S-4 1 rc004_s4.htm FORM S-4

  

As filed with the Securities and Exchange Commission on October 17, 2022

 

Registration No. 333-   

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM S-4

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

 

TradeUP Acquisition Corp.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware 6770 85-1314502

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification No.)

 

437 Madison Avenue, 27th Floor

New York, New York 10022

Telephone: (732) 910-9692

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

 

 

 

Jianwei Li

Chairman & Co-Chief Executive Officer

c/o TradeUP Acquisition Corp.

437 Madison Avenue, 27th Floor

New York, New York 10022

Telephone: (732) 910-9692

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

 

 

 

Copies to:

Arila E. Zhou

Anna Jinhua Wang

Robinson & Cole LLP

666 Third Avenue, 20th floor

New York, NY 10017

Telephone: (212) 451-2908

Michael J. Blankenship

James R. Brown 

Winston & Strawn LLP

800 Capitol Street, Suite 2400

Houston, TX 77002-2925

Telephone: (713) 651-2600

 

 

 

  

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after this Registration Statement is declared effective and all other conditions to the transactions contemplated by the Merger Agreement described in the enclosed proxy statement/prospectus have been satisfied or waived.

 

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 an 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 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

   

 

 

The information in this preliminary proxy statement/prospectus is not complete and may be changed. These securities may not be issued until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary proxy statement/prospectus does not constitute an offer to sell or a solicitation of offers to buy these securities in any jurisdiction in which such offer or sale is not permitted.

 

PRELIMINARY PROXY STATEMENT/PROSPECTUS — SUBJECT TO COMPLETION, DATED

OCTOBER 17, 2022

 

PROXY STATEMENT FOR SPECIAL MEETING OF

 

TradeUP Acquisition Corp.

 

PROSPECTUS FOR 32,500,000 SHARES OF COMMON STOCK

 

 

 

The board of directors (the “Board”) of TradeUp Acquisition Corp., a Delaware corporation (“UPTD”), has unanimously approved (i) the Agreement and Plan of Merger, dated as of September 30, 2022 (as amended from time to time, the “Merger Agreement”), by and among UPTD, Tradeup Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of UPTD (“Merger Sub”), and Estrella Biopharma, Inc., a Delaware corporation (“Estrella”), pursuant to which Merger Sub will merge with and into Estrella, with Estrella surviving as a wholly-owned subsidiary of UPTD (the “Merger”); (ii) each Ancillary Document (as defined in the Merger Agreement); and (iii) the Merger and other transactions contemplated therein (collectively, the “Business Combination”).

 

Consummation of the Business Combination is subject to the satisfaction or waiver by the respective parties of a number of conditions, including the approval of the Merger Agreement and the Business Combination by UPTD’s stockholders. Other conditions to each party’s obligations include, among other things: (i) the respective representations and warranties of the parties being true and correct; (ii) performance and compliance with all material respects of the Merger Agreement applicable to each party, respectively; (iii) delivery of the officer’s certificates certifying (i) and (ii) hereof, as applicable; (iv) the applicable waiting periods, if any, under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 having expired or terminated; (v) no governmental order, statute, rule, or regulation having been enacted or promulgated enjoining or prohibiting the consummation of the Business Combination; (vi) the net tangible assets upon the consummation of the Business Combination being no less than $5,000,0001; (vii) the Merger Consideration Shares (as defined below) having been approved for listing on Nasdaq, subject only to official notice of issuance thereof; (viii) an aggregate of at least $20,000,000 cash including (a) the amount of cash available in the Trust Account (as defined in this proxy statement/prospectus) immediately prior to the Closing (as defined below) (after payment of amounts due to stockholders redeeming their UPTD Common Stock (as defined below), and certain expenses related to the consummation of the Business Combination born by UPTD and Estrella, respectively, and the amount necessary to obtain the insurance listed in the Merger Agreement), as certified, (b) the proceeds of the Merger Financing (as defined below), and (c) the amount of cash available in any bank account of Estrella, as certified; and (iv) the completion of transaction financing (the “Merger Financing”), prior to or at the Closing, of at least $20,000,000 by UPTD or Estrella, including equity financing of no less than $15.0 million (excluding equity-linked securities such as convertible debt or debt plus warrants) and debt or equity-linked financing of no more than $5,000,000, on terms acceptable to Estrella.

 

Pursuant to the Merger Agreement, the Merger will become effective at such time on the date of the closing of the Merger (the “Closing”) as the certificate of merger is duly filed with the Secretary of State of the State of Delaware or at such other time specified in the certificates of merger (the “Effective Time”). Effective from the Closing, UPTD will change its name to “Estrella Immunopharma, Inc.” In this proxy statement/prospectus, when we refer to “Estrella,” we mean Estrella Biopharma, Inc. prior to the consummation of the Business Combination, and when we refer to “New Estrella” or the “Combined Company,” we mean UPTD, under its new corporate name, Estrella Immunopharma, Inc., after the consummation of the Business Combination.

 

Pursuant to the Merger Agreement, stockholders of Estrella immediately prior to the Effective Time collectively will receive from UPTD, in the aggregate, a number of newly issued shares of common stock of UPTD, par value $0.0001 per share (“UPTD Common Stock”) equal to: (i) $325,000,000 (the “Merger Consideration”), divided by (ii) $10.00 per share (such shares of UPTD Common Stock are referred to as “Merger Consideration Shares”) in consideration of converting their shares of common stock of Estrella, par value $0.0001 per share (“Estrella Common Stock”). Each share of Series A Preferred Stock of Estrella (the “Series A Preferred Stock”) and Series AA Preferred Stock of Estrella (the “Series AA Preferred Stock,” and together with the Series A Preferred Stock, the “Estrella Preferred Stock”) that is issued and outstanding immediately prior to the Effective Time will automatically convert into a number of shares of Estrella Common Stock in accordance with the certificate of incorporation of Estrella. See the section titled “Proposal 1: The Business Combination Proposal” for further information.

 

   

 

 

In connection with the execution of the Merger Agreement, TradeUP Acquisition Sponsor LLC and Tradeup INC. (collectively, the “Founders”), together with certain stockholders of UPTD (collectively, the “UPTD Initial Stockholders”), representing 24.27% of issued and outstanding shares of UPTD Common Stock, entered into a support agreement with UPTD and Estrella, pursuant to which each of the UPTD Initial Stockholders agreed to vote all the shares of UPTD Common Stock beneficially owned by it in favor of each of the Proposals in connection with the Business Combination, to use its reasonable best efforts to take all actions reasonably necessary to consummate the Business Combination, and to not take any action that would reasonably be expected to materially delay or prevent the satisfaction of the conditions to the Business Combination set forth in the Merger Agreement.

 

Based on an assumed closing date of for the Business Combination, assuming (i) no additional shares of UPTD Common Stock are issued prior to or upon Closing, (ii) there is no issuance of any equity awards resulting in additional outstanding shares of UPTD Common Stock in connection with the Estrella Immunopharma, Inc. 2023 Omnibus Incentive Plan (as defined in this proxy statement/prospectus) immediately following the Business Combination, (iii) excludes the issuance of any shares or other awards in connection with the Incentive Plan following the Business Combination, and (iv) 1,500,000 shares of UPTD Common Stock will be issued in connection with the Merger Financing at the Effective Time, assuming a minimum equity financing of $15.0 million at $10.00 per share of UPTD Common Stock, the Merger Consideration Shares are expected to represent between approximately 81.6% and 91.7% of the issued and outstanding shares of UPTD Common Stock (which will be New Estrella common stock following the Closing) and the voting power in New Estrella immediately following the closing of the Business Combination. These percentages assume, at the low end of the range, that no redemptions from the Trust Account occur, and, at the high end of the range, that maximum redemptions from the Trust Account occur as of the date of this proxy statement/prospectus are redeemed. Please see the section of this proxy statement/prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Information” for further information regarding what constitutes a “maximum redemptions” scenario.

 

Subject to the same assumptions set forth in the preceding paragraph, UPTD’s public stockholders are expected to hold between 11.1% and 0.1% of the issued and outstanding common stock and voting power in New Estrella. These percentages assume, at the low end of the range, that no redemptions from the Trust Account occur, and, at the high end of that range, that maximum redemptions from the Trust Account occur. See the section of this proxy statement/prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Information” for further information regarding what constitutes a “maximum redemptions” scenario.

 

Proposals to approve the Merger Agreement and the other matters discussed in this proxy statement/prospectus will be presented for approval by UPTD’s stockholders at the special meeting of stockholders of UPTD (the “Special Meeting”) scheduled to be held on  , in virtual format. The Board recommends that UPTD stockholders vote “FOR” the proposals described in this proxy statement/prospectus.

 

As described in this proxy statement/prospectus, after careful consideration, the board of directors of each of UPTD, Merger Sub, and Estrella has unanimously approved the Merger Agreement, each Ancillary Document, and the Business Combination, and has determined that it is advisable to consummate the Business Combination. In addition, certain holders of a requisite number of the outstanding shares of Estrella Common Stock and Estrella Preferred Stock have delivered a written consent sufficient to approve and adopt the Merger Agreement, each Ancillary Document, and the Business Combination. UPTD, as the sole stockholder of Merger Sub, has delivered to Estrella a written consent sufficient to approve and adopt the Merger Agreement, each Ancillary Document, and the Business Combination. Therefore, no additional approval or vote from any holders of any class or series of stock of Estrella or Merger Sub will be necessary to approve the Business Combination.

 

   

 

 

UPTD’s units (the “UPTD Units”), UPTD Common Stock, and UPTD’s warrants are currently listed on The Nasdaq Capital Market under the symbols “UPTDU,” “UPTD” and “UPTDW,” respectively. UPTD intends to apply to list the shares of common stock of New Estrella (the “New Estrella Common Stock”) and warrants of New Estrella (the “New Estrella Warrants”) effective upon the consummation of the Business Combination on the Nasdaq Global Market (“Nasdaq”) under the proposed symbols “       ” and “     W,” respectively. The UPTD Units will be automatically separated into underlying New Estrella Common Stock and New Estrella Warrants and will no longer be traded on the open market following the consummation of the Business Combination. No securities will trade on Nasdaq (or on The Nasdaq Capital Market) under the symbol “UPTDU,” “UPTD” or “UPTDW” following the consummation of the Business Combination. It is a condition of the consummation of the Business Combination that New Estrella Common Stock is approved for listing on Nasdaq (subject only to official notice of issuance thereof), but there can be no assurance that such listing condition will be met. If such listing condition is not met, the Business Combination will not be consummated unless the listing condition set forth in the Merger Agreement is waived by the parties to the Merger Agreement.

 

UPTD is an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, and has elected to comply with certain reduced public company reporting requirements.

 

This proxy statement/prospectus incorporates by reference important business and financial information about UPTD from documents that are not included in or delivered with this proxy statement/prospectus. You can obtain documents incorporated by reference in this proxy statement/prospectus and other filings of UPTD with the Securities and Exchange Commission (the “SEC”) by visiting its website at www.sec.gov or requesting them in writing or by telephone from UPTD using the following details:

 

TradeUP Acquisition Corp.
437 Madison Avenue, 27th Floor

New York, NY 10022

+1 (732) 910-9692

 

You will not be charged for any of these documents that you request. Stockholders requesting documents should do so by         (five business days prior to the date of the Special Meeting) in order to receive them before the Special Meeting.

 

This proxy statement/prospectus provides you with detailed information about the Business Combination and other matters to be considered at the Special Meeting. We urge you to carefully read this entire document and the documents incorporated herein by reference. In particular, you should review the matters discussed under the heading “Risk Factors” beginning on page 21 of this proxy statement/prospectus.

 

Neither the SEC nor any state securities commission has approved or disapproved of the transactions described in this proxy statement/prospectus or the securities referenced herein, passed upon the merits or fairness of the Business Combination or related transactions, or passed upon the adequacy or accuracy of this proxy statement/prospectus. Any representation to the contrary is a criminal offense.

 

This proxy statement/prospectus is dated            , and is first being mailed to stockholders of UPTD on or about           .

 

   

 

  

NOTICE OF THE SPECIAL MEETING OF STOCKHOLDERS
OF TRADEUP ACQUISITION CORP.

 

To Be Held On       

 

To the Stockholders of TradeUP Acquisition Corp.:

 

On behalf of the board of directors of TradeUP Acquisition Corp. (“UPTD,” “we,” “our” or “us”), a Delaware corporation, we are pleased to enclose the proxy statement/prospectus relating to the proposed merger of Tradeup Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of UPTD (“Merger Sub”), and Estrella Biopharma, Inc., a Delaware corporation (“Estrella”), pursuant to which Merger Sub will merge with and into Estrella, with Estrella surviving as a wholly-owned subsidiary of UPTD (the “Merger”), pursuant to an Agreement and Plan of Merger, dated as of September 30, 2022 (as amended or supplemented from time to time, the “Merger Agreement”), by and among UPTD, Merger Sub, and Estrella. At the closing of the Merger (the “Closing”), UPTD will change its name to “Estrella Immunopharma, Inc.” In this proxy statement/prospectus, when we refer to “Estrella,” we mean Estrella Biopharma, Inc. prior to the consummation of the Business Combination, and when we refer to “New Estrella” or the “Combined Company,” we mean UPTD, under its new corporate name, Estrella Immunopharma, Inc., after the consummation of the Business Combination (as defined below).

 

NOTICE IS HEREBY GIVEN that a special meeting of stockholders (the “Special Meeting”) of UPTD, will be held virtually on            , at          , Eastern Time, at the following Internet address:          . You will need the meeting control number that is printed on your proxy card to enter the Special Meeting. UPTD recommends that you log in at least 15 minutes before the Special Meeting to ensure you are logged in when the Special Meeting starts. Please note that you will not be able to attend the Special Meeting in person. You are cordially invited to attend the Special Meeting to consider the following proposals (the “Proposals”):

 

1.to (a) adopt and approve the Merger Agreement; (b) adopt and approve each Ancillary Document (as defined in the Merger Agreement); and (c) approve the Merger and other transactions contemplated therein (collectively, the “Business Combination”).

 

Pursuant to the Merger Agreement, the Merger will become effective at such time on the date of the Closing as the certificate of merger is duly filed with the Secretary of State of the State of Delaware or at such other time specified in the certificates of merger (the “Effective Time”).

 

Pursuant to the Merger Agreement, stockholders of Estrella immediately prior to the Effective Time collectively will receive from UPTD, in the aggregate, a number of newly issued shares of common stock of UPTD, par value $0.0001 per share (“UPTD Common Stock”) equal to: (i) $325,000,000 (the “Merger Consideration”), divided by (ii) $10.00 per share (such shares of UPTD Common Stock is referred as “Merger Consideration Shares”) in consideration of converting their shares of common stock of Estrella, par value $0.0001 per share (“Estrella Common Stock”). Each share of Series A and Series AA Preferred Stock of Estrella (collectively, the “Estrella Preferred Stock”) that is issued and outstanding immediately prior to the Effective Time will automatically convert into a number of shares of Estrella Common Stock in accordance with the certificate of incorporation of Estrella.

 

We refer to this proposal as the “Business Combination Proposal.” A copy of the Merger Agreement is attached to the accompanying proxy statement/prospectus as Annex A;

 

2.to approve, assuming the Business Combination Proposal is approved and adopted, a proposed second amended and restated certificate of incorporation (the “Proposed Charter,” a copy of which is attached to the accompanying proxy statement/prospectus as Annex B) of the Combined Company, which will amend and restate UPTD’s current amended and restated certificate of incorporation (the “Current Charter”), which will be in effect upon the Closing (the “Charter Amendment Proposal”);

 

   

 

 

3.to approve, on a non-binding advisory basis, the following material differences between the Proposed Charter and the Current Charter, which are being presented pursuant to guidance of the Securities and Exchange Commission as six separate sub-proposals (the “Advisory Charter Amendment Proposals”):

 

(a)Advisory Charter Amendment Proposal A — to change the corporate name of the Combined Company to “Estrella Immunopharma, Inc.” on and from the time of the Business Combination;

 

(b)Advisory Charter Amendment Proposal B — to increase the authorized shares of common stock of the Combined Company to 250,000,000 shares of common stock, par value of $0.0001 per share;

 

  (c) Advisory Charter Amendment Proposal C — to increase the authorized shares of preferred stock to 10,000,000 shares of preferred stock, par value of $0.0001 per share;

 

(d)Advisory Charter Amendment Proposal D — to provide that certain named individuals be elected to serve as Class I, Class II, and Class III directors to serve staggered terms on the board of directors of the Combined Company until their respective successors are duly elected and qualified, or until their earlier resignation, death, or removal, and to provide that the removal of any director be only for cause and only by the affirmative vote of the holders of at least two-thirds (66 and 2/3%) of the Combined Company’s then-outstanding shares of capital stock entitled to vote at an election of directors;

 

(e)Advisory Charter Amendment Proposal E — to provide that certain amendments to provisions of the Proposed Charter will require the approval of the holders of at least two-thirds (66 and 2/3%) of the Combined Company’s then-outstanding shares of capital stock entitled to vote on such amendments, and of the holders of shares of each class entitled to vote thereon as a class; and

 

(f)Advisory Charter Amendment Proposal F — to make the Combined Company’s corporate existence perpetual instead of requiring UPTD to be dissolved and liquidated 18 months following the closing of the Initial Public Offering (as defined below), and to omit from the Proposed Charter the various provisions applicable only to special purpose acquisition companies;

 

4.to approve, assuming the Business Combination Proposal is approved and adopted, for purposes of complying with the applicable provisions of Nasdaq Listing Rule 5635, the issuance of 32,500,000 shares of UPTD Common Stock in connection with the Business Combination and the issuance of at least 1,500,000 shares of UPTD Common Stock in connection with transaction financing (the “Merger Financing”) to certain investors, prior to or at the Closing, which amount will be determined as described in more detail in the accompanying proxy statement/prospectus (the “Nasdaq Stock Issuance Proposal”);

 

5.to approve, assuming the Business Combination Proposal is approved and adopted, the appointment of five directors who, upon consummation of the Business Combination, will become directors of the Combined Company (the “Director Election Proposal”);

 

6.to approve, assuming the Business Combination Proposal is approved and adopted, the Estrella Immunopharma, Inc. 2023 Omnibus Incentive Plan (the “Incentive Plan”), a copy of which is attached to the accompanying proxy statement/prospectus as Annex C, which will become effective as of and is contingent on the consummation of the Business Combination (the “Incentive Plan Proposal”); and

 

7.to approve a proposal to adjourn the Special Meeting to a later date or dates if it is determined that more time is necessary or appropriate, in the judgment of the board of directors of UPTD or the officer presiding over the Special Meeting, for UPTD to consummate the Business Combination (the “Adjournment Proposal”).

 

Only holders of record of UPTD Common Stock at the close of business on         (the “Record Date”) are entitled to notice of the Special Meeting and to vote at the Special Meeting and any adjournments or postponements of the Special Meeting. A complete list of UPTD stockholders of record entitled to vote at the Special Meeting will be available for 10 days before the Special Meeting at the principal executive offices of UPTD for inspection by stockholders during ordinary business hours for any purpose germane to the Special Meeting.

 

   

 

 

Pursuant to the Current Charter, UPTD is providing its public stockholders (“Public Stockholders”) with the opportunity to redeem, in connection with the consummation of the Merger, the shares of UPTD Common Stock issued in UPTD’s initial public offering consummated on July 19, 2021 (the “Initial Public Offering”) and the partial exercise of the underwriter’s over-allotment option in connection therewith consummated on July 21, 2021 (collectively, the “Public Shares”) then held by them for cash equal to their pro rata share of the aggregate amount of the deposit (as of two business days prior to the Closing) in the trust account (the “Trust Account”) that holds the proceeds (including interest but less taxes payable) of the Initial Public Offering and certain proceeds from the private placement of certain private placement shares in conjunction with the closing of the Initial Public Offering. For illustrative purposes, based on funds in the Trust Account of $ on the Record Date, the estimated per share redemption price would have been approximately $ . Public Stockholders may elect to redeem Public Shares regardless of whether they vote for, against, or abstain from voting on the Business Combination Proposal. A Public Stockholder, together with any of his, her, or its affiliates or any other person with whom he, she, or it is acting in concert or as a “group” (as defined under Section 13 of the Securities Exchange Act of 1934, as amended), will be restricted from redeeming in the aggregate his, her, or its shares or, if part of such a group, the group’s shares, with respect to more than an aggregate of 15% of the Public Shares. In connection with the Initial Public Offering, TradeUP Acquisition Sponsor LLC (the “Sponsor”), Tradeup INC. (collectively with the Sponsor, the “Founders”), and other initial stockholders of UPTD (collectively with the Founders, the “UPTD Initial Stockholders”) have agreed to waive their redemption rights with respect to any shares of UPTD Common Stock they may hold, and such shares will be excluded from the pro rata calculation used to determine the per-share redemption price. The UPTD Initial Stockholders have agreed to vote any shares of UPTD Common Stock owned by them, which represent approximately 24.27% of the voting power of UPTD as of the Record Date, in favor of the Business Combination Proposal. The UPTD Initial Stockholders have also agreed to vote their shares in favor of all other Proposals being presented at the Special Meeting and use their reasonable best efforts to take all actions reasonably necessary to consummate the Merger and the Business Combination pursuant to a support agreement they entered into with UPTD and Estrella in connection with the Merger Agreement.

 

Pursuant to UPTD’s bylaws, the presence of the holders of a majority of the issued and outstanding shares of UPTD Common Stock entitled to vote at the Special Meeting or by proxy will constitute a quorum for the transaction of business at the Special Meeting. Under the Delaware General Corporation Law, shares that are voted “abstain” or “withheld” are counted as present for purposes of determining whether a quorum is present at the Special Meeting. Because the Proposals are “non-discretionary” items, your broker will not be able to vote uninstructed shares for any of the Proposals. As a result, if you do not provide voting instructions to your broker, a broker “non-vote” will be deemed to have occurred for each of the Proposals. Broker “non-votes” will not be counted as present for purposes of determining whether a quorum is present.

 

The approval of the Business Combination Proposal requires the affirmative vote of the holders of a majority of the shares of UPTD Common Stock cast in respect of the Business Combination Proposal and entitled to vote thereon at the Special Meeting. The approval of the Charter Amendment Proposal requires a majority vote of outstanding UPTD Common Stock entitled to vote thereon. The Nasdaq Stock Issuance Proposal, the Incentive Plan Proposal, the Adjournment Proposal, and each of the Advisory Charter Amendment Proposals also requires the affirmative vote of the holders of a majority of the shares of UPTD Common Stock cast in respect of the relevant Proposal and entitled to vote thereon at the Special Meeting.

 

The approval of the Director Election Proposal requires a plurality vote of the shares of UPTD Common Stock cast in respect of the Director Election Proposal present in person (including virtual presence) or represented by proxy and entitled to vote thereon at the Special Meeting. A “plurality of vote” means that the nominees receiving the greatest number of votes cast “FOR” are elected as directors up to the maximum number of directors to be elected. Consequently, any shares not voted “FOR” a particular nominee (whether as a result of an abstention, a direction to withhold authority, or a broker non-vote) will not be counted in the nominee’s favor.

 

If the Business Combination Proposal is not approved, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal will not be presented to UPTD stockholders for a vote. The approval of the Business Combination Proposal and, unless otherwise waived by the parties thereof, the Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are preconditions to the Closing. The Adjournment Proposal is not conditioned on the approval of any other Proposal.

 

   

 

 

As of the Record Date, there was $          in the Trust Account. Each redemption of the Public Shares by Public Stockholders will decrease the amount in the Trust Account. UPTD will not redeem Public Shares in an amount that would cause it to have net tangible assets of less than $5,000,001 either immediately prior to or upon the consummation of the Business Combination.

 

Your attention is directed to the proxy statement/prospectus accompanying this notice (including the Annexes thereto) for a more complete description of the proposed Business Combination and related transactions and each of the Proposals. We encourage you to read the proxy statement/prospectus carefully. If you have any questions or need assistance voting your shares, please call our proxy solicitor,          ,Toll-free at         , or email at          .

 

          , 2022    
     
By Order of the Board of Directors    
     
     
Jianwei Li    
Chairman of the Board of Directors    

 

   

 

 

TABLE OF CONTENTS

 

  Page
   
Market and Industry Data ii
Trademarks ii
Frequently Used Terms ii
Summary Term Sheet vii
Questions and Answers About The Proposals x
Summary of the Proxy Statement/Prospectus 1
Forward-Looking Statements 18
Risk Factors 21
Special Meeting of UPTD Stockholders 102
Proposal 1: The Business Combination Proposal 108
Material U.S. Federal Income Tax Considerations 126
Unaudited Pro Forma Condensed Combined Financial Information 133
Proposal 2: The Charter Amendment Proposal 142
Proposal 3: The Advisory Charter Amendment Proposals 144
Proposal 4: The Nasdaq Stock Issuance Proposal 146
Proposal 5: The Director Election Proposal 148
Proposal 6: The Incentive Plan Proposal 150
Proposal 7: The Adjournment Proposal 157
Information About UPTD 158
UPTD Management’s Discussion and Analysis of Financial Condition and Results of Operations 168
Information About Eureka 174
Information About Estrella 175
Business 175
Estrella Management’s Discussion and Analysis of Financial Condition and Results of Operations 201
Security Ownership of Certain Beneficial Owners and Management of New Estrella 212
Certain Relationships and Related Party Transactions 214
Description of New Estrella’s Securities After the Business Combination 216
Securities Act Restrictions on Resale of Common Stock 219
Comparison of Governance and Stockholders’ Rights 220
Trading Symbol, Market Price and Dividend Policy 229
Management of the Combined Company 230
Appraisal Rights 236
Stockholder Nominations and Proposals 237
Stockholder Communications and Delivery of Documents to Stockholders 240
Legal Matters 240
Experts 240
Change in Accountants 241
Enforceability of Civil Liability 241
Other Matters 241
Where You Can Find More Information 243
Index to Consolidated Financial Statements F-1

 

Annex A Agreement and Plan of Merger, by and among TradeUP Acquisition Corp., Tradeup Merger Sub Inc., and Estrella Biopharma, Inc., dated as of September 30, 2022
Annex B Form of TradeUP Acquisition Corp. Second Amended and Restated Certificate of Incorporation
Annex C Form of Estrella Immunopharma, Inc. 2023 Equity Omnibus Incentive Plan
Annex D Form of Proposed Bylaws
Annex E Opinion of The Benchmark Company, LLC

 

 i 

 

 

MARKET AND INDUSTRY DATA

 

Certain information contained in this document relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and UPTD’s own internal estimates and research. While we are not aware of any misstatements regarding such third-party information and data presented in this proxy statement/prospectus, such information and data involves risks and uncertainties and is subject to change based on various factors, including, potentially, those discussed under the section of this proxy statement/prospectus entitled “Risk Factors.” Furthermore, such information and data cannot always be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process, and other limitations and uncertainties inherent in any statistical survey. Finally, while we believe our own internal estimates and research are reliable, and are not aware of any misstatements regarding such information and data presented in this proxy statement/prospectus, such research has not been verified by any independent source. Notwithstanding anything in this proxy statement/prospectus to the contrary, UPTD is responsible for all disclosures in this proxy statement/prospectus.

 

TRADEMARKS

 

This document contains references to trademarks, trade names, and service marks belonging to other entities. Solely for convenience, trademarks, trade names, and service marks referred to in this proxy statement/prospectus may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entities.

 

FREQUENTLY USED TERMS

 

As used in this proxy statement/prospectus, unless otherwise noted or the context otherwise requires, references to:

 

Adjournment Proposal” means that proposal that UPTD stockholders will be asked to consider and vote upon at the Special Meeting to adjourn the Special Meeting.

 

Association of South East Asian Nations” or “ASEAN Countries” means the countries of Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam

 

Available Combined Cash Amount” means the sum of (a) the amount of cash available in the Trust Account immediately prior to the Closing (after payment of amounts due to UPTD stockholders redeeming their Public Shares, and certain expenses related to the consummation of the Business Combination born by UPTD and Estrella, respectively, and the amount necessary to obtain the insurance as provided in the Merger Agreement), as certified, (b) the proceeds of the Merger Financing, and (c) the amount of cash available in any bank account of Estrella as certified.

 

Additional Private Placement” means the private placement of 17,200 shares of UPTD Common Stock consummated on July 21, 2021.

 

ARTEMIS®”, “ARTEMIS® platform”, or “ARTEMIS® Cell Receptor Platform” means the Antibody Redirected T-Cells with Endogenous Modular Immune Signaling platform.

  

Benchmark” means The Benchmark Company, LLC.

 

Board” means UPTD’s board of directors.

 

Business Combination” means the transactions contemplated by the Merger Agreement, including the merger between Merger Sub and Estrella.

 

Business Combination Marketing Agreement” means an agreement among UPTD and the Representatives to engage the Representatives as financial advisors in connection with UPTD’s business combination.

 

Business Combination Proposal” means the proposal that UPTD stockholders will be asked to consider and vote upon at the Special Meeting to adopt the Merger Agreement and approve the Business Combination.

 

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CD19” means the target corresponding to the B lymphocyte antigen Cluster of Differentiation 19.

 

CD22” means the target corresponding to the B lymphocyte antigen Cluster of Differentiation 22.

 

“Charter Amendment Proposal” means that proposal that UPTD stockholders will be asked to consider and vote upon at the Special Meeting to adopt the Proposed Charter and the Proposed Bylaws.

 

Closing” means the closing of the Business Combination.

 

Closing Price” means the redemption price of UPTD Common Stock on the date of the Closing.

 

Code” means the Internal Revenue Code of 1986, as amended.

 

Combined Company” means UPTD subsequent to the Business Combination (also referred to herein as “New Estrella”).

 

Concurrent Private Placement” means the private placement of 295,000 shares of UPTD Common Stock, which was consummated simultaneously with the Initial Public Offering.

 

Conversion Shares” means the shares of the UPTD Common Stock that the payees of the Notes are entitled to receive upon the conversion of the Notes, in whole or in part. 

 

Current Bylaws” means UPTD’s current bylaws.

 

Current Charter” means UPTD’s amended and restated certificate of incorporation.

 

DGCL” means the Delaware General Corporation Law, as amended.

 

Deferred Business Combination Fee” means an aggregate of $1,550,500 to be paid to the Representatives from the funds held in the Trust Account pursuant to the Business Combination Marketing Agreement.

 

Director Election Proposal” means that proposal that UPTD stockholders will be asked to consider and vote upon at the Special Meeting to appoint the directors of the Combined Company, effective upon the consummation of the Business Combination.

 

Dollars” or "$” means U.S. dollars.

 

Effective Time” means the effective time of the Business Combination.

 

Estrella” means Estrella Biopharma, Inc., a Delaware corporation.

 

Estrella Common Stock” means the common stock, par value $0.0001 per share, of Estrella.

 

Estrella Dissenting Shares” means the shares of Estrella Common Stock outstanding immediately prior to the Effective Time and owned by a holder who is entitled to demand and has properly demanded appraisal of such shares in accordance with, and who complies in all respects with, Section 262 of the DGCL.

 

Estrella Options” means options to purchase Estrella Common Stock, whether vested or unvested.

 

Estrella Preferred Stock” means Estrella Series A Preferred Stock and Estrella Series AA Preferred Stock.

 

Estrella Restricted Shares” means unvested restricted shares of Estrella Common Stock granted under Estrella’s current existing equity incentive plan adopted by Estrella on May 27, 2022.

 

Estrella Series A Preferred Stock” means the preferred stock, par value $0.0001 per share, of Estrella designated as Series A Preferred Stock.

 

“Estrella Series AA Preferred Stock” means the preferred stock, par value $0.0001 per share, of Estrella designated as Series AA Preferred Stock.

 

Eureka” means Eureka Therapeutics, Inc., a Delaware corporation.

 

Exchange Act” means the Securities Exchange Act of 1934, as amended.

 

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Fairness Opinion” means the fairness opinion rendered by Benchmark, dated September 30, 2022, in connection with the Business Combination.

 

FDA” means the United States Food and Drug Administration.

 

Founder Shares” mean the shares of UPTD Common Stock initially purchased by the Founders, some of which were assigned to certain directors of UPTD by the Founders immediately prior to the closing of the Initial Public Offering.

 

Founders” means the Sponsor and Tradeup INC., a Delaware corporation.

