BiomX Inc. announced positive results from Part 1 of the Phase 1b/2a trial evaluating the Company's novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis. Part 1 of the Phase 1b/2a study of BX004 evaluated the safety, tolerability, pharmacokinetics (PK), and microbiologic activity of BX004 over a 7-day treatment period in nine CF patients (seven on BX004, two on placebo) with chronic P. aeruginosa pulmonary infection in a single ascending dose and multiple dose design. Highlights Included: No safety events related to treatment with BX004 Mean P. aeruginosa colony forming units (CFU) at Day 15 (compared to baseline): -1.42 log10 CFU/g (BX004) vs.

-0.28 log10 CFU/g (placebo). This reduction was seen on top of standard of care inhaled antibiotics Phages were detected in all patients treated with BX004 during the dosing period, including in several patients up to Day 15 (one week after end of therapy); no phages were detected in patients receiving placebo There was no emerging resistance to BX004 during or after treatment with BX004 As expected, likely due to short course of therapy, there was no detectable effect on % predicted FEV1 BiomX is developing BX004, utilizing its proprietary BOLT platform, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In September 2021, BX004 was cleared by the U.S. Food and Drug Administration to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa.

Part 2 of the Phase 1b/2a study of BX004 will evaluate the safety and efficacy of BX004 in 24 CF patients with chronic pulmonary infection caused by P. aeruginosa randomized to treatment or placebo in a 2:1 ratio. Results from Part 2 are expected in the third quarter of 2023.