NESS ZIONA, Israel — August 13, 2025 — Leads & Copy — BiomX Inc. (NYSE American: PHGE) reported positive Phase 2 results for BX211, showing a >40% wound size reduction versus placebo in diabetic foot osteomyelitis patients. The company is planning a potential registrational study. A Nature Communications publication of new BX004 Phase 1b/2a data demonstrated a further ~500-fold (2.7 log₁₀)2 bacterial reduction versus placebo, with no detectable emergence of resistance observed.
The Phase 2b trial of BX004 in Cystic Fibrosis (CF) has commenced patient dosing, and the FDA feedback on a real-world evidence strategy is expected in H2 2025. Topline results are expected in Q1 2026. BiomX will host a conference call and webcast today at 8:00 AM ET.
Jonathan Solomon, CEO of BiomX, stated that the company has achieved significant milestones that advance its pipeline and further validate its phage therapy platform.
BiomX reported positive topline results from the Phase 2 trial of BX211 in March 2025, demonstrating that BX211 was safe and well-tolerated and produced sustained and statistically significant1 percentage area reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) with separation from placebo starting at week 7 and a difference greater than 40% by week 10.
The Phase 2 trial results also showed that BX211 produced statistically significant improvements in both ulcer depth at week 13 in patients with ulcer depth defined as bone exposure at baseline (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo, with all patients receiving standard of care including systemic antibiotic therapy as appropriate over the 12-week treatment period.
In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004. The Phase 2b trial is a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients with chronic P. aeruginosa infections.
The Company expects to report topline results from the Phase 2b study in the first quarter of 2026.
Cash balance and restricted cash as of June 30, 2025, were $15.2 million, compared to $18 million as of December 31, 2024. BiomX estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the first quarter of 2026.
Research and development expenses, net were $5.0 million for the second quarter of 2025, compared to $6.9 million for the second quarter of 2024.
Net loss was $6.0 million for the second quarter of 2025, compared to income of $4.5 million for the second quarter of 2024.
Contact:
Ben Cohen
Head Corporate Communications
benc@biomx.com
Source: BiomX Inc.
