BIOMEA FUSION INC (BMEA)

Biomea Fusion 52-Week Data Readout for COVALENT-111

Biomea Fusion, Inc. is anticipating a 52-week data readout from their Phase II COVALENT-111 study scheduled for July 1, 2025. This study investigates icovamenib, a leading product candidate for treating type 2 diabetes. Earlier 26-week results, disclosed in December 2024, revealed that icovamenib met its primary endpoint with a significant reduction in HbA1c levels in target patients. This marked a promising development for further advancement, potentially positioning icovamenib as a first-in-class menin inhibitor therapy. The company plans discussions with the FDA based on these findings, aiming for late-stage clinical development. The material financial impact is still unknown, pending the 52-week results. The study involves trials on several dosing regimens among a diverse group of patients to optimize treatment plans. Icovamenib was generally well tolerated with no serious adverse events noted during the study.

Expected Completion of Phase 2 Trial of BMF-219

Biomea Fusion Inc. is expected to complete its Phase 2 trial of BMF-219 for Type 1 Diabetes Mellitus on August 31, 2025. The study, identified as COVALENT-112, aims to evaluate beta-cell function, insulin sensitivity, and the impact on glucose and lipid metabolism. BMF-219 is an oral small-molecule menin inhibitor, and the trial has enrolled 190 participants. As of now, the trial remains active but is not recruiting new participants.

• www.clinicaltrials.gov/study/NCT06152042

Expected Completion of Phase 1 Study of BMF-500 in Adults with Acute Leukemia

Biomea Fusion Inc. is expected to complete a Phase 1 clinical trial of BMF-500 in adults with acute leukemia by December 31, 2025. This trial, which is currently recruiting participants, is a first-in-human dose-escalation and dose-expansion study targeting acute myeloid leukemia (AML) patients. BMF-500 is an oral covalent FLT3 inhibitor, and the study aims to enroll 84 participants. The trial's results could provide key insights into the drug's safety and efficacy, potentially impacting Biomea's stock performance and outlook.

• www.clinicaltrials.gov/study/NCT05918692