Biomea Fusion(BMEA) - 2025 Q1 - Quarterly Results

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 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] - A cost-reduction plan, including a 35% workforce reduction and facility consolidation, extends the cash runway into Q4 2025[7][8] - Non-core clinical and preclinical activities are being considered for partnership or discontinued[6] Pipeline and Clinical Development Milestones Biomea Fusion outlined key 2025 milestones, advancing its diabetes and obesity pipeline while concluding its oncology program Icovamenib (for Diabetes) 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] - A Type-C meeting with the FDA is planned for H2 2025 to discuss Phase IIb trial design[7] - A Phase II study of icovamenib in T2D patients uncontrolled on GLP-1 based therapy is planned for initiation in H2 2025[7] - Preliminary data from the Phase II COVALENT-112 study in type 1 diabetes is anticipated in H2 2025[7] BMF-650 (for Obesity) 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] BMF-500 (for Acute Leukemia) 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] - The company is ending its oncology efforts with BMF-500 and is seeking strategic partnerships[13] Corporate Updates 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] - In January 2025, Biomea formally transitioned to a diabetes and obesity medicines company, discontinuing internal oncology program development[13] First Quarter 2025 Financial Results 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] - Current cash, cash equivalents, and restricted cash of $36.2 million are expected to fund operating plans into Q4 2025[8] Financial Statements 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 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 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 |