Core Insights - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on the nebulizer device used in the Phase 2b trial of BX004 for cystic fibrosis patients [1][2][4] - An independent Data Monitoring Committee (DMC) has reviewed the safety of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen, with topline results now expected in Q2 2026 [3][4] Company Updates - The company is collaborating with a third-party manufacturer to provide the FDA with the necessary information to resolve outstanding questions regarding the nebulizer device [2][4] - BiomX has previously reported positive results from Part 1 and Part 2 of the Phase 1b/2a trials, demonstrating safety, tolerability, and improvement in pulmonary function in a specific patient subgroup [5] Product Information - BX004 is a multi-phage cocktail targeting Pseudomonas aeruginosa, a significant cause of morbidity in cystic fibrosis patients [5] - The company plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, pending the resolution of the FDA clinical hold [5]

Core Insights - BiomX Inc. will report its third quarter 2025 financial results and program updates on November 12, 2025, before the U.S. financial markets open [1] - A conference call and live audio webcast will be held at 8:30 a.m. ET on the same day to discuss the financial results and program updates [1][2] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria for chronic diseases with significant unmet needs [4] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [4]

Core Insights - BiomX has addressed the FDA's queries regarding the third-party nebulizer used for BX004, which were narrow in scope, and has responded to an additional request for technical clarifications [1][2] - The FDA's new feedback highlights the significant unmet need for therapies targeting chronic Pseudomonas aeruginosa infections in cystic fibrosis patients and outlines potential development pathways [5][6] - Patient enrollment and dosing in Europe for the BX004 Phase 2b trial are progressing ahead of schedule, with topline results expected in the first quarter of 2026 [3][4] FDA Interaction - BiomX, in collaboration with the nebulizer manufacturer, provided comprehensive data to address the FDA's initial clinical hold on the U.S. portion of the Phase 2b trial [2] - The FDA has not raised concerns regarding the BX004 drug product itself, focusing solely on the nebulizer device [2] Clinical Trial Progress - The BX004 Phase 2b trial is on track to report topline results in Q1 2026, with all nebulizer components used in the European trial being CE marked and approved for use in the EU [3][4] - BiomX plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, assessing lung function, bacterial load, and quality of life metrics [8] Development Strategies - The FDA's feedback recognizes the ongoing unmet need for therapies in cystic fibrosis, suggesting opportunities to refine inclusion criteria and enrich patient populations for a Phase 3 program [5][6] - BiomX intends to incorporate the FDA's recommendations into its development plans and anticipates further discussions at an End-of-Phase 2 meeting after the Phase 2b trial results [6]