SAN CARLOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or the "Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the appointment of Julianne Averill to its Board of Directors (the "Board"), effective July 22, 2025. Ms. Averill has also been appointed to serve as a member of the Audit Committee. She succeeds Bihua Chen, who has stepped down from the Board after more than four years of dedicated service. "Julianne i ...

Icovamenib Program - Icovamenib, a menin inhibitor, demonstrates significant and durable HbA1c reductions, up to approximately 1.5%, sustained well beyond the end of treatment[5] - In a Phase 2a study (COVALENT-111), a 12-week oral dosing of Icovamenib led to a placebo-adjusted HbA1c reduction of 1.5% (p=0.02) at Week 26 in patients with severe insulin-deficient diabetes[71] - At Week 26, patients with Severe Insulin-Deficient Diabetes (SIDD) showed a 53% mean increase in C-peptide levels after Icovamenib treatment[60] - Icovamenib has a $6 billion+ estimated U S revenue potential based on 10% penetration at $10,000 per year in the target T2D patients[7, 15] BMF-650 Program - BMF-650, an oral GLP-1 RA, is built on a similar scaffold as orforglipron, aiming for best-in-class status with an optimized exposure profile[7] - Preclinical studies of BMF-650 showed approximately 2 to 3-fold greater oral bioavailability compared to orforglipron[100] - In obese cynomolgus monkeys, BMF-650 demonstrated meaningful appetite suppression over a 6-day treatment period[110, 112] - In a weight loss study in obese cynomolgus monkeys, BMF-650 at 30 mg/kg resulted in a 15.2% average weight reduction from baseline over 28 days[126, 133] Financials and Milestones - For the three months ended March 31, 2025, Biomea Fusion reported a net loss of $29.262 million, or $0.80 per share[139] - As of March 31, 2025, Biomea Fusion had $36.2 million in cash, cash equivalents, and restricted cash[139]

Core Insights - Biomea Fusion, Inc. announced promising preclinical findings for BMF-650, an investigational oral GLP-1 receptor agonist, showing significant weight loss in obese non-human primates [1][3] Study Design and Key Preclinical Findings - The study involved 15 obese cynomolgus monkeys, with groups receiving either a vehicle or BMF-650 at doses of 10 mg/kg and 30 mg/kg for 28 days [7] - Results indicated a dose-dependent reduction in food intake, with average daily intake dropping to 35g/day (10 mg/kg) and 16g/day (30 mg/kg) compared to 109g/day for the control group [7] - Weight loss was significant, with reductions of 12% for the 10 mg/kg group and 15% for the 30 mg/kg group from baseline by Day 28 [7] - BMF-650 was well tolerated, showing no elevations in aminotransferase levels [7] BMF-650 Preclinical Highlights - BMF-650 demonstrated a favorable pharmacokinetic profile, with enhanced oral bioavailability and less variability compared to other oral GLP-1 RAs [9] - The compound showed robust glycemic control and appetite suppression, leading to pronounced weight reduction in preclinical models [9][10] - The company aims to submit an Investigational New Drug (IND) application in the second half of 2025, with a Phase I trial in obese volunteers expected to start in late 2025 [6][10] About Obesity - Obesity is a chronic disease affecting over 40% of adults in the U.S. and over 650 million adults globally, leading to serious health complications [11] - The condition is associated with metabolic disorders, cardiovascular diseases, and increased risks of chronic diseases [11] About GLP-1 Receptor Agonists - GLP-1 receptor agonists are medications that mimic the effects of the GLP-1 hormone, improving glycemic control and promoting weight loss in individuals with type 2 diabetes and obesity [12] About Biomea Fusion - Biomea Fusion focuses on developing oral small molecules for diabetes and obesity, including BMF-650, aimed at significantly improving patient outcomes [13]

Core Viewpoint - Biomea Fusion, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $40 million before expenses, with the offering expected to close on June 20, 2025 [1][2]. Group 1: Offering Details - The offering consists of 19,450,000 shares of common stock and accompanying warrants, along with pre-funded warrants for an additional 550,000 shares [1]. - The combined offering price for each share of common stock and accompanying warrant is set at $2.00, while the pre-funded warrant and accompanying warrant are priced at $1.9999 [1]. - Underwriters have a 30-day option to purchase up to an additional 3,000,000 shares and/or warrants at the public offering price [1]. Group 2: Financial Proceeds - The gross proceeds from the offering are expected to be approximately $40 million, excluding any additional shares or warrants purchased by underwriters [2]. - The offering is subject to customary closing conditions and is anticipated to close on June 20, 2025 [2]. Group 3: Management and Regulatory Information - Jefferies is acting as the sole book-running manager for the offering [3]. - The securities are being offered under an effective shelf registration statement previously filed with the SEC [3].

