• The Vertex Pharmaceuticals of cancer and diabetes drugs.
• Like an early Amgen, focused on innovative cancer and diabetes treatments.
• A clinical-stage Moderna, but aiming for breakthrough cancer and diabetes therapies.

• BMF-219: A covalent menin inhibitor in clinical trials for the treatment of various cancers and type 2 diabetes.
• BMF-500: A preclinical-stage covalent FGL2 inhibitor being developed for solid tumors.
• BMF-227: A preclinical-stage covalent menin inhibitor currently being investigated for potential cancer indications.

Biomea Fusion (BMEA) is a clinical-stage biopharmaceutical company focused on the development of novel medicines for serious diseases, primarily in oncology and metabolic diseases.

As a company in the clinical stage of development, Biomea Fusion does not currently have any commercialized products for sale, and therefore does not have major customers in the traditional sense that purchase goods or services. The company's primary activities involve the research and development of its drug candidates and conducting clinical trials, which are funded through capital raises from investors.

Should any of its drug candidates receive regulatory approval and be commercialized in the future, its eventual customers would primarily be healthcare providers, hospitals, and pharmacies. These entities would then dispense the medicines to individual patients who are prescribed the treatments by their physicians.

Michael J. M. Hitchcock, Ph.D. Interim Chief Executive Officer

Dr. Hitchcock was appointed Interim CEO in March 2025 and has served on Biomea Fusion's board since March 2021. He brings extensive pharmaceutical experience, including 27 years at Gilead Sciences in various vice president roles such as project and portfolio management, alliance management, strategic planning, and medical affairs. Prior to Gilead, he spent 13 years at Bristol-Myers Squibb in infectious disease research and project planning. Dr. Hitchcock was involved in the development and commercialization of anti-infective agents, particularly antivirals for HIV, HBV, influenza, and CMV. He holds a Ph.D. in microbiology from the University of Melbourne, Australia, and B.Sc. and M.Sc. degrees in biochemistry from the University of Manchester Institute of Science and Technology, England. He also conducted post-doctoral research at Georgetown University and NIH. Dr. Hitchcock currently serves as Past Chair of the University of Nevada, Reno (UNR) Foundation and Adjunct Professor of Microbiology at UNR Medical School.

Franco Valle Chief Financial Officer (Resigned effective March 7, 2025)

Mr. Valle was appointed Chief Financial Officer of Biomea Fusion in June 2021 and resigned effective March 7, 2025. Before joining Biomea, he served as Principal Accounting Officer & Senior Vice President of Finance at Eidos, a clinical-stage biopharmaceutical company that merged with BridgeBio for $2.83 billion in 2021. Prior to Eidos, Mr. Valle was the Principal Accounting Officer and Controller at Iovance Biotherapeutics from 2016 to 2018. He also worked at Pharmacyclics, which he joined in 2012 and supported through its merger with Abbvie as Senior Accounting Officer. Mr. Valle began his career in 2005 at Pricewaterhouse Coopers LLP (PWC) within the Life Science, Biotech, and Venture Capital Group. He is a certified public accountant.

Ramses Erdtmann President, Chief Operating Officer and Director

Mr. Erdtmann co-founded Biomea Fusion in August 2017 with Thomas Butler. He has served as President and a member of the board of directors since August 2017, and as Chief Operating Officer since February 2021. Since January 2016, Mr. Erdtmann has been a Managing Member of Point Sur Investors LLC, a biotech investment fund. From 2008 to 2016, he held various leadership roles at Pharmacyclics Inc., including Principal Financial and Accounting Officer and Executive Vice President of Corporate Affairs. Before Pharmacyclics, Mr. Erdtmann founded United Properties Immobilien and Anlagen Gmbh and Oxygen Investments, LLC, which he managed from 1995 to 2009.

