BiomX Announced That The U.S. FDA Is Continuing Its Evaluation Of The Nebulizer Device Used For Drug Administration In The Co's Phase 2b Trial Of BX004 In Patients With Cystic Fibrosis; Following The DMC Review, The Study Protocol Will Be Updated, And Topline Results Are Now Expected In Q2 2026

The Company continues working with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial

An independent Data Monitoring Committee (DMC) completed a safety review following adverse events identified in the BX004 Phase 2b trial and recommended that the study continue with revised dosing

Following the DMC review, the study protocol will be updated, and topline results are now expected in Q2 2026

NESS ZIONA, Israel, Nov. 25, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the Company's Phase 2b trial of BX004 in patients with cystic fibrosis. The Company is working with the third-party manufacturer to address recent FDA follow up information requests in order to lift the FDA's clinical hold with respect to the trial. In parallel, an independent DMC has completed a safety review of the BX004 Phase 2b clinical trial.

BiomX recently received additional follow-up questions from the FDA related to the third-party nebulizer device used for BX004 administration. The Company is working closely with the device manufacturer to assemble the remaining additional information requested by the Agency. BiomX considers the outstanding items readily addressable to resolve the outstanding questions raised by the FDA while maintaining a productive and ongoing dialogue with the Agency. The Company expects enrollment in the U.S. to resume once this process is complete.

Separately, an independent DMC has conducted a safety review of the BX004 Phase 2b clinical trial. The review included participants who experienced adverse events, and following its evaluation, the DMC recommended that the study continue with an adjusted dosing regimen. In accordance with the recommendations, BiomX is updating the trial protocol, and pending availability of financial resources and other factors, topline results are now expected in the second quarter of 2026.