 

Greater China” means the People’s Republic of China, Hong Kong SAR, Macau SAR, and Taiwan.

 

HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

 

Incentive Plan” means the Estrella Immunopharma, Inc. 2023 Omnibus Incentive Plan, approved by the Board and the holders of UPTD Common Stock, effective as of and contingent on the consummation of the Business Combination.

 

Incentive Plan Proposal” means the proposal that UPTD stockholders will be asked to consider and vote upon at the Special Meeting to adopt the Incentive Plan.

 

IND” means an Investigational New Drug Application, which is an application submitted to the FDA for approval to administer an investigational drug or biological product to humans.

 

Initial Public Offering” means the initial public offering of UPTD, which closed on July 19, 2021.

 

IPO Letter Agreement” means a letter agreement by and among UPTD and the UPTD Initial Stockholders, dated July 14, 2021, entered into in connection with the Initial Public Offering.

 

JOBS Act” means the Jumpstart Our Business Startups Act of 2012, as amended.

 

Licensed Territory” means all territories of the world excluding Greater China and the ASEAN Countries.

 

Lock-Up Agreement” means a lock-up agreement to be entered by certain stockholders of Estrella with respect to the Merger Consideration Shares that they will receive at the Closing.

 

Lock-Up Securities” means the Merger Consideration Shares subject to the Lock-Up Agreement.

 

Maturity Date” means the date on which the Notes are payable.

 

Merger Agreement” means the Agreement and Plan of Merger, dated as of September 30, 2022, as amended or modified from time to time, by and among UPTD, Merger Sub, and Estrella.

 

Merger Consideration” means $325,000,000, payable in newly issued shares of UPTD Common Stock at $10.00 per share.

 

Merger Consideration Shares” means in the aggregate, a number of newly issued shares of UPTD Common Stock to the Sellers equal to 32,500,000.

 

Merger Financing” means the transaction financing of cash actually raised by UPTD or Estrella in support of the Merger.

 

Merger Financing Investors” means those investors participating in the Merger Financing.

 

Merger Sub” means Tradeup Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of UPTD.

 

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Nasdaq” means The Nasdaq Stock Market LLC and, as the context may require, any of the capital markets which it operates.

 

New Estrella” means UPTD subsequent to the Business Combination under the name of “Estrella Immunopharma, Inc.” (also referred to herein as the “Combined Company”).

 

New Estrella Board” means the board of directors of New Estrella.

 

New Estrella Common Stock” means the issued and outstanding common stock of New Estrella, par value $0.0001 per share, immediately after the Effective Time, which, pursuant to the Proposed Charter, will replace the UPTD Common Stock upon consummation of the Business Combination as the only common stock of the Combined Company.

 

Note A” means an unsecured promissory note in the amount of $204,000 issued by UPTD to Running Lion Holdings Limited issued on July 25, 2022.

 

Note B” means an unsecured promissory note in the amount of $294,600 issued by UPTD to Tradeup INC. issued on July 25, 2022.

 

Notes” means, collectively, Note A and Note B.

 

Private Shares” means the shares of UPTD Common Stock sold to the Founders in the Concurrent Private Placement and the Additional Private Placement.

 

Proposals” means each of the proposals to be considered for approval at the Special Meeting, as set forth in the section entitled “Summary Term Sheet” below.

 

Proposed Bylaws” means the amended and restated certificate of bylaws of UPTD, attached to this proxy statement/prospectus as Annex D.

 

Proposed Charter” means the second amended and restated certificate of incorporation of UPTD, attached to this proxy statement/prospectus as Annex B.

 

Public Shares” means the shares of UPTD Common Stock issued in the Initial Public Offering.

 

Public Stockholders” means holders of Public Shares.

 

Record Date” means       .

 

Representatives” means the representative of the underwriters of the Initial Public Offering, including US Tiger Securities, Inc., EF Hutton, division of Benchmark Investments, LLC, and R.F. Lafferty & Co., Inc.

 

S-1” means UPTD’s registration statement on Form S-1 (File No.: 333-253322) filed with the SEC in connection with the Initial Public Offering, which was declared effective on July 14, 2022.

 

Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002, as amended.

 

SEC” means the U.S. Securities and Exchange Commission.

 

Securities Act” means the Securities Act of 1933, as amended.

 

Sellers” means the holders of Estrella Common Stock and Estrella Preferred Stock immediately prior to the Effective Time.

 

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Special Meeting” means the special meeting of stockholders of UPTD, scheduled to be held on         , at        , Eastern Time.

 

Sponsor” means TradeUP Acquisition Sponsor LLC, a Delaware limited liability company.

 

Support Agreement” means a support agreement by and among Estrella, UPTD, and the UPTD Initial Stockholders dated as of September 30, 2022.

 

Syracuse License Agreement” means that Amended and Restated License Agreement, effective as of June 30, 2020, by and among Eureka, Eureka Therapeutics (Cayman), Inc., and Syracuse Biopharma (Cayman) Ltd. (as predecessor in interest to JW (Cayman) Therapeutics Co. Ltd).

 

Trust Account” means the trust account maintained by WTNA, acting as trustee, established for the benefit of Public Stockholders in connection with the Initial Public Offering.

 

Trust Agreement” means an investment management trust account agreement, dated July 14, 2021, between UPTD and WTNA.

 

UPTD” means TradeUP Acquisition Corp., a Delaware corporation.

 

UPTD Common Stock” means the common stock of UPTD, par value $0.0001 per share.

 

UPTD Initial Stockholders” means the Founders and UPTD’s officers and directors or their permitted transferees, who hold the Founder Shares and Private Shares, as applicable. For the purpose of this defined term, UPTD Initial Stockholders exclude certain members of TradeUP Acquisition Sponsor LLC, each of whom purchased up to 9.9% of the UPTD Units sold in the Initial Public Offering as a qualified institutional buyer or institutional accredited investor and acquired membership interests in TradeUP Acquisition Sponsor LLC for nominal consideration, entitling them to an interest in an aggregate of up to 240,000 Founder Shares indirectly through TradeUP Acquisition Sponsor LLC.  

 

UPTD Units” means the units of UPTD issued in connection with the Initial Public Offering, each unit consisting of one share of UPTD Common Stock and one-half of one UPTD Warrant.

 

UPTD Warrants” mean the redeemable warrants of UPTD sold as part of the Units in the Initial Public Offering (whether they are purchased in the Initial Public Offering or thereafter in the open market).

 

U.S. GAAP” means the accounting principles generally accepted in the United States of America.

 

US Tiger” means US Tiger Securities, Inc., an underwriter of the Initial Public Offering and the financial advisor in connection with UPTD’s business combination.

 

VStock” means VStock Transfer, LLC, transfer agent for UPTD.

 

Working Capital Shares” means the shares of UPTD Common Stock issuable upon the conversion of the working capital loans, up to $1,200,000, made by the Founders or an affiliate of the Founders or certain officers and directors of UPTD to finance transaction costs in connection with an initial business combination, at a price of $10.00 per share at the option of the lender.

 

WTNA” means Wilmington Trust, National Association, trustee of the Trust Account.

 

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SUMMARY TERM SHEET

 

This Summary Term Sheet and the sections entitled “Questions and Answers About the Proposals” and “Summary of the Proxy Statement/Prospectus” summarize certain information contained in this proxy statement/prospectus, but do not contain all of the information that is important to you. You should carefully read this entire proxy statement/prospectus, including all of the accompanying financial statements and the attached annexes, for a more complete understanding of the matters to be considered at the Special Meeting.

 

·UPTD is a special purpose acquisition company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses.

 

  · On July 19, 2021, UPTD completed its Initial Public Offering of 4,000,000 UPTD Units at an offering price of $10.00 per unit, generating gross proceeds of $40,000,000. Simultaneously with the closing of the Initial Public Offering, UPTD consummated the Concurrent Private Placement of 295,000 Private Shares at $10.00 per share to the Founders, generating gross proceeds of $2,950,000. On July 21, 2021, in connection with the underwriters’ exercise of their over-allotment option, UPTD issued an additional 430,000 UPTD Units (the “Option Units”) at a price of $10.00 per unit, generating gross proceeds of $4,300,000, and simultaneously consummated the sale of 17,200 Private Shares to the Founders in the Additional Private Placement at a price of $10.00 per share, generating gross proceeds of $172,000.

 

·Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer with safe, effective therapies. To accomplish this mission, Estrella’s lead product candidate, EB103, which is a T-cell therapy also called “CD19-Redirected ARTEMIS® T-Cell Therapy,” utilizes Eureka’s ARTEMIS® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, a T-cell therapy also called “CD19/22 Dual-Targeting ARTEMIS® T-Cell Therapy.” Like EB103, EB104 utilizes Eureka’s ARTEMIS® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies. Estrella is also collaborating with Imugene and its product candidate, CF33-CD19t, to research the use of EB103 in conjunction with CF33-CD19t to treat solid tumors using a “mark and kill” strategy.

 

·On September 30, 2022, UPTD, Merger Sub, and Estrella entered into the Merger Agreement, pursuant to which, among other things, Merger Sub will merge with and into Estrella with Estrella surviving as a wholly-owned subsidiary of UPTD.

 

·Pursuant to the Merger Agreement, stockholders of Estrella immediately prior to the Effective Time collectively will receive from UPTD, in the aggregate, a number of newly issued shares of UPTD Common Stock equal to: (i) $325,000,000, divided by (ii) $10.00 per share in consideration of converting their shares of Estrella Common Stock. Each share of Estrella Preferred Stock that is issued and outstanding immediately prior to the Effective Time will automatically convert into a number of shares of Estrella Common Stock in accordance with the certificate of incorporation of Estrella. For more information regarding the consideration to be paid in connection with the Business Combination, please see the section entitled “Proposal 1: The Business Combination Proposal.

 

·In connection with UPTD’s entry into the Merger Agreement, the UPTD Initial Stockholders have entered into the Support Agreement, a copy of which is filed with this proxy statement/prospectus, and effective as of the consummation of the Closing further described in the section entitled “Proposal 1: The Merger Agreement – Related Agreements –Support Agreement.”

 

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·Consummation of the Business Combination is subject to the satisfaction or waiver by the respective parties of a number of conditions, including the approval of the Merger Agreement and the Business Combination by UPTD’s stockholders. Other conditions to each party’s obligations, include, among other things: (i) the respective representations and warranties of the parties being true and correct; (ii) performance and compliance with all material respects of the Merger Agreement applicable to each party, respectively; (iii) delivery of the officer’s certificates certifying (i) and (ii) hereof, as applicable; (iv) the applicable waiting periods, if any, under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 having expired or terminated; (v) no governmental order, statute, rule or regulation having been enacted or promulgated enjoining or prohibiting the consummation of the Business Combination; (vi) the net tangible assets upon the consummation of the Business Combination being no less than $5,000,0001; (vii) the Merger Consideration Shares (as defined below) having been approved for listing on Nasdaq, subject only to official notice of issuance thereof; (viii) an aggregate of at least $20,000,000 cash including (a) the amount of cash available in the Trust Account immediately prior to the Closing (after payment of amounts due to stockholders redeeming their UPTD Common Stock, and certain expenses related to the consummation of the Business Combination born by UPTD and Estrella, respectively, and the amount necessary to obtain the insurance listed in the Merger Agreement), as certified, (b) the proceeds of the Merger Financing, and (c) the amount of cash available in any bank account of Estrella, as certified; and (iv) the completion of the Merger Financing prior to or at the Closing of at least $20,000,000 by UPTD or Estrella, including equity financing of no less than $15,000,000 (excluding equity-linked securities such as convertible debt or debt plus warrants) and debt or equity-linked financing of no more than $5,000,000, on terms acceptable to Estrella.

 

·It is anticipated that, upon the Closing:

 

othe Sellers will own approximately 81.6% of the outstanding UPTD Common Stock;

 

othe UPTD Initial Stockholders will own approximately 3.6% of the outstanding UPTD Common Stock;

 

oPublic Stockholders will own approximately 11.1% of the outstanding UPTD Common Stock; and

 

othe Merger Financing Investors will own approximately 3.7% of the outstanding UPTD Common Stock.

 

These levels of ownership interest assume that (i) no Public Shares are elected to be redeemed in connection with the Business Combination, (ii) no additional shares of UPTD Common Stock are issued prior to or upon Closing, (iii) there is no issuance of any equity awards resulting in additional outstanding shares of UPTD Common Stock in connection with the Incentive Plan, (iv) excludes the issuance of any shares or other awards in connection with the Incentive Plan following the Business Combination, and (v) assume 1,500,000 shares of UPTD Common Stock will be issued in connection with the Merger Financing at the Effective Time, assuming minimum equity financing of $15.0 million at $10.00 per share of UPTD Common Stock. For more information, please see the section entitled “Unaudited Pro Forma Condensed Combined Financial Information.”

 

·The Board considered a wide variety of factors, including the Fairness Opinion, in connection with its evaluation of the Business Combination and determining whether to approve the Merger Agreement. For more information about the Board’s decision-making process, as well as other factors, uncertainties, and risks considered, see the section entitled “Proposal 1: The Business Combination Proposal — The Board’s Reasons for the Approval of the Business Combination.”

 

·Pursuant to the Current Charter, Public Stockholders may request that UPTD redeem all or a portion of their Public Shares for cash if the Business Combination is consummated. Public Stockholders may elect to redeem their Public Shares regardless of whether they vote “FOR,” “AGAINST,” or abstain from voting on the Business Combination Proposal, or any other Proposal. If the Business Combination is not consummated, the Public Shares will be returned to the respective Public Stockholder or their broker, bank, or other nominee. If the Business Combination is consummated, and if a Public Stockholder properly exercises their right to redeem all or a portion of their Public Shares, including by timely delivering their shares to VStock, we will redeem such Public Shares for a per-share price, payable in cash, equal to the pro rata portion of the Trust Account, calculated as of two business days prior to the consummation of the Business Combination, including interest earned on the funds held in the Trust Account (net of taxes payable). For illustrative purposes, based on funds in the Trust Account of $             on the Record Date, the estimated per share redemption price would have been approximately $            . If a Public Stockholder properly exercises their redemption rights in full, then they will be electing to exchange all of their Public Shares for cash and will not own any shares of the Combined Company. Please see the section entitled “Summary of the Proxy Statement/Prospectus—Redemption Rights of UPTD Stockholders” for further information regarding the redemption rights of Public Stockholders.

 

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·In addition to voting on the Business Combination Proposal at the Special Meeting, UPTD stockholders will be asked to vote to approve the following Proposals:

 

oassuming the Business Combination Proposal is approved and adopted the Proposed Charter, which will amend and restate the Current Charter for the Combined Company, which will be in effect upon the Closing (the “Charter Amendment Proposal”);

 

oon a non-binding advisory basis, the following material differences between the Proposed Charter and the Current Charter, which are being presented pursuant to guidance of the Securities and Exchange Commission as six separate sub-proposals (the “Advisory Charter Amendment Proposals”):

 

(a)Advisory Charter Amendment Proposal A — to change the corporate name of the Combined Company to “Estrella Immunopharma, Inc.” on and from the time of the Business Combination;

 

(b)Advisory Charter Amendment Proposal B — to increase the authorized shares of common stock of the Combined Company to 250,000,000 shares of common stock, par value of $0.0001 per share;

 

(c)Advisory Charter Amendment Proposal C — to increase the authorized shares of preferred stock to 10,000,000 shares of preferred stock, par value of $0.0001 per share;

 

(d)Advisory Charter Amendment Proposal D — to provide that certain named individuals be elected to serve as Class I, Class II and Class III directors to serve staggered terms on the board of directors of the Combined Company until their respective successors are duly elected and qualified, or until their earlier resignation, death, or removal, and to provide that the removal of any director be only for cause and only by the affirmative vote of the holders of at least two-thirds (66 and 2/3%) of the Combined Company’s then-outstanding shares of capital stock entitled to vote at an election of directors;

 

(e)Advisory Charter Amendment Proposal E — to provide that certain amendments to provisions of the Proposed Charter will require the approval of the holders of at least two-thirds (66 and 2/3%) of the Combined Company’s then-outstanding shares of capital stock entitled to vote on such amendments, and of the holders of shares of each class entitled to vote thereon as a class;

 

(f)Advisory Charter Amendment Proposal F — to make the Combined Company’s corporate existence perpetual instead of requiring UPTD to be dissolved and liquidated 18 months following the closing of the Initial Public Offering, and to omit from the Proposed Charter the various provisions applicable only to special purpose acquisition companies; and

 

oassuming the Business Combination Proposal is approved and adopted, for purposes of complying with the applicable provisions of Nasdaq Listing Rule 5635, the issuance of 32,500,000 shares of UPTD Common Stock in connection with the Business Combination and issuance of at least 1,500,000 shares of UPTD Common Stock to Merger Financing Investors in connection with the Merger Financing, which amount will be determined as described in more detail in the accompanying proxy statement/prospectus (the “Nasdaq Stock Issuance Proposal”)

 

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oassuming the Business Combination Proposal is approved and adopted, the appointment of five directors who, upon consummation of the Business Combination, will become directors of the Combined Company (the “Director Election Proposal”);

 

oassuming the Business Combination Proposal is approved and adopted, the Estrella Immunopharma, Inc. 2023 Omnibus Incentive Plan (the “Incentive Plan”) (the “Incentive Plan Proposal”); and

 

oto approve a proposal to adjourn the Special Meeting to a later date or dates if it is determined that more time is necessary or appropriate, in the judgment of the board of directors of UPTD or the officer presiding over the Special Meeting, for UPTD to consummate the Business Combination (the “Adjournment Proposal”).

 

For further information, please see the section entitled “Summary of the Proxy Statement/Prospectus—Additional Matters Being Voted On By UPTD Stockholders.” The approval of the Business Combination Proposal, the Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are preconditions to the Closing. Each of these Proposals is more fully described in this proxy statement/prospectus, which each UPTD stockholder is encouraged to read carefully and in its entirety.

 

·The proposed Business Combination, including the business of UPTD (which will be New Estrella) following the Business Combination, involves numerous risks. For more information about these risks, please see the section entitled “Risk Factors.”

 

·When you consider the recommendation of the Board in favor of approval of the Business Combination Proposal and the other Proposals included herein, you should keep in mind that the UPTD Initial Stockholders have interests in such Proposals that are different from, or in addition to, those of UPTD’s stockholders generally. The Board was aware of and considered these interests, among other matters, in evaluating and negotiating the Merger Agreement and recommending to UPTD stockholders that they vote in favor of the Proposals presented at the Special Meeting, including the Business Combination Proposal. UPTD stockholders should take these interests into account in deciding whether to approve the Proposals presented at the Special Meeting, including the Business Combination Proposal. For further information, please see the section entitled “Proposal 1: The Business Combination Proposal — Interests of the Founders and UPTD’s Directors and Officers in the Business Combination.”

  

QUESTIONS AND ANSWERS ABOUT THE PROPOSALS

 

The questions and answers below highlight only selected information from this proxy statement/prospectus and only briefly address some commonly asked questions about the Special Meeting and the Proposals to be presented at the Special Meeting, including with respect to the proposed Business Combination. The following questions and answers do not include all the information that may be important to UPTD stockholders. UPTD stockholders are urged to read this entire proxy statement/prospectus, including the Annexes and the other documents referred to herein.

 

QUESTIONS AND ANSWERS ABOUT THE BUSINESS COMBINATION

 

Q:What is the Merger and the Business Combination?

 

A:UPTD, Merger Sub, and Estrella have entered into the Merger Agreement, pursuant to which Merger Sub will merge with and into Estrella, with Estrella surviving the merger as a wholly-owned subsidiary of UPTD. Effective from the Closing, UPTD will change its name to “Estrella Immunopharma, Inc.” The Merger and other transactions contemplated in the Merger Agreement are referred as the “Business Combination.”

 

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

 

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A:UPTD and Estrella have agreed to the Business Combination under the terms of the Merger Agreement that is described in this proxy statement/prospectus. A copy of the Merger Agreement is attached to this proxy statement/prospectus as Annex A, and UPTD encourages its stockholders to read it in its entirety. UPTD’s stockholders are being asked to consider and vote upon a proposal to approve the Merger Agreement, any Ancillary Document (as defined in the Merger Agreement), and the Business Combination. See the section entitled “Proposal 1: The Business Combination Proposal” for further information.

 

This document is a proxy statement because the Board is soliciting proxies using this proxy statement/prospectus from UPTD stockholders. It is a prospectus because UPTD, in connection with the Business Combination, is offering shares of UPTD Common Stock in exchange for the outstanding shares of Estrella Common Stock. See the section entitled “Proposal 1: The Business Combination Proposal” for further information.

 

Q:What is the Merger Consideration and what will Estrella stockholders receive in the Merger?

 

A:Pursuant to the Merger Agreement, stockholders of Estrella immediately prior to the Effective Time, or the Sellers, collectively will receive from UPTD, in the aggregate, a number of newly issued shares of UPTD Common Stock, par value $0.0001 per share, equal to: (i) $325,000,000, divided by (ii) $10.00 per share in consideration of converting their shares of Estrella Common Stock. Each share of Estrella Preferred Stock that is issued and outstanding immediately prior to the Effective Time will automatically convert into a number of shares of Estrella Common Stock in accordance with the certificate of incorporation of Estrella.

 

Q:What equity stake will non-redeeming Public Stockholders, the Merger Financing Investors, the Sellers, and the UPTD Initial Stockholders hold in New Estrella following the consummation of the Business Combination and the Merger Financing and what is the expected pro forma equity value of New Estrella at the Closing?

 

A:The equity stake held by our non-redeeming Public Stockholders, the Merger Financing Investors, the Sellers, and the UPTD Initial Stockholders in New Estrella immediately following consummation of the Business Combination and the Merger Financing will depend on the number of redemptions from the Trust Account by Public Stockholders at the Closing as well as various other factors, as described in the assumptions set forth below. Approximate equity stakes for each of these stockholder groups upon consummation of the Business Combination and the Merger Financing, and their corresponding approximate collective voting power in New Estrella, are set forth in the table below in respect of three redemption scenarios: (1) “Scenario A,” in which there are no redemptions of our Public Shares; (2) “Scenario B,” in which 25% of the Public Shares as of the date of this proxy statement/prospectus are redeemed; (3) “Scenario C,” in which 75% of the Public Shares as of the date of this proxy statement/prospectus are redeemed; and (4) “Scenario D,” in which there are maximum redemptions from the Trust Account. For further information on what constitutes a “maximum redemptions” scenario, please see the section of this proxy statement/prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Information.” All else being equal, if any Public Stockholders exercise their redemption rights, then the percentage of New Estrella Common Stock held collectively by all non-redeeming Public Stockholders will decrease and the percentage of New Estrella Common Stock held by the Merger Financing Investors, the Sellers, and the UPTD Initial Stockholders will increase, in each case, relative to the percentage held if no Public Shares are redeemed.

 

Each of the scenarios presented below (i) assumes that no additional shares of UPTD Common Stock are issued prior to or upon Closing, (ii) assumes there is no exercise of any options to purchase shares of UPTD Common Stock that will be outstanding immediately following the Business Combination, whether such options are issued under the Incentive Plan or otherwise, (iii) excludes the issuance of any shares or other awards in connection with the Incentive Plan following the Business Combination, and (iv) assumes 1,500,000 shares of UPTD Common Stock will be issued in connection with the Merger Financing at the Effective Time, assuming a minimum equity financing of $15.0 million at $10.00 per share of UPTD Common Stock, as described in the section of this proxy statement/prospectus entitled “Summary Term Sheet.”

 

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The table set forth below also states the anticipated pro forma equity value of New Estrella for each of the scenarios described above. These pro forma equity values reflect an assumed price for New Estrella Common Stock of $10.00 per share, being the price per share negotiated with Estrella and set forth in the Merger Agreement for shares of UPTD Common Stock to be issued as Merger Consideration (as described in the preceding question entitled “What is the Merger Consideration and what will Estrella stockholders receive in the Merger?”). The pro forma equity values include the equity consideration to be issued to the Sellers at the Closing (being approximately 32,500,000 shares of UPTD Common Stock, or $325,000,000 in Merger Consideration, based on the assumed price of $10.00 per share). The number of Public Shares redeemed by Public Stockholders with cash from the Trust Account at the Closing is not, all else being equal, expected to materially affect the equity value per share of UPTD Common Stock held by non-redeeming Public Stockholders as at the time immediately following the Closing, as each redemption will result in (x) the cancellation of one Public Share, and (y) the payment of approximately $           to the redeeming Public Stockholder (given that, based on funds in the Trust Account of $          on the Record Date, the estimated per share redemption price would have been approximately $          ) and, accordingly, such funds will not be available to the Combined Company or reflected in its financial statements following the Closing. You should note, however, that the level of redemptions of Public Shares from our Trust Account may affect the market price for shares of UPTD Common Stock following the Closing in ways which we cannot predict. For further information, please refer to the section of this proxy statement/prospectus entitled “Risk Factors — Redemptions of Public Shares by Public Stockholders may affect the market price of New Estrella Common Stock.

 

   Scenario A
No redemptions
  

Scenario B
25% redemptions(1)

  

Scenario C
75% redemptions(2)

  

Scenario D
Maximum redemptions(3)

 
Holder of shares of New Estrella
Common Stock
  No. of shares  

Voting
Power(4)

   No. of shares   Voting
power
   No. of shares   Voting
power
   No. of shares   Voting
power
 
Public Stockholders(5)   4,430,000    11.1%   3,322,500    8.6%   1,107,500    3.0%   39,666    0.1%
Merger Financing Investors(6)   1,500,000    3.7%   1,500,000    3.9%   1,500,000    4.1%   1,500,000    4.2%
The Sellers(7)   32,500,000    81.6%   32,500,000    83.8%   32,500,000    89.0%   32,500,000    91.7%
The UPTD Initial Stockholders(8)   1,419,700    3.6%   1,419,700    3.7%   1,419,700    3.9%   1,419,700    4.0%
Pro Forma New Estrella Common Stock at Closing(9)   39,849,700    100.0%   38,742,200    100.0%   36,527,200    100.0%   35,459,366    100.0%
Pro Forma Equity Value(9)  $398,497,700       $387,422,000       $365,272,000       $354,593,660     
Pro Forma Book Value(9)                                        
Total Pro Forma Book Value  $59,639,127       $48,342,627       $25,749,627       $14,857,720     
Pro Forma Book Value Per Share  $1.50       $1.25       $0.70       $0.42     

 

The ownership percentages set forth below for non-redeeming Public Stockholders and all other New Estrella stockholders may be diluted, all else being equal, in the event that the exercise of all UPTD Warrants, each of which are exercisable for one share of UPTD Common Stock at a price of $11.50 per share. The issuance of any shares or other awards in connection with the Incentive Plan following the Business Combination would also have a dilutive effect on New Estrella stockholders’ ownership percentages, all else being equal, however, the magnitude of any such potential issuances is not known as at the date of this proxy statement/prospectus.

 

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   Scenario A
No redemptions
  

Scenario B
25% redemptions(1)

  

Scenario C
75% redemptions(2)

  

Scenario D
Maximum redemptions(3)

 
Holder of shares of New Estrella
Common Stock
  No. of shares  

Voting
Power(4)

   No. of shares   Voting
power
   No. of shares   Voting
power
   No. of shares   Voting
power
 
Public Stockholders   6,645,000    15.7%   5,537,500    13.5%   3,322,500    8.5%   2,254,666    6.0%
Merger Financing Investors   1,500,000    3.6%   1,500,000    3.6%   1,500,000    3.9%   1,500,000    4.0%
The Sellers   32,500,000    77.0%   32,500,000    79.1%   32,500,000    83.5%   32,500,000    85.8%
The UPTD Initial Stockholders   1,575,800    3.7%   1,575,800    3.8%   1,575,800    4.1%   1,575,800    4.2%
Pro Forma New Estrella Common Stock at Closing   42,220,800    100.0%   41,113,300    100.0%   38,898,300    100.0%   37,830,466    100.0%

 

(1) As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding which are subject to redemption. The numbers set forth in this column assume that 1,107,500 Public Shares, or approximately 25%, of the 4,430,000 Public Shares as of the date of this proxy statement/prospectus are redeemed at $10.20 per share.

(2) As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding which are subject to redemption. The numbers set forth in this column assume that 3,322,500 Public Shares, or approximately 75%, of the 4,430,000 Public Shares as of the date of this proxy statement/prospectus are redeemed at $10.20 per share.

(3) As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. The numbers set forth in this column assume that the maximum of 4,390,334 Public Shares as of the date of this proxy statement/prospectus are redeemed at $10.20 per share in order to satisfy the $20.0 million Available Combined Cash Amount closing condition.

(4) All voting power percentages in this table are approximate and have been rounded to one decimal place.

(5) Shares held by Public Stockholders.

(6) Shares issued to the Merger Financing Investors in connection of equity financing of no less than $15.0 million (excluding equity-linked securities such as convertible debt or debt plus warrants), assuming 1,500,000 shares of UPTD Common Stock are issued in connection with the Merger Financing at the Effective Time, assuming a minimum equity financing of $15.0 million at $10.00 per share of UPTD Common Stock

(7) The total number of shares of UPTD Common Stock which may be issued as Merger Consideration Shares is 32,500,000 shares. Approximately 32,500,000 of these shares are expected to be issued at Closing to the Sellers.

(8) The UPTD Initial Stockholders’ equity interests following the Closing are expected to comprise, as of the date of this proxy statement/prospectus, 312,200 Private Shares and 1,107,500 Founder Shares.

(9)Excluding the effect of any “potential additional sources of dilution,” as set forth in the table, which potential additional sources of dilution are subject to certain conditions being satisfied, as set forth in the section of this proxy statement/prospectus entitled “Proposal 1: The Business Combination Proposal — Summary of the Merger Agreement.”

  

The anticipated ownership of New Estrella’s securities set forth above, including the potential effect of any dilutive events, is accurate, subject to the assumptions and exclusions set forth above, as of the date of filing of this proxy statement/prospectus, and does not take into account any transactions that may be entered into after the date hereof unless explicitly set forth above. If the actual facts differ from our assumptions, the numbers of shares and ownership percentages set forth above, including the anticipated equity stake of non-redeeming Public Stockholders in New Estrella following the Business Combination and Merger Financing, will be different.

 

You should read the section of this proxy statement/prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Information” for further information.

 

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Q:When do you expect the Business Combination to be completed?

 

A:It is currently anticipated that the Business Combination will be consummated promptly following the Special Meeting, which is set for           ; however, the Special Meeting could be adjourned, as described herein. UPTD cannot assure you of when or if the Business Combination will be completed, and it is possible that factors outside of the control of UPTD and Estrella could result in the Business Combination being completed at a different time or not at all. UPTD must first obtain the approval of its stockholders for certain of the Proposals set forth in this proxy statement/prospectus before consummating the Business Combination.

 

Q:What happens if the Business Combination is not consummated?

 

A:If UPTD does not complete the Business Combination with Estrella, for whatever reason, UPTD will search for another target business with which to complete a business combination. If UPTD does not complete the Business Combination with Estrella or another business combination by January 19, 2023 (or such later date as may be approved by UPTD stockholders in an amendment to its Current Charter), UPTD must redeem 100% of the Public Shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest earned on the funds held in the Trust Account and not previously released to UPTD to pay its franchise and income taxes (less up to $50,000 of interest to pay dissolution expenses), divided by the number of then-outstanding Public Shares. The UPTD Initial Stockholders have waived any rights they may have with respect to any monies held in the Trust Account or any other asset of UPTD as a result of any liquidation of UPTD with respect to the Founder Shares and Private Shares and, accordingly, in the event a business combination is not effected by UPTD in the required time period, the Founder Shares and the Private Shares held by the UPTD Initial Stockholders would be worthless. If UPTD cannot complete an initial business combination and is forced to liquidate, all UPTD Warrants will be worthless.

 

In addition, if the Business Combination is not consummated for any reason, no Deferred Business Combination Fee will be due or payable to the Representatives pursuant to the Business Combination Marketing Agreement.

 

Q:Did the Board obtain a third-party valuation or fairness opinion in determining whether or not to proceed with the Business Combination?

