BiomX Inc. (PHGE) Q3 2025 Earnings Call

Investor webinar replay

Replay transcript excerpt

or as pathogen, but in an earlier stage of disease where infection remains localized to the ulcer. The program advances toward an off-the-shelf formulation intended for broad outpatient use in diabetic foot infections, while also offering dual-use potential as a rapidly deployable solution for treating combat-related wound infection as an approach well aligned with the priorities of the U.S. Defense Health Agency, or DHA, for future conflict environments. I want to take a minute to explain why we're targeting DFI initially. The DFI indication addresses a critical unmet medical need. Approximately 160,000 lower limb amputations occur in diabetic patients in the U.S. annually, with 85% stemming from diabetic foot infection or osteomyelitis. Despite this urgent need, no new drugs have been approved for DFI in the U.S. in over two decades. Additionally, BFI patients represent a large addressable patient population with significant commercial opportunity with a regulatory pathway that's clearly supported by established FDA guidance. These factors make BFI a strategically compelling indication for our program to focus on while leveraging the strong clinical data we already have. The FDA provided detailed constructive guidance for BX011, outlining the clear potential pathway toward a BLA biologics license application. Notably, no additional non-clinical studies were requested and their CMC comments are aligned with our established manufacturing approach. This feedback confirms our development plan harmonizes with current FDA guidance for DFI product development. BX011 will be applied topically and includes proprietary phage previously evaluated in our successful BX211 study. We plan to advance BX011 in coordination with ongoing discussion with the DHA and subject to securin...