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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): January 13, 2025

 

 

Biomea Fusion, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-40335   82-2520134

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

900 Middlefield Road, 4th Floor

Redwood City, CA

  94063
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 980-9099

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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value   BMEA   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 8.01.

Other Events.

On January 13, 2025, Biomea Fusion, Inc. (the “Company”) issued a press release titled, “Biomea Fusion to Become a Diabetes & Obesity Medicines Company.” The information described in the press release was presented by the Company in an updated corporate presentation at the 43rd Annual J.P. Morgan Healthcare Conference, which took place from January 13-16, 2025 in San Francisco, California.

Copies of the press release and the Company’s presentation are attached to this Current Report on Form 8-K as Exhibits 99.1 and 99.2 and are incorporated herein by reference.

Forward-Looking Statements

Statements made or incorporated by reference in this Current Report on Form 8-K 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 the Company’s product candidates and development programs, their mechanism of action, 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; the Company’s research, development and regulatory plans, including the Company’s plans to engage with the U.S. Food and Drug Administration, the progress of the Company’s ongoing and planned clinical trials, including anticipated data readouts from such trials, and the timing of such events may be deemed to be forward-looking statements. The Company intends 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 is making this statement for purposes of complying with those safe harbor provisions.

Any forward-looking statements made or incorporated by reference in this Current Report on Form 8-K are based on the Company’s current expectations, estimates and projections only as of the date of this Current Report on Form 8-K 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 ongoing or 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 the Company’s ongoing and planned clinical trials and other research and development activities. These risks concerning the Company’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. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

   Description
99.1    Press release titled, “Biomea Fusion to Become a Diabetes & Obesity Medicines Company.”
99.2    Corporate Slide Presentation of Biomea Fusion, Inc.
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.

 

    BIOMEA FUSION, INC.
Date: January 15, 2025     By:  

   /s/ Thomas Butler

               Thomas Butler
               Principal Executive Officer

Exhibit 99.1

 

 

LOGO

 

Biomea Fusion to Become a Diabetes & Obesity Medicines Company

January 13, 2025

Icovamenib & BMF-650 (oral small molecule GLP-1) are the cornerstones

of the metabolic franchise

Biomea preparing icovamenib for late-stage clinical development

2025 corporate update to be presented at the 43rd Annual J.P. Morgan Healthcare Conference

REDWOOD CITY, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” 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 announced today that the company will become a diabetes and obesity medicines company. Based on the most recent clinical trial results, the strategic focus for icovamenib will be in metabolic disorders. The company will prioritize insulin deficient patients and combination strategies with GLP-1-based therapies for obesity and diabetes. Biomea plans to conclude its studies exploring icovamenib’s potential in oncology and explore partnerships to further advance its oncology assets, while concentrating internal resources on metabolic disorders.

Icovamenib, a potential first-in-class menin inhibitor for the treatment of diabetes, demonstrated the strongest activity in patients with the lowest insulin production

Placebo adjusted 1.5% mean reduction in HbA1c (a measure of blood glucose control) in severe insulin deficient patients uncontrolled on one or more antidiabetic agents at baseline.

Icovamenib showed strong activity in patients uncontrolled on GLP-1-based therapies

Placebo adjusted mean HbA1c reduction of 1.0% in patients suboptimally controlled at baseline with GLP-1-based therapies, consistent with preclinical findings demonstrating enhanced GLP-1 receptor expression and increased glucose-stimulated insulin secretion with the combination of icovamenib and a GLP-1-based therapy such as semaglutide.

Icovamenib demonstrated statistically significant and clinically meaningful benefits validating the mechanism of action

Greater clinical benefits were achieved in patients who were most insulin deficient.

Icovamenib achieved these results while patients were off treatment for 14 weeks

Patients received icovamenib for only 12 weeks, with a primary follow up at Week 26.

Icovamenib was well tolerated and demonstrated a favorable safety profile

No adverse-event related discontinuations, hypoglycemic events, or serious adverse events were reported.

In the prespecified subgroup of severely insulin deficient patients, all patients (100%) responded to 100mg of icovamenib for 12 weeks, displaying a durable reduction in HbA1c 14 weeks after treatment completion, with a continued decline in mean HbA1c while off therapy. In the United States and Europe, these patients represent approximately 20% of the type 2 diabetes patient population. They typically have the lowest insulin production, highest unmet medical need, highest all-cause mortality and worst cardiovascular outcomes. These patients can be easily identified using their HbA1c and body mass index (BMI). These results give us great hope to have identified a pathway with the potential to address diabetes at the root cause level, the depleted pool and function of beta cells. We plan to present further results of the COVALENT-111 trial at an upcoming medical conference.

