating in the Disc pre-closing financing. Further, certain current members of Disc’s board of directors will continue as directors of the combined company after the effective time of the merger, and, following the closing of the merger, will be eligible to be compensated as non-employee directors of the combined company pursuant to the Gemini non-employee director compensation policy that is expected to remain in place following the effective time of the merger. The directors and executive officers own options and/or, with respect to Gemini, RSUs, to purchase the shares of their respective companies.

The Gemini and Disc boards were aware of and considered those interests, among other matters, in reaching their decisions to approve and adopt the Merger Agreement, approve the merger, and recommend the approval of the Merger Agreement to Gemini and Disc stockholders. These interests, among other factors, may have influenced the directors and executive officers of Gemini and Disc to support or approve the merger.

For more information regarding the interests of Gemini and Disc directors and executive officers in the merger, please see the sections titled “The Merger—Interests of Gemini Directors and Executive Officers in the Merger” beginning on page 164 and “The Merger—Interests of Disc Directors and Executive Officers in the Merger” beginning on page 170 of this proxy statement/prospectus.

Gemini stockholders and Disc stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger, including the conversion of Disc common stock issued in the Disc pre-closing financing.

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the merger, Gemini stockholders and Disc stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the merger.

If the merger is not completed, Gemini’s stock price may decline significantly.

The market price of Gemini common stock is subject to significant fluctuations. During the 12-month period ended November 30, 2022, the closing sales price of Gemini’s common stock on Nasdaq ranged from a high of $3.08 on January 3, 2022 to a low of $1.22 on May 26, 2022. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of Gemini common stock will likely be volatile based on whether stockholders and other investors believe that Gemini can complete the merger or otherwise raise additional capital to support Gemini’s operations if the merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of Gemini common stock is exacerbated by low trading volume. Additional factors that may cause the market price of Gemini common stock to fluctuate include:

• the entry into, or termination of, key agreements, including commercial partner agreements;

• announcements by commercial partners or competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

• the loss of key employees;

• future sales of its common stock;

• general and industry-specific economic conditions that may affect its research and development expenditures;

• the failure to meet industry analyst expectations; and

• period-to-period fluctuations in financial results.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Gemini common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

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Gemini and Disc securityholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company 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 stockholders of Gemini and Disc will generally own a smaller percentage of the combined company than their ownership of their respective companies prior to the merger. Immediately after the merger, Gemini stockholders as of immediately prior to the merger are expected to own approximately 24% of the outstanding shares of the combined company, former Disc securityholders, excluding shares purchased in the Disc pre-closing financing are expected to own approximately 63% of the outstanding shares of the combined company and shares issued in the Disc pre-closing financing are expected to represent approximately 13% of the outstanding shares of capital stock of the combined company, subject to certain assumptions, including, but not limited to, Gemini’s net cash as of closing being between $87.4 million and $96.6 million. The Chief Executive Officer of Disc will serve as the Chief Executive Officer of the combined company following the completion of the merger.

The financial projections for Disc included in this proxy statement/prospectus under “The Merger—Certain Unaudited Financial Projections”, which were considered by the Gemini Board in evaluating the Merger and used by Gemini's financial advisor in rendering its fairness opinion and performing its related financial analyses, reflect numerous variables, estimates and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the approval of Disc's product candidates, the actual results for the combined company's business may be materially different than the results reflected in the financial projections.

As further described below in the section entitled “The Merger—Certain Unaudited Financial Projections”, in connection with the Gemini Board's evaluation of the merger, preliminary internal financial projections for Disc were prepared by the management of Disc and provided to the management of Gemini, and then adjusted by the management of Gemini, solely for use by Gemini's financial advisor, SVB Securities, in connection with the rendering of its fairness opinion and performing its related financial analyses, as described below under “The Merger—Opinion of Gemini's Financial Advisor”. Although presented with numerical specificity, these financial projections reflect numerous variables, estimates, and assumptions made by Disc's and Gemini's respective management at the time the initial financial projections were prepared by Disc and adjusted by Gemini. If any of these variables, estimates and assumptions prove to be wrong, the actual results for the combined company's business may differ materially from the results reflected in the financial projections. These assumptions include assumptions as to the timing and likelihood of the Disc product candidates receiving marketing authorization and revenue from these product candidates and are subject to the risk that none of the Disc product candidates receive marketing authorization on the timeline assumed in the projections or at all, that the Disc product candidates that do not receive marketing authorization do not generate the revenue anticipated or any revenue and the risk that, even assuming marketing authorization for one or more of the Disc product candidates, one or more of the Disc product candidates are not commercialized or do not realize the anticipated benefits, including the generation of revenue, reflected in the financial projections. For instance, the financial projections assume approval of bitopertin for the treatment of erythropoietic porphyrias in 2026, DISC-0974 for the treatment of myelofibrosis in 2028, and DISC-0974 for the treatment of anemia of chronic kidney disease in 2030, and were risk-adjusted to reflect, among other things, a downward adjustment based on cumulative probabilities of success of 27% for bitopertin, 25% for DISC-0974 for the treatment of myelofibrosis, and 15% for DISC-0974 for the treatment of anemia of chronic kidney disease. Gemini based the estimated probabilities of success on industry benchmarks for probabilities of success for similarly situated product candidates. However, the estimated probabilities of success take into account a range of potential outcomes, including outcomes in which product candidates fail to achieve commercial launch due to commercial and regulatory uncertainty (including failure to obtain regulatory authorization to market the applicable product candidate) as well as economic and portfolio management decisions and competition, and these assumptions, including those with respect to regulatory approval and probability of success more broadly, are inherently uncertain and could prove inaccurate. If one or more of the Disc product candidates do not receive marketing authorization when anticipated, for the indications anticipated, or at all, or the other assumptions reflected in the estimates as to probability of success prove untrue, the actual results of the combined company's business will differ materially from the results reflected in the financial projections. For example, while the Financial Forecasts reflect the blended probability of success assessments described below in the section entitled “The Merger—Certain Unaudited Financial Projections” for each of Disc’s product candidates, if one or both of these product candidates are not approved then actual results will differ materially, including the potential for one or both of these product candidates to generate no revenue at all.

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In addition, the financial projections cover a significant period of time, specifically 19 years through 2041. This extended period was used in light of the anticipated timing for regulatory approval and the initiation of commercial sales of the Disc product candidates and the anticipated period of patent exclusivity for each product candidate. However, the risks and uncertainties regarding the financial projections, including the potential for adverse developments such as delays in obtaining or failure to obtain regulatory approvals or additional competition or changes in the competitive or regulatory landscape, increase with each successive year and the likelihood that the actual results will differ materially from the projected results increase with each successive year. The financial projections also do not reflect general business, economic, market and financial conditions and any changes in any of these conditions over the period of the projections could result in the actual results differing materially from the results reflected in the financial projections.

During the pendency of the merger, Gemini and Disc may not be able to enter into a business combination with another party on more favorable terms because of restrictions in the Merger Agreement, which could adversely affect their respective business prospects.

Covenants in the Merger Agreement impede the ability of Gemini and Disc to make acquisitions during the pendency of the merger, subject to specified exceptions. 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 prohibited from soliciting, seeking, initiating or knowingly encouraging, inducing or facilitating the communication, making, submission or announcement of any acquisition proposal or acquisition inquiry or taking any action that could reasonably be expected to lead to certain transactions involving a third party, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “The Merger Agreement—Non-Solicitation” beginning on page 189 of this proxy statement/prospectus.

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

The terms of the Merger Agreement prohibit each of Gemini and Disc from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances as described in further detail in the section titled “The Merger Agreement—Non-Solicitation” beginning on page 189 of this proxy statement/prospectus. In addition, if Gemini terminates the Merger Agreement under specified circumstances, Gemini could be required to pay Disc a termination fee of $3.0 million, or Disc could be required to pay Gemini a termination fee of $7.8 million, plus, in each case, up to $750,000 in expense reimbursements. This termination fee may discourage third parties from submitting competing proposals to Gemini, Disc or their respective stockholders, and may cause the Gemini or Disc board of directors to be less inclined to recommend a competing proposal.

Because the lack of a public market for Disc’s capital stock makes it difficult to evaluate the fair market value of Disc’s capital stock, the value of the Gemini common stock to be issued to Disc stockholders may be more or less than the fair market value of Disc’s capital stock.

The outstanding capital stock of Disc is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Disc’s capital stock. Because the percentage of Gemini equity to be issued to Disc stockholders was determined based on negotiations between the parties, it is possible that the value of the Gemini common stock to be issued to Disc stockholders will be more or less than the fair market value of Disc’s capital stock.

The tax treatment of the CVRs is uncertain.

The U.S. federal income tax treatment of the CVRs is uncertain. There is no legal authority directly addressing the U.S. federal income tax treatment of the receipt of, and distribution of shares of Gemini common stock under, the CVRs, and there can be no assurance that the IRS would not assert, or that a court would not sustain, a position that could result in adverse U.S. federal income tax consequences to holders of the CVRs.

As discussed in the section titled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Gemini Common Stock,” Gemini will treat (i) receipt of the CVRs as a non-taxable distribution with respect to existing shares of Gemini common stock, and (ii) receipt of shares of Gemini common stock in respect of the CVRs as a non-taxable exercise of the right to receive stock under the CVRs. This position may be challenged by the IRS in which case holders of Gemini common stock

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could be required to recognize taxable income in respect of the receipt of the CVRs or the receipt of Gemini common stock under the CVRs, in each case, without a corresponding receipt of cash. For example, the IRS may assert that the fair market value of the CVRs, at the time of distribution, is a taxable distribution of property, which would be taxable as a dividend to the extent of the holder’s pro rata share of Gemini’s current and accumulated earnings and profits, if any, with any excess being treated as a return of capital to the extent thereof and then as capital gain. Please review the information in the section titled “Agreements Related to the Merger—Contingent Value Rights Agreement—Material U.S. Federal Income Tax Consequences of the CVRs to Holders of Gemini Common Stock” for a discussion of the material U.S. federal income tax consequences of the CVRs to holders of Gemini common stock.

Risks Related to the Proposed Reverse Stock Split

The reverse stock split may not increase the combined company’s stock price over the long-term.

The principal purpose of the reverse stock split is to increase the per-share market price of Gemini’s common stock above the minimum bid price requirement under the Nasdaq rules so that the listing of Gemini and the shares of Gemini common stock being issued in the merger on Nasdaq will be approved. It cannot be assured, however, that the 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 common stock will proportionally increase the market price of Gemini’s common stock, it cannot be assured that the reverse stock split will increase the market price of its common stock by a multiple of the reverse stock split ratio mutually agreed by Gemini and Disc, or result in any permanent or sustained increase in the market price of Gemini’s common stock, which is dependent upon many factors, including Gemini’s business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of Gemini might meet the listing requirements for Nasdaq initially, it cannot be assured that it will continue to do so.

The reverse stock split may decrease the liquidity of the combined company’s common stock.

Although the Gemini board believes that the anticipated increase in the market price of the combined company’s common stock resulting from the proposed reverse stock split 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 reverse stock split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for the combined company’s common stock. In addition, the reverse stock split may not result in an increase in the combined company’s stock price necessary to satisfy Nasdaq’s initial listing requirements for the combined company.

The reverse stock split may lead to a decrease in the combined company’s overall market capitalization.

Should the market price of the combined company’s common stock decline after the 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 reverse stock split. A reverse stock split is often viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s overall market capitalization. If the per share market price does not increase in proportion to the reverse stock split ratio, then the value of the combined company, 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 the combined company’s common stock will remain the same after the reverse stock split is effected, or that the reverse stock split will not have an adverse effect on the combined company’s stock price due to the reduced number of shares outstanding after the reverse stock split.

Risks Related to Gemini

Failure to complete, or delays in completing, the proposed merger transaction with Disc could materially and adversely affect Gemini’s results of operations, business, financial results and/or stock price.

In February 2022, Gemini announced a corporate restructuring and that it initiated a process to evaluate strategic alternatives. After a comprehensive review of strategic alternatives, including identifying and reviewing potential candidates for a strategic transaction, on August 9, 2022, Gemini entered into an agreement and plan of merger and reorganization with Disc and Merger Sub, pursuant to which, subject to the satisfaction or waiver of the conditions therein, Merger Sub will merge with and into Disc, with Disc continuing as the surviving company and a wholly-owned subsidiary of Gemini. The closing of the merger is subject to approval by the stockholders of Gemini

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and Disc as well as other customary closing conditions, including the effectiveness of a registration statement filed with the SEC in connection with the transaction. If the merger is completed, the business of Disc will continue as the business of the combined company. Any failure to satisfy a required condition to closing may prevent, delay or otherwise materially and adversely affect the completion of the transaction, which could materially and adversely affect Gemini’s results of operations, business, financial results and/or stock price. Gemini cannot predict with certainty whether or when any of the required closing conditions will be satisfied or if another uncertainty may arise and cannot assure you that the proposed merger will be successfully consummated or that Gemini will be able to successfully consummate the proposed merger as currently contemplated under the Merger Agreement or at all.

Gemini’s efforts to complete the merger could cause substantial disruptions in, and create uncertainty surrounding, Gemini’s business, which may materially adversely affect Gemini’s results of operations and Gemini’s business. Uncertainty as to whether the merger will be completed may affect Gemini’s ability to recruit prospective employees or to retain and motivate existing employees. Employee retention may be particularly challenging while the transaction is pending because employees may experience uncertainty about their roles following the transaction. A substantial amount of Gemini’s management’s and employees’ attention is being directed toward the completion of the transaction and thus is being diverted from Gemini’s day-to-day operations. Uncertainty as to Gemini’s future could adversely affect Gemini’s business and Gemini’s relationship with collaborators, suppliers, vendors, regulators and other business partners. For example, vendors, collaborators and other counterparties may defer decisions about working with Gemini or seek to change existing business relationships with Gemini. Changes to, or termination of, existing business relationships could adversely affect Gemini’s results of operations and financial condition, as well as the market price of Gemini’s common stock. The adverse effects of the pendency of the transaction could be exacerbated by any delays in completion of the transaction or termination of the Merger Agreement.

Risks related to the failure to consummate, or delay in consummating, the proposed merger transaction with Disc include, but are not limited to, the following:

• Gemini would not realize any or all of the potential benefits of the merger, which could have a negative effect on Gemini’s results of operations, business or stock price;

• under some circumstances, Gemini may be required to pay a termination fee to Disc of $3,000,000, and/or expense reimbursement of up to $750,000;

• Gemini would remain liable for significant transaction costs, including legal, accounting, financial advisory and other costs relating to the merger regardless of whether the merger is consummated;

• the trading price of Gemini’s common stock may decline to the extent that the current market price for Gemini’s stock reflects a market assumption that the merger will be completed;

• the attention of Gemini’s management and employees may have been diverted to the merger rather than to Gemini’s operations and the pursuit of other opportunities that could have been beneficial to Gemini;

• Gemini could be subject to litigation related to any failure to complete the merger;

• Gemini could potentially lose key personnel during the pendency of the merger as employees and other service providers may experience uncertainty about their future roles with Gemini following completion of the merger; and

• under the Merger Agreement, Gemini is subject to certain customary restrictions on the conduct of Gemini’s business prior to completing the merger, which restrictions could adversely affect Gemini’s ability to conduct Gemini’s business as Gemini otherwise would have done if Gemini was not subject to these restrictions.

The occurrence of any of these events individually or in combination could materially and adversely affect Gemini’s results of operations, business, and Gemini’s stock price.

Gemini cannot be sure if or when the merger will be completed.

The consummation of the merger is subject to the satisfaction or waiver of various conditions, including the authorization of the merger by Gemini’s stockholders and Disc’s stockholders. Gemini cannot guarantee that the closing conditions set forth in the Merger Agreement will be satisfied. If Gemini is unable to satisfy certain closing conditions or if other mutual closing conditions are not satisfied, Disc will not be obligated to complete the merger. Under certain circumstances, Gemini would be required to pay Disc a termination fee of $3,000,000, and/or expense reimbursement of Disc of up to $750,000.

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If the merger is not completed, Gemini’s board of directors, in discharging its fiduciary obligations to Gemini’s stockholders, would evaluate other strategic alternatives or financing options that may be available, which alternatives may not be as favorable to Gemini’s stockholders as the merger, including a liquidation and dissolution. Any future sale or merger, financing or other transaction, including a liquidation or dissolution, may be subject to further stockholder approval. Gemini may also be unable to find, evaluate or complete other strategic alternatives, which may have a materially adverse effect on Gemini’s business.

Until the merger is completed, the Merger Agreement restricts Disc and Gemini from taking specified actions without the consent of the other party, and requires Gemini to operate in the ordinary course of business consistent with past practice. These restrictions may prevent Disc and Gemini from making appropriate changes to Gemini respective businesses or pursuing attractive business opportunities that may arise prior to the completion of the merger. Further, if Gemini's net cash at closing is lower than anticipated, either because expenses exceed current estimates or due to delays prior to closing, then the pre-closing stockholders of Gemini will own less of the combined company pursuant to the exchange ratio adjustment set forth in the merger agreement.

Any delay in completing the proposed merger may materially and adversely affect the timing and benefits that are expected to be achieved from the proposed merger.

The exchange ratio set forth in the Merger Agreement is not adjustable based on the market price of Gemini’s common stock, so the merger consideration at the closing of the merger may have a greater or lesser value than at the time the Merger Agreement was signed.

The Merger Agreement has set the exchange ratio for Disc capital stock being converted into Gemini’s common stock, and the exchange ratio is based on the outstanding capital stock of Disc and the outstanding common stock of Gemini, in each case immediately prior to the closing of the merger. Applying the exchange ratio formula in the merger agreement, the former Disc equityholders immediately before the merger are expected to own approximately 72% of the outstanding capital stock of the combined company immediately following the merger, and the equityholders of Gemini immediately before the merger are expected to own approximately 28% of the outstanding capital stock of the combined company immediately following the merger, in each case, before giving effect to the Disc pre-closing financing and subject to certain assumptions detailed in the merger agreement. Under certain circumstances further described in the merger agreement, however, these ownership percentages may be adjusted upward or downward based on the cash levels of the respective companies at the closing of the merger, and as a result, either the Gemini stockholders or the Disc stockholders could own less of the combined company than expected.

Any changes in the market price of Gemini’s common stock before the completion of the merger will not affect the number of shares of Gemini’s common stock issuable to Disc’s stockholders pursuant to the Merger Agreement. Therefore, if before the completion of the merger the market price of Gemini’s common stock declines from the market price on the date of the merger agreement, then Disc’s stockholders could receive merger consideration with substantially lower value than the value of such merger consideration on the date of the merger agreement. Similarly, if before the completion of the merger the market price of Gemini’s common stock increases from the market price of Gemini’s common stock on the date of the merger agreement, then Disc’s stockholders could receive merger consideration with substantially greater value than the value of such merger consideration on the date of the merger agreement. The Merger Agreement does not include a price-based termination right.

The Merger Agreement contains provisions that limit Gemini’s ability to pursue alternatives to the merger, could discourage a potential competing acquiror of Gemini from making an alternative transaction proposal and, in specified circumstances, could require Gemini to pay a termination fee to Disc, which could significantly harm Gemini’s financial condition and the market price of Gemini’s common stock and negatively affect the future business and operations of each company.

The Merger Agreement contains provisions that make it difficult for Gemini to entertain a third-party proposal for an acquisition of Gemini. These provisions include Gemini’s agreement not to solicit or initiate any additional discussions with third parties regarding other proposals for Gemini’s acquisition, as well as restrictions on Gemini’s ability to respond to such proposals, subject to fulfillment of certain fiduciary requirements of Gemini’s board of directors.

If the proposed merger is not completed and the Merger Agreement is terminated under certain circumstances, Gemini may be required to pay Disc a termination fee of up to $3,000,000, and/or expense reimbursement of up to $750,000. Even if a termination fee is not payable in connection with a termination of the merger agreement, Gemini

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will have incurred significant fees and expenses, which must be paid whether or not the merger is completed. Further, if the proposed merger is not completed, it could significantly harm the market price of Gemini’s common stock.

In addition, if the Merger Agreement is terminated and the board of directors of Gemini determines to seek another business combination, there can be no assurance that either Gemini will be able to find a partner and close an alternative transaction on terms that are as favorable or more favorable than the terms set forth in the merger agreement.

Lawsuits may be filed against Gemini and the members of Gemini’s board of directors arising out of the proposed merger, which may delay or prevent the proposed merger.

Putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against Gemini, Gemini’s board of directors, Disc, Disc’s board of directors and others in connection with the transactions contemplated by the merger agreement. The outcome of litigation is uncertain, and Gemini may not be successful in defending against any such future claims. Lawsuits that may be filed against Gemini, Gemini’s board of directors, Disc, or Disc’s board of directors could delay or prevent the merger, divert the attention of Gemini’s management and employees from Gemini’s day-to-day business and otherwise adversely affect Gemini’s financial condition.

Gemini’s stockholders potentially may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.

The Merger Agreement contemplates that, at or prior to the effective time of the merger, Gemini, the holder’s representative and the rights agent (as defined in the CVR Agreement) will execute and deliver a contingent value rights agreement, or the CVR Agreement, pursuant to which each person who as of immediately prior to the effective time was a stockholder of record of Gemini or had the right to receive Gemini’s common stock will be entitled to receive a contractual contingent value right, or CVR, issued by Gemini subject to and in accordance with the terms and conditions of the CVR Agreement. Each CVR will entitle the holder of the CVR to receive a certain number of shares of common stock of the combined company calculated based on the quotient of the gross proceeds, if any, received in connection with the sale, license, transfer, disposition or other monetizing event of any assets related to drug products, raw materials, and biological materials to which Gemini or any of its subsidiaries owned or had rights to immediately prior to the effective time and the weighted average closing market price for the five trading days prior to the date of issuance of the CVR. The right of Gemini’s stockholders to derive any value from the CVRs will be contingent solely upon the disposition of such assets within the time periods specified in the CVR Agreement.

Gemini may not be able to achieve successful results from the disposition of such assets as described above. If this is not achieved for any reason within the time periods specified in the CVR Agreement, no payments will be made under the CVRs, and the CVRs will expire valueless.

Certain of Gemini’s officers and directors may have interests in the proposed merger that are different from, or in conflict with or in addition to, those of Gemini’s stockholders generally.

Certain officers and directors of Gemini may have interests in the proposed merger that are different from the interests of Gemini’s stockholders generally, including potentially, among others, the continued service as a director of the combined company, the acceleration of stock option vesting, and continued indemnification.

The closing of the merger will also result in the acceleration of vesting of options to purchase shares of Gemini’s common stock held by Gemini’s executive officers and directors, whether or not there is a covered termination of such officer's employment or board membership. In addition, one of Gemini’s current directors and executive officers is expected to become a director of the surviving company upon the closing of the merger, and all of Gemini’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 Gemini and cause them to view the merger differently from how Gemini’s stockholders generally may view it.

For more information regarding the interests of Gemini and Disc directors and executive officers in the merger, please see the sections titled “The Merger—Interests of Gemini Directors and Executive Officers in the Merger” beginning on page 164 and “The Merger—Interests of Disc Directors and Executive Officers in the Merger” beginning on page 170 of this proxy statement/prospectus, as well as the risk factor “Some Gemini and Disc directors and executive officers 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”.

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Gemini’s equityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, Gemini following the closing of the merger as compared to their current ownership and voting interest in Gemini.

After the completion of the merger, the current securityholders of Gemini will own a smaller percentage of the combined company than their ownership in Gemini prior to the merger. Immediately after the merger, it is currently estimated that pre-merger Gemini’s equityholders will own approximately 28% of the common stock of the combined company, and pre-merger Disc equityholders will own approximately 72% of the common stock of the combined company, in each case, before giving effect to the Disc pre-closing financing and subject to certain assumptions. These estimates are based on the anticipated exchange ratio and are subject to adjustment as provided in the merger agreement.

