Basisstatistiken
| CIK | 1840439 |
SEC Filings
SEC Filings (Chronological Order)
| May 11, 2026 |
BIOMEA FUSION, INC. CHANGE IN CONTROL AND SEVERANCE AGREEMENT Exhibit 10.1 BIOMEA FUSION, INC. CHANGE IN CONTROL AND SEVERANCE AGREEMENT This Change in Control and Severance Agreement (the “Agreement”) is made and entered into by and between Michael J.M. Hitchcock, Ph.D. (“Executive”) and Biomea Fusion, Inc. (the “Company”), effective as of March 25, 2025 (the “Effective Date”). Background A. The Board of Directors of the Company (the “Board”) recognizes tha |
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| May 11, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2026 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| May 11, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| May 11, 2026 |
Exhibit 99.1 Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights • Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12‑week clinical dosing that has been used to date • Topline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1 dia |
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| April 28, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 27, 2026 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| April 28, 2026 |
EX-99.1 COVALENT-112 Topline Results BIOMEA FUSION CONFERENCE CALL 28 APRIL 2026 Icovamenib in Type 1 Diabetes Exhibit 99.1 Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, u |
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| April 27, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) շ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ն TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| April 27, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy State |
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| March 24, 2026 |
BIOMEA FUSION, INC. CHANGE IN CONTROL AND SEVERANCE AGREEMENT Exhibit 10.10 BIOMEA FUSION, INC. CHANGE IN CONTROL AND SEVERANCE AGREEMENT This Change in Control and Severance Agreement (the “Agreement”) is made and entered into by and between Thomas Butler (“Executive”) and Biomea Fusion, Inc. (the “Company”), effective as of August 16, 2018 (the “Effective Date”). Background A. The Board of Directors of the Company (the “Board”) recognizes that the possibil |
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| March 24, 2026 |
Exhibit 99.1 Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights • Initiated two Phase II trials COVALENT-211 and COVALENT-212 (icovamenib in type 2 diabetes) with 26-week primary endpoint data anticipated in the fourth quarter of 2026 • Completed 52-week follow-up from Phase II trial COVALENT-112 (icovamenib in type 1 diabetes) with data expected in the second quarter |
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| March 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| March 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 24, 2026 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| March 24, 2026 |
Exhibit 4.2 DESCRIPTION OF REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following summary describes our capital stock and the material provisions of our amended and restated certificate of incorporation and our amended and restated bylaws, the investors’ rights agreement to which we and certain of our stockholders are parties and of the Delaw |
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| February 25, 2026 |
EX-99.1 Exhibit 99.1 st 1 QUARTER 2026 Biomea Fusion Corporate Presentation 1 Legal disclaimer & forward-looking statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, u |
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| February 25, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2026 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission F |
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| January 14, 2026 |
EX-99.2 Exhibit 99.2 1ST QUARTER 2026 Biomea Fusion Corporate Presentation LEGAL DISCLAIMER & FORWARD-LOOKING STATEMENTS Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, unce |
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| January 14, 2026 |
EX-99.1 2026 J.P. Morgan Healthcare Conference Mick Hitchcock, CEO Biomea Fusion January 14, 2026 Exhibit 99.1 Legal Disclaimer & Forward-looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and i |
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| January 14, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 14, 2026 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| January 6, 2026 |
Table 1: Newly Registered Securities Calculation of Filing Fee Tables S-8 Biomea Fusion, Inc. Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Common Stock, $0.0001 par value per share Other 3,614,972 $ 1.30 $ 4,699,463.60 0.0001381 $ 649.00 2 Equity Commo |
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| January 6, 2026 |
As filed with the U.S. Securities and Exchange Commission on January 6, 2026 S-8 As filed with the U.S. Securities and Exchange Commission on January 6, 2026 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) |
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| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 04, 2025 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission F |
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| November 4, 2025 |
Exhibit 10.1 July 7, 2025 Michael J.M. Hitchcock, Ph.D. Dear Mick: This letter agreement is executed in connection with that certain employment offer letter agreement (the “Employment Agreement”), made and entered into as of April 2, 2025, by and between you and Biomea Fusion, Inc. (the “Company”). You and the Company hereby agree that Section 1.C. of the Employment Agreement is hereby amended and |
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| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| November 4, 2025 |
Press release dated November 4, 2025, furnished herewith. Exhibit 99.1 Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights • Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trial • Presented preclinical ac |
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| October 7, 2025 |
EX-1.1 Exhibit 1.1 Biomea Fusion, Inc. 11,195,121 Shares of Common Stock Pre-Funded Warrants to Purchase 1,000,000 Shares of Common Stock Warrants to Purchase 12,195,121 Shares of Common Stock (or Pre-Funded Warrants in lieu thereof) Underwriting Agreement October 6, 2025 Jefferies LLC As Representative of the several Underwriters listed in Schedule 1 hereto c/o Jefferies LLC 520 Madison Avenue |
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| October 7, 2025 |
Biomea Fusion Announces Pricing of Public Offering of Securities EX-99.2 Exhibit 99.2 Biomea Fusion Announces Pricing of Public Offering of Securities October 7, 2025 SAN CARLOS, Calif., Oct. 07, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced the pricing of its previously announced underwritten public offering consisting of (i) 11,195,121 shares of its common stock and accomp |
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| October 7, 2025 |
Biomea Fusion Announces Proposed Public Offering of Securities EX-99.1 Exhibit 99.1 Biomea Fusion Announces Proposed Public Offering of Securities October 6, 2025 SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its c |
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| October 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 6, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| October 7, 2025 |
BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK OR PRE-FUNDED WARRANTS EX-4.2 Exhibit 4.2 BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK OR PRE-FUNDED WARRANTS Number of Shares: [] (subject to adjustment) Warrant No. CW2-[] Original Issue Date: October [], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered |
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| October 7, 2025 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-289262 Prospectus supplement (To prospectus dated August 15, 2025) 11,195,121 Shares of Common Stock Pre-funded Warrants to Purchase up to 1,000,000 Shares of Common Stock Warrants to Purchase up to 12,195,121 Shares of Common Stock (or Pre-Funded Warrants) We are offering 11,195,121 shares of our common stock, $0.0001 p |
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| October 7, 2025 |
BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK EX-4.1 Exhibit 4.1 BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK Number of Shares: [] (subject to adjustment) Warrant No. PFW2-[ ] Original Issue Date: October [ ], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered assigns (the “Holde |
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| October 6, 2025 |