In preclinical in vivo studies of icovamenib in combination with GLP-1-based therapies, icovamenib demonstrated encouraging metabolic benefits, including superior glycemic control, enhanced beta cell function, significant body weight reduction and improved lean muscle mass. We believe these findings not only underscore the potential for icovamenib to enhance GLP-1-based therapies but also highlight its promise as a disease-modifying agent. Further clinical evaluation will follow, with additional insights anticipated during the J.P. Morgan Conference. Biomea will discuss its clinical plan with FDA to support these two patient groups and move into late-stage development. The current plan includes the following two clinical trials:

 

   

Phase 2/3 (adaptive design): icovamenib in patients with insulin deficient type 2 diabetes (HbA1c >8.5% and BMI <32 kg/m2), uncontrolled at baseline on current antidiabetic medication

 

   

Phase 2b: icovamenib in combination with a GLP-1-based therapy in patients uncontrolled on a GLP-1-based therapy at baseline and in patients initiating a GLP-1-based therapy

“We are excited to focus our efforts on metabolic disorders and to accelerate the development of icovamenib in 2025,” said Thomas Butler, Chief Executive Officer of Biomea Fusion. “Our decision reflects the significant potential we see in addressing the insulin deficient patients and those initiating or failing on a GLP-1-based therapy. Today we have a clear understanding of where our menin inhibitor icovamenib has the most impact and which patient population has the most potential benefit. We can easily identify those patients using HbA1c and BMI alone. Icovamenib was only dosed for 12 weeks in our study COVALENT-111, yet we saw continued reductions in HbA1c 3 months thereafter. We look forward to seeing the 52-week data as we expect the responses to further deepen beyond Week 26.”


JP Morgan Presentation Information

Thomas Butler, Chief Executive Officer and Chairman of the Board, will present on the company and its plans for 2025 at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 1:30 PM Pacific Time / 4:30 PM Eastern Time. Additionally, Biomea’s management team will be hosting one-on-one meetings throughout the conference, taking place from January 13 to January 16.

A live audio webcast of the presentation can be accessed here or by visiting the Investors & Media section of Biomea’s website at https://investors.biomeafusion.com/news-events/events. A replay of the webcast will be available following the live presentation.

About lcovamenib

lcovamenib 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. lcovamenib’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 type 1 diabetes and type 2 diabetes, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies.

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 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, their mechanism of action, 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 including our plans to engage with the U.S. Food and Drug Administration, progress of our ongoing and planned clinical trials, including anticipated data readouts from such 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 ongoing or 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:

Ramses Erdtmann

COO & President of Biomea Fusion

re@biomeafusion.com

Exhibit 99.2

 

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Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference—January 15, 2025


LOGO

Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. All statements other than statements of historical fact could be deemed forward-looking, including any projections of financial information or profitability, the initiation, timing and results of pending or future preclinical studies and clinical trials, the actual or potential actions of the Food and Drug Administration (FDA), the status and timing of ongoing research, development and corporate partnering activities, any statements about historical results that may suggest trends for the Company’s business; any statements of the plans, strategies, and objectives of management for future operations and any statements of expectation or belief regarding future events, potential markets or market size, or technology developments. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission (the SEC), as well as discussions of potential risks, uncertainties, and other important factors in our other subsequent filings with the SEC. The forward-looking statements in this presentation are made only as of the date hereof. Except as required by law, the Company assumes no obligation and does not intend to update these forward-looking statements or to conform these statements to actual results or to changes in the Company’s expectations. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. J.P. Morgan Healthcare Conference – January 15, 2025 Slide 2


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Biomea Fusion: A Diabetes and Obesity Medicines Company Study Indications Anticipated Milestones for 2025 COVALENT-111 Type 2 Diabetes 2H 2025: 52 Week Data Phase 2 Icovamenib COVALENT-112 Type 1 Diabetes 2H 2025: Open Label Data (BMF-219) Phase 2 Menin Program (Potential Type 2 Diabetes COVALENT- 311 1H 2025 Meet with FDA to Discuss Phase II/III (Adaptive Severe Insulin Deficient Best-In-Class) Phase 2/3 Design) and Advance to Late-stage Development Diabetes COVALENT-211 Type 2 Diabetes 1H 2025 Meet with FDA to Discuss Phase II and Initiate Phase 2 GLP-1RA combination Combination Study BMF-650 GLP-1R Agonist IND-Enabling Diabetes/Obesity 2H 2025 IND Cleared and First Participant Dosed (Potential Best-In- Studies Class) BMF-500 COVALENT-103 AML/ALL Dose Escalation Completion – Partnering Strategy FLT-3 Program Phase 1 (Acute Leukemia) J.P. Morgan Healthcare Conference – January 15, 2025 Slide 3