Core Viewpoint - Biomea Fusion, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, with a potential additional 15% of shares available for underwriters [1][2]. Group 1: Offering Details - The offering includes common stock, pre-funded warrants, and warrants to purchase common stock, all to be sold by Biomea [1]. - The expected closing date for the offering is around June 20, 2025, pending customary closing conditions [2]. - Jefferies is the sole book running manager for this public offering [2]. Group 2: Regulatory Information - The securities are being offered under an effective shelf registration statement on Form S-3, filed with the SEC on October 14, 2022, and declared effective on October 24, 2022 [3]. - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and will be available through Jefferies and the SEC's website [3]. Group 3: Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral small molecules, icovamenib and BMF-650, aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [5].

Core Insights - Biomea Fusion, Inc. announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory acute leukemia, highlighting sustained clinical responses and encouraging survival rates in FLT3-mutant AML patients [1][8] Clinical Activity Observed - Among 27 enrolled patients, 9 of 11 efficacy-evaluable FLT3m patients showed bone marrow blast reduction, with 5 achieving over 50% reduction [7] - One FLT3m patient achieved complete remission with incomplete hematologic recovery (CRi) sustained for 6 cycles, while another achieved a morphologic leukemia-free state (MLFS) [7] - Two of four efficacy-evaluable FLT3 wild-type patients achieved durable disease control for at least 120 days [7] Pharmacokinetics/Pharmacodynamics - BMF-500 demonstrated good compartmental penetration, with bone marrow and plasma concentrations being comparable [7] - The median overall survival (mOS) for all treated FLT3m patients was 3.8 months for Arm A and 3.5 months for Arm B, which is an improvement compared to the historical mOS of 2.1 months for similar patients [7] Ongoing Dose Escalation - Dose escalation is ongoing at 200 mg BID for Arm A and 75 mg BID for Arm B, with no dose-limiting toxicities reported [7][13] - The company plans to conclude the internal development of BMF-500 in oncology and is exploring strategic partnerships to advance the program [8] About BMF-500 - BMF-500 is an investigational, orally bioavailable, covalent small molecule inhibitor of FLT3, designed to be highly potent and selective, with encouraging potential demonstrated in preclinical studies [10]

Core Viewpoint - Biomea Fusion, Inc. (BMEA) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - A strong correlation exists between earnings estimate revisions and near-term stock price movements, making the Zacks rating system valuable for investors [4][6]. Institutional Investor Influence - Institutional investors utilize earnings estimates to determine the fair value of a company's shares, impacting stock price movements through their large transactions [4]. Business Improvement Indicators - The upgrade in rating for Biomea Fusion signifies an improvement in the company's underlying business, which is expected to drive the stock price higher [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Biomea Fusion is projected to earn -$3 per share, reflecting a 21.7% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Biomea Fusion has increased by 20.8%, indicating a positive trend in earnings estimates [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of generating significant returns for top-ranked stocks [7][9]. - Biomea Fusion's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Insights - Biomea Fusion, Inc. announced preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500, a covalent FLT3 inhibitor, in adults with acute leukemia, which will be presented at the EHA 2025 Congress [1][2] Group 1: Clinical Trial Overview - The COVALENT-103 study is an open-label Phase I trial evaluating BMF-500 in patients with relapsed or refractory acute leukemia, particularly those with FLT3 mutations who have failed prior therapies [5][15] - As of February 3, 2025, 24 patients were enrolled in the trial, with 4 remaining on treatment, and the study aims to determine the optimal biologic dose and recommended Phase II dose [7][15] Group 2: Efficacy and Safety Results - BMF-500 was well tolerated, with no dose-limiting toxicities or treatment-related discontinuations reported; common treatment-emergent adverse events included febrile neutropenia and nausea [8][13] - Among efficacy-evaluable patients, 81.8% showed clinical activity, with significant reductions in bone marrow blasts observed [8][13] - The median overall survival for the 23 patients enrolled was 3.48 months, while the median overall survival for the efficacy-evaluable FLT3m patients has not yet been reached [8][13] Group 3: Future Directions - Following the completion of the dose escalation phase, Biomea plans to conclude its internal development of BMF-500 in oncology and is actively seeking strategic partnerships to advance the program [14][16]

