Reversing Diabetes at Its Root

Biomea Fusion (NASDAQ: BMEA) is a U.S.-based clinical-stage biotech company pioneering the development of oral small molecules that target the root cause of diabetes and obesity. Its lead candidate, icovamenib, is a first-in-class oral menin inhibitor that has demonstrated the ability to regenerate insulin-producing beta cells This approach has the potential to reverse the progression of diabetes, rather than simply managing its symptoms. With a Phase 2 trial underway in severe insulin-deficient patients with type 2 diabetes (T2D) and a Phase 2 combination trial with a GLP-1 receptor agonist expected to begin in late 2025, Biomea is poised to redefine the $100B+ diabetes market.

✅ Game-Changing Pipeline

Lead Candidate: Icovamenib

l Mechanism: Menin is a key negative regulator of beta cell mass and GLP-1 receptor expression. Under hyperglycemic conditions, icovamenib reduces menin levels, driving beta cell proliferation and increasing both GLP-1 receptor density and insulin expression in human islets. This enhances islets responsiveness to GLP-based therapies.

l Unique Value: Directly addresses beta cell depletion — a root cause of T2D that remains unaddressed by currently available therapies.

l Clinical Data Highlights: Placebo-adjusted HbA1c reduction of up to 1.5% in severely insulin-deficient T2D patients.

l Durable effect maintained for 3+ months post-treatment after only 12 weeks of dosing.

l Strong response rate in severe insulin-deficient patients (SIDD) at Week 26 (14 weeks post-treatment).

l Combination Potential: In preclinical in vivo studies, icovamenib in combination with semaglutide demonstrated synergistic benefits compared to low dose semaglutide alone, including:

n Additional 10% reduction in body weight;

n 11.5% reduction in fat mass while preserving lean mass; and

n 60% reduction in fasting blood glucose

l Safety Profile: To date, no discontinuations due to adverse events, no hypoglycemic events, and no serious adverse events attributable to icovamenib. Safety has been consistent with placebo

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✅ Urgent Need in Asia: A Diabetes Epicenter

· China alone has an estimated 148M adults with diabetes, the highest of any country.

· Japan, South Korea, and Taiwan add another estimated 16.4M patients.

· Over 40% of T2D patients in Asia are severely insulin deficient, which have the highest treatment failure rates as well as highest risk of retinopathy, neuropathy and cardiovascular morbidity.

· The Western Pacific region has:

o 215M diabetes patients, which is 1/3 of the global diabetes population

o The 3rd highest prEvalence of diabetes globally (12.4%)

o The highest number of diabetes-related deaths among adults (20–79 yrs)

· Juliana CN Chan, world-renowned diabetes expert, Chair Professor at The Chinese University of Hong Kong, is our lead PI in Asia

*Sources: International Diabetes Federation (lDF, Diabetes Atlas, 11th edition, 2025, Etiologies underlying subtypes of long-standing type 2 diabetes l PlOS One https://doi.org/10.1371/journal.pone.0304036 l Lancet Diabetes Endocrinol 2018; 6; 361-69

Note: Western Pacific region, as defined by lDF includes China, Japan, Korea, etc.

Upcoming Milestones in 2H 2025

🗓52-week readout (secondary/final endpoint) from the Phase 2a trial across all T2D subtypes

🗓 Initiation of Phase 2b in severe insulin-deficient T2D

🗓 Initiation of Phase 2a combination trial of icovamenib with GLP-1 RA inGLP-1 uncontrolled T2D

Join Us

Meet Rohit Kulkarni, M.D., Ph.D., Professor of Medicine at Harvard Medical School alongside Biomea leadership during our August 27, 2025, virtual roadshow to discuss: Biomea’s opportunities in Asia