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A Long History of Developing Multi-Billion Dollar Drugs—Together Thomas Butler Ramses Erdtmann Juan Frías, M.D. Naomi Cretcher Heow Tan Franco Valle Chairman & CEO President & COO Chief Medical Chief of People Chief Technical & Chief Financial Officer Quality Officer Officer Co-Founder Co-Founder The FUSIONTM SYSTEM icovamenib* Co-Inventor Co-Inventor J.P. Morgan Healthcare Conference – January 15, 2025 Slide 4


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Icovamenib & BMF-650 (Oral Small Molecule GLP-1 RA) to Become Cornerstones of Our Metabolic Franchise Our Strategic Focus Anticipated Key Milestones for 2025 • Biomea to prioritize the development of 1H: 2025 icovamenib to address critical needs in the metabolic disease space • Meet with the FDA to discuss icovamenib clinical development plan • Previously announced COV-111 positive topline data and in-vivo GLP-1 RA combination data 2H:2025 supports focus • COV-111 52-Week Data • Icovamenib development in type 2 diabetes to • COV-112 Open Label Data focus on patients with severe insulin deficiency • IND filing for BMF-650 and on patients treated with GLP-1 RA therapies • Advance icovamenib in late-stage development for type 2 diabetes • Initiate Phase I for BMF-650 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 5


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Icovamenib Value Proposition Key Benefits of Icovamenib • First-in-class therapy with a novel mechanism of action • Unique treatment effect: Durable treatment impact on beta cell function and incretin effect • Oral, once-daily, 12-week treatment • Has enhanced endogenous insulin production • Has improved beta cell function* • Has promoted body weight loss * • Has increased proportion of lean mass / preserve lean mass* Development Rationale • People with the lowest insulin production demonstrate the highest all-cause mortality, and the highest treatment failure • Icovamenib has demonstrated superior treatment efficacy in this patient population • Has promoted weight loss and increases muscle mass pct when combined with a GLP-1 RA therapy* • Supports GLP-1 RA combination, GLP-1 RA mono as maintenance post combination • Supports Novel-Novel combo with oral small molecule GLP-1 RA *in preclinical studies J.P. Morgan Healthcare Conference – January 15, 2025 Slide 6


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1 in 3 Americans will Develop Diabetes During Their Lifetime—CDC In the U.S. 80% of people with diabetes will die from diabetes.1 Premature mortality caused by diabetes results in an estimated 12-14 years of life lost.2 Diabetes creates one of the largest economic burdens on the U.S. health care system. $1 out of every $4 in U.S. health care costs is being spent on caring for people with diabetes. There are over 60+ approved type 2 diabetes therapies but none of them address the root cause of the disease. In the US today, 38.4 Million adults have diabetes, and 97.6 Million have prediabetes3 Over 800 million adults globally are living with diabetes4 Today diabetes remains poorly controlled in approximately 50% of patients treated with standard of care agents4 J.P. Morgan Healthcare Conference – January 15, 2025 1. Tabish Int J Health Sci. 2007 Jul;1(2):V–VIII. 2. National library of Medicine 1(2); 2007 Jul PMC3068646 3. CDC National Diabetes Statistics Report accessed January 2025 4. Zohu Lancet 2024; 404: 2077–93 Slide 7


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Challenges with Current Standard of Care 6 months 12 months 18 months GLP-1 RAs 50-75% Discontinue @ 12mos1 SGLT2i 69% Discontinue @ 18mos2 DPP-4i 74% Discontinue @ 18mos2 Reasons for Discontinuations • Side Effects • Glycemic Control Not Met • Injection Aversion • Cost and Affordability 1. Khan, et al. JAMA 2024 doi:10.1001/jama.2024.22284. 2. Alkabbani W, et al. Diabetes Obes Metab. 2023;25:3490-3500 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 8


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Current Diabetes Treatments: Despite Initial Effectiveness There is No Lasting Impact Mean time to Loss of Glucose Control (A1c>7%) Nathan, et al. N Engl J Med 2022;387:1063-107 Impact of tirzepatide on HbA1c: Sustained Reduction During Treatment, Rebound After Discontinuation Kubota M, et al. Cureus. 2023 Oct 4;15(10) • Average time to loss of glucose control ranges from less than 2 years to just over 2.4 years • Highlights the progressive nature of diabetes and the inability of current therapies to provide lasting glycemic control • HbA1c levels rebound during the 52-week off-treatment phase, approaching baseline levels • Continuous therapy is necessary to sustain glycemic control with current treatments • There is a need for novel, durable solutions to improve long-term outcomes for diabetes patients J.P. Morgan Healthcare Conference – January 15, 2025 Slide 9


