Joseph Pantginis

Yale Jen

Michael Higgins

Sara Nik

- BiomX believes it has **fully addressed the FDA's queries** related to the third-party nebulizer used to deliver BX004, with the FDA not raising any concerns regarding the BX004 drug product itself.  **[1739174_2cf7f850d663469892497cb46ef35dd2_0]** 
- Despite the U.S. clinical hold, European enrollment and dosing for the BX004 Phase 2b trial are progressing **faster than expected**, and **topline results remain on track for the first quarter of 2026**.  **[1739174_2cf7f850d663469892497cb46ef35dd2_0]** 
- The FDA has provided new written feedback, recognizing a **significant unmet need** for therapies addressing chronic *Pseudomonas aeruginosa* infection in cystic fibrosis patients and outlining potential development pathways for BX004, including strategies for Phase 3 study population enrichment.  **[1739174_2cf7f850d663469892497cb46ef35dd2_0]** **[1739174_2cf7f850d663469892497cb46ef35dd2_1]**

BiomX (PHGE)