 

A:The Board has obtained a fairness opinion from The Benchmark Company, LLC, dated September 30, 2022 (the “Fairness Opinion”). The Board has not obtained nor will it obtain an additional updated fairness opinion prior to the Closing. The operations and prospects of Estrella, general market and economic conditions, and other factors that may be beyond the control of UPTD and Estrella, and on which the Fairness Opinion was based, may alter the value of UPTD or Estrella or the price of UPTD’s securities by the time the Business Combination is completed. The Fairness Opinion does not speak to any date other than the date of such opinion, and as such, the opinion will not address the fairness of the Merger Consideration, from a financial point of view, at any date after the date of such opinion, including at the time the Business Combination is completed. For a description of the opinion, see “Proposal 1: The Business Combination Proposal — Basis for the Board’s Recommendation — Fairness Opinion.”

 

Q:Will any UPTD securities have registration rights following the consummation of the Business Combination?

 

A:Yes. Founder Shares, Private Shares, and Working Capital Shares will have registration rights following the consummation of the Business Combination. In addition, UPTD has agreed that as soon as practicable, but in no event later than 30 business days after the consummation of the Business Combination, UPTD will use commercially reasonable efforts to file, and within 60 business days following the Business Combination to have declared effective, a registration statement covering the shares of UPTD Common Stock issuable upon exercise of the UPTD Warrants. In summary, an aggregate of 3,754,700 shares of New Estrella Common Stock will be subject to registration rights, comprising 312,200 Private Shares, 1,107,500 Founder Shares, up to 120,000 Working Capital Shares if the holders of working capital promissory notes select to convert the working capital promissory notes into Working Capital Shares, and 2,215,000 shares of New Estrella Common Stock underlying UPTD Warrants. For further information, please see the section of this proxy statement/prospectus entitled “UPTD Management’s Discussion and Analysis of Financial Condition and Results of Operations – Commitments and Contingencies.”

 

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Q:What are the risks to UPTD stockholders of the Business Combination with Estrella rather than an underwritten initial public offering of New Estrella’s securities?

 

A:Upon the Closing, we intend to list the UPTD Common Stock (which will be New Estrella Common Stock) and the UPTD Warrants (which will be the warrants of New Estrella) on Nasdaq under the symbol “          ” and “          .” respectively. Unlike an underwritten initial public offering of New Estrella’s securities, the listing of New Estrella’s securities as a result of the Business Combination will not benefit from, including, but not limited to, (i) the book-building process undertaken by underwriters, which helps to inform efficient price discovery with respect to opening trades of newly listed securities; (ii) underwriter support to help stabilize, maintain, or affect the public price of the securities immediately after listing; and (iii) underwriter due diligence review of the offering and potential liability for material misstatements or omissions of fact in a prospectus used in connection with the securities being offered, or for statements made by its securities analysts or other personnel. See “Risk FactorsThe listing of New Estrella’s securities on Nasdaq will not benefit from the process undertaken in connection with an underwritten initial public offering” for more information.

 

Q:Who will become the executive officers and directors of New Estrella?

 

A:It is anticipated that, upon the Closing, the management team of New Estrella will consist of Dr. Cheng Liu, who is Estrella’s current Chief Executive Officer (“CEO”), President, and director, as the CEO, President, and Chairman of New Estrella, Mr. Jiandong (Peter) Xu as the Chief Financial Officer of New Estrella, and Qian (Vicky) Yang as the Chief Operating Officer of New Estrella. The New Estrella Board will be comprised of Dr. Liu and four independent directors: Ms. Janelle Wu, Mr. Fan Wu, and Dr. Jiang Lin, who are nominated by New Estrella and Ms. Pei Xu who is nominated by UPTD. See "Management of The Combined Company” for more information regarding the management team of New Estrella and the New Estrella Board after the Closing.

 

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QUESTIONS AND ANSWERS ABOUT THE SPECIAL MEETING

 

Q:When and where is the Special Meeting?

 

A:The Special Meeting will be held on           , 2022, unless postponed or adjourned to a later date. The Special Meeting will be held virtually. All UPTD stockholders as of the Record Date, or their duly appointed proxies, may attend the Special Meeting. You will be able to log in beginning at            Eastern Time.

 

Q:Why is the Special Meeting a virtual, online meeting?

 

A:UPTD has decided to hold the Special Meeting virtually due to the COVID-19 pandemic and the emergence of new variant strains of COVID-19. UPTD is sensitive to the public health and travel concerns of UPTD’s stockholders and employees and the protocols that federal, state, and local governments may impose. UPTD believes that hosting a virtual meeting will enable greater stockholder attendance by enabling stockholders to participate from any location around the world.

 

Q:How do I attend a virtual meeting?

 

A:We are pleased to use the virtual meeting format to facilitate stockholder attendance, voting, and questions by leveraging technology to communicate more effectively and efficiently with our stockholders. This format allows stockholders to participate fully from any location, without the cost of travel. As a registered stockholder, along with this proxy statement/prospectus, you received a proxy card from           , which contains instructions on how to attend the virtual Special Meeting, including the URL address and your control number. You will need your control number for access. If you do not have your control number, contact            at           , or email            at           .

 

You can pre-register to attend the virtual Special Meeting starting on            (five business days prior to the meeting). Enter the following URL address into your browser           , then enter your control number, name, and email address. Once you pre-register, you can vote or enter questions in the chat box. At the start of the Special Meeting, you will need to re-login using the same control number and, if you want to vote during the meeting, you will be prompted to enter your control number again.

 

Beneficial owners who own their UPTD Common Stock through a bank, broker, or other nominee will need to contact            to receive a control number. If you plan to vote at the Special Meeting, you will need to have a legal proxy from your broker, bank, or other nominee or, if you would like to join and not vote,            can issue you a guest control number with proof of ownership. Either way, you must contact            at the number or email address above for specific instructions on how to receive the control number. Please allow up to 72 hours prior to the meeting for processing your control number.

 

If you do not have internet capabilities, you can only listen to the Special Meeting by dialing            (toll-free, within the U.S. and Canada) or            (with toll, outside the U.S. or Canada) and when prompted, enter the pin           . This method supports listening only, so you will not be able to vote or ask questions during the Special Meeting. A replay of the Special Meeting will be made available promptly after the meeting at            and remain available for at least one year from the date it is made available.

 

Q:How do I ask questions during the Virtual Special Meeting?

 

A:Stockholders may submit questions during the Special Meeting using the “Ask a Question” field on the virtual meeting website. You will need to log in with your control number found on your proxy card to submit a question. Time has been allocated on the agenda to respond to questions submitted during the Special Meeting. Questions we do not answer during the Special Meeting will be answered in writing and posted at           . Please refer to the Special Meeting Rules of Conduct and Procedures for more information on how to ask questions. The Rules of Conduct and Procedures are available at            and during the Special Meeting at           .

 

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We encourage you to access the Special Meeting early. Online check-in will begin approximately            minutes before the           , Eastern Time, start time. If you encounter difficulties during the check-in or meeting time, we have technicians available to help you. The technical support contact information will be posted on the virtual meeting login page.

 

Q:What am I being asked to vote on and why is this approval necessary?

 

A:UPTD stockholders are being asked to vote on the following Proposals:

 

1. the Business Combination Proposal;

 

2. the Charter Amendment Proposal;

 

3. the Advisory Charter Amendment Proposals;

 

4. the Nasdaq Stock Issuance Proposal;

 

5. the Director Election Proposal;

 

6. the Incentive Plan Proposal; and

 

7. the Adjournment Proposal

 

If the Business Combination Proposal is not approved, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal will not be presented to UPTD stockholders for a vote. The approval of the Business Combination Proposal and, unless otherwise waived by the parties thereof, the Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are preconditions to the Closing. The Adjournment Proposal is not conditioned on the approval of any other Proposal.

 

Q:Are there any other matters being presented to UPTD stockholders at the Special Meeting?

 

A:In addition to voting on the Business Combination Proposal, assuming it is approved and adopted, the stockholders of UPTD will vote on each of the other Proposals described in the section above entitled “Summary Term Sheet.”

 

UPTD will hold the Special Meeting to consider and vote upon these Proposals. This proxy statement/prospectus contains important information about the proposed Business Combination and the other matters to be considered at the Special Meeting. Stockholders should read it carefully.

 

If the Business Combination Proposal is not approved, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal will not be presented to UPTD stockholders for a vote. The approval of the Business Combination Proposal and, unless otherwise waived by the parties thereof, the Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are preconditions to the Closing. The Adjournment Proposal is not conditioned on the approval of any other Proposal.

 

The vote of stockholders is important. UPTD stockholders are encouraged to vote as soon as possible after carefully reviewing this proxy statement/prospectus.

 

Q:What will happen to UPTD’s securities upon consummation of the Business Combination?

 

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A:The UPTD Units, UPTD Common Stock, and UPTD Warrants are currently listed on Nasdaq under the symbols “UPTDU,” “UPTD” and “UPTDW,” respectively. Upon the Closing, UPTD will change its name to “Estrella Immunopharma, Inc.” and the Combined Company will have one class of common stock, which will be listed on Nasdaq under the symbol “          .” Public Stockholders who do not elect to have their Public Shares redeemed for a pro rata share of the Trust Account need not submit Public Shares, and such shares of stock (which will be New Estrella Common Stock following the Closing) will remain outstanding. The UPTD Units will not be traded on Nasdaq following the Closing and will automatically be separated into their component securities (“          ” and “          W”) without any action needed to be taken on the part of the holders of such UPTD Units. UPTD warrant holders and those stockholders who do not elect to have their shares of UPTD Common Stock redeemed need not deliver their shares of UPTD Common Stock or warrant certificates to UPTD or to UPTD’s transfer agent and such securities will remain outstanding.

 

Q:Why is UPTD proposing the Business Combination?

 

A:UPTD was organized to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or other similar business combination with one or more businesses.

 

On July 19, 2021, UPTD completed its Initial Public Offering of 4,000,000 UPTD Units. Each Unit consists of one share of UPTD Common Stock and one-half of one UPTD Warrant. The UPTD Units were sold at an offering price of $10.00 per unit, generating gross proceeds of $40,000,000. Simultaneously with the closing of the Initial Public Offering, UPTD completed the sale of 295,000 Private Shares to the Founders in the Concurrent Private Placement.

 

In connection with the Initial Public Offering, the underwriters were granted an option to purchase up to 600,000 additional Units to cover over-allotments. On July 19, 2021, the underwriters partially exercised the over-allotment option, and on July 21, 2021, the underwriters purchased 430,000 Option Units, generating gross proceeds of $4,300,000, and simultaneously completed the sale of 17,200 Private Shares at a purchase price of $10.00 per share in the Additional Private Placement, generating total proceeds of $172,000. Since its Initial Public Offering, UPTD’s activity has been limited to identifying and evaluating suitable business combination candidates.

 

Estrella is a preclinical-stage biopharmaceutical company developing T-cell therapies with the capacity to more effectively treat patients with blood cancers and solid tumors. Estrella believes T-cell therapy continues to represent a revolutionary step towards providing a potential solution for many forms of cancer, including cancers poorly addressed by current approaches. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer with safe, effective therapies.

 

Based on UPTD’s due diligence investigations of Estrella and the industry in which Estrella operates, including the financial and other information provided by Estrella in the course of the negotiations in connection with the Merger Agreement, UPTD believes that Estrella has an appealing market opportunity and growth profile and a compelling valuation. As a result, UPTD believes that the Business Combination with Estrella will provide UPTD stockholders with an opportunity to participate in the ownership of a company with growth potential and significant value. See the section entitled “Proposal 1: The Business Combination Proposal — The Board’s Reasons for the Approval of the Business Combination.”

 

Q:Do I have redemption rights?

 

A:If you are a Public Stockholder, you have the right to demand that UPTD redeem your Public Shares for a pro rata portion of the cash held in the Trust Account, which holds the proceeds of the Initial Public Offering (including aggregate fees of $1,550,500 payable to the underwriters at the Closing as the Deferred Business Combination Fee) and certain proceeds from the Concurrent Private Placement and the Additional Private Placement, calculated as of two business days prior to the Closing, including interest earned on the funds held in the Trust Account (net of taxes payable). We sometimes refer to these rights to demand redemption of the Public Shares as “redemption rights.”

 

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Notwithstanding the foregoing, a UPTD stockholder, together with any affiliate or any other person with whom such holder is acting in concert or as a “group” (as defined in Section 13 of the Exchange Act), will be restricted from exercising redemption rights with respect to more than an aggregate of 15% of the Public Shares. Accordingly, all Public Shares in excess of 15% held by a Public Stockholder, together with any affiliate of such holder or any other person with whom such holder is acting in concert or as a “group,” will not be redeemed.

 

Holders of the outstanding UPTD Warrants do not have redemption rights with respect to such warrants in connection with the transactions contemplated by the Business Combination Proposal.

 

The amount of the Deferred Business Combination Fee is fixed regardless of the level of redemptions from our Trust Account in connection with the Business Combination. Please see the section of this proxy statement/prospectus entitled “Summary of the Proxy Statement/Prospectus – Underwriting Fees as a Percentage of Initial Public Offering Proceeds Net of Redemptions” for further information.

 

Q:If I am a holder of the UPTD Units, can I exercise redemption rights with respect to my Units?

 

A:No. You can only exercise redemption rights with respect to your Public Shares. Holders of outstanding UPTD Units must separate the underlying Public Shares and UPTD Warrants prior to exercising redemption rights with respect to the Public Shares.

 

If you hold UPTD Units registered in your own name, you must deliver the certificate for such units to VStock, our transfer agent, with written instructions to separate such units into Public Shares and UPTD Warrants.

 

This must be completed far enough in advance to permit the mailing of the Public Share certificates back to you so that you may then exercise your redemption rights upon the separation of the Public Shares from the UPTD Units. See “How do I exercise my redemption rights?” below. The address of VStock is listed under the question “Who can help answer my questions?” below.

 

If a broker, dealer, commercial bank, trust company, or other nominee holds your UPTD Units, you must instruct such nominee to separate your UPTD Units. Your nominee must send written instructions by facsimile to VStock, our transfer agent. Such written instructions must include the number of UPTD Units to be separated and the nominee holding such UPTD Units. Your nominee must also initiate electronically, using DTC’s deposit/withdrawal at custodian (DWAC) system, a withdrawal of the relevant UPTD Units and a deposit of an equal number of Public Shares and UPTD Warrants. This must be completed far enough in advance to permit your nominee to exercise your redemption rights upon the separation of the Public Shares from the UPTD Units. While this is typically completed electronically the same business day, you should allow at least one full business day to accomplish the separation. If you fail to cause your Public Shares to be separated from your UPTD Units in a timely manner, you will likely not be able to exercise your redemption rights.

 

Q:If I am a holder of the UPTD Warrants, whether, when and how will UPTD exercise its redemption rights with respect to my UPTD Warrants?

 

A:UPTD has the ability to redeem outstanding UPTD Warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of UPTD Common Stock equals or exceeds $16.50 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading-day period ending on the third business day prior to the date on which UPTD gives proper notice of such redemption and provided certain other conditions are met. While UPTD Common Stock has not exceeded the $16.50 per share threshold at which UPTD Warrants would become redeemable since the announcement of the Business Combination, there is no assurance that the price of New Estrella Common Stock will not exceed the threshold. If and when the UPTD Warrants become redeemable by UPTD, UPTD may exercise its redemption right even if UPTD is unable to register or qualify the underlying securities for sale under all applicable state securities laws.

 

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Notice of redemption shall be mailed by first class mail, postage prepaid, by UPTD not less than 30 days prior to the date that fixed by UPTD for the redemption to the registered holders of the UPTD Warrants to be redeemed at their last addresses as they shall appear on the registration books. Any notice mailed in the manner herein provided shall be conclusively presumed to have been duly given whether or not the registered holder received such notice. UPTD will not redeem the UPTD Warrants unless a registration statement under the Securities Act covering the shares of UPTD Common Stock issuable upon exercise of the UPTD Warrants is effective and a current prospectus relating to those shares of UPTD Common Stock is available throughout the 30-day redemption period, except if the UPTD Warrants may be exercised on a cashless basis and such cashless exercise is exempt from registration under the Securities Act. If and when the UPTD Warrants become redeemable by UPTD, UPTD may exercise its redemption right even if UPTD is unable to register or qualify the underlying securities for sale under all applicable state securities laws. If UPTD elect to redeem the UPTD Warrants on a cashless basis, then UPTD will not receive any cash proceeds from the exercise of such UPTD Warrants. See “Risk Factors – UPTD may redeem the unexpired UPTD Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your UPTD Warrants worthless.”

 

Q:Will how I vote affect my ability to exercise redemption rights?

 

A:No. You may exercise your redemption rights whether you vote your shares of UPTD Common Stock for or against, or whether you abstain from voting on, the Business Combination Proposal or any other Proposal described in this proxy statement/prospectus. As a result, the Business Combination Proposal can be approved by stockholders who will redeem their UPTD Common Stock and no longer be UPTD stockholders and the Business Combination may be consummated even though the funds available from the Trust Account and the number of Public Stockholders are substantially reduced as a result of redemptions by Public Stockholders. With fewer shares of UPTD Common Stock outstanding and fewer Public Stockholders, the trading market for UPTD Common Stock or New Estrella Common Stock, as applicable, may be less liquid than the market for such stock prior to the Business Combination and UPTD or New Estrella, as applicable, may not be able to meet the listing standards of a national securities exchange. In addition, with fewer funds available from the Trust Account due to redemptions by Public Stockholders, the capital infusion from the Trust Account into New Estrella’s business will be reduced and the amount of working capital available to New Estrella following the Business Combination may be reduced. Your decision to exercise your redemption rights with respect to shares of UPTD Common Stock will have no effect on UPTD Warrants you may also hold.

 

Q:How do I exercise my redemption rights?

 

A:If you are a Public Stockholder and wish to exercise your redemption rights with respect to your Public Shares, you must, prior to 5:00 p.m. Eastern Time on            (two business days before the Special Meeting), (i) submit a written request to our transfer agent that we redeem your Public Shares for cash, and (ii) deliver your stock to our transfer agent physically or electronically through Depository Trust Company, or DTC. The address of VStock, our transfer agent, is listed under the question “Who can help answer my questions?” below. The redemption rights include the requirement that a beneficial holder must identify itself in writing as a beneficial holder and provide its legal name, phone number and address to our transfer agent in order to validly redeem its shares. Any Public Stockholder will be entitled to demand that such holder’s Public Shares be redeemed for a pro rata portion of the amount then in the Trust Account (which, for illustrative purposes, was approximately $            million, or $10.20 per share, as of           ). Such amount, including interest earned on the funds held in the Trust Account and not previously released to UPTD to pay its taxes (less up to $50,000 of interest to pay dissolution expenses), will be paid promptly upon consummation of the Business Combination. However, under Delaware law, the proceeds held in the Trust Account could be subject to claims that could take priority over those of Public Stockholders exercising redemption rights, regardless of whether such Public Stockholders vote for or against, or abstain from voting on, the Business Combination Proposal. Therefore, the per-share distribution from the Trust Account in such a situation may be less than originally anticipated due to such claims. Your vote on any Proposal will have no impact on the amount you will receive upon exercise of your redemption rights.

 

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Any request for redemption, once made by a Public Stockholder, may be withdrawn at any time up to the time of the vote on the Business Combination Proposal (the “withdrawal deadline”). If you deliver your shares certificate for redemption to UPTD’s transfer agent and later decide prior to the withdrawal deadline not to elect redemption, you may request that UPTD’s transfer agent return the shares certificate (physically or electronically).

 

Any corrected or changed written demand of exercise of redemption rights must be received by UPTD’s transfer agent prior to the withdrawal deadline. No demand for redemption will be honored unless the Public Stockholder’s Public Shares have been delivered (either physically or electronically) to UPTD’s transfer agent prior to the applicable date.

 

If a Public Stockholder properly makes a request for redemption and such Public Stockholder’s Public Shares are delivered as described herein to UPTD’s transfer agent, then, if the Business Combination is consummated, UPTD will redeem such Public Shares for a pro rata portion of the funds deposited in the Trust Account. If you exercise your redemption rights, then you will be exchanging your Public Shares for cash. For additional information about the exercise of redemption rights, see “Special Meeting of UPTD StockholdersRedemption Rights.”

 

If you are a holder of Public Shares (including through the ownership of the UPTD Units) and you exercise your redemption rights, it will not result in the loss of any UPTD Warrants that you may hold (including those included in any UPTD Units you hold). Your whole UPTD Warrants will become exercisable to purchase one share of UPTD Common Stock (which will be New Estrella Common Stock after the Closing) 30 days after the completion of the Business Combination.

 

Based on the market value per warrant as of the closing price of $0.1319 on October 14, 2022 for the UPTD Warrants, redeeming stockholders may retain UPTD Warrants with an aggregate value of approximately $0.3 million of an aggregate of 2,215,000 UPTD Warrants (after redeeming their shares). Additionally, as a result of redemptions, the trading market for New Estrella Common Stock may be less liquid than the market for UPTD Common Stock was prior to consummation of the Business Combination, and New Estrella may not be able to meet the listing standards for the Nasdaq or another national securities exchange.

 

For a discussion of the material U.S. federal income tax considerations for holders of UPTD Common Stock with respect to the exercise of these redemption rights, see “Material U.S. Federal Income Tax Consideration — Material Tax Considerations Related to a Redemption of UPTD Common Stock” beginning on page 126. The consequences of a redemption to any particular Public Stockholder will depend on that holder’s particular facts and circumstances. Accordingly, you are urged to consult your tax advisor to determine your tax consequences from the exercise of your redemption rights, including the applicability and effect of U.S. federal, state and local and non-U.S. income and other tax laws in light of your particular circumstances.

 

Q:Do I have appraisal rights if I object to the proposed Business Combination?

 

A:No. UPTD stockholders do not have appraisal rights in connection with the proposed Business Combination under Delaware law.

 

Q:What happens if a substantial number of stockholders vote in favor of the Business Combination Proposal and exercise redemption rights?

 

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A:Public Stockholders may vote in favor of the Business Combination and still exercise their redemption rights and are not required to vote in any way to exercise their redemption rights. Accordingly, the Business Combination may be consummated even though the funds available from the Trust Account and the number of Public Shares are substantially reduced as a result of redemptions by Public Stockholders (however, the condition to the consummation of the Business Combination requiring that UPTD have at least $5,000,001 of net tangible assets may not be waived). In addition, with fewer Public Shares and Public Stockholders, it would be harder to meet the requirement of an Available Combined Cash Amount of $20.0 million at the Closing unless such closing condition is subsequently waived by the parties, and the trading markets for UPTD Common Stock following the Closing (which will be New Estrella Common Stock) may be less liquid than the market for UPTD Common Stock prior to the Business Combination, and New Estrella may not be able to meet the listing standards of a national securities exchange, including Nasdaq. In addition, with fewer funds available from the Trust Account, the capital infusion from the Trust Account into New Estrella’s business will be reduced and New Estrella may not be able to achieve its business plans.

 

Q:What happens to the funds deposited in the Trust Account after consummation of the Business Combination?

 

A:After consummation of the Business Combination, the funds in the Trust Account will be used to pay Public Stockholders who exercise redemption rights with respect to their redeemed Public Shares, to pay fees and expenses incurred in connection with the Business Combination (including aggregate fees of approximately $1.55 million for the Deferred Business Combination Fee), and then will be released to the Combined Company for its working capital and general corporate purposes.

 

Q:How do the UPTD Initial Stockholders intend to vote on the Proposals?

 

A:The UPTD Initial Stockholders beneficially own and are entitled to vote an aggregate of approximately 24.27% of the outstanding UPTD Common Stock as of the Record Date. Pursuant to the IPO Letter Agreement and the Support Agreement, these UPTD Initial Stockholders have agreed to vote their shares in favor of the Business Combination Proposal. The UPTD Initial Stockholders have also agreed to vote their shares in favor of all other Proposals being presented at the Special Meeting.

 

Q:What do I need to do now?

 

A:UPTD urges you to carefully read and consider the information contained in this proxy statement/prospectus, including the Annexes, and to consider how the Business Combination will affect you as a stockholder of UPTD. UPTD stockholders should then vote as soon as possible in accordance with the instructions provided in this proxy statement/prospectus and on the enclosed proxy card.

 

Q:How many votes do I have at the Special Meeting?

 

A:UPTD stockholders are entitled to one vote at the Special Meeting for each share of UPTD Common Stock held of record at the close of the Record Date for the Special Meeting.

 

Q:What constitutes a quorum at the Special Meeting?

 

A:The presence, in person (including virtual presence) or by proxy, at the Special Meeting of holders of shares of outstanding UPTD Common Stock representing a majority of the voting power of all outstanding shares of UPTD Common Stock entitled to vote at the Special Meeting will constitute a quorum for the transaction of business at the Special Meeting. The UPTD Initial Stockholders, who currently own approximately 24.27% of the voting power of the issued and outstanding shares of UPTD Common Stock, will count towards this quorum. In the absence of a quorum, the chairman of the Special Meeting has power to adjourn the Special Meeting. As of the Record Date,             shares of UPTD Common Stock would be required to achieve a quorum.

 

Q:What vote is required to approve each Proposal at the Special Meeting?

 

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A:The Business Combination Proposal: The affirmative vote of a majority of the votes cast by holders of UPTD Common Stock present in person (including virtual presence) or represented by proxy and entitled to vote thereon, at a meeting at which a quorum is present, is required to approve the Business Combination Proposal. UPTD stockholders must approve the Business Combination Proposal in order for the Business Combination to occur. If UPTD stockholders fail to approve the Business Combination Proposal, the Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal will not be presented to UPTD stockholders for a vote. The Business Combination and the Charter Amendment Proposal are not conditioned upon the approval of the Advisory Charter Amendment Proposals. The Charter Amendment Proposal, the Advisory Charter Amendment Proposals, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are conditioned on the approval of the Business Combination Proposal. The Adjournment Proposal is not conditioned on the approval of any other Proposal. If the Business Combination Proposal is not approved, the other Proposals (except the Adjournment Proposal) will not be presented to the UPTD stockholders for a vote.

 

The Charter Amendment Proposal: A majority vote of outstanding UPTD Common Stock entitled to vote present in person (including virtual presence) or represented by proxy, at a meeting at which a quorum is present, is required to approve the Charter Amendment Proposal. The Business Combination is conditioned upon the approval of the Charter Amendment Proposal, subject to the terms of the Merger Agreement. Notwithstanding the approval of the Charter Amendment Proposal, if the Business Combination is not consummated for any reason, the actions contemplated by the Charter Amendment Proposal will not be effected.

 

The Advisory Charter Amendment Proposals: The affirmative vote of a majority of the votes cast by holders of UPTD Common Stock present in person (including virtual presence) or represented by proxy and entitled to vote thereon, at a meeting at which a quorum is present, is required to approve the Advisory Charter Amendment Proposals. In accordance with SEC guidance, the Advisory Charter Amendment Proposals are being presented separately and will be voted upon on a non-binding advisory basis. The Business Combination and the Charter Amendment Proposal are not conditioned upon the approval of the Advisory Charter Amendment Proposals.

 

The Nasdaq Stock Issuance Proposal: The affirmative vote of a majority of the votes cast by holders of UPTD Common Stock present in person (including virtual presence) or represented by proxy and entitled to vote thereon, at a meeting at which a quorum is present, is required to approve the Nasdaq Stock Issuance Proposal. The Business Combination is conditioned upon the approval of the Nasdaq Stock Issuance Proposal, subject to the terms of the Merger Agreement. Notwithstanding the approval of the Nasdaq Stock Issuance Proposal, if the Business Combination is not consummated for any reason, the actions contemplated by the Nasdaq Stock Issuance Proposal will not be effected.

 

The Director Election Proposal: The approval of the Director Election Proposal requires a plurality vote of the shares of UPTD Common Stock cast by stockholders present in person (including virtual presence) or represented by proxy and entitled to vote thereon at the Special Meeting. A “plurality of vote” means that the nominees receiving the greatest number of votes cast “FOR” are elected as directors up to the maximum number of directors to be elected. Consequently, any shares not voted “FOR” a particular nominee (whether as a result of an abstention, a direction to withhold authority or a broker non-vote) will not be counted in the nominee’s favor. The Business Combination is conditioned upon the approval of the Director Election Proposal, subject to the terms of the Merger Agreement. Notwithstanding the approval of the Director Election Proposal, if the Business Combination is not consummated for any reason, the actions contemplated by the Director Election Proposal will not be effected.

 

The Incentive Plan Proposal: The affirmative vote of a majority of the votes cast by holders of UPTD Common Stock present in person (including virtual presence) or represented by proxy and entitled to vote thereon, at a meeting at which a quorum is present, is required to approve the Incentive Plan Proposal. The Business Combination is conditioned upon the approval of the Incentive Plan Proposal, subject to the terms of the Merger Agreement. Notwithstanding the approval of the Incentive Plan Proposal, if the Business Combination is not consummated for any reason, the actions contemplated by the Incentive Plan Proposal will not be effected.

 

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The Adjournment Proposal: The affirmative vote of a majority of the votes cast by holders of UPTD Common Stock present in person (including virtual presence) or represented by proxy and entitled to vote thereon, at a meeting at which a quorum is present, is required to approve the Adjournment Proposal. The Business Combination is not conditioned upon the approval of the Adjournment Proposal.

 

In connection with the entry into the Merger Agreement, the UPTD Initial Stockholders, representing 24.27% of the voting power of the issued and outstanding shares of UPTD Common Stock, have agreed to vote their shares in favor of the Proposals. As a result, to approve all Proposals (except the Charter Amendment Proposal and the Director Election Proposal), in addition to the Founder Shares and the Private Shares held by the UPTD Initial Stockholders, 1,505,151 shares, or approximately 25.73% (assuming all shares of UPTD Common Stock issued and outstanding as of the Record Date are voted), or 42,726 shares, or approximately 0.73% (assuming only the minimum number of shares of UPTD Common Stock representing a quorum is present and voting), of the 5,849,700 shares of UPTD Common Stock outstanding as of the Record Date, would be required to vote in favor of each Proposal. To approve the Charter Amendment Proposal, in addition to the Founder Shares and the Private Shares held by the UPTD Initial Stockholders, 1,505,151 shares, or approximately 25.73% of the 5,849,700 shares of UPTD Common Stock outstanding as of the Record Date, would be required to vote in favor of the Charter Amendment Proposal. The approval of the Director Election Proposal requires a plurality vote of the shares of UPTD Common Stock cast in respect of that Proposal present in person (including virtual presence) or represented by proxy and entitled to vote thereon at the Special Meeting. A “plurality of vote” means that the nominees receiving the greatest number of votes cast “FOR” are elected as directors up to the maximum number of directors to be elected. Consequently, any shares not voted “FOR” a particular nominee (whether as a result of an abstention, a direction to withhold authority or a broker non-vote) will not be counted in the nominee’s favor.

 

Q:Do any of UPTD’s directors or officers have interests in the Business Combination that may differ from or be in addition to the interests of UPTD stockholders?