Subject to completion, dated October 6, 2025 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-289262 The information in this preliminary prospectus supplement is not complete and may be changed. A registration statement relating to these securities has been filed with the Securities and Exchange Commission and is effective. This preliminary prospectus supplement and the accompanying prospectus are not an offer to |
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| October 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 6, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| August 13, 2025 |
Biomea Fusion, Inc. 1599 Industrial Road San Carlos, CA 94070 CORRESP Biomea Fusion, Inc. 1599 Industrial Road San Carlos, CA 94070 August 13, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance – Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 File No. 333-289262 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities A |
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| August 12, 2025 |
August 12, 2025 Dr. Michael J.M. Hitchcock Interim Chief Executive Officer and Director Biomea Fusion, Inc. 1599 Industrial Road San Carlos, CA 94070 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 Filed August 5, 2025 File No. 333-289262 Dear Dr. Michael J.M. Hitchcock: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rule |
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| August 5, 2025 |
Exhibit 4.5 BIOMEA FUSION, INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [ ] Subordinated Debt Securities TABLE OF CONTENTS1 Page Article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 Article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 3 Section 2.01 Designation and Terms of Securities. 3 Section 2.02 Form of Securities and Trustee’s Certificate |
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| August 5, 2025 |
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights • Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health: • In patients with type 2 diabetes (T2D) not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and improved beta-cell function subsequent to the |
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| August 5, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Biomea Fusion, Inc. |
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| August 5, 2025 |
Form of indenture for senior debt securities and the related form of senior debt security Exhibit 4.4 BIOMEA FUSION, INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [ ] Senior Debt Securities TABLE OF CONTENTS1 Page Article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 Article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 4 Section 2.01 Designation and Terms of Securities. 4 Section 2.02 Form of Securities and Trustee’s Certificate 6 Sec |
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| August 5, 2025 |
As filed with the Securities and Exchange Commission on August 5, 2025 As filed with the Securities and Exchange Commission on August 5, 2025 Registration No. |
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| August 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| August 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 05, 2025 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 22, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| July 24, 2025 |
Biomea Fusion Appoints Julianne Averill to its Board of Directors Exhibit 99.1 Biomea Fusion Appoints Julianne Averill to its Board of Directors SAN CARLOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the appointment of Julianne Averill to its Board of Directors (the “Board”), effective July 22, 2025. Ms. Averill |
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| June 20, 2025 |
Exhibit 1.1 Biomea Fusion, Inc. 19,450,000 Shares of Common Stock Pre-Funded Warrants to Purchase 550,000 Shares of Common Stock Warrants to Purchase 20,000,000 Shares of Common Stock (or Pre-Funded Warrants in lieu thereof) Underwriting Agreement June 17, 2025 Jefferies LLC As Representative of the several Underwriters listed in Schedule 1 hereto c/o Jefferies LLC 520 Madison Avenue New York, NY |
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| June 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 17, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 20, 2025 |
EX-4.2 Exhibit 4.2 BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK OR PRE-FUNDED WARRANTS Number of Shares: [] (subject to adjustment) Warrant No. [] Original Issue Date: June [ ], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered assig |
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| June 20, 2025 |
Exhibit 4.1 Form of Pre-Funded Warrant BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK Number of Shares: [] (subject to adjustment) Warrant No. [] Original Issue Date: June [], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered assigns ( |
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| June 18, 2025 |
EX-4.1 Exhibit 4.1 Form of Pre-Funded Warrant BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK Number of Shares: [] (subject to adjustment) Warrant No. [] Original Issue Date: June [], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered as |
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| June 18, 2025 |
Biomea Fusion Announces Pricing of Public Offering of Securities Exhibit 99.2 Biomea Fusion Announces Pricing of Public Offering of Securities REDWOOD CITY, Calif., June 17, 2025 – Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced the pricing of its previously announced underwritten public offering consisting of (i) 19,450,000 shares of its common stock and accompanying warrants to purchase an aggregat |
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| June 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 17, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 18, 2025 |
Biomea Fusion Announces Proposed Public Offering of Securities EX-99.1 Exhibit 99.1 Biomea Fusion Announces Proposed Public Offering of Securities REDWOOD CITY, Calif.,– June 17, 2025 – Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded war |
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| June 18, 2025 |
EX-4.2 Exhibit 4.2 BIOMEA FUSION, INC. WARRANT TO PURCHASE COMMON STOCK OR PRE-FUNDED WARRANTS Number of Shares: [] (subject to adjustment) Warrant No. [] Original Issue Date: June [], 2025 Biomea Fusion, Inc., a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered assign |
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| June 18, 2025 |
Exhibit 1.1 Biomea Fusion, Inc. 19,450,000 Shares of Common Stock Pre-Funded Warrants to Purchase 550,000 Shares of Common Stock Warrants to Purchase 20,000,000 Shares of Common Stock (or Pre-Funded Warrants in lieu thereof) Underwriting Agreement June 17, 2025 Jefferies LLC As Representative of the several Underwriters listed in Schedule 1 hereto c/o Jefferies LLC 520 Madison Avenue New York, NY |
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| June 18, 2025 |
Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-267884 Prospectus supplement (To prospectus dated October 24, 2022) 19,450,000 Shares of Common Stock Pre-funded Warrants to Purchase up to 550,000 Shares of Common Stock Warrants to Purchase up to 20,000,000 Shares of Common Stock (or Pre-Funded Warrants) We are offering 19,450,000 shares of our common stock, $0.0001 par valu |
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| June 17, 2025 |
EX-99.1 Exhibit 99.1 Corporate Update June 2025 Slide 1 Legal Disclaimer & Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, uncertainties and other |
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| June 17, 2025 |
Subject to completion, dated June 17, 2025 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-267884 The information in this preliminary prospectus supplement is not complete and may be changed. A registration statement relating to these securities has been filed with the Securities and Exchange Commission and is effective. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell |
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| June 17, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 17, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 11, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| May 5, 2025 |
Employment Offer Letter Agreement by and between the Company and Michael J.M. Hitchcock Exhibit 10.1 April 2, 2025 Michael J.M. Hitchcock, Ph.D. Dear Michael: I am pleased to offer you employment with Biomea Fusion Inc. (the "Company"). The purpose of this letter is to set forth the terms of your proposed employment with the Company. If you indicate your agreement to the terms in this letter by signing the last page, this letter will constitute your employment agreement with the Comp |
