BX004 Phase IIb Trial Progress and FDA Feedback
The BX004 program for cystic fibrosis patients showed significant progress with first patient dosing in the Phase IIb trial. Despite a clinical hold on U.S. trial sites due to a third-party nebulizer device, the European trial continues uninterrupted. FDA feedback recognized the unmet need for treatments targeting chronic Pseudomonas aeruginosa infections and provided constructive guidance for development pathways, including Phase III criteria.
Positive FDA Feedback for BX011 in Diabetic Foot Infections
The FDA provided positive feedback on the development plan for BX011 targeting Staphylococcus aureus infections in diabetic foot infections (DFI). The program aims to provide an off-the-shelf formulation with potential for dual-use in combat-related wound infections, aligning with U.S. Defense Health Agency priorities. The FDA outlined a clear pathway toward a Biologics License Application without additional nonclinical studies, supporting the commercial opportunity.
Financial Management and Reduced Expenses
Research and development expenses decreased to $6.1 million in Q3 2025 from $7.3 million in Q3 2024, attributed to workforce reduction and lower rent expenses. General and administrative expenses also decreased to $2.4 million from $3.2 million. BiomX estimates its cash reserves are sufficient to fund operations into Q1 2026.