[PART I—FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed financial statements for the quarter ended March 31, 2025, show a net loss of **$29.3 million** and a significant decrease in cash and cash equivalents to **$35.9 million** from **$58.3 million** at year-end 2024. The company has an accumulated deficit of **$416.5 million** and management has expressed substantial doubt about its ability to continue as a going concern without raising additional capital [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, the company reported total assets of **$55.1 million**, a decrease from **$79.9 million** at December 31, 2024. This was primarily driven by a reduction in cash and cash equivalents. Total liabilities stood at **$26.3 million**, and total stockholders' equity was **$28.7 million**, down from **$51.6 million** at year-end Condensed Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $35,864 | $58,279 | | Total current assets | $44,685 | $68,332 | | Total assets | $55,055 | $79,938 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $19,817 | $21,673 | | Total liabilities | $26,318 | $28,365 | | Total stockholders' equity | $28,737 | $51,573 | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, the company reported a net loss of **$29.3 million**, or **($0.80)** per share. This is an improvement from the net loss of **$39.1 million**, or **($1.09)** per share, in the same period of 2024. The reduced loss was primarily due to a decrease in research and development expenses Condensed Statements of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $22,897 | $33,776 | | General and administrative | $6,815 | $7,283 | | **Total operating expenses** | **$29,712** | **$41,059** | | Loss from operations | ($29,712) | ($41,059) | | **Net and comprehensive loss** | **($29,262)** | **($39,061)** | | Net loss per common share | ($0.80) | ($1.09) | [Condensed Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from **$51.6 million** at December 31, 2024, to **$28.7 million** at March 31, 2025. The decrease was primarily driven by the net loss of **$29.3 million**, partially offset by **$3.3 million** in net proceeds from the issuance of common stock under the ATM program and **$3.2 million** in stock-based compensation expense - During Q1 2025, the company issued **1,261,537 shares** of common stock under its 'at the market' (ATM) equity offering program, raising net proceeds of **$3.257 million**[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the first quarter of 2025, net cash used in operating activities was **$25.7 million**. The company generated **$3.3 million** from financing activities, primarily from its ATM program. This resulted in a net decrease in cash, cash equivalents, and restricted cash of **$22.4 million**, ending the period with a total of **$36.2 million** Summary of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($25,667) | ($32,030) | | Net cash used in investing activities | $0 | ($35) | | Net cash provided by financing activities | $3,252 | $116 | | **Net decrease in cash, cash equivalents, and restricted cash** | **($22,415)** | **($31,949)** | [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Key notes to the financial statements highlight the company's status as a clinical-stage biopharmaceutical firm with no revenue and a history of net losses. Crucially, Note 1 states there is substantial doubt about the company's ability to continue as a going concern, as existing financial resources are insufficient to fund operations for at least one year. Note 5 details the capital structure, including the ATM offering program. Note 9 provides a breakdown of R&D expenses by clinical trial and activity - The company has incurred net operating losses since inception, with an accumulated deficit of **$416.5 million** as of March 31, 2025. Management has concluded there is substantial doubt about the company's ability to continue as a going concern[33](index=33&type=chunk) - As of March 31, 2025, the company has received net proceeds of **$3.3 million** from its 2022 ATM Offering Program by issuing **1,261,537 shares** of common stock[49](index=49&type=chunk) Research and Development Expenses Breakdown (in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | COVALENT - 111 | $2,242 | $7,760 | | Other clinical related expenses | $2,487 | $3,903 | | Preclinical activities related expenses | $1,956 | $2,965 | | Personnel-related expenses | $7,827 | $9,507 | | **Total R&D Expenses** | **$22,897** | **$33,776** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to focus on diabetes and obesity, leveraging its FUSION™ platform. The lead candidate, icovamenib, is in clinical trials for type 1 and type 2 diabetes. The company reported a net loss of **$29.3 million** for Q1 2025, a decrease from **$39.1 million** in Q1 2024, mainly due to lower R&D spending on clinical activities. The company's cash of **$36.2 million** is not sufficient to fund operations beyond the fourth quarter of 2025, raising substantial doubt about its ability to