Biomea Fusion (BMEA) Piper Sandler 37th Annual Healthcare Conference summary

Market and industry context

• Biotech sector is experiencing a strong recovery, with the Nasdaq Biotech Index up over 40% since April, driven by innovation and new product launches.

• Small-cap biotech stocks have outperformed, with some up over 90% in the same period.

Scientific and clinical insights

• Menin inhibition in the pancreas promotes beta cell proliferation, potentially addressing the root cause of diabetes by restoring insulin production.

• Animal and human studies show that inhibiting menin can lead to improved glucose absorption and beta cell regeneration.

• All-comers clinical study segmented patients by insulin deficiency, finding the most profound response in insulin-deficient individuals.

• Up to 1.8% placebo-adjusted A1C reduction was observed after 12 weeks of dosing, with effects sustained for nine months post-treatment.

Development plans and regulatory strategy

• Chronic dosing studies are planned, with regulatory approval for longer dosing expected next year.

• Upcoming 52-week data, including C-peptide results, will be presented at a major diabetes congress.

• Initial focus is on severe insulin-deficient diabetics, a clearly identifiable group with high unmet need.

• Additional studies will target GLP-1 uncontrolled patients and explore combination therapies for obesity and type 1 diabetes.