BiomX

PHGE

Market cap $7.18M

BiomX Inc. (NYSE: PHGE) on Tuesday 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 cystic fibrosis patients.

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

BiomX Inc. ( PHGE ) Q3 2025 Earnings Call November 12, 2025 8:30 AM EST Company Participants Marina Wolfson - CFO & Secretary Jonathan Solomon - CEO & Director Conference Call Participants Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division Yale Jen - Laidlaw & Company (UK) Ltd.

Positive FDA feedback confirms clear clinical pathway for BX011 targeting S. aureus in Diabetic Foot Infections, building on Company's prior Phase 2 success

BiomX believes that it has fully addressed the FDA's queries related to the third-party nebulizer used to deliver BX004, which are narrow in scope; an additional FDA request for limited technical clarifications on the nebulizer has also been addressed

U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate

BiomX Inc. (NYSE:PHGE ) Q2 2025 Earnings Conference Call August 13, 2025 8:00 AM ET Company Participants Jonathan Eitan Solomon - CEO & Director Marina Wolfson - CFO & Secretary Conference Call Participants I-Eh Jen - Laidlaw & Company (UK) Ltd., Research Division Joseph Pantginis - H.C.

Positive Phase 2 results for BX211 demonstrated >40% wound size reduction vs. placebo in diabetic foot osteomyelitis patients; Planning underway for potential registrational study

NESS ZIONA, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it will report its second quarter 2025 financial results and program updates before the open of the U.S. financial markets on Wednesday, August 13, 2025. The Company will host a conference call and a live audio webcast at 8 a.m. ET, to discuss the second quarter of 2025 financial results and provide program updates.

First patient dosing in Company's Phase 2b trial marks pivotal milestone in phage therapy development program targeting antibiotic-resistant lung infections in Cystic Fibrosis patients; topline results are expected in Q1 2026 Prior Phase 1b/2a efficacy findings demonstrated complete bacterial clearance in 14.3% of patients after just 10 days of treatment Feedback from U.S. Food and Drug Administration (FDA) anticipated in H2 2025, regarding plans to evaluate investigation and use of real-world evidence linking bacterial reduction to clinical outcomes; successful alignment could potentially streamline approval pathway for this urgently needed treatment option