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Type 2 Diabetes Today—Chronic and Stacked Treatments to Overcome B-cell Loss Adapted from IQVIA disease analyser Nov 2022; UCSF FAQ; Diabetes.org Fast Facts J.P. Morgan Healthcare Conference – January 15, 2025 Slide 10


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Current Treatment Landscape in Type 2 Diabetes Adults with type 2 diabetes see multiple agents over time Agents are prescribed to drive Medication patients to glycemic target Stacking Agents are prescribed for extra-glycemic benefit Higher the baseline HbA1c, higher # of agents are needed Current type 2 diabetes agents yield poor compliance Oral is the preferred route versus injectable High Discontinuation Difficult to continue Rates “medication for life” Poor tolerability at the most effective dose levels Adults with Type 2 Diabetes Cycle Through Many Therapies to Tackle Their Disease J.P. Morgan Healthcare Conference – January 15, 2025 Slide 11


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Type 2 Diabetes (T2D) is a Heterogeneous Disease – Two Core Drivers Analysis from two independent 4,000 patient studies, (ADOPT and RECORD) INSULIN DEFICIENT DIABETES Severe insulin-deficient diabetes (SIDD) low BMI, severe beta-cell dysfunction, low insulin resistance, and high HbA1c, often with early onset and a high risk of complications. 18% Median HOMA-B 49% Median HbA1c 8.3% Median BMI 29 kg/m2 Mild age-related diabetes (MARD) older age at onset, normal to slightly elevated BMI, mild beta-cell dysfunction, low insulin resistance, and slow disease progression 39% Median HOMA-B 64% Median HbA1c 7.0% Median BMI 29 kg/m2 Adjusted from: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/abstract “Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables“ Ahlqvist et al. Diabetes 2020;69:2086–2093 | https://doi.org/10.2337/dbi20-0001 INSULIN RESISTANT DIABETES Mild obesit related diabetes (MOD) high BMI, insulin resistance, preserved beta-cell function, and a strong link to obesity with moderate HbA1c levels. 22% Median HOMA-B 74% Median HbA1c 7.2% Median BMI 36 kg/m2 Severe insulin resistant diabetes (SIRD) high BMI, severe ins resistance, normal elevated insulin production, and a hi risk of cardiovascul disease and metab complications. 15% Median HOMA-B 101% Median HbA1c 7.0% Median BMI 34 kg/m2 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 12


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What is a SIDD patient? • SIDD Patients have the lowest insulin production out of all adults with type 2 diabetes • They represent the highest unmet medical need, displaying the highest all-cause mortality and worst CV outcomes • They have the highest treatment failure rate among adults with type 2 diabetes • They represent approximately 18% of the type 2 diabetes patient population (approx. 14M U.S./EU and 50 Million in Asia) • They typically present with a BMI less than 32 kg/m2 and a baseline HbA1c of at least 8.5% Reduce the proportion of adults with diabetes who have an A1c value above 9 percent — D-03—Healthy People 2030 | odphp.health.gov Severe insulin-deficient diabetes (SIDD) 18% Low Insulin Resistance Low Insulin Production Lower BMI J.P. Morgan Healthcare Conference – January 15, 2025 Slide 13


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Icovamenib: First-in-Class Product Candidate for the Treatment of Diabetes Mechanism of Action: Selective & Partial Menin Inhibition Dual Effect Beta Cell Quantity & Function Increased beta cell mass and function Increased Insulin Synthesis and Secretion GLP-1 Expression Increased GLP-1 Receptor Expression & Incretin Effect Enhanced Weight Loss with Preservation of Muscle Mass* *in preclinical studies J.P. Morgan Healthcare Conference – January 15, 2025 Slide 14


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COVALENT-111 Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes


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Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes (T2D) An ongoing dose-finding study evaluating the addition of icovamenib in T2D patients with uncontrolled glycemia on standard of care Patients receive icovamenib for a fixed treatment period, up to 12 weeks Durability of treatment effect is measured at Week 26 and Week 52 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 16


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Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes A dose-finding study in T2D patients on standard of care with uncontrolled glycemia Prespecified subgroup analysis to include review of HbA1c reduction within each subgroup (SIDD, MARD, MOD, and SIRD) Statistical Subgroup analysis based on algorithm Analysis Plan for established per Ahlqvist E, et al. Lancet Diabetes Endocrinol. 2018;6:361-369 COVALENT-111 Arm A, B, C primary analysis of HbA1c reduction J.P. Morgan Healthcare Conference – January 15, 2025 Slide 17