continue as a going concern without additional financing - The company has strategically focused on becoming a diabetes and obesity medicines company, planning to conclude studies of icovamenib in oncology and seek partnerships for its oncology assets (like BMF-500) to concentrate resources on metabolic disorders[66](index=66&type=chunk) - The company nominated BMF-650, an oral small molecule GLP-1 RA, which is advancing through IND-enabling studies, with the goal of providing a best-in-class therapeutic option for diabetes and obesity[67](index=67&type=chunk) - R&D expenses decreased by **$10.9 million** in Q1 2025 compared to Q1 2024, primarily due to a **$7.3 million** decrease in clinical activities, a **$1.8 million** decrease in manufacturing costs, and a **$1.7 million** decrease in personnel-related expenses[86](index=86&type=chunk)[87](index=87&type=chunk) - As of March 31, 2025, the company had **$36.2 million** in cash, cash equivalents, and restricted cash. Management states these funds will only be sufficient to fund operations into the fourth quarter of 2025, creating substantial doubt about its ability to continue as a going concern[92](index=92&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate sensitivities on its cash and cash equivalents, which consist of money market funds. Due to the short-term nature of these investments, management believes that a **10%** relative change in interest rates would not have a material effect on their fair market value - The company's primary market risk is interest rate sensitivity. As of March 31, 2025, it held **$36.2 million** in cash, cash equivalents, and restricted cash, primarily in money market funds. A **10%** change in interest rates is not expected to have a material impact[106](index=106&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025. There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[107](index=107&type=chunk) - There were no material changes to the company's internal control over financial reporting during the first quarter of 2025[108](index=108&type=chunk) [PART II—OTHER INFORMATION](index=33&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings. It acknowledges that litigation can arise in the ordinary course of business and could have an adverse impact regardless of the outcome - As of the filing date, the company is not a party to any material legal proceedings[112](index=112&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company outlines extensive risks to its business, categorized into several key areas. These include risks related to its limited operating history, financial condition, and need for capital, such as its history of losses and the substantial doubt about its ability to continue as a going concern. It also details risks in product development, including the novel and unproven nature of its covalent small molecule approach. Other significant risks involve the lengthy and unpredictable regulatory process, reliance on third parties for manufacturing and clinical trials, protection of intellectual property, and the volatility of its common stock [Risks Related to Financial Condition and Need for Capital](index=33&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Business,%20Financial%20Condition,%20Results%20of%20Operations,%20and%20Need%20for%20Additional%20Capital) This section highlights the company's vulnerability due to its limited operating history, lack of revenue, and significant net losses (**$416.5 million** accumulated deficit). It emphasizes the urgent need for substantial additional capital to continue operations, stating that current cash will not be sufficient for another year, which raises substantial doubt about its ability to continue as a going concern. The company's strategic focus on diabetes and obesity is presented as a risk if this new direction is unsuccessful - The company has a limited operating history, no approved products, and has never generated revenue, making it difficult to evaluate its prospects[114](index=114&type=chunk)[115](index=115&type=chunk) - The company will require substantial additional capital. Existing cash of **$36.2 million** as of March 31, 2025, is not sufficient to continue as a going concern for at least one year, raising substantial doubt about its viability[130](index=130&type=chunk)[131](index=131&type=chunk)[134](index=134&type=chunk) - The company's strategic decision to focus on metabolic disorders (diabetes, obesity) and seek partners for its oncology assets is a risk. If this focus does not lead to success, the business could be materially harmed[125](index=125&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) [Risks Related to Product Development](index=44&type=section&id=Risks%20Related%20to%20Product%20Development) The company's product development risks stem from its novel and unproven approach using covalent small molecules and the FUSION™ System. There is substantial dependency on its lead candidates, icovamenib and BMF-500. The report warns that preclinical and early clinical results may not predict success in