 

A:UPTD’s executive officers and directors may have interests in the Business Combination that are different from, in addition to or in conflict with, yours. These interests include, among other things:

 

·the fact that the UPTD Initial Stockholders, including the Founders and UPTD’s officers and directors have agreed not to redeem any shares of UPTD Common Stock in connection with a stockholder vote to approve a proposed initial business combination;

 

·the beneficial ownership by the Sponsor of an aggregate of 862,000 Founder Shares and 249,760 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as the Sponsor has waived any right to redemption with respect to these shares. The Sponsor paid an aggregate of approximately $19,458 for the Founders Shares and $2,497,600 for the Private Shares. The Private Shares have an aggregate market value of approximately $           , based on the redemption price of UPTD Common Stock on the date of the Closing (the “Closing Price”), resulting in a theoretical gain of $            (or $            per share);

 

·the beneficial ownership by Tradeup INC. of an aggregate of 104,750 Founder Shares and 31,220 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as Tradeup INC. has waived any right to redemption with respect to these shares. Tradeup INC. paid an aggregate of approximately $2,365 for the Founders Shares and $312,200 for the Private Shares. The Private Shares have an aggregate market value of approximately $           , based on the Closing Price, resulting in a theoretical gain of $            (or $            per share);

 

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·Tradeup INC. is an affiliate of US Tiger, an underwriter of the Initial Public Offering. US Tiger is a New York based investment bank. Both Tradeup INC. and US Tiger are owned by UP Fintech, a Nasdaq listed company (Nasdaq: TIGR). UP Fintech is an online brokerage firm focusing on global Chinese investors. UPTD has entered into the Business Combination Marketing Agreement to engage the Representatives, pursuant to which UPTD engages the Representatives as advisors in connection with UPTD’s potential business combination. UPTD will pay the Representatives the Deferred Business Combination Fee for such services upon the consummation of an initial business combination in an amount of $1,550,000, equal to 3.5% of the gross proceeds of the Initial Public Offering (exclusive of any fees which might become payable to third parties for supporting services related to a business combination);

 

·Mr. Jianwei Li, UPTD’S Chairman and Chief Executive Officer, is the managing member of the Sponsor, and as such may be deemed to have sole voting and investment discretion with respect to the shares of UPTD Common Stock held by the Sponsor, including 862,000 Founder Shares and 249,760 Private Shares as described above. In addition, Mr. Jianwei Li directly holds 110,750 Founder Shares and 31,220 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as Mr. Li has waived any right to redemption with respect to these shares;

 

·each of the three independent directors of UPTD holds 10,000 Founder Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as the independent directors have waived any right to redemption with respect to these shares. Further, each of the independent directors is entitled to purchase 10,000 Founder Shares from the Sponsor and Tradeup INC. upon the completion of the Business Combination at the original purchase price (80% from the Sponsor and 20% from Tradeup INC);

 

·in order to finance transaction costs in connection with an intended initial business combination, the Founders, an affiliate of the Founders, or certain of UPTD’s officers and directors may, but are not obligated to, loan UPTD funds as may be required. If UPTD completes the Business Combination, UPTD would repay such loaned amounts out of the proceeds of the Trust Account released to UPTD. Otherwise, such loans would be repaid only out of funds held outside the Trust Account. In the event that the Business Combination does not close, UPTD may use a portion of the working capital held outside the Trust Account to repay such loaned amounts but no proceeds from the Trust Account would be used to repay such loaned amounts. Up to $1,200,000 of such loans may be convertible into the Working Capital Shares, at a price of $10.00 per share at the option of the lender. The terms of such loans by UPTD’s officers and directors, if any, have not been determined and no written agreements exist with respect to such loans. As of the date hereof, UPTD had $498,600 outstanding under the working capital loans;

 

·the Founders and UPTD’s officers and directors, or any of their respective affiliates will be reimbursed for any out-of-pocket expenses incurred related to identifying, investigating, and consummating an initial business combination, provided, that, if UPTD does not consummate the Business Combination, a portion of the working capital held outside the Trust Account may be used by UPTD to repay such reimbursements so long as no proceeds from the Trust Account are used for such repayment. As of            , 2022, the Founders and UPTD’s directors and officers and their respective affiliates had incurred approximately $             of such reimbursable out-of-pocket expenses;

 

·the nomination of Ms. Pei Xu by UPTD as a director of New Estrella following the Closing; Ms. Xu is also the CFO of Zhongchao Inc. (Nasdaq: ZCMD) of which Mr. Weiguang Yang is the CEO;

 

·the continued indemnification of current directors and officers of UPTD and the continuation of directors’ and officers’ liability insurance after the Business Combination;

 

·the fact that the Founders and their respective affiliates can earn a positive return on their investment, even if the Public Stockholders have a negative return on their investment in New Estrella; and

 

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·in addition to these interests of the UPTD Initial Stockholders, to the fullest extent permitted by applicable laws, the Current Charter waives certain applications of the doctrine of corporate opportunity in some circumstances where the application of any such doctrine would conflict with any fiduciary duties or contractual obligations they may have as of the date of the Current Charter or in the future, and UPTD will renounce any expectancy that any of the directors or officers of UPTD will offer any such corporate opportunity of which he or she may become aware to UPTD. UPTD does not believe that the pre-existing fiduciary duties or contractual obligations of its officers and directors materially impacted its search for an acquisition target. Further, UPTD does not believe that the waiver of the application of the corporate opportunity doctrine in the Current Charter had any impact on its search for a potential business combination target.

 

The Board was aware of and considered these interests, among other matters, in evaluating and negotiating the Merger Agreement and in recommending that UPTD stockholders approve the Merger Agreement and the Business Combination. See “Proposal 1: The Business Combination Proposal — Interests of the Founders and UPTD’s Directors and Officers in the Business Combination” beginning on page 108 of this proxy statement/prospectus.

 

Q:How do I vote?

 

A:If you are a holder of record of UPTD Common Stock on the Record Date, you may vote virtually at the Special Meeting or by submitting a proxy for the Special Meeting.

 

you may submit your proxy before the Special Meeting in any of the following ways, if available:

 

·use the toll-free number shown on your proxy card;

 

·visit the website shown on your proxy card to vote via the Internet; or

 

·complete, sign, date, and return the enclosed proxy card in the enclosed postage-paid envelope. Stockholders who choose to participate in the Special Meeting can vote their shares electronically during the meeting via live audio webcast by visiting www.          . You will need the control number that is printed on your proxy card to enter the Special Meeting. UPTD recommends that you log in at least 15 minutes before the meeting to ensure you are logged in when the Special Meeting starts.

 

If you hold your shares in “street name,” which means your shares are held of record by a broker, bank, or nominee, you should contact your broker, bank, or nominee to ensure that votes related to the shares you beneficially own are properly counted. In this regard, you must provide the broker, bank, or nominee with instructions on how to vote your shares or, if you wish to attend the meeting and vote in person (which would include presence at a virtual meeting), obtain a legal proxy from your broker, bank or nominee.

 

If you do not give instructions to your brokerage firm, the brokerage firm will not be allowed to vote your shares with respect to the Proposals. The Proposals are “non-discretionary” items. Your broker may not vote for non-discretionary items, and those votes will be counted as broker “non-votes.”

 

Q:If my shares are held in “street name,” will my broker, bank, or nominee automatically vote my shares for me?

 

A:No. Your broker, bank, or nominee cannot vote your shares unless you provide instructions on how to vote in accordance with the information and procedures provided to you by your broker, bank, or nominee.

 

Q:What happens if I sell my shares of UPTD Common Stock before the Special Meeting?

 

A:The Record Date for the Special Meeting will be earlier than the date of the Special Meeting. If you transfer your shares of UPTD Common Stock after the Record Date, but before the Special Meeting, unless the transferee obtains from you a proxy to vote those shares, you will retain your right to vote at the Special Meeting. However, you will not be able to seek redemption of your shares of UPTD Common Stock because you will no longer be able to deliver them for cancellation upon the consummation of the Business Combination in accordance with the provisions described herein.

 

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If you transfer your shares of UPTD Common Stock prior to the Record Date, you will have no right to vote those shares at the Special Meeting or redeem those shares for a pro rata portion of the proceeds held in the Trust Account.

 

Q:What if I attend the Special Meeting and abstain or do not vote?

 

A:For purposes of the Special Meeting, an abstention occurs when a stockholder virtually attends the Special Meeting online and does not vote or returns a proxy with an “abstain” vote.

 

If you are an UPTD stockholder that attends the Special Meeting virtually and fails to vote on the Business Combination Proposal, the Charter Amendment Proposal, the Advisory Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, the Incentive Plan Proposal, or the Adjournment Proposal, your failure to vote will have the same effect as a vote “AGAINST” the Charter Amendment Proposal, but will have no effect on the vote count for such other Proposals. If you are an UPTD stockholder that attends the Special Meeting virtually and you respond to such proposals with an “abstain” vote (or if you return a proxy with an “abstain” vote), your “abstain” vote will have the same effect as a vote “AGAINST” the Charter Amendment Proposal but will have no effect on any of the other Proposals.

 

Q:What will happen if I return my proxy card without indicating how to vote?

 

A:If you sign and return your proxy card without indicating how to vote on any particular proposal, the UPTD Common Stock represented by your proxy will be voted as recommended by the Board with respect to that Proposal.

 

Q:May I change my vote after I have mailed my signed proxy card?

 

A:Yes. You may change your vote at any time before your proxy is voted at the Special Meeting. You may do this in one of three ways:

 

·submitting a notice to UPTD;

 

·mailing a new, subsequently dated proxy card or submitting a new proxy online or by telephone; or

 

·by attending the Special Meeting virtually and electing to vote your shares online.

 

If you are a stockholder of record of UPTD and you choose to send a written notice or to mail a new proxy, you must submit your notice of revocation or your new proxy to TradeUP Acquisition Corp., 437 Madison Avenue, 27th Floor, New York, NY 10022, and it must be received at any time before the vote is taken at the Special Meeting. Any proxy that you submitted may also be revoked by submitting a new proxy online or by telephone not later than 11:59 p.m. Eastern Time on           , or by voting online at the Special Meeting. Simply attending the Special Meeting will not revoke your proxy. If you have instructed a broker, bank, or other nominee to vote your shares of UPTD Common Stock, you must follow the directions you receive from your broker, bank, or other nominee in order to change or revoke your vote.

 

Q:What happens if I fail to take any action with respect to the Special Meeting?

 

A:If you fail to take any action with respect to the Special Meeting and the Business Combination is approved by UPTD’s stockholders and consummated, you will continue to be a holder of UPTD Common Stock (which will be New Estrella Common Stock upon the Closing). As a corollary, failure to deliver (either physically or electronically) your stock certificate(s) to UPTD’s transfer agent, VStock, no later than two business days prior to the Special Meeting, means you will not have any right in connection with the Business Combination to exchange your Public Shares for a pro rata share of the funds held in the Trust Account. If you fail to take any action with respect to the Special Meeting and the Business Combination is not approved, you will continue to be a stockholder of UPTD.

 

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Q:What should I do with my share certificate(s)?

 

A:Those Public Stockholders who do not elect to have their Public Shares redeemed for a pro rata share of the funds held in the Trust Account need not submit their certificate(s). Public Stockholders who exercise their redemption rights must deliver their share certificate(s) to VStock (either physically or electronically) or through DTC to VStock at least two business days before the Special Meeting, as described above.

 

Q:What should I do if I receive more than one set of voting materials?

 

A:UPTD stockholders may receive more than one set of voting materials, including multiple copies of this proxy statement/prospectus and multiple proxy cards or voting instruction cards. For example, if you hold your shares of UPTD Common Stock in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold such shares. If you are a holder of record and your shares of UPTD Common Stock are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date, and return each proxy card and voting instruction card that you receive in order to cast a vote with respect to all of your shares of UPTD Common Stock.

 

Q:Who can help answer my questions?

 

A:If you have questions about the Business Combination or if you need additional copies of this proxy statement/prospectus or the enclosed proxy card, you should contact:

 

TradeUP Acquisition Corp.
437 Madison Avenue, 27th Floor

New York, NY 10022

 

You may also obtain additional information about UPTD from documents filed with the SEC by following the instructions in the section entitled “Where You Can Find More Information.” If you are a UPTD stockholder and you intend to seek redemption of your shares, you will need to deliver your Public Shares (either physically or electronically) to VStock (or through DTC to VStock) at the address listed below at least two business days prior to the vote at the Special Meeting. If you have questions regarding the certification of your position or delivery of your stock, please contact:

 

VStock Transfer, LLC

18 Lafayette Place

Woodmere, NY 11598

Attn: Chief Executive Officer

 

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SUMMARY OF THE PROXY STATEMENT/PROSPECTUS

 

This summary highlights selected information from this proxy statement/prospectus and does not contain all of the information that is important to you. To better understand the Proposals to be submitted for a vote at the Special Meeting, including the Business Combination Proposal, you should read this entire document carefully, including the Annexes attached to this proxy statement/prospectus. The Merger Agreement is the primary legal document that governs the Business Combination and other transactions that will be undertaken in connection with the Business Combination. It is described in detail in this proxy statement/prospectus in the section entitled “Proposal 1: The Business Combination Proposal.”

 

The Parties

 

UPTD

 

TradeUP Acquisition Corp. is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. UPTD was incorporated under the laws of the State of Delaware on January 6, 2021.

 

On July 19, 2021, UPTD closed its Initial Public Offering of 4,000,000 UPTD Units at an offering price of $10.00 per unit, generating gross proceeds of $40,000,000. The Initial Public Offering was conducted pursuant to a registration statement on Form S-1 (File No. 333-253322). Simultaneously with the consummation of the Initial Public Offering, UPTD consummated the Concurrent Private Placement of 295,000 Private Shares at $10.00 per share to the Founders, generating gross proceeds of $2,950,000. On July 21, 2021, in connection with the underwriters’ partial exercise of their over-allotment option, UPTD issued 430,000 Option Units at a price of $10.00 per unit, generating gross proceeds of $4,300,000, and simultaneously completed the sale of 17,200 Private Shares to the Founders in the Additional Private Placement at a price of $10.00 per share, generating gross proceeds of $172,000. Following the expiration of the remaining over-allotment option, 42,500 Founder Shares were subsequently forfeited.

 

Following the closings of the Initial Public Offering and the sales of the Private Shares in the Concurrent Private Placement on July 19, 2021, and the sales of the Option Units and the sales of the Private Shares in Additional Private Placement on July 21, 2021, a total of $45,186,000 was placed in the Trust Account, and we had $767,026 of cash held outside of the Trust Account, after payment of costs related to the Initial Public Offering, available for working capital purposes. As of the Record Date, there was $           held in the Trust Account.

 

The UPTD Units, UPTD Common Stock, and UPTD Warrants are listed on Nasdaq under the symbols “UTDU,” “UPTD,” and “UPTDW.”

 

The mailing address of UPTD’s principal executive office is 437 Madison Avenue, 27th Floor, New York, New York 10022, and its telephone number is (732) 910-9692. After the consummation of the Business Combination, UPTD’s principal executive office will be that of Estrella.

 

For additional information about UPTD, see the section entitled “Information about UPTD.”

 

Merger Sub

 

Merger Sub is a wholly-owned subsidiary of UPTD, formed solely for the purpose of effectuating the Business Combination described herein. Merger Sub was incorporated under the laws of the State of Delaware on July 26, 2022. Merger Sub owns no material assets and does not operate any business.

 

The mailing address of Merger Sub’s principal executive office is 437 Madison Avenue, 27th Floor, New York, New York 10022, and its telephone number is (732) 910-9692. After the consummation of the Business Combination, Merger Sub will cease to exist.

 

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Eureka

 

Eureka Therapeutics, Inc. (“Eureka”) is a clinical-stage biopharmaceutical company developing transformative technology platforms that can access cancer-specific targets and harness the evolutionary power of T-cells for the treatment of solid tumors and other malignancies. Eureka was incorporated as a California corporation in February 2006 and reincorporated in Delaware in March 2018. Eureka’s principal executive offices are located at 5858 Horton Street, Suite 170, Emeryville, CA 94608, and its telephone number is (510) 654-7045.

 

Estrella

 

Estrella is a preclinical-stage biopharmaceutical company developing T-cell therapies with the capacity to address treatment challenges for patients with blood cancers and solid tumors. Estrella believes that T-cell therapy continues to represent a revolutionary step towards providing a potential solution for many forms of cancer, including cancers poorly addressed by current approaches. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer with safe, effective therapies. To accomplish this mission, Estrella’s lead product candidate, EB103, which is a T-cell therapy also called “CD19-Redirected ARTEMIS® T-Cell Therapy,” utilizes Eureka’s ARTEMIS® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, a T-cell therapy also called “CD19/22 Dual-Targeting ARTEMIS® T-Cell Therapy.” Like EB103, EB104 utilizes Eureka’s ARTEMIS® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies. Estrella is also collaborating with Imugene Limited (“Imugene”) and its product candidate, CF33-CD19t an oncolytic virus (“CF33-CD19t”), to research the use of EB103 in conjunction with CF33-CD19t to treat solid tumors using a “mark and kill” strategy.

 

Estrella was incorporated as a Delaware corporation on March 30, 2022. On June 28, 2022, pursuant to a Contribution Agreement between Estrella and Eureka (the “Contribution Agreement"), Eureka contributed certain assets related to T-cell therapies targeting CD19 and/or CD22 to Estrella in exchange for 105,000,000 shares of Estrella Series A Preferred Stock of Estrella (the “Separation”). As part of the Separation, Estrella entered into a License Agreement (the “License Agreement”) with Eureka and Eureka Therapeutics (Cayman) Ltd., an affiliate of Eureka, and a Services Agreement (the “Services Agreement”) with Eureka, and Eureka contributed and assigned the Collaboration Agreement between Eureka and Imugene (the “Collaboration Agreement”) to Estrella. The License Agreement grants Estrella an exclusive license relating to targeted T-cell therapies, which Estrella is developing using Eureka’s platform technology in the territories of the world excluding Greater China and the ASEAN Countries (the “Licensed Territory”). Under the Services Agreement, Eureka has agreed to perform certain services for Estrella in connection with the development of Estrella’s product candidates. The Collaboration Agreement establishes the collaboration between Estrella and Imugene related to the investigation of solid tumor treatments using Imugene’s product candidate, CF33-CD19t, in conjunction with EB103. These agreements are discussed in further detail in the section entitled “Business.”

 

The mailing address of Estrella’s principal executive office is 5858 Horton Street. Suite 170, Emeryville, CA 94608, and its telephone number is (510) 318-9098.

 

For additional information about Estrella, see the section entitled “Information about Estrella.

 

Emerging Growth Company

 

UPTD is an “emerging growth company,” as defined under the JOBS Act. As an emerging growth company, UPTD is eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. These include, but are not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and the requirement to obtain stockholder approval of any golden parachute payments not previously approved.

 

New Estrella will remain an emerging growth company until the earlier of (1) December 31, 2026 (the last day of the fiscal year following the fifth anniversary of the consummation of the Initial Public Offering), (2) the last day of the fiscal year in which New Estrella has total annual gross revenue of at least $1.07 billion, (3) the last day of the fiscal year in which New Estrella is deemed to be a “large accelerated filer,” as defined in the Exchange Act, and (4) the date on which New Estrella has issued more than $1.0 billion in nonconvertible debt securities during the prior three-year period.

 

 2 

 

  

The Business Combination Proposal

 

Pursuant to the Merger Agreement, a Business Combination between UPTD and Estrella will be effected whereby Merger Sub will merge with and into Estrella, with Estrella surviving as a wholly-owned subsidiary of UPTD.

 

After consideration of the factors identified and discussed in the section entitled “Proposal 1: The Business Combination Proposal — The Board’s Reasons for the Approval of the Business Combination,” the Board concluded that the Business Combination should be approved.

 

The terms and conditions of the Business Combination are contained in the Merger Agreement, which is attached to this proxy statement/prospectus as Annex A and is incorporated by reference herein in its entirety. UPTD encourages you to read the Merger Agreement carefully, as it is the primary legal document that governs the Business Combination. For more information on the Merger Agreement, see the section entitled “Proposal 1: The Business Combination Proposal.”

 

Merger Consideration

 

Pursuant to the Merger Agreement, stockholders of Estrella immediately prior to the Effective Time collectively will receive from UPTD, in the aggregate, a number of newly issued shares of UPTD Common Stock equal to: (i) $325,000,000, divided by (ii) $10.00 per share in consideration of converting their shares of Estrella Common Stock. Each share of Estrella Preferred Stock that is issued and outstanding immediately prior to the Effective Time will automatically convert into a number of shares of Estrella Common Stock in accordance with the certificate of incorporation of Estrella.

 

As a result, the total number of shares of UPTD Common Stock expected to be issued at the Closing is 32,500,000 shares, and these shares are expected to represent between approximately 81.6% and 91.7% of the issued and outstanding shares of UPTD Common Stock (which will be New Estrella Common Stock) immediately following the closing of the Merger Financing and the Business Combination, assuming, at the low end of that range, no redemptions from our Trust Account occur, and, at the high end of that range, maximum redemptions from our Trust Account occur. Please see the section entitled “Unaudited Pro Forma Condensed Combined Financial Information” for further information regarding what constitutes a “maximum redemption” scenario.

 

The Board’s Reasons for the Approval of the Business Combination

 

The Board considered a wide variety of factors, including the Fairness Opinion, in connection with its evaluation of the Business Combination. In light of the complexity of those factors, the Board, as a whole, did not consider it practicable to, nor did it attempt to, quantify or otherwise assign relative weights to the specific factors it took into account in reaching its decision. Individual members of the Board may have given different weight to different factors.

 

For a more complete description of the Board’s reasons for the approval of the Business Combination and its recommendation in favor of the Business Combination Proposal, please see the section entitled “Proposal 1: The Business Combination — The Board’s Reasons for the Approval of the Business Combination.

 

Accounting Treatment

 

Notwithstanding the legal form, the Business Combination will be accounted for as a reverse recapitalization in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Under this method of accounting, UPTD will be treated as the acquired company for financial reporting purposes, whereas Estrella will be treated as the accounting acquiror. In accordance with this accounting method, the Business Combination will be treated as the equivalent of Estrella issuing stock for the net assets of UPTD, accompanied by a recapitalization. The net assets of Estrella will be stated at historical cost, with no goodwill or other intangible assets recorded, and operations prior to the Business Combination will be those of Estrella. Estrella has been determined to be the accounting acquiror for purposes of the Business Combination based on an evaluation of the following facts and circumstances Notwithstanding the legal form, the Business Combination will be accounted for as a reverse recapitalization in accordance with U.S. GAAP:

 

 3 

 

  

·if the Director Election Proposal is approved by UPTD stockholders, persons affiliated with Estrella will control a majority of the governing body of New Estrella;

 

·Estrella’s operations prior to the Business Combination will comprise the ongoing operations of New Estrella;

 

·Estrella’s existing senior management team will comprise all of the senior management team of the Combined Company; and

 

·Estrella’s stockholders are expected to have a majority of the voting power of the Combined Company.

 

Pro Forma Ownership of New Estrella Upon Closing

 

Immediately after the Closing, assuming no Public Stockholder exercises its redemption rights and no additional shares are issued prior to Closing, the Sellers will own approximately 81.6% of the shares of New Estrella Common Stock to be outstanding immediately after the Business Combination, Public Stockholders will own approximately 11.1% of the shares of New Estrella Common Stock, the UPTD Initial Stockholders will own approximately 3.6% of the shares of New Estrella Common Stock, and the Merger Financing Investors will own approximately 3.7% of the shares of New Estrella Common Stock, in each case, based on the number of shares of UPTD Common Stock outstanding as of the Record Date. These pro forma ownership percentages also (a) assume no exercise of any options to purchase UPTD Common Stock (which will be New Estrella Common Stock) that will be outstanding immediately following the Business Combination, whether such options are issued under the Incentive Plan or otherwise, (b) exclude the issuance of any shares of New Estrella Common Stock in connection with the Incentive Plan following the Business Combination, and (c) assume that 1,500,000 shares of UPTD Common Stock will be issued in connection with the Merger Financing at the Effective Time, assuming minimum equity financing of $15.0 million at $10.00 per share of UPTD Common Stock. If the actual facts differ from these assumptions, the numbers of shares and ownership percentages set forth above, including the anticipated equity stake of non-redeeming Public Stockholders in New Estrella following the Business Combination and Merger Financing, will be different. For more information, please see the section entitled “Unaudited Pro Forma Condensed Combined Financial Information.”

 

Additional Matters Being Voted On By UPTD Stockholders

 

In addition to voting on the Business Combination Proposal, UPTD stockholders will vote on the following Proposals:

 

The Charter Amendment Proposal

 

Assuming the Business Combination Proposal is approved and adopted, UPTD stockholders will vote on a proposal to approve the Proposed Charter, which will amend and restate the Current Charter, and the Proposed Bylaws of the Combined Company. If approved, the Proposed Charter and the Proposed Bylaws will be in effect upon the Closing. See the section entitled “Proposal 2: The Charter Amendment Proposal” for further information. A copy of the Proposed Charter and the Proposed Bylaws is attached to this proxy statement/prospectus as Annex B and Annex C, respectively.

 

 4 

 

 

The Advisory Charter Amendment Proposals

 

On a non-binding advisory basis, UPTD stockholders will vote on a proposal to approve the Advisory Charter Amendment Proposals, which are being presented pursuant to guidance of the SEC as six separate sub-proposals. See the section entitled “Proposal 3: The Advisory Charter Amendment Proposals” for further information.

 

The Nasdaq Stock Issuance Proposal

 

Assuming the Business Combination Proposal is approved and adopted, for purposes of complying with the applicable provisions of Nasdaq Listing Rule 5635, UPTD stockholders will vote on the issuance of 32,500,000 shares of UPTD Common Stock in connection with the Business Combination and issuance of at least 1,500,000 shares of UPTD Common Stock to Merger Financing Investors in connection with the Merger Financing. See the section entitled “Proposal 4: The Nasdaq Stock Issuance Proposal” for further information.

 

The Director Election Proposal

 

Assuming the Business Combination Proposal is approved and adopted, UPTD stockholders will vote on a proposal to approve the appointment of five directors who, upon consummation of the Business Combination, will become the directors of the Combined Company. See the section entitled “Proposal 5: The Director Election Proposal” for further information.

 

The Incentive Plan Proposal

 

Assuming the Business Combination Proposal is approved and adopted, UPTD stockholders will vote on a proposal to approve the Incentive Plan, which will become effective as of and contingent on the consummation of the Business Combination. See the section entitled “Proposal 6: The Incentive Plan Proposal” for further information.

 

The Adjournment Proposal

 

UPTD stockholders will be asked to consider and vote upon a proposal to adjourn the Special Meeting to a later date or dates if it is determined that more time is necessary or appropriate, in the judgment of the Board or the officer presiding over the Special Meeting, for UPTD to consummate the Business Combination (including to solicit additional votes in favor of any of the Proposals). See the section entitled “Proposal 7: The Adjournment Proposal” for further information.

 

UPTD’s Founders and Officers and Directors

 

As of the Record Date, the UPTD Initial Stockholders beneficially owned and were entitled to vote an aggregate of 1,419,700 shares of UPTD Common Stock. The shares owned by the UPTD Initial Stockholders currently constitute approximately 24.27% of the outstanding shares of UPTD Common Stock.

 

In connection with the Initial Public Offering, the Founders and each of UPTD’s officers and directors agreed to vote their Founder Shares, Private Shares, and any Public Shares they hold in favor of an initial business combination (including any proposals recommended by the Board in connection with such business combination). This commitment would extend to include the Business Combination Proposal and the other Proposals.

 

 5 

 

 

In connection with the Initial Public Offering, the UPTD Initial Stockholders entered into the IPO Letter Agreement pursuant to which they agreed (subject to limited exceptions): (i) in the case of the Founder Shares, 50% of Founder Shares may not be transferred, assigned, or sold until the earlier to occur of: (a) six months after the date of the consummation of an initial business combination, or (b) the date on which the closing price of UPTD Common Stock equals or exceeds $12.50 per share (as adjusted for share splits, share dividends, reorganizations, and recapitalizations) for any 20 trading days within any 30-trading day period commencing after the completion of an initial business combination and the remaining 50% of the Founder Shares may not be transferred, assigned, or sold until six months after the date of the consummation of an initial business combination, or earlier, in either case, if, subsequent to such business combination, UPTD consummates a subsequent liquidation, merger, capital stock exchange, reorganization, or other similar transaction which results in all of UPTD’s stockholders having the right to exchange their shares of UPTD Common Stock for cash, securities, or other property, and (ii) in the case of the Private Shares, until 30 days after the completion of an initial business combination, except in each case (a) to UPTD’s officers or directors, any affiliates or family members of any of UPTD’s officers or directors, any affiliate of the Founders, any members of the Founders, or any of their affiliates, officers, directors, or direct and indirect equityholders, (b) in the case of an individual, by gift to a member of the individual’s immediate family, to a trust, the beneficiary of which is a member of the individual’s immediate family or an affiliate of such person, or to a charitable organization; (c) in the case of an individual, transfers by virtue of laws of descent and distribution upon death of the individual; (d) in the case of an individual, transfers pursuant to a qualified domestic relations order; (e) transfers by private sales or transfers made in connection with the consummation of a business combination at prices no greater than the price at which the securities were originally purchased; (f) transfers in the event of UPTD’s liquidation prior to the completion of an initial business combination; or (g) transfers by virtue of the laws of the State of Delaware or the Founders’ respective governing documents upon dissolution of the Founders, provided, however, that in the case of clauses (a) through (e), or (g) these permitted transferees must enter into a written agreement agreeing to be bound by these transfer restrictions.

 

In connection with UPTD’s entry into the Merger Agreement, the UPTD Initial Stockholders have entered into the Support Agreement, a copy of which is filed with this proxy statement/prospectus, and effective as of the consummation of the Closing further described in the section entitled “Proposal 1: The Merger Agreement – Related Agreements –Support Agreement.”

 

Special Meeting Information

 

Date, Time, and Place of Special Meeting

 

The Special Meeting will be held virtually on           , at           , Eastern Time, at           . UPTD stockholders may attend, vote, and examine the list of UPTD stockholders entitled to vote at the Special Meeting by visiting            and entering the control number found on their proxy card, voting instruction form, or notice they previously received. In light of public health concerns regarding the COVID-19 pandemic, the Special Meeting will be held in a virtual meeting format only. You will not be able to attend the Special Meeting in person.

 

Voting Power; Record Date

 

UPTD stockholders will be entitled to vote or direct votes to be cast at the Special Meeting if they owned UPTD Common Stock at the close of business on            , which is the Record Date for the Special Meeting. Stockholders will have one vote for each share of UPTD Common Stock owned at the close of business on the Record Date in respect of each Proposal on which they are entitled to vote. If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted. On the Record Date, there were             shares of UPTD Common Stock entitled to vote at the Special Meeting, of which 1,419,700 were owned by the UPTD Initial Stockholders or an affiliate thereof.

 

Quorum and Vote of UPTD Stockholders

 

A quorum of UPTD stockholders is necessary to hold a valid meeting. A quorum will be present at the Special Meeting if a majority of the voting power of all outstanding shares of UPTD Common Stock entitled to vote at the meeting are represented in person (which would include presence at a virtual meeting) or by proxy. As of the Record Date, there were 5,849,700 shares of UPTD Common Stock; therefore, a total of 2,924,851 shares of UPTD Common Stock must be represented at the Special Meeting in order to constitute a quorum. Abstentions and withheld votes will count as present for the purposes of establishing a quorum, but will not count as votes cast at the Special Meeting for any of the Proposals (except for the Charter Amendment Proposal, for which abstentions and withheld votes will have the same effect as a vote “AGAINST”). Because the Proposals are “non-discretionary” items, your broker will not be able to vote uninstructed shares for any of the Proposals. As a result, if you do not provide voting instructions, a broker “non-vote” will be deemed to have occurred for each of the Proposals. Broker “non-votes” will not be counted as present for purposes of determining whether a quorum is present. As of the Record Date, the UPTD Initial Stockholders hold approximately            % of the outstanding UPTD Common Stock.

 

 6 

 

  

The Proposals presented at the Special Meeting will require the following votes:

 

·The approval of the Business Combination Proposal will require the affirmative vote of the holders of a majority of the shares of UPTD Common Stock cast in respect of that Proposal and entitled to vote thereon at the Special Meeting.

 

·The approval of the Charter Amendment Proposal will require a majority vote of outstanding UPTD Common Stock entitled to vote present in person (including virtual presence) or represented by proxy, at a meeting at which a quorum is present. Accordingly, a UPTD stockholder’s failure to vote by proxy or in person (which would include presence at a virtual meeting) at the Special Meeting or an abstention will have the same effect as a vote “AGAINST” the Charter Amendment Proposal.

 

·The approval of each of the Nasdaq Stock Issuance Proposal, Incentive Plan Proposal, the Adjournment Proposal, and each of the Advisory Charter Amendment Proposals will require the affirmative vote of the holders of a majority of the shares of UPTD Common Stock cast in respect of that Proposal and entitled to vote thereon at the Special Meeting.

 

·The approval of the Director Election Proposal requires a plurality vote of the shares of UPTD Common Stock cast by stockholders present in person (including virtual presence) or represented by proxy and entitled to vote thereon at the Special Meeting. A “plurality of vote” means that the nominees receiving the greatest number of votes cast “FOR” are elected as directors up to the maximum number of directors to be elected. Consequently, any shares not voted “FOR” a particular nominee (whether as a result of an abstention, a direction to withhold authority or a broker non-vote) will not be counted in the nominee’s favor.

 

Abstentions, withheld votes, and broker non-votes will have no effect on any of the Proposals that will be presented at the Special Meeting, aside from those effects set forth above.

