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Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights

Key Takeaway: Biomea Fusion reported its third quarter 2025 financial results, highlighting significant advancements in its clinical programs. The company announced promising Phase II data for icovamenib, demonstrating effective HbA1c reduction in target populations. Additionally, Biomea successfully completed a public offering, raising approximately $25 million to support its operations and clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Icovamenib shows promising Phase II data with significant HbA1c reduction.
  • Successful public offering raised $25 million for future operations.
  • Company streamlined operations, reducing expenses by over 50%.

Full Press Release Details

SAN CARLOS, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the third quarter ended September 30, 2025, and provided a business update.
"Since I joined the company we have reduced our expenses and focused the team on our core assets, advancing them to the next clinical milestones. During the third quarter we streamlined the operations, bringing the workforce down to approximately 40 employees. In addition, we released promising Phase II icovamenib data, which then provided the necessary tailwind to gain funding into 2027,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “Icovamenib demonstrated continued reduction in HbA1c, nine months-post dosing in both of our identified target populations while maintaining a safety profile similar to placebo. These findings support our thesis that menin inhibition can potentially address the underlying cause of diabetes. Icovamenib is now moving rapidly into two Phase II studies enrolling each of these patient subtypes. With BMF-650, we also made great progress and have now dosed our first patient in a Phase I study.”

Third Quarter Highlights:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (“T1D”))

BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

Financing & Operations

In October 2025, Biomea completed its previously announced underwritten public offering. The gross proceeds from the offering were approximately $25.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea.
During the third quarter, Biomea continued to reduce its expenses, achieving a year-over-year decrease of more than 50% in operating expenses.

Key Anticipated Milestones:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)

BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

Third Quarter 2025 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 Phase I/II COVALENT-111 study of icovamenib in T2D, our Phase II COVALENT-112 study of icovamenib in T1D, and our Phase I trial for BMF-650;  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 WeissSr. Director of Investor Relations and Corporate Developmentmweiss@biomeafusion.com
BIOMEA FUSION, INC.Condensed Statement of Operations and Comprehensive Loss(Unaudited)(in thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
Operating expenses:
Research and development(1) $ 14,401 $ 27,244 $ 53,864 $ 92,845
General and administrative(1) 4,199 6,795 15,724 21,151
Impairment of long-lived assets 2,205 2,205
Total operating expenses 20,805 34,039 71,793 113,996
Loss from operations (20,805 ) (34,039 ) (71,793 ) (113,996 )
Interest and other income, net 4,398 1,252 5,384 4,872
Net loss and comprehensive loss $ (16,407 ) $ (32,787 ) $ (66,409 ) $ (109,124 )
Net loss per common share, basic and diluted $ (0.27 ) $ (0.91 ) $ (1.45 ) $ (3.03 )
Weighted-average number of shares used tocompute basic and diluted net loss per common share 59,848,325 36,220,736 45,787,018 36,052,173
(1)Includes stock-based compensation as follows (non-cash operating expenses):
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
Research and development $ 1,075 $ 2,478 $ 4,563 $ 7,472
General and administrative 865 2,264 3,119 7,132
Total stock-based compensation expense $ 1,940 $ 4,742 $ 7,682 $ 14,604
BIOMEA FUSION, INC.Condensed Balance Sheet Data(Unaudited)(in thousands)
September 30, December 31,
2025 2024
Cash, cash equivalents, and restricted cash $ 47,011 $ 58,648
Working capital $ 33,875 $ 46,659
Total assets $ 55,187 $ 79,938
Stockholders' equity $ 15,619 $ 51,573

Frequently Asked Questions

What were the key highlights from Biomea's Q3 2025 results?

Biomea reported promising Phase II data for icovamenib and raised $25 million through a public offering.

What is icovamenib used for?

Icovamenib is an oral small molecule menin inhibitor targeting Type 2 Diabetes and Type 1 Diabetes.

How much did Biomea raise in its recent public offering?

Biomea raised approximately $25 million in its recent underwritten public offering.

What progress has been made with BMF-650?

Biomea has dosed its first patient in a Phase I study for BMF-650, targeting obesity.

Last updated: Nov 4, 2025