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Icovamenib Met the Primary Endpoint: Statistically Significant in Key Patient Population Arm A: 8 weeks of dosing 100mg QD Arm B: 12 weeks of dosing 100 mg QD Arm C: 8 weeks of 100 mg QD + 4 weeks of 100 BID MARD/SIDD: Mild Age-Related and Severe Insulin-Deficient Diabetes (insulin deficient) MOD/SIRD: Mild Obesity-Related Diabetes and Severe Insulin-Resistant Diabetes (insulin resistant) Clear Dose Response MOA Validation 0.0 0.0 All 8 Weeks 12 Weeks All MOD + MARD + patients N=44 N=69 patients N=113 N=113 SIRD SIDD -0.1 -0.1 N=69 N=44 -0.13 26 -0.2 -0.2 (p=0.492) Week26 at -0.3 -0.3 -0.27 Week (p=0.160) at HbA1c -0.4 -0.36 * HbA1c -0.4 -0.36 * (p=0.022) (p=0.022) -0.42 * baseline, -0.5 (p=0.015) -0.5 baseline, from -0.6 from -0.6 Insulin Deficient change 12 Week Dosing Outperformed % Outperformed 8 Weeks -0.7 change -0.7 Insulin Resistant (55% additional % Patients by -0.73 * reduction in HbA1c) -0.8 -0.8 560% (p=0.009) -0.9 -0.9 *statistical significance J.P. Morgan Healthcare Conference – January 15, 2025 Slide 18


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Icovamenib Dosed at 100mg for 12 Weeks Demonstrated Statistically Significant Reductions in HbA1c Across All Patient Segments Placebo-Adjusted Mean Change in HbA1c at Week 26 Patients Uncontrolled with at Least 1 Prior Therapy The SIDD Patient population is approximately 14 Million in the U.S./EU and 50 Million in Asia Arm B: 12 weeks of dosing 100 mg QD MARD/SIDD: Mild Age-Related and Severe Insulin-Deficient Diabetes (insulin deficient) Ahlqvist et al. Diabetes 2020;69:2086–2093 | https://doi.org/10.2337/dbi20-0001 0.0 All MARD SIDD + (Arm B) -0.1 Subtypes SIDD (Arm B) N=7 (Arm B) -0.2 N=37 N=22 -0.3 90 Million -0.4 Patients in U.S./EU -0.5 HbA1c -0.50 * 14 Million (p=0.012) 45 Million Patients -0.6 Patients in in U.S./EU baseline, -0.7 U.S./EU from -0.8 change -0.9 % -1.0 -1.1 -1.05 * (p=0.004) -1.2 Severe Insulin -1.3 Deficient Patient -1.4 Population Showed Greatest Reduction -1.5 -1.47 * in HbA1c (p=0.038) -1.6 *statistical significance Slide 19


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Summary Table of Efficacy Analysis Targeted Patients – Severe Insulin Deficient Patients (SIDD) Number of Reduction in P Value Patients HbA1C ARM B & C All patients 12 weeks dosing 69 -0.42% 0.015 * ARM B & C SIDD/MARD (12 weeks) 22 -0.84% 0.008 * ARM B & C SIDD (12 weeks) 11 -1.17% 0.038 * Number of Reduction in P Value Patients HbA1C ARM B All patients 12 weeks dosing 37 -0.50% 0.012 * ARM B SIDD/MARD (12 weeks) 13 -1.05% 0.004 * ARM B SIDD (12 weeks) 7 -1.47% 0.022 * * Statistically Significant icovamenib has the potential to be the only disease modifying agent in diabetes Arm B: 12 weeks of dosing at 100 mg QD Arm C: 2/4 Arm B: 6/7 Arm C: 8 weeks of 100 mg QD + 4 weeks of 100 BID SIDD pts SIDD pts MARD/SIDD: insulin deficient diabetes patients completed full completed full 12 weeks 12 weeks J.P. Morgan Healthcare Conference – January 15, 2025 Slide 20


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Prespecified SIDD Subgroup Performed In-line with GLP-1 RA Based Therapies Currently Approved Type 2 Diabetes Agents w/Chronic Dosing Drug Dosing Medication Observation Mean HbA1c Reduction (Mechanism of Action) Frequency Route Period (placebo adj., %) ICOVAMENIB (Menin Inhibitor) 12 Weeks Oral Week 26 1.5% (100mg) Ozempic Chronic -1.2 (0.5mg) (GLP 1 Agonist) Injectable Week 30 Dosing -1.5 (1mg) Mounjaro Chronic -1.7 (5mg) (GLP-1/GIP Agonist) Injectable Week 40 Dosing -1.6 (15mg) Jardiance Chronic -0.7 (10mg) (SGLT2 Inhibitor) Dosing Oral Week 24 -0.9 (25mg) Januvia Chronic (DPP4 Inhibitor) Dosing Oral Week 24 -0.8 (100mg) Summary — 0.7% ~ 1.7% Note: data shown are not from head-to-head studies and no head-to-head studies have been conducted Mounjaro FDA Label; Ozempic FDA Label; Jardiance FDA Label; Januvia Label J.P. Morgan Healthcare Conference – January 15, 2025 Slide 21