In addition, the nine-member board of directors of the combined company will initially include one individual with prior affiliations with Gemini. Consequently, securityholders of Gemini will not be able to exercise the same influence over the management and policies of the combined organization following the closing of the merger than they currently exercise over the management and policies of Gemini.

Gemini’s 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 company is unable to realize the strategic and financial benefits currently anticipated from the proposed merger, Gemini’s stockholders will have experienced substantial dilution of their ownership interests in Gemini without receiving the expected commensurate benefit, or only receive part of the commensurate benefit to the extent the combined company is able to realize only part of the expected strategic and financial benefits currently anticipated from the proposed merger.

If Gemini does not successfully consummate the merger or another strategic transaction, Gemini’s board of directors may decide to pursue a dissolution and liquidation of Gemini. In such an event, the amount of cash available for distribution to Gemini’s 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 Gemini can give you no assurance.

There can be no assurance that the merger will be completed. If the merger is not completed, Gemini’s board of directors may decide to pursue a dissolution and liquidation of Gemini. In such an event, the amount of cash available for distribution to Gemini’s 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 Gemini funds its operations while pursuing the merger. In addition, if Gemini’s board of directors were to approve and recommend, and Gemini’s stockholders were to approve, a dissolution and liquidation of the company, Gemini would be required under Delaware corporate law to pay Gemini’s outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to stockholders. Gemini’s commitments and contingent liabilities may include obligations under Gemini’s 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 the company, litigation against Gemini, and other various claims and legal actions arising in the ordinary course of business, and other unexpected and/or contingent liabilities. As a result of this requirement, a portion of Gemini’s assets would need to be reserved pending the resolution of such obligations.

In addition, Gemini may be subject to litigation or other claims related to a dissolution and liquidation of Gemini. If a dissolution and liquidation were to be pursued, Gemini’s board of directors, in consultation with Gemini’s advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Gemini’s common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of the company. A liquidation would be a lengthy and uncertain process with no assurance of any value ever being returned to Gemini’s stockholders.

Gemini is substantially dependent on Gemini’s remaining employees to facilitate the consummation of the merger.

As of November 30, 2022, Gemini had only four full-time employees and one part-time employee. Gemini’s ability to successfully complete the merger depends in large part on Gemini’s ability to retain certain remaining personnel. Despite Gemini’s efforts to retain these employees, one or more may terminate their employment with Gemini on short notice. The loss of the services of certain employees could potentially harm Gemini’s ability to consummate the merger, to run Gemini’s day-to-day business operations, as well as to fulfill Gemini’s reporting obligations as a public company.

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Risks Related to Gemini’s Financial Position and Need for Additional Capital in Event the Merger is Not Consummated

Gemini has incurred significant losses since Gemini’s inception and may incur losses for the foreseeable future.

Gemini has no products approved for commercial sale and has not generated any revenue to date, and Gemini continues to incur significant research and development and other expenses related to Gemini’s ongoing operations. As a result, Gemini is not profitable and has incurred significant losses in each period since Gemini’s inception in March 2015.

For the years ended December 31, 2021 and 2020, Gemini reported net losses of $71.9 million and $40.8 million, respectively. As of December 31, 2021, Gemini had an accumulated deficit of $184.7 million. Despite the contemplated reverse merger with Disc, the ceased Gemini's Phase 2 trials and pre-merger significant workforce restructuring, Gemini expects to incur significant losses for the foreseeable future. In the event that the merger is not consummated and it does not pursue a liquidation or dissolution or alternative strategic transaction, Gemini anticipates that Gemini’s expenses would increase substantially if, and as, Gemini:

• conducts larger scale clinical trials for product candidates;

• discovers and develops new product candidates, and conduct nonclinical studies, other investigational new drug (“IND”) enabling studies and clinical trials;

• manufactures, or has manufactured, preclinical, clinical and commercial supplies of Gemini’s product candidates;

• seeks regulatory approvals for Gemini’s product candidates;

• commercializes any product candidates, if approved;

• attempts to transition from a company with a clinical development focus to a company capable of supporting commercial activities, including establishing sales, marketing and distribution infrastructure;

• hires additional clinical, scientific, and management personnel;

• adds operational, financial, and management information systems and personnel including costs related to funding Gemini’s restructuring obligations;

• identifies additional compounds or product candidates and acquire rights from third parties to those compounds or product candidates through licenses; and

• incurs additional costs associated with operating as a public company.

Even if Gemini continues to pursue product development and succeeds in commercializing any product candidates, Gemini may continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Gemini may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect Gemini’s business for any reason, including as a result of the COVID-19 pandemic. The size of Gemini’s future net losses will depend, in part, on the rate of future growth of Gemini’s expenses and Gemini’s ability to generate revenue. Gemini’s prior losses and expected future losses have had and will continue to have an adverse effect on Gemini’s stockholders’ equity and working capital.

Gemini currently has a limited operating history, has not generated any revenue to date and may never become profitable.

Gemini is a clinical-stage biotechnology company with a limited operating history. Gemini’s operations to date have been limited to organizing and staffing the company, acquiring, developing and securing Gemini’s technology and product candidates, and conducting clinical trials and preclinical studies of Gemini’s product candidates. Gemini has not yet demonstrated Gemini’s ability to complete clinical trials, obtain regulatory approval, formulate and manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful product commercialization. Investment in biotechnology product development is highly speculative because it entails substantial upfront expenditures in contract research organizations (“CROs”), and contract manufacturing organizations (“CMOs”), and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable. Consequently, any predictions you may make about Gemini’s future success or viability may not be as accurate as they could be if Gemini had a longer operating history.

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To date, Gemini has not generated any revenue, and Gemini will not be able to generate product revenue unless and until any product candidate, successfully completes clinical trials, receives regulatory approval and is commercialized, if ever. If the merger is not consummated and Gemini does not decide to pursue a wind-down or dissolution or alternative strategic transaction, Gemini may seek to obtain revenue from collaboration or licensing agreements with third parties. Gemini’s ability to generate future product revenue from any product candidates also depends on a number of additional factors, including Gemini’s, or Gemini’s current and future collaborators’, ability to:

• successfully complete nonclinical studies and clinical trials for any product candidates;

• seek and obtain marketing approvals for any product candidates that complete clinical development;

• establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

• launch and commercialize any product candidates for which Gemini obtains marketing approval, and, if launched independently, successfully establish a sales, marketing and distribution infrastructure;

• demonstrate the necessary safety data post-approval to ensure continued regulatory approval;

• obtain coverage and adequate product reimbursement from third-party payors, including government payors;

• achieve market acceptance for any approved products;

• address any competing technological and market developments for Gemini’s product candidates;

• negotiate favorable terms in strategic alternatives including, but not limited to, any collaboration, licensing or other arrangements into which Gemini may enter in the future and performing Gemini’s obligations in such collaborations;

• establish, maintain, protect and enforce Gemini’s intellectual property rights; and

• attract, hire and retain qualified personnel.

In addition, because of the numerous risks and uncertainties associated with biotechnology product development, including that Gemini’s product candidates may not advance through development or achieve the endpoints of applicable clinical trials, Gemini is unable to predict the timing or amount of increased expenses, or if or when Gemini would achieve or maintain profitability if Gemini continues to pursue product development. In addition, Gemini’s expenses could increase beyond expectations if Gemini decides, or is required by the U.S. Food and Drug Administration (“FDA”) or applicable foreign regulatory authorities in other jurisdictions where Gemini may pursue regulatory approval, or applicable foreign regulatory authorities, to perform nonclinical studies or clinical trials in addition to those that Gemini currently anticipates. Even if Gemini completes the development and regulatory processes described above, Gemini anticipates incurring significant costs associated with launching and commercializing any approved product.

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

If Gemini continues to pursue product development in the event that the merger is not consummated, Gemini will require additional capital to finance Gemini’s operations, which may not be available to Gemini on acceptable terms, or at all. As a result, Gemini may not complete the development and commercialization of any product candidates.

As a clinical development company, Gemini’s operations have consumed substantial amounts of cash since inception.

As of December 31, 2021, Gemini had $136.6 million of cash and cash equivalents. Subject to the outcome of Gemini’s exploration of strategic alternatives, Gemini believes that Gemini’s current cash resources will enable Gemini to fund Gemini’s operating expenses and capital expenditure requirements through at least the next twelve months from the filing date of this proxy statement/prospectus. Gemini’s forecast of the period of time through which Gemini’s financial reserves will adequately support Gemini’s operations is a forward-looking statement and involves

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risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. Gemini has based this estimate on assumptions that may prove to be wrong, and Gemini could utilize Gemini’s available capital resources sooner than Gemini currently expects. Gemini’s future funding requirements, both short and long-term, will depend on many factors, including, but not limited to:

• the timing and outcome of the consummation of the merger or Gemini’s exploration of potential strategic alternatives;

• the initiation, progress, timing, costs and results of nonclinical studies and clinical trials for any product candidates Gemini may develop, including COVID-19-related delays or other effects on Gemini’s development programs;

• the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and applicable foreign regulatory authorities, including the potential for such authorities to require that Gemini performs more nonclinical studies or clinical trials than those that Gemini currently expects or changes their requirements on studies that had previously been agreed to;

• the cost to establish, maintain, expand, enforce and defend the scope of Gemini’s intellectual property portfolio, including the amount and timing of any payments Gemini may be required to make, or that Gemini may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights;

• the effect of competing technological and market developments;

• market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors;

• the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;

• the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing;

• the cost of establishing sales, marketing and distribution capabilities for any product candidates for which Gemini may receive regulatory approval and that Gemini determines to commercialize; and

• Gemini’s need to implement additional internal systems and infrastructure, including financial and reporting systems.

Gemini does not have any committed external source of funds or other support for Gemini’s development efforts, and Gemini cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent Gemini continues to pursue product development, until Gemini can generate sufficient revenue to finance Gemini’s cash requirements, which Gemini may never do, Gemini expects to finance its future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, and other marketing or distribution arrangements. If Gemini raises additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect Gemini’s stockholders’ rights. Further, to the extent that Gemini raises additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted. If Gemini raises additional capital through debt financing, Gemini could be subject to fixed payment obligations and may be subject to covenants limiting or restricting Gemini’s ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If Gemini raises additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, Gemini may have to relinquish certain valuable rights to Gemini’s product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to Gemini. Gemini also could be required to seek collaborators for one or more of Gemini’s product candidates at an earlier stage than otherwise would be desirable or relinquish Gemini’s rights to product candidates or technologies that Gemini otherwise would seek to develop or commercialize itself. If Gemini is unable to raise additional capital in sufficient amounts or acceptable terms, Gemini may have to significantly delay, scale back or discontinue the development or commercialization of one or more of Gemini’s product candidates or one or more of Gemini’s other research and development initiatives. Any of the above events could significantly harm Gemini’s business, prospects, financial condition and results of operations and cause the price of Gemini’s common stock to decline.

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Risks Related to Gemini’s Business if Merger is Not Consummated

Gemini’s business has been dependent on the success of GEM103, the trials of which have been discontinued.

Gemini currently has no products that are approved for commercial sale and may never be able to develop marketable products. If Gemini continues to pursue regulatory approval of Gemini’s product candidates, Gemini expects that a substantial portion of Gemini’s efforts and expenditures over the next several years would be devoted to Gemini’s lead product candidate, GEM103. Accordingly, Gemini’s business would depend heavily on the successful development, regulatory approval, and commercialization of GEM103. GEM103 was tested in a Phase 2a clinical trial in genetically defined patients with dry age-related macular degeneration (“AMD”) and in a Phase 2a clinical trial as an add-on to anti-VEGF therapy for the treatment of wet AMD patients at risk for progressive vision loss due to macular atrophy. Gemini announced that it was ending both of these studies in January 2022. Gemini cannot be certain that Gemini would successfully commence or complete any further clinical trials, receive regulatory approval or successfully commercialize GEM103 even if Gemini was to receive regulatory approval. If the merger is not consummated and Gemini does not decide to pursue a wind-down or dissolution or alternative strategic transaction, Gemini does not perform any future clinical development of GEM103 or if GEM103 does not receive regulatory approval or fails to achieve significant market acceptance, Gemini would be substantially delayed in Gemini’s ability to achieve profitability, if ever.

If Gemini is not successful in discovering, developing, receiving regulatory approval for and commercializing a product candidate, Gemini’s ability to expand Gemini’s business and achieve Gemini’s strategic objectives would be impaired.

If Gemini determines to continues to pursue regulatory approval of Gemini’s product candidates, Gemini would plan to devote a majority of Gemini’s resources to the continued preclinical and clinical testing and potential approval of GEM103 for the treatment of patients with AMD. However, another key element of Gemini’s strategy could be to discover, develop and commercialize a portfolio of products. Gemini could seek to do so through its internal discovery programs, but its resources are limited. Gemini may also explore strategic collaborations for the development or acquisition of new product candidates, but Gemini may not be successful in entering into such relationships. GEM103 is Gemini’s only product candidate in clinical stages of development. Research programs to identify product candidates require substantial technical, financial and human resources, regardless of whether any product candidates are ultimately identified. Gemini’s research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including:

• the research methodology used may not be successful in identifying potential product candidates;

• competitors may develop alternatives that render Gemini’s product candidates obsolete;

• product candidates Gemini develops may nevertheless be covered by third parties’ patents or other exclusive rights;

• a product candidate may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

• a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;

• an approved product may not be accepted as safe and effective by trial participants, the medical community or third-party payors; and

• intellectual property or other proprietary rights of third parties for product candidates Gemini develops may potentially block Gemini’s entry into certain markets or make such entry economically impracticable.

If Gemini continues to pursue product development and Gemini fails to develop and successfully commercialize other product candidates, Gemini’s business and future prospects may be harmed, and Gemini’s business will be more vulnerable to any problems that Gemini encounters in developing and commercializing its product candidates.

Product candidates would need to undergo rigorous clinical trials and regulatory approvals, and success in nonclinical studies or earlier-stage clinical trials may not be indicative of results in future clinical trials.

To the extent Gemini continues to pursue product development, product candidates would be subject to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA and applicable foreign

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regulatory authorities. The approval process is typically lengthy and expensive, and approval is never certain. Gemini has limited experience in conducting the clinical trials required to obtain regulatory approval. Gemini may not be able to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical trials in a timely fashion, if at all. Gemini’s planned clinical trials may be insufficient to demonstrate that its potential products will be active, safe or effective. Additional clinical trials may be required if clinical trial results are negative or inconclusive, which will require Gemini to incur additional costs and significant delays.

Success in preclinical studies and earlier-stage clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the effectiveness and safety of a product candidate. In addition, the design of a clinical trial can determine whether Gemini’s results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. Because Gemini has limited experience designing clinical trials, Gemini may be unable to design and execute a clinical trial to support regulatory approval. In addition, there is a high failure rate for drugs and biologics proceeding through clinical trials. In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in nonclinical studies and earlier-stage clinical trials. Similarly, the outcome of nonclinical studies may not predict the success of clinical trials. Moreover, data obtained from nonclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. For example, Gemini provided updates from Gemini’s Phase 2a studies in January 2022. Both studies were ended early, which may limit the ability of the data to support regulatory approval. In addition, Gemini may experience regulatory delays or rejections as a result of many factors, including due to changes in regulatory policy during the period of development of Gemini’s product candidates. Any such delays could negatively impact Gemini’s business, financial condition, results of operations and prospects.

Gemini has published, and may from time to time in the future, publish interim “top-line” or preliminary data from Gemini’s clinical trials. Preliminary or interim data from clinical trials that Gemini may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or interim data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data Gemini previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm Gemini’s business and financial prospects.

Additionally, several of Gemini’s previous clinical trials utilized an “open-label” trial design. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved biologic, drug, or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results with any of Gemini’s product candidates for which Gemini includes an open-label clinical trial when studied in a controlled environment with a placebo or active control.

Gemini has been and may in the future be subject to many manufacturing risks, any of which could substantially increase Gemini’s costs, delay clinical programs and limit supply of Gemini’s products.

Gemini has historically contracted with third party manufacturers to make new drug substance to support clinical trials and for commercial sale, if approved. Gemini’s CMOs may not be able to adopt, adapt or scale up the manufacturing process in a timely manner to support Gemini’s future clinical trials. The process of manufacturing Gemini’s products is complex, highly regulated and subject to several risks, including:

• the manufacturing processes are susceptible to product loss due to contamination by adventitious microorganisms, equipment failure, improper installation or operation of equipment, vendor or operator error and improper storage conditions. Even minor deviations from normal manufacturing processes could

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result in reduced production yields and quality as well as other supply disruptions. If microbial, viral or other contaminations are discovered in Gemini’s products or in the manufacturing facilities in which Gemini’s products are made, the manufacturing facilities may need to be closed for an extended period of time to investigate and eliminate the contamination;

• the manufacturing facilities in which Gemini’s products are made could be adversely affected by equipment failures, labor and raw material shortages, financial difficulties of Gemini’s CMOs, natural disasters, power failures, local political unrest and numerous other factors; and

• any adverse developments affecting manufacturing operations for Gemini’s products may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the supply of Gemini’s products. Gemini may also have to record inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more expensive manufacturing alternatives.

The manufacture of product candidates requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of these products sometimes encounter difficulties in production, especially during scale-up from the manufacturing process used for pre-clinical and early clinical trials to a validated process needed for pivotal clinical studies and commercial launch. These problems include failure to meet target production costs and yields, sub-par quality control testing, including stability of the product, quality assurance system failures, operator error and shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Gemini cannot assure you that any product quality issues relating to the manufacture of any product candidates will not occur in the future.

Gemini does not have and does not currently plan to acquire or build the facilities or internal capabilities to manufacture bulk drug substance or filled drug product for use in pre-clinical studies, clinical trials or commercialization. To a large extent, that makes Gemini dependent on the goodwill of Gemini’s contract manufacturing partners to quickly fix deviations that will inevitably occur during the manufacturing of Gemini’s product. Any delay or interruption in the supply of clinical trial materials could delay the completion of pre-clinical studies or clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require Gemini to commence new pre-clinical studies or clinical trials at additional expense or terminate pre-clinical studies or clinical trials altogether.

Gemini has no manufacturing facility. As a result, Gemini has been dependent on third-party manufacturers, as well as on third parties for Gemini’s supply chain, and if Gemini experiences problems with any third parties, or the actual demand for Gemini’s future product candidates, if any, exceed Gemini’s forecasts, the manufacture of adequate supplies of Gemini’s future product candidates or products could be delayed.

Gemini does not own or operate facilities for the manufacture of Gemini’s future product candidates, if any. Gemini currently has no plans to build its own manufacturing facilities for clinical or commercial operations. Gemini has in the past relied on third party manufacturers for the chemical manufacture of active pharmaceutical ingredient and for the production of final product formulation and packaging for clinical trials, and expect to rely on such third party manufacturers for any future product candidate Gemini is able to advance into clinical development. Although alternative third party suppliers with the necessary manufacturing and regulatory expertise and facilities exist, it could be expensive and take a significant amount of time to arrange for alternative suppliers should Gemini commence clinical development of any future product candidate. Gemini may encounter technical difficulties or delays in the transfer of manufacturing on a commercial scale to third party manufacturers. Gemini may be unable to enter into agreements for commercial supply with third party manufacturers, or may be unable to do so on acceptable terms. If Gemini is unable to arrange for alternative third-party manufacturing sources, or to do so on commercially reasonable terms or in a timely manner, Gemini may not be able to complete development of any future product candidates, or market or distribute them.

Reliance on third party manufacturers entails risks to which Gemini would not be subject if Gemini manufactured product candidates or products itself, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond Gemini’s control, including a failure to manufacture Gemini’s product candidates or any products Gemini may eventually commercialize in accordance with Gemini’s specifications, and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to Gemini. In addition, the FDA and other regulatory authorities require that Gemini’s product candidates

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and any products that Gemini may eventually commercialize be manufactured according to cGMP and similar foreign standards. Any failure by Gemini’s third-party manufacturers to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of Gemini’s product candidates and could cause Gemini to incur higher costs and prevent Gemini from commercializing Gemini’s product candidates successfully. In addition, such failure could be the basis for the FDA to issue a warning letter, withdraw approvals for product candidates previously granted to Gemini, or take other regulatory or legal action, including recall or seizure of outside supplies of the product candidate, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications, detention of products, refusal to permit the import or export of products, injunction, or imposing civil and criminal penalties.

Any significant disruption in Gemini’s supplier relationships could harm Gemini’s business. Any significant delay in the supply of a product candidate or its key materials for a clinical trial could considerably delay completion of Gemini’s clinical trials, product testing and potential regulatory approval of Gemini’s future product candidates. If Gemini’s manufacturers or Gemini is unable to purchase these key materials after regulatory approval has been obtained for Gemini’s product candidates, the commercial launch of Gemini’s product candidates would be delayed or there would be a shortage in supply, which would impair Gemini’s ability to generate revenues from the sale of Gemini’s product candidates. If Gemini’s third party manufacturers cannot manufacture sufficient quantity to meet the demand for Gemini’s product candidates after regulatory approval, there would be a shortage in supply which would negatively impact Gemini’s revenue from the sale of Gemini’s product candidates. It may take several years to establish an alternative source of supply for Gemini’s product candidates and to have any such new source approved by the FDA.

Gemini’s business could continue to be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic, including in regions where third parties on which Gemini relies have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

Gemini’s business could be adversely affected by health epidemics in regions where third parties on which Gemini relies, such as CROs or CMOs, have concentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom Gemini relies. The ongoing COVID-19 pandemic and the increased prevalence of variants of the virus, and government measures taken in response, have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. The ongoing COVID-19 pandemic and related impacts have resulted in, and will likely continue to result in, significant disruptions to the global economy and capital markets around the world. Gemini cannot predict the future progression or full impact of the outbreak and its effects on Gemini’s business and operations.

Gemini and its third-party CMOs, CROs and clinical sites have experienced, and may continue to experience, disruptions in supply of product candidates and/or procuring items that are essential for Gemini’s research and development activities, including raw materials used in the manufacturing of Gemini’s product candidates, medical and laboratory supplies used in Gemini’s clinical trials or preclinical studies or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the pandemic.

Additionally, Gemini enrolled patients in its clinical trials at sites located both in the United States and internationally. Gemini’s clinical trial sites were located in areas that were affected by COVID-19 and, as a result, Gemini’s ability to enroll patients and complete Gemini’s trials were impacted. Gemini cannot predict how long these types of delays and impacts many continue, and whether they will similarly affect any future clinical trials. For example, even if sites are initiating and actively recruiting, Gemini may face difficulties recruiting or retaining patients in Gemini’s planned clinical trials if patients are affected by the virus or are unable to or are fearful of visiting or traveling to Gemini’s clinical trial sites because of the pandemic, or if patients are unable or unwilling to be vaccinated or tested. Prolonged delays or closure to enrollment in Gemini’s planned trials or patient discontinuations could have a material adverse impact on Gemini’s clinical trial plans and timelines. In addition, Gemini’s ability to collect and verify data requested of patients enrolled in Gemini’s clinical trials during this pandemic was impacted to varying degrees by COVID-19, and COVID-19 could similarly impact future clinical trials. Although clinical trial data collection continued for each of Gemini’s clinical trials, data was collected at a slower pace, and with challenges and interruptions in data

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collection, including, in some instances, disruption of collection of complete study data. This could have a material adverse impact on Gemini’s data quality and analysis. In addition, clinical trial sites for any potential future clinical trials may be unable or unwilling to initiate a new trial if factors relevant to the pandemic render doing so impracticable. These COVID-19 related issues may prolong the time required to conduct any potential clinical trials and/or impact the quality of the data obtained from one or more of Gemini’s completed or potential studies.

