On March 31, 2025 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights (Press release, Biomea Fusion, MAR 31, 2025, View Source [SID1234651662]).
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"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 step in and contribute decades of experience in late-stage development, regulatory strategy, and commercialization to help guide Biomea forward. This transition reflects the continued confidence in our menin inhibitor program and the strength of our covalent small molecule platform. We remain fully committed to advancing icovamenib and delivering on our mission to transform diabetes treatment through this disease-modifying therapy. With key data readouts and regulatory milestones ahead, 2025 is set to be a pivotal year for the company."
In March 2025, the Company announced a leadership transition, appointing Board member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler.
In January 2025, we announced plans to position Biomea as a dedicated diabetes and obesity medicines company. Building on our most recent clinical trial results, our strategic focus for icovamenib is now exclusively centered on metabolic disorders. As a result, we are terminating all ongoing oncology trials involving icovamenib and will conclude the BMF-500 study in patients with relapsed/refractory acute leukemia with FLT3 gene mutations following the dose escalation phase. Biomea will seek strategic partnerships to advance its oncology portfolio and the capabilities of its FUSION System, while reallocating internal resources to accelerate our metabolic disease programs.
In October 2024, we announced the formation of our Global Scientific Advisory Board, comprised of 22 internationally recognized experts in beta cell science and diabetes therapeutics. This board will work closely with our leadership team as we continue to explore menin biology and beta cell regeneration, and advance the clinical development of icovamenib as a novel, disease-modifying treatment targeting a root cause of diabetes.
RECENT DIABETES AND OBESITY PROGRAM UPDATES
COVALENT-111 (Icovamenib for Type 2 Diabetes ("T2D"))
Study Results:
In the dose expansion portion of the COVALENT-111 study, icovamenib demonstrated statistically significant reductions in HbA1c in the prespecified per protocol patient population, with notable effects in the severe insulin deficient patients.
In this group, icovamenib achieved a 1.47% reduction in HbA1c at Week 26 following 12 weeks of treatment with 100 mg once a day ("QD").
Severe insulin deficient patients also experienced the largest mean increase in C-peptide index levels, with a 53% mean increase from baseline by Week 26, indicating enhanced endogenous insulin production.
In a broader subset of insulin deficient patients, icovamenib treatment led to a 1.0% reduction in HbA1c at Week 26 following 12 weeks of treatment with 100 mg QD.
The data showed that icovamenib preferentially increased insulin secretion in insulin-deficient patients, supporting its potential as a targeted therapy for individuals with severe insulin deficiency, a population with limited treatment options and the highest risk profile.
Across all dosing groups in the severe insulin deficient subgroup, there was a strong correlation between increases in C-peptide and reductions in HbA1c, consistent with the proposed mechanism through beta cell restoration.
HbA1c reductions were durable at 26 weeks, 3 months post last dose, further supporting the long-lasting effect of icovamenib on glycemic control.
Icovamenib was generally well tolerated, with no treatment discontinuations due to adverse events, no hypoglycemic episodes, and no drug-related serious adverse events reported.
Preclinical Findings:
In preclinical experiments, including in ex vivo human islets, icovamenib was able to enhance the activity of GLP-1 RA-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes. These effects were associated with an increase in the expression levels of the GLP-1 receptors ("GLP-1R").
Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets potentially reducing side effects and improving the tolerability of GLP-1 based therapies.
Anticipated 2025 Milestones:
Planned U.S. Food and Drug Administration ("FDA") discussions regarding Phase II/III trial designs and the advancement of icovamenib into late-stage clinical development in the first half of 2025.
52-week data from the COVALENT-111 Phase II study anticipated in the second half of 2025.
COVALENT-112 (Icovamenib for Type 1 Diabetes ("T1D"))
Anticipated 2025 Milestones:
Initial open label data from the Phase II study is expected in the second half of 2025.
BMF-650 (Oral small molecule GLP-1 RA)
Preclinical Progress:
Preclinical studies evaluating the properties of our investigational, next-generation, oral small molecule GLP-1 RA (BMF-650) demonstrated positive early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, and appetite suppression in cynomolgus monkeys.
In comparison to a leading oral GLP-1 RA, BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and enable successful dose escalation in patients.
Human donor islet studies confirmed that BMF-650 significantly enhanced glucose-stimulated insulin secretion, aligning with findings from animal models.
In cynomolgus monkey studies, BMF-650 demonstrated robust improvements in glucose control and insulin secretion, consistent with its effects in human donor islets.
Appetite suppression studies revealed that daily oral dosing of BMF-650 significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period.
Anticipated 2025 Milestones:
Submission of the Investigational New Drug ("IND") application for BMF-650 is planned for the second half of 2025.
ONCOLOGY PROGRAM
COVALENT-103 Study (BMF-500):
Preliminary Phase I data for BMF-500 in relapsed/refractory acute leukemia patients with FLT3 gene mutations having failed gilteritinib indicated clinical activity with evidence of responses, including a first complete response with incomplete hematologic recovery (CRi) and reductions in bone marrow blasts in five of six evaluable FLT3 mutated patients.
Pharmacokinetic and pharmacodynamic analyses confirmed dose-proportional on-target FLT3 inhibition and good compartmental penetration, and BMF-500 showed a favorable safety and tolerability profile with no dose-limiting toxicities observed.
Anticipated 2025 Milestones:
After the completion of the dose escalation of BMF-500 in relapsed/refractory acute leukemia patients with FLT3 gene mutations, we intend to conclude our oncology study with BMF-500 and explore strategic partnerships.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2024, the Company had cash, cash equivalents and restricted cash of $58.6 million, compared to $177.2 million as of December 31, 2023.
Net Income/Loss: The Company reported a net loss attributable to common stockholders of $29.3 million for the three months ended December 31, 2024, compared to a net loss of $34.9 million for the same period in 2023. Net loss attributable to common stockholders was $138.4 million for the year ended December 31, 2024, compared to a net loss of $117.3 million for the same period in 2023.
Research and Development ("R&D") Expenses: R&D expenses were $25.2 million for the three months ended December 31, 2024, compared to $30.9 million for the same period in 2023. The decrease of $5.6 million was primarily due to the decrease in compensation and related expenses, manufacturing related expenses, and clinical related expenses. R&D expenses were $118.1 million for the year ended December 31, 2024, compared to $102.5 million for the same period in 2023. The increase of $15.5 million was primarily due to an increase in clinical development of icovamenib, consultants, advisors and other professional services to support our clinical studies, discovery research and overall research and development programs.
General and Administrative ("G&A") Expenses: G&A expenses were $4.8 million for the three months ended December 31, 2024, compared to $6.5 million for the same period in 2023. The decrease of $1.6 million was primarily due to the decrease in compensation and related expenses. G&A expenses were $26.0 million for the year ended December 31, 2024, compared to $23.6 million for the same period in 2023. The increase of $2.4 million was primarily due to increased personnel-related expenses, including stock-based compensation, due to an increase in headcount, as well as an increase in professional and consulting services to support the growth of the Company.
About Icovamenib
Icovamenib 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. Icovamenib’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 T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed clinical studies.