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HbA1c Reduction Has Continued Over Time – Outside the Treatment Period Severe Insulin Deficient Diabetes (SIDD) Patients Mean Change in HbA1c – All Arms 0 k 12 Week 16 Week 22 Week 26 -0.2 -0.4 Icovamenib Icovamenib Mean Treatment Off-Treatment HbA1c in Period Period -0.6 Adjusted Patients continued to exhibit—Change a reduction in HbA1c during Pbo -0.8 the off-treatment period (Week 26 represents 14 weeks since the completion of the -1 treatment period) Low Insulin Resistance Low Insulin Production Lower BMI -1.2 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 22


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Icovamenib Drives Continued Glycemic Control During Off-Therapy Week 12 Week 26 (last day of dose) (14 weeks after last dose) 0 – 12 weeks 12 – 26 weeks Icovamenib Icovamenib Treatment Off-Treatment HbA1c Period Period in change Response Rate of SIDD Patients in COVALENT 111: 100% (All severe insulin deficient adjusted -0.75% diabetes patients treated with—100mg of icovamenib for 12 weeks responded with a HbA1c Placebo reduction) Icovamenib dosed -1.47% Low Insulin Resistance Low Insulin Production 100mg for 12-Weeks Lower BMI J.P. Morgan Healthcare Conference – January 15, 2025 Slide 23


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Baseline HbA1c and BMI Can Enrich for the Desired Phenotype BMI and baseline HbA1c inclusion criteria can COVALENT-111 Week 26 enrich for SIDD to over 90% (12 Weeks at 100mg) Baseline HbA1c 8.5 HbA1c BMI <32 in of higher Change Mean Adjusted Placebo—-1.47% -1.54% Low Insulin Resistance SIDDs All patients with Low Insulin Production per Alquist HbA1c ≥ 8.5 & BMI <32 Lower BMI Algorithm Adapted from Ahlqvist et al. Diabetes 2020;69:2086–2093 | https://doi.org/10.2337/dbi20-0001 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 24


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icovamenib in combination with GLP-1 based therapies


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Menin Suppresses GLP-1 Receptor Transcript Levels J.P. Morgan Healthcare Conference – January 15, 2025 Slide 26


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Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to GLP-1/GIP Dual Receptor Agonist—Tirzepatide Day Culture 7 days under glucotox conditions Day 1 (8 mM glucose) 8 Cadaver derived DMSO human islets Icovamenib, 30 nM Icovamenib, 100 nM Perform GSIS -/+ Tirzepatide Non-diabetic donor: Icovamenib, 300 nM 38-year-old white male, BMI: 29.2, HbA1C 5.2% J.P. Morgan Healthcare Conference – January 15, 2025 Slide 27


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Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to GLP-1 Receptor Agonist—Semaglutide Day 1 Culture 7 days under glucotox conditions Day 8 Cadaver derived (8mM glucose) human islets DMSO Icovamenib, 100 nM Perform GSIS -/+ Semaglutide Non-diabetic donor: Icovamenib, 300 nM (200nM) 41-year-old Hispanic male, BMI 27.8, HbA1c 5.3% Insulin Secretion Index 8) 12 . (G9/G2 9 Index 6 Secretion 3 0 Icovamenib:—100 300 nM—100 300 nM—Semaglutide + Semaglutide J.P. Morgan Healthcare Conference – January 15, 2025 Slide 28


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Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to the Small Molecule GLP-1 Receptor Agonists—Orforglipron and BMF-650 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 29


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Combination Treatment of Icovamenib and Low Dose Semaglutide Extends Marked Glycemic Control in Diabetic Animals Fasting Blood Glucose OGTT – Day 28 500 450 p<0.0001 400 p<0.001 60000 350 min) 50000 300 . 250 40000 ~-50% mg/dL 200 ~-60% 30000 150 (mg/dL 100 20000 50 AUC 10000 0 Baseline day 28 0 vehicle + icovamenib + vehicle + semaglutide icovamenib + semaglutide semaglutide semaglutide Fasting blood glucose reduced to normal range in Significant reduction in combination group vs. semaglutide combination group semaglutide ZDF rats, male Group 1 vehicle (0.02 mg/kg) 12- to 13-week-old, Day 0 14 28 n=10/group) icovamenib icovamenib + Group 2 (200 mg/kg) semaglutide Day 0 14 28 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 30


