BiomX Advances Phage Therapy, Citing Positive Trial Data for Diabetic Foot Ulcers and Cystic Fibrosis.
The clinical-stage company highlights significant reductions in wound size and bacterial load in its key programs, setting the stage for future regulatory milestones while managing operational costs.
YAVNE, ISRAEL – BiomX Inc. (NYSE: PHGE), a leader in developing novel phage therapies, has announced significant progress in its clinical programs, underscoring the potential of its treatments for persistent bacterial infections. In its second-quarter 2025 update, the company shared positive Phase 2 results for its diabetic foot osteomyelitis candidate, BX211, and new compelling data for its cystic fibrosis therapy, BX004.
Clinical Triumphs Take Center Stage
The highlight of the announcement was the strong clinical data, demonstrating the efficacy and potential of BiomX’s targeted phage-based approach.
Promising Results for Diabetic Foot Osteomyelitis (BX211)
Patients treated with BX211 in a Phase 2 trial for diabetic foot osteomyelitis experienced a greater than 40% reduction in wound size compared to those on placebo. This statistically significant improvement points to the therapy’s ability to effectively combat the underlying infection and promote healing in a notoriously difficult-to-treat condition.
Building on this success, BiomX is now planning for a potential registrational study, which is typically the final step before seeking regulatory approval. The company is actively engaged in discussions with the U.S. Food and Drug Administration (FDA) and the U.S. Defense Health Agency to define the next steps for the BX211 program.
Breakthrough Data for Cystic Fibrosis Candidate (BX004)
BiomX also reported key advancements for BX004, its phage therapy designed to target Pseudomonas aeruginosa infections in patients with Cystic Fibrosis (CF). The company has officially commenced patient dosing in its Phase 2b trial, with topline results anticipated in the first quarter of 2026.
Supporting the trial’s promise, new data recently published in the prestigious journal Nature Communications revealed that BX004 achieved an approximately 500-fold greater reduction in bacterial load compared to a placebo. Critically, the study found no detectable emergence of bacterial resistance to the phage therapy, addressing a major challenge in modern antibiotic treatments.
A Word from the CEO
Jonathan Solomon, Chief Executive Officer of BiomX, expressed confidence in the company’s trajectory. “Positive Phase 2 results for BX211 in diabetic foot osteomyelitis demonstrated sustained, statistically significant improvements in wound size reduction… and a favorable safety profile,” he stated.
He added, “In parallel, new peer-reviewed data for BX004 reported approximately 500-fold further bacterial reduction versus placebo and no detectable emergence of resistance, critical evidence supporting the strength of our candidate BX004.”
Navigating Financials and the Regulatory Path
For the second quarter ending June 30, 2025, BiomX reported a net loss of $6.0 million, a shift from the $4.5 million in income recorded in the same period of 2024. The company clarified that this loss was primarily driven by non-cash changes related to the fair value of warrants from a March 2024 financing round, not by operational performance.
Demonstrating disciplined cost management, BiomX saw a decrease in operational spending.
Research and Development (R&D) expenses fell to $5.0 million from $6.9 million, thanks to reduced salary and rent expenses, alongside increased grant funding.
General and Administrative (G&A) expenses also decreased to $2.4 million from $2.8 million year-over-year.
Strategically, the company is also looking to streamline its path to market. BiomX expects to receive feedback from the FDA in the second half of 2025 regarding the potential use of real-world evidence to support the approval pathway for BX004, a modern approach that could accelerate its availability to patients.
Future Outlook: Key Catalysts Ahead
With its clinical programs advancing and key regulatory discussions underway, BiomX is positioned for several value-driving catalysts over the next 12 months. The ongoing Phase 2b study of BX004 and the anticipated topline results in early 2026, combined with the planned registrational study for BX211, mark a pivotal period for the company as it moves closer to delivering a new class of treatments for patients battling life-threatening bacterial infections.