Gemini has not incurred impairment losses in the carrying values of Gemini’s assets as a result of the ongoing COVID-19 pandemic, and Gemini is not aware of any specific related event or circumstance that would require Gemini to revise its estimates reflected in its consolidated financial statements. Although the COVID-19 pandemic did not have a significant impact on Gemini’s financial results in 2021, the full extent to which the ongoing COVID-19 pandemic may impact Gemini’s business, results of operations, financial condition and cash flows will depend on future developments that are highly uncertain, and the estimates of the impact on Gemini’s business may change based on new information that may emerge concerning COVID-19, including the duration of the pandemic, any potential subsequent waves or strains of COVID-19 infection, the effectiveness, distribution and acceptance of COVID-19 vaccines and the actions to contain it or treat its impact and the economic impact on local, regional, national and international markets.

If Gemini does not retain key employees, Gemini’s ability to maintain its ongoing operations or execute a potential strategic option could be impaired.

On February 28, 2022, Gemini announced a workforce reduction by up to 24 positions, or approximately 80% of Gemini’s workforce. The loss of services from any of Gemini’s existing or continuing employees could substantially disrupt Gemini’s operations. To be successful and achieve Gemini’s strategic objectives, Gemini must retain qualified personnel. The continued review of Gemini’s strategic options may create continued uncertainty for Gemini’s employees and this uncertainty may adversely affect Gemini’s ability to retain key employees and to hire new talent necessary to maintain Gemini’s ongoing operations or to execute additional potential strategic options, which could have a material adverse effect on Gemini’s business.

In addition, Gemini’s current strategy and any changes to this strategy could place significant strain on Gemini’s resources and Gemini’s ability to maintain Gemini’s ongoing operations. Gemini may also be required to rely more heavily on temporary or part-time employees, third party contractors and consultants to assist with managing Gemini’s operations. These consultants are not Gemini’s employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to Gemini. Gemini will have only limited control over the activities of these consultants and can generally expect these individuals to devote only limited time to Gemini’s activities. Failure of any of these persons to devote sufficient time and resources to Gemini’s business could harm its business.

Accordingly, Gemini may fail to maintain Gemini’s ongoing operations or execute Gemini’s strategic plan if Gemini is unable to retain or hire qualified personnel or to manage its employees and consultants effectively.

Gemini may encounter difficulties in managing any future growth, which could adversely affect Gemini’s operations.

If Gemini pursues further clinical development and the potential commercialization of Gemini’s product candidates, Gemini will need to expand its financial, development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for Gemini. If Gemini’s operations were to expand, it would expect that it would need to manage additional relationships with various strategic collaborators, suppliers and other third parties. Gemini’s future financial performance and its ability to develop and commercialize its product candidates and to compete effectively would depend, in part, on Gemini’s ability to manage any future growth effectively. Gemini has undertaken restructurings in October 2021 and February 2022 with a substantial reduction in headcount, which would adversely impact its ability to meet any potential growth needs.

If Gemini fails to maintain an effective system of internal control over financial reporting, it may not be able to accurately report its financial results or prevent fraud. As a result, stockholders could lose confidence in Gemini’s financial and other public reporting, which would harm Gemini’s business and the trading price of its common stock.

Effective internal controls over financial reporting are necessary for Gemini to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause Gemini to fail to

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meet its reporting obligations. In addition, any testing by Gemini conducted in connection with Section 404 of the Sarbanes-Oxley Act (“Section 404”) or any subsequent testing by Gemini’s independent registered public accounting firm, may reveal deficiencies in Gemini’s internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to Gemini’s financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in Gemini’s reported financial information, which could have a negative effect on the trading price of Gemini’s stock.

Commencing with the end of the fiscal year ended December 31, 2021, Gemini was required to perform system and process design evaluation and testing of the effectiveness of Gemini’s internal controls over financial reporting to allow management to report on the effectiveness of Gemini’s internal controls over financial reporting, as required by Section 404. This has required that Gemini incur substantial additional and recurring professional fees and internal costs to expand Gemini’s accounting and finance functions and that Gemini expends significant management efforts. Gemini will be required to disclose changes made in its internal controls and procedures on a quarterly basis. However, for as long as Gemini is an emerging growth company (“EGC”), its independent registered public accounting firm will not be required to attest to the effectiveness of its internal controls over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of Gemini’s internal controls over financial reporting could detect problems that Gemini’s management’s assessment might not. Undetected material weaknesses in Gemini’s internal controls over financial reporting could lead to restatements of Gemini’s financial statements and require Gemini to incur the expense of remediation.

If Gemini is not able to comply with the requirements of Section 404 in a timely manner or it is unable to maintain proper and effective internal controls over financial reporting Gemini may not be able to produce timely and accurate financial statements. As a result, Gemini’s investors could lose confidence in its reported financial information, the market price of Gemini’s stock could decline and Gemini could be subject to sanctions or investigations by the SEC or other regulatory authorities.

Gemini’s disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Gemini’s disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by Gemini in reports it files or submits under the Securities Exchange Act of 1934, as amended (“Exchange Act”), is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. Gemini believes that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in Gemini’s control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

As a result of Gemini’s business combination with a special purpose acquisition company, regulatory obligations may impact Gemini differently than other publicly traded companies.

Gemini became a publicly traded company by completing a transaction with a special purpose acquisition company (“SPAC”). As a result of this transaction, regulatory obligations have, and may continue, to impact Gemini differently than other publicly traded companies. For instance, the SEC and other regulatory agencies may issue additional guidance or apply further regulatory scrutiny to companies like Gemini that have completed a business combination with a SPAC. Managing this regulatory environment, which has and may continue to evolve, could divert management’s attention from the operation of Gemini’s business, negatively impact Gemini’s ability to raise additional capital when needed or have an adverse effect on the price of Gemini’s common stock.

Gemini’s employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Gemini cannot ensure that its compliance controls, policies, and procedures will in every instance protect Gemini from acts committed by Gemini’s employees, agents, contractors, or collaborators that would violate the law or regulation, including, without limitation, healthcare, employment, foreign corrupt practices, environmental, competition, and patient privacy and other privacy laws and regulations. Such improper actions could subject Gemini to civil or criminal investigations, and monetary and injunctive penalties, and could adversely impact Gemini’s ability to conduct business, operating results, and reputation.

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Gemini is exposed to the risk of employee fraud or other illegal activity by Gemini’s employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws enforced by the FDA and applicable foreign regulatory authorities, fails to provide true, complete and accurate information to the FDA and applicable foreign regulatory authorities, fails to comply with manufacturing standards Gemini has established, fails to comply with healthcare fraud and abuse laws in the United States and similar foreign laws, or fails to report financial information or data accurately or to disclose unauthorized activities to Gemini. If Gemini obtains FDA approval of any of Gemini’s product candidates and begin commercializing those products in the United States, Gemini’s potential exposure under these laws will increase significantly, and its costs associated with compliance with these laws are also likely to increase. Additionally, Gemini is subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. These laws may impact, among other things, Gemini’s current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. If any such actions are instituted against Gemini, and Gemini is not successful in defending itself or asserting its rights, those actions could have a significant impact on Gemini’s business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Gemini’s operations, any of which could adversely affect Gemini’s ability to operate Gemini’s business and Gemini’s results of operations. It is not always possible to identify and deter employee misconduct, and the precautions Gemini takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Gemini from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against Gemini and it is not successful in defending itself or asserting its rights, those actions could result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of Gemini’s operations.

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 Gemini’s control, significant competition for recruiting patients with AMD in clinical trials.

Identifying and qualifying patients to participate in Gemini’s clinical trials is critical to its success. To the extent Gemini continues to pursue product development, Gemini may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of Gemini’s clinical trials, and even once enrolled Gemini may be unable to retain a sufficient number of patients to complete any of Gemini’s trials.

Factors that may generally affect patient enrollment include:

• the size and nature of the patient population;

• the number and location of clinical sites where patients are to be enrolled;

• competition with other companies for clinical sites or patients;

• the eligibility and exclusion criteria for the trial;

• the design of the clinical trial;

• inability to obtain and maintain patient consents;

• risk that enrolled participants will drop out before completion; and

• competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation to other available therapies, including any new products that may be approved for the indications Gemini is investigating.

In addition, if any significant adverse events or other side effects are observed in any of Gemini’s future clinical trials, it may make it more difficult for Gemini to recruit patients to Gemini’s clinical trials and patients may drop out of Gemini’s trials, or Gemini may be required to abandon the trials or Gemini’s development efforts of one or more product candidates altogether. Gemini’s inability to enroll a sufficient number of patients for Gemini’s clinical trials would result in significant delays, which would increase Gemini’s costs and have an adverse effect on Gemini.

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Gemini faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than Gemini.

The biotechnology industry is intensely competitive and subject to rapid and significant technological change. Gemini’s current competitors include multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions. A number of pharmaceutical companies, as well as large and small biotechnology companies such as Apellis Pharmaceuticals, Inc. and IVERIC bio are pursuing the development or marketing of pharmaceuticals that target AMD. It is also probable that the number of companies seeking to develop products and therapies for the treatment of serious eye diseases, such as AMD, will increase. Many of Gemini’s competitors have substantially greater financial, technical, human and other resources than Gemini does and may be better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly greater experience than Gemini does in undertaking nonclinical studies and human clinical trials of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Accordingly, Gemini’s competitors may succeed in obtaining FDA approval for superior products. In addition, to the extent Gemini continues to pursue product development, many competitors have greater name recognition and more extensive collaborative relationships. Smaller and earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Gemini’s competitors may obtain regulatory approval of their products more rapidly than Gemini does or may obtain patent protection or other intellectual property rights that limit Gemini’s ability to develop or commercialize its product candidates. Gemini’s competitors may also develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than Gemini’s products and these competitors may also be more successful than Gemini is in manufacturing and marketing their products. If Gemini is unable to compete effectively against these companies, then Gemini may not be able to commercialize Gemini’s product candidates or achieve a competitive position in the market. This would adversely affect Gemini’s ability to generate revenue. Gemini’s competitors also compete with Gemini in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Gemini’s programs.

Gemini’s business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in Gemini’s or related parties’ cyber security.

Given Gemini’s limited operating history, Gemini is still in the process of implementing Gemini’s internal security measures. Gemini’s internal computer systems and those of current and future third parties on which Gemini relies may fail and are vulnerable to damage from computer viruses and unauthorized access. Gemini’s information technology and other internal infrastructure systems, including corporate firewalls, servers, leased lines and connection to the Internet, face the risk of systemic failure that could disrupt Gemini’s operations. While Gemini has not, to its knowledge, experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in Gemini’s operations, it could result in a material disruption of Gemini’s development programs and Gemini’s business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in Gemini’s regulatory approval efforts and significantly increase Gemini’s costs to recover or reproduce the data. Likewise, Gemini relies on third parties for the manufacture of Gemini’s product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on Gemini’s business. To the extent that any disruption or security breach were to result in a loss of, or damage to, Gemini’s data or applications, or inappropriate disclosure of confidential or proprietary information, Gemini could incur liability, Gemini’s competitive position could be harmed and the further development and commercialization of Gemini’s product candidates could be hindered or delayed.

Comprehensive tax reform legislation could adversely affect Gemini’s business and financial condition.

The rules dealing with United States federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the IRS and the United States Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect Gemini or holders of Gemini’s common stock. In recent years, many such changes have been made and changes are likely to continue to occur in the future. It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be promulgated or issued under existing or new tax laws, which could result in an increase in Gemini’s or Gemini’s stockholders’ tax liability or require changes in the manner in which Gemini operates in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

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Gemini might not be able to utilize a significant portion of Gemini’s U.S. NOL carryforwards and U.S. research and development tax credit carryforwards.

As of December 31, 2021, Gemini had federal net operating loss carryforwards of $7.6 million that are subject to expire at various dates through 2037, and net operating loss carryforwards of $156.5 million, which have no expiration date, can be carried forward indefinitely, and are limited to a deduction to 80% of annual taxable income. Gemini has state tax net operating loss carryforwards of $143.1 million, which may be available to offset future income tax liabilities and expire at various dates through 2041, and state net operating loss carryforwards of $1.0 million, which have no expiration date and can be carried forward indefinitely. Gemini also has federal and state research and development tax credit carryforwards of $5.0 million and $1.2 million, respectively, which expire at various dates through 2041. Gemini does not anticipate generating revenue from sales of products for the foreseeable future, if ever, and Gemini may never achieve profitability. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities. Unused losses generated in taxable years beginning after December 31, 2017 will not expire and may be carried forward indefinitely, and generally may not be carried back to prior taxable years, except that, under the CARES Act a 5-year carryback of NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021 is permitted. Additionally, for taxable years beginning after December 31, 2020, the deductibility of such U.S. federal NOLs is limited to 80% of Gemini’s taxable income in any future taxable year. In addition, under Section 382 of the Code, the amount of benefits from Gemini’s NOL carryforwards may be impaired or limited if Gemini incurs a cumulative ownership change of more than 50% over a three-year period. Gemini has not conducted a study to determine if any such changes have occurred that could limit its ability to use the net operating loss and tax credit carryforwards. Gemini may have experienced ownership changes in the past and the merger is expected to result in an ownership change. As a result, Gemini’s use of U.S. federal NOL carryforwards will likely be limited, and state NOL carryforwards may be similarly limited. Any such disallowances may result in greater tax liabilities than Gemini would incur in the absence of such a limitation and any increased liabilities could adversely affect Gemini’s business, results of operations, financial position and cash flows.

Gemini uses and generates materials that may expose Gemini to material liability.

Gemini’s research programs involve the use of hazardous materials and chemicals, which are currently only handled by third parties. Gemini is subject to foreign, federal, state and local environmental and health and safety laws and regulations governing, among other matters, the use, manufacture, handling, storage and disposal of hazardous materials and waste products. To the extent Gemini continues to pursue product development, Gemini may incur significant costs to comply with these current or future environmental and health and safety laws and regulations. In addition, Gemini cannot completely eliminate the risk of contamination or injury from hazardous materials and may incur material liability as a result of such contamination or injury. In the event of an accident, an injured party may seek to hold Gemini liable for any damages that result. Any liability could exceed the limits or fall outside the coverage of Gemini’s workers’ compensation, property and business interruption insurance and Gemini may not be able to maintain insurance on acceptable terms, if at all. Gemini currently carries no insurance specifically covering environmental claims.

Risks Related to Government Regulation

The regulatory approval processes of the FDA and applicable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. Gemini’s inability to obtain regulatory approval for any product candidate would substantially harm Gemini’s business.

The time required to obtain approval from the FDA and applicable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of nonclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. In addition, 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 development and may vary among jurisdictions.

To the extent Gemini continues to pursue product development, its product candidates could fail to receive regulatory approval from the FDA or an applicable foreign regulatory authority for many reasons, including:

• disagreement with the design or implementation of Gemini’s clinical trials;

• failure to demonstrate that a product candidate is safe and effective for Gemini’s proposed indication;

• failure of clinical trials to meet the level of statistical significance required for approval;

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• failure to demonstrate that a product candidate’s clinical and other benefits outweigh Gemini’s safety risks;

• disagreement with Gemini’s interpretation of data from nonclinical studies or clinical trials;

• the insufficiency of data collected from clinical trials of Gemini’s product candidates to obtain regulatory approval;

• failure to obtain approval of the manufacturing processes or facilities of third-party manufacturers with whom Gemini contracts for clinical and commercial supplies; or

• changes in the approval policies or regulations that render Gemini’s nonclinical and clinical data insufficient for approval.

The FDA or an applicable foreign regulatory authority may require more information, including additional nonclinical or clinical data to support approval, which may delay or prevent approval and Gemini’s commercialization plans, or Gemini may decide to abandon the development program for other reasons. If Gemini was to obtain approval, regulatory authorities may approve any of Gemini’s product for fewer more limited indications than Gemini requests, may require labeling or a Risk Evaluation Mitigation Strategy (“REMS”) that includes significant use or distribution restrictions or safety warnings, precautions, or contraindications, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Failures or delays in the commencement or completion of, or ambiguous or negative results from, Gemini’s previous and potential clinical trials of Gemini’s product candidates could result in increased costs to Gemini and could delay, prevent, or limit Gemini’s ability to generate revenue and continue Gemini’s business.

Gemini does not know whether any of its potential clinical trials will be completed on schedule, if at all, as the commencement and completion of clinical trials can be delayed or prevented for a number of reasons, including, among others:

• the FDA or applicable foreign regulatory authorities may not authorize Gemini or Gemini’s investigators to commence its planned clinical trials or any other clinical trials Gemini may initiate, or may suspend Gemini’s clinical trials, for example, through imposition of a clinical hold, and may request additional data to permit allowance of Gemini’s IND;

• delays in filing or receiving allowance of additional IND applications that may be required;

• lack of adequate funding to continue Gemini’s clinical trials, such as Gemini’s previous Phase 2a studies, and nonclinical studies;

• negative results from Gemini’s ongoing nonclinical studies;

• delays in reaching or failing to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites;

• the inability of CROs to perform under these agreements, including due to impacts from the COVID-19 pandemic on their workforce;

• inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical trials, for example delays in the manufacturing of sufficient supply of finished drug product;

• difficulties obtaining ethics committee or Institutional Review Board (“IRB”) approval to conduct a clinical study at a prospective site or sites;

• challenges in recruiting and enrolling subjects to participate in clinical trials, the proximity of subjects to study sites, eligibility criteria for the clinical study, the nature of the clinical study protocol, the availability of approved effective treatments for the relevant disease, and competition from other clinical study programs for similar indications;

• severe or unexpected drug-related side effects experienced by subjects in a clinical trial;

• Gemini may decide, or regulatory authorities may require Gemini, to conduct additional nonclinical or clinical trials or abandon product development programs;

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• delays in validating, or inability to validate, any endpoints utilized in a clinical trial;

• the FDA or applicable foreign regulatory authorities may disagree with Gemini’s clinical study design and Gemini’s interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for Gemini’s clinical trials; and

• difficulties retaining subjects who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the clinical trials, lack of efficacy, side effects, personal issues, or loss of interest.

Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results. In addition, a clinical study may be suspended or terminated by Gemini, the FDA or applicable foreign regulatory authorities, the IRBs at the sites where the IRBs are overseeing a clinical study, a data and safety monitoring board (“DSMB”) overseeing the clinical study at issue or other regulatory authorities due to a number of factors, including, among others:

• failure to conduct the clinical study in accordance with regulatory requirements or Gemini’s clinical protocols;

• inspection of the clinical study operations or study sites by the FDA or other regulatory authorities that reveals deficiencies or violations that require Gemini to undertake corrective action, including in response to the imposition of a clinical hold;

• unforeseen safety issues or safety signals, including any that could be identified in Gemini’s ongoing nonclinical studies or clinical trials, adverse side effects or lack of effectiveness;

• changes in government regulations or administrative actions;

• problems with clinical supply materials; and

• lack of adequate funding to continue clinical trials.

Any inability to successfully complete nonclinical and clinical development could result in additional costs to Gemini or impair Gemini’s ability to generate revenue. In addition, if Gemini makes changes to a product candidate, such as changes to the formulation, Gemini may need to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of Gemini’s modified product candidate to earlier versions, which could delay Gemini’s clinical development plan or marketing approval for Gemini’s product candidates. Clinical trial delays could also shorten any periods during which Gemini may have the exclusive right to commercialize Gemini’s product candidates or allow Gemini’s competitors to bring products to market before Gemini does, which could impair Gemini’s ability to successfully commercialize its product candidates and may harm its business and results of operations.

Gemini has limited experience in conducting clinical trials and has never obtained approval for any product candidates and may be unable to do so successfully.

As a company, Gemini has limited experience in designing, conducting or completing clinical trials and has never progressed a product candidate through to regulatory approval. In part because of this lack of experience, to the extent Gemini continues to pursue product development, Gemini’s potential clinical trials may require more time and incur greater costs than Gemini anticipates, and Gemini may not have sufficient resources to complete these trials. Gemini cannot be certain that the planned clinical trials will begin or conclude on time, if at all. Large-scale trials will require significant additional financial and management resources. Any performance failure on the part of such third parties could delay the clinical development of Gemini’s product candidates or delay or prevent Gemini from obtaining regulatory approval or commercializing Gemini’s product candidates, depriving Gemini of potential product revenue and resulting in additional losses.

The advancement of healthcare reform may negatively impact Gemini’s ability to profitably sell Gemini’s product candidates, if approved.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of Gemini’s product candidates, restrict or regulate post-approval activities and affect Gemini’s ability to profitably sell any product for which Gemini

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obtains marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact Gemini’s business in the future by requiring, for example: (i) changes to Gemini’s manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of Gemini’s products; or (iv) additional record-keeping requirements.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), was enacted, which includes measures that has significantly changed the way health care is financed by both governmental and private insurers. Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the Affordable Care Act brought by several states without specifically ruling on the constitutionality of the Affordable Care Act. Prior to the Supreme Court's decision, the current President of the United States issued an Executive Order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace. The Executive Order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act. It is unclear how other healthcare reform measures of the current administrations or other efforts, if any, to challenge repeal or replace the Affordable Care Act, will impact Gemini’s business.

In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the Affordable Care Act was enacted:

• On August 2, 2011, the U.S. Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic. Following the temporary suspension, a 1% payment reduction will occur beginning April 1, 2022 through June 30, 2022, and the 2% payment reduction will resume on July 1, 2022.

• On January 2, 2013, the U.S. American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.

• On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the Affordable Care Act for plans sold through such marketplaces.

• On May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

• On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

• On December 20, 2019, the former President of the United States signed into law the Further Consolidated Appropriations Act (H.R. 1865), which repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax. It is impossible to determine whether similar taxes could be instated in the future.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs. At a federal level, the current President of the United States signed an Executive Order on July 9, 2021 affirming the administration’s policy to (i) support legislative reforms that would lower the

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prices of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and, by supporting the development and market entry of lower-cost generic drugs and biosimilars; and (ii) support the enactment of a public health insurance option. Among other things, the Executive Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply chain, reduce the price that the Federal government pays for drugs, and address price gouging in the industry; and directs the FDA to work with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the FDA’s implementing regulations. FDA released such implementing regulations on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. On September 25, 2020, CMS stated drugs imported by states under this rule will not be eligible for federal rebates under Section 1927 of the Social Security Act and manufacturers would not report these drugs for “best price” or Average Manufacturer Price purposes. Since these drugs are not considered covered outpatient drugs, CMS further stated it will not publish a National Average Drug Acquisition Cost for these drugs. If implemented, importation of drugs from Canada may materially and adversely affect the price Gemini receives for any of Gemini’s product candidates. Further, on November 20, 2020 CMS issued an Interim Final Rule implementing the Most Favored Nation (“MFN”) Model under which Medicare Part B reimbursement rates would have been be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. However, on December 29, 2021, CMS rescinded the Most Favored Nations rule. Additionally, on November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed, and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the current administration may reverse or otherwise change these measures, both the current administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs. Gemini expects that the healthcare reform measures that has been adopted and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that Gemini receives for any approved product and could seriously harm Gemini’s future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private third-party payors.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm Gemini’s business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for Gemini’s drugs or put pressure on Gemini’s drug pricing, which could negatively affect Gemini’s business, financial condition, results of operations and prospects.

There has been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent Gemini from being able to generate revenue, attain profitability, or commercialize Gemini’s product. Such reforms could have an adverse effect on anticipated revenue from product candidates that Gemini may successfully develop and for which Gemini may obtain regulatory approval and may affect Gemini’s overall financial condition and ability to develop product candidates.

