BiomX Reports Third Quarter 2025 Financial Results and Provides Program Updates

Core Insights - BiomX received positive FDA feedback confirming a clear clinical development pathway for BX011, a multi-phage cocktail targeting S. aureus in diabetic foot infections, building on prior Phase 2 success [1][3] - The company anticipates imminent FDA feedback regarding the clinical hold on BX004, a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients [1][3] - BiomX plans to prioritize diabetic foot infections (DFI) for regulatory development, leveraging positive Phase 2 results from BX211 in diabetic foot osteomyelitis [6][14] Clinical Program Updates - BX004 is currently under a clinical hold by the FDA while the company reviews data on a third-party nebulizer; however, patient enrollment and dosing outside the U.S. continue [6][8] - The Phase 2b trial for BX004 involves approximately 60 cystic fibrosis patients and aims to measure efficacy endpoints such as bacterial burden reduction and lung function improvement [6][13] - BiomX plans to initiate a Phase 2a trial for BX011 following FDA feedback, with no additional non-clinical studies required [6][14] Financial Results - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, down from $18 million at the end of 2024, primarily due to operating cash usage [8] - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, attributed to reduced salary and lower rent expenses [9] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, mainly due to changes in the fair value of warrants [11][21]