 

Consummation of the Business Combination is conditioned on approval of the Business Combination Proposal and, unless otherwise waived by the parties thereof, the Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, and the Incentive Plan Proposal are preconditions to the Closing. The Adjournment Proposal is not conditioned on the approval of any other Proposal.

 

Redemption Rights of UPTD Stockholders

 

Public Stockholders may seek to redeem their Public Shares for cash, regardless of whether they vote for or against, or whether they abstain from voting on, the Business Combination Proposal. Any Public Stockholder may demand that UPTD redeem such Public Stockholder’s Public Shares for a pro rata portion of the Trust Account (which, for illustrative purposes, was $10.20 per share as of          , 2022), calculated as of two business days prior to the anticipated consummation of the Business Combination. If a holder properly seeks redemption as described in this section and the Business Combination with Estrella is consummated, UPTD will redeem the holder’s Public Shares for a pro rata portion of funds deposited in the Trust Account and the holder will no longer own these shares following the Business Combination.

 

Notwithstanding the foregoing, a holder of UPTD Common Stock, together with any affiliate of such holder or any other person with whom such holder is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Exchange Act), will be restricted from seeking redemption rights with respect to more than 15% of the UPTD Common Stock. Accordingly, all shares of UPTD Common Stock in excess of 15% held by a Public Stockholder, together with any affiliate of such Public Stockholder or any other person with whom such Public Stockholder is acting in concert or as a “group,” will not be redeemed for cash.

 

Holders of Founder Shares and Private Shares will not have redemption rights with respect to such shares.

 

 7 

 

 

Holders may demand redemption by delivering their stock, either physically or electronically using Depository Trust Company’s DWAC System, to UPTD’s transfer agent two business days prior to the Special Meeting. If you hold the shares in “street name,” you will have to coordinate with your broker to have your shares certificated or delivered electronically. Certificates that have not been tendered (either physically or electronically) in accordance with these procedures will not be redeemed for cash. There is a nominal cost associated with this tendering process and the act of certificating the shares or delivering them through the DWAC system. The transfer agent will typically charge the tendering broker a fee of approximately $120.00 and it would be up to the broker whether or not to pass this cost on to the redeeming stockholder. In the event the proposed Business Combination is not consummated this may result in an additional cost to stockholders for the return of their shares.

 

UPTD’s transfer agent can be contacted at the following address:

 

VStock Transfer, LLC

18 Lafayette Place

Woodmere, NY 11598

Attn: Chief Executive Officer

 

Any request to redeem such shares, once made, may be withdrawn at any time up to the time of the vote on the Business Combination Proposal. Furthermore, if a Public Stockholder delivers its certificate in connection with an election of its redemption and subsequently decides prior to the applicable date not to elect to exercise such rights, the holder may simply request that the transfer agent return the certificate (physically or electronically).

 

If the Business Combination is not approved or completed for any reason, then UPTD’s Public Stockholders who elected to exercise their redemption rights will not be entitled to redeem their Public Shares for a pro rata portion of the Trust Account. In such case, UPTD will promptly return any Public Shares delivered by Public Stockholders. If UPTD would be left with less than $5,000,001 of net tangible assets upon the consummation of the Business Combination, unless waived by each party to the Merger Agreement, as a result of the holders of UPTD Common Stock properly demanding redemption of their shares for cash, UPTD will not be able to consummate the Business Combination.

 

The closing price of the UPTD Common Stock on            , the Record Date for the Special Meeting, was $            . The cash held in the Trust Account on such date was approximately $             million ($             per Public Share). Prior to exercising redemption rights, stockholders should verify the market price of UPTD Common Stock as they may receive higher proceeds from the sale of their shares of UPTD Common Stock in the public market than from exercising their redemption rights if the market price per share is higher than the redemption price. UPTD cannot assure its stockholders that they will be able to sell their shares of UPTD Common Stock in the open market, even if the market price per share is higher than the redemption price stated above, as there may not be sufficient liquidity in UPTD’s securities when its stockholders wish to sell their shares.

 

If a holder of UPTD Common Stock exercises such holder’s redemption rights, then such holder will be exchanging such holder’s shares of UPTD Common Stock for cash and will no longer own those shares. You will be entitled to receive cash for these shares only if you properly demand redemption by no later than the close of the vote on the Business Combination Proposal by delivering your stock certificate (either physically or electronically) to UPTD’s transfer agent prior to the vote at the Special Meeting, and the Business Combination is consummated.

 

For a discussion of the material U.S. federal income tax considerations for holders of UPTD Common Stock with respect to the exercise of these redemption rights, see “Material U.S. Federal Income Tax ConsiderationsMaterial Tax Considerations Related to a Redemption of UPTD Common Stock” beginning on page 126. The consequences of a redemption to any particular holder of UPTD Common Stock will depend on that holder’s particular facts and circumstances. Accordingly, you are urged to consult your tax advisor to determine your tax consequences from the exercise of your redemption rights, including the applicability and effect of U.S. federal, state, and local and non-U.S. income and other tax laws in light of your particular circumstances.

 

Underwriting Fees as a Percentage of Initial Public Offering Proceeds Net of Redemptions

 

  

No
redemptions(2)

  

25%
redemptions(3)

   75%
redemptions(4)
  

Maximum
redemptions(5) 

 
Initial Public Offering underwriting fees(1)  $886,000   $886,000   $886,000   $886,000 
Initial Public Offering proceeds net of redemptions  $45,186,000   $33,889,500   $11,296,500   $404,593 
Underwriting fees as a % of Initial Public Offering proceeds net of redemptions (approx.)   2.0%   2.6%   7.8%   219.0%

 

 

 8 

 

 

(1)$886,000 underwriting discount was paid at the consummation of the Initial Public Offering.
(2)This scenario assumes that no Public Shares are redeemed.
(3) As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that 1,107,500 Public Shares are redeemed, resulting in an aggregate payment of approximately $11.3 million from the Trust Account based on an assumed redemption price of $10.20 per share.

(4)As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that 3,322,500 Public Shares are redeemed, resulting in an aggregate payment of approximately $33.9 million from the Trust Account based on an assumed redemption price of $10.20 per share.
(5)As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that a maximum of 4,390,334 Public Shares are redeemed to meet the $20.0 million Available Combined Cash Amount closing condition, resulting in an aggregate payment of approximately $44.8 million from the Trust Account (based on an assumed redemption price of $10.20 per share).

 

Deferred Business Combination Fee as a Percentage of Initial Public Offering Proceeds Net of Redemptions

 

   No
redemptions(2)
   25%
redemptions(3)
   75%
redemptions(4)
   Maximum
redemptions(5) 
 
Deferred Business Combination Fee (1)  $1,550,500   $1,550,500   $1,550,500   $1,550,500 
Initial Public Offering proceeds net of redemptions  $45,186,000   $33,889,500   $11,296,500   $404,593 
Deferred Business Combination Fee as a % of Initial Public Offering proceeds net of redemptions (approx.)   3.4%   4.6%   13.7%   383.2%

 

 
(1)$1,550,500 of the Deferred Business Combination Fee is payable at the closing of the Business Combination.
(2)This scenario assumes that no Public Shares are redeemed.
(3)As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that 1,107,500 Public Shares are redeemed, resulting in an aggregate payment of approximately $11.3 million from the Trust Account based on an assumed redemption price of $10.20 per share.
(4)As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that 3,322,500 Public Shares are redeemed, resulting in an aggregate payment of approximately $33.9 million from the Trust Account based on an assumed redemption price of $10.20 per share.
(5)As of the date of this proxy statement/prospectus, there are 4,430,000 Public Shares issued and outstanding. This scenario assumes that a maximum of 4,390,334 Public Shares are redeemed to meet the $20.0 million Available Combined Cash Amount closing condition, resulting in an aggregate payment of approximately $44.8 million from the Trust Account (based on an assumed redemption price of $10.20 per share).

 

Tax Consequences of Business Combination

 

For a description of the material U.S. federal income tax consequences of the Business Combination, please see the information set forth in the section entitled “Material U.S. Federal Income Tax Considerations.”

 

Appraisal Rights

 

UPTD stockholders do not have appraisal rights in connection with the Business Combination under Delaware law.

 

Regulatory Matters

 

At any time before or after consummation of the Business Combination, the applicable competition authorities in the United States or any other applicable jurisdiction could take such action under applicable antitrust laws as such authority deems necessary or desirable in the public interest, including seeking to enjoin the consummation of the Business Combination, conditionally approving the Business Combination upon divestiture of certain of New Estrella’s assets, subjecting the completion of the Business Combination to regulatory conditions or seeking other remedies. Private parties may also seek to take legal action under the antitrust laws under certain circumstances. UPTD cannot assure you that the U.S. Antitrust Division, the U.S. Federal Trade Commission (the “FTC”), any state attorney general, or any other government authority, or any private party, will not attempt to challenge the Business Combination on antitrust grounds, and, if such a challenge is made, UPTD cannot assure you as to its result. Under the Merger Agreement, UPTD and Estrella are not obligated to sell, license, or otherwise dispose of any entities, assets, or facilities (or agree to do so), or terminate, assign, or amend any existing relationships or contractual rights or obligations, or enter into new licenses or other contracts in order to obtain approval of the Business Combination by the U.S. Antitrust Division, the FTC, or otherwise.

 

 9 

 

 

Neither UPTD nor Estrella is aware of any material regulatory approvals or actions that are required for completion of the Business Combination. It is presently contemplated that if any such regulatory approvals or actions are required, those approvals or actions will be sought. There can be no assurance, however, that any approvals or actions which are required will be obtained.

 

Proxy Solicitation

 

Proxies may be solicited by mail, telephone, or in person (which would include presence at a virtual meeting). UPTD has engaged            to assist in the solicitation of proxies. If a stockholder grants a proxy, they may still vote their shares in person (which would include presence at a virtual meeting) if they revoke their proxy before the Special Meeting. A stockholder may also change their vote by submitting a later-dated proxy as described in the section entitled “Special Meeting of UPTD Stockholders — Revoking Your Proxy.”

 

Interests of the Founders and UPTD’s Directors and Officers in the Business Combination

 

In considering the recommendation of the Board to vote in favor of approval of the Business Combination Proposal, the Charter Amendment Proposal, and the other Proposals, UPTD stockholders should keep in mind that the Founders (which are affiliated with certain of UPTD’s officers and directors) and UPTD’s officers and directors have interests in such Proposals that are different from, or in addition to, UPTD’s stockholders’ interests. These interests include, among other things:

 

·the fact that the UPTD Initial Stockholders, including the Founders and UPTD’s officers and directors, have agreed not to redeem any shares of UPTD Common Stock in connection with a stockholder vote to approve a proposed initial business combination;

 

·the beneficial ownership by the Sponsor of an aggregate of 862,000 Founder Shares and 249,760 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as the Sponsor has waived any right to redemption with respect to these shares. The Sponsor paid an aggregate of $19,458 for the Founders Shares and $2,497,600 for the Private Shares. The Private Shares have an aggregate market value of approximately $          , based on the Closing Price, resulting in a theoretical gain of $           (or $           per share);

 

·the beneficial ownership by Tradeup INC. of an aggregate of 104,750 Founder Shares and 31,220 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as Tradeup INC. has waived any right to redemption with respect to these shares. Tradeup INC. paid an aggregate of $2,365 for the Founders Shares and $312,200 for the Private Shares. The Private Shares have an aggregate market value of approximately $          , based on the Closing Price, resulting in a theoretical gain of $           (or $           per share);

 

 10 

 

 

·

Tradeup INC. is an affiliate of US Tiger, an underwriter of the Initial Public Offering. US Tiger is a New York based investment bank. Both Tradeup INC. and US Tiger are owned by UP Fintech, a Nasdaq listed company (Nasdaq: TIGR). UP Fintech is an online brokerage firm focusing on global Chinese investors. UPTD has entered into the Business Combination Marketing Agreement to engage the Representatives,   pursuant to which UPTD engages the Representatives as advisors in connection with UPTD’s potential business combination. UPTD will pay the underwriters of the Initial Public Offering the Deferred Business Combination Fee for such services upon the consummation of an initial business combination in an amount of $1,550,000, equal to 3.5% of the gross proceeds of the Initial Public Offering (exclusive of any fees which might become payable to third parties for supporting services related to a business combination)

 

·Mr. Jianwei Li, UPTD’S Chairman and Chief Executive Officer, is the managing member of the Sponsor, and as such may be deemed to have sole voting and investment discretion with respect to the shares of UPTD Common Stock held by the Sponsor, including 862,000 Founder Shares and 249,760 Private Shares as described above. In addition, Mr. Jianwei Li directly holds 110,750 Founder Shares and 31,220 Private Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as Mr. Li has waived any right to redemption with respect to these shares;

 

·each of the three independent directors of UPTD holds 10,000 Founder Shares, which would become worthless if UPTD does not complete a business combination within the applicable time period, as the independent directors have waived any right to redemption with respect to these shares. Further, each of the independent directors is entitled to purchase 10,000 Founder Shares from the Sponsor and Tradeup INC. upon the completion of the Business Combination at the original purchase price (80% from the Sponsor and 20% from Tradeup INC);

 

·in order to finance transaction costs in connection with an intended initial business combination, the Founders, an affiliate of the Founders, or certain of UPTD’s officers and directors may, but are not obligated to, loan UPTD funds as may be required. If UPTD completes the Business Combination, UPTD would repay such loaned amounts out of the proceeds of the Trust Account released to UPTD. Otherwise, such loans would be repaid only out of funds held outside the Trust Account. In the event that the Business Combination does not close, UPTD may use a portion of the working capital held outside the Trust Account to repay such loaned amounts but no proceeds from the Trust Account would be used to repay such loaned amounts. Up to $1,200,000 of such loans may be convertible into the Working Capital Shares, at a price of $10.00 per share at the option of the lender. The terms of such loans by UPTD’s officers and directors, if any, have not been determined and no written agreements exist with respect to such loans. As of June 30, 2022, UPTD had $498,600 outstanding under the Notes;

 

·the Founders and UPTD’s officers and directors, or any of their respective affiliates will be reimbursed for any out-of-pocket expenses incurred related to identifying, investigating, and consummating an initial business combination, provided, that, if UPTD does not consummate the Business Combination, a portion of the working capital held outside the Trust Account may be used by UPTD to repay such reimbursements so long as no proceeds from the Trust Account are used for such repayment. As of            , 2022, the Founders and UPTD’s directors and officers and their respective affiliates had incurred approximately $             of such reimbursable out-of-pocket expenses;

 

·the nomination of Ms. Pei Xu by UPTD as a director of New Estrella following the Closing (Ms. Xu is also the CFO of Zhongchao Inc. (Nasdaq: ZCMD) of which Mr. Weiguang Yang is the CEO);

 

·the continued indemnification of current directors and officers of UPTD and the continuation of directors’ and officers’ liability insurance after the Business Combination;

 

·the fact that the Founders and their affiliates can earn a positive return on their investment, even if the Public Stockholders have a negative return on their investment in New Estrella; and

 

·in addition to these interests of the UPTD Initial Stockholders, to the fullest extent permitted by applicable laws, the Current Charter waives certain applications of the doctrine of corporate opportunity in some circumstances where the application of any such doctrine would conflict with any fiduciary duties or contractual obligations they may have as of the date of the Current Charter or in the future, and UPTD will renounce any expectancy that any of the directors or officers of UPTD will offer any such corporate opportunity of which he or she may become aware to UPTD. UPTD does not believe that the pre-existing fiduciary duties or contractual obligations of its officers and directors materially impacted its search for an acquisition target. Further, UPTD does not believe that the waiver of the application of the corporate opportunity doctrine in the Current Charter had any impact on its search for a potential business combination target.

 

 11 

 

 

The Board was aware of and considered these interests, to the extent such interests existed at the time, as well as the Fairness Opinion, among other matters, in approving the Merger Agreement and in recommending that UPTD stockholders approve the Merger Agreement and the Business Combination. See “Proposal 1: The Business Combination Proposal — Interests of the Founders and UPTD’s Directors and Officers in the Business Combination” beginning on page 108 of this proxy statement/prospectus.

 

Recommendation to UPTD Stockholders

 

After careful consideration, the Board unanimously determined that each of the Business Combination Proposal, the Charter Amendment Proposal, the Advisory Charter Amendment Proposal, the Nasdaq Stock Issuance Proposal, the Director Election Proposal, the Incentive Plan Proposal, and the Adjournment Proposal, if presented, is fair to and in the best interests of UPTD and its stockholders. The Board has approved and declared advisable and unanimously recommends that you vote or give instructions to vote “FOR” each of these Proposals.

 

For a description of various factors considered by the Board in reaching its decision to recommend in favor of voting for each of the Proposals to be presented at the Special Meeting, see the sections herein regarding each of the Proposals. In particular, in respect of the Board’s unanimous determination that the Business Combination Proposal is fair to and in the best interests of UPTD and its stockholders, and its recommendation that UPTD stockholders vote or give instructions to vote “FOR” such Proposal, you should carefully review the substantive factors considered by UPTD’s management team and the Board in coming to such determination and in making such recommendation, as set forth in the section of this proxy statement/prospectus entitled “Proposal 1: The Business Combination Proposal – The Board’s Reasons for the Approval of the Business Combination.”

 

Summary of Risk Factors

 

The following is a summary of the principal risks to which (i) Estrella’s business, operations and financial performance and (ii) the Business Combination are subject. Each of these risks is more fully described in the individual risk factors set forth under “Risk Factors” in this proxy statement/prospectus. Unless the context otherwise requires, all references in this subsection to “Estrella,” “we,” “us” or “our” refer to the business of Estrella prior to the consummation of the Business Combination, which will be the business of the Combined Company following the consummation of the Business Combination.

 

Risks Related to the Business, Operations and Financial Performance of Estrella

 

·We are a preclinical stage biotechnology company and expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

 

·We will need substantial additional funds to advance development of product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates and technologies.

 

·Our anticipated expenditures raise substantial doubt about our ability to continue as a going concern.

 

·Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

 

 12 

 

 

·Our current or potential future product candidates may not demonstrate the safety, purity, or efficacy necessary to become approvable or commercially viable.

 

·Although we intend to explore other therapeutic opportunities in addition to the product candidates we are currently pursuing, we may fail to identify viable new product candidates for clinical development, which could materially harm our business.

 

·Clinical development includes a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

 

·We rely on third parties to conduct our preclinical studies, and plan to rely on third parties to conduct clinical trials, and those third parties may not perform satisfactorily. If third parties on which we intend to rely to conduct certain preclinical and clinical studies do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected, or at all.

 

·We may not be able to maintain our existing strategic partnerships and collaboration arrangements or enter into new strategic partnerships and collaborations for the development, manufacturing, and commercialization of product candidates on terms that are acceptable to us, or at all.

 

·The manufacturing of our product candidates is complex. If Eureka, or other third parties, encounter difficulties in production, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale, could be delayed or halted entirely.

 

·We face competition from companies that have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platform technologies. If these companies develop platform technologies or product candidates more rapidly than we do, or if their platform technologies or product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidates may be adversely affected.

 

·Our future success depends on our ability and Eureka’s ability to retain key employees, directors, and advisors and to attract, retain, and motivate qualified personnel.

 

·Our business, operations, and clinical development plans and timelines could be adversely affected by the ongoing COVID-19 pandemic, including business interruptions, staffing shortages and supply chain issues arising from the pandemic on the manufacturing, clinical trial, and other business activities performed by us or by third parties with whom we may conduct business, including our anticipated contract manufacturers, contract research organizations (“CROs”), suppliers, shippers, and others.

 

·The anticipated benefits of the Separation may not be achieved.

 

·If we are unable to obtain or protect intellectual property rights related to our in-licensed technology, future technologies, and current or future product candidates, or if our intellectual property rights are inadequate, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any product candidates we may develop.

 

·We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize our current or potential future product candidates.

 

·Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.

 

 13 

 

  

·We or the third parties we depend on may be adversely affected by natural disasters, including earthquake, flood, fire, explosion, extreme weather conditions, or epidemics.

 

  · If any negative data were to arise with respect to the use of our licensed technology in territories where such technology is licensed to a third party, it could negatively affect our ability to develop our product candidates in territories where we license such technology.  

 

Risks Related to the Business Combination and Redemptions

 

·UPTD will have limited rights after the Closing to make claims for damages against Estrella or Estrella’s stockholders for the breach of representations, warranties, or covenants made by Estrella in the Merger Agreement.

 

·Subsequent to the Closing, New Estrella may be required to take write-downs or write-offs, restructuring and impairment, or other charges that could have a significant negative effect on its financial condition, results of operations, and the price of shares of New Estrella Common Stock, which could cause you to lose some or all of your investment.

 

·The UPTD Initial Stockholders own UPTD Common Stock that will be worthless and may incur reimbursable expenses that may not be reimbursed or repaid if the Business Combination is not approved. Such interests may have influenced their decision to approve and, in the case of the Board, recommend, the Business Combination with Estrella.

 

·The exercise of UPTD’s directors’ and officers’ discretion in agreeing to changes or waivers in the terms of the Merger Agreement may result in a conflict of interest when determining whether such changes to the terms of the Merger Agreement or waivers of conditions are appropriate and in the best interests of UPTD’s stockholders.

 

·If UPTD is unable to complete the Business Combination with Estrella or another business combination by January 19, 2023 (or such later date as may be approved by UPTD’s stockholders), its Public Stockholders may receive only approximately $10.20 per Public Share, or less than such amount in certain circumstances based on the balance of the Trust Account (as of the Record Date), and the UPTD Warrants will expire worthless.

 

·There is no guarantee that a stockholder’s decision to continue to hold shares of UPTD Common Stock following the Business Combination will put the stockholder in a better future economic position than if they decided to redeem their Public Shares for a pro rata portion of the Trust Account, and vice versa.

 

·The consummation of the Business Combination is conditioned on, among other things, there being at least a $20.0 million Available Combined Cash Amount at the Closing. There is no guarantee that there will be a $20.0 million Available Combined Cash Amount. As this condition is for Estrella’s benefit, it is possible that Estrella could waive it prior to Closing, subject to compliance with applicable Nasdaq listing requirements, although there is no guarantee that Estrella would waive this condition. If Estrella did waive the condition in these circumstances, it is possible that New Estrella would have insufficient capital to conduct and grow its business after the Closing in the manner described in this proxy statement/prospectus or that New Estrella would not be able to meet applicable Nasdaq listing requirements.

 

·UPTD may redeem the unexpired UPTD Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your UPTD Warrants worthless.

 

·The listing of New Estrella’s securities on Nasdaq will not benefit from the process undertaken in connection with an underwritten initial public offering.

 

·Redemptions of Public Shares by Public Stockholders may affect the market price of New Estrella Common Stock.

 

  · A new 1% U.S. federal excise tax could be imposed on UPTD in connection with redemptions.

 

 14 

 

 

Comparison of Governance and Stockholders’ Rights

 

Following the Closing, the rights of UPTD stockholders who remain New Estrella stockholders will no longer be governed by the Current Charter and the Current Bylaws and will instead be governed by the Proposed Charter and the Proposed Bylaws (as amended from time to time) adopted in connection with the Charter Amendment Proposal. See “Comparison of Governance and Stockholders’ Rights” for further information.

 

 15 

 

  

SELECTED HISTORICAL FINANCIAL INFORMATION

 

UPTD is providing the following selected historical financial information to assist you in your analysis of the financial aspects of the Business Combination.

 

UPTD’s selected historical financial information is derived from UPTD’s unaudited financial statements as of June 30, 2022 and for the six months then ended, and the audited financial statements as of December 31, 2021 and for the period from January 6, 2021 (inception) to December 31, 2021, each of which is included elsewhere in this proxy statement/prospectus.

 

Estrella’s balance sheet data as of June 30, 2022 and June 30, 2021 (Estrella’s Predecessor), and statements of operations data for the period from March 30, 2022 (inception) through June 30, 2022, for the period from July 1, 2021 to March 29, 2022 (Estrella’s Predecessor) and for the year ended June 30, 2021 (Estrella’s Predecessor) are derived from Estrella’s audited financial statements, included elsewhere in this proxy statement/prospectus.

 

The financial data set forth below should be read in conjunction with, and is qualified by reference to, the text of the sections entitled “Information about UPTD – UPTD Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business – Estrella Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements and notes thereto included elsewhere in this proxy statement/prospectus. UPTD’s and Estrella’s financial statements are prepared and presented in accordance with U.S. GAAP. The historical results included below and elsewhere in this proxy statement/prospectus are not indicative of future performance of UPTD or Estrella.

 

Selected Historical Financial Information: UPTD

 

   For the Six
Months Ended
June 30, 2022
   For the Period
from January 6,
2021 (inception)
through June 30,
2021
   For the Period
from January 6,
2021 (inception)
through
December 31, 2021
 
Statements of Operations Data:  (Unaudited)   (Unaudited)     
Formation and operating costs  $(520,505)  $(4,378)  $(178,992)
Franchise tax expenses   (48,200)   -    

(70,154

)
Other income   67,867    4    1,428 
Net loss  $(500,838)  $(4,374)  $(247,718)
Basic and diluted weighted average shares outstanding, common stock subject to possible redemption   4,430,000    -    2,033,677 
Basic and diluted net income (loss) per share, common stock subject to possible redemption  $(0.09)  $-   $0.76 
Basic and diluted weighted average shares outstanding, common stock attributable to UPTD   1,419,700    1,000,000    1,179,328 
Basic and diluted net loss per share, common stock attributable to UPTD  $(0.09)  $(0.00)  $(1.52)
                
Cash Flows Data:               
Net cash used in operating activities  $(390,587)  $(6,874)  $(316,158)
Net cash used in investing activities  $-   $(3,190,004)  $(45,186,000)
Net cash provided by financing activities  $-   $3,207,896   $45,981,026 

 

 16 

 

 

   As of
June 30, 2022
   As of
December 31,
2021
 
   (Unaudited)     
Balance Sheets Data:          
Cash  $88,281   $478,868 
Other current assets   40,541    137,166 
Investments held in Trust Account   45,255,295    45,187,428 
Total assets  $45,384,117   $45,803,462 
Total liabilities  $1,705,147   $1,623,654 
Common stock subject to possible redemption  $45,186,000   $45,186,000 
Total stockholders’ deficit  $(1,507,030)  $(1,006,192)

 

Selected Historical Financial Information: Estrella 

 

    For the Period
from March 30, 2022
(inception)
through
June 30, 2022
    For the Period
from July 1,
2021 to
March 29,
2022
    For the Year
Ended June
30, 2021
 
Statements of Operations Data:         (Predecessor)     (Predecessor)  
Operating expenses                        
Research and development   $ (1,041,892 )   $ (347,207 )   $ (457,231 )
General and administrative     (32,259 )     (263,989 )     (276,462 )
Net loss   $ (1,074,151 )   $ (611,196 )   $ (733,693 )
                         
Cash Flows Data:                        
Net cash used in operating activities   $ (926,667 )   $ (515,361     $ (670,820
Net cash used in investing activities     -       -       -  
Net cash provided by financing activities     5,015,000       515,361       670,820  
Net changes in cash   $ 4,088,333     $ -     $ -  

 

   As of   As of 
   June 30, 2022   June 30, 2021 
Balance Sheets Data:      (Predecessor) 
Cash  $4,088,333   $- 
Other current assets   833,333    - 
Total assets  $4,921,666   $- 
Current liabilities  $946,684   $- 
Other liabilities   14,825    - 
Total liabilities  $961,509   $- 
Mezzanine equity  $5,000,000   $- 
Total stockholders’ deficit  $(1,039,843)  $- 

 

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FORWARD-LOOKING STATEMENTS

 

This proxy statement/prospectus contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations, including as they relate to the potential Business Combination. These statements constitute projections, forecasts, and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this proxy statement/prospectus, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When UPTD discusses its strategies or plans, including as they relate to the potential Business Combination, it is making projections, forecasts, or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, UPTD’s management.

 

Forward-looking statements in this proxy statement/prospectus may include, for example, statements about:

 

·UPTD’s ability to complete the Business Combination or, if UPTD does not consummate such Business Combination, any other initial business combination;

 

·satisfaction or waiver (if applicable) of the conditions to the Merger Agreement;

 

·the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement;

 

·the projected financial information, anticipated growth rate, and market opportunities of the Combined Company;

 

·the ability to obtain or maintain the listing of New Estrella Common Stock on Nasdaq following the Business Combination;

 

·New Estrella’s public securities’ potential liquidity and trading;

 

·New Estrella’s ability to raise financing in the future;

 

·New Estrella’s success in retaining or recruiting, or changes required in, officers, key employees, or directors following the completion of the Business Combination;

 

·UPTD’s officers and directors allocating their time to other businesses and potentially having conflicts of interest with UPTD’s business or in approving the Business Combination;

 

·the use of proceeds not held in the Trust Account or available to UPTD from interest income on the Trust Account balance;

 

·potential effects of extensive government regulation;

 

·New Estrella’s future financial performance and capital requirements;

 

·the impact of supply chain disruptions;

 

·high inflation rates and interest rate increases;

 

·the impact of the 2022 Russian invasion of Ukraine;

 

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·the impact of the COVID-19 pandemic, including on preclinical studies and potential future clinical trials; and

 

·factors relating to the business, operations, and financial performance of New Estrella, including:

 

(a)New Estrella’s ability to operate as a standalone company;

 

(b)the initiation, cost, timing, progress, and results of research and development activities, preclinical studies, or clinical trials with respect to New Estrella’s current and potential future product candidates;

 

  (c) New Estrella’s ability to advance research on EB103 and its use in conjunction with CF33-CD19t;

 

(d)New Estrella’s ability to identify, develop, and commercialize product candidates;

 

(e)New Estrella’s ability to advance its current and potential future product candidates into, and successfully complete, preclinical studies and clinical trials;

 

(f)New Estrella’s or Eureka’s ability to obtain and maintain regulatory approval of New Estrella’s current and potential future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

 

(g)New Estrella’s ability to obtain funding for its operations;

 

(h)New Estrella’s and Eureka’s ability to obtain, maintain and enforce intellectual property protection for their technologies and product candidates;

 

(i)New Estrella’s ability to successfully commercialize its current and any potential future product candidates;

 

(j)the rate and degree of market acceptance of New Estrella’s current and any potential future product candidates;

 

(k)regulatory developments in the United States and international jurisdictions;

 

(l)New Estrella’s and Eureka’s ability to attract and retain key scientific and management personnel;

 

(m)New Estrella’s ability to effectively manage the growth of its operations;

 

(n)New Estrella’s ability to maintain its current licenses and contractual arrangements with Eureka;

 

(o)potential liability lawsuits and penalties related to New Estrella’s licensed or acquired technologies, product candidates, and current and future relationships with third parties;

 

(p)New Estrella’s ability to continue to contract with third-party suppliers and manufacturers and their ability to perform adequately under those arrangements; and

 

(q)New Estrella’s ability to compete effectively with existing competitors and new market entrants.

 

UPTD cautions you that the foregoing list may not contain all of the forward-looking statements made in this proxy statement/prospectus.

 

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These forward-looking statements are only predictions based on the current expectations and projections of UPTD and Estrella about future events and are subject to a number of risks, uncertainties, and assumptions, including those described in the section titled “Risk Factors” and elsewhere in this proxy statement/prospectus. Moreover, Estrella operates in a competitive industry, and new risks emerge from time to time. It is not possible for the management of UPTD or Estrella to predict all risks, nor can UPTD or Estrella assess the impact of all factors on their respective businesses or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements UPTD may make in this proxy statement/prospectus. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this proxy statement/prospectus may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this proxy statement/prospectus.

  

The forward-looking statements included in this proxy statement/prospectus are made only as of the date hereof. You should not rely upon forward-looking statements as predictions of future events. Although UPTD believes that the expectations reflected in its forward-looking statements are reasonable, neither UPTD nor Estrella can guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Neither UPTD nor Estrella undertakes any obligation to update publicly any forward-looking statements for any reason after the date of this proxy statement/prospectus to conform these statements to actual results or to changes in expectations, except as required by law.

 

You should read this proxy statement/prospectus and the documents that have been filed as annexes and exhibits hereto with the understanding that the actual future results, levels of activity, performance, or events and circumstances of UPTD and Estrella may be materially different from what is expected.

