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    SEC Form S-8 filed by Biomea Fusion Inc.

    1/6/25 4:57:44 PM ET
    $BMEA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $BMEA alert in real time by email
    S-8 1 d878908ds8.htm S-8 S-8

    As filed with the U.S. Securities and Exchange Commission on January 6, 2025

    Registration No. 333-   

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

     

    FORM S-8

    REGISTRATION STATEMENT

    UNDER

    THE SECURITIES ACT OF 1933

     

     

    BIOMEA FUSION, INC.

    (Exact name of registrant as specified in its charter)

     

     

     

    Delaware   82-2520134

    (State or other jurisdiction of

    incorporation or organization)

     

    (I.R.S. Employer

    Identification No.)

    900 Middlefield Road, 4th Floor

    Redwood City, California 94063

    (Address of Principal Executive Offices)

    2021 INCENTIVE AWARD PLAN

    2021 EMPLOYEE STOCK PURCHASE PLAN

    (Full title of the plans)

    Thomas Butler

    Chief Executive Officer

    900 Middlefield Road, 4th Floor

    Redwood City, California 94063

    (Name and address of agent for service)

    (650) 980-9099

    (Telephone number, including area code, of agent for service)

     

     

    Copies to:

     

    Maggie L. Wong

    Alicia M. Tschirhart

    Goodwin Procter LLP

    525 Market Street

    San Francisco, CA 94105

    Telephone: (415) 733-6000

     

    Franco Valle

    Chief Financial Officer

    Biomea Fusion, Inc.

    900 Middlefield Road, 4th Floor

    Redwood City, California 94063

    Telephone: (650) 980-9099

     

     

    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. (Check one):

     

    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. ☐

    Proposed sales to take place as soon after the effective date of the registration statement as awards are granted, exercised or distributed under the 2021 Plan or the ESPP, as applicable.

     

     

     


    EXPLANATORY NOTE

    In this Registration Statement, Biomea Fusion, Inc. is sometimes referred to as “Registrant,” “we,” “us” or “our.” This Registration Statement on Form S-8 registers (i) additional shares of the Registrant’s common stock, $0.0001 par value per share (“Common Stock”) under the Registrant’s 2021 Incentive Award Plan (the “2021 Plan”) and (ii) additional shares of Common Stock under the Registrant’s 2021 Employee Stock Purchase Plan (the “ESPP”).

    The number of shares of Common Stock reserved and available for issuance under the 2021 Plan is subject to an automatic annual increase on the first day of each year beginning in 2022 and ending in 2031, equal to the lesser of (A) five percent of the shares of Common Stock outstanding on the last day of the immediately preceding fiscal year and (B) such smaller number of shares as determined by the Board or the Committee (as defined in the 2021 Plan). Accordingly, on January 1, 2025, the number of shares of Common Stock reserved and available for issuance under the 2021 Plan increased by 1,815,535 shares.

    The number of shares of Common Stock reserved and available for issuance under the ESPP is subject to an annual increase on the first day of each year beginning in 2022 and ending in 2031 equal to the lesser of (i) one percent of the shares of Common Stock outstanding on the last day of the immediately preceding fiscal year and (ii) such number of shares as may be determined by the Board (as defined in the ESPP); provided, however, no more than 4,500,000 shares may be issued under the ESPP. Accordingly, on January 1, 2025, the number of shares of Common Stock reserved and available for issuance under the ESPP increased by 363,107 shares.

    This Registration Statement registers the aggregate of these additional 2,178,642 shares of Common Stock.

    PART I

    INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS

    The information called for in Part I of Form S-8 to be contained in the Section 10(a) prospectus is not being filed with or included in this registration statement (by incorporation by reference or otherwise) in accordance with the rules and regulations of the Securities and Exchange Commission (the “Commission”).

    PART II

    INFORMATION REQUIRED IN THE REGISTRATION STATEMENT

    Item 3. Incorporation of Documents by Reference.

