Highest-materiality recent filing
Biomea Fusion reports Phase 2 COVALENT-112 positive topline: 52% C-peptide increase in early T1D
In patients diagnosed within 3 years, icovamenib 200mg QD for 12 weeks increased mean C-peptide AUC by 52% (p<0.001, n=5) at Week 12; effect sustained with ~7% decline from baseline at Week 52.
Net loss $61.8M for FY2025 vs $138.4M in FY2024; R&D expenses decreased 47% to $62.0M.
Biomea Q3 net loss $16.4M (down 50% YoY); cash $47M; advances icovamenib and BMF-650
Net loss $16.4M for Q3 2025 vs $32.8M in Q3 2024; R&D expenses down ~47% YoY.
Biomea Fusion prices $25M public offering of common stock and warrants at $2.05/unit
Offering of 11,195,121 shares + 1,000,000 pre-funded warrants, each paired with a warrant to buy one share at $2.50.
In severe insulin-deficient T2D patients (n=10), icovamenib achieved durable HbA1c reduction of 1.2% (p=0.01) through Week 52 after 12 weeks dosing.
Biomea Fusion Q2 net loss narrows to $20.7M, raises $42.8M, pipeline advances
Net loss $20.7M (Q2 2025) vs $37.3M (Q2 2024); R&D expenses halved to $16.6M.
Biomea Fusion closes $37.1M offering of 20M shares and warrants
Offering of 19.45M shares, 550K pre-funded warrants, and 20M common stock warrants at $2.00 per unit.
Biomea Fusion prices $40M public offering of 19.45M shares and warrants at $2.00/unit
Offering of 19.45M common shares and 19.45M accompanying warrants; 550K pre-funded warrants for certain investors.
BMF-650 preclinical shows 12-15% weight loss in obese monkeys; IND on track H2 2025
28-day study in 15 obese cynomolgus monkeys; oral BMF-650 at 10 or 30 mg/kg daily.
Biomea Fusion Q1 loss $29.3M; realigns on diabetes/obesity, cuts workforce 35%
Q1 net loss $29.3M ($36.2M cash); cash runway extended into Q4 2025.
Biomea Fusion Q4 net loss $29.3M; cash drops to $58.6M; interim CEO appointed, pivots to diabetes
Net loss $29.3M for Q4 2024 ($34.9M in Q4 2023); FY net loss $138.4M vs $117.3M.
Biomea Fusion CEO Thomas Butler out; Board member Mick Hitchcock named interim CEO
Thomas Butler terminated as CEO, resigned as director and Chairman effective March 25, 2025.
Placebo-adjusted 1.5% mean HbA1c reduction in severe insulin-deficient T2D patients after 12 weeks of icovamenib, sustained 14 weeks off treatment.
Best response in beta-cell deficient patients on antidiabetic agents: placebo-adjusted HbA1c reduction 1.47% at Week 26 (p=0.022) after 12 weeks dosing.
Biomea Fusion reports Q3 net loss of $32.8M; FDA lifts clinical hold on diabetes trials
Cash and cash equivalents $88.3M as of Sep 30, 2024, down from $177.2M at Dec 31, 2023.
FDA lifts clinical hold on Biomea Fusion's BMF-219 for type 2 and type 1 diabetes trials
FDA lifted clinical hold on Phase I/II trials COVALENT-111 (type 2 diabetes) and COVALENT-112 (type 1 diabetes) as of Sept 26, 2024.
Net loss $37.3M in Q2 vs $24.9M YoY; cash $113.7M, down from $177.2M end of 2023.
Full clinical hold on Phase I/II COVALENT-111 and COVALENT-112 for BMF-219 in type 2 and type 1 diabetes.
Biomea Fusion Q1 2024 net loss $39.1M; cash $145.3M; positive diabetes clinical data
Net loss of $39.1M in Q1 2024 (incl. $5.0M stock comp) vs $29.1M in Q1 2023; R&D expenses rose to $33.8M.
Biomea Fusion reports Q4 2023 net loss $34.9M; cash $177.2M; clinical data readouts expected 2024
Net loss $117.3M for FY 2023 vs $81.8M in 2022; Q4 loss $34.9M vs $25.3M.
Patient 1 (200 mg): fasting C-peptide +57% at week 4, +80% at week 8; MMTT C-peptide index AUC +12% and +40%.
Placebo-adjusted mean HbA1c reduction up to 1.4% at Week 26 after 28-day BMF-219 treatment.
