Biomea Fusion reports sustained responses in leukemia patients

REDWOOD CITY, Calif. - Biomea Fusion, Inc. (NASDAQ:BMEA), a clinical-stage biopharmaceutical company with a current market capitalization of $98 million, reported updated preliminary data from its Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory acute leukemia. According to InvestingPro data, while the company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 2.25, it faces significant cash burn challenges typical of clinical-stage biotech firms.

The trial enrolled 27 heavily pretreated patients across two study arms, with a median of four prior lines of therapy. Eighteen patients had FLT3 mutations, all of whom had previously failed gilteritinib treatment, while nine patients had FLT3 wild-type acute leukemia. Nearly all patients (96%) had also failed venetoclax therapy.

Among 11 efficacy-evaluable FLT3-mutant patients, nine showed bone marrow blast reduction, with five achieving greater than 50% reduction. One patient achieved complete remission with incomplete hematologic recovery sustained for six cycles, while another reached morphologic leukemia-free state with the response ongoing.

The median overall survival for all treated FLT3-mutant patients was 3.8 months in Arm A (no CYP3A4 inhibitor) and 3.5 months in Arm B (with CYP3A4 inhibitor). The company noted these survival durations compare favorably to the historical median overall survival of 2.1 months in similar patient populations. Despite these promising clinical results, InvestingPro analysis shows the company reported negative EBITDA of $131 million in the last twelve months, reflecting the substantial investments in research and development.

BMF-500, described as a selective covalent FLT3 inhibitor, was generally well-tolerated with no dose-limiting toxicities, QT prolongation, or treatment-related discontinuations reported. Dose escalation continues at 200 mg twice daily in Arm A and 75 mg twice daily in Arm B.

The results were presented at the European Hematology Association 2025 Congress in Milan, Italy. Following completion of the dose escalation phase, Biomea plans to conclude its internal development of BMF-500 in oncology and is exploring strategic partnerships to advance the program. The stock, currently trading at $2.61, has shown recent momentum with a 4.8% gain over the past week, though it remains significantly below its 52-week high of $13.07. For deeper insights into Biomea’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro.

In other recent news, Biomea Fusion reported its first-quarter 2025 earnings, revealing an earnings per share (EPS) of ($0.80). This result slightly exceeded H.C. Wainwright’s estimate of ($0.85) but fell short of the consensus estimate of ($0.60). The company ended the quarter with $36.2 million in cash reserves, which management expects to support operations until the fourth quarter of 2025. H.C. Wainwright subsequently adjusted the price target for Biomea Fusion shares to $18 from $40, maintaining a Buy rating. The decision was influenced by the removal of type 1 diabetes from revenue projections and a delay in the projected launch years for icovamenib in treating type 2 diabetes.

Biomea Fusion also presented promising data at the ATTD 2025 Conference regarding its investigational drug, icovamenib, which may modify the progression of type 2 diabetes. The data showed that icovamenib could sustain reductions in HbA1c levels and improve beta-cell function, even three months after treatment cessation. The drug demonstrated a significant placebo-adjusted mean reduction in HbA1c of 1.47% in a specific group of beta-cell deficient patients. Additionally, preclinical experiments indicated that icovamenib enhances the responsiveness of human islets to GLP-1-based medicines. These findings underscore the potential of icovamenib to significantly impact the treatment of severe insulin-deficient diabetes.

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