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Gemini’s relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose Gemini to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which Gemini obtains marketing approval. Gemini’s current and future arrangements with healthcare providers, third-party payors and customers may expose Gemini to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which Gemini researches, and if approved, markets, sells and distributes Gemini’s products. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

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

• federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which can be enforced through civil whistleblower or qui tam actions, prohibit individuals or entities from, among other things knowingly presenting, or causing to be presented, to the federal government or a government contractor, grantee, or other recipient of federal funds, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

• the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense or knowingly and willfully making false statements relating to healthcare matters;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their implementing regulations, imposes obligations on certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as their business associates, which are individuals and entities that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

• federal government price reporting laws, which require Gemini to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

• federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

• the federal Open Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians (as defined above) and their immediate family members. Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified-nurse midwives); and

• analogous state, local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance

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guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug prices; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws that govern the privacy and security of health information in certain 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 Gemini’s business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that Gemini’s business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If Gemini’s operations are found to be in violation of any of these laws or any other governmental regulations that may apply to Gemini, Gemini may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of Gemini’s operations. If any of the physicians or other healthcare providers or entities with whom Gemini expects to do business is found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect Gemini’s operating results and business.

Gemini and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act and California Consumer Privacy Act of 2018 (“CCPA”)), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to Gemini’s operations or the operations of Gemini’s collaborators. The state of California, for example, adopted the CCPA, which went into effect in 2020. The CCPA has been characterized as the first “GDPR-like” privacy statute to be enacted in the United States because it mirrors a number of the key provisions of the European Union General Data Protection Regulation (“EU GDPR”). The CCPA establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches. In addition, Gemini may obtain health information from third parties (including research institutions from which Gemini obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, Gemini could be subject to civil, criminal, and administrative penalties if Gemini knowingly obtains, uses, or discloses individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Compliance with U.S. and international data protection laws and regulations, including the EU GDPR and other EU data protection laws, could require Gemini to take on more onerous obligations in Gemini’s contracts, restrict Gemini’s ability to collect, use and disclose data, or in some cases, impact Gemini’s ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect Gemini’s operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom Gemini or Gemini’s potential collaborators obtain personal information, as well as the providers who share this information with Gemini, may limit Gemini’s ability to collect, use and disclose the information. Claims that Gemini has violated individuals’ privacy rights, failed to comply with data protection laws, or breached Gemini’s contractual obligations, even if Gemini is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm Gemini’s business.

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Clinical development is uncertain, and Gemini’s clinical trials for any product candidates may experience delays, which would adversely affect Gemini’s ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on Gemini’s business.

Gemini cannot be sure that Gemini will be able to submit INDs or similar applications for Gemini’s preclinical programs on the timelines Gemini expects, if at all. To proceed with Gemini’s development plans and ultimately commercialization, Gemini may need to conduct and meet regulatory requirements for preclinical and clinical studies. For therapeutic applications, the FDA may require additional extensive preclinical and other studies. Gemini cannot be certain of the timely completion or outcomes of Gemini’s preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept Gemini’s proposed clinical programs or if the outcomes of Gemini’s preclinical testing and studies will ultimately support the further development of Gemini’s programs. As a result, there is no assurance that Gemini will be able to submit INDs or similar applications on the timelines Gemini expects, if at all, and Gemini cannot be sure that submission of an IND or similar applications will result in the FDA or other regulatory authorities allowing a clinical trial design to begin.

Even if Gemini is able to obtain regulatory approvals for Gemini’s product candidates, if they exhibit harmful side effects after approval, Gemini’s regulatory approvals could be revoked or otherwise negatively impacted, and Gemini could be subject to costly and damaging product liability claims.

Clinical trials are conducted in representative samples of the potential patient population which may has significant variability. Even if Gemini receives regulatory approval for any of Gemini’s product candidates, Gemini will have tested them in only a small number of patients during Gemini’s clinical trials. Clinical trials are by design based on a limited number of subjects and of limited duration for exposure to the product used to determine whether, on a potentially statistically significant basis, the planned safety and efficacy of any product candidate can be achieved. As with the results of any statistical sampling, Gemini cannot be sure that all side effects of Gemini’s product candidates may be uncovered, and it may be the case that only with a significantly larger number of patients exposed to the product candidate for a longer duration, may a more complete safety profile be identified. Further, even larger clinical trials may not identify rare serious adverse effects or the duration of such studies may not be sufficient to identify when those events may occur. If Gemini’s applications for marketing are approved and more patients begin to use Gemini’s product, new risks and side effects associated with Gemini’s products may be discovered. There have been other products that have been approved by the regulatory authorities but for which safety concerns has been uncovered following approval. Such safety concerns have led to labelling changes or withdrawal of products from the market, and any of Gemini’s product candidates may be subject to similar risks. Additionally, Gemini may be required to conduct additional nonclinical and clinical trials, require additional warnings on the label of Gemini’s products, reformulate Gemini’s product or make changes, create a medication guide outlining the risks of such side effects for distribution to patients and obtain new approvals for Gemini’s and Gemini’s suppliers’ manufacturing facilities for any product candidates. Gemini might have to withdraw or recall its products from the marketplace. Gemini may also experience a significant drop in the potential sales of Gemini’s products if and when regulatory approvals for such products are obtained, experience harm to Gemini’s reputation in the marketplace or become subject to lawsuits, including class actions. Any of these results could decrease or prevent any sales of Gemini’s approved products or substantially increase the costs and expenses of commercializing and marketing Gemini’s products.

Even if Gemini’s product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still face future development and regulatory difficulties.

Even if Gemini obtains regulatory approval for a product candidate, regulatory authorities may still impose significant restrictions on Gemini’s product candidates, including their indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies. Further, even if Gemini obtains regulatory approval for a product candidate, Gemini would be subject to ongoing requirements by the governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, tracking and tracing, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information.

The FDA and applicable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval. If the FDA or applicable foreign regulatory authorities become aware of new safety information after approval of Gemini’s product candidates, they may require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

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In addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practice (“cGMP”) regulations and standards. If Gemini or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or Gemini, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If Gemini, Gemini’s product candidates or the manufacturing facilities for Gemini’s product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

• issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;

• mandate modifications to promotional materials or require Gemini to provide corrective information to healthcare practitioners;

• require that Gemini conducts post-marketing studies;

• require Gemini to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;

• seek an injunction or impose civil or criminal penalties or monetary fines;

• suspend marketing of, withdraw regulatory approval of or recall such product;

• suspend any ongoing clinical studies;

• refuse to approve pending applications or supplements to applications filed by Gemini;

• suspend or impose restrictions on operations, including costly new manufacturing requirements; or

• seize or detain products, refuse to permit the import or export of products or require Gemini to initiate a product recall.

The occurrence of any event or penalty described above may inhibit Gemini’s ability to commercialize its products and generate revenue.

Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress and the public. Violations, including promotion of Gemini’s products for unapproved (or off-label) uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the government. Additionally, applicable foreign regulatory authorities will heavily scrutinize advertising and promotion of any product candidate that obtains approval outside of the United States.

In the United States, engaging in the impermissible promotion of Gemini’s products for off-label uses can also subject Gemini to false claims litigation under federal and state statutes, which can lead to civil and criminal penalties and fines and agreements that materially restrict the manner in which a company promotes or distributes drug and biologic products. These false claims statutes include the federal False Claims Act, which allows any individual to bring a lawsuit against a pharmaceutical company on behalf of the federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid. If the government prevails in the lawsuit, the individual will share in any fines or settlement funds. Since 2004, these federal False Claims Act lawsuits against pharmaceutical companies has increased significantly in volume and breadth, leading to several substantial civil and criminal settlements regarding certain sales practices promoting off-label product uses involving fines in excess of $1 billion. This growth in litigation has increased the risk that a pharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, agree to comply with burdensome reporting and compliance obligations and be excluded from Medicare, Medicaid and other federal and state healthcare programs. If Gemini does not lawfully promote Gemini’s approved products, Gemini may become subject to such litigation and, if Gemini does not successfully defend against such actions, those actions may have a material adverse effect on Gemini’s business, financial condition and results of operations.

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The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Gemini’s product candidates. If Gemini is slow or unable to adapt to changes in existing requirements or adopt new requirements or policies, or if Gemini is not able to maintain regulatory compliance, Gemini may lose any marketing approval that Gemini may have obtained, which would adversely affect Gemini’s business, prospects and ability to achieve or sustain profitability.

Healthcare insurance coverage and reimbursement may be limited or unavailable for Gemini’s product candidates, if approved, which could make it difficult for Gemini to sell its product candidates profitably.

To the extent Gemini continues to pursue product development, the success of Gemini’s product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors including governmental healthcare programs, such as Medicare and Medicaid, commercial payors, and health maintenance organizations. Gemini cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, Gemini’s product candidates or assure that coverage and reimbursement will be available for any product that Gemini may develop.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from third-party payors is critical to new product acceptance.

Third-party payors decide which products and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

• a covered benefit under its health plan;

• safe, effective and medically necessary;

• appropriate for the specific patient;

• cost-effective; and

• neither experimental nor investigational.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Gemini cannot be sure that reimbursement will be available for any product candidate that Gemini commercialize and, if reimbursement is available, the level of reimbursement.

In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price (“ASP”) and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a third-party payor is a time consuming and costly process that could require Gemini to provide to each payor supporting scientific, clinical and cost effectiveness data for the use of Gemini’s products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private third-party payors tend to follow Medicare coverage and reimbursement limitations to a substantial degree, but also has their own methods and approval process apart from Medicare determinations. Even if Gemini obtains coverage for a given product, the resulting reimbursement payment rates might not be adequate for Gemini to achieve or sustain profitability or may require co-payments that patients find unacceptably high.

In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European

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Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies. A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Gemini’s product candidates. Historically, products launched in the European Union do not follow price structures of the U.S. and generally prices tend to be significantly lower.

Gemini’s failure to obtain regulatory approval in international jurisdictions would prevent Gemini from marketing Gemini’s product candidates outside the United States.

Even if Gemini’s products are approved for marketing in the United States, in order to market and sell Gemini’s products in other jurisdictions, Gemini must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, Gemini must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that country. Obtaining applicable foreign regulatory authorities and compliance with applicable foreign regulatory requirements could result in significant delays, difficulties and costs for Gemini and could delay or prevent the introduction of Gemini’s products in certain countries. Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries and regulatory approval in one country does not ensure approval in any other country, while a failure or delay in obtaining regulatory approval in one country may has a negative effect on the regulatory approval process in others.

Also, regulatory approval for Gemini’s product candidates may be withdrawn if Gemini fails to comply with regulatory requirements, if problems occur after the product candidate reaches the market or for other reasons. If Gemini fails to comply with the regulatory requirements in international markets and fail to receive applicable marketing approvals, Gemini’s target market will be reduced and Gemini’s ability to realize the full market potential of Gemini’s product candidates will be harmed and Gemini’s business will be adversely affected. Gemini may not obtain applicable foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions. 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. If Gemini fails to obtain approval of Gemini’s product candidates by applicable foreign regulatory authorities, Gemini will be unable to commercialize Gemini product in that country, and the commercial prospects of that product candidate and Gemini’s business prospects could decline.

Gemini is subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair Gemini’s ability to compete in domestic and international markets. Gemini can face criminal liability and other serious consequences for violations, which can harm Gemini’s business.

Gemini is subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which Gemini conducts activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. Gemini may engage third parties to sell Gemini’s products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. Gemini has direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. Gemini can be held liable for the corrupt or other illegal activities of Gemini’s employees, agents, contractors, and other collaborators, even if Gemini does not explicitly authorize or has actual knowledge of such

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activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new or existing product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of Gemini’s business may rely, which could negatively impact Gemini’s business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency has fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which Gemini’s operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect Gemini’s business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, has had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process Gemini’s regulatory submissions, which could have a material adverse effect on Gemini’s business. Further, future government shutdowns could impact Gemini’s ability to access the public markets and obtain necessary capital in order to properly capitalize and continue Gemini’s operations.

Separately, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold due to the COVID-19 pandemic, the FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed. During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities.

If the FDA becomes unable to continue its current level of performance, Gemini could experience delays and setbacks for Gemini’s product candidates and for any approvals Gemini may seek which could adversely affect Gemini’s business.

Product candidates for which Gemini may choose to seek approval as biologic products may face competition sooner than anticipated.

Gemini believes that any of Gemini’s product candidates approved in the United States as a biological product under a Biologics License Application (“BLA”) should qualify for the 12-year period of regulatory exclusivity. The enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as part of the Affordable Care Act, created an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA. Certain changes, however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest, or other related entity do not qualify for the 12-year exclusivity period. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement the BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for Gemini’s biological products.

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However, there is also a risk that this exclusivity could be changed in the future. For example, this exclusivity could be shortened due to congressional action or through other actions, including future proposed budgets, international trade agreements and other arrangements or proposals. The extent to which a biosimilar, once approved, will be substituted for any one of its reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. It is also possible that payers will give reimbursement preference to biosimilars over reference biologics, even absent a determination of interchangeability.

To the extent that Gemini does not receive any anticipated periods of regulatory exclusivity for its product candidates or the FDA or foreign regulatory authorities approve any biosimilar, interchangeable, or other competing products to its product candidates, it could have a material adverse effect on Gemini’s business, financial condition, results of operations, stock price and prospects.

Risks Related to Intellectual Property

Gemini’s success depends upon its ability to obtain and maintain intellectual property protection for its products and technologies. It is difficult and costly to protect Gemini’s proprietary rights and technology, and Gemini may not be able to ensure their protection.

Gemini’s commercial success depends in part on its ability to obtain and maintain patent protection and trade secret protection for its product candidates, proprietary patient screening technologies and their uses as well as its ability to operate without infringing upon the proprietary rights of others. Gemini generally seeks to protect Gemini’s proprietary position by filing patent applications in the United States and abroad related to Gemini’s product candidates, proprietary technologies and their uses that are important to Gemini’s business. Gemini also seeks to protect its proprietary position by acquiring or in-licensing relevant issued patents or pending applications from third parties. Finally, Gemini maintains its non-patented, but proprietary technologies, as company trade secrets.

Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. There can be no assurance that Gemini’s patent applications or the patent applications of Gemini’s licensors will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.

Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for Gemini’s and Gemini’s licensors’ proprietary rights is uncertain. Only limited protection may be available and may not adequately protect Gemini’s rights or permit Gemini to gain or keep any competitive advantage. These uncertainties and/or limitations in Gemini’s ability to properly protect the intellectual property rights relating to Gemini’s product candidates could have a material adverse effect on Gemini’s financial condition and results of operations.

Gemini currently does not have any company-owned or in-licensed patents covering its product candidates. Gemini cannot be certain that the claims in U.S. pending patent applications, corresponding international patent applications and patent applications in certain foreign territories, or those of Gemini’s licensors, will be considered patentable by the United States Patent and Trademark Office (“USPTO”), courts in the United States or by the patent offices and courts in foreign countries, nor can Gemini be certain that the claims in Gemini’s issued patent or Gemini’s licensor’s issued patents will not be found invalid or unenforceable if challenged.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that Gemini or any of Gemini’s potential future collaborators will be successful in protecting Gemini’s product candidates by obtaining and defending patents. These risks and uncertainties include the following:

• the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;

• patent applications may not result in any patents being issued;

• patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

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• Gemini’s competitors, many of whom have substantially greater resources than Gemini does and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate Gemini’s ability to make, use and sell Gemini’s potential product candidates;

• there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and

• countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

The patent prosecution process is also expensive and time-consuming, and Gemini or Gemini’s licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that Gemini or Gemini’s licensors will fail to identify patentable aspects of Gemini’s research and development output before it is too late to obtain patent protection.

In addition, although Gemini enters into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of Gemini’s research and development output, such as Gemini’s employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing Gemini’s ability to seek patent protection.

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, Gemini’s intellectual property may not provide Gemini with sufficient rights to exclude others from commercializing products similar or identical to Gemini’s.

Gemini may be unable to obtain intellectual property rights or technology necessary to develop and commercialize Gemini’s product candidates.

Several third parties are actively researching and seeking and obtaining patent protection in the AMD field, and there are issued third-party patents and published third-party patent applications in these fields. Although no third party has asserted a claim of patent infringement against Gemini as of the date of this proxy statement/prospectus, a third party may hold proprietary rights that could prevent Gemini’s product candidates from being marketed. Gemini may not be aware of all third-party intellectual property rights potentially relating to Gemini’s product candidates and technologies.

Depending on what patent claims ultimately issue and how courts construe the issued patent claims, as well as depending on the ultimate formulation and method of use of Gemini’s product candidates, Gemini may need to obtain a license under such patents. There can be no assurance that such licenses will be available on commercially reasonable terms, or at all. If a third party does not offer Gemini a necessary license or offers a license only on terms that are unattractive or unacceptable to Gemini, Gemini might be unable to develop and commercialize one or more of Gemini’s product candidates, which would have a material adverse effect on Gemini’s business, financial condition and results of operations. Moreover, even if Gemini obtains licenses to such intellectual property, but subsequently fails to meet Gemini’s obligations under its license agreements, or such license agreements are terminated for any other reasons, Gemini may lose its rights to in-licensed technologies.

The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that Gemini may consider attractive or necessary. These established companies may have a competitive advantage over Gemini due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive Gemini to be a competitor may be unwilling to assign or license rights to Gemini. Gemini also may be unable to license or acquire third-party intellectual property rights on terms that would allow Gemini to make an appropriate return on Gemini’s investment, or at all. If Gemini is unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights Gemini has, Gemini may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on Gemini’s business, financial condition, results of operations and prospects.

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If Gemini fails to comply with its obligations under any license, collaboration or other agreements, Gemini may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting its product candidates.

Gemini is dependent on patents, know-how and proprietary technology in-licensed from licensors. Gemini’s commercial success depends upon its ability to develop, manufacture, market and sell Gemini’s product candidates and use Gemini’s and Gemini’s licensor’s proprietary technologies without infringing the proprietary rights of third parties. Licensors may have the right to terminate the license agreement in full in the event Gemini materially breaches or defaults in the performance of any of the obligations under the license agreement. A termination of the license agreement with any licensors could result in the loss of significant rights and could harm Gemini’s ability to commercialize Gemini’s product candidates.

Disputes may also arise between Gemini and any current or future potential licensors, regarding intellectual property subject to a license agreement, including:

• the scope of rights granted under the license agreement and other interpretation-related issues;

• whether and the extent to which Gemini’s technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

• Gemini’s right to sublicense patent and other rights to third parties under collaborative development relationships;

• Gemini’s diligence obligations with respect to the use of the licensed technology in relation to Gemini’s development and commercialization of Gemini’s product candidates and what activities satisfy those diligence obligations;

• the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Gemini’s licensors and Gemini and Gemini’s partners; and

• the priority of invention of patented technology.

If disputes over intellectual property that Gemini has licensed prevent or impair Gemini’s ability to maintain Gemini’s current licensing arrangements on acceptable terms, Gemini may be unable to successfully develop and commercialize the affected product candidates.

Gemini is generally also subject to all of the same risks with respect to protection of intellectual property that Gemini licenses, as Gemini is for intellectual property that Gemini owns, which are described below. If Gemini or Gemini’s licensors fail to adequately protect this intellectual property, Gemini’s ability to commercialize products could suffer.

Patent terms may be inadequate to protect Gemini’s competitive position on its product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering Gemini’s product candidates are obtained, once the patent life has expired, Gemini may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting Gemini’s product candidates might expire before or shortly after Gemini or Gemini’s partners commercialize those candidates. As a result, Gemini’s owned and licensed patent portfolio may not provide Gemini with sufficient rights to exclude others from commercializing products similar or identical to Gemini’s products.

Gemini may not be able to protect its intellectual property rights throughout the world.

The legal protection afforded to inventors and owners of intellectual property in countries outside of the United States may not be as protective or effective as that in the United States and Gemini may, therefore, be unable to acquire and enforce intellectual property rights outside the United States to the same extent as in the United States. Whether filed in the United States or abroad, Gemini’s patent applications may be challenged or may fail to result in issued patents.

Currently, Gemini does not own or have in-licensed issued patents covering its product candidates. Any future patents Gemini obtains may not be sufficiently broad to prevent others from practicing Gemini’s technologies or from

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developing or commercializing competing products. Furthermore, others may independently develop or commercialize similar or alternative technologies or drugs, or design around Gemini’s patents. Gemini’s patents may be challenged, invalidated, circumvented or narrowed, or fail to provide Gemini with any competitive advantages. In many foreign countries, patent applications and/or issued patents, or parts thereof, must be translated into the native language. If Gemini’s patent applications or issued patents are translated incorrectly, they may not adequately cover Gemini’s technologies; in some countries, it may not be possible to rectify an incorrect translation, which may result in patent protection that does not adequately cover Gemini’s technologies in those countries.

Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and Gemini’s intellectual property rights in some countries outside the United States are less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and certain state laws in the United States. Consequently, Gemini and Gemini’s licensor may not be able to prevent third parties from practicing Gemini’s and Gemini’s licensor’s inventions in all countries outside the United States, or from selling or importing products made using Gemini’s and Gemini’s licensor’s inventions in and into the United States or other jurisdictions. Competitors may use Gemini’s and Gemini’s licensor’s technologies in jurisdictions where Gemini has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Gemini and Gemini’s licensor have patent protection, but enforcement is not as strong as that in the United States. These products may compete with Gemini’s product candidates Gemini’s and Gemini’s licensor’s patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology. This could make it difficult for Gemini and Gemini’s licensor to stop the infringement of Gemini’s and Gemini’s licensor’s patents or the marketing of competing products in violation of Gemini’s and Gemini’s licensor’s proprietary rights, generally. Proceedings to enforce Gemini’s and Gemini’s licensor’s patent rights in foreign jurisdictions could result in substantial costs and divert Gemini’s and Gemini’s licensor’s efforts and attention from other aspects of Gemini’s business, could put Gemini’s and Gemini’s licensor’s patents at risk of being invalidated or interpreted narrowly, could place Gemini’s and Gemini’s licensor’s patent applications at risk of not issuing and could provoke third parties to assert claims against Gemini’s or Gemini’s licensor. Gemini’s or Gemini’s licensor may not prevail in any lawsuits that Gemini’s or Gemini’s licensor initiates and the damages or other remedies awarded, if any, may not be commercially meaningful.

The requirements for patentability differ in certain countries, particularly developing countries. For example, China has a heightened requirement for patentability and, specifically, requires a detailed description of medical uses of a claimed drug. In addition, India, certain countries in Europe and certain developing countries, including Thailand, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, Gemini’s and Gemini’s licensor may have limited remedies if patents are infringed or if Gemini’s or Gemini’s licensor are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit Gemini’s potential revenue opportunities. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. Accordingly, Gemini’s and Gemini’s licensor’s efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Gemini owns or licenses.

Obtaining and maintaining Gemini’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Gemini’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on issued United States patents and most foreign patent applications and patents must be paid to the USPTO and foreign patent agencies, respectively, in order to maintain such patents and patent applications. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application, examination and issuance processes. While an inadvertent lapse can, in some cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance 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. Non-compliance events that could result in abandonment or lapse of a patent or patent

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application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If Gemini or Gemini’s licensor fails to maintain the patents and patent applications covering Gemini’s product candidates, Gemini’s competitors might be able to enter the market with similar or identical products or technology, which would have a material adverse effect on Gemini’s business, financial condition and results of operations.

Gemini may become involved in lawsuits or other proceedings to protect or enforce Gemini’s intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of Gemini’s business.

Third parties may infringe on Gemini’s or Gemini’s licensor’s patents or misappropriate or otherwise violate Gemini’s or Gemini’s licensor’s intellectual property rights. In the future, Gemini or Gemini’s licensor may initiate legal proceedings to enforce or defend Gemini’s or Gemini’s licensor’s intellectual property rights, to protect Gemini’s or Gemini’s licensor’s trade secrets or to determine the validity or scope of intellectual property rights Gemini owns or controls. Also, third parties may initiate legal proceedings against Gemini’s or Gemini’s licensor to challenge the validity or scope of intellectual property rights Gemini owns, controls or to which Gemini has rights. For example, generic or biosimilar drug manufacturers or other competitors or third parties may challenge the scope, validity or enforceability of Gemini’s or Gemini’s licensor’s patents, requiring Gemini or Gemini’s licensor to engage in complex, lengthy and costly litigation or other proceedings. These proceedings can be expensive and time-consuming and many of Gemini’s or Gemini’s licensor’s adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than Gemini can. Moreover, the outcome following legal assertions of invalidity and unenforceability is unpredictable. Accordingly, despite Gemini’s or Gemini’s licensor’s efforts, Gemini or Gemini’s licensor may not be able to prevent third parties from infringing upon or misappropriating intellectual property rights Gemini owns, controls or has rights to, particularly in countries where the laws may not protect those rights as fully as in the United States. Litigation could result in substantial costs and diversion of management resources, which could harm Gemini’s business and financial results. In addition, if Gemini or Gemini’s licensor initiated legal proceedings against a third party to enforce a patent covering a product candidate, the defendant could counterclaim that such patent is 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 or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. In an infringement or declaratory judgment proceeding, a court may decide that a patent owned by or licensed to Gemini is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that Gemini or Gemini’s licensor’s patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of Gemini’s or Gemini’s licensor’s patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that would not preclude third parties from entering the market with competing products.

Third-party pre-issuance submission of prior art to the USPTO, or opposition, derivation, revocation reexamination, or inter partes review, or other pre-issuance or post-grant proceedings or other patent office proceedings or litigation in the United States or other jurisdictions provoked by third parties or brought by Gemini or Gemini’s licensor, may be necessary to determine the inventorship, priority, patentability or validity of inventions with respect to Gemini’s or Gemini’s licensor’s patents or patent applications. An unfavorable outcome could leave Gemini’s technology or product candidates without patent protection, allow third parties to commercialize Gemini’s technology or product candidates and compete directly with Gemini, without payment to Gemini, or could require Gemini or Gemini’s licensor to obtain license rights from the prevailing party in order to be able to manufacture or commercialize Gemini’s product candidates without infringing third-party patent rights. Gemini’s business could be harmed if the prevailing party does not offer Gemini or Gemini’s licensor a license on commercially reasonable terms, or at all. Even if Gemini or Gemini’s licensor obtains a license, it may be non-exclusive, thereby giving Gemini’s competitors access to the same technologies licensed to Gemini or Gemini’s licensor. In addition, if the breadth or strength of protection provided by Gemini’s or Gemini’s licensor’s patents and patent applications is threatened, it could dissuade companies from collaborating with Gemini to license, develop or commercialize product candidates. Even if Gemini successfully defends such litigation or proceeding, Gemini may incur substantial costs and it may distract Gemini’s management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on Gemini’s ability to raise the funds necessary to continue Gemini’s clinical trials, continue Gemini’s research programs, license necessary technology from third parties, or enter into collaborations.

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Gemini’s confidential information could be compromised by disclosure during this type of litigation. In addition, many foreign jurisdictions have rules of discovery that are different than those in the United States and which may make defending or enforcing Gemini’s or Gemini’s licensor’s patents extremely difficult. 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 a material adverse effect on the price of shares of Gemini’s Common Stock.

Third parties may initiate legal proceedings against Gemini alleging that Gemini is infringing on their intellectual property rights or Gemini may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, the outcome of which would be uncertain and could have a material adverse effect on the success of Gemini’s business.

Gemini’s commercial success depends upon Gemini’s ability to develop, manufacture, market and sell any product candidates that Gemini may develop and use Gemini’s proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights. Third parties may initiate legal proceedings against Gemini or Gemini’s licensor alleging that Gemini or Gemini’s licensor is infringing on their intellectual property rights or Gemini or Gemini’s licensor may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions, revocations, reexaminations, inter partes review or derivation proceedings before the USPTO or its counterparts in other jurisdictions. These proceedings can be expensive and time-consuming and many of Gemini’s or Gemini’s licensor’s adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than Gemini or Gemini’s licensor can.

An unfavorable outcome in any such proceeding could require Gemini or Gemini’s licensor to cease using the related technology or developing or commercializing Gemini’s product candidates, or to attempt to license rights to it from the prevailing party, which may not be available on commercially reasonable terms, or at all.

Gemini could be found liable for monetary damages, including treble damages and attorneys’ fees, if Gemini is found to have willfully infringed a patent. A finding of infringement could prevent Gemini from commercializing Gemini’s product candidates or force Gemini to cease some of Gemini’s business operations, which could materially harm Gemini’s business.

Gemini performs searches of patent and scientific databases in order to identify documents that may be of potential relevance to the freedom-to-operate and/or patentability of Gemini’s product candidates. In general, such searches are conducted based on keywords, sequences, inventors/authors and assignees/entities to capture U.S. and European patents and patent applications, PCT publications and scientific journal articles.

Gemini may not be aware of all third-party intellectual property rights potentially relating to Gemini’s product candidates and technologies. Moreover, it is possible that Gemini may become aware of patents or pending patent applications that Gemini thinks do not relate to Gemini’s product candidates or that Gemini believes are invalid or unenforceable, but that may nevertheless be interpreted to encompass Gemini’s product candidates and to be valid and enforceable. As to pending third-party applications, Gemini cannot predict with any certainty which claims will issue, if any, or the scope of such issued claims. If any third party intellectual property claims are asserted against Gemini, even if Gemini believes the claims are without merit, there is no assurance that a court would find in Gemini’s favor, e.g., on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect Gemini’s ability and the ability of Gemini’s licensor to commercialize any product candidates Gemini may develop and any other product candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, Gemini would need to overcome a presumption of validity. As this burden is a high one requiring Gemini 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 any such third-party patents (including those that may issue from such applications) were successfully asserted against Gemini or Gemini’s licensor or other commercialization partners and Gemini were unable to successfully challenge the validity or enforceability of any such asserted patents, then Gemini or Gemini’s licensor and other commercialization partners may be prevented from commercializing Gemini’s product candidates, or may be required to pay significant damages, including treble damages and attorneys’ fees if Gemini is found to willfully infringe the asserted patents, or obtain a license to such patents, which may not

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be available on commercially reasonable terms, or at all. Even if Gemini was able to obtain a license, it could be non-exclusive, thereby giving Gemini’s competitors and other third parties access to the same technologies licensed to Gemini, and it could require Gemini to make substantial licensing and royalty payments. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from Gemini’s business. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of Gemini’s confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on Gemini’s ability to raise additional funds or otherwise have a material adverse effect on Gemini’s business, results of operations, financial condition and prospects. Any of the foregoing would have a material adverse effect on Gemini’s business, financial condition and operating results.

Gemini may be subject to claims by third parties asserting that Gemini’s employees or Gemini has misappropriated a third party’s intellectual property, or claiming ownership of what Gemini regards as Gemini’s own intellectual property.

Many of Gemini’s employees, including Gemini’s senior management, were previously employed at other biotechnology or pharmaceutical companies, including Gemini’s competitors or potential competitors. Some of these employees executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Gemini may be subject to claims that Gemini or these employees have used or disclosed confidential information or intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer, or that third parties have an interest in Gemini’s patents as an inventor or co-inventor. Litigation may be necessary to defend against these claims. If Gemini fails in prosecuting or defending any such claims, in addition to paying monetary damages, Gemini may lose valuable intellectual property rights or personnel or sustain other damages. Such intellectual property rights could be awarded to a third party, and Gemini could be required to obtain a license from such third party to commercialize Gemini’s technology or products. Such a license may not be available on commercially reasonable terms, or at all. Even if Gemini successfully prosecutes or defends against such claims, litigation could result in substantial costs and distract management.

In addition, while it is Gemini’s policy to require Gemini’s employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Gemini, Gemini may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Gemini regards as Gemini’s own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and Gemini may be forced to bring claims against third parties, or defend claims that they may bring against Gemini, to determine the ownership of what Gemini regards as Gemini’s intellectual property. Such claims could have a material adverse effect on Gemini’s business, financial condition, results of operations and prospects.

Gemini’s inability to protect Gemini’s confidential information and trade secrets would harm Gemini’s business and competitive position.

In addition to seeking patents for some of Gemini’s technology and products, in Gemini’s activities Gemini also relies substantially on trade secrets, including unpatented know-how, technology and other proprietary materials and information, to maintain Gemini’s competitive position. Gemini seeks to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as Gemini’s employees, corporate collaborators, outside scientific collaborators, CMOs, consultants, advisors and other third parties. Gemini also enters into confidentiality and invention or patent assignment agreements with Gemini’s employees and consultants. However, these steps may be inadequate, Gemini may fail to enter into agreements with all such parties or any of these parties may breach the agreements and disclose Gemini’s proprietary information, and there may be no adequate remedy available for such breach of an agreement. Gemini cannot assure you that Gemini’s proprietary information will not be disclosed or that Gemini can meaningfully protect Gemini’s trade secrets. 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 both within and outside the United States may be less willing, or unwilling, to protect trade secrets. If a competitor lawfully obtained or independently developed any of Gemini’s trade secrets, Gemini would have no right to prevent such competitor from using that technology or information to compete with Gemini, which could harm Gemini’s competitive position.

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Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by Gemini’s intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect Gemini’s business or permit Gemini to maintain Gemini’s competitive advantage. For example:

• others may be able to make products that are similar to any product candidates Gemini may develop or utilize similar technology but that are not covered by the claims of the patents that Gemini licenses or may own in the future;

• Gemini’s, or Gemini’s current or future collaborators, might not have been the first to make the inventions covered by the issued patents and pending patent applications that Gemini licenses or may own in the future;

• Gemini, or Gemini’s current or future collaborators, might not have been the first to file patent applications covering certain of Gemini’s or their inventions;

• others may independently develop similar or alternative technologies or duplicate any of Gemini’s technologies without infringing Gemini’s owned or licensed intellectual property rights;

• it is possible that Gemini’s pending patent applications or those that Gemini may own in the future will not lead to issued patents;

• issued patents that Gemini holds rights to may be held invalid or unenforceable, including as a result of legal challenges by Gemini’s competitors;

• Gemini’s competitors might conduct research and development activities in countries where Gemini does not have patent rights and then use the information learned from such activities to develop competitive products for sale in Gemini’s major commercial markets;

• Gemini may not develop additional proprietary technologies that are patentable;

• the patents of others may harm Gemini’s business; and

• Gemini may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on Gemini’s business, financial condition, results of operations and prospects.

Patents that ultimately issue that cover Gemini’s product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If Gemini or Gemini’s licensing partner initiate legal proceedings against a third party to enforce a patent, if obtained, covering Gemini’s product candidates, the defendant could counterclaim that the patent covering Gemini’s product candidates, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. These types of mechanisms include inter partes review, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). These types of proceedings could result in revocation or amendment to Gemini’s patents such that they no longer cover Gemini’s product candidates. The outcome for any particular patent following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, Gemini cannot be certain that there is no invalidating prior art, of which Gemini, Gemini’s patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if Gemini is otherwise unable to adequately protect Gemini’s rights, Gemini would lose at least part, and perhaps all, of the patent protection on Gemini’s product candidates. A loss of patent protection for Gemini’s product candidates could have a material adverse impact on Gemini’s ability to commercialize or license Gemini’s technology and product candidates and, resultantly, on Gemini’s business, financial condition, prospects and results of operations.

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Changes in patent law could diminish the value of patents in general, thereby impairing Gemini’s ability to protect Gemini’s product candidates.

As is the case with other biotechnology and pharmaceutical companies, Gemini’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnology industry involves technological and legal complexity, and obtaining and enforcing biotechnology patents is costly, time-consuming and inherently uncertain. 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, weakening the rights of patent owners in certain situations or ruling that certain subject matter is not eligible for patent protection. In addition to increasing uncertainty with regard to Gemini’s and Gemini’s licensor’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 decisions by Congress, the federal courts, the USPTO and equivalent bodies in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken Gemini’s and Gemini’s licensor’s ability to obtain new patents or to enforce existing patents and patents Gemini and Gemini’s licensor may obtain in the future.

Patent reform laws, such as the Leahy-Smith America Invents Act (“Leahy-Smith Act”), as well as changes in how patent laws are interpreted, could increase the uncertainties and costs surrounding the prosecution of Gemini’s and Gemini’s licensor’s patent applications and the enforcement or defense of Gemini’s or Gemini’s licensor’s issued patents. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the filing and prosecution strategies associated with patent applications, including a change from a “first-to-invent” to a “first-inventor-to-file” patent system, and may also affect patent prosecution and litigation, such as by allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The USPTO has developed 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-inventor-to-file” provisions, became effective in 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will has on the operation of Gemini’s business. However, the Leahy-Smith Act and Gemini’s implementation could increase the uncertainties and costs surrounding the prosecution of Gemini’s or Gemini’s licensor’s patent applications and the enforcement or defense of Gemini’s or Gemini’s licensor’s issued patents, all of which could has a material adverse effect on Gemini’s business, financial condition and results of operations.

Risks Related to Reliance on Third Parties

Gemini may rely on third parties to conduct Gemini’s clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, Gemini may not be able to obtain regulatory approval of or commercialize any potential product candidates.

Gemini continues to depend upon third parties, including independent investigators, to conduct Gemini’s clinical trials under agreements with universities, medical institutions, CROs, strategic partners and others. Gemini continues to negotiate budgets and contracts with CROs and trial sites, which may result in delays to Gemini’s development timelines and increased costs.

Gemini continues to rely heavily on third parties over the course of Gemini’s clinical trials, and, as a result, will have limited control over the clinical investigators and limited visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol. Nevertheless, Gemini’s reliance on third parties does not relieve Gemini of Gemini’s regulatory responsibilities and Gemini are responsible for ensuring that each of Gemini’s trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. Gemini and these third parties are required to comply with good clinical practice (“GCP”) requirements, which are regulations and guidelines enforced by the FDA and applicable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites. If Gemini or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated in Gemini’s clinical trials may be deemed unreliable and the FDA or applicable foreign regulatory authorities may require Gemini to suspend or terminate these trials or perform additional nonclinical studies or clinical trials before approving Gemini’s marketing applications. Gemini cannot be certain that, upon inspection, regulatory authorities will determine that any of Gemini’s clinical trials comply with the GCP requirements. In addition, Gemini’s clinical trials must be conducted with products produced under cGMP requirements and may require a large number of patients. Gemini’s failure or any failure by these third parties to comply with these applicable regulations or to recruit a sufficient number of patients may require

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Gemini to repeat clinical trials, which would delay the regulatory approval process. Moreover, Gemini’s business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

The third parties who may conduct Gemini’s future clinical trials will not be Gemini’s employees and, except for remedies that may be available to Gemini under Gemini’s agreements with those third parties, Gemini cannot control whether or not they devote sufficient time and resources to Gemini’s ongoing nonclinical and clinical programs. These third parties may also have relationships with other commercial entities, including Gemini’s competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on Gemini’s behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to Gemini’s clinical protocols or regulatory requirements or for other reasons, Gemini’s clinical trials may be extended, delayed or terminated and Gemini may not be able to complete development of, obtain regulatory approval of or successfully commercialize Gemini’s product candidates in a timely manner or at all. As a result, Gemini’s financial results and the commercial prospects for Gemini’s product candidates would be harmed, Gemini’s costs could increase and Gemini’s ability to generate revenue could be delayed.

If any of Gemini’s relationships with these third-party CROs or others terminate, Gemini may not be able to enter into arrangements with alternative CROs or other third parties or to do so on commercially reasonable terms. Switching or adding additional CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result, delays may occur, which can materially impact Gemini’s ability to meet Gemini’s desired clinical development timelines. Though Gemini carefully manages Gemini’s relationships with Gemini’s CROs, there can be no assurance that Gemini will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on Gemini’s business, financial condition and prospects.

If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure (including by clinical sites or investigators) to adhere to Gemini’s clinical protocols, regulatory requirements or for other reasons, Gemini’s clinical trials may be extended, delayed or terminated and Gemini may not be able to obtain regulatory approval for or successfully commercialize Gemini’s product candidates. As a result, Gemini’s results of operations and the commercial prospects for Gemini’s product candidates would be harmed, Gemini’s costs could increase substantially and Gemini’s ability to generate revenues could be delayed significantly.

Gemini contracts with third parties for the manufacture of Gemini’s product candidates for nonclinical testing and expects to continue to do so for clinical trials and for commercialization, if approved. This reliance on third parties increases the risk that Gemini will not have sufficient quantities of Gemini’s product candidates or products, if approved, or that such supply will not be available to Gemini at an acceptable cost, which could delay, prevent or impair Gemini’s development or commercialization efforts.

Gemini does not have any manufacturing facilities. Gemini currently relies, and expects to continue to rely, on third-party manufacturers for the manufacture of Gemini’s product candidates for nonclinical and clinical testing and for commercial supply of any of these product candidates for which Gemini obtains marketing approval. Reliance on third-party manufacturers may expose Gemini to different risks than if Gemini was to manufacture product candidates itself. Any disruption in supply from any supplier or manufacturing location, including on account of the ongoing COVID-19 pandemic, could lead to supply delays or interruptions which would damage Gemini’s business, financial condition, results of operations and prospects. To the extent any issues arise with Gemini’s third-party manufacturers, Gemini may be unable to establish any agreements with any other third-party manufacturers or to do so on acceptable terms. Even if Gemini is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

• the possible breach of the manufacturing agreement by the third party;

• the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for Gemini; and

• reliance on the third party for regulatory compliance, quality assurance and safety and pharmacovigilance reporting.

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Third-party manufacturers may not be able to comply with cGMP regulations or applicable foreign regulatory requirements. Gemini’s failure, or the failure of third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on Gemini, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or medicines, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of Gemini’s product candidates and harm Gemini’s business and results of operations.

Any product candidates that Gemini may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for Gemini.

Any performance failure on the part of Gemini’s existing or future manufacturers could delay clinical development or marketing approval. Gemini does not currently have arrangements in place for redundant supply for bulk drug substances. If any one of Gemini’s current CMOs cannot perform as agreed, Gemini may be required to replace that manufacturer. Although Gemini believes that there are several potential alternative manufacturers who could manufacture Gemini’s product candidates, Gemini may incur added costs and delays in identifying and qualifying any such replacement.

Gemini’s current and anticipated future dependence upon others for the manufacture of Gemini’s product candidates may adversely affect Gemini’s future profit margins and Gemini’s ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

The manufacturing of Gemini’s product candidates is complex, and Gemini may encounter difficulties in production. If Gemini or any of Gemini’s third-party manufacturers encounter such difficulties, or fails to meet rigorously enforced regulatory standards, Gemini’s ability to provide supply of Gemini’s product candidates for clinical trials or Gemini’s products for patients, if approved, could be delayed or stopped, or Gemini may be unable to maintain a commercially viable cost structure.

The processes involved in manufacturing Gemini’s product candidates are complex, expensive, highly-regulated, and subject to multiple risks. Further, as product candidates are developed through nonclinical studies to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause Gemini’s product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

In addition, the manufacturing process for any products that Gemini may develop is subject to FDA and other applicable foreign regulatory authority approval processes and continuous oversight, and Gemini will need to contract with manufacturers who can meet all applicable FDA and applicable foreign regulatory authority requirements, including, for example, complying with cGMPs, on an ongoing basis. If Gemini or Gemini’s third-party manufacturers are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, Gemini may not obtain or maintain the approvals Gemini needs to commercialize such products. Even if Gemini obtains regulatory approval for any of Gemini’s product candidates, there is no assurance that either Gemini or Gemini’s CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Any of these challenges could delay completion of clinical trials, require bridging or comparability nonclinical or clinical trials or the repetition of one or more clinical trials, increase clinical study costs, delay approval of Gemini’s product candidates, impair commercialization efforts, increase Gemini’s cost of goods, and has an adverse effect on Gemini’s business, financial condition, results of operations, and growth prospects.

Gemini may seek to establish collaborations, and, if Gemini is not able to establish them on commercially reasonable terms, Gemini may have to alter Gemini’s development and commercialization plans.

Gemini may pursue collaborations in order to develop and commercialize its product candidates. Gemini faces significant competition in seeking appropriate collaborators. Whether Gemini reaches a definitive agreement for a collaboration will depend, among other things, upon Gemini’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 clinical trials, the likelihood of approval by the

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FDA or applicable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and the existence of uncertainty with respect to Gemini’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 collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with Gemini for Gemini’s product candidates.

Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

Gemini may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If Gemini is unable to do so, Gemini may have to curtail the development of the product candidate for which Gemini is seeking to collaborate, reduce or delay Gemini’s development program or one or more of Gemini’s other development programs, delay Gemini’s potential commercialization or reduce the scope of any sales or marketing activities or increase Gemini’s expenditures and undertake development or commercialization activities at Gemini’s own expense. If Gemini elects to increase Gemini’s expenditures to fund development or commercialization activities on Gemini’s own, Gemini may need to obtain additional capital, which may not be available to Gemini on acceptable terms, or at all. If Gemini does not have sufficient funds, Gemini may not be able to further develop Gemini’s product candidates or bring them to market and generate product revenue.

Risks Related to Commercialization

Even if Gemini commercializes Gemini’s product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm Gemini’s business.

The regulations that govern marketing approvals, pricing and reimbursement for new drugs and biologics vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, Gemini might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay or limit Gemini’s commercial launch of the product, possibly for lengthy time periods, which could negatively impact the revenue Gemini generates from the sale of the product in that particular country. Adverse pricing limitations may hinder Gemini’s ability to recoup Gemini’s investment in one or more product candidates, even if Gemini’s product candidates obtain marketing approval.

Gemini’s ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors such as government health administration authorities, private health insurers and other organizations. Third-party payors determine which medications they will cover and establish reimbursement levels. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Gemini cannot be sure that coverage and reimbursement will be available for any product that Gemini commercialize and, if reimbursement is available, what the level of reimbursement will be. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which Gemini obtains marketing approval, if any. If coverage and reimbursement are not available or reimbursement is available only to limited levels, Gemini may not be able to successfully commercialize any product candidate for which marketing approval is obtained, if any.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which the product is approved by the FDA or applicable foreign regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers Gemini’s costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs and biologics, if applicable, may also not be sufficient to cover Gemini’s costs and may only be temporary. Reimbursement rates may vary according to the use of the

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product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost products and may be incorporated into existing payments for other services. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs and biologics from countries where they may be sold at lower prices than in the United States. Gemini’s inability to promptly obtain coverage and profitable reimbursement rates third-party payors for any approved products that Gemini develops could have a material adverse effect on Gemini’s operating results, Gemini’s ability to raise capital needed to commercialize products and Gemini’s overall financial condition.

If, in the future, Gemini is unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates Gemini may develop, Gemini may not be successful in commercializing those product candidates if and when they are approved.

Gemini does not currently have an infrastructure for the sales, marketing, and distribution of pharmaceutical products. In order to market Gemini’s product candidates, if approved by the FDA or any other regulatory body, Gemini must build Gemini’s sales, marketing, managerial, and other non-technical capabilities, or make arrangements with third parties to perform these services. There are risks involved with both establishing Gemini’s own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which Gemini recruits a sales force and establishes marketing and other commercialization capabilities is delayed or does not occur for any reason, Gemini would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and Gemini’s investment would be lost if Gemini cannot retain or reposition Gemini’s commercialization personnel.

If Gemini enters into arrangements with third parties to perform sales, marketing, commercial support, and distribution services, Gemini’s product revenue or the profitability of product revenue may be lower than if Gemini was to market and sell any products Gemini may develop itself. In addition, Gemini may not be successful in entering into arrangements with third parties to commercialize Gemini’s product candidates or may be unable to do so on terms that are favorable to Gemini. Gemini may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market Gemini’s products effectively and they could expose Gemini’s company to regulatory enforcement and legal risk in the execution of their sales and commercialization activities. If Gemini does not establish commercialization capabilities successfully, either on Gemini’s own or in collaboration with third parties, Gemini will not be successful in commercializing Gemini’s product candidates if approved.

If Gemini is unable to establish adequate sales, marketing, and distribution capabilities, whether independently or with third parties, or if Gemini is unable to do so on commercially reasonable terms, Gemini’s business, results of operations, financial condition, and prospects will be materially adversely affected.

Gemini’s product candidates may not achieve adequate market acceptance among physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even if Gemini’s product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors, pharmaceutical companies and others in the medical community. Demonstrating the safety and efficacy of Gemini’s product candidates and obtaining regulatory approvals will not guarantee future revenue. Gemini’s commercial success also depends on coverage and adequate reimbursement of Gemini’s product candidates by third-party payors, including government payors and private insurers, which may be difficult or time-consuming to obtain, may be limited in scope and may not be obtained in all jurisdictions in which Gemini may seek to market Gemini’s products. Third-party payors closely examine medical products to determine whether they should be covered by reimbursement and, if so, the level of reimbursement that will apply. Gemini cannot be certain that third-party payors will sufficiently reimburse sales of Gemini’s product, or enable Gemini to sell Gemini’s product at a profitable price. Similar concerns could also limit the reimbursement amounts that health insurers or government agencies in other countries are prepared to pay for Gemini’s products. In many regions outside the United States where Gemini may pursue regulatory approvals and market Gemini’s products, the pricing of prescription drugs is controlled by the government or regulatory agencies.

Regulatory agencies in these countries could determine that the pricing for Gemini’s products should be based on prices of other commercially available products for the same disease, rather than allowing Gemini to market Gemini’s

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products at a premium as new drugs. The degree of market acceptance of any of Gemini’s approved product candidates will depend on a number of factors, including:

• the efficacy and safety profile of the product candidate as demonstrated in clinical trials;

• the timing of market introduction of the product candidate as well as competitive products;

• the clinical indications for which the product candidate is approved;

• acceptance of the product candidate as a safe and effective treatment by clinics and patients;

• the potential and perceived advantages of the product candidate over alternative treatments, including any similar generic treatments;

• the cost of treatment in relation to alternative treatments;

• the availability of coverage and adequate reimbursement and pricing by third-party payors;

• the relative convenience and ease of administration;

• the frequency and severity of adverse events;

• the effectiveness of sales and marketing efforts; and

• unfavorable publicity relating to Gemini’s product candidates.

Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. Gemini cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that Gemini’s product is safe, therapeutically effective and cost effective as compared with competing treatments. If any product candidate is approved but does not achieve an adequate level of acceptance by such parties, Gemini may not generate or derive sufficient revenue from that product candidate and may not become or remain profitable.

Potential product liability lawsuits against Gemini could cause Gemini to incur substantial liabilities and to limit commercialization of any products that Gemini may develop and insurance coverage may not be adequate.

Gemini faces an inherent risk of product liability exposure related to the testing of Gemini’s product candidates in human clinical trials and will face an even greater risk if Gemini commercializes any resulting products. Product liability claims may be brought against Gemini by subjects enrolled in Gemini’s clinical trials, patients, their family members, healthcare providers or others using, administering or selling Gemini’s products. If Gemini cannot successfully defend itself against claims that Gemini’s product candidates or products that Gemini may develop caused injuries, Gemini could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

• decreased demand for any product candidates or products that Gemini may develop;

• termination of clinical trial sites or entire trial programs;

• injury to Gemini’s reputation and significant negative media attention;

• withdrawal of clinical trial participants;

• significant costs to defend the related litigation;

• substantial monetary awards to trial subjects or patients;

• loss of revenue;

• diversion of management and scientific resources from Gemini’s business operations;

• the inability to commercialize any products that Gemini may develop; and

• a decline in Gemini’s stock price.

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Gemini’s clinical trial liability insurance coverage may not adequately cover all liabilities that Gemini may incur. Gemini may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Gemini’s inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or delay the commercialization of any products or product candidates that Gemini develops. Gemini intends to expand Gemini’s insurance coverage for products to include the sale of commercial products if Gemini obtains marketing approval for Gemini’s product candidates in development, but Gemini may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. Large judgments have been awarded in lawsuits based on drugs that had unanticipated side effects. If Gemini is sued for any injury caused by Gemini’s products, product candidates or processes, Gemini’s liability could exceed Gemini’s product liability insurance coverage and Gemini’s total assets. Claims against Gemini, regardless of their merit or potential outcome, may also generate negative publicity or hurt Gemini’s ability to obtain physician adoption of Gemini’s product or expand Gemini’s business.

Risks Related to Gemini’s Common Stock

There can be no assurance that Gemini will be able to comply with the continued listing standards of Nasdaq.

If Nasdaq delists Gemini’s shares of common stock from trading on its exchange for failure to meet Nasdaq’s listing standards, Gemini and Gemini’s stockholders could face significant material adverse consequences including:

• a limited availability of market quotations for Gemini’s securities;

• reduced liquidity for Gemini’s securities;

• a determination that Gemini’s common stock is a “penny stock” which will require brokers trading in Gemini’s common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for Gemini’s securities;

• a limited amount of news and analyst coverage; and

• a decreased ability to issue additional securities or obtain additional financing in the future.

The price of Gemini’s common stock has been and may continue to be volatile and the value of an investment in Gemini’s common stock may decline.

Gemini’s stock price has been and is likely to continue to be highly volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced periods of extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, a holder may not be able to sell Gemini’s common stock at or above the price at which such holder acquired shares of Gemini’s common stock.

The price of Gemini’s common stock may fluctuate due to a variety of factors, including:

• changes in the industries in which Gemini’s and Gemini’s customers operate;

• variations in Gemini’s operating performance and the performance of Gemini’s competitors in general;

• material and adverse impact of the ongoing COVID-19 pandemic on the markets and the broader global economy;

• actual or anticipated fluctuations in Gemini’s quarterly or annual operating results;

• publication of research reports by securities analysts about Gemini or Gemini’s competitors or Gemini’s industry;

• the public’s reaction to Gemini’s press releases, Gemini’s other public announcements and Gemini’s filings with the SEC;

• Gemini’s failure or the failure of Gemini’s competitors to meet analysts’ projections or guidance that Gemini or Gemini’s competitors may give to the market;

• additions and departures of key personnel;

• changes in laws and regulations affecting Gemini’s business;

• commencement of, or involvement in, litigation involving Gemini;

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• changes in Gemini’s capital structure, such as future issuances of securities or the incurrence of additional debt;

• the volume of shares of Gemini’s common stock available for public sale; and

• general economic, political and geopolitical conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs, social, political and economic risks and acts of war or terrorism, such as the recent invasion by Russia of Ukraine.

These market and industry factors may materially reduce the market price of Gemini’s common stock regardless of Gemini’s operating performance.

Reports published by analysts, including projections in those reports that differ from Gemini’s actual results, could adversely affect the price and trading volume of Gemini’s common stock.

Securities research analysts may establish or discontinue coverage and may publish their own periodic projections for Gemini. These projections may vary widely and may not accurately predict the results Gemini actually achieves. Gemini’s share price may decline if Gemini’s actual results do not match the projections of these securities research analysts. Similarly, if one or more of the analysts who write reports on Gemini downgrades Gemini’s stock or publishes inaccurate or unfavorable research about Gemini’s business, Gemini’s share price could decline. If one or more of these analysts ceases coverage of Gemini or fails to publish reports on Gemini regularly, Gemini’s share price or trading volume could decline.

The future sales of shares by existing stockholders and future exercise of registration rights may adversely affect the market price of Gemini’s Common Stock.

Sales of a substantial number of shares of Gemini’s Common Stock in the public market could occur at any time. If Gemini’s stockholders sell, or the market perceives that Gemini’s stockholders intend to sell, substantial amounts of Gemini’s Common Stock in the public market, the market price of Gemini’s Common Stock could decline.

Gemini’s issuance of additional capital stock in connection with financings, acquisitions, investments, Gemini’s stock incentive plans or otherwise will dilute all other stockholders.

Gemini expects to issue additional capital stock in the future that will result in dilution to all other stockholders. Gemini expects to grant equity awards to employees, directors, and consultants under Gemini’s stock incentive plans. Gemini may also raise capital through equity financings in the future. As part of Gemini’s business strategy, Gemini may acquire or make investments in complementary companies, products, or technologies and issue equity securities to pay for any such acquisition or investment. Any such issuances of additional capital stock may cause stockholders to experience significant dilution of their ownership interests and the per share value of Gemini’s common stock to decline.

Because Gemini has no current plans to pay cash dividends on Gemini’s common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.

Gemini has no current plans to pay cash dividends on Gemini’s common stock. The declaration, amount and payment of any future dividends will be at the sole discretion of Gemini’s board of directors. Gemini’s board of directors may take into account general and economic conditions, Gemini’s financial condition and operating results, Gemini’s available cash, current and anticipated cash needs, capital requirements, contractual, legal, tax and regulatory restrictions, implications on the payment of dividends by Gemini to Gemini’s stockholders or by Gemini’s subsidiary to Gemini and such other factors as Gemini’s board of directors may deem relevant. In addition, the terms of Gemini’s existing financing arrangements restrict or limit Gemini’s ability to pay cash dividends. Accordingly, Gemini may not pay any dividends on Gemini’s common stock in the foreseeable future.

Future offerings of debt or equity securities by Gemini may adversely affect the market price of Gemini’s common stock.

In the future, Gemini may attempt to obtain financing or to further increase Gemini’s capital resources by issuing additional shares of Gemini’s common stock or offering debt or other equity securities, including commercial paper, medium-term notes, senior or subordinated notes, debt securities convertible into equity or shares of preferred stock. Future acquisitions could require substantial additional capital in excess of cash from operations. Gemini would expect to obtain the capital required for acquisitions through a combination of additional issuances of equity, corporate indebtedness and/or cash from operations.

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Issuing additional shares of Gemini’s common stock or other equity securities or securities convertible into equity may dilute the economic and voting rights of Gemini’s existing stockholders or reduce the market price of Gemini’s common stock or both. Upon liquidation, holders of such debt securities and preferred shares, if issued, and lenders with respect to other borrowings would receive a distribution of Gemini’s available assets prior to the holders of Gemini’s common stock. Debt securities convertible into equity could be subject to adjustments in the conversion ratio pursuant to which certain events may increase the number of equity securities issuable upon conversion. Preferred shares, if issued, could have a preference with respect to liquidating distributions or a preference with respect to dividend payments that could limit Gemini’s ability to pay dividends to the holders of Gemini’s common stock. Gemini’s decision to issue securities in any future offering will depend on market conditions and other factors beyond Gemini’s control, which may adversely affect the amount, timing and nature of Gemini’s future offerings.

Gemini may incur significant additional costs as a result of being a public company, which may adversely affect Gemini’s operating results and financial condition.

Gemini may incur costs associated with corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”), as well as rules implemented by the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”), the SEC and Nasdaq. Gemini’s management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, Gemini expects these rules and regulations are expected to increase Gemini’s accounting, legal and financial compliance costs and make some activities more time-consuming and costly. In addition, Gemini will incur additional costs associated with Gemini’s public company reporting requirements and Gemini expects those costs to increase in the future. For example, Gemini has and will continue to devote significant resources for the continuing assessment and documentation of Gemini’s internal control system and financial processes under Section 404, including an assessment of the design of Gemini’s information systems associated with Gemini’s internal controls.

Gemini may identify control deficiencies and be unable to remediate them. Furthermore, if Gemini fails to remediate any potential material weakness in Gemini’s internal control over financial reporting or if material weaknesses are identified or arise in the future, Gemini may not detect errors on a timely basis and Gemini’s financial statements may be materially misstated. Gemini may not be able to conclude on an ongoing basis that Gemini has effective internal control over financial reporting, which could harm Gemini’s operating results, cause investors to lose confidence in Gemini’s reported financial information and cause the trading price of Gemini’s stock to fall. In addition, as a public company, Gemini will be required to timely file accurate quarterly and annual reports with the SEC under the Exchange Act. Any failure to report Gemini’s financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of Gemini’s shares from Nasdaq or other adverse consequences. Gemini will incur significant costs to remediate any potential material weaknesses that Gemini may identify through these efforts. The increased costs would increase Gemini’s net loss and may require Gemini to reduce costs in other areas of Gemini’s business. Gemini also expects these rules and regulations to make it more expensive for Gemini to maintain directors’ and officers’ liability insurance, and Gemini may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for Gemini to attract and retain qualified persons to serve on Gemini’s board of directors, Gemini’s board committees or as executive officers. Gemini cannot predict or estimate the amount or timing of such costs.

New laws and regulations, as well as changes to existing laws and regulations affecting public companies, including the provisions of the Sarbanes-Oxley Act, the Dodd-Frank Act and rules adopted by the SEC and Nasdaq, would likely result in increased costs as Gemini responds to their requirements, which may adversely affect Gemini’s operating results and financial condition.

Gemini may be at increased risk of securities class action litigation.

Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for Gemini because biotechnology and pharmaceutical companies, including Gemini, have experienced significant stock price volatility in the past.

Anti-takeover provisions contained in Gemini’s charter and Gemini’s by-laws, as well as provisions of Delaware law, could impair a takeover attempt.

Gemini’s charter contains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests. Gemini is also subject to anti-takeover provisions under Delaware law, which

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could discourage, delay, defer or prevent a merger, tender offer, proxy contest or other change of control transaction that a stockholder might consider in Gemini’s best interest, including those attempts that might result in a premium over the market price for the shares of common stock held by Gemini’s stockholders. These provisions provide for, among other things:

• a classified board with a three-year staggered term;

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

• the ability of Gemini’s board of directors to issue one or more series of “blank check” preferred stock;

• certain limitations on convening special stockholder meetings;

• advance notice for nominations of directors by stockholders and for stockholders to include matters to be considered at Gemini’s annual meetings; and

• amendment of certain provisions of the organizational documents only by the affirmative vote of at least two-thirds of Gemini’s then-outstanding shares of capital stock entitled to vote generally at an election of directors.

These anti-takeover provisions as well as certain provisions of Delaware law could make it more difficult for a third party to acquire Gemini, even if the third party’s offer may be considered beneficial by many of Gemini’s stockholders. As a result, Gemini’s stockholders may be limited in their ability to obtain a premium for their shares. If prospective takeovers are not consummated for any reason, Gemini may experience negative reactions from the financial markets, including negative impacts on the price of Gemini’s Common Stock. These provisions could also discourage proxy contests and make it more difficult for Gemini’s stockholders to elect directors of their choosing and to cause Gemini to take other corporate actions that Gemini’s stockholders desire.

Gemini’s by-laws provide that the Court of Chancery of the State of Delaware and the federal district courts of the District of Massachusetts will be the exclusive forums for substantially all disputes between Gemini and Gemini’s stockholders, which could limit Gemini’s stockholders’ ability to obtain a favorable judicial forum for disputes with Gemini or Gemini’s directors, officers, or employees.

Gemini’s by-laws provide that the Court of Chancery of the State of Delaware is the exclusive forum for:

• any derivative action or proceeding brought on Gemini’s behalf;

• any action asserting a breach of fiduciary duty;

• any action asserting a claim against Gemini arising under the Delaware General Corporation Law (“DGCL”), Gemini’s charter, or Gemini’s by-laws;

• any action to interpret, apply, enforce or determine the validity of Gemini’s charter or Gemini’s by-laws; and

• any action asserting a claim against Gemini that is governed by the internal-affairs doctrine.

This exclusive-forum provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or the Securities Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, Gemini’s by-laws provides that the federal district courts of the District of Massachusetts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.

These exclusive-forum provisions may make it more expensive for stockholders to bring a claim than if the stockholders were permitted to select another jurisdiction and may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with Gemini or Gemini’s directors, officers, or other employees, which may discourage lawsuits against Gemini and Gemini’s directors, officers, and other employees. If a court were to find either exclusive-forum provision in the By-laws to be inapplicable or unenforceable in an action, Gemini may incur additional costs associated with resolving the dispute in other jurisdictions, which could harm Gemini’s business.

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Risks Related to Disc

Risks Related to Disc’s Limited Operating History, Financial Position, and Capital Requirements

Disc’s limited operating history may make it difficult for you to evaluate the success of Disc’s business to date and to assess Disc’s future viability.

Disc commenced operations in 2017 and is a clinical-stage biopharmaceutical company with a limited operating history. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Since Disc’s inception in October 2017, Disc has devoted substantially all of its efforts to organizing and staffing its company, business planning, capital raising, establishing and maintaining its intellectual property portfolio, building its pipeline of product candidates, conducting drug discovery activities, undertaking preclinical studies, conducting early-stage clinical trials, and providing general and administrative support for these operations. Disc has not yet demonstrated its ability to successfully develop any product candidate, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about Disc’s future success or viability may not be as accurate as they could be if Disc had a longer operating history or a history of successfully developing and commercializing products.

In addition, as Disc’s business grows, Disc may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. Disc will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. Disc may not be successful in such a transition.

Disc has incurred significant net losses since its inception and anticipates that it will continue to incur losses for the foreseeable future.

Disc’s net losses were $20.9 million and $36.0 million for the years ended December 31, 2020 and 2021, respectively. Disc had an accumulated deficit of $101.0 million as of September 30, 2022. Substantially all of Disc’s net losses have resulted from costs incurred in connection with Disc’s research and development programs and from general and administrative costs associated with Disc’s operations. Disc expects its research and development expenses to increase significantly in connection with the commencement and continuation of clinical trials of its product candidates. In addition, if Disc obtains regulatory approval for its product candidates, Disc will incur significant sales, marketing and manufacturing expenses. Once Disc is a public company, Disc will incur additional costs associated with operating as a public company. As a result, Disc expects to continue to incur significant and increasing operating losses over the next several years and for the foreseeable future. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, Disc is unable to predict the extent of any future losses or when Disc will become profitable, if at all. Even if Disc does become profitable, Disc may not be able to sustain or increase its profitability on a quarterly or annual basis.

The amount of Disc’s future losses is uncertain and Disc’s quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of its control and may be difficult to predict, including the following:

• the timing and success or failure of preclinical studies and clinical trials for its product candidates or competing product candidates, or any other change in the competitive landscape of its industry, including consolidation among its competitors or partners;

• Disc’s ability to successfully open clinical trial sites and recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;

• Disc’s ability to obtain regulatory approval for its product candidates, and the timing and scope of any such approvals Disc may receive;

• the timing and cost of, and level of investment in, research and development activities relating to Disc’s product candidates, which may change from time to time;

• the cost of manufacturing Disc’s product candidates and products, should they receive regulatory approval, which may vary depending on the quantity of production and the terms of its agreements with manufacturers;

• Disc’s ability to attract, hire and retain qualified personnel;

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• expenditures that Disc will or may incur to develop additional product candidates;

• the level of demand for Disc’s products should they receive regulatory approval, which may vary significantly;

• the risk/benefit profile, cost and reimbursement policies with respect to Disc’s product candidates, if approved, and existing and potential future therapeutics that compete with Disc’s product candidates;

• the changing and volatile U.S. and global economic environments, including as a result of the ongoing COVID-19 pandemic; and

• future accounting pronouncements or changes in Disc’s accounting policies.

The cumulative effects of these factors could result in large fluctuations and unpredictability in Disc’s quarterly and annual operating results. As a result, comparing Disc’s operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in Disc failing to meet the expectations of industry or financial analysts or investors for any period. If Disc’s revenue or operating results fall below the expectations of analysts or investors or below any forecasts Disc may provide to the market, or if the forecasts Disc provides to the market are below the expectations of analysts or investors, the price of Disc’s common stock could decline substantially. Such a stock price decline could occur even if Disc has met any previously publicly stated guidance it may provide.

Disc has no products approved for commercial sale and has not generated any revenue from product sales.

Disc’s ability to become profitable depends upon Disc’s ability to generate revenue. To date, Disc has not generated collaborative revenue from its product candidates and has not generated revenue from product sales, and does not expect to generate any revenue from the sale of products in the near future. Disc does not expect to generate significant revenue unless and until Disc obtains regulatory approval of, and begins to sell, one or more of its product candidates. Disc’s ability to generate revenue depends on a number of factors, including, but not limited to, Disc’s ability to:

• successfully complete its ongoing and planned preclinical studies for its current and future product candidates;

• timely file and receive acceptance of its INDs in order to commence its planned clinical trials or future clinical trials;

• successfully enroll subjects in, and complete, its ongoing and planned clinical trials;

• initiate and successfully complete all safety and efficacy studies necessary to obtain U.S. and foreign regulatory approval for its product candidates;

• successfully address the prevalence, duration and severity of potential side effects or other safety issues experienced with its product candidates, if any;

• timely file New Drug Applications, or NDAs, and Biologic License Applications, or BLAs, and receive regulatory approvals for its product candidates from the U.S. Food and Drug Administration, or the FDA, and comparable foreign regulatory authorities;

• establish and maintain clinical and commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical supply and commercial manufacturing;

• obtain and maintain patent and trade secret protection or regulatory exclusivity for its product candidates;

• launch commercial sales of its products, if and when approved, whether alone or in collaboration with others;

• obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payors;

• position its product candidates to effectively compete with other therapies;

• obtain and maintain healthcare coverage and adequate reimbursement;

• enforce and defend intellectual property rights and claims;

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• implement measures to help minimize the risk of COVID-19 to its employees as well as patients and subjects enrolled in its clinical trials; and

• maintain a continued acceptable safety profile of its products following approval.

If Disc does not achieve one or more of these factors in a timely manner or at all, Disc could experience significant delays or an inability to successfully commercialize its product candidates, which would materially harm its business. If Disc does not receive regulatory approvals for its product candidates, it may not be able to continue its operations.

Even if Disc completes the merger, Disc will need to raise substantial additional funding. If Disc is unable to raise capital when needed or on terms acceptable to Disc, it would be forced to delay, reduce, or eliminate some of its product development programs or commercialization efforts.

The development of pharmaceutical products is capital-intensive. Disc is currently advancing its hematologic disease programs through preclinical and clinical development. Disc expects its expenses to significantly increase in connection with its ongoing activities, particularly as Disc continues the research and development of, initiates and completes clinical trials of, and seeks regulatory approval for, its product candidates. In addition, depending on the status of regulatory approval or, if Disc obtains regulatory approval for any of its product candidates, Disc expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Disc may also need to raise additional funds sooner if Disc chooses to pursue additional indications and/or geographies for its current or future product candidates or otherwise expands more rapidly than presently anticipated. Furthermore, upon the closing of the merger, Disc expects to incur additional costs associated with operating as a public company. Accordingly, even if the merger is consummated, Disc will need to obtain substantial additional funding in connection with its continuing operations. If Disc is unable to raise capital when needed or on attractive terms, Disc would be forced to delay, reduce, or eliminate certain of its research and development programs or future commercialization efforts.

