BiomX Inc. announced the dosing of the first two patients in the Company's Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis (“CF”). BiomX is developing BX004 for the treatment of CF patients with chronic respiratory infections caused by Pseudomonas 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 respiratory infections caused by Pseudomonas aeruginosa.

The Phase 1b/2a study of BX004 is composed of two parts. Part 1 of the study will evaluate the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the study will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio.

Results from Part 2 are expected in the first quarter of 2023. In January 2022, BiomX received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation (“CF Foundation”). The award is structured as an equity investment in which the CF Foundation has agreed to purchase up to $5M million of BiomX common stock across two separate tranches.

The first tranche was received on December 21, 2021, with the CF Foundation making an initial equity investment of $3 million.