    The SEC allows us to incorporate by reference the information we file with them, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this registration statement, and later information filed with the SEC will update and supersede this information. We hereby incorporate by reference into this registration statement the following documents previously filed with the SEC:

     

    (a)

    The registrant’s Annual Report on Form 10-K for the fiscal year ended December  31, 2023 (including the sections of the Registrant’s Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 26, 2024 and relating to its June 12, 2024 annual meeting of stockholders, that are incorporated by reference therein);

     

    (b)

    The registrant’s Quarterly Reports on Form 10-Q for the quarters ended March  31, 2024, June  30, 2024, and September 30, 2024;

     

    (c)

    The registrant’s Current Reports on Form 8-K and Form 8-K/A filed with the Commission dated January  10, 2024, March  7, 2024, April  1, 2024, June  7, 2024, June  12, 2024, September  27, 2024, October  31, 2024 and December 17, 2024 (in each case, except for information contained therein which is furnished rather than filed); and

     

    (d)

    The description of the registrant’s common stock which is registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), contained in the registrant’s registration statement on Form 8-A (Registration No. 001-40335) filed by the registrant with the SEC on April 14, 2021 and as set forth by the description of the Registrant’s capital stock set forth in Exhibit 4.4 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, in each case, including any amendments or reports filed for the purpose of updating such description.

     


    All documents that the Registrant subsequently files pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act prior to the filing of a post-effective amendment to the registration statement which indicates that all of the shares of common stock offered have been sold or which deregisters all of such shares then remaining unsold, shall be deemed to be incorporated by reference in this registration statement and to be a part hereof from the date of the filing of such documents; except as to any portion of any future annual or quarterly report to stockholders or document or current report furnished under current Items 2.02 or 7.01 of Form 8-K, and exhibits furnished on such form that relate to such items, that is not deemed filed under such provisions. For the purposes of this registration statement, any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this registration statement.

    Under no circumstances will any information filed under current Items 2.02 or 7.01 of Form 8-K, and exhibits furnished on such form that relate to such items, be deemed incorporated herein by reference unless such Form 8-K expressly provides to the contrary.

    Item 4. Description of Securities.

    Not applicable.

    Item 5. Interests of Named Experts and Counsel.

    None.

    Item 6. Indemnification of Directors and Officers.

    As permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate of incorporation (the “Certificate of Incorporation”) filed with the Secretary of State of the State of Delaware and our amended and restated bylaws (the “Bylaws”) that will limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

     

      •  

    any breach of the director’s duty of loyalty to us or our stockholders;

     

      •  

    any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

     

      •  

    any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or

     

      •  

    any transaction from which the director derived an improper personal benefit.

    These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our Certificate of Incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.

    As permitted by Section 145 of the Delaware General Corporation Law, our Bylaws provide that:

     

      •  

    we shall indemnify our directors and officers to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;

     

      •  

    we may indemnify our employees and agents to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;


      •  

    we shall advance expenses to our directors and officers and may advance expenses of our employees and agents in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and

     

      •  

    the rights provided in our Bylaws are not exclusive.

    Our Certificate of Incorporation and our Bylaws provide for the indemnification provisions described above. We have entered into separate indemnification agreements with our directors and officers which may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. In addition, we have purchased a policy of directors’ and officers’ liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment in some circumstances. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933 (the “Securities Act”).

    Item 7. Exemption from Registration Claimed.

    Not applicable.

    Item 8. Exhibits.

     

    Exhibit
    Number
           Incorporated by Reference     Filed
    Herewith
     
     

    Exhibit Description

       Form      Date      Number  
     4.1   Amended and Restated Certificate of Incorporation.      8-K        4/20/21        3.2    
     4.2   Amended and Restated Bylaws.      8-K        4/20/21        3.4    
     4.3   Form of Common Stock Certificate.      S-1/A        4/12/21        4.2    
     5.1   Opinion of Goodwin Procter LLP.              X  
    23.1   Consent of Independent Registered Public Accounting Firm.              X  
    23.2   Consent of Goodwin Procter LLP (included in Exhibit 5.1).              X  
    24.1   Power of Attorney (included on signature page).              X  
    99.1(a)   2021 Incentive Award Plan.      S-1        4/12/21        10.4 (a)   
    99.1(b)   Form of Stock Award Grant Notice and Stock Award Agreement under the 2021 Incentive Award Plan.      S-1        4/12/21        10.4 (b)   
    99.1(c)   Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2021 Incentive Award Plan.      S-1        4/12/21        10.4 (c)   
    99.1(d)   Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2021 Incentive Award Plan.      S-1        4/12/21        10.4 (d)   
    99.2   2021 Employee Stock Purchase Plan.      S-1        4/12/21        10.5    
    107   Filing Fee Table              X  


    Item 9. Undertakings.