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| May 5, 2025 |
Exhibit 99.1 Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights 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 therapy • Biomea's next generation |
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| May 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| May 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 05, 2025 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| April 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential , for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy Stat |
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| April 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy State |
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| March 31, 2025 |
Exhibit 99.1 Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights • Mick Hitchcock, Ph.D., appointed Interim Chief Executive Officer • Biomea preparing icovamenib for late-stage clinical development • Multiple milestones anticipated in 2025 including: • FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe in |
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| March 31, 2025 |
Biomea Fusion, Inc.’s Compensation Recovery Policy Exhibit 97.1 Biomea fusion, inc. COMPENSATION RECOVERY POLICY Adopted as of November 17, 2023 Biomea Fusion, Inc., a Delaware corporation (the “Company”), has adopted a Compensation Recovery Policy (this “Policy”) as described below. 1. Overview The Policy sets forth the circumstances and procedures under which the Company shall recover Erroneously Awarded Compensation from Covered Persons (as def |
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| March 31, 2025 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Biomea Fusion, Inc. None. |
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| March 31, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| March 31, 2025 |
Exhibit 19.1 BIOMEA FUSION, INC. Insider Trading POLICY This memorandum sets forth the policy of Biomea Fusion, Inc. and its subsidiaries, if any (collectively, the “Company”), regarding trading in the Company’s securities as described below and the disclosure of information concerning the Company. This Insider Trading Policy (the “Insider Trading Policy”) is designed to prevent the misuse of mate |
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| March 31, 2025 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 31, 2025 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| March 27, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 25, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| March 27, 2025 |
Exhibit 99.1 Biomea Fusion Announces Leadership Transition Board member Mick Hitchcock named interim CEO replacing Thomas Butler. COO and President Ramses Erdtmann continuing at Biomea in current role. REDWOOD CITY, California, March 25, 2025 — Biomea Fusion, Inc. (“Biomea,” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, announced today an executive lead |
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| February 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 24, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission F |
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| January 15, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 13, 2025 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| January 15, 2025 |
Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference—January 15, 2025 Exhibit 99.2 Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference—January 15, 2025 Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known |
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| January 15, 2025 |
Exhibit 99.1 Biomea Fusion to Become a Diabetes & Obesity Medicines Company January 13, 2025 Icovamenib & BMF-650 (oral small molecule GLP-1) are the cornerstones of the metabolic franchise Biomea preparing icovamenib for late-stage clinical development 2025 corporate update to be presented at the 43rd Annual J.P. Morgan Healthcare Conference REDWOOD CITY, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — |
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| January 6, 2025 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Biomea Fusion, Inc. |
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| January 6, 2025 |
As filed with the U.S. Securities and Exchange Commission on January 6, 2025 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) |
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| December 20, 2024 |
Exhibit 99.2 COVALENT-111 Topline Results December 17, 2024 COVALENT-111 Topline Results - Conference Call December 17, 2024 Agenda Thomas Butler Introduction & Chief Executive Officer, Chairman of the Board & Co-Founder of Biomea Fusion Executive Summary COVALENT-111 Dr. Juan Pablo Frias Chief Medical Officer of Biomea Fusion Topline Results Dr. Alex Abitbol Key Opinion LMC Healthcare, Endocrinol |
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| December 20, 2024 |
Exhibit 99.1 Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes December 17, 2024 • Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient population • Best response achieved in target, beta-cell deficient patient |
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| December 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 17, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission F |
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| November 12, 2024 |
SC 13G/A 1 bmeaa1111224.htm LAURION CAPITAL MANAGEMENT LP UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biomea Fusion Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 09077A106 (CUSIP Number) September 30, 2024 (Date of Event which Requires Filing of thi |
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| October 31, 2024 |
Biomea Fusion Presents Preclinical Data Showing Icovamenib Exhibit 99.2 Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate • Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, |
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| October 31, 2024 |
BIOMEA cONFERENCE Call Preclinical Data Combining icovamenib with a GLP-1-Based Therapy & Biomea’s Oral GLP-1 RA Candidate BMF-650 October 30, 2024 Exhibit 99. |
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| October 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission Fi |
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| October 29, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 29, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission Fi |
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| October 29, 2024 |
Exhibit 99.1 Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights • U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trials • COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024 • COVALENT-112 Phase 2a 26-week topline data of the open label po |
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| October 29, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| September 27, 2024 |
EX-99.1 Exhibit 99.1 FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials REDWOOD CITY, Calif., September 26, 2024 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or the “Company”) (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 metabolic diseases and |
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| September 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 26, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission |
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| July 31, 2024 |
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights • COVALENT-111 Phase 2b on track for Q4 2024 readout • COVALENT-112 Phase 2a on track for Q4 2024 readout • Announcement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) - Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinica |
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| July 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| July 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 31, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| July 18, 2024 |
July 18, 2024 Franco Valle Principal Financial and Accounting Officer Biomea Fusion, Inc. |
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| July 10, 2024 |
BMEA / Biomea Fusion, Inc. / STATE STREET CORP Passive Investment SC 13G/A 1 BiomeaFusionInc.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 EXIT FILING BIOMEA FUSION INC (NAME OF ISSUER) COMMON STOCK (TITLE OF CLASS OF SECURITIES) 09077A106 (CUSIP NUMBER) 06/30/2024 (DATE OF EVENT WHICH REQUIRES FILING OF THIS STATEMENT) CHECK THE APPROPRIATE BOX TO DESIGNATE THE RULE PURSUANT TO |
