[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 |

Core Viewpoint - Biomea Fusion, Inc. is undergoing a strategic realignment to focus on core programs, particularly in diabetes and obesity, while extending its cash runway for long-term success [2][10]. Strategic Realignment Highlights - The company is prioritizing the development of icovamenib, an oral small molecule menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist [8]. - A workforce reduction of approximately 35% has been implemented to streamline operations and reduce costs [8]. - Biomea is consolidating its workforce at the Biomea Innovation Lab Center in San Carlos, CA, effective May 31, 2025 [8]. Key Anticipated 2025 Milestones - Submission of the Investigational New Drug (IND) application for BMF-650 is planned for the second half of 2025 [5]. - Phase II study of icovamenib in T2D patients currently uncontrolled on GLP-1 therapy is set to initiate in the second half of 2025 [8]. - Preliminary data from the Phase II COVALENT-112 study in type 1 diabetes is expected in the second half of 2025 [8]. Financial Results - As of March 31, 2025, the company had cash, cash equivalents, and restricted cash totaling $36.2 million, expected to fund operations into the fourth quarter of 2025 [11]. - The net loss for the first quarter of 2025 was $29.3 million, a decrease from a net loss of $39.1 million in the same period of 2024 [12]. - Research and Development (R&D) expenses were $22.9 million for the first quarter of 2025, down from $33.8 million in the same period of 2024 [13].

Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook. Contact: Meichiel Jennifer Weiss Sr. Director, Investor Relations and Corporate Development IR@biomeafusion.com Biomea is a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and metabolic disease. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offe ...

Core Viewpoint - Biomea Fusion, Inc. (BMEA) has experienced a significant downtrend with a 19.3% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) for BMEA is currently at 26.33, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound [5]. - RSI is a momentum oscillator that helps identify whether a stock is oversold, typically when the reading falls below 30 [2][3]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding BMEA, with a 1.7% increase in the consensus EPS estimate over the last 30 days, suggesting potential price appreciation [7]. - BMEA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a favorable outlook for a turnaround [8].

Financial Performance - The company has incurred significant net losses of $138.4 million and $117.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $387.3 million as of December 31, 2024[173]. - The company has not generated any revenues from product sales and has incurred significant operating losses since inception, with substantial doubt about its ability to continue as a going concern for the next twelve months[185]. - As of December 31, 2024, the company had $58.6 million in cash, cash equivalents, and restricted cash, which is insufficient to continue operations for at least one year without additional financing[182]. - The company expects to continue incurring significant losses for the foreseeable future, particularly as it advances its research and development efforts and clinical trials[174]. - The company anticipates that its financial condition and results of operations will fluctuate significantly from quarter to quarter and year to year[171]. - The company may need to seek additional funding sooner than planned due to changing circumstances that could accelerate capital consumption[182]. Product Development and Clinical Trials - The company currently has two product candidates, icovamenib and BMF-500, under investigation in clinical trials, with the first patient dosed with BMF-500 in October 2023[168]. - The lead product candidate, icovamenib, is in clinical development, and the second product candidate, BMF-500, was dosed for the first time in October 2023[196]. - The company is currently conducting clinical trials for two product candidates: icovamenib and BMF-500, with ongoing trials for various types of tumors and diabetes[209]. - The company has not yet completed clinical testing of icovamenib or BMF-500 in human subjects, and revenue generation is not expected for many years, if at all[204]. - The lengthy and expensive process of preclinical and clinical development may lead to increased operating expenses and uncertainty in obtaining regulatory approvals[210]. - The company must demonstrate safety and efficacy through well-controlled clinical trials to meet FDA requirements before seeking marketing approvals[215]. - Delays in clinical trials could significantly harm the company's ability to commercialize product candidates and generate revenue[213]. - The company faces challenges in recruiting and retaining participants for clinical trials, which could delay regulatory submissions and approvals[219]. Regulatory and Compliance Risks - The FDA imposed a clinical hold on the Phase I/II trials of icovamenib for type 1 and type 2 diabetes in June 2024, which was lifted in September 2024[205]. - The company has not submitted an NDA to the FDA or similar filings to foreign regulatory authorities for any product candidate, which is necessary for marketing approval[207]. - Regulatory authorities may impose additional warnings or require further studies if toxicities develop post-approval, affecting market acceptance[242]. - The regulatory approval processes are lengthy and unpredictable, and delays in obtaining approvals could materially impair the company's ability to generate revenue[261]. - The FDA or foreign regulatory authorities may require additional data for approval, which could delay or prevent commercialization plans[266]. - The company faces potential penalties and regulatory challenges that could inhibit the commercialization of its product candidates and affect revenue generation[284]. Market and Competitive Landscape - The company is the only one in the U.S. developing covalent small molecule product candidates specifically targeting menin, but faces competition from various sources[229]. - The market opportunities for the company's product candidates are estimated to be small, targeting patients who are ineligible for or have failed prior treatments[222]. - The success of the company's product candidates will depend on their safety, effectiveness, and competitive positioning against existing therapies[236]. - The company faces significant competition in clinical trials, which may limit participant availability and increase development costs[220]. Intellectual Property and Legal Risks - The company’s ability to protect its intellectual property rights is critical, as failure to do so could allow competitors to develop similar technologies[341]. - Patent applications may not result in issued patents that adequately protect the company's technology, leading to potential challenges in the market[343]. - The strength of the company's patents may be challenged, impacting its ability to commercialize its product candidates effectively[346]. - Protecting intellectual property globally is costly, and rights may be less extensive outside the United States[350]. - Legal challenges to patent validity could result in loss of protection for product candidates[361]. Operational and Management Challenges - The company is highly dependent on key personnel, and failure to attract and retain qualified staff could adversely affect its business strategy[304]. - Competition for qualified personnel is intense, with larger biotechnology firms potentially offering better compensation and career advancement opportunities[305]. - The company relies on independent organizations, advisors, and consultants for key aspects of clinical development and manufacturing, which may affect the timely availability of services[309]. - Future growth will require additional managerial, clinical, regulatory, operational, sales, marketing, financial, and other personnel[308]. Financial and Economic Factors - Inflation and rapid increases in interest rates have led to declines in the trading value of government securities, potentially impacting the company’s access to capital[191]. - The company’s ability to utilize net operating loss carryforwards may be limited due to U.S. tax law restrictions[313]. - Changes in U.S. tax laws could adversely affect cash flow, particularly with the capitalization of R&D expenses starting in taxable years after December 31, 2021[316].