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Combination Treatment of Icovamenib and Low Dose Semaglutide Significantly Reduced Insulin Resistance and Elevates C-peptide Index HOMA-IR C-peptide Index p<0.0001 0.02 60 ~2x 50 0.015 40 index IR—~-75% 0.01 HOMA 30 peptide 1x 20 c—0.005 10 0 0 day -3 day 28 day -3 day 28 vehicle + semaglutide icovamenib + semaglutide vehicle + semaglutide icovamenib + semaglutide Significant reduction in combination group vs. semaglutide C-peptide index is doubled in combination group vs. semaglutide semaglutide ZDF rats, male Group 1 vehicle (0.02 mg/kg) 12- to 13-week-old, Day 0 14 28 n=10/group) icovamenib icovamenib + Group 2 (200 mg/kg) semaglutide Day 0 14 28 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 31


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Combination Treatment of Icovamenib and Low Dose Semaglutide Reduces Body Weight and Boosts Lean Mass Body Weight Lean Mass Composition Fat Mass Composition 0.00 14.00 0.00 -2.00 BW) 12.00 +43% BW) -1.00 -4.00 10.00 total total -2.00 -6.00to 8.00 additional to -3.00 change -8.00 6.00 % 11.5% -4.00 -10.00 (relative 4.00 (relative 2.00 -5.00 -12.00 -29.5% -14.00 change 0.00 -6.00 vehicle + semaglutide icovamenib + change vehicle + icovamenib + vehicle + icovamenib + % -7.00 semaglutide % semaglutide semaglutide semaglutide semaglutide Greater body weight loss in combination group Higher gain in lean mass in combination group Greater reduction in fat mass in combination group vs. low dose semaglutide at Day 25 vs. low dose semaglutide at Day 25 vs. low dose semaglutide at Day 25 semaglutide ZDF rats, male Group 1 vehicle (0.02 mg/kg) 12- to 13-week-old, Day 0 14 28 n=10/group) icovamenib icovamenib + Group 2 (200 mg/kg) semaglutide Day 0 14 28 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 32


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Icovamenib Drove Additional HbA1c Reduction in Patients on a GLP-1 RA Based Therapy Placebo-Adjusted Mean Change in HbA1c at Week 26 Uncontrolled with GLP-1 Agonist-Based Therapy Icovamenib displays clinically meaningful 1.0% reduction in HbA1c in patients currently uncontrolled on GLP-1 RA based therapies • 5/5 pts on 0.25mg to 1mg Ozempic lost additional weight when initiating icovamenib • Up to 14% of additional weight loss observed at Week 26 • ~1.0% reduction in HbA1c of add-on therapy • COV-111 did not have meal requirements n=3 during study n=3 n=10 n=4 Arm A: 8 weeks of dosing 100mg QD; Arm B: 12 weeks of dosing 100 mg QD; Arm C: 8 weeks of 100 mg QD + 4 weeks of 100 BID J.P. Morgan Healthcare Conference – January 15, 2025 Slide 33


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Overview of Adverse Events Through 26 Weeks (mITT Population, N=225) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=59) (N=54) (N=55) (N=168) (N=57) Patients with ≥1 TEAE 18 (31) 19 (35) 13 (24) 50 (30) 18 (32) SAEs 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) Treatment Discontinuation 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) due to AE Study Discontinuation 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) due to AE Deaths 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) Data are n (%) TEAE, treatment-emergent adverse event SAE, serious adverse event J.P. Morgan Healthcare Conference – January 15, 2025 Slide 34


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Safety and Tolerability (mITT Population, N=225) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=59) (N=54) (N=55) (N=168) (N=57) Diarrhea 4 (7) 2 (4) 1 (2) 7 (4) 0 (0) Nausea 2 (3) 3 (6) 2 (4) 7 (4) 1 (2) Hyperglycemia 1 (2) 4 (7) 1 (2) 6 (4) 3 (5) Headache 0 3 (6) 1 (2) 4 (2) 3 (5) ALT increase 2 (3) 0 2 (4) 4 (2) 0 AST increase 2 (3) 0 1 (2) 3 (2) 0 Data are n (%) of TEAE with ≥5% frequency in any arm and ALT or AST increase irrespective of incidence; mITT population (safety analysis set) TEAE, treatment-emergent adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase Diarrhea: In icovamenib arms, all 7 events were Grade 1. Nausea: In icovamenib arms, 6 of 7 events were Grade 1 and 1 event was Grade 2 (Arm B). In placebo arm, the 1 event was Grade 1. Hyperglycemia: In icovamenib and placebo arms, all events were Grade 2. Headache: In icovamenib arms, 3 of the 4 events were Grade 1 and 1 event was Grade 2 (Arm B). In the placebo arm, 3 of the 4 events were Grade 1 and 1 event was Grade 2. ALT increase: In the icovamenib arms, 3 of the 4 events were Grade 1 and 1 event was Grade 2 (Arm A). AST increase: In the icovamenib arms, all 3 events were Grade 1. J.P. Morgan Healthcare Conference – January 15, 2025 Slide 35


