BiomX Inc., a clinical-stage company focused on advancing novel phage therapies to combat pathogenic bacteria, has announced the completion of a series of financing agreements expected to raise $12 million in aggregate gross proceeds. This funding will accelerate the development of BX004, a phage cocktail designed to treat chronic pulmonary infections in cystic fibrosis (CF) patients caused by Pseudomonas aeruginosa, and will also support the analysis of real-world evidence to explore the impact of P. aeruginosa reduction on clinical outcomes.

Strong investor support and strategic use of funds

The financing round was led by Deerfield Management Company and saw significant participation from the Cystic Fibrosis Foundation, alongside contributions from Nantahala Capital and other investors. The funds raised will primarily be directed towards the ongoing Phase 2b study of BX004, with topline results from this trial expected in the first quarter of 2026. BiomX also plans to leverage these funds to analyze real-world data, particularly focusing on the correlation between reduced P. aeruginosa levels and improvements in CF patient outcomes.

Jonathan Solomon, CEO of BiomX, expressed his optimism about the company’s financial position, stating: “Following these offerings, we expect to have sufficient funding to reach substantial inflection points, including topline results of our Phase 2b study of BX004 in Q1 2026, and our Phase 2 readout for BX211 in Diabetic Foot Osteomyelitis later this quarter.”

BX004: a potential breakthrough in cystic fibrosis care

BX004 is a fixed multi-phage cocktail that targets P. aeruginosa, a leading cause of lung infections and respiratory decline in CF patients. In November 2023, BiomX reported promising topline results from Part 2 of its Phase 1b/2a trial, where BX004 demonstrated a significant reduction in P. aeruginosa burden and improved pulmonary function in CF patients with pre-existing lung damage (baseline FEV1 <70%).

The ongoing Phase 2b trial will include 60 CF patients and will evaluate the safety, tolerability, and microbiological effects of BX004, specifically its ability to reduce P. aeruginosa in the lungs. The treatment will be administered via inhalation twice daily for eight weeks, with follow-up to assess lung function, measured by FEV1, and patient-reported outcomes. The FDA has granted BX004 both Fast Track and Orphan Drug Designation, highlighting the urgent need for new treatments in this area.

Real-world evidence and regulatory plans

In addition to advancing its clinical trials, BiomX is looking to deepen its understanding of how reducing P. aeruginosa can improve patient health outcomes. BiomX plans to analyze real-world evidence from CF patients to support its regulatory filings with the FDA. Discussions with the FDA and the European Medicines Agency (CHMP) are expected later this year to further refine the company’s development plans for BX004.

The real-world data will provide valuable insights into the clinical impact of P. aeruginosa reduction, complementing the results from BiomX’s ongoing clinical studies. These insights are anticipated to play a key role in shaping the regulatory path forward for BX004 and could significantly improve the therapeutic options available to CF patients.

Looking ahead: a robust pipeline

Beyond BX004, BiomX is also advancing its pipeline, including BX211, a personalized phage therapy for treating diabetic foot osteomyelitis (DFO) caused by Staphylococcus aureus. The ongoing Phase 2 trial for BX211 has shown promising early results, with data on wound healing and infection resolution expected later this year.

BiomX’s ability to develop personalized and multi-phage treatments places it at the forefront of phage therapy, a promising field for addressing chronic, antibiotic-resistant infections. The company’s proprietary BOLT platform, which enables the design of customized phage compositions, underscores its innovative approach to tackling significant unmet medical needs.