Item 8.01 Other Events.

On August 19, 2025 BiomX Inc. ("BiomX" or the "Company") announced that the U.S. Food and Drug Administration ("FDA") has placed a clinical hold on the Company's Phase 2b study (the "Study") that is design to test the Company's drug candidate BX004 ("BX004") in treating Cystic Fibrosis ("CF") as the FDA reviews data submitted by the Company on a third-party nebulizer used in the Study to deliver BX004.

The FDA did not raise concerns in the clinical hold notification regarding BX004. Following the FDA's hold notification the Company submitted additional requested data. As a result of the FDA's notification, patient screening and enrollment in the U.S. portion of the Study have now been paused. In Europe, all components of the third-party nebulizer device are CE marked and thus have been deemed to meet applicable regulatory requirements. The Study in the EU has been approved and enrollment and dosing of patients are continuing in accordance with the protocol of the Study.