later, larger trials. The company also faces intense competition from established pharmaceutical companies with greater resources and acknowledges that its product candidates could cause significant adverse events - The company's approach of developing novel covalent small molecule therapies is unproven and may not lead to marketable products[145](index=145&type=chunk)[149](index=149&type=chunk) - The business is substantially dependent on the success of its lead product candidates, icovamenib and BMF-500. Failure to advance these through clinical development and obtain regulatory approval would materially harm the company[153](index=153&type=chunk) - Preclinical and early clinical trial results are not predictive of success in later-stage trials. Product candidates may fail to demonstrate sufficient safety and efficacy[164](index=164&type=chunk) - The company faces substantial competition from major pharmaceutical and biotech companies with significantly greater financial, technical, and marketing resources[178](index=178&type=chunk)[179](index=179&type=chunk) [Risks Related to Regulatory Process and Legal Compliance](index=67&type=section&id=Risks%20Related%20to%20Regulatory%20Process%20and%20Other%20Legal%20Compliance%20Matters) This section details the lengthy, expensive, and unpredictable nature of the FDA and foreign regulatory approval processes. The company notes that obtaining special designations like Orphan Drug, Breakthrough Therapy, or Fast Track does not guarantee a faster review or approval. It also highlights risks from ongoing regulatory obligations post-approval, potential healthcare reform impacting pricing and reimbursement, and strict enforcement against off-label promotion - The regulatory approval process is lengthy, time-consuming, and unpredictable. Delays or failure to obtain approval for product candidates would materially impair the ability to generate revenue[209](index=209&type=chunk)[210](index=210&type=chunk) - A clinical hold was previously placed on the INDs for icovamenib in type 1 and type 2 diabetes from June 2024 to September 2024, illustrating the risk of trial delays[212](index=212&type=chunk) - Even if granted, special designations like Breakthrough Therapy or Fast Track do not guarantee a faster development or approval process, nor do they increase the likelihood of approval[219](index=219&type=chunk)[220](index=220&type=chunk) - The company is subject to extensive healthcare laws, including anti-kickback and false claims statutes, which could expose it to significant penalties if its operations are found to be in violation[241](index=241&type=chunk) [Risks Related to Reliance on Third Parties](index=88&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company heavily relies on third parties, such as CROs and CMOs, for conducting clinical trials and manufacturing its product candidates. This reliance creates risks, as the company has limited control over these third parties' performance, quality, and compliance with regulations like GCP and cGMP. Any failure by these partners could lead to significant delays, increased costs, and jeopardize regulatory approval. The company also notes its dependence on single-source suppliers for certain materials, which poses a supply chain risk - The company depends on third-party CROs and medical institutions to conduct its clinical trials. If these parties fail to perform their duties properly, regulatory approval could be delayed or prevented[270](index=270&type=chunk)[272](index=272&type=chunk) - The company relies on third-party manufacturers (CMOs) for its product candidates and does not own its own manufacturing facility. These CMOs must be approved by the FDA, and any failure to comply with cGMP could halt production and development[276](index=276&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk) - The company depends on single-source suppliers for some ingredients and materials, creating a risk of supply disruption, price increases, or delays that could materially harm the business[282](index=282&type=chunk) [Risks Related to Intellectual Property](index=96&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success is highly dependent on its ability to obtain, maintain, and enforce its intellectual property rights. This section outlines the uncertainty and complexity of patent law in the biopharmaceutical field. Risks include pending patent applications not being issued, issued patents being challenged and invalidated, and competitors designing around their claims. The company also faces the risk of litigation from third parties claiming infringement of their IP, which would be costly and time-consuming to defend - The company's success depends on its ability to obtain and maintain patent protection for its technology and product candidates, but the issuance, scope, and validity of such patents are highly uncertain[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk) - Issued patents can be challenged and invalidated. If the company's patents are found to be invalid or unenforceable, it could have a material adverse