Disc believes that, following the closing of the merger, Disc will have cash and cash equivalents that will enable Disc to fund operating expenses and capital expenditure requirements into 2025. However, Disc has based this estimate on assumptions that may prove to be wrong, and Disc could exhaust its available capital resources sooner than expected. Disc’s future capital requirements will depend on and could increase significantly as a result of many factors, including:

• the timing and progress of preclinical and clinical development activities;

• the number and scope of preclinical and clinical programs Disc decides to pursue;

• Disc’s ability to raise additional funds necessary to complete clinical development of and commercialize its product candidates;

• Disc’s ability to establish new licensing or collaboration arrangements and the progress of the development efforts of third parties with whom Disc may enter into such arrangements;

• Disc’s ability to maintain its current research and development programs and to establish new programs;

• the successful initiation, enrollment and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

• the receipt and related terms of regulatory approvals from applicable regulatory authorities for any product candidates;

• the availability of raw materials for use in production of its product candidates;

• establishing agreements with third-party manufacturers for supply of product candidate components for its clinical trials;

• Disc’s ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally;

• Disc’s ability to protect its other rights in its intellectual property portfolio;

• commercializing product candidates, if and when approved, whether alone or in collaboration with others;

• obtaining and maintaining third-party insurance coverage and adequate reimbursement for any approved products; and

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• the potential additional expenses attributable to adjusting Disc’s development plans (including any supply related matters) to the ongoing COVID-19 pandemic.

Identifying potential product candidates and conducting preclinical development testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and Disc may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, Disc’s product candidates, if approved, may not achieve commercial success. Disc’s commercial revenue, if any, will be derived from sales of products that Disc does not expect to be commercially available for many years, if at all. Accordingly, Disc will need to continue to rely on additional financing to achieve its business objectives.

Any additional fundraising efforts may divert Disc’s management from their day-to-day activities, which may adversely affect Disc’s ability to develop and commercialize its product candidates. Disruptions in the financial markets in general and more recently due to the ongoing COVID-19 pandemic may make equity and debt financing more difficult to obtain and may have a material adverse effect on Disc’s ability to meet its fundraising needs. Disc cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to Disc, if at all.

If Disc is unable to obtain funding on a timely basis or on acceptable terms, Disc may be required to significantly curtail, delay or discontinue one or more of its research or development programs or the commercialization of any product that has received regulatory approval or be unable to expand its operations or otherwise capitalize on its business opportunities as desired, which could materially affect its business, financial condition and results of operations.

Raising additional capital may cause dilution to the combined company’s stockholders, restrict its operations or require it to relinquish rights to its technologies or product candidates.

Until such time, if ever, as the combined company, operating as Disc, can generate substantial product revenue, Disc expects to finance its cash needs through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. Disc does not have any committed external source of funds. The terms of any financing may adversely affect the holdings or the rights of Disc’s stockholders and the issuance of additional securities, whether equity or debt, by Disc, or the possibility of such issuance, may cause the market price of Disc’s shares to decline. To the extent that Disc raises additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted, and the terms of those securities may include liquidation or other preferences that may materially adversely affect your rights as a common stockholder. Debt financing, if available, would increase Disc’s fixed payment obligations and may involve agreements that include covenants limiting or restricting Disc’s ability to take specific actions, such as incurring additional debt, acquiring, selling or licensing intellectual property rights, and making capital expenditures, declaring dividends or other operating restrictions that could adversely impact Disc’s ability to conduct its business. Disc could also be required to meet certain milestones in connection with debt financing and the failure to achieve such milestones by certain dates may force Disc to relinquish rights to some of its technologies or product candidates or otherwise agree to terms unfavorable to Disc which could have a material adverse effect on Disc’s business, operating results and prospects

Disc also could be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable. If Disc raises funds through collaborations, strategic alliances or licensing arrangements with third parties, Disc may have to relinquish valuable rights to its intellectual property, future revenue streams, research programs or product candidates, grant licenses on terms that may not be favorable to Disc or grant rights to develop and market product candidates that Disc would otherwise prefer to develop and market itself, any of which may have a material adverse effect on Disc’s business, operating results and prospects.

Risks Related to the Discovery and Development of Disc’s Product Candidates

The ongoing COVID-19 pandemic, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect Disc’s business and financial results and could cause a disruption to the development of Disc’s product candidates.

Public health crises such as pandemics, including the ongoing COVID-19 pandemic, or similar outbreaks could adversely impact Disc’s business. The extent to which the coronavirus impacts Disc’s operations or those of its third-party partners, including its preclinical studies or clinical trial operations, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, the

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identification of new variants of the virus, new information that will emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. The global impact of COVID-19 could adversely impact Disc’s preclinical or clinical trial operations, including Disc’s ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19. For example, similar to other biopharmaceutical companies, Disc may experience delays in initiating preclinical studies or clinical trials, protocol deviations, enrolling its clinical trials, or dosing of patients in its clinical trials, activating new trial sites or in receiving supplies for preclinical study or clinical trial operations. For example, Disc previously experienced delays in recruiting trial participants at its clinical site for its Phase 1 clinical trial of DISC-0974, and could in the future experience similar delays in recruiting patients to its clinical trials, including BEACON, a Phase 2 open-label, parallel-dose clinical trial of bitopertin in EPP and XLP patients that is being conducted at sites in Australia, and/or AURORA, a Phase 2, randomized, double-blind, placebo-controlled clinical trial of bitopertin in EPP patients that is being conducted at sites in the United States.

Since the beginning of the COVID-19 pandemic, several vaccines for COVID-19 have received Emergency Use Authorization by the FDA and a number of those later received marketing approval. Additional vaccines may be authorized or approved in the future. The resultant demand for vaccines and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials or manufacturing slots for the products needed for Disc’s clinical trials, which could lead to delays in these trials. COVID-19 may also affect employees of third-party CROs located in affected geographies that Disc relies upon to carry out its clinical trials. Personnel and raw materials have been allocated preferentially to manufacturing of COVID-19 vaccines and therapies, which caused delays to Disc’s Phase 1 clinical trial of DISC-0974. In addition, supply chains for reagents and equipment have similarly been disrupted requiring long lead time and additional expenses to secure necessary supplies for Disc’s clinical trials.

In addition, the patient populations that Disc’s product candidates target may be particularly susceptible to COVID-19, which may make it more difficult for Disc to identify patients able to enroll in its current and future clinical trials and may impact the ability of enrolled patients to complete any such trials. There may also be delays in necessary interactions with regulators, institutional review boards, or IRBs, or ethics committees, and other important agencies and contractors due to limitations in employee resource or forced furlough of government employees. Any negative impact COVID-19 has to patient enrollment or treatment or the supply of Disc’s product candidates could cause costly delays to clinical trial activities, which could adversely affect Disc’s ability to obtain regulatory approval for and to commercialize its product candidates, increase its operating expenses, and have a material adverse effect on its financial results.

Additionally, timely enrollment in planned and ongoing clinical trials is dependent upon clinical trial sites which could be adversely affected by global health matters, such as pandemics. Disc is currently conducting and planning to conduct clinical trials for its product candidates in geographies which are currently being affected by the COVID-19 pandemic. Some factors from the COVID-19 pandemic that will delay or otherwise adversely affect enrollment in the clinical trials of Disc’s product candidates, as well as Disc’s business generally, include:

• the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as Disc’s clinical trial investigators, hospitals serving as Disc’s clinical trial sites and hospital staff supporting the conduct of Disc’s prospective clinical trials;

• limitations on travel that could interrupt key trial and business activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to Disc’s clinical trial sites or secure visas or entry permissions, a loss of face-to-face meetings and other interactions with potential partners, any of which could delay or adversely impact the conduct or progress of Disc’s prospective clinical trials;

• the potential negative affect on the operations of Disc’s third-party manufacturers;

• interruption in global shipping affecting the transport of clinical trial materials, such as patient samples, investigational drug product and other supplies used in Disc’s clinical trials;

• business disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments;

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• operations, staffing shortages, travel limitations or mass transit disruptions, any of which could adversely impact Disc’s business operations or delay necessary interactions with local regulators, ethics committees and other important agencies and contractors;

• changes in local regulations as part of a response to the COVID-19 pandemic, which may require Disc to change the ways in which its clinical trials are conducted, which may result in unexpected costs, or to discontinue such clinical trials altogether; and

• interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines.

Further, as a result of the COVID-19 pandemic, the extent and length of which is uncertain, Disc may be required to develop and implement additional clinical trial policies and procedures designed to help protect trial participants from the COVID-19 virus, which may include using telemedicine visits, remote monitoring of patients and clinical sites, and measures to ensure that data from clinical trials that may be disrupted as a result of the pandemic are collected pursuant to the trial protocol and consistent with Good Clinical Practice, or GCP, requirements, with any material protocol deviation reviewed and approved by the site IRB. Patients who may miss scheduled appointments, any interruption in trial drug supply or other consequence that may result in incomplete data being generated during a trial as a result of the pandemic must be adequately documented and justified.

Disc has also taken temporary precautionary measures intended to help minimize the risk of the virus to its employees, including reduced and optional on-site work hours, allowing employees to work remotely at their discretion, reduced travel for work-related meetings, and requiring all employees to be vaccinated against COVID-19. Disc cannot presently predict the scope and severity of the planned and potential shutdowns or disruptions of businesses and government agencies, such as the Securities and Exchange Commission, or the SEC, or FDA.

These and other factors arising from COVID-19 could worsen. Any of these factors, and other factors related to any such disruptions that are unforeseen, could have a material adverse effect on Disc’s business and results of operation and financial condition. Further, uncertainty around these and related issues could lead to adverse effects on the economy of the United States and other economies, which could impact Disc’s ability to raise the necessary capital needed to develop and commercialize its programs and product candidates.

Disc has only successfully completed one Phase 1 clinical trial, and may be unable to successfully complete any additional clinical trials for any product candidates it develops. Certain of Disc’s programs are still in preclinical development and may never advance to clinical development.

Disc has completed one Phase 1 clinical trial and has not yet demonstrated its continued ability to successfully complete clinical trials, including large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product, or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful commercialization. Disc’s programs are still in preclinical and early clinical development. Disc’s clinical programs may not advance to the next stage of clinical development, and its preclinical programs may never advance to clinical development or through clinical development, as applicable. Disc currently only has two product candidates in clinical development. In July 2022, Disc initiated BEACON, a Phase 2 open-label, parallel-dose clinical trial of bitopertin in EPP and XLP patients that is being conducted at sites in Australia. Separately, Disc has initiated AURORA, a Phase 2, randomized, double-blind, placebo-controlled clinical trial of bitopertin in EPP patients that is being conducted at sites in the United States. Disc completed its Phase 1 clinical trial of DISC-0974 in healthy volunteers. Disc initiated a Phase 1b/2 clinical trial in June 2022 in patients with anemia of MF, and plans to initiate a separate Phase 1b/2 clinical trial by the end of 2022 in patients with anemia of CKD. Disc may not initiate the DISC-0974 Phase 1b/2 clinical trial in patients with anemia of CKD until it has submitted an IND application to the FDA or comparable submissions with equivalent regulatory authorities and received regulatory clearance. Disc may not be able to submit INDs or other regulatory filings for bitopertin or any of its other product candidates on the timelines Disc expects, if at all. For example, Disc may experience manufacturing delays or other delays with IND-enabling studies. Moreover, Disc cannot be sure that submission of regulatory filings with the FDA or other regulatory authorities will result in such regulatory authorities allowing clinical trials to begin on a timely basis or at all, or that, once begun, such trials will be completed on schedule, if at all, or that issues will not arise that require Disc to revise, postpone, suspend or terminate its clinical trials. For example, Disc filed an IND in April 2022 with the FDA to initiate the AURORA Phase 2 trial of bitopertin in EPP patients, but the FDA initially placed the initiation of this trial on clinical hold; Disc received clearance to initiate the study in July 2022 after the

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study design was finalized with the FDA and initiated the study in October 2022. Commencing each of these clinical trials is subject to finalizing the trial design based on discussions with the FDA and other regulatory authorities. Any guidance Disc receives from the FDA or other regulatory authorities is subject to change. These regulatory authorities could change their position, including on the acceptability of Disc’s trial designs or the clinical endpoints selected, which may require Disc to complete additional clinical trials or result in the composition of stricter approval conditions than currently expected. For a further example, Disc relied on the data package generated by Roche to support its IND submission for bitopertin to initiate its planned Phase 2 clinical trial in patients with EPP, as well as its submission of an application with the Australian Therapeutic Goods Administration (TGA), for a Phase 2 clinical trial in patients with EPP or XLP, and it is possible that the FDA or TGA, as applicable, may require Disc to conduct additional preclinical studies to support a future marketing application of bitopertin. Successful completion of Disc’s clinical trials is a prerequisite to submitting an NDA or a BLA, to the FDA, a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, or other marketing applications to regulatory authorities in other jurisdictions, for each product candidate and, consequently, the regulatory approval of each product candidate.

A single well-controlled clinical trial may not be sufficient for approval. In general, the FDA requires two well-controlled clinical trials to support registration of a new drug or biologic. Exceptions may be made in cases of a severe disease with few treatment options, and in principle this exception may appear applicable to many of the diseases that Disc seeks to treat, such as EPP, XLP, anemia of MF, DBA and others. Nonetheless, the FDA and other regulators may always require additional clinical trials to support regulatory approval.

If Disc is required to conduct additional preclinical studies or clinical trials or other testing of its product candidates beyond those that are currently contemplated, if Disc is unable to successfully complete clinical trials of its product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, Disc may:

• be delayed in obtaining regulatory approval for its product candidates;

• not obtain regulatory approval at all;

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

• continue to be subject to post-marketing testing requirements; or

• experience having the product removed from the market after obtaining regulatory approval.

Disc’s programs are focused on the development of therapeutics for patients with hematologic diseases, which is a rapidly evolving area of science, and the approach Disc is taking to discover and develop product candidates is novel and may never lead to approved or marketable products.

The discovery and development of therapeutics for patients with hematologic diseases is an emerging field, and the scientific discoveries that form the basis for Disc’s efforts to discover and develop product candidates are relatively new. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. Although Disc believes, based on its preclinical work, that its programs have the potential to provide disease-modifying therapies, clinical results may not confirm this hypothesis or may only confirm it for certain alterations or certain indications. The patient populations for Disc’s product candidates are limited to those with specific hematologic diseases. Disc cannot be certain that the patient populations for each specific disease will be large enough to allow Disc to successfully obtain approval and commercialize its product candidates and achieve profitability.

Clinical product development involves a lengthy and expensive process, with an uncertain outcome.

Disc’s preclinical studies and future and ongoing clinical trials may not be successful. Currently, all of Disc’s programs are in preclinical and early clinical development. It is impossible to predict when or if any of Disc’s product candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining regulatory approval from regulatory authorities for the sale of any product candidate, Disc must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of its product candidates or the safety, purity and potency of its biological product candidates in humans. There is no guarantee that Disc’s product candidates will advance in accordance with the timelines Disc anticipates, if at all. Clinical testing is expensive, difficult to design and implement, can take many years to complete and outcomes are uncertain. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical development testing and early clinical

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trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval of their product candidates. Disc’s preclinical studies and future and ongoing clinical trials may not be successful.

Additionally, some of the clinical trials Disc conducts may be open-label in study design and may be conducted at a limited number of clinical sites on a limited number of patients. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label clinical trial may not be predictive of future clinical trial results when studied in a controlled environment with a placebo or active control.

In May 2021, Disc entered into a License Agreement, or the Roche Agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., or Roche, pursuant to which, among other things, Roche granted Disc an exclusive and sublicensable (subject to Roche’s consent, except with respect to affiliates) worldwide license under certain of Roche’s patent rights and know-how to develop and commercialize bitopertin. Although bitopertin was originally evaluated by Roche in over 4,000 individuals, Roche did not evaluate bitopertin in EPP or XLP, so the safety data generated from Roche’s clinical trials of bitopertin may not be predictive or indicative of the results of Disc’s clinical trials. Regulatory authorities may also raise questions regarding the transition in the future from Roche-manufactured drug substance to drug substance manufactured by Disc or another party, and Disc may be required to conduct comparability assessments, which could result in delays in development and additional costs.

Because Disc is developing some of its product candidates for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulatory authorities may not consider the endpoints of Disc’s clinical trials to predict or provide clinically meaningful results.

Many of Disc’s product candidates are designed to treat diseases for which there are few available therapeutic options. For example, there are currently no therapies approved to treat anemia of MF and there is only one approved therapy to treat EPP. As a result, the design and conduct of clinical trials of product candidates for the treatment of these diseases may take longer, be more costly or be less effective as part of the novelty of development in these diseases. In some cases, Disc may use new or novel endpoints or methodologies. The FDA or other regulatory authorities may not consider the endpoints of Disc’s clinical trials to be validated or clinically meaningful and Disc may need to conduct proof-of-concept studies or additional work to refine its endpoints and inform the design of future studies before initiating pivotal studies of its product candidates. Even if applicable regulatory authorities do not object to Disc’s proposed endpoints in an earlier stage clinical trial, such regulatory authorities may require evaluation of additional or different clinical endpoints in later-stage clinical trials.

Even if the FDA does find Disc’s clinical trial success criteria to be sufficiently supported and clinically meaningful at the time, Disc may not achieve the pre-specified endpoint to a degree of statistical significance in any pivotal or other clinical trials it may conduct for its product candidates. Further, even if Disc does achieve the pre-specified criteria, its trials may produce results that are unpredictable or inconsistent with the results of the more traditional efficacy endpoints in the trial. The FDA also could change its view or give overriding weight to other efficacy endpoints over a primary endpoint, even if Disc achieves statistically significant results on that primary endpoint, if for example Disc does not do so on its secondary efficacy endpoints. The FDA also weighs the benefits of a product candidate against its risks and the FDA may view the efficacy results in the context of safety as not being supportive of approval. Other regulatory authorities in Europe and other countries may make similar findings with respect to these endpoints.

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Interim, top-line, and preliminary data from Disc’s clinical trials that Disc announces or publishes from time to time may change as more patient data become available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data.

From time to time, Disc may publicly disclose interim, top-line or preliminary data from its clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. Disc announced top-line results from the Phase 1 DISC-0974 clinical trial in June 2022. Disc also may make assumptions, estimations, calculations and conclusions as part of its analyses of data, and may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, top-line or preliminary results that Disc reports may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Interim, top-line and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim, top-line or preliminary data Disc previously published. As a result, interim, top-line and preliminary data should be viewed with caution until the final data are available. Adverse differences between interim, top-line or preliminary data and final data could significantly harm Disc’s business prospects and may cause the price of Disc’s common stock to fluctuate or decline.

Further, regulatory agencies and others, may not accept or agree with Disc’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could adversely impact the potential of the particular program, the likelihood of obtaining regulatory approval of the particular product candidate, commercialization of any approved product and the business prospects of the company in general. In addition, the information Disc chooses to publicly disclose regarding a particular study or clinical trial is derived from information that is typically extensive, and you or others may not agree with what Disc determines is material or otherwise appropriate information to include in Disc’s disclosure.

If the interim, top-line or preliminary data that Disc reports differs from actual results, or if regulatory authorities or others, disagree with the conclusions reached, Disc’s ability to obtain approval for, and commercialize, its product candidates may be significantly impaired, which could materially harm Disc’s business, operating results, prospects or financial condition.

Disc may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of its product candidates.

Disc may experience delays in initiating or completing its preclinical studies or clinical trials, including as a result of delays in obtaining, or failure to obtain, the FDA’s authorization to initiate clinical trials under future INDs. Additionally, Disc cannot be certain that preclinical studies or clinical trials for its product candidates will not require redesign, will enroll an adequate number of subjects on time, or will be completed on schedule, if at all. Disc may experience numerous unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent its ability to receive regulatory authorizations, regulatory approval or commercialize its product candidates, including:

• Disc may receive feedback from regulatory authorities that requires Disc to modify the design or implementation of its preclinical studies or clinical trials or to delay or terminate a clinical trial;

• regulators or IRBs or ethics committees may delay or may not authorize Disc or its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

• Disc may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective clinical research organizations, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

• preclinical studies or clinical trials of Disc’s product candidates may fail to show safety or efficacy or otherwise produce negative or inconclusive results, and Disc may decide, or regulators may require Disc, to conduct additional preclinical studies or clinical trials, or Disc may decide to abandon product research or development programs;

• preclinical studies or clinical trials of Disc’s product candidates may not produce differentiated or clinically significant results across indications;

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• the number of patients required for clinical trials of Disc’s product candidates may be larger than anticipated, enrollment in these clinical trials may be slower than anticipated or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than anticipated;

• Disc’s third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls, be unable to provide Disc with sufficient product supply to conduct or complete preclinical studies or clinical trials, fail to meet their contractual obligations to Disc in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that Disc adds new clinical trial sites or investigators;

• Disc may elect to, or regulators or IRBs or ethics committees may require Disc or its investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants in Disc’s clinical trials are being exposed to unacceptable health risks;

• the cost of clinical trials of Disc’s product candidates may be greater than anticipated;

• clinical trials of Disc’s product candidates may be delayed due to complications associated with the ongoing COVID-19 pandemic;

• the supply or quality of Disc’s product candidates or other materials necessary to conduct clinical trials of its product candidates may be insufficient or inadequate, and any transfer of manufacturing activities may require unforeseen manufacturing or formulation changes;

• Disc’s product candidates may have undesirable side effects or other unexpected characteristics, causing Disc, regulators or IRBs or ethics committees to suspend or terminate the trials, or reports may arise from preclinical or clinical testing of other hematologic disease therapies that raise safety or efficacy concerns about Disc’s product candidates;

• any future collaborators may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for Disc; and

• regulators may revise the requirements for approving Disc’s product candidates, or such requirements may not be as anticipated.

Disc could encounter delays if a clinical trial is suspended or terminated by Disc, by the IRBs or ethics committees of the institutions at which such trials are being conducted, by the Data Safety Monitoring Board, or DSMB, for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination or clinical hold due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Disc clinical protocols, adverse findings upon an inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. For example, Disc filed an IND in April 2022 with the FDA to initiate the AURORA Phase 2 trial of bitopertin in EPP patients, but the FDA initially placed the initiation of this trial on clinical hold; Disc received clearance to initiate the study in July 2022 after the study design was finalized with the FDA and initiated the study in October 2022. 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 Disc’s product candidates. Further, the FDA may disagree with Disc’s clinical trial design or Disc’s interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for Disc’s clinical trials.

Moreover, principal investigators for Disc’s current and future clinical trials may serve as scientific advisors or consultants to Disc from time to time and receive compensation in connection with such services. Under certain circumstances, Disc may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between Disc and a principal investigator has created a conflict of interest or otherwise affected the interpretation of the trial. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data

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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 Disc’s marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of regulatory approval of one or more of Disc’s product candidates.

Disc’s product development costs will also increase if Disc experiences delays in testing or regulatory approvals. Disc does not know whether any of its future clinical trials will begin as planned, or whether any of its current or future clinical trials will need to be restructured or will be completed on schedule, if at all. Significant preclinical study or clinical trial delays, including those caused by the ongoing COVID-19 pandemic, also could shorten any periods during which Disc may have the exclusive right to commercialize its product candidates or allow its competitors to bring products to market before Disc does, which would impair Disc’s ability to successfully commercialize its product candidates and may significantly harm its business, operating results, financial condition and prospects.

If Disc experiences delays or difficulties in the enrollment of patients in clinical trials, Disc’s receipt of necessary regulatory approvals could be delayed or prevented.

Disc may not be able to initiate or continue clinical trials for its product candidates if Disc is unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or comparable foreign regulatory authorities, or as needed to provide appropriate statistical power for a given trial. In particular, because Disc is focused on patients with specific rare hematologic diseases for the development of its product candidates, Disc’s ability to enroll eligible patients may be limited or may result in slower enrollment than Disc anticipate.

Disc may experience difficulties with identifying specific patient populations for any defined trial cohorts. The patient eligibility criteria defined in Disc’s trial protocols, may limit the patient populations eligible for Disc’s clinical trials. Disc will also rely on the willingness and ability of clinicians to screen their patients, such as for specific genetic hematologic conditions, to indicate which patients may be eligible for enrollment in Disc’s clinical trials.