 

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RISK FACTORS

 

Stockholders should consider and read carefully all of the risks and uncertainties described below, as well as other information included in this proxy statement/prospectus, before they decide whether to vote or instruct their vote to be cast to approve the Proposals described in this proxy statement/prospectus. The value of your investment in New Estrella following consummation of the Business Combination will be subject to the significant risks affecting New Estrella and inherent to the industry in which it will operate. If any of the events described below occur, the post-acquisition business and financial results could be adversely affected in a material way. This could cause the trading price of New Estrella’s common stock to decline, perhaps significantly, and you therefore may lose all or part of your investment. Unless the context otherwise requires, all references in this subsection to the “Company,” “we,” “us” or “our” refer to the business of Estrella prior to the consummation of the Business Combination, which will be the business of New Estrella following the consummation of the Business Combination.

 

Risks Related to Estrella’s Limited Operating History and Financial Condition

 

We  are a preclinical stage biotechnology company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

 

We are a preclinical-stage biotechnology company with a history of losses. Since our inception, we have devoted substantially all of our resources to preparing for the Business Combination, drafting regulatory filings (including the INDs), planning preclinical studies, and building our management team, and we have incurred significant operating losses. Our net losses were approximately $1.7 million and $0.7 million for the years ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we had an accumulated deficit of approximately $1.1 million. Substantially all of our losses have resulted from expenses incurred in connection with preparing for the Business Combination, regulatory filings, and from general and administrative costs associated with our operations. To date, we have not generated any revenue from product sales, and we have not sought or obtained regulatory approval for any product candidate. Furthermore, we do not expect to generate any revenue from product sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies, clinical trials, and the regulatory approval process for our current and potential future product candidates.

 

We expect our net losses to increase substantially as we:

 

·continue preclinical development of EB103 and EB104;

 

·continue researching the use of EB103 in conjunction with CF33-CD19t;

 

·continue preclinical development of EB103 and EB104;

 

·commence clinical trials of our current and future product candidates;

 

·acquire and license technologies, if any are discovered, that are aligned with our product candidates;

 

·seek regulatory approval of our current and future product candidates;

 

·expand our operational, financial, and management systems and increase personnel, including personnel to support our preclinical and clinical development and commercialization efforts;

 

·continue to develop, perfect, and defend our intellectual property portfolio; and

 

·incur additional legal, accounting, or other expenses in operating our business, including the additional costs associated with operating as a public company.

 

However, the amount of our future losses is uncertain. Our ability to achieve or sustain profitability, if ever, will depend on, among other things, successfully developing product candidates, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, entering into potential future alliances, establishing a sales and marketing organization or suitable third-party alternatives for any approved product, and raising sufficient funds to finance business activities. If we, or our potential future collaborators, are unable to commercialize one or more of our product candidates, or if sales revenue from any product candidate that receives approval is insufficient, we will not achieve or sustain profitability, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

 

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Even if we consummate the Business Combination, we will need substantial additional funds to advance development of our product candidates, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates and technologies.

 

The development of biotechnology product candidates is capital-intensive. If any of our current or potential future product candidates enter and advance through preclinical studies and clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing, and sales capabilities. We will require significant funds to continue to develop our product candidates and conduct further research and development, including preclinical studies and clinical trials. In addition, upon the closing of the Business Combination, we expect to incur significant additional costs associated with operating as a public company.

 

As of June 30, 2022, we had approximately $4.1 million in cash and cash equivalents. Our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect. Because the length of time and activities associated with successful research and development of platform technologies and product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. The timing and amount of our operating expenditures will depend largely on:

 

·the timing and progress of preclinical and clinical development of our current and potential future product candidates;

 

  · the timing and progress of our research of the use of EB103 in conjunction with CF33-CD19t;

 

·the number and scope of preclinical and clinical programs we decide to pursue;

 

·the terms of any third-party manufacturing contract or biomanufacturing partnership we may enter into;  

 

·our ability to maintain our current licenses and collaborations, conduct our research and development programs and establish new strategic partnerships and collaborations;

 

·the progress of the development efforts of our existing strategic partners and third parties with whom we may in the future enter into collaboration and research and development agreements;

 

·the costs involved in obtaining, maintaining, enforcing, and defending patents and other intellectual property rights;

 

·the impact of the COVID-19 pandemic on our business;

 

·the cost and timing of regulatory approvals; and

 

·our efforts to enhance operational systems and hire additional personnel, including personnel to support development of our product candidates and satisfy our obligations as a public company.

 

To date, we have primarily financed our operations through the sale of equity securities. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, grants, and other marketing and distribution arrangements. We cannot assure you that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. Because of the numerous risks and uncertainties associated with the development and commercialization of our current and potential future product candidates and the extent to which we may enter into collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated preclinical studies and clinical trials, including related manufacturing costs. To the extent that we raise additional capital through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our current and potential future product candidates, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.

 

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We do not expect to realize revenue from product sales or royalties from licensed products for the foreseeable future, if at all, and unless and until our current and potential future product candidates are clinically tested, approved for commercialization, and successfully marketed.

 

Members of our management team have limited experience in managing the day-to-day operations of a public company and, as a result, we may incur additional expenses associated with the management of our company.

 

Members of our management team have limited experience in managing the day-to-day operations of a public company. As a result, we may need to obtain outside assistance from legal, accounting, investor relations, or other professionals that could be more costly than planned. We may also hire additional personnel to comply with additional SEC reporting requirements. These compliance costs will make some activities significantly more time-consuming and costly. If we lack cash resources to cover these costs in the future, our failure to comply with reporting requirements and other provisions of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cash flow and financial condition.

 

Our history of recurring losses and anticipated expenditures raises substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

 

We have incurred significant operating losses to date, and it is possible we may never generate a profit. Our consolidated financial statements included elsewhere in this proxy statement/prospectus have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. These consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of these uncertainties related to our ability to operate on a going concern basis.

 

We have concluded that our recurring losses from operations and need for additional financing to fund future operations raise substantial doubt about our ability to continue as a going concern. Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements as of and for the period from March 30, 2022 (inception) through June 30, 2022 with respect to this uncertainty. We believe that the $15,000,000 of gross proceeds raised in the Merger Financing from the sale of the 1,500,000 shares of UPTD Common Stock, coupled with successful completion of the Business Combination, will eliminate this doubt and enable us to continue as a going concern; however, we may need to obtain alternative financing or significantly modify our operational plans for us to continue as a going concern. Based upon our current operating plan and assumptions, we believe that our existing cash and cash equivalents, including the results of the Business Combination, will be sufficient to fund our operations for at least the next 12 months. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in and progress of our development activities and changes in regulation. Our future capital requirements will depend on many factors, including:

 

·the scope, rate of progress, results, and costs of preclinical studies, laboratory testing, and clinical trials for our product candidates;

 

·the number and development requirements of product candidates that we may pursue, and other indications for our current product candidates that we may pursue;

 

·the costs, timing, and outcome of regulatory review of our product candidates;

 

·the scope and costs of manufacturing arrangements;

 

·the cost associated with commercializing any approved product candidates;

 

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·the cost and timing of developing our ability to establish sales and marketing capabilities, if any;

 

·the costs of preparing, filing and prosecuting patent applications, maintaining, enforcing, and protecting our intellectual property rights, defending intellectual property-related claims, and obtaining licenses to third-party intellectual property;

 

·the timing and amount of any milestone and royalty payments we are required to make under our present or future license agreements;

 

·our ability to establish and maintain strategic partnerships and collaborations, including any biomanufacturing partnerships or collaborations involving the use of our products, on favorable terms, if at all; and

 

·the extent to which we acquire or in-license other product candidates and technologies and associated intellectual property.

 

We will require additional capital to complete our planned clinical development programs for our current product candidates to obtain regulatory approvals. Any additional capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current and future product candidates, if approved.

 

In addition, we cannot guarantee that future financing will be available on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities by us, whether equity or debt, or the market perception that such issuances are likely to occur, could cause the market price of New Estrella Common Stock to decline. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be harmed, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our consolidated financial statements.

 

Risks Related to the Development and Clinical Testing of Our Product Candidates

 

Our current product candidates are in preclinical development. One or all of our current product candidates may fail in clinical development or suffer delays that materially and adversely affect their commercial viability.

 

We have no products on the market or that have gained regulatory approval or that have entered clinical trials. Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and successfully commercializing product candidates, either with Eureka pursuant to the Services Agreement or with other collaborators.

 

Before obtaining regulatory approval for the commercial distribution of our product candidates, we or a collaborator must conduct extensive preclinical studies, followed by clinical trials to demonstrate the safety, purity and potency, or efficacy of our product candidates in humans. There is no guarantee that the U.S. Food and Drug Administration (the “FDA”) will permit us to conduct clinical trials. Further, we cannot be certain of the timely completion or outcome of our preclinical studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs, our clinical protocols or if the outcome of our preclinical studies will ultimately support the further development of our preclinical programs or testing in humans. As a result, we cannot be sure that we will be able to submit investigational new drug applications (“INDs”) or similar applications for our proposed clinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials for any of our product candidates to begin.

 

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Our current product candidates are in preclinical development and we are subject to the risks of failure inherent in the development of product candidates based on novel approaches, targets, and mechanisms of action. Although we anticipate initiating clinical trials for our lead product candidates, there is no guarantee that we will be able to proceed with clinical development of any of these product candidates or that any product candidate will demonstrate a clinical benefit once we advance these candidates to testing in patients. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by preclinical stage biotechnology companies such as ours.

 

We may not be able to access the financial resources to continue development of, or to enter into any collaborations for, any of our current or potential future product candidates. This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, a product candidate, such as:

 

·negative or inconclusive results from our preclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon any or all of our programs;

 

·product-related side effects experienced by participants in our clinical trials or by individuals using therapeutics similar to our product candidates;

 

·delays in submitting INDs or comparable foreign applications, or delays or failures to obtain the necessary approvals from regulatory authorities to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

 

·conditions imposed by the FDA or other regulatory authorities regarding the scope or design of our clinical trials;

 

·delays in enrolling research subjects in clinical trials;

 

·high drop-out rates of research subjects;

 

·inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our clinical trials;

 

·chemistry, manufacturing, and control (“CMC”) challenges associated with the manufacturing and scaling up product candidates to ensure consistent quality, stability, purity, and potency among different batches used in clinical trials;

 

·greater-than-anticipated clinical trial costs;

 

·poor effectiveness of our product candidates during clinical trials;

 

·unfavorable FDA or other regulatory authority inspection and review of a clinical trial or manufacturing site;

 

·delays as a result of the COVID-19 pandemic or events associated with the pandemic;

 

·failure of Eureka or our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;

 

·delays and changes in regulatory requirements, policies and guidelines; or

 

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·the FDA or other regulatory authorities interpreting our data differently than we do.

 

Further, we, Eureka, and any existing or potential future collaborator may never receive approval to market and commercialize any product candidate. Even if we, Eureka, or any existing or potential future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. We, Eureka, or an existing or potential future collaborator may also be subject to post-marketing testing requirements to maintain regulatory approval.

 

We may not be successful in our efforts to use and expand our use of the ARTEMIS® platform to expand our pipeline of product candidates.

 

A key element of our strategy is to use and advance our use of the ARTEMIS® platform to design, test, and build our portfolio of product candidates focused on the treatment of cancer. Although our and Eureka’s research and development efforts to date have resulted in our discovery and preclinical development of EB103 and other potential product candidates, none of these product candidates has advanced to clinical development in the United States. We cannot assure you that any of our existing product candidates will advance to clinical trials or, if they do, that such trials will demonstrate these product candidates to be safe or effective therapeutics, and we may not be able to successfully develop any product candidates. Even if we are successful in expanding our pipeline of product candidates, any additional product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance. If we do not successfully develop and commercialize product candidates, we will not be able to generate product revenue in the future.

 

Although we intend to explore other therapeutic opportunities in addition to the product candidates that we are currently developing, we may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional potential product candidates, our business could be materially harmed.

 

Although a substantial amount of our efforts will focus on the planned clinical trials and potential approval of the current and potential future product candidates we are evaluating, we also intend to discover, develop, and globally commercialize additional targeted therapies beyond our current product candidates to treat various forms of cancer and in a variety of therapeutic areas. Even if we identify investigational therapies that initially show promise, we may fail to successfully develop and commercialize such products for many reasons, including the following:

 

·the research methodology used may not be successful in identifying potential investigational therapies;

 

·competitors may develop alternatives that render our investigational therapies obsolete;

 

·investigational therapies we develop may nevertheless be covered by third parties’ patents or other exclusive rights;

 

·an investigational therapy 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;

 

·it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio;

 

·an investigational therapy may not be capable of being produced in clinical or commercial quantities at an acceptable cost, or at all; and

 

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

 

Identifying new investigational therapies requires substantial technical, financial, and human resources, whether or not any investigational therapies are ultimately identified. Because we have limited financial and human resources, we may initially focus on research programs and product candidates for a limited set of indications. As a result, we may forgo 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. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. For example, if we do not accurately evaluate the commercial potential or target market for a particular product candidate or technology, we may relinquish valuable rights to that product candidate or technology through collaborations, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or technology.

 

Accordingly, there can be no assurance that we will ever be able to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, which could materially adversely affect our future growth and prospects. We may focus our efforts and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful.

 

The occurrence of serious complications or side effects in connection with use of our product candidates, either in clinical trials or post-approval, could lead to discontinuation of our clinical development programs, refusal of regulatory authorities to approve our product candidates or, post-approval, revocation of marketing authorizations or refusal to approve applications for new indications, which could severely harm our business, prospects, operating results and financial condition.

 

Undesirable side effects caused by any of our current or potential future product candidates could cause regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. While we have not yet initiated clinical trials for our product candidates, it is likely that there will be side effects associated with their use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these side effects. It is possible that safety events or concerns such as these or others could negatively affect the development of our product candidates, including adversely affecting patient enrollment among the patient populations that we intend to treat. In such an event, our trials could be suspended or terminated, and the FDA or other regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. Such side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. There can be no guarantee that our current or future product candidates will not cause such effects in clinical trials. Any of these occurrences may materially and adversely affect our business and financial condition and impair our ability to generate revenues.

 

Further, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may only be uncovered when a significantly larger number of patients are exposed to the product candidate or when patients are exposed for a longer period of time.

 

In the event that any of our current or potential future product candidates receives regulatory approval and we or others identify undesirable side effects caused by one of these products, any of the following events could occur, which could result in the loss of significant revenue to us and materially and adversely affect our results of operations and business:

 

·regulatory authorities may withdraw their approval of the product or seize the product;

 

·we may be required to recall the product or change the way the product is administered to patients;

 

·additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

 

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·we may be subject to fines, injunctions, or the imposition of civil or criminal penalties;

 

·regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;

 

·we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;

 

·we could be sued and held liable for harm caused to patients;

 

·the product may become less competitive; and

 

·our reputation may suffer.

 

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.

 

While we believe our pipeline will yield multiple INDs, we may not be able to file INDs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.

 

We expect our pipeline to yield multiple INDs beginning with EB103 in the first half of 2023. We cannot be sure that submission of an IND will result in the FDA allowing testing and clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such clinical trials. The manufacturing of our product candidates, including EB103 and EB104, as well as manufacturing processes surrounding the research of the use of EB103 in conjunction with CF33-CD19t, remain an emerging and evolving field. Accordingly, we expect CMC-related topics, including product specifications, will be a focus of IND reviews, which may delay the clearance of INDs.

 

Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or clinical trial application, we cannot guarantee that such regulatory authorities will not change their requirements in the future.

 

In addition to the submission of an IND to the FDA before initiation of a clinical trial in the United States, certain human clinical trials involving recombinant or synthetic nucleic acid molecules are subject to oversight of institutional biosafety committees (“IBCs”), as set forth in the National Institutes of Health (“NIH”) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). Under the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: (i) molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (i.e., recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or (iii) molecules that result from the replication of those described in (i) or (ii). Specifically, under the NIH Guidelines, supervision of human gene transfer trials includes evaluation and assessment by an IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.

 

Interim, topline and preliminary data that we announce or publish from time to time for any clinical trials that we initiate may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data.

 

From time to time, we may publicly disclose interim, preliminary, or topline data from our preclinical studies and 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 related to the particular trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary, or topline results that we report 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. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim, preliminary, or topline data from our clinical studies. Interim, topline, or preliminary data from clinical trials that we 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. Adverse differences between preliminary, topline, or interim data and final data could significantly harm our business prospects.

 

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Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the value of our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects, or financial condition.

 

We and our collaborators may not achieve projected discovery and development milestones and other anticipated key events in the time frames that we or they announce, which could have an adverse impact on our business and could cause our stock price to decline.

 

From time to time, we expect that we will make public statements regarding the expected timing of certain milestones and key events, such as the commencement and completion of preclinical and IND-enabling studies in our product candidate discovery programs with collaborators as well as the commencement and completion of planned clinical trials in those programs. The actual timing of these events can vary dramatically due to a number of factors such as delays or failures in our or any current or future collaborators’ product candidate discovery and development programs, the amount of time, effort and resources committed by us and any current or future collaborators, and the numerous uncertainties inherent in the development of therapies. As a result, there can be no assurance that our or any current or future collaborators’ programs will advance or be completed in the time frames we or they announce or expect. If we or any collaborators fail to achieve one or more of these milestones or other key events as planned, our business could be materially adversely affected, and the price of our common stock could decline.

 

Clinical trials are expensive, time-consuming, and difficult to design and implement.

 

Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our current and potential future product candidates are based on new technologies and discovery approaches, we expect that they will require extensive research and development and have substantial manufacturing and processing costs. In addition, the FDA or other regulatory authorities may require us to perform additional testing before commencing clinical trials and be hesitant to allow us to enroll patients impacted with our targeted disease indications in our future clinical trials. If we are unable to enroll patients impacted by our targeted disease indications in our future clinical trials, we would be delayed in obtaining potential proof-of-concept data in humans, which could extend our development timelines. In addition, costs to treat patients and to treat potential side effects that may result from our product candidates may be significant. Accordingly, our clinical trial costs are likely to be high and could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

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If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

 

We may not be able to initiate or continue any clinical trials for our current or potential future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. We cannot predict how difficult it will be to enroll patients for trials in the indications we are studying. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:

 

·the severity of the disease under investigation;

 

·the patient eligibility criteria defined in the clinical trial protocol;

 

·the size of the patient population required for analysis of the trial’s primary endpoints;

 

·the proximity and availability of clinical trial sites for prospective patients;

 

·willingness of physicians to refer their patients to our clinical trials;

 

·our ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

·clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

 

·our ability to obtain and maintain patient consents;

 

·the risk that patients enrolled in clinical trials will drop out of the trials before completion; and

 

·factors we may not be able to control, such as current or potential pandemics, including the ongoing COVID-19 pandemic, that may limit the availability of patients, principal investigators or staff or clinical sites to participate in our clinical trials.

 

In addition, our future clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Additionally, because some of our clinical trials will be in patients with advanced disease who may experience disease progression or adverse events independent from our product candidates, such patients may be unevaluable for purposes of the trial and, as a result, we may require additional enrollment. Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.

 

If clinical trials for our product candidates are prolonged, delayed, or stopped, we may be unable to seek or obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.

 

We may experience delays in our ongoing or future preclinical studies or clinical trials, and we do not know whether future preclinical studies or clinical trials will begin on time, need to be redesigned, enroll an adequate number of patients on time, or be completed on schedule, if at all. The commencement or completion of these clinical trials could be substantially delayed or prevented by many factors, including:

 

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·further discussions with the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, including the endpoint measures required for regulatory approval and our statistical plan;

 

·the limited number of, and competition for, suitable study sites and investigators to conduct our clinical trials, many of which may already be engaged in other clinical trial programs with similar patients, including some that may be for the same indications as our product candidates;

 

·any delay or failure to obtain timely approval or agreement to commence a clinical trial in any of the countries where enrollment is planned;

 

·inability to obtain sufficient funds required for a clinical trial;

 

·clinical holds on, or other regulatory objections to, a new or ongoing clinical trial;

 

·delay or failure to manufacture sufficient quantities or inability to produce quantities of consistent quality, purity and potency of the product candidate for our clinical trials;

 

·delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs;

 

·delay or failure to obtain institutional review board (“IRB”) or ethics committee approval to conduct a clinical trial at a prospective site;

 

·the FDA or other comparable foreign regulatory authorities may require us to submit additional data or impose other requirements before permitting us to initiate a clinical trial;

 

·slower than expected rates of patient recruitment and enrollment;

 

·failure of patients to complete the clinical trial;

 

·the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects;

 

·unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths;

 

·lack of efficacy or failure to measure a statistically significant clinical benefit within the dose range with an acceptable safety margin during clinical trials;

 

·termination of our clinical trials by one or more clinical trial sites;

 

·inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols;

 

·inability to monitor patients adequately during or after treatment by us or our CROs;

 

·our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study;

 

·inability to address any noncompliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;

 

·the impact of, and delays related to, health epidemics such as the COVID-19 pandemic;

 

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·the need to suspend, repeat or terminate clinical trials as a result of non-compliance with regulatory requirements, inconclusive or negative results or unforeseen complications in testing; and

 

·the suspension or termination of our clinical trials upon a breach or pursuant to the terms of any agreement with, or for any other reason by, any future strategic collaborator that has responsibility for the clinical development of any of our product candidates.

 

Changes in regulatory requirements, policies, and guidelines may also occur and we may need to significantly modify our clinical development plans to reflect these changes with appropriate regulatory authorities. These changes may require us to renegotiate terms with CROs or resubmit clinical trial protocols to IRBs for re-examination, which may impact the costs, timing, or successful completion of a clinical trial. Our clinical trials may be suspended or terminated at any time by us, the FDA, other regulatory authorities, the IRB overseeing the clinical trial at issue, any of our clinical trial sites with respect to that site, or us.

 

Any failure or significant delay in commencing or completing clinical trials for our product candidates, any failure to obtain positive results from clinical trials, any safety concerns related to our product candidates, or any requirement to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate would adversely affect our ability to obtain regulatory approval and our commercial prospects and ability to generate product revenue will be diminished.

 

If we decide to seek orphan drug designation for one or more of our product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation for our current or future product candidates that we may develop.

 

Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug or biologic product intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or where there is no reasonable expectation that the cost of developing the product will be recovered from sales in the United States. We may seek orphan drug designation for certain indications for our product candidates in the future. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. Orphan drug designation can entitle a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

 

In addition, if a product candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for the same indication for seven years. The FDA may reduce the seven-year exclusivity if the same drug from a competitor demonstrates clinical superiority to the product with orphan exclusivity or if the FDA finds that the holder of the orphan exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan product to meet the needs of patients with the disease or condition for which the drug was designated. Even if one of our product candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease.

 

In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition, and while we may seek orphan drug designation for our product candidates, we may never receive such designations. In addition, the FDA may reevaluate the Orphan Drug Act and its regulations and policies. We do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future, and it is uncertain how any changes might affect our business. Depending on what changes the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted.

 

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We may not be able to conduct, or contract with others to conduct, animal testing in the future, which could harm our research and development activities.

 

Certain laws and regulations relating to drug development require us to test our product candidates on animals before initiating clinical trials involving humans. Animal testing activities have been the subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through protests and other means. To the extent the activities of these groups are successful, our research and development activities may be interrupted or delayed.

 

Risks Related to Third Parties

 

We rely on third parties to conduct our preclinical studies, and plan to rely on third parties to conduct clinical trials, and those third parties may not perform satisfactorily.

 

We expect to rely on third-party clinical investigators, CROs, clinical data management organizations, and consultants to design, conduct, supervise, and monitor certain preclinical studies and any clinical trials. Because we intend to rely on these third parties and will not have the ability to conduct certain preclinical studies or clinical trials independently, we will have less control over the timing, quality, and other aspects of such preclinical studies and clinical trials than we would have had we conducted them on our own. These investigators, CROs, clinical data management organizations, and consultants will not be our employees and we will have limited control over the amount of time and resources that they dedicate to our programs. Some of these third parties may terminate their engagements with us at any time. We also expect to have to negotiate budgets and contracts with CROs, clinical trial sites and contract manufacturing organizations and we may not be able to do so on favorable terms, which may result in delays to our development timelines and increased costs. If we need to enter into alternative arrangements with, or replace or add any third parties, it would involve substantial cost and require extensive management time and focus, or involve a transition period, and may delay our drug development activities, as well as materially impact our ability to meet our desired clinical development timelines. These third parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources from our programs. The third parties with which we may contract might not be diligent, careful, or timely in conducting our preclinical studies or clinical trials, resulting in the preclinical studies or clinical trials being delayed or unsuccessful.

 

Our reliance on these third parties for such drug development activities will reduce our control over these activities. As a result, we will have less direct control over the conduct, timing, and completion of preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we will be responsible for ensuring that each of our studies and trials is conducted in accordance with applicable protocol, legal, and regulatory requirements and scientific standards, including good laboratory practice (“GLP”), good clinical practice (“GCP”), Current Good Manufacturing Practice (“cGMP”), and Current Good Tissue Practice (“cGTP”), and our reliance on third parties does not relieve us of our regulatory responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and other regulatory authorities require us to comply with GCP standards, regulations for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are reliable and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of our CROs, clinical sites and investigators fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, European Medicines Agency (“EMA”), or other regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. There can be no assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials substantially comply with GCP regulations. In addition, our clinical trials must be conducted with product candidates produced under cGMP regulations and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients, may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates FDA regulatory requirements as well as federal or state healthcare laws and regulations or healthcare privacy and security laws.

 

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If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, or if these third parties need to be replaced, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

 

We depend on strategic partnerships and collaboration arrangements, such as the Collaboration Agreement with Imugene and the Licensing Agreement with Eureka, for the development and commercialization of EB103, EB104, and future product candidates in certain indications, and if these arrangements are unsuccessful, this could impair our ability to generate revenues and materially harm our results of operations.

 

Our business strategy for the research of EB103’s use in conjunction with CF33-CD19t is dependent upon maintaining our current arrangements and potentially establishing new arrangements with strategic partners, research collaborators, and other third parties. The Collaboration Agreement with Imugene allows us to investigate the use of EB103 in conjunction with CF33-CD19t in the treatment of solid tumors and to discuss the development and commercialization of collaboration results. The Licensing Agreement with Eureka grants us an exclusive license to use ARTEMIS® technology in connection with CD19 and CD22 in the Licensed Territory. These agreements provide for, among other things, intellectual property rights and significant future payments should certain development, regulatory, and commercial milestones be achieved. 

 

As a result, we may not be able to conduct these collaborations in the manner or on the time schedule we currently contemplate, which may negatively impact our business operations.

 

Additionally, the development and commercialization of potential product candidates under our collaboration agreements could be substantially delayed, and our ability to receive future funding could be substantially impaired if one or more of our collaborators:

 

·shifts its priorities and resources away from our collaborations due to a change in business strategies, or a merger, acquisition, sale, or downsizing of its company or business unit;

 

·ceases development in therapeutic areas which are the subject of our collaboration;

 

·fails to select a product candidate for advancement into preclinical development, clinical development, or subsequent clinical development into a marketed product;

 

·changes the success criteria for a particular product candidate, thereby delaying or ceasing development of such product candidate;

 

·significantly delays the initiation or conduct of certain activities which could delay our receipt of milestone payments tied to such activities, thereby impacting our ability to fund our own activities;

 

·develops a product candidate that competes, either directly or indirectly, with our product candidates;

 

·does not obtain the requisite regulatory approval of a product candidate;

 

·does not successfully commercialize a product candidate;

 

·encounters regulatory, resource or quality issues and is unable to meet demand requirements;

 

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·exercises its rights under the agreement to terminate the collaboration, or otherwise withdraws support for, or otherwise impairs development under the collaboration;

 

·disagrees on the research, development or commercialization of a product candidate resulting in a delay in milestones, royalty payments, or termination of research and development activities for such product candidate; and

 

·uses our proprietary information or intellectual property in such a way as to jeopardize our rights in such property.

 

In addition, the termination of our existing collaborations or any future strategic partnership or collaboration arrangement that we enter into may prevent us from receiving any milestone, royalty payment, sharing of profits, and other benefits under such agreement. Furthermore, disagreements with these parties could require or result in litigation or arbitration, which would be time-consuming and expensive. Any of these events could have a material adverse effect on our ability to develop and commercialize any of our product candidates and may adversely impact our business, prospects, financial condition, and results of operations.

 

We may not realize the anticipated benefits of our collaboration agreement with Imugene.

 

Our collaboration with Imugene will explore the therapeutic potential of a combination of Imugene’s CF33-CD19t in conjunction with EB103 for the treatment of solid tumors. However, Imugene could develop therapies outside of our collaboration that do not utilize EB103. For example, Imugene could develop an oncolytic virus that forces tumors to express a protein other than CD19 for a “mark and kill” approach to treating solid tumors, which would require a combination with a T-cell therapy other than EB103.

 

We may not be able to enter into additional strategic transactions on acceptable terms, if at all, which could adversely affect our ability to develop and commercialize current and potential future product candidates and technologies, impact our cash position, increase our expenses and present significant distractions to our management.

 

From time to time, we consider strategic transactions, such as collaborations, geographic partnerships for the co-development and/or co-commercialization of our product candidates in selected territories, acquisitions of companies, asset purchases, joint ventures, out- or in-licensing of product candidates or technologies and biomanufacturing partnerships. For example, we will evaluate and, if strategically attractive, seek to enter into collaborations, including with biotechnology or biopharmaceutical companies, contract development manufacturing organizations, or hospitals. The competition for collaborators is intense, and the negotiation process is time-consuming and complex. If we are not able to enter into strategic transactions, we may not have access to required liquidity or expertise to further develop our current or potential future product candidates. Any such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose significant integration or implementation challenges or disrupt our management or business.

 

We also may acquire additional technologies and assets, form strategic alliances, or create joint ventures with third parties that we believe will complement or augment our existing business, but we may not be able to realize the benefit of acquiring such assets. Conversely, any new collaboration that we do enter into may be on terms that are not optimal for us, our product candidates, or our technologies. These transactions would entail numerous operational and financial risks, including:

 

·exposure to unknown liabilities;

 

·disruption of our business and diversion of our management’s time and attention in order to negotiate and manage a collaboration or develop acquired products, product candidates, or technologies;

 

·incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs;

 

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·higher-than-expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, or increased amortization expenses;

 

·difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business;

 

·impairment of relationships with key suppliers, manufacturers, or customers of any acquired business due to changes in management and ownership; and

 

·the inability to retain key employees of any acquired business.

 

Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and our business could be materially harmed by such transactions. Conversely, any failure to enter any collaboration or other strategic transaction that would be beneficial to us could delay the development and potential commercialization of our product candidates and technologies and have a negative impact on the competitiveness of any product candidate or technology that reaches market.

 

In addition, to the extent that any future collaborators terminate a collaboration agreement, we may be forced to independently develop our current and future product candidates and technologies, including funding preclinical studies or clinical trials, assuming marketing and distribution costs and maintaining, enforcing and defending intellectual property rights, or, in certain instances, abandon product candidates and technologies altogether, any of which could result in a change to our business plan and have a material adverse effect on our business, financial condition, results of operations and prospects.

 

The manufacturing of our product candidates is complex. We may encounter difficulties in production. If we encounter any such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale, could be delayed or halted entirely.

 

The manufacture of biopharmaceutical products is complex and requires significant expertise, including the development of advanced manufacturing techniques and process controls. The process of manufacturing our product candidates is also extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, operator error, contamination and inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or the manufacturing facilities in which they are made, the facilities may need to be closed for an extended period of time to investigate and remedy the contamination. As a result of the complexities, the cost to manufacture biologics in general, and our cell-based product candidates in particular, is generally higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce.

 

Any adverse developments affecting manufacturing operations for our product candidates, if any are approved, may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our products. We may also have to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. Furthermore, it is too early to estimate our cost of goods sold. The actual cost to manufacture our product candidates could be greater than we expect because we are early in our development efforts.

 

Changes in methods of product candidate manufacturing or formulation may result in the need to perform new clinical trials, which would require additional costs and cause delay.

 

As product candidates are developed through preclinical to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of ongoing, planned, or future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence product sales and generate revenue.

 

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Risks Related to Our Business and Operations

 

If the market opportunities for our current and potential future product candidates, are smaller than we believe they are, our future product revenues may be adversely affected, and our business may suffer.

