On August 5, 2025 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Biomea Fusion, AUG 5, 2025, View Source [SID1234654777]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA, BMF-650, showed encouraging results in a 28-day study in obese cynomolgus monkeys, achieving up to 15% weight reduction and robust dose-dependent appetite suppression. These findings reinforce BMF-650’s potential as an oral GLP-1 RA. With these clinical advances and the completion of our $42.8 million equity financing, we now have the necessary resources to advance these high-priority diabetes and obesity programs."

Second Quarter Highlights:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (T1D))

Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health:
In patients with T2D not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months subsequent to the dosing period, particularly in severe insulin deficient patients enrolled in its Phase II trial; icovamenib was well tolerated across the dosing arms.
In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone:
60% lower fasting blood glucose and 50% lower glucose OGTT AUC
Greater HbA1c decline of >1% by Day 28 and >2% by Day 39
Greater improvement in insulin sensitivity with a 75% lower HOMA-IR (marker of insulin resistance)
2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function
Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone
The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass
Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of 15% at the higher dose of 30 mg/kg/day.
BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations.
These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development and support BMF-650’s potential as a best-in-class oral small-molecule GLP-1 RA.
BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia (AML))

Presented updated Phase I data at EHA (Free EHA Whitepaper) 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib.
The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500.
Financing & Operations

In June 2025, Biomea closed its previously announced underwritten public offering and in July 2025 the underwriters partially exercised their over-allotment option to purchase additional shares of common stock. The aggregate gross proceeds from the offering, including the over-allotment option, were approximately $42.8 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea.

During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately 40% lower than the most recent quarter, depending on study enrollments and expansion.

Key Anticipated 2025 Milestones:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)

52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025.
Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025.
Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

Submission of the IND application for BMF-650 is planned for the second half of 2025.
Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of $56.6 million. The Company expects its cash, cash equivalents, and restricted cash to be sufficient to fund planned operating activities into the second half of 2026.

Net Loss: The Company reported a net loss attributable to common stockholders of $20.7 million for the three months ended June 30, 2025, which included $2.6 million of stock-based compensation, compared to a net loss of $37.3 million for the same period in 2024, which included $4.8 million of stock-based compensation. Net loss attributable to common stockholders was $50.0 million for the six months ended June 30, 2025, which included $5.7 million of stock-based compensation, compared to a net loss of $76.3 million for the same period in 2024, which included $9.9 million of stock-based compensation.

Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024. The decrease of approximately $15.3 million was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount. R&D expenses were $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024. The decrease of $26.1 million was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount.

General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024. The decrease of $2.4 million is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services. G&A expenses were $11.5 million for the six months ended June 30, 2025, compared to $14.4 million for the same period in 2024. The decrease of $2.8 million is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount.