BMEA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Our lead clinical program’s drug candidate, icovamenib, is currently being developed as an orally bioavailable, and selective, covalent inhibitor of menin, which serves as a checkpoint to prevent beta cell proliferation and is an important transcriptional regulator known to play a direct role in bet…

• In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. In October 2025, we reported 52-week results from our Phase II COVALENT-111 trial of icovamenib in typ…

• With our strategic focus to become a diabetes and obesity medicines company, we are concluding our studies exploring icovamenib’s potential in oncology and plan to explore partnerships to further advance our oncology assets (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I trial), while…

• In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule glucagon-like peptide-1 GLP-1 receptor agonist (GLP-1 RA), received IND-clearance from the FDA. Our Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers is ongoing, and data is…

• Since commencing operations in 2017, we have devoted substantially all of our efforts and financial resources to conducting research and development activities, including drug discovery and preclinical studies and clinical trials, establishing and maintaining our intellectual property portfolio, the…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Our lead clinical program’s drug candidate, icovamenib, is currently being developed as an orally bioavailable, and selective covalent inhibitor of menin in two clinical and multiple preclinical studies, investigating icovamenib’s potential in type 1 and type 2 diabetes, as well as its impact in obe…

• In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. As of September 30, 2025 icovamenib is being evaluated in type 1 and type 2 diabetes across two ongoin…

• Beyond icovamenib, we are utilizing our novel FUSION™ System to pioneer treatments against other high-value genetic drivers of disease. In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule GLP-1 receptor agonist (RA), received IND-clearance from the…

• Since commencing operations in 2017, we have devoted substantially all of our efforts and financial resources to conducting research and development activities, including drug discovery and preclinical studies, establishing and maintaining our intellectual property portfolio, the manufacturing of cl…

• As of September 30, 2025, we had an accumulated deficit of $453.7 million. We incurred net losses of $66.4 million and $109.1 million for the nine months ended September 30, 2025 and 2024, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and …

Text added vs the prior filing · source: 10-Q · 2026-05-11

• whether we are required by the FDA or other comparable foreign regulatory authorities to conduct additional clinical trials or other

• studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;

• our ability to demonstrate to the satisfaction of the FDA and comparable foreign regulatory authorities the safety, efficacy, consistent manufacturing quality, and acceptable risk-benefit profile of our novel small molecule product candidates or any future product candidates;

• Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any even…

• Our lead product candidate, icovamenib, and our next-generation product candidate, BMF-650, are in clinical development. Our

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• continue our efforts to develop product candidates from our FUSIONTM System discovery platform;

• conduct preclinical studies and initiate and conduct clinical trials;

• whether we are required by the FDA or other comparable foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our product candidates or any future product candidates;

• our ability to demonstrate to the satisfaction of the FDA and comparable foreign regulatory authorities the safety, efficacy, consistent manufacturing quality, and acceptable risk-benefit profile of our small molecule product candidates or any future product candidates;

• Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any even…