In addition, some of Disc’s competitors have ongoing clinical trials for product candidates that are intended to treat the same indications as Disc’s product candidates, and patients who would otherwise be eligible for Disc’s clinical trials may choose instead to enroll in clinical trials of Disc’s competitors’ product candidates. Furthermore, Disc’s ability to enroll patients may be significantly delayed by the ongoing COVID-19 pandemic, and Disc cannot accurately predict the extent and scope of such delays at this point.

Additionally, the process of finding patients may prove costly. Disc also may not be able to identify, recruit or enroll a sufficient number of patients to complete its clinical trials because of the small patient populations with rare hematologic diseases, the perceived risks and benefits of the product candidates under study, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, and the patient referral practices of physicians. If patients are unwilling to participate in Disc’s studies for any reason, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed.

Patient enrollment may be affected by other factors, including:

• the severity of the disease under investigation;

• the efforts to obtain and maintain patient consents and facilitate timely enrollment in clinical trials;

• the ability to monitor patients adequately during and after treatment;

• the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion;

• the ability to recruit clinical trial investigators with the appropriate competencies and experience;

• reporting of the preliminary results of any of Disc’s clinical trials; and

• factors Disc may not be able to control, including the impacts of the COVID-19 pandemic, that may limit patients, principal investigators or staff or clinical site availability.

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Results from early preclinical studies and clinical trials of Disc’s programs and product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of Disc’s programs and product candidates. If Disc cannot replicate the results from earlier preclinical studies and clinical trials of its programs and product candidates in its later preclinical studies and clinical trials, Disc may be unable to successfully develop, obtain regulatory approval for and commercialize its product candidates.

Any results from early preclinical studies and clinical trials of bitopertin, DISC-0974, DISC-0998 or Disc’s other product candidates or programs may not necessarily be predictive of the results from later preclinical studies and clinical trials. For example, DISC-0974 has undergone testing in healthy volunteers and just begun clinical testing for anemia of MF. DISC-0974 has not yet undergone testing for anemia associated with CKD and therefore there can be no assurance that DISC-0974 will achieve the desired effects in these indications. Similarly, even if Disc is able to complete its planned preclinical studies and clinical trials of its product candidates according to its current development timeline, the results from such preclinical studies and clinical trials of its product candidates may not be replicated in subsequent preclinical studies or clinical trial results.

Many companies in the biopharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and Disc cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain regulatory approval.

Disc’s clinical trials or those of its future collaborators may reveal significant adverse events not seen in prior preclinical studies or clinical trials and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of its product candidates.

Before obtaining regulatory approvals for the commercial sale of any products, Disc must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that its product candidates are both safe and effective for use in each target indication. Clinical testing is expensive and can take many years to complete, and outcomes are inherently uncertain. Failure can occur at any time during the clinical trial process. Because Disc’s programs and product candidates are in an early stage of development, there is a high risk of failure, and Disc may never succeed in developing marketable products. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials also may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. For example, Roche had previously developed bitopertin as a potential therapy for certain symptoms of schizophrenia and obsessive-compulsive disorder, but discontinued the program for lack of efficacy in those indications after completing over 30 clinical trials in over 4,000 individuals. If the results of Disc’s ongoing or future preclinical studies and clinical trials are inconclusive with respect to the safety and efficacy of Disc’s programs and product candidates, if Disc does not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with Disc’s product candidates, Disc may be prevented from, or delayed in, obtaining regulatory approval for such product candidates. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. Results of Disc’s trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, Disc’s trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order Disc to cease further development of or deny approval of Disc’s product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.

Further, Disc’s product candidates could cause undesirable side effects in clinical trials related to on-target toxicity. If on-target toxicity is observed, or if Disc’s product candidates have characteristics that are unexpected, Disc may need to abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. In addition, Disc’s product candidates could cause undesirable side effects that have not yet been observed. For example, bitopertin may demonstrate toxicities in patients with hematologic diseases not previously observed by Roche when it was studied in different indications. Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the compound.

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Most product candidates that commence clinical trials are never approved as products, and there can be no assurance that any of Disc’s current or future clinical trials will ultimately be successful or support further clinical development or regulatory approval of any of Disc’s product candidates.

As is the case with many treatments for hematologic and rare diseases, it is likely that there may be side effects associated with the use of Disc’s product candidates. If significant adverse events or other side effects are observed in any of Disc’s current or future clinical trials, Disc may have difficulty recruiting patients to its clinical trials, patients may drop out of its trials, or Disc may be required to abandon the trials or development efforts of one or more product candidates altogether. Disc, the FDA or other applicable regulatory authorities, or an IRB may suspend or terminate clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Even if the side effects do not preclude the product from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm Disc’s business, operating results, financial condition and prospects.

Some of Disc’s product candidates modulate pathways for which there are currently no approved or effective therapies, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or discovery of unknown or unanticipated adverse effects on safety or efficacy.

Some of Disc’s product candidates modulate pathways for which there are currently no approved or effective therapies, which may result in uncertainty. Disc selects programs for targets based on compelling biological rationale, including evidence of expected biological effects in humans. Disc explores new programs based on extensive preclinical data analysis which sometimes cannot predict efficacy or safety in humans. Regulatory approval of novel product candidates such as Disc’s can be more expensive, riskier and take longer than for other, more well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due to Disc’s and regulatory agencies’ lack of experience with them. The novelty of the mechanism of action of any of Disc’s product candidates may lengthen the regulatory review process, require Disc to conduct additional studies or clinical trials, increase Disc’s development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of Disc’s product candidates or lead to significant post-approval limitations or restrictions. The novel mechanism of action also means that fewer people are trained in or experienced with product candidates of this type, which may make it more difficult to find, hire and retain personnel for research, development and manufacturing positions. If Disc’s product candidates utilize a novel mechanism of action that has not been the subject of extensive study compared to more well-known product candidates, there is also an increased risk that Disc may discover previously unknown or unanticipated adverse effects during its preclinical studies and clinical trials. Disc’s product candidates may achieve lower efficacy in patients than expected. Any such events could adversely impact Disc’s business prospects, operating results and financial condition.

Disc is currently conducting a Phase 2 clinical trial for bitopertin in Australia and may in the future conduct additional clinical trials for its product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.

In July 2022, Disc initiated BEACON, a Phase 2 open-label, parallel-dose clinical trial of bitopertin in EPP and XLP patients that is being conducted at sites in Australia. In addition, Disc may in the future choose to conduct additional clinical trials outside the United States, including in Europe, Australia, or other foreign jurisdictions. The acceptance of trial data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions. In cases where data from clinical trials conducted outside the United States are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practices, (ii) the trials were performed by clinical investigators of recognized competence and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have similar approval requirements. In addition, such foreign trials will be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority, including the TGA, will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly

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and time-consuming and delay aspects of Disc’s business plan, and which may result in Disc’s product candidates not receiving regulatory approval or clearance for commercialization in the applicable jurisdiction.

Although Disc intends to explore other therapeutic opportunities in addition to the programs and product candidates that Disc is currently developing, Disc may fail to identify viable new product candidates for clinical development for a number of reasons. If Disc fails to identify additional product candidates, its business could be materially harmed.

Research programs to pursue the development of Disc’s existing and planned product candidates for additional indications and to identify new product candidates and disease targets require substantial technical, financial and human resources whether or not they are ultimately successful. Disc’s research programs may initially show promise in identifying potential indications and/or product candidates, yet fail to yield results for clinical development for a number of reasons, including:

• the research methodology used may not be successful in identifying potential indications and/or product candidates;

• potential product candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective products; or

• it may take greater human and financial resources than Disc will possess to identify additional therapeutic opportunities for Disc’s product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting Disc’s ability to develop, diversify and expand its product portfolio.

Because Disc has limited financial and human resources, Disc intends to initially focus on research programs and product candidates for a limited set of indications. As a result, Disc may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Disc’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities.

Accordingly, there can be no assurance that Disc will ever be able to identify additional therapeutic opportunities for its product candidates or to develop suitable product candidates through internal research programs, which could materially adversely affect Disc’s future growth and prospects. Disc may focus its efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful.

If Disc is not able to obtain, or if there are delays in obtaining, required regulatory approvals for Disc’s product candidates, Disc will not be able to commercialize, or will be delayed in commercializing, its product candidates, and its ability to generate revenue will be materially impaired.

Disc’s product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable foreign regulatory authorities. Before Disc can commercialize any of its product candidates, Disc must obtain regulatory approval. Currently, all of Disc’s product candidates are in discovery, preclinical or clinical development, and Disc has not received approval to market any of its product candidates from regulatory authorities in any jurisdiction. It is possible that Disc’s product candidates, including any product candidates Disc may seek to develop in the future, will never obtain regulatory approval. Disc has limited experience in filing and supporting the applications necessary to gain regulatory approvals and relies on third-party CROs and/or regulatory consultants to assist Disc in this process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Disc’s product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude Disc obtaining regulatory approval or prevent or limit commercial use. In addition, regulatory authorities may find fault with Disc’s manufacturing process or facilities or that of third-party contract manufacturers. Disc may also face greater than expected difficulty in manufacturing its product candidates.

The process of obtaining regulatory approvals, both in the United States and abroad, is expensive and often takes many years. If the FDA or a comparable foreign regulatory authority requires that Disc perform additional preclinical

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studies or clinical trials, approval may be delayed, if obtained at all. The length of such a delay varies substantially based upon a variety of factors, including the type, complexity and novelty of the product candidate involved. Changes in regulatory approval policies during the development period, changes in or enactment of additional statutes or regulations, or changes in regulatory review policies for each submitted NDA, BLA, or equivalent application types, may cause delays in the approval or rejection of an application. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that Disc’s data are insufficient for approval and require additional preclinical, clinical or other studies. Disc’s product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

• the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Disc’s clinical trials;

• Disc may not be able to enroll a sufficient number of patients in its clinical trials;

• Disc may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

• the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

• Disc may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

• the FDA or comparable foreign regulatory authorities may disagree with Disc’s interpretation of data from preclinical studies or clinical trials;

• the data collected from clinical trials of Disc’s product candidates may not be sufficient to support the submission of an NDA, BLA or other submission or to obtain regulatory approval in the United States or elsewhere;

• the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which Disc contracts for clinical and commercial supplies; and

• the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change such that Disc’s clinical data are insufficient for approval.

Even if Disc were to obtain regulatory approval, regulatory authorities may approve any of Disc’s product candidates for fewer or more limited indications than Disc requests, thereby narrowing the commercial potential of the product candidate. In addition, regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for Disc’s product candidates.

If Disc experiences delays in obtaining, or if Disc fails to obtain, approval of its product candidates, the commercial prospects for Disc’s product candidates may be harmed and its ability to generate revenue will be materially impaired.

Risks Related to Commercialization

Disc faces substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than Disc does.

The development and commercialization of new products in the biopharmaceutical and related industries is highly competitive. Disc competes in the segments of the pharmaceutical, biotechnology, and other related markets that develop therapies in the field of hematologic diseases. There are other companies focusing on developing therapies in the field of hematologic diseases. Disc also competes more broadly across the market for cost-effective and reimbursable treatments. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to its approach, and others are based on entirely different approaches. These companies include divisions of large pharmaceutical companies and biotechnology companies of various sizes. Disc faces competition with respect to its current product candidates, and will face competition with respect to any product candidates that it may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include

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academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Any product candidates that Disc successfully develops and commercializes will compete with currently approved therapies and new therapies that may become available in the future from segments of the pharmaceutical, biotechnology and other related markets. Key product features that would affect its ability to effectively compete with other therapeutics include the efficacy, safety and convenience of its products. Disc believes principal competitive factors to its business include, among other things, its ability to successfully transition research programs into clinical development, ability to raise capital, and the scalability of the platform, pipeline, and business.

Many of the companies that Disc competes against or which Disc may compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing approved products than it does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of its competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Disc in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, its programs. If these or other barriers to entry do not remain in place, other companies may be able to more directly or effectively compete with Disc.

Disc’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that Disc or its collaborators may develop. Disc’s competitors also may obtain FDA or other regulatory approval for their products sooner than Disc may obtain approval for its product candidates, which could result in Disc’s competitors establishing a strong market position before Disc or its collaborators are able to enter the market. The key competitive factors affecting the success of all of Disc’s product candidates, if approved, are likely to be their efficacy, safety, convenience, price, level of generic competition and availability of reimbursement from government and other third-party payors.

If the market opportunities for Disc’s programs and product candidates are smaller than Disc estimates or if any regulatory approval that Disc obtains is based on a narrower definition of the patient population, Disc’s revenue and ability to achieve profitability could be materially adversely affected.

The incidence and prevalence for the target patient populations of Disc’s programs and product candidates have not been established with precision. Disc’s lead heme biosynthesis modulation product candidate, bitopertin, is an oral, selective inhibitor of GlyT1. Disc is initially focused on developing bitopertin for the treatment of EPP and XLP, which are both diseases marked by severe photosensitivity and damage to the hepatobiliary system caused by the accumulation of PPIX. In July 2022, Disc initiated BEACON, a Phase 2 open-label, parallel-dose clinical trial of bitopertin in EPP and XLP patients that is being conducted at sites in Australia. Separately, Disc has initiated AURORA, a Phase 2, randomized, double-blind, placebo-controlled clinical trial of bitopertin in EPP patients that is being conducted at sites in the United States. Disc completed its Phase 1 clinical trial of DISC-0974 in healthy volunteers. Disc initiated a Phase 1b/2 clinical trial in June 2022 in the United States in patients with anemia of MF, and plans to initiate a separate Phase 1b/2 clinical trial by the end of 2022 in patients with anemia of CKD. Disc’s projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with its programs and product candidates, are based on its estimates.

The total addressable market opportunity will ultimately depend upon, among other things, the diagnosis criteria included in the final label, the indications for which Disc’s product candidates are approved for sale, acceptance by the medical community and patient access, product pricing and reimbursement. The number of patients with erythropoietic porphyria and anemias of inflammation for which Disc’s product candidates may be approved as treatment may turn out to be lower than expected, patients may not be otherwise amenable to treatment with its products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect its results of operations and its business. Disc may not be successful in its efforts to identify additional product candidates. Due to its limited resources and access to capital, Disc must prioritize development of certain product candidates, which may prove to be the wrong choice and may adversely affect its business.

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If its current product candidates or any future product candidates do not achieve broad market acceptance, the revenue that Disc generates from its sales may be limited, and Disc may never become profitable.

Disc has never commercialized a product candidate for any indication. Even if its current product candidates and any future product candidates are approved by the appropriate regulatory authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical community. If any product candidates for which Disc may obtain regulatory approval do not gain an adequate level of market acceptance, Disc may not generate significant revenue and may not become profitable or may be significantly delayed in achieving profitability. Market acceptance of its current product candidates and any future product candidates by the medical community, patients and third-party payors will depend on a number of factors, some of which are beyond its control. For example, physicians are often reluctant to switch their patients, and patients may be reluctant to switch, from existing therapies even when new and potentially more effective or safer treatments enter the market. If public perception is influenced by claims that the use of heme biosynthesis modulation therapies or hepcidin-targeted agents is unsafe, whether related to its or its competitors’ products, its products may not be accepted by the general public or the medical community. Future adverse events in the hematologic diseases or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of its product candidates.

In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Disc’s ability to successfully commercialize its product candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow Disc to establish or maintain pricing sufficient to realize a sufficient return on its investment. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.

Efforts to educate the medical community and third-party payors on the benefits of its current product candidates and any future product candidates may require significant resources and may not be successful. If its current product candidates or any future product candidates are approved but do not achieve an adequate level of market acceptance, Disc could be prevented from or significantly delayed in achieving profitability. The degree of market acceptance of any of Disc’s current product candidates and any future product candidates will depend on a number of factors, including:

• the efficacy of its current product candidates and any future product candidates;

• the prevalence and severity of adverse events associated with its current product candidates and any future product candidates;

• the clinical indications for which its product candidates are approved and the approved claims that Disc may make for the products;

• limitations or warnings contained in the product’s FDA-approved labeling or those of comparable foreign regulatory authorities, including potential limitations or warnings for its current product candidates and any future product candidates that may be more restrictive than other competitive products;

• changes in the standard of care for the targeted indications for its current product candidates and any future product candidates, which could reduce the marketing impact of any claims that Disc could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained;

• the relative convenience and ease of administration of its current product candidates and any future product candidates;

• the cost of treatment compared with the economic and clinical benefit of alternative treatments or therapies;

• the availability of adequate coverage or reimbursement by third-party payors, including government healthcare programs such as Medicare and Medicaid and other healthcare payors;

• the price concessions required by third-party payors to obtain coverage;

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• the willingness of patients to pay out-of-pocket in the absence of adequate coverage and reimbursement;

• the extent and strength of Disc’s marketing and distribution of its current product candidates and any future product candidates;

• the safety, efficacy, and other potential advantages over, and availability of, alternative treatments already used or that may later be approved;

• distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities with respect to its current product candidates and any future product candidates or to which Disc agrees as part of a Risk Evaluation and Mitigation Strategy, or REMS, or voluntary risk management plan;

• the timing of market introduction of its current product candidates and any future product candidates, as well as competitive products;

• its ability to offer its current product candidates and any future product candidates for sale at competitive prices;

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

• the extent and strength of its third-party manufacturer and supplier support;

• the approval of other new products;

• adverse publicity about its current product candidates and any future product candidates, or favorable publicity about competitive products; and

• potential product liability claims.

There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Further, due to the COVID-19 pandemic, millions of individuals have lost or will be losing employer-based insurance coverage, which may adversely affect Disc’s ability to commercialize its products. It is unclear what effect, if any, the American Rescue Plan will have on the number of covered individuals.

Disc may not be successful in addressing these or other factors that might affect the market acceptance of its product candidates. Failure to achieve widespread market acceptance of Disc’s product candidates would materially harm its business, financial condition and results of operations.

Even if Disc receives regulatory approval for any of its product candidates, Disc will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, its product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, Disc may be subject to penalties or other enforcement action if it fails to comply with regulatory requirements.

If the FDA or a comparable foreign regulatory authority approves any of Disc’s product candidates, the manufacturing processes, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion, monitoring, and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, establishment registration and listing, as well as continued compliance with cGMPs and GCPs for any clinical trials that Disc conducts post-approval. Any regulatory approvals that Disc receives for its product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing studies, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product. The FDA may also require a REMS in order to approve its product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. For certain commercial prescription drug and biological products,

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manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or other products that are otherwise unfit for distribution in the United States. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with its third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

• restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;

• manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation;

• revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;

• imposition of a REMS which may include distribution or use restrictions;

• requirements to conduct additional post-market clinical trials to assess the safety of the product;

• clinical trial holds;

• fines, warning letters or other regulatory enforcement action;

• refusal by the FDA to approve pending applications or supplements to approved applications filed by Disc or suspension or revocation of approvals;

• product seizure or detention, or refusal to permit the import or export of products; and

• injunctions or the imposition of civil or criminal penalties.

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of its product candidates. If Disc is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Disc is not able to maintain regulatory compliance, Disc may lose any regulatory approval that it may have obtained, which would adversely affect its business, prospects and ability to achieve or sustain profitability.

Risks Related to Disc’s Reliance on Third Parties

Disc relies on third parties to conduct its Phase 2 clinical trials of bitopertin and Phase 1b/2 clinical trial of Disc-0974 and expects to rely on third parties to conduct other clinical trials for its product candidates, as well as potential investigator-sponsored clinical trials of its product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, Disc may not be able to obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed.

Disc does not have the ability to independently conduct clinical trials. Disc relies and expects to continue to rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, to conduct or otherwise support clinical trials for its product candidates, including its Phase 2 clinical trials of bitopertin, Phase 1b/2 clinical trial of Disc-0974 in patients with anemia of MF, as well as any other product candidates that it develops. Disc may also rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to its product candidates, as is planned for bitopertin in DBA. Disc will not control the design or conduct of any investigator-sponsored trials, and it is possible that the FDA or non-U.S. regulatory authorities will not view these investigator-sponsored trials as providing adequate support for future clinical trials, whether controlled by Disc or third parties, for any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results.

Such arrangements will likely provide Disc certain information rights with respect to the investigator-sponsored trials, including access to and the ability to use and reference the data, including for its own regulatory filings, resulting from the investigator-sponsored trials. However, Disc would not have control over the timing and reporting of the data from investigator-sponsored trials, nor would Disc own the data from the investigator-sponsored trials. If Disc is unable to confirm or replicate the results from the investigator-sponsored trials or if negative results are obtained, Disc would likely be further delayed or prevented from advancing further clinical development of its product candidates. Further, if investigators or institutions breach their obligations with respect to the clinical

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development of Disc’s product candidates, or if the data proves to be inadequate compared to the first-hand knowledge Disc might have gained had the investigator-sponsored trials been sponsored and conducted by Disc, then Disc’s ability to design and conduct any future clinical trials itself may be adversely affected.

Disc relies and expects to continue to rely heavily on these parties for execution of clinical trials for its product candidates and control only certain aspects of their activities. Nevertheless, Disc is responsible for ensuring that each of its clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and its reliance on CROs or other third parties will not relieve Disc of its regulatory responsibilities. For any violations of laws and regulations during the conduct of its clinical trials, Disc could be subject to warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.

Disc, its principal investigators and its CROs are required to comply with regulations, including GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial patients are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, or the EEA, and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces GCP regulations through periodic inspections of clinical trial sponsors, principal investigators and trial sites. If Disc, its principal investigators or its CROs fail to comply with applicable GCPs, the clinical data generated in its clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Disc to perform additional clinical trials before approving its marketing applications. Disc cannot assure you that, upon inspection, the FDA will determine that any of its future clinical trials will comply with GCPs. In addition, Disc’s clinical trials must be conducted with product candidates produced under current Good Manufacturing Practice, or cGMP, regulations. Disc’s failure or the failure of its principal investigators or CROs to comply with these regulations may require Disc to repeat clinical trials, which would delay the regulatory approval process, significantly increase its expenditures and could also subject Disc to enforcement action. Disc also is required to register ongoing 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.

Although Disc designed its Phase 1b/2 clinical trial of DISC-0974 and ongoing Phase 2 clinical trials of bitopertin and intends to design the future clinical trials for its product candidates, these trials are or will be conducted by CROs and Disc expects CROs will conduct all of its future clinical trials. As a result, many important aspects of Disc’s development programs, including their conduct and timing, are outside of Disc’s direct control. Disc’s reliance on third parties to conduct future clinical trials also results in less direct control over the management of data developed through clinical trials than would be the case if Disc were relying entirely upon its own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:

• have staffing difficulties;

• fail to comply with contractual obligations;

• experience regulatory compliance issues;

• undergo changes in priorities or become financially distressed; or

• form relationships with other entities, some of which may be Disc’s competitors.

These factors may materially adversely affect the willingness or ability of third parties to conduct Disc’s clinical trials and may subject Disc to unexpected cost increases that are beyond its control. If the principal investigators or CROs do not perform clinical trials in a satisfactory manner, breach their obligations to Disc or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of its product candidates may be delayed, Disc may not be able to obtain regulatory approval and commercialize its product candidates or its development program may be materially and irreversibly harmed. If Disc is unable to rely on clinical data collected by its principal investigators or CROs, Disc could be required to repeat, extend the duration of, or increase the size of any clinical trials it conducts and this could significantly delay commercialization and require significantly greater expenditures.

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If any of Disc’s relationships with these third-party principal investigators or CROs terminate, Disc may not be able to enter into arrangements with alternative CROs. If principal investigators or CROs do not successfully carry out their contractual obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is com