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| June 21, 2024 |
June 21, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N. |
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| June 12, 2024 |
United States securities and exchange commission logo June 12, 2024 Franco Valle Principal Financial and Accounting Officer Biomea Fusion, Inc. |
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| June 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 12, 2024 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 7, 2024 |
EX-99.1 Exhibit 99.1 Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold REDWOOD CITY, Calif., June 6, 2024 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the C |
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| June 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 6, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| May 2, 2024 |
Offer Letter, dated July 24, 2023, by and between the Registrant and Juan Pablo Frias Exhibit 10.1 July 24, 2023 Juan Pablo Frias, MD Dear Juan, I am pleased to offer you employment with Biomea Fusion Inc. (the "Company"). The purpose of this letter is to set forth the terms of your proposed employment with the Company. If you indicate your agreement to the terms in this letter by signing the last page, this letter will constitute your employment agreement with the Company (the "Ag |
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| May 2, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 02, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| May 2, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| May 2, 2024 |
Exhibit 99.1 Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, |
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| April 26, 2024 |
We continued progress towards our mission in 2023, expanding on the strong foundation we laid in the years prior, “to build a biopharmaceutical company capable of creating and developing innovative best-and-rst-in-class therapies that set new standards for patient benet as we aim to cure”. |
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| April 26, 2024 |
DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 10, 2024 |
BMEA / Biomea Fusion, Inc. / STATE STREET CORP Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 INITIAL FILING BIOMEA FUSION INC (NAME OF ISSUER) COMMON STOCK (TITLE OF CLASS OF SECURITIES) 09077A106 (CUSIP NUMBER) 03/31/2024 (DATE OF EVENT WHICH REQUIRES FILING OF THIS STATEMENT) CHECK THE APPROPRIATE BOX TO DESIGNATE THE RULE PURSUANT TO WHICH THIS SCHEDULE IS FILE |
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| April 1, 2024 |
Exhibit 99.1 Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights • In 2023, reported Phase 2 data (COVALENT-111) in type 2 diabetes patients supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells. o After just a 4-week treatment period in type 2 diabetes patients, who |
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| April 1, 2024 |
Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with Exhibit 99.1 Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219 BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes • The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of |
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| April 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 1, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| April 1, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 01, 2024 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| March 28, 2024 |
Updated Form Executive Change in Control and Severance Agreement adopted November 13, 2023 Exhibit 10-5(c) UPDATED FORM EXECUTIVE CHANGE IN CONTROL AND SEVERANCE AGREEMENT ADOPTED NOVEMBER 13, 2023 This Change in Control and Severance Agreement (the “Agreement”) is made and entered into by and between NAME (“Executive”) and Biomea Fusion, Inc. |
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| March 28, 2024 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Biomea Fusion, Inc. None. ACTIVE/115593365.1 |
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| March 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| March 28, 2024 |
Biomea Fusion, Inc.’s Compensation Recovery Policy Exhibit 97.1 Biomea fusion, inc. COMPENSATION RECOVERY POLICY Adopted as of November 17, 2023 Biomea Fusion, Inc., a Delaware corporation (the “Company”), has adopted a Compensation Recovery Policy (this “Policy”) as described below. 1. Overview The Policy sets forth the circumstances and procedures under which the Company shall recover Erroneously Awarded Compensation from Covered Persons (as def |
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| March 7, 2024 |
CASE STUDIES FROM COVALENT-111, A PHASE 1/2 TRIAL OF BMF-219, A COVALENT MENIN Exhibit 99. |
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| March 7, 2024 |
EX-99.2 DURABLE GLYCEMIC CONTROL WITH BMF-219 DURING OFF-TREATMENT PERIOD AT WEEK 26: Exhibit 99.2 A PHASE 1/2 TRIAL OF BMF-219 IN PATIENTS WITH TYPE 2 DIABETES (COVALENT-111) 1 2 3 4 5 6 7 7 7 7 7 7 Jose Rodriguez , Alexander Abitbol , Douglas Denham , Rizwana Mohseni , Janice Faulknor , Cesar Perez , Brian Munneke , Courtney Follit , Juan Frias , Sanchita Mourya , Thomas Butler , Steve Morris ; |
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| March 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2024 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| March 7, 2024 |
Biomea Fusion Presents Patient Cohorts in Exhibit 99.1 Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function Three Clinical Data Sets from the Dose Escalation Phase of COVALENT-111 to be Presented at the 17th Annual ATTD Conference Highlighting BMF-219’s |
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| March 7, 2024 |
KEY OBSERVATIONS FROM THE DOSE-ESCALATION PORTION OF COVALENT-111, A PHASE 1/2 Exhibit 99. |
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| February 14, 2024 |
BMEA / Biomea Fusion, Inc. / BAKER BROS. ADVISORS LP - SC 13G/A Passive Investment SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 12, 2024 |
BMEA / Biomea Fusion, Inc. / Erdtmann Rainer M - SC 13G/A Passive Investment SC 13G/A 1 d725490dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to design |
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| February 12, 2024 |
BMEA / Biomea Fusion, Inc. / JANUS HENDERSON GROUP PLC - JHG OWNS <5% Passive Investment SC 13G/A 1 biomea123123.txt JHG OWNS <5% UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Amendment No.: 3* Name of Issuer: Biomea Fusion, Inc. Title of Class of Securities: Common Stock CUSIP Number: 09077A106 Date of Event Which Requires Filing of this Statement: 12/31/2023 Check the appropriate box to designate the ru |
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| February 12, 2024 |
BMEA / Biomea Fusion, Inc. / Butler Thomas Andrew - SC 13G/A Passive Investment SC 13G/A 1 d665198dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to design |
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| February 9, 2024 |
BMEA / Biomea Fusion, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.1 BIOMEA FUSION INC COMMON STOCK Cusip #09077A106 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #09077A106 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 5,355,690 Item 6: 0 Item 7: 5,355,867 Item 8: 0 Item 9: 5 |
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| February 8, 2024 |
BMEA / Biomea Fusion, Inc. / Laurion Capital Management LP Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| January 29, 2024 |
BMEA / Biomea Fusion, Inc. / BlackRock Inc. Passive Investment us09077a1060012924.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: ) BIOMEA FUSION, INC. - (Name of Issuer) Common Stock - (Title of Class of Securities) 09077A106 - (CUSIP Number) December 31, 2023 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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| January 10, 2024 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2024 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| January 10, 2024 |
Exhibit 99.1 JP Morgan 2024 Corporate Presentation Page 1 Disclaimer Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, uncertaint |
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| January 5, 2024 |
Form of Restricted Stock Award Agreement under the 2023 Inducement Plan EX-99.3(c) Exhibit 99.3(c) BIOMEA FUSION, INC. 2023 INDUCEMENT PLAN RESTRICTED STOCK AWARD GRANT NOTICE Biomea Fusion, Inc., a Delaware corporation, (the “Company”), pursuant to its 2023 Inducement Plan, as amended from time to time (the “Plan”), hereby grants to the holder listed below (“Participant”) the number of shares of the Company’s Common Stock set forth below (the “Shares”) as an induceme |