     

    (a)

    The undersigned registrant hereby undertakes:

     

    (1)

    To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

     

    (i)

    To include any prospectus required by Section 10(a)(3) of the Securities Act;

     

    (ii)

    To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

     

    (iii)

    To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

    Provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) of this section shall not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in the registration statement.

     

    (2)

    That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

     

    (3)

    To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

     

    (b)

    The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

     

    (h)

    Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by


    such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.


    SIGNATURES

    Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Redwood City, State of California, this 6th day of January, 2025.

     

    BIOMEA FUSION, INC.
    By:   /s/ Thomas Butler
      Thomas Butler
      Chief Executive Officer and Director

    POWER OF ATTORNEY AND SIGNATURES

    We, the undersigned officers and directors of Biomea Fusion, Inc., hereby severally constitute and appoint Thomas Butler and Franco Valle, and each of them singly (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign for us and in our names in the capacities indicated below any and all amendments (including post-effective amendments) to this registration statement on Form S-8, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

    Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the date indicated below.

     

    Signature

      

    Title

     

    Date

    /s/ Thomas Butler

    Thomas Butler

      

    Chief Executive Officer and Director

    (Principal Executive Officer)

      January 6, 2025

    /s/ Franco Valle

    Franco Valle

      

    Chief Financial Officer

    (Principal Financial and Principal Accounting Officer)

      January 6, 2025

    /s/ Eric Aguiar

    Eric Aguiar, M.D.

       Director   January 6, 2025

    /s/ Bihua Chen

    Bihua Chen

       Director   January 6, 2025

    /s/ Ramses Erdtmann

    Ramses Erdtmann

       Director   January 6, 2025

    /s/ Elizabeth Faust

    Elizabeth Faust, Ph.D.

       Director   January 6, 2025

    /s/ Michael J. M. Hitchcock

    Michael J. M. Hitchcock, Ph.D.

       Director   January 6, 2025

    /s/ Sumita Ray

    Sumita Ray, J.D.

       Director   January 6, 2025
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    Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapyBiomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the first quarter ended March 31, 202

    5/5/25 4:05:00 PM ET
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    Biotechnology: Pharmaceutical Preparations
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    Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights

    Mick Hitchcock, Ph.D., appointed Interim Chief Executive OfficerBiomea preparing icovamenib for late-stage clinical developmentMultiple milestones anticipated in 2025 including:FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patientsCOVALENT-111 (T2D) 52-week data anticipated in second half 2025COVALENT-112 (T1D) open label data anticipated in second half 2025BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, reported

    3/31/25 4:10:00 PM ET
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    Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations

    Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B)Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials

    10/6/25 4:03:07 PM ET
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    Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes

    Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient populationBest response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks of dosing icovamenib with 100 mgIcovamenib was well-tolerated, with no adverse-event related discontinuations, no hypoglycemic events and no serious adverse events REDWOOD CITY, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company

    12/17/24 8:10:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
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    Biomea Fusion to Host Conference Call to Announce Topline Results from Phase II COVALENT-111 Study in Patients with Type 2 Diabetes (T2D)

    REDWOOD CITY, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Tuesday, December 17, 2024 at 8:00 am EST to present topline results from COVALENT-111, the company's Phase II trial of icovamenib in patients with type 2 diabetes. Conference Call and Webcast Details Webcast of Biomea's investor update on Tuesday, December 17, 2024, at 8:00 am EST will be available to reg

    12/16/24 6:15:01 PM ET
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    Amendment: SEC Form SC 13G/A filed by Biomea Fusion Inc.

    SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

    11/12/24 12:31:45 PM ET
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    Amendment: SEC Form SC 13G/A filed by Biomea Fusion Inc.

    SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

    7/10/24 6:39:58 AM ET
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    SEC Form SC 13G filed by Biomea Fusion Inc.

    SC 13G - Biomea Fusion, Inc. (0001840439) (Subject)

    4/10/24 9:45:50 AM ET
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    Biotechnology: Pharmaceutical Preparations
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