impact on the business[301](index=301&type=chunk)[302](index=302&type=chunk)[312](index=312&type=chunk) - The company may be subject to lawsuits from third parties alleging infringement of their intellectual property rights, which could be expensive to defend and result in substantial damages or injunctions[332](index=332&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk) [Risks Related to Our Common Stock](index=114&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) This section details risks for investors, highlighting that the stock price has been and is likely to remain highly volatile. Future capital raises may cause significant dilution to existing stockholders. A significant portion of shares is held by a small number of principal stockholders and management, who can exert significant influence. The company does not intend to pay dividends, and provisions in its charter and Delaware law could discourage or prevent a change in control - The trading price of the company's common stock has been and is likely to continue to be highly volatile due to factors like clinical trial results, regulatory decisions, and market conditions[350](index=350&type=chunk) - Future fundraising through equity offerings will cause dilution to existing stockholders. The company has an active ATM program and a shelf registration statement for future sales[355](index=355&type=chunk)[359](index=359&type=chunk) - Executive officers, directors, and their affiliates beneficially own approximately **18%** of the company's stock, allowing them to exert significant influence over stockholder matters[362](index=362&type=chunk) - The company is not in compliance with Nasdaq's audit committee composition rule and must regain compliance within a specified cure period to avoid potential delisting[361](index=361&type=chunk) [General Risk Factors](index=123&type=section&id=General%20Risk%20Factors) This section covers a range of general business risks. These include the potential for securities litigation due to stock price volatility, the significant costs of operating as a public company, and the risk of failing to maintain effective internal controls over financial reporting. The company also notes risks from cybersecurity threats, geopolitical events, changes in tax laws, and increasing scrutiny over Environmental, Social, and Governance (ESG) matters - The company is an 'emerging growth company' and takes advantage of reduced reporting requirements, which may make its stock less attractive to some investors[392](index=392&type=chunk) - The company is exposed to cybersecurity risks. A compromise of its information technology or data could result in program disruptions, regulatory actions, and financial loss[401](index=401&type=chunk)[402](index=402&type=chunk) - Geopolitical events, such as global conflicts and trade tensions (e.g., tariffs), could disrupt the supply chain and adversely affect the business[412](index=412&type=chunk)[413](index=413&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds. and Issuer Purchases of Equity Securities](index=137&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds.%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, no use of proceeds from such sales, and no issuer purchases of equity securities during the period - None[418](index=418&type=chunk) [Defaults Upon Senior Securities](index=137&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[419](index=419&type=chunk) [Mine Safety Disclosures](index=137&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[420](index=420&type=chunk) [Other Information](index=137&type=section&id=Item%205.%20Other%20Information) The company disclosed that during the quarter ended March 31, 2025, none of its directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan or any other non-Rule 10b5-1 trading arrangement - During Q1 2025, no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading plan[421](index=421&type=chunk) [Exhibits](index=138&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the CEO and CFO certifications (31.1, 31.2, 32.1, 32.2) and XBRL data files - The report includes standard exhibits such as officer certifications under Sarbanes-Oxley Sections 302 and 906, and Inline XBRL documents[422](index=422&type=chunk) [Signatures](index=139&type=section&id=Signatures) - The report was signed on May 5, 2025, by Michael J.M. Hitchcock as Interim Chief Executive Officer and Rainer Erdtmann as Chief Operating Officer (acting as Principal Financial and Accounting Officer)[426](index=426&type=chunk)