Biomea Fusion reports Q3 net loss of $28.4M, advances diabetes and oncology pipeline
Net loss of $28.4M for Q3 2023 vs $22.9M in Q3 2022; cash of $199.5M as of Sep 30, 2023.
Biomea Fusion Q2 2023: positive diabetes & AML data; net loss widens
Diabetes: in Cohort 3 (100 mg BMF-219 QD), mean HbA1c reduction of 1.49% at Week 12, 62% greater than at end of 4-week dosing.
BMF-219 induces 2 complete responses in 5 AML patients with menin mutations in Phase I trial
2 of 5 relapsed/refractory AML patients with menin-dependent mutations achieved CRs at Dose Level 4 (500mg or 125mg QD).
Net loss $29.1M vs $16.4M in Q1 2022; R&D expense $24.4M (up from $11.4M).
Biomea Fusion receives FDA clearance for IND of BMF-500 in relapsed/refractory acute leukemia
FDA cleared IND for BMF-500, a novel covalent FLT3 inhibitor, to begin Phase I trial COVALENT-103 in adult patients with relapsed or refractory acute leukemia.
Biomea Fusion prices upsized $150M public offering of 5M shares at $30; net proceeds ~$161.6M
Offering of 5,000,000 shares at $30.00 per share; gross proceeds of $150.0 million.
Biomea Fusion reports FY2022 net loss of $81.8M; cash $113.4M; clinical progress across three trials
Net loss $25.3M in Q4 2022 ($14.7M in Q4 2021); full-year loss $81.8M vs $41.6M in 2021.
Cohort 3 (100 mg BMF-219 without food, n=9) showed 89% response rate, median HbA1c reduction of -1.0% at day 28.
FDA cleared IND for BMF-219 (covalent menin inhibitor) in type 2 diabetes; will activate US sites in ongoing COVALENT-111 study.
Biomea Fusion presents preclinical data for BMF-500 at ASH; IND on track for H1 2023
BMF-500 demonstrated picomolar affinity to FLT3 mutations, including ITD and TKD.
Biomea Fusion enters ATM equity distribution agreement for up to $100M with Piper Sandler
Entered equity distribution agreement with Piper Sandler for up to $100M ATM offering of common stock.
Biomea Fusion Q3 net loss $22.9M, cash $133.8M; advances BMF-219 into KRAS solid tumors and T2D
Net loss $22.9M in Q3 2022 ($12.6M in Q3 2021); cash & investments $133.8M vs $175.7M year-end 2021.
Biomea Fusion doses first T2D patient in Phase II of BMF-219; Phase I completed
First patient with type 2 diabetes dosed in Phase II portion of COVALENT-111 (Phase I/II) of BMF-219.
FDA cleared IND for BMF-219 to initiate Phase I/Ib trial (COVALENT-102) in KRAS-mutant NSCLC, CRC, and PDAC.
BMF-219 increased beta cell mass in ex vivo human donor islets, first such translational data presented.
BMF-219 lowered HbA1c by 3.5% vs. liraglutide 1.7% in ZDF rat model; effect maintained through 2-week drug washout.
The employment of Thomas Butler as Chief Executive Officer of the Company ended on March 25, 2025 (the “Effective Date”).
Dr. Hitchcock, a member of the Board, was appointed as the Company’s interim Chief Executive Officer and principal executive officer
On the Effective Date, Mr. Butler resigned as a director and Chairman of the Board
Rainer (Ramses) Erdtmann, the Company’s President, Chief Operating Officer and a member of the Board, was appointed as the Company’s principal financial officer and principal accounting officer
On February 24, 2025, Franco Valle resigned as the Chief Financial Officer (principal financial officer and principal accounting officer) of Biomea Fusion, Inc. (the “Company”), effective March 7, 2025.
On July 7, 2021, Sunny Lee Ryan, Executive Vice President of Finance of the Company, notified the Company of her decision to resign her position with Company, effective July 31, 2021
On June 28, 2021, Biomea Fusion, Inc. Biomea Fusion, Inc. (“Biomea Fusion” or the “Company”) announced that Franco Valle, Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer, will commence employment with the Company on July 26, 2021
On July 7, 2021, Sunny Lee Ryan, Executive Vice President of Finance of the Company, notified the Company of her decision to resign her position with Company, effective July 31, 2021 (the “Effective Date”).
Max materiality 0.90 · Median 0.70 · Most common event other_material