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 |
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(State or other jurisdiction |
(Commission File Number) |
(IRS Employer |
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900 Middlefield Road, 4th Floor |
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Redwood City, California |
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94063 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: 650 980-9099 |
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Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, $0.0001 par value |
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BMEA |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 31, 2025, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended and year ended December 31, 2024. The full text of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Biomea Fusion, Inc. |
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Date: |
March 31, 2025 |
By: |
/s/ Michael J.M. Hitchcock |
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Interim Chief Executive Officer, Director |
Exhibit 99.1
Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights
REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company reported fourth quarter and full year 2024 financial results and corporate highlights.
"2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "As we move into this next phase, the Board made a strategic decision to align leadership with the company’s evolution, and I’m honored to step in and contribute decades of experience in late-stage development, regulatory strategy, and commercialization to help guide Biomea forward. This transition reflects the continued confidence in our menin inhibitor program and the strength of our covalent small molecule platform. We remain fully committed to advancing icovamenib and delivering on our mission to transform diabetes treatment through this disease-modifying therapy. With key data readouts and regulatory milestones ahead, 2025 is set to be a pivotal year for the company.”
In March 2025, the Company announced a leadership transition, appointing Board member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler.
In January 2025, we announced plans to position Biomea as a dedicated diabetes and obesity medicines company. Building on our most recent clinical trial results, our strategic focus for icovamenib is now exclusively centered on metabolic disorders. As a result, we are terminating all ongoing oncology trials involving icovamenib and will conclude the BMF-500 study in patients with relapsed/refractory acute leukemia with FLT3 gene mutations following the dose escalation phase. Biomea will seek strategic partnerships to advance its oncology portfolio and the capabilities of its FUSION™ System, while reallocating internal resources to accelerate our metabolic disease programs.
In October 2024, we announced the formation of our Global Scientific Advisory Board, comprised of 22 internationally recognized experts in beta cell science and diabetes therapeutics. This board will work closely with our leadership team as we continue to explore menin biology and beta cell regeneration, and advance the clinical development of icovamenib as a novel, disease-modifying treatment targeting a root cause of diabetes.
RECENT DIABETES AND OBESITY PROGRAM UPDATES
COVALENT-111 (Icovamenib for Type 2 Diabetes ("T2D"))
Study Results:
Preclinical Findings:
Anticipated 2025 Milestones:
COVALENT-112 (Icovamenib for Type 1 Diabetes ("T1D"))
Anticipated 2025 Milestones:
BMF-650 (Oral small molecule GLP-1 RA)
Preclinical Progress:
Anticipated 2025 Milestones:
ONCOLOGY PROGRAM
COVALENT-103 Study (BMF-500):
Anticipated 2025 Milestones:
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
About Icovamenib
Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea Fusion’s FUSION™ System and is designed to regenerate insulin-producing beta cells with the aim to cure diabetes. Icovamenib’s proposed mechanism of action in diabetes is to enable the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the potentially first disease-modifying therapy for T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed clinical studies.
About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and metabolic diseases. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.
We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.
Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib, BMF-500, and BMF-650, the potential of icovamenib as a treatment for T12 and T2D, the potential of BMF-650 as a treatment for diabetes and obesity, our research, development and regulatory plans, and our expectations regarding the Biomea FUSION™ System; the mechanism of action of our product candidate and development programs, and their potential relative to approved products marketed by third parties; the potential benefits to future trial design and program development of subtyping diabetes patients and their potential to be used in combination with approved products marketed by third parties; our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, including our Phase I/II COVALENT-111 study of icovamenib in T2D, our Phase II COVALENT-112 study of icovamenib in T1D, and IND enabling studies for the BMF-650 program, the anticipated enrollment and dosing of patients and availability of data from our clinical trials, and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter.
Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
mweiss@biomeafusion.com
- See attached for financial tables -
BIOMEA FUSION, INC.
Condensed Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development (1) |
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$ |
25,240 |
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$ |
30,866 |
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$ |
118,085 |
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$ |
102,546 |
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General and administrative (1) |
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4,834 |
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6,462 |
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25,985 |
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23,589 |
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Total operating expenses |
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30,074 |
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37,328 |
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144,070 |
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126,135 |
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Loss from operations |
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(30,074 |
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(37,328 |
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(144,070 |
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(126,135 |
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Interest and other income, net |
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772 |
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2,444 |
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5,644 |
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8,880 |
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Net loss |
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$ |
(29,302 |
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$ |
(34,884 |
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$ |
(138,426 |
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$ |
(117,255 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net |
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— |
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— |
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— |
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1 |
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Comprehensive loss |
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$ |
(29,302 |
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$ |
(34,884 |
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$ |
(138,426 |
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$ |
(117,254 |
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Net loss per common share, basic and diluted |
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$ |
(0.81 |
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$ |
(0.98 |
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$ |
(3.83 |
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$ |
(3.44 |
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Weighted-average number of common shares used to |
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36,265,001 |
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35,754,165 |
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36,105,671 |
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34,106,923 |
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(1) Includes stock-based compensation as follows (non-cash operating expenses):
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Research and development |
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$ |
2,344 |
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$ |
2,031 |
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$ |
9,816 |
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$ |
6,933 |
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General and administrative |
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2,146 |
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1,833 |
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9,278 |
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7,198 |
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Total stock-based compensation expense |
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$ |
4,490 |
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$ |
3,864 |
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$ |
19,094 |
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$ |
14,131 |
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BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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December 31, |
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents, and restricted cash |
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$ |
58,648 |
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$ |
177,236 |
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Working capital |
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46,659 |
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156,321 |
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Total assets |
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79,938 |
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199,927 |
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Stockholders' equity |
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51,573 |
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169,237 |
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