BiomX receives FDA feedback on potential development strategies for BX004

BiomX (PHGE) provided an update on progress relating to the previously disclosed U.S. Food and Drug Administration clinical hold placed on the U.S. portion of the BX004 Phase 2b trial in cystic fibrosis. The Company also announced that it has received new encouraging written feedback provided by the FDA outlining potential development strategies for BX004, including approaches to enrich study populations in Phase 3 development. In responding to the initial clinical hold of the U.S. portion of the Phase 2b trial, BiomX, together with the third-party nebulizer manufacturer, promptly provided a comprehensive package of data and analyses to address the FDA’s feedback and queries related to the third-party nebulizer device used to deliver BX004. Following its review of this package, the FDA issued an additional request for limited technical clarifications related to the nebulizer’s performance. BiomX believes that it has fully addressed the FDA’s queries, which are narrow in scope and pertain solely to the nebulizer device. The FDA has not raised any concern regarding the BX004 drug product itself. Importantly, patient recruitment and dosing in Europe have continued ahead of plan throughout the U.S. clinical hold. The BX004 Phase 2b trial remains on track to report topline results in the first quarter of 2026. All third-party nebulizer components used in the European trial are CE marked and approved for use in the EU. BiomX has also received new written feedback from the FDA recognizing that, even in the era of Cystic Fibrosis Transmembrane Conductance Regulator modulators, there remains a significant unmet need for therapies addressing chronic Pseudomonas aeruginosa infection in individuals with CF. The FDA outlined several potential development pathways, including opportunities to refine inclusion criteria and enrich patient populations in a Phase 3 program, with the aim of enhancing the ability to demonstrate therapeutic benefits. BiomX plans to incorporate the FDA’s recommendations, as appropriate, into ongoing development plans and anticipates further discussion with the FDA at an End-of-Phase 2 meeting following completion and review of the Phase 2b trial results.