Earnings release
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biomea FUSION Biomea Fusion Reports Second Quarter 2026 Financial Results and Corporate Highlights August 5 , 2026 • Enrollment ongoing for the Phase II COVALENT - 211 clinical trial in patients with insulin deficiency in Type 2 diabetes ( " T2D " ) ; data expected in the first quarter of 2027 • Enrollment also ongoing for the Phase II COVALENT - 212 clinical trial in patients with T2D not achieving glycemic targets while on glucagon - like peptide - 1 receptor agonists ( " GLP - 1 RA " ) - based therapy ; data expected in the second quarter of 2027 • Phase I GLP - 131 ( BMF - 650 ) obesity clinical trial on track with initial 28 - day weight reduction data expected in the third quarter of 2026 • Research collaboration initiated with the University of Leicester to evaluate icovamenib in combination with semaglutide in a Phase II clinical trial in obesity • Cash runway projected into the second quarter of 2027 SAN CARLOS , Calif . , Aug. 05 , 2026 ( GLOBE NEWSWIRE ) -- Biomea Fusion , Inc. ( " Biomea ” or “ Biomea Fusion " or " the Company " ) ( Nasdaq : BMEA ) , a clinical - stage diabetes and obesity company , today reported its financial results for the second quarter ended June 30 , 2026 , and provided a business update . " The second quarter marked continued execution across our diabetes and obesity programs . We are near completion of enrollment in our COVALENT - 211 Phase II clinical trial , continue to advance enrollment in COVALENT - 212 , and remain on track to report initial 28 - day clinical weight reduction data from our BMF - 650 Phase I clinical trial in the third quarter , " said Mick Hitchcock , Ph.D. , Interim Chief Executive Officer of Biomea Fusion . " The Type 1 diabetes data presented at the American Diabetes Association's Scientific Sessions strengthened our confidence in icovamenib's potential to preserve and improve endogenous insulin secretion , providing additional evidence that this program may have potential to address a significant unmet need . We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program . " Recent Corporate Highlights : Icovamenib Potential First - in - Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes • Two Phase II clinical trials evaluating icovamenib in T2D are ongoing : • COVALENT - 211 , a Phase II , randomized , double - blind , placebo - controlled trial in patients with insulin - deficient T2D not achieving glycemic targets despite standard of care therapy . The trial is currently enrolling patients , with 26 - week primary endpoint data expected in the first quarter of 2027 . • COVALENT - 212 , a Phase II , randomized , double - blind , placebo - controlled trial in patients with T2D not achieving glycemic targets while on a GLP - 1 RA - based therapy . The trial is currently enrolling patients , with 26 - week primary endpoint data expected in the second quarter of 2027 . • The Company presented 52 - week follow - up data from the Phase II COVALENT - 112 clinical trial evaluating icovamenib in Type 1 diabetes ( " T1D " ) patients at the American Diabetes Association's ( " ADA " ) Scientific Sessions : • A 52 % increase from baseline in mean C - peptide AUC at Week 12 was observed in T1D patients diagnosed within 0 to 3 years who received icovamenib 200 mg ( n = 3 ) . The effect was durable , with mean C - peptide AUC largely preserved through Week 52 following completion of the 12 - week dosing period ( ~ 7 % decline from baseline ) . • Preservation of C - peptide also observed in T1D patients diagnosed between 3-15 years ( n = 9 ) . • Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 . • Planning a Phase II clinical trial in recently diagnosed T1D patients ( ≤ 3 years since diagnosis ) , in collaboration with four U.S. academic centers , to evaluate extended dosing ( 6-12 months ) of icovamenib 200 mg and assess potential combination with an immunosuppressive agent ; trial initiation expected in the second half of the year at leading