"2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "As we move into this next phase, the Board made a strategic decision to align leadership with the company's evolution, and I'm honored to ...

Core Insights - Biomea Fusion, Inc. reported transformative advancements in 2024, particularly with icovamenib entering late-stage development for diabetes treatment, especially for patients with severe insulin deficiency [2][3] - The company announced a leadership transition with Mick Hitchcock, Ph.D., appointed as Interim CEO, reflecting confidence in the menin inhibitor program and the covalent small molecule platform [2][3] - Biomea is focusing exclusively on metabolic disorders, terminating ongoing oncology trials for icovamenib and reallocating resources to enhance diabetes and obesity programs [3] Financial Results - As of December 31, 2024, the company had cash, cash equivalents, and restricted cash of $58.6 million, a decrease from $177.2 million as of December 31, 2023 [17][29] - The net loss attributable to common stockholders was $29.3 million for Q4 2024, compared to a net loss of $34.9 million for the same period in 2023; for the full year, the net loss was $138.4 million, up from $117.3 million in 2023 [18] - Research and Development (R&D) expenses for Q4 2024 were $25.2 million, down from $30.9 million in Q4 2023; however, R&D expenses for the full year increased to $118.1 million from $102.5 million in 2023 [19] Clinical Development Updates - Icovamenib demonstrated significant reductions in HbA1c levels, achieving a 1.47% reduction in severe insulin deficient patients after 26 weeks of treatment [7] - The company anticipates key milestones in 2025, including an FDA meeting to discuss icovamenib's late-stage development and data readouts from ongoing studies [6][9] - Preclinical studies for BMF-650, an oral small molecule GLP-1 RA, showed promising results, including improved glucose-stimulated insulin secretion and appetite suppression [14] Strategic Initiatives - The formation of a Global Scientific Advisory Board with 22 experts in beta cell science and diabetes therapeutics aims to advance the clinical development of icovamenib [4] - Biomea plans to seek strategic partnerships to further its oncology portfolio while focusing on metabolic disease programs [3][16] - The company is utilizing its proprietary FUSION™ System to develop next-generation covalent-binding small-molecule medicines targeting diabetes and obesity [22][23]

Technically, every stock oscillates between being overbought and oversold irrespective of the quality of their fundamentals. And the beauty of RSI is that it helps you quickly and easily check if a stock's price is reaching a point of reversal. Biomea Fusion, Inc. (BMEA) has been on a downward spiral lately with significant selling pressure. After declining 20.4% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement am ...

Executive Leadership Change - Biomea Fusion, Inc. announced the appointment of Mick Hitchcock as interim CEO, replacing Thomas Butler, effective immediately [2][4] - Hitchcock has been a board member since 2021 and has extensive experience in pharmaceutical research and development [3] Clinical Development Progress - The company is focused on developing a novel therapy for diabetes, with recent positive Phase II data for icovamenib in insulin-deficient patients marking a significant milestone [3] - Biomea is advancing late-stage development efforts and preparing for regulatory engagement [3] Company Mission and Strategy - Biomea aims to cure diabetes through innovative covalent therapies, utilizing its proprietary FUSION™ System to develop next-generation small-molecule medicines [5][6] - The company emphasizes the advantages of covalent small molecules, including greater target selectivity and the potential for deeper, more durable responses [5]