 

Our understanding of the number of people who suffer from diseases that our current product candidates may be able to treat are based on estimates. These estimates may prove to be incorrect, and new studies may reduce the estimated incidence or prevalence of these diseases. The number of patients in the United States or elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our current or potential future product candidates or patients may become increasingly difficult to identify and access, all of which would adversely affect our business prospects and financial condition. In particular, the treatable population for our candidates may further be reduced if our estimates of addressable populations are erroneous or sub-populations of patients do not derive benefit from our product candidates.

 

Further, there are several factors that could contribute to making the actual number of patients who receive our current or potential future product candidates less than the potentially addressable market. These include the lack of widespread availability of, and limited reimbursement for, new therapies in many underdeveloped markets.

 

We face competition from companies that have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platform technologies. If these companies develop therapies or platform technologies more rapidly than we do, or if their therapies or platform technologies are more effective or have fewer side effects, our ability to develop and successfully commercialize therapies may be adversely affected.

 

The development and commercialization of T-cell therapies is highly competitive. We compete with a variety of large pharmaceutical companies, multinational biopharmaceutical companies, other biopharmaceutical companies, and specialized biotechnology companies, as well as technology and therapeutics being developed at universities and other research institutions. Our competitors are often larger and better funded than we are. Our competitors have developed, are developing, or will develop product candidates and processes competitive with ours. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments that are currently in development or that enter the market. We believe that a significant number of product candidates are currently under development, and may become commercially available in the future, for the treatment of conditions for which we may try to develop product candidates. There is intense and rapidly evolving competition in the biotechnology and biopharmaceutical fields. We believe that while EB103, EB104, and research relating to the use of EB103 in conjunction with CF33-CD19t, their associated intellectual property, the characteristics of our current and potential future product candidates, and our scientific and technical know-how together give us a competitive advantage in this space, competition from many sources remains.

 

Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales, and supply resources or experience than we do. If we successfully obtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectiveness of our product candidates, the ease with which our product candidates can be administered, the timing and scope of regulatory approvals for these product candidates, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage, and patent position. Competing products and product candidates could present superior treatment alternatives, including by being more effective, safer, less expensive, or marketed and sold more effectively than any products we may develop. Competitive products and product candidates may make any product we develop obsolete or noncompetitive before we recover the expense of developing and commercializing such product. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.

 

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Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan.

 

Our success largely depends on the continued service of our and Eureka’s key executive management, advisors, and other specialized personnel. Our and Eureka’s senior management may terminate their employment with us and Eureka, as applicable, at any time and will continue to be able to do so after the closing of the Business Combination. We do not maintain “key person” insurance for any of our employees. The loss of one or more members of our or Eureka’s executive team, management team, or other key employees or advisors could delay our research and development programs and have a material adverse effect on our business, financial condition, results of operations, and prospects.

 

Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of any of our product candidates, commercialization, manufacturing, and sales and marketing personnel, will be critical to our success. The loss of the services of members of our or Eureka’s senior management or other key employees could impede the achievement of our research, development, and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing members of our or Eureka’s senior management and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of, and commercialize our product candidates. Our success also depends on our and Eureka’s ability to continue to attract, retain, and motivate highly skilled junior, mid-level, and senior managers, as well as and Eureka’s junior, mid-level, and senior scientific and medical personnel. Competition to hire from this limited candidate pool is intense, and we and Eureka may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We and Eureka also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

 

In addition, through the Services Agreement with Eureka, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Such consultants and advisors are also consultants and advisors to Eureka, and may have additional commitments under consulting or advisory contracts with other entities, that may limit their availability to us and adversely impact the benefits we realize from the Services Agreement and our research and development and commercialization strategy

 

We may experience difficulties in managing our growth and expanding our operations.

 

As our current and potential future product candidates enter and advance through preclinical studies and any clinical trials, we will need to expand our development, regulatory, and manufacturing capabilities or contract with other organizations to provide these capabilities for us.

 

To manage our anticipated future growth, we will continue to implement and improve our managerial, operational, and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the complexity in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

 

In addition, future growth imposes significant added responsibilities on members of management, including: identifying, recruiting, integrating, maintaining, and motivating additional employees; managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and improving our operational, financial and management controls, reporting systems and procedures.

 

We may also experience difficulties in the discovery and development of potential future product candidates if we are unable to meet demand as we grow our operations. In the future, we also expect to have to manage additional relationships with collaborators, suppliers, and other organizations. Our ability to manage our operations and future growth will require us to continue to improve our operational, financial, and management controls, reporting systems, and procedures, and to secure adequate facilities for our operational needs. We may not be able to implement improvements to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems and controls.

 

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If any of our product candidates is approved for marketing and commercialization in the future and we are unable to develop sales, marketing, and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to successfully commercialize any such future products.

 

We will need to develop internal sales, marketing, and distribution capabilities to commercialize each current and potential future product candidate that gains, if ever, FDA or other regulatory authority approval, which would be expensive and time-consuming, or enter into collaborations with third parties to perform these services. If we decide to market any approved products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration, and compliance capabilities. If we rely on third parties with such capabilities to market any approved products or decide to co-promote products with third parties, we will need to establish and maintain marketing and distribution arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all. In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for any approved product. If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our business and results of operations could be materially and adversely affected.

 

Public opinion and scrutiny of immunotherapy approaches may impact public perception of the combined company and product candidates, or may adversely affect our ability to conduct our business and our business plans.

 

Public perception may be influenced by claims, such as claims that immunotherapies are unsafe, unethical, or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to immunotherapy in general could result in greater government regulation and stricter labeling requirements of immunotherapy products, including any of our product candidates, and could cause a decrease in the demand for any products we may develop. Adverse public attitudes may adversely impact our ability to enroll clinical trials. Moreover, our success will depend upon physicians specializing in the treatment of those diseases that our product candidates target prescribing, and their patients being willing to receive, treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop. Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.

 

Our potential future international operations may expose us to business, political, operational, and financial risks associated with doing business outside of the United States.

 

Our business is subject to risks associated with conducting business internationally. Some of our future clinical trials may be conducted outside of the United States and we may enter into key supply arrangements or do other business with persons outside of the United States. Furthermore, if we or any future collaborator succeeds in developing any products, we anticipate marketing them in the European Union and other jurisdictions in addition to the United States. If approved, we or any future collaborator may hire sales representatives and conduct physician and patient association outreach activities outside of the United States. Doing business internationally involves a number of risks, including but not limited to:

 

·multiple, conflicting, and changing laws and regulations such as those relating to privacy, data protection and cybersecurity, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits and licenses;

 

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·failure by us to obtain and maintain regulatory approvals for the commercialization of our product candidates in various countries;

 

·rejection or qualification of foreign clinical trial data by the competent authorities of other countries;

 

·additional potentially relevant third-party patent rights;

 

·complexities and difficulties in obtaining, maintaining, protecting and enforcing our intellectual property rights;

 

·difficulties in staffing and managing foreign operations;

 

·complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

 

·limits in our ability to penetrate international markets;

 

·financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand, and payment for our products and exposure to foreign currency exchange rate fluctuations;

 

·natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease (including the COVID-19 pandemic), boycotts, curtailment of trade, and other business restrictions;

 

·certain expenses including, among others, expenses for travel, translation, and insurance; and

 

·regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its accounting provisions or its anti-bribery provisions or provisions of anti-corruption or anti-bribery laws in other countries.

 

Any of these factors could harm our ongoing international operations and supply chain, as well as any future international expansion and operations and, consequently, our business, financial condition, prospects and results of operations.

 

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Our business entails a significant risk of product liability, and our inability to obtain sufficient insurance coverage could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

As we conduct preclinical studies and future clinical trials of our current and potential future product candidates, we will be exposed to significant product liability risks inherent in the development, testing, manufacturing, and marketing of these product candidates. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA investigation of the safety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we or any future collaborators may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

Our employees, principal investigators, consultants, and commercial collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 

We are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants, and commercial collaborators. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material adverse effect on our business and financial condition, including the imposition of significant criminal, civil and administrative fines or other sanctions, such as monetary penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity obligations, reputational harm and the curtailment or restructuring of our operations.

 

We  depend on sophisticated information technology systems and data processing to operate our business. If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand, and business disruption.

 

We rely on information technology systems and data processing that we or our service providers, collaborators, consultants, contractors, or partners operate to collect, process, transmit and store electronic information in our day-to-day operations, including a variety of personal data, such as name, mailing address, email addresses, phone number and potentially clinical trial information. Additionally, we, and our service providers, collaborators, consultants, contractors or partners, do or will collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, and share personal information, health information, and other information to host or otherwise process some of our anticipated future clinical data and that of users, to develop our products, to operate our business, for clinical trial purposes, for legal and marketing purposes, and for other business-related purposes. Our internal computer systems and data processing and those of our third-party vendors, consultants, collaborators, contractors, or partners, including future CROs may be vulnerable to a cyber-attack (including supply chain cyber-attacks), malicious intrusion, breakdown, destruction, loss of data privacy, actions or inactions by our employees or contractors that expose security vulnerabilities, theft, or destruction of intellectual property or other confidential or proprietary information, business interruption or other significant security incidents. As the cyber-threat landscape evolves, these attacks are growing in frequency, level of persistence, sophistication, and intensity, and are becoming increasingly difficult to detect. In addition to traditional computer “hackers,” threat actors, software bugs, malicious code (such as viruses and worms), employee theft or misuse, denial-of-service attacks (such as credential stuffing), phishing and ransomware attacks, sophisticated nation-state and nation-state supported actors now engage in attacks (including advanced persistent threat intrusions). These risks may be increased as a result of COVID-19, owing to an increase in personnel working remotely and higher reliance on internet technology. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period.

 

To date, we have not implemented any privacy, data protection or cybersecurity policies, have not implemented any physical, technical, organizational, and administrative security measures and policies, and have not been, to our knowledge, in compliance in all material respects with all Privacy and Security Requirements (as that term is defined in the Merger Agreement) relating to data loss, theft, and breach of security notification obligations.

 

There can be no assurance that we, our service providers, collaborators, consultants, contractors, or partners will be successful in efforts to detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks or breaches of systems that could adversely affect our business and operations and/or result in the loss of critical or sensitive data. Any failure by us or our service providers, collaborators, consultants, contractors or partners to detect, prevent, respond to or mitigate security breaches or improper access to, use of, or inappropriate disclosure of any of this information or other confidential or sensitive information, including patients’ personal data, or the perception that any such failure has occurred, could result in claims, litigation, regulatory investigations and other proceedings, significant liability under state, federal and international law, and other financial, legal or reputational harm to us. Further, such failures or perceived failures could result in liability and a material disruption of our development programs and our business operations, which could lead to significant delays or setbacks in our research, delays to commercialization of our product candidates, lost revenues, or other adverse consequences, any of which could have a material adverse effect on our business, results of operations, financial condition, prospects and cashflow. For example, the loss or alteration of clinical trial data from future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

 

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Additionally, applicable laws and regulations relating to privacy, data protection or cybersecurity, external contractual commitments, and internal privacy and security policies may require us to notify relevant stakeholders if there has been a security breach, including affected individuals, business partners and regulators. Such disclosures are costly, and the disclosures or any actual or alleged failure to comply with such requirements could lead to a materially adverse impact on the business, including negative publicity, a loss of confidence in our services or security measures by our business partners or breach of contract claims. There can be no assurance that the limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with applicable data protection laws, privacy policies or other data protection obligations related to information security or security breaches.

 

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

 

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

  

Although we maintain insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development, or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions..

 

Our business, operations and clinical development plans and timelines could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic, on the manufacturing, clinical trial, and other business activities performed by us or by third parties with whom we may conduct business, including our anticipated contract manufacturers, CROs, shippers, and others.

 

Health epidemics could cause significant disruption in our operations and the operations of third-party manufacturers, CROs and other third parties upon whom we rely. For example, in March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. Since then, COVID-19 has spread to most countries and all 50 states within the United States, and the U.S. government has, at various times, ordered the closure of all non-essential businesses, and imposed social distancing measures, “shelter-in-place” orders and restrictions on travel between the United States, Europe, and certain other countries. The global pandemic and government measures taken in response have also had a significant impact on businesses and commerce worldwide, as worker shortages have occurred, supply chains have been disrupted, facilities and production have been suspended across a variety of industries, 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 effects of government orders may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

 

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If our relationships with our suppliers or other vendors are terminated or scaled back as a result of the COVID-19 pandemic or other health epidemics, we may not be able to enter into arrangements with alternative suppliers or vendors or do so on commercially reasonable terms or in a timely manner. Switching or adding additional suppliers or vendors involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new supplier or vendor commences work. As a result, delays may occur, which could adversely impact our ability to meet our desired clinical development and any future commercialization timelines. Although we carefully manage our relationships with our suppliers and vendors, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not harm our business.

 

In addition, our preclinical studies and future clinical trials may be affected by the COVID-19 pandemic or other health epidemics. Clinical site initiation, patient enrollment and activities that require visits to clinical sites, including data monitoring, may be delayed due to prioritization of hospital resources towards the COVID-19 pandemic or concerns among patients about participating in clinical trials during a pandemic. Some patients may have difficulty following certain aspects of clinical trial protocols if quarantines impede patient movement or interrupt healthcare services. These challenges may also increase the costs of completing our clinical trials. Similarly, if we are unable to successfully recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 or experience additional restrictions by their institutions, city or state, our preclinical studies and future clinical trial operations could be adversely impacted.

 

The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic has resulted in significant volatility for global financial markets, resulting in economic uncertainty that could continue to significantly impact our business and operations and may reduce our ability to access capital, which could in the future negatively affect our liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our common stock. In addition, any recurrence or new increases in the rates and severity of COVID-19 infection could cause other widespread or more severe impacts depending on where infection rates are highest.

 

Further, we may experience additional disruptions that could severely impact our business and future clinical trials, including:

 

·diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

 

·interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

 

·limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

 

·risk that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse events; and

 

·refusal of the FDA or other regulatory authorities to accept data from clinical trials in these affected geographies.

 

In particular,             vaccines for COVID-19 have been granted Emergency Use Authorization by the FDA, and             of those later received full FDA 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 product candidates needed for our clinical trials, which could lead to delays in these trials. These and similar, and perhaps more severe, disruptions in our operations could have a material adverse effect on our business, results of operations, cash flows, financial condition, and/or prospects.

 

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As a result of the COVID-19 public health emergency, we may be required to develop and implement additional clinical trial policies and procedures designed to help protect subjects from the COVID-19 virus. The ultimate impact of the COVID-19 pandemic on our business operations is highly uncertain and subject to change and will depend on future developments, including new regulatory requirements and changes to existing regulations.

 

The global pandemic of COVID-19 continues to evolve rapidly. We do not yet know the full extent of potential delays or impacts on our business, our future clinical trials, healthcare systems or the global economy as a whole that may result from the ongoing COVID-19 pandemic. However, these effects could have a material impact on our operations, and we continue to monitor the COVID-19 situation closely. To the extent the COVID-19 pandemic adversely affects our business, results of operations, cash flows, financial condition, and/or prospects, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.

 

Our business, operations, financial position and clinical development plans and timelines, and our ability to consummate the Business Combination, could be materially adversely affected by the continuing military action in Ukraine.

 

As a result of the military action commenced in February 2022 by the Russian Federation and Belarus in Ukraine, and related economic sanctions imposed by certain governments and our financial position and operations may be materially and adversely affected. As our ability to continue to operate will be dependent on raising debt and equity finance, any adverse impact to those markets as a result of this military action, including due to increased market volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all), could negatively impact our business, results of operations, cash flows, financial condition, and/or prospects. The extent of any potential impact is not yet determinable, however.

 

Recent volatility in capital markets and lower market prices for our securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.

 

Our operations consume substantial amounts of cash, and we intend to continue to make significant investments to support our business growth, respond to business challenges or opportunities, develop new solutions, retain or expand our current levels of personnel, improve our existing solutions, enhance our operating infrastructure, and potentially acquire complementary businesses and technologies. Our future capital requirements may be significantly different from our current estimates and will depend on many factors, including the need to:

 

·finance unanticipated working capital requirements;

 

·develop or enhance our technological infrastructure and our existing solutions;

 

·pursue acquisitions or other strategic relationships; and

 

·respond to competitive pressures.

 

Accordingly, we may need to pursue equity or debt financings to meet our capital needs. With uncertainty in the capital markets and other factors, such financing may not be available on terms favorable to us or at all. If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences, and privileges superior to those of holders of Estrella Common Stock. Any debt financing secured by us in the future could involve additional restrictive covenants relating to our capital-raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. If we are unable to obtain adequate financing or financing on terms satisfactory to us, we could face significant limitations on our ability to invest in our operations and otherwise suffer harm to our business.

 

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Rising inflation rates could negatively impact our revenues and profitability if increases in the prices of our products or a decrease in consumer spending results in lower sales. In addition, if our costs increase and we are not able to pass along these price increases to our customers, our net income would be adversely affected, and the adverse impact may be material.

 

Inflation rates, particularly in the United States, have increased recently to levels not seen in years. Increased inflation may result in decreased demand for our products and services, increased operating costs (including our labor costs), reduced liquidity, and limitations on our ability to access credit or otherwise raise debt and equity capital. In addition, the United States Federal Reserve has raised, and may again raise, interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks.

 

Risks Related to the Separation and Our Relationship with Eureka

 

We will incur significant charges in connection with the Business Combination and incremental costs as a standalone public company.

 

We estimate that we will incur approximately $1.7 million in transaction costs in connection with the Business Combination, including accounting, legal, underwriting, financial and capital markets advisory, and other fees and expenses. These estimated transaction costs are reflected in the unaudited pro forma condensed combined financial information of UPTD and Estrella contained elsewhere in this proxy statement/prospectus/information statement. For operational matters outside of the scope of the Services Agreement, we may hire additional employees, or out-source certain functions, systems, and infrastructure through contracts with third parties. These initiatives may be costly to implement. To the extent we implement any of these initiatives, we may incur additional operating costs beyond what is included in our historical and pro forma financial statements, and the amount and timing of such costs is uncertain.

 

Eureka currently performs or supports many important corporate functions for us pursuant to the Services Agreement. The Services Agreement may be terminated by mutual agreement at any time. Following the termination of, or the expiration of the term of, the Service Agreement, we may not be able to replace the services or enter into appropriate third-party arrangements on terms and conditions, including cost, comparable to those that we will receive from Eureka under our Services Agreement. Additionally, after the Services Agreement terminates, we may be unable to sustain the services at the same levels or obtain the same benefits as when we were receiving such services and benefits from Eureka. If we are required to operate these functions separately in the future, and we do not have our own adequate systems and business functions in place at that time, or are unable to obtain them from other providers, we may not be able to operate our business effectively or at comparable costs, and our profitability may decline.

 

We also share office space with Eureka pursuant to an office sharing agreement that commenced in August 2022. If Eureka were to leave or lose its office space, we may not have adequate facilities to operate our business effectively and as required by the Collaboration Agreement or the costs of our office space could increase.

 

Our historical combined financial data and pro forma financial statements are not necessarily representative of the results we would have achieved as a standalone company and may not be a reliable indicator of our future results.

 

Our historical combined financial data included in this proxy statement/prospectus/information statement does not reflect the financial condition, results of operations, or cash flows we would have achieved as a standalone company during the periods presented or those we will achieve in the future. This is primarily the result of the following factors:

 

·our historical combined financial data does not reflect the Business Combination;

 

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·our historical combined financial data reflects expense allocations for certain support functions that are provided on a centralized basis within Eureka that may be higher or lower than the comparable expenses we would have actually incurred, or will incur in the future, as a standalone company;

 

·our cost of debt and our capital structure will be different from that reflected in our historical combined financial statements;

 

·significant increases may occur in our cost structure as a result of the Business Combination, including costs related to public company reporting, investor relations and compliance with the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act).

 

Our financial condition and future results of operations, after giving effect to the Business Combination, will be materially different from amounts reflected in our historical combined financial statements included elsewhere in this proxy statement/prospectus/information statement. As a result of the Business Combination, it may be difficult for investors to compare our future results to historical results or to evaluate our relative performance or trends in our business.

 

Certain of our officers or directors may have actual or potential conflicts of interest because of their equity interests in or positions with Eureka.

 

Our CEO, President, and director, Dr. Liu, currently serves as, and will continue to serve as, the CEO and President of Eureka after the completion of the Business Combination. Dr. Liu’s position at Eureka and the ownership by our officers and directors of any Eureka equity or equity awards, or Estrella equity awards the vesting for which is based in part on the total shareholder return of Eureka, creates, or may create the appearance of, conflicts of interest when these officers or directors are faced with decisions that could have different implications for Eureka than for us. These potential conflicts could arise, for example, over matters such as the desirability of changes in our business and operations, funding and capital matters, regulatory matters, intellectual property-related conflicts, including those relating to potential improvements to the ARTEMIS® platform, possible acquisitions or other corporate opportunities, and agreements with Eureka relating to the Separation or otherwise, allocation of resources and personnel pursuant to the Services Agreement, employee retention or recruiting, or our dividend policy.

 

In addition, our officers or directors may own Eureka common stock or equity awards. Certain of our officers, including Dr. Liu, and our director nominees have holdings of Eureka common stock or equity awards that have a material monetary value.

 

We rely on Eureka for our research and development efforts.

 

Pursuant to the Services Agreement, Eureka currently performs or supports our important research and development activities. The Services Agreement may be terminated by mutual agreement at any time. Following the termination of, or the expiration of the term of, the Services Agreement, we may not be able to replace the research and development-related services that Eureka provides or enter into appropriate third-party arrangements on terms and conditions, including cost, comparable to those that we will receive from Eureka. Additionally, after the Services Agreement terminates, we may be unable to sustain the research and development-related services at the same levels or obtain the same benefits as when we were receiving such services and benefits from Eureka. If we are required to operate these research and development functions separately in the future, and we do not have our own adequate systems and business functions in place at that time, or are unable to obtain them from other providers, we may not be able to operate our business effectively.

 

Additionally, our CEO and President, Dr. Liu, currently serves as, and will continue to serve as, the CEO and President of Eureka upon the Closing. Dr. Liu may have a conflict of interest in allocating resources and personnel between Estrella and Eureka, including pursuant to the Services Agreement, which may adversely impact the benefits we realize from the Services Agreement and our research and development and commercialization strategy.

 

Risks Related to Our Intellectual Property

 

If we are unable to obtain or protect intellectual property rights related to our in-licensed technology, future technologies and current or future product candidates, or if our intellectual property rights are inadequate, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any product candidates we may develop.

 

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Our success depends in part on our ability to obtain and maintain protection for our in-licensed  intellectual property rights and proprietary technology. We rely on a combination of patents, trademarks, trade secret protection and confidentiality agreements, including in-licenses of intellectual property rights and biologic materials of others, to protect our current or future product candidates, methods used to manufacture our current or future product candidates and methods for treating patients using our current or future product candidates.

 

We in-license patents and patent applications relating to our product candidates. There is no guarantee that any patents covering our product candidates will issue from the patent applications we in-license, or from any patent applications that we may file in the future, or, if they do, that the issued claims will provide adequate protection for our product candidates, or any meaningful competitive advantage. Further, there is no assurance that any such patents issued will not be infringed, designed around, invalidated by third parties or effectively prevent others from commercializing competitive technologies, products or product candidates.

 

The patent prosecution process is expensive, complex and time-consuming. Patent license negotiations also can be complex and protracted, with uncertain results. We may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patents and patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. The patent applications that we in-license may fail to result in issued patents, and, even if they do issue as patents, such patents may not cover our current or future technologies or product candidates in the United States or in other countries or provide sufficient protection from competitors. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. We do not have exclusive control over the preparation, filing and prosecution of patent applications under certain of our in-license agreements, and we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents, that we may file and then out-license to third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. Even if our in-licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our in-licensed patents by developing similar or alternative product candidates in a non-infringing manner.

 

Further, although we make reasonable efforts to ensure patentability of our in-licensed inventions and our future inventions, we cannot guarantee that all of the potentially relevant prior art relating to our in-licensed patents and any patent applications that we may file in the future has been or will be found. For example, publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, and in some cases not at all. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our licensed platform technologies, our product candidates, or the use of our technologies. We thus cannot know with certainty whether our licensors were the first to file for patent protection of our licensors’ inventions. In addition, the United States Patent and Trademark Office (“USPTO”) might require that the term of a patent issuing from a pending patent application be disclaimed and limited to the term of another patent that is commonly owned or that names a common inventor. There is no assurance that all potentially relevant prior art relating to our in-licensed patents has been found. For this reason, and because there is no guarantee that any prior art search is absolutely correct and comprehensive, we may be unaware of prior art that could be used to invalidate an issued patent that we license or to prevent any patent applications that we may file in the future from issuing as patents. Invalidation of any patent rights with respect to our in-licensed patents could materially harm our business.

 

Moreover, the patent positions of biotechnology companies like ours are generally uncertain because they may involve complex legal and factual considerations that have, in recent years, been the subject of legal development and change. The relevant patent laws and their interpretation, both inside and outside of the United States, is also uncertain. Changes in either the patent laws or their interpretation in the United States and other jurisdictions may diminish our ability to protect our platform technology or product candidates and could affect the value of such intellectual property. In particular, our ability to stop third parties from making, using, selling, offering to sell or importing products that infringe, misappropriate or otherwise violate our intellectual property will depend in part on our success in obtaining and enforcing patent claims that cover our in-licensed platform technology and inventions, our product candidates, future inventions and improvements. We cannot guarantee that patents will be granted with respect to any patent applications we may file or in license in the future, nor can we be sure that any patents that may be granted to us or our licensors in the future will be commercially useful in protecting our products, or the methods of use or manufacture of those products. Additionally, third parties, including our former employees and collaborators, may challenge the ownership or inventorship of our licensed or future patent rights to claim that they are entitled to ownership and inventorship interest, and we may not be successful in defending against such claims. However, we are not currently facing any such challenges. Moreover, issued patents do not guarantee the right to practice our in-licensed or owned technology or inventions in relation to the commercialization of our products. Issued patents only allow us to block—in some cases—potential competitors from practicing the claimed inventions of the issued patents.

 

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The standards applied by the USPTO and foreign patent offices in granting patents are not always certain and moreover, are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in patents. The in-licensed patents and patent applications, and our potential future patent applications, if any, may not result in patents being issued in the United States or in other jurisdictions which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of any patent applications we may file in the future or narrow the scope of any patent protection we may obtain from any such patent applications. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

 

Further, patents and other intellectual property rights in the pharmaceutical and biotechnology space are evolving and involve many risks and uncertainties. For example, third parties may have blocking patents that could be used to prevent us from commercializing our product candidates and any future product candidates and practicing the in-licensed proprietary technology, and any issued patents may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or could limit the term of patent protection that otherwise may exist for our product candidate and any future product candidates. In addition, the scope of the rights granted under any issued patents may not provide us with protection or competitive advantages against competitors or other parties with similar technology. Additionally, our competitors may initiate legal proceedings, such as declaratory judgment actions in federal court or reexaminations or an inter partes review at the USPTO in an attempt to invalidate or narrow the scope of our in-licensed patents. However, neither we nor our licensors are currently facing any such proceedings. Furthermore, our competitors or other parties may independently develop similar technologies that are outside the scope of the rights granted under any issued patents. For these reasons, we may face competition with respect to our product candidates and any future product candidates. Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent protection for such product candidate may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.

 

Even if patents do successfully issue from any patent applications we may file in the future, and even if such patents cover our in-licensed current technologies or any future technologies or product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful challenge to these patents or to any other patents licensed to us could deprive us of rights necessary for the successful commercialization of any current or future technologies or product candidates that we may develop. Likewise, if such patent applications with respect to our development programs and current or future technologies or product candidates fail to issue, if their breadth or strength is threatened, or if they fail to provide meaningful exclusivity, other companies could be dissuaded from collaborating with us to develop current or future technologies or product candidates. Lack of valid and enforceable patent protection could threaten our ability to commercialize current or future products and could prevent us from maintaining exclusivity with respect to the invention or feature claimed in the patent applications. Any failure to obtain or any loss of patent protection could have a material adverse impact on our business and ability to achieve profitability. We may be unable to prevent competitors from entering the market with a product that is similar or identical to any of our current or potential future product candidates or from utilizing technologies similar to those in our in-licensed T-cell immunotherapy technologies.

 

The filing of a patent application or the issuance of a patent is not conclusive as to its ownership, inventorship, scope, patentability, validity or enforceability. Issued patents and patent applications may be challenged in the courts and in the patent office in the United States and abroad. For example, any potential future patent applications filed by us or our licensors, or any patents that issue therefrom, may be challenged through third-party submissions, opposition or derivation proceedings. By further example, any such issued patents may be challenged through reexamination, inter partes review or post-grant review proceedings before the USPTO, or in declaratory judgment actions or counterclaims. An adverse determination in any such submission, proceeding or litigation could prevent the issuance of, reduce the scope of, invalidate or render unenforceable our in-licensed patent rights or any patent rights arising from issuance of a patent based on an application that we may file in the future, result in the loss of exclusivity, limit our ability to stop others from using or commercializing similar or identical platforms and product candidates, or allow third parties to compete directly with us without payment to us. In addition, if the breadth or strength of protection provided by any patents that might result from our in-licensed patent applications or any patent applications that we may file in the future is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future platforms or product candidates. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

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Moreover, the Collaboration Agreement allows us to co-own with Imugene patent applications relating to inventions jointly developed under the Collaboration Agreement, and we may in the future co-own additional patents and patent applications with third parties pursuant to agreements that we may enter into.  If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent application, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. We may need the cooperation of any such co-owners to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business prospects and financial conditions.

 

Our in-licensed patent rights may be subject to a reservation of rights by one or more third parties, such as the U.S. government. In addition, our rights in such inventions may be subject to certain requirements to manufacture product candidates embodying such inventions in the United States. Any exercise by the U.S. government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.

 

Our in-licensed patent rights may not cover our products or processes, including ARTEMIS®, or any otherwise viable commercial products or processes and/or may be invalid or unenforceable

 

We have not specifically evaluated the scope of coverage, validity, or enforceability of our in-licensed patent rights. These patents may not cover any of our current or future products or processes, including ARTEMIS® platform technology, or any otherwise viable commercial products or processes. Even if the patents do cover any of our current or future products, we have not evaluated whether and how easily a competitor may be able to design and market a competing product that does not infringe on any of our in-licensed patent rights. The in-licensed patent rights may have no commercial value. The in-licensed patent rights may be invalid or unenforceable for a variety of reasons including, non-patentable subject matter, anticipation, on-sale bar, public use bar, public disclosure, obviousness, inadequate written description, inadequate disclosure, lack of enablement, estoppel, laches, implied license, failure to mark, misuse, and/or inequitable conduct.

 

Our licenses and other material contracts may be invalid, unenforceable, or limited as to intellectual property and/or may impede, limit, or eliminate our ability to secure or protect our intellectual property, including in-licensed patent rights and any future developments.

 

We have not specifically evaluated the scope, validity, or enforceability of Eureka’s license of patent rights to Estrella. The license may not be valid, may be unenforceable, may have a limited scope, and may not confer adequate rights or standing. These risks may undermine our ability to enforce, control, and protect our in-licensed patent rights. We have not specifically evaluated the scope, validity, enforceability, or commercial usefulness of materials contracts as they relate to intellectual property. These contracts may not enable development of commercially valuable intellectual property and may materially limit or eliminate our ability to secure or protect our intellectual property, including in-licensed patent rights.

 

The patent protection and patent prosecution for some of our product candidates and technologies may be dependent on third parties.

 

While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates and technologies, there may be times when the filing and prosecution activities for patents and patent applications relating to our product candidates and technologies are controlled by our licensors or collaborators. Our licensors may not successfully prosecute the patent applications to which we are licensed. Even if patents are issued in respect of these patent applications, our licensors may fail to maintain these patents, may determine not to pursue litigation against other companies that are infringing these patents, or may pursue such litigation less aggressively than we would.

 

If any of our licensors or collaborators fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering our product candidates and technologies, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates and technologies may be adversely affected and we may not be able to prevent competitors from making, using and selling competing product candidates. In addition, even where we have the right to control the prosecution of patents and patent applications we have licensed from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our current and future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

 

Further, we may have limited control over the manner in which our licensors initiate an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual property that is licensed to us. It is possible that the licensors’ infringement proceeding(s) or defense activities may be less vigorous than had we conducted them ourselves.