Juan Pablo Frías, M.D. Chief Medical Officer

Dr. Frías was appointed Chief Medical Officer of Biomea Fusion in August 2023. He is a board-certified endocrinologist with extensive expertise in diabetes therapeutics. Dr. Frías has served as a principal investigator on over 250 clinical diabetes studies, with more than half being Phase III studies, and contributed to the clinical development of over 20 approved diabetic agents, including Mounjaro, Ozempic, Trulicity, and Farxiga. His career includes leadership positions in Clinical and Medical Affairs at Eli Lilly, Amylin Pharmaceuticals, Pfizer, and Johnson & Johnson, where he was CMO and Global Vice President of Clinical and Medical Affairs, Diabetes Care. He has also held academic positions at the University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes, and the University of California San Diego School of Medicine. Dr. Frías has published over 125 articles in peer-reviewed journals.

Steve Morris, M.D. Chief Development Officer

Dr. Morris transitioned to the role of Chief Development Officer in August 2023, having previously served as Chief Medical Officer from February 2022. He has been a clinical consultant to Biomea Fusion since 2020. Dr. Morris is an internationally recognized physician-scientist and translational investigator with over 30 years of clinical and academic research experience. He leads the clinical development of Biomea's oncology portfolio, including BMF-219 and BMF-500. Since leaving academic medicine, Dr. Morris has served as a consultant or CMO for multiple oncology-focused biotech startups.

The key risks to Biomea Fusion (BMEA) are primarily centered around its financial viability as a clinical-stage biotechnology company, the inherent uncertainties of drug development and regulatory approval, and the highly competitive market for its pipeline candidates.

1. Financial Dependency and Going Concern Risk: Biomea Fusion is a clinical-stage biotechnology company that has not generated revenue from product sales and continues to incur significant operating losses. The company is heavily reliant on securing additional capital to fund its operations, with multiple sources indicating substantial doubt about its ability to continue as a going concern without further financing. This dependency on external funding introduces risks such as market volatility and potential dilution of stockholder value through future equity offerings.
2. Clinical Development and Regulatory Approval Risk: The future prospects of Biomea Fusion are largely contingent on the successful development, clinical trials, and regulatory approval of its lead product candidates, particularly icovamenib for diabetes. The process of preclinical and clinical drug development is lengthy, expensive, and uncertain, and the results from early-stage trials may not predict success in later, larger studies. Past clinical holds, such as the full clinical hold placed on the COVALENT study program due to concerns about possible drug-induced hepatotoxicity, highlight the inherent regulatory uncertainties and potential for setbacks.
3. Market Competition and Strategic Concentration: Biomea Fusion has made a strategic shift to focus predominantly on metabolic disorders, specifically diabetes, and is winding down its oncology programs. While this focus may allow for more efficient resource allocation, it also narrows the company's pipeline and increases its dependence on the success of its diabetes treatments. The diabetes treatment market is highly competitive, featuring numerous established pharmaceutical companies and a constant influx of new therapies. Biomea's success will require its candidates to demonstrate superior efficacy, safety, or convenience compared to existing and emerging treatments to gain market share.

Biomea Fusion (BMEA) is a clinical-stage biopharmaceutical company focused on developing oral small molecules for metabolic diseases and genetically defined cancers. Their primary product candidates, icovamenib (formerly BMF-219) and BMF-650, target several significant markets.

Here are the addressable market sizes for their main product indications:

• Icovamenib (BMF-219) for Type 1 Diabetes: The global market for Type 1 Diabetes is estimated at approximately USD 34.87 billion in 2024, with projections to reach USD 74.03 billion by 2034. The U.S. market alone is valued at about USD 11.23 billion in 2024 and is anticipated to grow to USD 24.27 billion by 2034.
• Icovamenib (BMF-219) for Type 2 Diabetes: The global Type 2 Diabetes market is estimated to be approximately USD 40.09 billion in 2025 and is projected to reach around USD 76.39 billion by 2034. The U.S. Type 2 Diabetes market is valued at roughly USD 10.82 billion in 2025, with an expectation to reach approximately USD 21.05 billion by 2034.
• Icovamenib (BMF-219) for Acute Myeloid Leukemia (AML): The global acute myeloid leukemia treatment market was estimated at USD 3.47 billion in 2024 and is projected to grow to USD 6.29 billion by 2030. North America dominated the global market in 2024 with a 37.6% revenue share, and the U.S. market further dominated North America with a 90.9% share in the same year.
• Icovamenib (BMF-219) for Non-Small Cell Lung Cancer (NSCLC): The Non-Small Cell Lung Cancer treatment market size globally reached USD 21.98 billion in 2025 and is expected to reach USD 36.50 billion by 2030. North America accounted for 42.34% of the market share in 2024.
• Icovamenib (BMF-219) for Chronic Lymphocytic Leukemia (CLL): The chronic lymphocytic leukemia market across the top seven markets (U.S., EU4: Germany, Spain, Italy, France; U.K., and Japan) reached a value of USD 9.3 billion in 2024, with projections to reach USD 15.0 billion by 2035. The U.S. market holds the largest patient pool and represents the largest market for CLL treatment within these regions.

For other oncology indications such as Diffuse Large B-Cell Lymphoma, Multiple Myeloma, Pancreatic Cancer, Colorectal Cancer, and Acute Lymphoblastic Leukemia, and for obesity as a distinct market for BMF-650 (beyond its role in Type 2 Diabetes), specific addressable market sizes directly attributable to Biomea Fusion's products are not explicitly detailed in the provided information. Therefore, these are identified as null.

Biomea Fusion (BMEA) is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules for metabolic diseases, primarily diabetes and obesity. The following are 3-5 expected drivers of future revenue growth for Biomea Fusion over the next 2-3 years:

1. Successful Clinical Development and Commercialization of Icovamenib for Type 2 Diabetes: Biomea Fusion's lead product candidate, icovamenib (formerly BMF-219), has shown promising results in its Phase II COVALENT-111 study for Type 2 Diabetes (T2D). The company reported durable 52-week data demonstrating sustained reductions in HbA1c, a key measure of blood sugar control, particularly in severe insulin-deficient T2D patients. Biomea Fusion plans to initiate two new Phase II trials for icovamenib in different T2D patient subtypes in the fourth quarter of 2025, with the first patient expected in early 2026. The successful progression through these trials and eventual market approval and launch would be a primary driver of revenue.
2. Advancement and Potential Commercialization of BMF-650 for Obesity: Biomea Fusion is also developing BMF-650, a next-generation oral GLP-1 receptor agonist, targeting the significant obesity market. The company has initiated a Phase I clinical trial for BMF-650 to assess its weight loss potential in obese volunteers, following positive preclinical data that demonstrated favorable results in non-human primates, including insulin release, glucose reduction, and appetite suppression. The successful development and eventual commercialization of BMF-650 would open up a substantial new revenue stream.
3. Expansion into Combination Therapies for Metabolic Diseases: Biomea Fusion is exploring and prioritizing combination strategies, particularly for icovamenib with GLP-1-based therapies, for both obesity and diabetes. Preclinical data has already shown enhanced activity when icovamenib is combined with semaglutide in a T2D animal model, demonstrating improved glycemic control and body weight reduction. The successful development and market entry of such combination therapies could expand the addressable patient population and enhance product value, driving additional revenue growth.

Share Issuance

• Biomea Fusion completed a public offering in June 2025.
• In October 2025, the company priced an underwritten public offering, expecting to generate approximately $25.0 million in gross proceeds from the sale of common stock and warrants.
• As of November 4, 2025, the number of shares outstanding increased by 20.63% over one year, reaching 70.70 million.

Capital Expenditures

• Over the last 12 months, Biomea Fusion's capital expenditures amounted to -$82,000.
• In Q3 2025, a $2.2 million non-cash impairment was recorded following the cessation of laboratory use for research and development.
• Capital expenditures are primarily focused on supporting the company's clinical-stage development of oral small molecule drugs for metabolic diseases, including icovamenib and BMF-650.