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| January 5, 2024 |
Form of Non-Qualified Stock Option Agreement under the 2023 Inducement Plan EX-99.3(b) Exhibit 99.3(b) BIOMEA FUSION, INC. 2023 INDUCEMENT PLAN NONQUALIFIED STOCK OPTION GRANT NOTICE Biomea Fusion, Inc., a Delaware corporation, (the “Company”), pursuant to its 2023 Inducement Plan, as may be amended from time to time (the “Plan”), hereby grants to the holder listed below (“Participant”), an option to purchase the number of shares of the Company’s Common Stock (the “Shares |
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| January 5, 2024 |
Form of Restricted Stock Unit Agreement under the 2023 Inducement Plan EX-99.3(d) Exhibit 99.3(d) BIOMEA FUSION, INC. 2023 INDUCEMENT PLAN RESTRICTED STOCK UNIT AWARD GRANT NOTICE Biomea Fusion, Inc., a Delaware corporation, (the “Company”), pursuant to its 2023 Inducement Plan, as amended from time to time (the “Plan”), hereby grants to the holder listed below (“Participant”), an award of restricted stock units (“Restricted Stock Units” or “RSUs”) as an inducement p |
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| January 5, 2024 |
As filed with the U.S. Securities and Exchange Commission on January 5, 2024 S-8 As filed with the U.S. Securities and Exchange Commission on January 5, 2024 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 |
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| January 5, 2024 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Biomea Fusion, Inc. |
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| January 5, 2024 |
EX-99.3(a) Exhibit 99.3(a) BIOMEA FUSION, INC. 2023 INDUCEMENT PLAN ARTICLE I. PURPOSE The Plan’s purpose is to enable the Company to grant equity awards to induce highly-qualified prospective officers and employees who are not currently employed by the Company or any of its Subsidiaries to accept employment and provide these individuals with a proprietary interest in the Company. The Company inte |
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| October 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| October 30, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission Fi |
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| October 30, 2023 |
Exhibit 99.1 Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights • Demonstrated durable HbA1c lowering in the escalation portion of ongoing Phase II study in type 2 diabetes (COVALENT-111), with 84% of all patients showing a reduction of HbA1c after 4 weeks dosing and 74% after another 8 weeks off-treatment period • Expansion portion of COVALENT-111 cleared and acti |
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| July 31, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| July 31, 2023 |
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights • Reported additional positive clinical data at ADA 83rd Scientific Sessions from the first two cohorts of patients with type 2 diabetes from ongoing Phase I/II study (COVALENT-111) evaluating BMF-219 as a novel, potentially disease-modifying treatment candidate for patients with type 2 diabetes o New |
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| July 31, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 31, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| July 25, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 24, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| July 25, 2023 |
BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population EX-99.1 Exhibit 99.1 BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population • Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4 • Dose Level 4 exposure correlates with initial activity seen in BMF-219’s pre-clinical studies • Safe |
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| June 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 14, 2023 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| May 10, 2023 |
BMEA / Biomea Fusion Inc / FMR LLC Passive Investment SCHEDULE 13G Amendment No.0 BIOMEA FUSION INC COMMON STOCK Cusip #09077A106 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #09077A106 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 4,994,817 Item 6: 0 Item 7: 4,994,898 Item 8: 0 Item 9: 4,994,898 Item 11: 14.0 |
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| May 2, 2023 |
Exhibit 99.1 Biomea Fusion Reports First Quarter 2023 Financial Results and Corporate Highlights • Reported initial positive clinical data from first two cohorts of Phase II of ongoing Phase I/II study (COVALENT-111) of BMF-219, Biomea’s lead investigational, orally administered covalent menin inhibitor, as a novel, potentially disease-modifying treatment for patients with type 2 diabetes • Contin |
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| May 2, 2023 |
EX-99.1 Exhibit 99.1 Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia • BMF-500, a novel 3rd generation covalent inhibitor of fms-like tyrosine kinase 3 (FLT3), is the second investigational compound, discovered and developed by Biomea’s FUSION™ System, to advance to the clinic. • Phase |
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| May 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 02, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| May 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| May 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 1, 2023 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File Nu |
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| April 28, 2023 |
DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 28, 2023 |
The company entered 2022 with big plans for BMF-219, an investigational small-molecule, covalent inhibitor of menin. |
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| April 3, 2023 |
Exhibit 1.1 Biomea Fusion, Inc. 5,000,000 Shares of Common Stock, par value $0.0001 per share Underwriting Agreement March 29, 2023 J.P. Morgan Securities LLC Citigroup Global Markets Inc. As Representatives of the several Underwriters listed in Schedule 1 hereto c/o J.P. Morgan Securities LLC 383 Madison Avenue New York, NY 10179 c/o Citigroup Global Markets Inc. 388 Greenwich Street New York, NY |
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| April 3, 2023 |
EX-99.1 Exhibit 99.1 Biomea Fusion Announces Proposed Public Offering of Common Stock REDWOOD CITY, Calif.,– March 29, 2023 – Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, announced tod |
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| April 3, 2023 |
Biomea Fusion Announces Pricing of Upsized Public Offering of Common Stock EX-99.2 Exhibit 99.2 Biomea Fusion Announces Pricing of Upsized Public Offering of Common Stock REDWOOD CITY, Calif., March 29, 2023 – Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, toda |
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| April 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 29, 2023 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| April 3, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) Neb Obradovic Cormorant Asset Management, L.P. 200 Clarendon Street, 52nd Floor Boston, MA 02116 Tel. No.: 857-702-0386 (Name, Address and Telephone |
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| March 30, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-267884 Prospectus supplement (To prospectus dated October 24, 2022) 5,000,000 shares Common stock We are offering 5,000,000 shares of our common stock. Our common stock is listed on The Nasdaq Global Select Market under the symbol “BMEA.” On March 29, 2023, the last reported sale price of our common stock on The Nasdaq G |
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| March 29, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-267884 The information in this preliminary prospectus supplement is not complete and may be changed. A registration statement relating to these securities has been filed with the Securities and Exchange Commission and is effective. This preliminary prospectus supplement and the accompanying prospectus are not an offer to |
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| March 28, 2023 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Biomea Fusion, Inc. None. ACTIVE/115593365.1 |
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| March 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| March 28, 2023 |
EX-99.1 Exhibit 99.1 Biomea Fusion Announces Positive Data from Initial Cohorts of Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes; 100 mg Cohort 3 Demonstrated an 89% Response Rate and 1% Median Reduction in HbA1c at Day 28 • In Cohort 3, after 4 weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients ac |
