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NESS ZIONA, Israel - BiomX Inc. (NYSE American:PHGE), a clinical-stage biotech company with a market capitalization of $10.9 million, has initiated patient dosing in its Phase 2b clinical trial evaluating BX004, a phage therapy targeting antibiotic-resistant Pseudomonas aeruginosa infections in cystic fibrosis patients. According to InvestingPro analysis, the company maintains a healthy balance sheet with more cash than debt, though it’s currently trading near its 52-week low of $0.34.
The randomized, double-blind, placebo-controlled study will enroll approximately 60 patients who will receive either BX004 or placebo via inhalation twice daily for 8 weeks. Patients will be randomized in a 2:1 ratio favoring the treatment group. While the company shows promise in its clinical programs, InvestingPro data reveals the company is rapidly burning through cash, with analysts projecting continued losses this year.
The trial follows promising Phase 1b/2a results in which 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment, according to the company’s press release statement.
"This first patient dosing marks a significant milestone for our BX004 program and for CF patients with chronic P. aeruginosa infections who desperately need new options," said Jonathan Solomon, Chief Executive Officer of BiomX.
The company expects topline results from the Phase 2b trial in the first quarter of 2026. The study will measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and quality of life metrics.
BiomX anticipates feedback from the FDA in the second half of 2025 regarding plans to evaluate real-world evidence linking bacterial reduction to clinical outcomes. The company stated that regulatory alignment on a microbiological endpoint could potentially streamline the approval pathway.
P. aeruginosa infections remain a leading cause of death in cystic fibrosis patients despite modern treatments. BX004 has received both Fast Track and Orphan Drug designations from the FDA.
The Phase 2b trial builds on earlier clinical work that demonstrated the therapy’s potential to target bacteria that conventional treatments failed to eradicate, according to the company.
In other recent news, BiomX reported its first-quarter financial results for 2025, revealing a loss per share of $0.33, which was better than the anticipated $0.42 loss per share. The company concluded the quarter with $21.2 million in cash reserves, expected to support operations until the first quarter of 2026. BiomX is engaged in ongoing discussions with the U.S. Defense Health Agency regarding its BX211 program, following positive Phase 2 results. The company is also awaiting feedback from the FDA and plans to initiate a Phase 2/3 trial. Additionally, BiomX is preparing for a Phase 2b study data readout for BX004 in early 2026. Analyst Joseph Pantginis from H.C. Wainwright adjusted the price target for BiomX shares to $15 from $21, while maintaining a Buy rating. The adjustment was attributed to an increase in the company’s share count. BiomX is also planning to meet with the FDA and other regulatory bodies later in 2025 to discuss real-world evidence data related to cystic fibrosis.
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