BMEA 8-K
Biomea Fusion, Inc. (BMEA)
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
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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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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 August 5, 2026, Biomea Fusion, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. 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: |
August 5, 2026 |
By: |
/s/ Michael J.M. Hitchcock |
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Michael J.M. Hitchcock |
Exhibit 99.1
Biomea Fusion Reports Second Quarter 2026 Financial Results and Corporate Highlights
SAN CARLOS, Calif., August 5, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the second quarter ended June 30, 2026, and provided a business update.
“The second quarter marked continued execution across our diabetes and obesity programs. We are near completion of enrollment in our COVALENT-211 Phase II clinical trial, continue to advance enrollment in COVALENT-212, and remain on track to report initial 28-day clinical weight reduction data from our BMF-650 Phase I clinical trial in the third quarter," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion."The Type 1 diabetes data presented at the American Diabetes Asociation's Scientific Sessions strengthened our confidence in icovamenib's potential to preserve and improve endogenous insulin secretion, providing additional evidence that this program may have potential to address a significant unmet need. We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program.”
Recent Corporate Highlights:
Icovamenib
Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes
BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity
Second Quarter 2026 Financial Results
About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; clinical and therapeutic potential of our product candidates and development programs, including icovamenib and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our plans to initiate a Phase II clinical trial in T1D, our Phase II COVALENT-211 clinical trial, our Phase II COVALENT-212 clinical trial and our Phase I GLP-131 clinical trial; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events; and our expected cash runway 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
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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Six Months Ended |
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June 30, |
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June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development (1) |
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$ |
9,142 |
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$ |
16,566 |
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$ |
18,262 |
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$ |
39,463 |
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General and administrative (1) |
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3,624 |
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4,710 |
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7,278 |
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11,525 |
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Total operating expenses |
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12,766 |
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21,276 |
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25,540 |
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50,988 |
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Loss from operations |
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(12,766 |
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(21,276 |
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(25,540 |
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(50,988 |
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Change in fair value of common warrant liability |
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4,119 |
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227 |
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3,538 |
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227 |
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Gain on sale of property and equipment |
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— |
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— |
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510 |
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— |
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Interest and other income, net |
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319 |
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309 |
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749 |
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759 |
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Net and comprehensive loss |
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$ |
(8,328 |
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$ |
(20,740 |
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$ |
(20,743 |
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$ |
(50,002 |
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Net loss per common share, basic and diluted |
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$ |
(0.12 |
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$ |
(0.51 |
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$ |
(0.29 |
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$ |
(1.29 |
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Weighted-average number of common shares |
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72,360,235 |
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40,630,403 |
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72,330,005 |
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38,639,834 |
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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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Six Months Ended |
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June 30, |
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June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Research and development |
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$ |
779 |
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$ |
1,568 |
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$ |
1,563 |
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$ |
3,488 |
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General and administrative |
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808 |
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1,005 |
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1,606 |
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2,254 |
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Total stock-based compensation expense |
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$ |
1,587 |
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$ |
2,573 |
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$ |
3,169 |
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$ |
5,742 |
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BIOMEA FUSION, INC.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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June 30, |
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December 31, |
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2026 |
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2025 |
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Cash, cash equivalents, and restricted cash |
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$ |
35,193 |
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$ |
56,181 |
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Working capital |
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$ |
25,576 |
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$ |
46,949 |
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Total assets |
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$ |
36,873 |
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$ |
58,572 |
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Stockholders' equity |
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$ |
12,137 |
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$ |
29,552 |
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