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| March 28, 2023 |
Exhibit 99.1 Biomea Fusion Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Highlights • Expanded clinical development footprint of BMF-219, the company’s lead investigational, orally administered, covalent menin inhibitor, to eight liquid and solid tumor indications and type 2 diabetes across three ongoing clinical trials o COVALENT-101 (Phase I study) enrolling four liqu |
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| March 28, 2023 |
EX-99.2 Exhibit 99.2 COVALENT-111: Phase II First Data Readout of Initial Healthy Volunteer (HV) and Type 2 Diabetes Mellitus (T2DM) Cohorts March 28, 2023 COVALENT-111 First Data Readout of Initial Cohorts - Conference Call March 28, 2023 Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These |
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| March 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 28, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| March 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 28, 2023 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| February 14, 2023 |
BMEA / Biomea Fusion, Inc. / BAKER BROS. ADVISORS LP - SC 13G Passive Investment SC 13G 1 tm234999d10sc13g.htm SC 13G SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Under the Securities Exchange Act of 1934 (Amendment No. )* Biomea Fusion, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box |
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| February 14, 2023 |
EX-99.1 2 tm234999d10ex99-1.htm EXHIBIT 99.1 EXHIBIT 99.1 AGREEMENT In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended, the undersigned hereby agree that this Statement on Schedule 13G relating to the Common Stock of Biomea Fusion, Inc. is being filed with the Securities and Exchange Commission on behalf of each of them. February 14, 2023 BAKER BROS. ADVISORS |
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| February 10, 2023 |
BMEA / Biomea Fusion, Inc. / Erdtmann Rainer M - SC 13G/A Passive Investment SC 13G/A 1 d438702dsc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to design |
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| February 10, 2023 |
BMEA / Biomea Fusion, Inc. / JANUS HENDERSON GROUP PLC - JHG PLC OWNS >5% Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Amendment No.: 2* Name of Issuer: Biomea Fusion, Inc. Title of Class of Securities: Common Stock CUSIP Number: 09077A106 Date of Event Which Requires Filing of this Statement: 12/31/2022 Check the appropriate box to designate the rule pursuant to which this Schedule is fil |
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| February 10, 2023 |
BMEA / Biomea Fusion, Inc. / Butler Thomas Andrew - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which |
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| January 12, 2023 |
Biomea Fusion to Present at 41 Exhibit 99.1 Biomea Fusion to Present at 41st Annual J.P. Morgan Healthcare Conference and Highlight 2023 Corporate Milestones REDWOOD CITY, Calif., Jan. 9, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined c |
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| January 12, 2023 |
Exhibit 99.2 JP Morgan 2023 Corporate Presentation 1 Disclaimer Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, uncertainties a |
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| January 12, 2023 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2023 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| January 4, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Biomea Fusion, Inc. |
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| January 4, 2023 |
As filed with the U.S. Securities and Exchange Commission on January 4, 2023 As filed with the U.S. Securities and Exchange Commission on January 4, 2023 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 |
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| December 16, 2022 |
Exhibit 99.1 Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes ? COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the US ? As previously reported, the Phase I portion of COVALENT-111 has been completed, with BMF-219 demonstratin |
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| December 16, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 14, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission F |
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| December 13, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 12, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission F |
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| December 13, 2022 |
EX-99.2 3 d424536dex992.htm EX-99.2 Exhibit 99.2 Abstract 2756 ASH Dec. 10 – 13, 2022 BMF-500: An Orally Bioavailable Covalent Inhibitor of FLT3 with High Selectivity and Potent Antileukemic Activity in FLT3-Mutated AML Brian Law, BS1, Tripta Rughwani, MS1, Tenley Archer PhD1, Lekha Kumar, MS1, Daniel Lu, MS1, Priyanka Somanath, PhD1, Yan Ma, PhD1, Xiaodong Wang, MS*1, David Sperandio, PhD1, Steve |
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| December 13, 2022 |
Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on Exhibit 99.1 Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date ? BMF-500, an investigational third generation covalent FLT3 inhibitor, demonstrated preclinically: ? Picomolar affinity to activating FLT3 mutations including FLT3-ITD and various tyrosine kinase domain (TKD) mutations ? Mu |
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| November 25, 2022 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 25, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission F |
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| November 25, 2022 |
EX-1.1 2 d721850dex11.htm EX-1.1 Exhibit 1.1 BIOMEA FUSION, INC. EQUITY DISTRIBUTION AGREEMENT November 25, 2022 PIPER SANDLER & CO. U.S. Bancorp Center 800 Nicollet Mall Minneapolis, Minnesota 55402 Ladies and Gentlemen: As further set forth in this agreement (this “Agreement”), Biomea Fusion, Inc., a company organized under the laws of Delaware (the “Company”), proposes to issue and sell from ti |
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| November 25, 2022 |
Piper Sandler The date of this prospectus supplement is November 25, 2022 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-267884 PROSPECTUS SUPPLEMENT (To prospectus dated October 24, 2022) Up to $100,000,000 Common Stock We have entered into an equity distribution agreement, or the equity distribution agreement, with Piper Sandler & Co., or Piper Sandler, dated November 25, 2022, relating to shares of our common stock offered by this prospectus |
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| November 7, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 07, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission F |
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| November 7, 2022 |
Exhibit 99.1 Biomea Fusion Reports Third Quarter 2022 Financial Results and Business Highlights ? Continued to establish Biomea Fusion as the next-generation leader in covalent medicines ? Expanded clinical development footprint of BMF-219, the company?s lead investigational, orally administered, covalent menin inhibitor, in multiple liquid and solid tumor indications, including first in class pot |
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| November 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| November 1, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 31, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| November 1, 2022 |
Exhibit 99.1 Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219 ? BMF-219 is the first menin inhibitor to reach the clinic for type 2 diabetes. The Phase II portion of COVALENT-111 is designed to examine the capacity of BMF-219 to provide long-term glycemic control by restoring the p |
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| October 20, 2022 |
Biomea Fusion, Inc. 900 Middlefield Road, 4th Floor Redwood City, CA 94063 Biomea Fusion, Inc. 900 Middlefield Road, 4th Floor Redwood City, CA 94063 October 20, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance ? Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 File No. 333-267884 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securi |
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| October 19, 2022 |
United States securities and exchange commission logo October 19, 2022 Mr. Franco Valle Chief Financial Officer Biomea Fusion, Inc. 900 Middlefield Road, 4th Floor Redwood City, CA 94063 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 Filed on October 14, 2022 File No. 333-267884 Dear Mr. Franco Valle: This is to advise you that we have not reviewed and will not review your registration |