Biomea Fusion Q1 2025 Financial Results and Corporate Highlights Biomea Fusion presents its first quarter 2025 financial results and corporate highlights, detailing strategic realignment and pipeline advancements [Strategic Realignment and Business Update](index=1&type=section&id=Strategic%20Realignment%20Highlights) Biomea Fusion strategically realigned in Q1 2025, focusing on core programs and implementing cost reductions to extend cash runway - The company prioritizes development and investment in core programs: **icovamenib** (oral menin inhibitor for diabetes) and **BMF-650** (oral GLP-1 receptor agonist)[7](index=7&type=chunk) - A cost-reduction plan, including a **35% workforce reduction** and facility consolidation, extends the cash runway into **Q4 2025**[7](index=7&type=chunk)[8](index=8&type=chunk) - Non-core clinical and preclinical activities are being considered for partnership or discontinued[6](index=6&type=chunk) [Pipeline and Clinical Development Milestones](index=1&type=section&id=Key%20Anticipated%202025%20Milestones) Biomea Fusion outlined key 2025 milestones, advancing its diabetes and obesity pipeline while concluding its oncology program [Icovamenib (for Diabetes)](index=1&type=section&id=Icovamenib%20(Oral%20Small%20Molecule%20Menin%20Inhibitor%20for%20Type%202%20and%20Type%201%20Diabetes)) The icovamenib program anticipates significant H2 2025 progress with key data releases and regulatory interactions for diabetes studies - **52-week data** from the Phase II COVALENT-111 study in type 2 diabetes is expected in **H2 2025**[7](index=7&type=chunk) - A Type-C meeting with the FDA is planned for **H2 2025** to discuss Phase IIb trial design[7](index=7&type=chunk) - A Phase II study of icovamenib in T2D patients uncontrolled on GLP-1 based therapy is planned for initiation in **H2 2025**[7](index=7&type=chunk) - Preliminary data from the Phase II COVALENT-112 study in type 1 diabetes is anticipated in **H2 2025**[7](index=7&type=chunk) [BMF-650 (for Obesity)](index=1&type=section&id=BMF-650%20(Next-generation%20Oral%20Small%20Molecule%20GLP-1%20Receptor%20Agonist%20for%20Obesity)) The company is advancing BMF-650 for obesity, planning an Investigational New Drug (IND) application submission in H2 2025 - Submission of the Investigational New Drug (IND) application for **BMF-650** is planned for **H2 2025**[5](index=5&type=chunk) [BMF-500 (for Acute Leukemia)](index=2&type=section&id=BMF-500%20(Oral%20Small%20Molecule%20FLT3%20Inhibitor%20in%20Acute%20Leukemia)) Biomea is concluding internal development of BMF-500, expecting survival data in Q2 2025 and seeking strategic partnerships for the oncology program - Survival data from the dose escalation study in relapsed/refractory acute leukemia is expected in the **second quarter of 2025**[13](index=13&type=chunk) - The company is ending its oncology efforts with **BMF-500** and is seeking strategic partnerships[13](index=13&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Biomea underwent significant corporate changes in Q1 2025, including an Interim CEO appointment and a strategic shift to diabetes and obesity programs - In **March 2025**, Board Member **Mick Hitchcock, Ph.D.**, was appointed as Interim Chief Executive Officer[13](index=13&type=chunk) - In **January 2025**, Biomea formally transitioned to a diabetes and obesity medicines company, discontinuing internal oncology program development[13](index=13&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Biomea reported a net loss of **$29.3 million** in Q1 2025, with **$36.2 million** cash and reduced operating expenses reflecting strategic realignment Q1 2025 Key Financial Metrics | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents and restricted cash** | $36.2 million | N/A | | **Net Loss** | $29.3 million | $39.1 million | | **R&D Expenses** | $22.9 million | $33.8 million | | **G&A Expenses** | $6.8 million | $7.3 million | - The decrease in R&D expenses was primarily driven by a **$7.3 million** reduction in clinical activities and a **$1.8 million** reduction in manufacturing costs[10](index=10&type=chunk) - Current cash, cash equivalents, and restricted cash of **$36.2 million** are expected to fund operating plans into **Q4 2025**[8](index=8&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Biomea Fusion's condensed financial statements, including the statement of operations and balance sheet data for Q1 2025 [Condensed Statement of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2025, Biomea reported total operating expenses of **$29.7 million** and a net loss of **$29.3 million**, or **($0.80)** per share Condensed Statement of Operations (Unaudited, in thousands, except per share data) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $22,897 | $33,776 | | General and administrative | $6,815 | $7,283 | | **Total operating expenses** | **$29,712** | **$41,059** | | **Loss from operations** | **($29,712)** | **($41,059)** | | Interest and other income, net | $450 | $1,998 | | **Net loss and comprehensive loss** | **($29,262)** | **($39,061)** | | **Net loss per common share, basic and diluted** | **($0.80)** | **($1.09)** | [Condensed Balance Sheet Data](index=5&type=section&id=Condensed%20Balance%20Sheet%20Data) As of March 31, 2025, Biomea reported **$36.2 million** in cash and **$55.1 million** in total assets, a decrease from December 31, 2024 Condensed Balance Sheet Data (Unaudited, in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | $36,233 | $58,648 | | Working capital | $24,868 | $46,659 | | Total assets | $55,055 | $79,938 | | Stockholders' equity | $28,737 | $51,573 |