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Icovamenib: Late-Stage Clinical Development in Type 2 Diabetes Development of icovamenib to focus on two key patient segments—Severe Insulin Deficient Diabetes Patients—All Patients in Combination with a GLP-1 RA 1. Severely Insulin Deficient Diabetes (SIDD) Subjects We aim to improve glycemic control in the patient population with the highest unmet medical need in type 2 diabetes 2. GLP-1 Combination We aim to maximize the incretin effect while preserving lean mass and increasing body weight loss A. Subjects initiating a GLP-1 RA based therapy B. Subject uncontrolled on a GLP-1 RA based therapy J.P. Morgan Healthcare Conference – January 15, 2025 Slide 36


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Biomea Fusion: A Diabetes and Obesity Medicines Company Study Indications Anticipated Milestones for 2025 COVALENT-111 Type 2 Diabetes 2H 2025: 52 Week Data Phase 2 Icovamenib COVALENT-112 Type 1 Diabetes 2H 2025: Open Label Data (BMF-219) Phase 2 Menin Program (Potential Type 2 Diabetes COVALENT- 311 1H 2025 Meet with FDA to Discuss Phase II/III (Adaptive Severe Insulin Deficient Best-In-Class) Phase 2/3 Design) and Advance to Late-stage Development Diabetes COVALENT-211 Type 2 Diabetes 1H 2025 Meet with FDA to Discuss Phase II and Initiate Phase 2 GLP-1RA combination Combination Study BMF-650 GLP-1R Agonist IND-Enabling Diabetes/Obesity 2H 2025 IND Cleared and First Participant Dosed (Potential Best-In- Studies Class) BMF-500 COVALENT-103 AML/ALL Dose Escalation Completion – Partnering Strategy FLT-3 Program Phase 1 (Acute Leukemia) J.P. Morgan Healthcare Conference – January 15, 2025 Slide 37


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JP MORGAN 2025 Summary Advancing a First-in-Class, Precision-Based Treatment for Diabetes • Icovamenib is an oral, once daily, simple, 12-week treatment for diabetes • Icovamenib displayed comparable efficacy to a GLP-1 RA chronic therapy in the target patient population at Week 26, with just 12 weeks of treatment • Icovamenib displayed in the pre-specified severe insulin deficient diabetes (SIDD) patients a placebo-adjusted mean reduction in HbA1c 1.5% • The SIDD patient population represents the highest unmet medical need and approx 18% of the diabetes population • Icovamenib was well tolerated with no study drug discontinuations due to TEAEs • Icovamenib added on top of an existing GLP-1 RA therapy demonstrated a clinically meaningful 1% reduction in HbA1c in study participants with uncontrolled diabetes • BMF-650 a next generation oral GLP-1 RA to treat diabetes and obesity is on schedule, advancing towards the clinic with IND filing in 2H 2025. J.P. Morgan Healthcare Conference – January 15, 2025 Slide 38


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Company Financials (NASDAQ: BMEA) As of September 30, 2024 Three Months Ended September 30, 2024 Operating expenses: R&D $ 27,244 G&A 6,795 Total Operating Expenses 34,039 Loss from operations (34,039) Interest and other income, net 1,252 Net loss $ (32,787) Other comprehensive loss: Changes in unrealized gain on short term investments, net —Comprehensive loss $ (32,787) Net loss per common share, basic and diluted $ (0.91) Weighted-average number of common shares used to compute basic and diluted net loss per common share 36,220,736 Q3 Operating Expenses minus Stock Based Comp $29.3 M Cash, Cash Equivalents, Investments, and Restricted Cash as of 30 September 2024 $88.3 M J.P. Morgan Healthcare Conference – January 15, 2025 Slide 39

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Jan. 13, 2025
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Entity Registrant Name Biomea Fusion, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-40335
Entity Tax Identification Number 82-2520134
Entity Address, Address Line One 900 Middlefield Road
Entity Address, Address Line Two 4th Floor
Entity Address, City or Town Redwood City
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94063
City Area Code (650)
Local Phone Number 980-9099
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