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| October 18, 2022 |
BMF-219 Enters the Clinic for KRAS Solid Tumors Exhibit 99.1 BMF-219 Enters the Clinic for KRAS Solid Tumors ? Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. ? Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung ca |
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| October 18, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 14, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| October 14, 2022 |
As filed with the Securities and Exchange Commission on October 14, 2022 Table of Contents As filed with the Securities and Exchange Commission on October 14, 2022 Registration No. |
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| October 14, 2022 |
Form of indenture for senior debt securities and the related form of senior debt security. Exhibit 4.4 BIOMEA FUSION, INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [ ] Senior Debt Securities TABLE OF CONTENTS1 Page Article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 Article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 4 Section 2.01 Designation and Terms of Securities. 4 Section 2.02 Form of Securities and Trustee?s Certificate 6 Sec |
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| October 14, 2022 |
Exhibit 4.5 BIOMEA FUSION, INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [ ] Subordinated Debt Securities TABLE OF CONTENTS1 Page Article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 Article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 4 Section 2.01 Designation and Terms of Securities. 4 Section 2.02 Form of Securities and Trustee?s Certificate |
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| October 14, 2022 |
Exhibit 107 Calculation of Filing Fees Table Form S-3 (Form Type) Biomea Fusion, Inc. |
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| September 23, 2022 |
Exhibit 99.2 Presentation # 197 Oral long-acting menin inhibitor normalizes type 2 diabetes in two rat models *Thomas Butler, Sanchita Mourya, Weiqun Li, Tenley Archer, Taisei Kinoshita, Mini Balakrishnan, Priyanka Somanath EASD Annual Meeting 2022 Oral Presentation Golgi Hall Session: OP 33 Therapy outside the box 1 September 22, 2022 Our understanding of diabetes has evolved; Progression of type |
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| September 23, 2022 |
Exhibit 99.1 Biomea Fusion Presents New Translational Data at the European Association for the Study of Diabetes (EASD) 2022 in Animal Models and Ex-vivo Human Donor Islets Further Supporting BMF-219?s Potential as an Oral, Long-Acting Treatment for Type 2 Diabetes September 22, 2022, at 9:30 AM EDT ???Treatment with BMF-219 led to an increase in beta cell mass in ex-vivo experiments with human do |
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| September 23, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 22, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission |
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| September 22, 2022 |
Exhibit 99.1 Biomea Fusion Presents New Preclinical Data at the European Association for the Study of Diabetes (EASD) Annual Meeting Describing BMF-219?s Potential as a Novel, Oral, Long-Acting Treatment for Type 2 Diabetes September 20, 2022, at 2:45 AM PDT ? Menin, a transcriptional scaffold protein, regulates pancreatic beta cell homeostasis; inhibiting menin function with BMF-219 increased bet |
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| September 22, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 20, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission |
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| September 22, 2022 |
Exhibit 99.2 Presentation #590 Oral Menin Inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a Type 2 Diabetes Rat Model Priyanka Somanath, Sanchita Mourya, Weiqun Li, Tenley Archer, Brian Law, Daniel Lu, Tripta Rughwani, Lekha Kumar, Taisei Kinoshita, Mini Balakrishnan, Thomas Butler EASD Annual Meeting 2022 September 20, 2022 1 Menin: A novel target for beta-cell homeos |
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| September 9, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 7, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission F |
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| September 9, 2022 |
Sublease Agreement between the Registrant and Box, Inc., dated September 7, 2022 Exhibit 10.1 Execution Version SUBLEASE This Sublease (?Sublease?), dated September 7, 2022 (the ?Execution Date?), is entered into by and between BOX, INC., a Delaware corporation (?Sublandlord?), and BIOMEA FUSION, INC., a Delaware corporation (?Subtenant?). 1. BASIC SUBLEASE PROVISIONS 1.1 Premises: The premises under this Sublease are deemed by the parties to consist of 27,003 rentable square |
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| August 29, 2022 |
Exhibit 99.1 Biomea Fusion Presents Additional Preclinical Data Demonstrating Anti- Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Annual Meeting ? Data demonstrated robust anti-tumor activity of BMF-219 and mechanistic evidence for novel inhibition of menin protein in preclinical models of Diffuse L |
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| August 29, 2022 |
Exhibit 99.2 Anti-tumor Activity of Covalent Menin Inhibitor, BMF-219, in High Grade B-Cell Lymphoma and Multiple Myeloma Preclinical Models 1 1 1 1 1 1 1 1 Daniel Lu, MS Priyanka Somanath, PhD , Brian Law, BS , Lekha Kumar, MS , James T. Palmer, PhD , Taisei Kinoshita, PhD , Mini Balakrishnan, PhD and Thomas Butler, MSc MBA , 1 Biomea Fusion, Inc. Redwood City, CA BMF-219 exerts pronounced lethal |
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| August 29, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 26, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| August 29, 2022 |
Exhibit 99.3 COVALENT-101 (NCT05153330) Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral, covalent, menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM) 1 3 3 4 5 6 7 7 7 7 2 Farhad Ravandi, MD ; Hetty Carraway, MD ; Jack Khouri, MD ; Ashwin Kishtagari, MD ; Emily Curran, MD ; Gary Schiller, |
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| August 1, 2022 |
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights ? Continued to make significant progress advancing BMF-219, the company?s lead investigational orally administered covalent menin inhibitor, in multiple oncology indications o COVALENT-101 (Phase I) study is enrolling for patients with Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), D |
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| August 1, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 01, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission Fil |
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| August 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| July 8, 2022 |
BMEA / Biomea Fusion, Inc. / BlackRock Inc. Passive Investment us09077a1060070822.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: ) BIOMEA FUSION, INC. - (Name of Issuer) Common Stock - (Title of Class of Securities) 09077A106 - (CUSIP Number) June 30, 2022 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to whi |
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| June 23, 2022 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 22, 2022 BIOMEA FUSION, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 6, 2022 |
Exhibit 99.2 Menin is a scaffold protein, encoded by the gene MEN1, that has been recently . recognized for its role in Type 2 Diabetes Mellitus (T2DM) as a key regulator of b-cell proliferation. Men1 knockout mice demonstrate increased B-cell mass generation (Yang et al., 2010) Menin inhibition has previously been shown to improve glycemic control in high fat induced diabetic mice (Ma et al., 202 |
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| June 6, 2022 |
Exhibit 99.3 Oral Menin Inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a Type 2 Diabetes Mellitus Rat ModelPriyanka Somanath, PhD1,, Sanchita Mourya, MD1, Weiqun Li, PhD1, Brian Law, BS 1, Tenley Archer, PhD, Daniel Lu, MS, Tripta Rughwani, Lekha Kumar, Taisei Kinoshita, PhD1, Mini Balakrishnan, PhD1 and Thomas Butler, MSc MBA1 1Biomea Fusion, Inc. Redwood City, CAInt |
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| June 6, 2022 |
Preclinical Activity of irreversible menin inhibitor, Exhibit 99.1 Preclinical Activity of irreversible menin inhibitor, BMF-219, in Chronic Lymphocytic LeukemiaPriyanka Somanath, PhD1, Daniel Lu, MS 1 Brian Law, BS 1, Lekha Kumar, MS1, Tenley Archer, PhD, Tripta Rughwani, MS, Taisei Kinoshita, PhD1, Mini Balakrishnan, PhD1 and Thomas Butler, MSc MBA1,1Biomea Fusion, Inc. Redwood City, CAIntroductionMenin is a scaffold protein that drives oncogenic f |
