BiomX reported significant advancements in its clinical programs despite regulatory challenges, maintaining confidence in its innovative phage therapy pipeline.

• Initiated Phase IIb trial for BX004 with first patient dosing, though faced a temporary clinical hold from the FDA related to the nebulizer delivery device.
• Received positive FDA feedback on BX011’s development for diabetic foot infections, outlining a clear pathway towards a Biologics License Application (BLA).
• European trials for BX004 continue without interruption, with planned data reporting set for Q1 2026.
• BX011 targets a critical unmet need in diabetic foot infections, promising substantial commercial potential in a market with no new drugs approved in over 20 years.
• Company remains optimistic about upcoming discussions with the FDA and the Department of Defense Health Agency as part of its strategic partnerships.