BiomX Inc. SEC 10-Q Report

BiomX Inc., a clinical-stage microbiome company developing both natural and engineered phage therapies that target specific pathogenic bacteria, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business developments, reflecting its ongoing efforts in advancing therapeutic candidates for cystic fibrosis and diabetic foot osteomyelitis.

Financial Highlights

Operating Loss: $7.4 million, decreased from $9.7 million in the same period in 2024, primarily due to decreased salaries and rent expenses.

Net Loss: $6.0 million, compared to a net income of $4.5 million in the same period in 2024, driven by a decrease in income from change in fair value of warrants.

Basic Loss Per Share of Common Stock: $0.19, compared to earnings per share of $0.14 in the same period in 2024, reflecting the net loss incurred in the current period.

Diluted Loss Per Share of Common Stock: $0.19, compared to $0.69 in the same period in 2024, influenced by an increase in the weighted average shares of Common Stock outstanding.

Business Highlights

Cystic Fibrosis Program: BiomX is advancing its BX004 therapeutic phage product candidate for chronic pulmonary infections caused by Pseudomonas aeruginosa in cystic fibrosis patients. The company has initiated a Phase 2b study, with the first patient dosed on July 14, 2025, aiming to enroll up to 60 patients. The study will assess safety, microbiological reduction, and clinical outcomes, with results expected in Q1 2026.

Diabetic Foot Osteomyelitis Program: Positive results were announced from a Phase 2 trial of BX211, a phage therapy for diabetic foot infections and osteomyelitis caused by Staphylococcus aureus. The trial demonstrated significant ulcer size reduction and other clinical improvements, supporting the potential for a registrational study pending FDA feedback.

Geographical Performance: BiomX's operations are primarily based in Israel, with significant activities in the United States. The company continues to monitor geopolitical conditions in Israel, which have not materially impacted operations to date.

Future Outlook: BiomX plans to focus on developing BX004 for cystic fibrosis and BX211 for diabetic foot osteomyelitis. The company is exploring the use of Real-World Evidence to support regulatory filings and anticipates feedback from regulatory agencies in 2025.

Operational Challenges: The company faces substantial doubt about its ability to continue as a going concern due to significant losses and negative cash flows. BiomX is exploring additional funding options to support its operations beyond Q1 2026.

Regulatory Designations: BX004 has received Fast Track and orphan drug designations from the FDA, highlighting its potential to address unmet medical needs in cystic fibrosis.

NIH Collaboration: BiomX is supporting an NIH study targeting Pseudomonas aeruginosa infections in cystic fibrosis patients, assessing the safety and microbiological activity of bacteriophage therapy.

SEC Filing: BiomX Inc. [ PHGE ] - 10-Q - Aug. 13, 2025