2 weeks Ago By [email protected] (MENAFN)
REDWOOD CITY, Calif., Oct. 29, 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 improve the lives of patients with diabetes, obesity, and genetically defined cancers, today reported third quarter 2024 financial results and corporate highlights. “Our third quarter was a pivotal quarter for the company. Through collaborative efforts with the FDA, we efficiently resolved the clinical hold on our studies for diabetes, while keeping the expansion study readout in type 2 diabetes on track and continuing to make fundamental progress with the third development program, BMF-650.
We are pleased to announce the advancement of our third clinical development candidate – a next-generation oral small molecule GLP-1 receptor agonist. Incretins have become the backbone of obesity treatment, and we believe icovamenib in combination with an incretin together can potentially become the backbone of both diabetes and obesity treatments. We have done extensive preclinical work combining icovamenib with a GLP-1 RA-based therapy and will be sharing this data together with an update on BMF-650 during our conference call on October 30th,” stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board.
“We are very excited for the planned remaining readouts this year, in particular the topline Week 26 data of Phase 2b COVALENT-111 with approximately 200 type 2 diabetes patients, which will help us define those patients that demonstrate response to icovamenib and will shape the Phase 3 patient population we should target.” DIABETES & OBESITY COVALENT-111 (icovamenib for Type 2 Diabetes) & COVALENT-112 (icovamenib for Type 1 Diabetes) Anticipated Milestones: BMF-650 (Oral, Small-Molecule GLP-1 RA) Anticipated Milestones: ONCOLOGY COVALENT-101 (icovamenib for Liquid Tumors) Anticipated Milestone: COVALENT-102 (icovamenib for Solid Tumors) Anticipated Milestone: COVALENT-103 (BMF-500 for Acute Leukemias) Anticipated Milestone: FUSIONTM SYSTEM DISCOVERY PLATFORM Anticipated Milestone: THIRD QUARTER 2024 FINANCIAL RESULTS About Biomea Fusion Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. 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 FUSIONTM 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, our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, the anticipated enrollment of patients and availability of data from our clinical trials, anticipated milestones, and the timing of such events, and our expectations regarding the Biomea FUSIONTM Platform and our plans to announce a third development candidate, 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 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 (the“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. - See attached for financial tables - (1) Includes stock-based compensation as follows (non-cash operating expenses): MENAFN29102024004107003653ID1108830931 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind.
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