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| June 6, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 4, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File N |
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| May 16, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |
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| May 16, 2022 |
Exhibit 99.1 Biomea Fusion Reports First Quarter 2022 Financial Results and Business Highlights ? COVALENT-101 study continues to enroll relapsed/refractory (R/R) acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients and has included R/R diffuse large B-cell lymphoma (DLBCL) and R/R multiple myeloma (MM) patients to the study. Company continues to explore indication expansion |
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| May 16, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 16, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File N |
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| May 16, 2022 |
Form of Indemnification and Advancement Agreement for Directors and Officers Exhibit 10.1 INDEMNIFICATION And Advancement AGREEMENT This Indemnification and Advancement Agreement (?Agreement?) is made as of [ ? ], 20[ ? ] by and between Biomea Fusion, Inc., a Delaware corporation (the ?Company?), and , [a member of the Board of Directors/an officer/an employee/an agent/a fiduciary] of the Company (?Indemnitee?). This Agreement supersedes and replaces any and all previous A |
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| April 29, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Defin |
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| April 29, 2022 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Defi |
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| April 22, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 19, 2022 Biomea Fusion, Inc. (Exact name of registrant as specified in its charter) Delaware 001-40335 82-2520134 (State or other jurisdiction of incorporation) (Commission File |
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| April 22, 2022 |
FIRST AMENDMENT TO CHANGE IN CONTROL AND SEVERANCE AGREEMENT Exhibit 99.1 FIRST AMENDMENT TO CHANGE IN CONTROL AND SEVERANCE AGREEMENT This First Amendment to Change in Control and Severance Agreement (this ?Amendment?) is executed as of [?], 2022, by and between Biomea Fusion, Inc., a Delaware corporation (the ?Company?), and [?] (the ?Executive?). WHEREAS, the Company and Executive are parties to a certain Biomea Fusion, Inc. Change in Control and Severan |
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| April 8, 2022 |
Exhibit 99.1 Biomea Fusion Reports Preclinical Data on BMF-219 and Trial in Progress Presentations at AACR 2022 Annual Meeting April 8, 2022 ? Covalent menin inhibitor BMF-219 showed strong cytotoxic activity as a single agent at similar concentrations across multiple preclinical patient derived (PDX) models ex vivo, including diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), colorecta |
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| April 8, 2022 |
Exhibit 99.3 |
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| April 8, 2022 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 8, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission File |
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| April 8, 2022 |
Exhibit 99.4 |
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| April 8, 2022 |
Exhibit 99.2 |
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| February 28, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, |
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| February 28, 2022 |
Biomea Fusion Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights Exhibit 99.1 Biomea Fusion Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights ? Phase I trial of BMF-219, an irreversible covalent menin inhibitor, is currently underway ? Plan to initiate trials of BMF-219 in up to seven solid and liquid tumor types and diabetes ? Plan to announce second clinical candidate in the first half of 2022 ? Cash, cash equivalents, restr |
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| February 28, 2022 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Biomea Fusion, Inc. None. ACTIVE/115593365.1 |
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| February 28, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K Biomea Fusion, Inc. Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 28, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commiss |
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| February 14, 2022 |
BMEA / Biomea Fusion, Inc. / Boxer Capital, LLC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biomea Fusion, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2021 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the ru |
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| February 11, 2022 |
BMEA / Biomea Fusion, Inc. / Butler Thomas Andrew - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Sche |
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| February 11, 2022 |
BMEA / Biomea Fusion, Inc. / Erdtmann Rainer M - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Biomea Fusion, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 09077A106 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Sche |
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| February 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Amendment No.: 1* Name of Issuer: Biomea Fusion, Inc. Title of Class of Securities: Common Stock CUSIP Number: 09077A106 Date of Event Which Requires Filing of this Statement: 12/31/2021 Check the appropriate box to designate the rule pursuant to which this Schedule is fil |
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| February 4, 2022 |
BMEA / Biomea Fusion, Inc. / BlackRock Inc. Passive Investment us09077a1060020422.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: ) BIOMEA FUSION, INC. - (Name of Issuer) Common Stock - (Title of Class of Securities) 09077A106 - (CUSIP Number) December 31, 2021 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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| February 2, 2022 |
As filed with the U.S. Securities and Exchange Commission on February 2, 2022 As filed with the U.S. Securities and Exchange Commission on February 2, 2022 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. |
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| February 2, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Biomea Fusion, Inc. |
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| January 12, 2022 |
Exhibit 99.1 Corporate Presentation January 2022 1 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the ?Company?) and involve known and unknown risks, uncertainties and other factors t |
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| January 12, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 12, 2022 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| November 15, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K Biomea Fusion, Inc. Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 11, 2021 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commiss |
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| November 15, 2021 |
Biomea fusion tm Corporate Presentation November 2021 Exhibit 99.1 Biomea fusion tm Corporate Presentation November 2021 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of Biomea Fusion, Inc. (the ?Company?) and involve known and unknown risks, uncertainties and other factor |
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| November 3, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K Biomea Fusion, Inc. Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2021 Biomea Fusion, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40335 82-2520134 (State or Other Jurisdiction of Incorporation) (Commissi |
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| November 3, 2021 |
Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights Exhibit 99.1 Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights ? Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company?s first development candidate from the FUSION platform ? Phase I trial to enroll adult patients with relapsed or refractory acute leukemia, including those with an MLL/KMT2A gene rearrangement or NPM1 mutati |
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| November 3, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40335 Biomea Fusion, Inc. |