 

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We may be unable to acquire or in-license any relevant third-party intellectual property rights that we identify as necessary or important to our business operations.

 

Because our development programs may in the future require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these third-party proprietary rights. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. The licensing of third-party intellectual property rights is a competitive area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, our business could be materially harmed. If we are unable to obtain a necessary license, we may be unable to develop or commercialize the affected current or future product candidates, which could materially harm our business, and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

 

Further, our licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.

 

Additionally, some intellectual property that we have in-licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers. As a result, the U.S. government may have certain rights to intellectual property embodied in our current or future product candidates pursuant to the Bayh-Dole Act of 1980 (“Bayh-Dole Act”) and implementing regulations. These U.S. government rights in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government may have the right to require us or our licensors to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions made through government funded programs if we, or the applicable licensor, fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified time limits. These time limits have recently been changed by regulation, and may change in the future. Intellectual property generated under a government-funded program is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. In addition, the U.S. government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. To the extent any of our current or future intellectual property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

 

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We currently, and in the future may continue to, enter into agreements involving licenses or collaborations that provide for access or sharing of intellectual property. These intellectual property-related agreements may impose certain obligations and restrictions on our ability to develop and commercialize our product candidates and technologies that are the subject of such licenses.

 

We license rights from third parties to use certain intellectual property relevant to one or more of our current and future product candidates. In the future, we may need to obtain additional licenses from others to advance our research and development activities or allow the commercialization of our current and future product candidates we may identify and pursue. These existing license agreements impose, and any future license agreements we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us. For example, we are a party to the License Agreement with Eureka and Eureka Therapeutics (Cayman), Inc. For a more detailed description of the License Agreement, see the section titled “Business — Intellectual Property.”

 

In addition, certain of our future agreements with third parties may limit or delay our ability to consummate certain transactions, may impact the value of those transactions, or may limit our ability to pursue certain activities. For example, we may in the future enter into license agreements that are not assignable or transferable, or that require the licensor’s express consent in order for an assignment or transfer to take place.

 

Further, we or our licensors, if any, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. It is possible that defects of form in the preparation or filing of our in-licensed patents may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If we or our licensors fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our licensors are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our in-licensed patents, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business, financial conditions, results of operations and prospects.

 

Furthermore, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications that we license from third parties. In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors for their patent prosecution and maintenance costs. If our licensors and future licensors fail to prosecute, maintain, enforce and defend patents we may license, or lose rights to licensed patents or patent applications, our licensed rights may be reduced or eliminated. In such circumstances, our right to develop and commercialize any of our products or product candidates that is the subject of such licensed rights could be materially adversely affected. Even where we have the right to control prosecution of patents and patent applications under license from third parties, we may still be adversely affected or prejudiced by actions or inactions of our predecessors or licensors and their counsel that took place prior to us assuming control over patent prosecution.

 

Our technology acquired or licensed currently or in the future from various third parties is or may be subject to retained rights. Our predecessors or licensors do and may retain certain rights under their agreements with us, including the right to use the underlying technology for non-commercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our predecessors or licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse.

 

If we are limited in our ability to utilize acquired or licensed technologies, or if we lose our rights to critical in-licensed technology, we may be unable to successfully develop, out-license, market and sell our product candidates, which could prevent or delay new product introductions. Our business strategy depends on the successful development of acquired technologies and licensed technology into commercial product candidates. Therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license or market and sell our product candidates.

 

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If we fail to comply with our obligations under any existing or future license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or product candidates or we could lose certain rights to grant sublicenses.

 

We have certain obligations to third-party licensors from whom we license certain patent rights that are relevant to one or more current and future product candidates. In the future, we may need to obtain additional licenses from other third parties to advance our research and development activities or allow the commercialization of our current and future product candidates. Our existing license agreements impose, and any future license agreements we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us. For a more detailed description of our existing license agreements, see the section titled “Business—License Agreement.” If we breach any of these obligations, including diligence obligations with respect to development and commercialization of product candidates covered by the intellectual property licensed to us, or use the intellectual property licensed to us in an unauthorized manner or we are subject to bankruptcy-related proceedings, we may be required to pay damages and the licensor may have the right to terminate the respective agreement or materially modify the terms of the license, such as by rendering currently exclusive licenses non-exclusive. License termination or modification could result in our inability to develop, manufacture and sell products that are covered by the licensed intellectual property or could enable a competitor to gain access to the licensed intellectual property.

 

In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors for their patent prosecution and maintenance costs. If our licensors and future licensors fail to prosecute, maintain, enforce and defend patents we may license, or lose rights to licensed patents or patent applications, our licensed rights may be reduced or eliminated. In such circumstances, our right to develop and commercialize any of our products or product candidates that are the subject of such licensed rights could be materially adversely affected.

 

Our current or future licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor’s intellectual property rights. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future products if infringement or misappropriation were found, those amounts could be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in products that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize products, we may be unable to achieve or maintain profitability.

 

Disputes may arise between us and our present and future licensors regarding intellectual property subject to a licensing agreement, including:

 

·the scope of rights granted under the license agreement and other interpretation-related issues, including but not limited to our right to transfer or assign the license;

 

·whether and the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

·our right to sublicense patents and other rights to third parties, including the terms and conditions thereof;

 

·our diligence obligations with respect to the development and commercialization of our product candidates that are covered by the license agreement, and what activities satisfy those diligence obligations;

 

·our right to transfer or assign the license;

 

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·the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators; and

 

·the priority of invention of patented technology.

 

If disputes over intellectual property that we license in the future prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may not be able to successfully develop and commercialize the affected product candidates, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

 

In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

In addition, while we currently do not have any liens, security interests, or other encumbrances on the intellectual property that we own, we may, in the future, need to obtain a loan or a line of credit that will require that we put up our intellectual property as collateral to our lenders or creditors. If we do so, and we violate the terms of any such loan or credit agreement, our lenders or creditors may take possession of such intellectual property, including the rights to receive proceeds derived from such intellectual property.

 

Patent terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future technologies or product candidates.

 

Patents have a limited lifespan. The term of individual patents and applications in-licensed to us and in our portfolio in the future depends upon the legal term of patents in the countries in which they are obtained. In most countries in which we would file, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. Extensions of a patent term may be available, but there is no guarantee that such patents may be eligible for extension, or that we would succeed in obtaining any particular extension, and no guarantee any such extension would confer a patent term for a sufficient period of time to exclude others from commercializing product candidates similar or identical to ours. In the United States, the term of a patent may be eligible for patent term adjustment, which permits patent term restoration as compensation for delays incurred at the USPTO during the patent prosecution process. In addition, for patents that cover an FDA-approved drug, the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) permits a patent term extension of up to five years beyond the expiration of the patent. While the length of the patent term extension is related to the length of time the drug is under regulatory review, patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only one patent per approved drug—and only those claims covering the approved drug, a method for using it or a method for manufacturing it—may be extended under the Hatch-Waxman Act. Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug. In the future, if and when our products receive FDA approval or applicable approval in other jurisdictions, we expect to apply for patent term extensions on any issued patents covering those products in the United States and other jurisdictions where such extensions are available; however, there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions. An extension may not be granted because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. If a patent term extension is not granted or the term of any such extension is less than requested, the period during which we can enforce such patent rights for the applicable product candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may be able to launch their products earlier by taking advantage of our investment in development and clinical trials along with our clinical and preclinical data. This could have a material adverse effect on our business and ability to achieve profitability.

 

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The life of a patent and the protection it affords are limited. As a result, our in-licensed patent portfolio provides us with limited rights that may not last for a sufficient period of time to exclude others from commercializing product candidates similar or identical to ours. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. For example, given the large amount of time required for the research, 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, our in-licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

 

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future technologies or product candidates.

 

Changes in either the patent laws or interpretation of the patent laws in the United States or elsewhere could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. The United States has enacted and implemented wide-ranging patent reform legislation. On September 16, 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law, which could increase the uncertainties and costs surrounding the prosecution of any potential future owned patents and our in-licensed patents and the enforcement or defense of any potential future owned patents or our in-licensed patents. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation and switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. A third party that files a patent application in the USPTO after March 16, 2013, but before us, could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications. The Leahy-Smith Act also allows third-party submission of prior art to the USPTO during patent prosecution and sets forth additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including derivation, reexamination, inter partes review, post-grant review and interference proceedings. The USPTO developed additional regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and, in particular, the first-to-file provisions, became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our in-licensed patents and any patent applications we may file in the future and the enforcement or defense of our in-licensed patents and any patents we may own in the future, all of which could have a material adverse impact on our business prospects and financial condition.

 

As referenced above, for example, courts in the U.S. continue to refine the heavily fact-and-circumstance-dependent jurisprudence defining the scope of patent protection available for therapeutics, narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. This creates uncertainty about our ability to obtain patents in the future and the value of such patents. In addition, the patent positions of companies in the development and commercialization of pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future. We cannot provide assurance that future developments in U.S. Congress, the federal courts and the USPTO will not adversely impact any patents we may own in the future or our in-licensed patents or any patent applications we may file in the future. The laws and regulations governing patents could change in unpredictable ways that could weaken our and our licensors’ ability to obtain new patents or to enforce our existing in-licensed patents and patents that we might obtain or in-license in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may have a material adverse effect on our and our licensors’ ability to obtain new patents or to protect and enforce our in-licensed patents or patents that we may obtain or in-license in the future.

 

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We or our licensors may be subject to lawsuits or litigation to protect or enforce our in-licensed patents or other intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.

 

Third parties may attempt to invalidate our or our licensors’ intellectual property rights via procedures including but not limited to patent infringement lawsuits, declaratory judgment actions, interferences, oppositions and inter partes reexamination proceedings before the USPTO, U.S. courts and foreign patent offices or foreign courts. An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our licensor’s patent rights, which could adversely affect our competitive position. Because of a lower evidentiary standard necessary to invalidate a patent claim in USPTO proceedings compared to the evidentiary standard in United States federal courts, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our licensors’ patent claims that would not have been invalidated if first challenged by the third party in a district court action. Even if such rights are not directly challenged, disputes could lead to the weakening of our or our licensors’ intellectual property rights. Our defense against any attempt by third parties to circumvent or invalidate our intellectual property rights could be costly to us, could require significant time and attention of our management, and could have a material and adverse impact on our profitability, financial condition and prospects or ability to successfully compete.

 

We or our licensors may find it necessary to pursue claims or to initiate lawsuits to protect or enforce our in-licensed patent or other intellectual property rights. The cost to us in defending or initiating any litigation or other proceedings relating to our in-licensed patent or other intellectual property rights, even if resolved in our favor, could be substantial, particularly in a foreign jurisdiction, and any litigation or other proceeding would divert our management’s attention. Such litigation or proceedings could materially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. Some of our competitors may be able to more effectively sustain the costs of complex patent litigation because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and materially limit our ability to continue our operations.

 

If we or our licensors were to initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or our technology, the defendant could counterclaim that such patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability of the asserted patent are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, claiming patent-ineligible subject matter, lack of novelty, indefiniteness, lack of written description, non-enablement, anticipation or obviousness. 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. The outcome of such invalidity and unenforceability claims is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we or our licensors and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we could lose at least part, and perhaps all, of the patent protection for one or more of our product candidates or certain aspects of our platform technologies. Such a loss of patent protection could have a material adverse effect on our business, financial condition, results of operations and prospects. Patents and other intellectual property rights also will not protect our product candidates and technologies if competitors or third parties design around such product candidates and technologies without legally infringing, misappropriating or violating our in-licensed patents or other intellectual property rights.

 

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We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.

 

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

 

Many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. The legal systems of certain countries, including certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the infringement of any in-licensed patents or patents that we may obtain in the future in other countries, or the marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our in-licensed intellectual property and other proprietary rights in foreign jurisdictions could result in substantial costs and could divert our efforts and attention from other aspects of our business. Such proceedings could also put any in-licensed patents or patents that we may hold in the future at risk of being invalidated or interpreted narrowly, could put our in-licensed patent applications or patent applications that we may file in the future at risk of not issuing, and could provoke third parties to assert claims against us or our licensors. We or our licensors may not prevail in any lawsuits or other adversarial proceedings that we or our licensors initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our and our licensors’ efforts to enforce such intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or in-license.

 

Further, many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. 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 its patents. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position in the relevant jurisdiction may be impaired and our business prospects may be materially adversely affected.

 

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or violating their intellectual property rights, or seeking to invalidate or avoid our in-licensed patent rights, the outcome of which would be uncertain and could have a material adverse impact on the success of our business.

 

Our commercial success depends, in part, upon our ability or the ability of our potential future collaborators to develop, manufacture, market and sell our current or any future product candidates and to use our proprietary technologies without infringing, misappropriating or violating the proprietary and intellectual property rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and inter partes review proceedings before the USPTO, U.S. courts, foreign patent offices or foreign courts. As the field of cell therapies advances, patent applications are being processed by national patent offices around the world. There is uncertainty about which patents will issue, and, if they do, there is uncertainty as to when, to whom, and with what claims. Any claims of patent infringement, or claims asserting invalidity, unenforceability, or invalidity of our in-licensed patent rights, asserted by third parties would be time consuming and could:

 

  · result in invalidation, unenforceability, scope limitation, or other adverse judgments against our in-licensed patents;

 

·result in costly litigation that may cause negative publicity;

 

·divert the time and attention of our technical personnel and management;

 

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·cause development delays;

 

·prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;

 

·require us to develop non-infringing technology, which may not be possible on a cost-effective basis;

 

·subject us to substantial damages for infringement, which we may have to pay if a court decides that the product candidate or technology at issue infringes on or violates the third party’s rights, and, if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; or

 

·require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology.

 

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.

 

Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that we may be subject to claims of infringement of the patent rights of third parties. Because patent applications can take many years to issue, there may also be currently pending patent applications that may later result in issued patents that our technology or product candidates may infringe. Further, we cannot guarantee that we are aware of all patents and patent applications potentially relevant to our technology or products. We may not be aware of potentially relevant third-party patents or applications for several reasons. For example, U.S. applications filed before November 29, 2000, and certain U.S. applications filed after that date that will not be filed outside the U.S. remain confidential until a patent issues. Patent applications filed in the United States (after November 29, 2000) and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our product candidates or platform technologies could have been filed by others without our knowledge. Any such patent application may have priority over our in-licensed patent applications or patents or any patent applications that we may file in the future and any patents issued therefrom, which could require us to obtain rights to issued patents covering such technologies. Additionally, claims pending in patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our platform, our product candidates or the use of our technologies.

 

Although no third party has asserted a claim of patent infringement against us as of the date of this proxy statement/prospectus, others may hold proprietary rights that could prevent our product candidates from being marketed. We or our licensors, or any future strategic collaborator, may be party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current or any potential future product candidates and technologies, including derivation, reexamination, inter partes review or post-grant review before the USPTO and similar proceedings in jurisdictions outside of the United States such as opposition proceedings. In some instances, we may be required to indemnify our licensors for the costs associated with any such adversarial proceedings or litigation. Third parties may assert infringement claims against us, our licensors or our strategic collaborators based on existing patents or patents that may be granted in the future, regardless of their merit. There is a risk that third parties may choose to engage in litigation or other adversarial proceedings with us, our licensors or our strategic collaborators to enforce or otherwise assert their patent rights. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are not invalid, and that they are enforceable and have been infringed, which could have a material adverse impact on our ability to utilize our platform technologies or to commercialize our current or any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity by presenting clear and convincing evidence of invalidity. There is no assurance that a court of competent jurisdiction, even if presented with evidence we believe to be clear and convincing, would invalidate the claims of any such U.S. patent.

 

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Further, we cannot guarantee that we will be able to successfully settle or otherwise resolve such adversarial proceedings or litigation. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or to continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing our product candidates. If we, or our licensors, or any future strategic collaborators are found to infringe, misappropriate or violate a third-party patent or other intellectual property rights, we could be required to pay damages, including treble damages and attorney’s fees, if we are found to have willfully infringed. In addition, we, or our licensors, or any future strategic collaborators may choose to seek, or be required to seek, a license from a third party, which may not be available on commercially reasonable terms, if at all. Even if a license can be obtained on commercially reasonable terms, the rights may be non-exclusive, which could give our competitors access to the same technology or intellectual property rights licensed to us, and we could be required to make substantial licensing and royalty payments. Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our current or future product candidates. We could be forced, including by court order, to cease utilizing, developing, manufacturing and commercializing our platform technologies or product candidates deemed to be infringing. We may be forced to redesign current or future technologies or products. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. Any of the foregoing could have a material adverse effect on our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.

 

Thus, it is possible that one or more third parties will hold patent rights to which we will need a license, which may not be available on reasonable terms or at all. If such third parties refuse to grant us a license to such patent rights on reasonable terms or at all, we may be required to expend significant time and resources to redesign our technology, product candidates or the methods for manufacturing our product candidates, or to develop or license replacement technology, all of which may not be commercially or technically feasible. In such case, we may not be able to market such technology or product candidates and may not be able to perform research and development or other activities covered by these patents. This could have a material adverse effect on our ability to commercialize our product candidates and our business and financial condition.

 

Lastly, if our in-licensed technology or products are found to infringe the intellectual property rights of third parties, these third parties may assert infringement claims against our licensees and other parties with whom we have business relationships, and we may be required to indemnify those parties for any damages they suffer as a result of these claims. The claims may require us to initiate or defend protracted and costly litigation on behalf of licensees and other parties regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of those parties or may be required to obtain licenses for the products they use.

 

Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of New Estrella Common Stock to decline.

 

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions and other interim proceedings or developments in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing product candidates, approved products, programs, or intellectual property could be diminished. Accordingly, the market price of shares of New Estrella Common Stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.

 

Intellectual property rights of third parties could adversely affect our ability to commercialize our current in-licensed technologies or future technologies or product candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current in-licensed technologies or future technologies or product candidates, which may not be available on commercially reasonable terms or at all.

 

Because the immunotherapy landscape is still evolving, it is difficult to conclusively assess our freedom to operate without infringing, misappropriating, or violating third-party rights. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect. For example, we may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. Also, our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect.

 

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There are numerous companies that have pending patent applications and issued patents broadly covering cell therapy generally or covering related inventions that may be relevant for product candidates that we wish to develop. There may be third-party patents and patent applications that claim aspects of our current or potential future product candidates and modifications that we may need to apply to our current or potential future product candidates. There are also many issued patents that claim inventions that may be relevant to products we wish to develop. The holders of such patents may be able to block our ability to develop and commercialize the applicable product candidate unless we obtain a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms or at all, or it may be non-exclusive, which could result in our competitors gaining access to the same intellectual property.

 

Our competitive position may materially suffer if patents issued to third parties or other third-party intellectual property rights cover our current in-licensed technologies or future technologies, product candidates or elements thereof or our manufacture or uses relevant to our development plans. In such cases, we may not be in a position to develop or commercialize current in-licensed technologies or future technologies or product candidates unless we successfully pursue litigation to narrow or invalidate the third-party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. There may be issued patents of which we are not aware, held by third parties that, if found to be valid and enforceable, could be alleged to be infringed by our current in-licensed technologies or future technologies or product candidates. There also may be pending patent applications of which we are not aware that may result in issued patents, which could be alleged to be infringed by our current in-licensed technologies or future technologies or product candidates. If such an infringement claim should successfully be brought, we may be required to pay substantial damages or be forced to abandon our current in-licensed technologies or future technologies or product candidates or to seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.

 

Third-party intellectual property right holders may also actively bring infringement, misappropriation, or other claims alleging violations of intellectual property rights against us. We cannot guarantee that we will be able to successfully settle or otherwise resolve such claims. If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or to continue costly, unpredictable, and time-consuming litigation and may be prevented from or experience substantial delays in marketing our product candidates. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our current in-licensed technologies or future technologies or product candidates that are held to be infringing, misappropriating, or otherwise violating third-party intellectual property rights. We might, if possible, also be forced to redesign current or future technologies or product candidates so that we no longer infringe, misappropriate, or violate the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business, which could have a material adverse effect on our financial condition and results of operations.

 

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

 

In addition to seeking patent protection for certain aspects of our current in-licensed technologies or future technologies and product candidates, we rely on trade secrets, including confidential and unpatented know-how, technology and other proprietary information, to maintain our competitive position and to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. Elements of our product candidates, including processes for their preparation and manufacture, may involve proprietary know-how, information, or technology that is not covered by patents, and thus for these aspects we may consider trade secrets and know-how to be our primary intellectual property.

 

Trade secrets and know-how can be difficult to protect. We seek to protect trade secrets and confidential and unpatented know-how, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants under which they are obligated to maintain confidentiality and to assign their inventions to us. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access (such as through a cybersecurity breach) to our trade secrets or independently develop substantially equivalent information and techniques. Moreover, individuals with whom we have such agreements may not comply with their terms. Any of these parties may breach such agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for any such breaches. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary technology by third parties.

 

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We may also become involved in inventorship disputes relating to inventions and patents developed by our employees or consultants under such agreements. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret, or securing title to an employee- or consultant-developed invention if a dispute arises, is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions disfavor or are unwilling to protect trade secrets. We may need to share our proprietary information, including trade secrets, with future business partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. Further, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent that competitor from using the technology or information to compete with us. If, in the future, any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be materially and adversely harmed.

 

We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or other proprietary information of third parties, including our employees’ or consultants’ former employers or their clients.

 

We are party to various contracts under which we are obligated to maintain the confidentiality of trade secrets or other confidential and proprietary information of third parties, including our licensors and strategic partners. In addition, many of our employees or consultants and our licensors’ employees or consultants were previously employed at universities or biotechnology or biopharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that one or more of these employees or consultants or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of third parties, including former employers of our employees and consultants. Litigation or arbitration may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel or may be enjoined from using such intellectual property. Any such proceedings and possible aftermath would likely divert significant resources from our core business, including distracting our technical and management personnel from their normal responsibilities. A loss of key research personnel or their work product could limit our ability to commercialize, or prevent us from commercializing, our current in-licensed technologies or future technologies or product candidates, which could materially harm our business. Even if we are successful in defending against any such claims, litigation or arbitration could result in substantial costs and could be a distraction to management.

 

Our licensors or we may be subject to claims challenging the inventorship of our in-licensed patents and other intellectual property.

 

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our in-licensed patents as an inventor or co-inventor, or in our trade secrets or other intellectual property as a contributor to its development. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our product candidates or as a result of questions regarding co-ownership of potential joint inventions. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or our licensors’ ownership of our in-licensed patents, our trade secrets or other intellectual property. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

 

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Also, our licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the U.S. government, such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.

 

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

 

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

 

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents or patent applications will be due to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our in-licensed patents and any patent rights we may own or in-license in the future. The USPTO and various non-U.S. patent offices require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply with these requirements, and we are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our in-licensed intellectual property. In many cases, an inadvertent lapse, including due to the effect of the COVID-19 pandemic on us, our patent counsel or other applicable patent maintenance vendors, can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, potential competitors might be able to enter the market with similar or identical product candidates or platforms, which could have a material adverse effect on our business prospects and financial condition.

 

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

 

We use and will continue to use registered and/or unregistered trademarks or trade names to brand and market ourselves and our products. Our trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we use for name recognition by potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business may be materially adversely affected.

 

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We may also license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and trade names by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.

 

Intellectual property rights do not necessarily address all potential threats to our business.

 

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business. The following examples are illustrative:

 

·others may be able to create T-cell therapies that are similar to our product candidates, but that are not covered by the claims of any patents that we own, license or control;

 

·we, our licensors, or any strategic collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own, license or control or may own, license or control in the future;

 

·we or our licensors might not have been the first to file patent applications covering certain of our in-licensed inventions;

 

·others may independently develop the same, similar, or alternative technologies without infringing, misappropriating, or violating our in-licensed intellectual property rights;

 

·it is possible that any patent applications we may file in the future will not lead to issued patents;

 

·issued patents that we in-license, control or may own in the future may not provide us with any competitive advantages, or may be narrowed or held invalid or unenforceable, including as a result of legal challenges;

 

·our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

 

·we 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 application covering such trade secrets or know-how; and

 

·the patents of others may have an adverse effect on our business.

 

Should any of these events occur, they could have a material adverse impact on our business, financial condition, results of operations and prospects.

 

If any negative data were to arise with respect to the use of our licensed technology in territories where such technology is licensed to a third party, it could negatively affect our ability to develop our product candidates in territories where we license such technology.

 

Pursuant to the Syracuse License Agreement, Eureka licensed to JW Therapeutics (Cayman) Co. Ltd ("JW”) the rights to use ARTEMIS® technology in connection with CD19 and CD22 in Greater China and the ASEAN countries (the "JW Territory”). The JW License allows JW to conduct research and development (but not commercialize) in the U.S., and for Eureka and Estrella to conduct research and development (but not commercialize) in the JW Territory. Accordingly, we may experience conflicts or have potential intellectual property-related disputes with JW in connection with the development of our product candidates. Additionally, if any negative data were to arise from the JW Territory with respect to the use of ARTEMIS® technology in the JW Territory, it could negatively affect our ability to develop our product candidates and adversely impact our success in the Licensed Territory.

 

Risks Related to Government Regulation

 

Clinical development includes a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

 

All of our current product candidates are in preclinical development and their risk of failure is high. It is impossible to predict when or if our candidates or any potential future product candidates will prove effective in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies for our current product candidates and then conduct extensive clinical trials to demonstrate the safety, purity and potency, or efficacy of that product candidate in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the development process. The results of preclinical studies and clinical trials of any of our current or potential future product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials.

 

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We may experience delays in completing our preclinical studies and initiating or completing our clinical studies. We do not know whether planned preclinical studies and clinical trials will be completed on schedule or at all, or whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Our development programs may be delayed for a variety of reasons, including delays related to:

 

·the FDA or other regulatory authorities requiring us to submit additional data or imposing other requirements before permitting us to initiate a clinical trial;

 

·obtaining regulatory approval to commence a clinical trial;

 

·reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

 

·obtaining IRB or ethics committee approval at each clinical trial site;

 

·recruiting suitable patients to participate in a clinical trial;

 

·having patients complete a clinical trial or return for post-treatment follow-up;

 

·clinical trial sites deviating from trial protocol or dropping out of a trial;

 

·the FDA placing the clinical trial on hold;

 

·subjects failing to enroll or remain in our trial at the rate we expect;

 

·subjects choosing an alternative treatment for the indication for which we are developing or other product candidates, or participating in competing clinical trials;

 

·lack of adequate funding to continue the clinical trial;

 

·subjects experiencing severe or unexpected drug-related adverse events;

 

·any changes to our manufacturing process that may be necessary or desired;

 

·adding new clinical trial sites; and

 

·manufacturing sufficient quantities of our product candidates for use in clinical trials.

 

Furthermore, we expect to rely on our CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we have limited influence over their actual performance.

 

We could encounter delays if prescribing physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our current or potential future product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, our collaborators, the IRBs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

 

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Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application we submit. Any such delay or rejection could prevent or delay us from commercializing our current or future product candidates.

 

If we experience delays in the completion of, or termination of, any clinical trial of any of our current or potential future product candidates, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenue from such product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow our product development and approval process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our current or potential future product candidates.

 

We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize our current or potential future product candidates.

 

Our current and any potential future product candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing, and distribution of therapeutic biologics. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required to be successfully completed in the U.S. and in many foreign jurisdictions before a new drug or therapeutic biologic can be marketed in the U.S. or foreign jurisdictions. Satisfaction of these and other regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated delays. It is possible that none of the product candidates we may develop will obtain the regulatory approvals necessary for us or our potential future collaborators to begin selling them.

 

The time required to obtain FDA and other approvals is unpredictable but typically takes many years following the commencement of clinical trials, depending upon the type, complexity, and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when regulating us require judgment and can change, which makes it difficult to predict with certainty how they will be applied. Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation or administrative action, or from changes in regulatory policy during the period of product development, clinical trials and regulatory review in the United States and other jurisdictions. It is impossible to predict whether legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be.

 

Any delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenue from the particular product candidate for which we are seeking approval. Further, we and our potential future collaborators may never receive approval to market and commercialize any product candidate. Even if we or a potential future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.

 

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Once a product obtains regulatory approval, numerous post approval requirements apply, including periodic monitoring and reporting obligations, review of promotional material, reports on ongoing clinical trials and adverse events and inspections of manufacturing facilities. In addition, material changes to approved products, including any changes to the manufacturing process or labeling, require further review by the appropriate authorities before marketing. Approvals may also be withdrawn or revoked due to safety, effectiveness, or potency concerns, including as a result of adverse events reported in patients or ongoing clinical trials, or failure to comply with cGMP. In addition to revocation or withdrawal of approvals, we and our partners may be subject to warnings, fines, recalls, criminal prosecution or other sanctions if we fail to comply with regulatory requirements. If we or our partners are unable to obtain or maintain regulatory approvals for our products and product candidates, our business, financial position, results of operations and future growth prospects will be negatively impacted and we or our partners may be subject to sanctions. If any of our product candidates prove to be ineffective, unsafe, or commercially unviable, we may have to re-engineer our current or potential future product candidates, and our entire pipeline could have little, if any, value, which could require us to change our focus and approach to product candidate discovery and therapeutic development, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

 

We will also be subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing, and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval in a foreign jurisdiction may differ from that required to obtain FDA approval.

 

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

 

If we succeed in developing any products, we intend to market them in the United States, as well as the European Union and other foreign jurisdictions. In order to market and sell our products in other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

 

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

 

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we or any partner we work with fails to comply with the regulatory requirements in international markets or fails to receive applicable marketing approvals, our target market will be reduced, and our ability to realize the full market potential of our product candidates will be harmed.

 

We may in the future conduct certain of our clinical trials for our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.

 

We may in the future choose to conduct one or more of our clinical trials for our product candidates outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will not approve the application on the basis of foreign data alone unless (i) those data are applicable to the U.S. population and U.S. medical practice; (ii) the studies were performed by clinical investigators of recognized competence; and (iii) the data are 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. For studies that are conducted only at sites outside of the United States and not subject to an IND, the FDA requires the clinical trial to have been conducted in accordance with GCPs, and the FDA must be able to validate the data from the clinical trial through an on-site inspection if it deems such inspection necessary. For such studies not subject to an IND, the FDA generally does not provide advance comment on the clinical protocols for the studies, and therefore there is an additional potential risk that the FDA could determine that the study design or protocol for a non-U.S. clinical trial was inadequate, which could require us to conduct additional clinical trials. There can be no assurance the FDA will accept data from clinical trials conducted outside of the United States. If the FDA does not accept data from our clinical trials of our product candidates, it would likely result in the need for additional clinical trials, which would be costly and time consuming and delay or permanently halt our development of our product candidates.

 

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Many foreign regulatory bodies have similar approval requirements. In addition, such foreign trials would 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 similar foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any similar foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

 

Conducting clinical trials outside of the United States also exposes us to additional risks, including risks associated with:

 

·additional foreign regulatory requirements;

 

·foreign exchange fluctuations;

 

·compliance with foreign manufacturing, customs, shipment and storage requirements;

 

·cultural differences in medical practice and clinical research; and

 

·diminished protection of intellectual property in some countries.

 

Even if we receive regulatory approval for any of our current or potential future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our current or potential future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

 

Any regulatory approvals that we or potential future collaborators obtain for any of our current or potential future product candidates will be subject to limitations on the approved indicated uses for which a product may be marketed or may be subject to the conditions of approval, or contain requirements for potentially costly post-marketing testing, and surveillance to monitor the safety and efficacy of such product candidate. In addition, if the FDA or any other regulatory authority approves any of our current or potential future product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, import, export, advertising, promotion and recordkeeping for such product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and good clinical practices for any clinical trials that we conduct post-approval. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP and cGTP regulations and applicable product tracking and tracing requirements.

 

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Later discovery of previously unknown problems with a product candidate, including adverse events of unanticipated severity or frequency, or with our 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 candidate, withdrawal of the product candidate from the market or voluntary or mandatory product recalls;

 

·fines, warning letters, untitled letters or holds on clinical trials;

 

·refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our strategic collaborators;

 

·suspension or revocation of product approvals;

 

·suspension of any ongoing clinical trials;

 

·product seizure or detention or refusal to permit the import or export of products; and

 

·