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BiomX (PHGE)

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Earnings summaries and quarterly performance for BiomX.

Recent press releases and 8-K filings for PHGE.

BiomX Inc. Reports Q3 2025 Financial Results and Provides Program Updates
PHGE
Earnings
Guidance Update
New Projects/Investments
  • BiomX Inc. reported a net loss of $9.2 million for the third quarter of 2025, compared to a net income of $9.6 million for the third quarter of 2024, primarily due to a change in the fair value of warrants.
  • As of September 30, 2025, the company's cash balance and restricted cash totaled $8.1 million, a decrease from $18 million as of December 31, 2024, with current funds estimated to support operations into the first quarter of 2026.
  • Research and development expenses, net, decreased to $6.1 million for the third quarter of 2025 from $7.3 million for the same period in 2024, mainly due to reduced salary expenses and lower costs related to the CF product candidate.
  • The FDA has placed a clinical hold on the BX004 Phase 2b study for cystic fibrosis, pending review of data on a third-party nebulizer, though enrollment and dosing continue outside the U.S.. BiomX expects imminent FDA feedback and anticipates topline results from the study in the first quarter of 2026.
  • BiomX received positive FDA feedback confirming a clear clinical development path for BX011, its new fixed multi-phage cocktail targeting S. aureus in diabetic foot infections, and plans to initiate a Phase 2a trial.
Nov 12, 2025, 12:45 PM
BiomX Receives Positive FDA Feedback for Diabetic Foot Infection Program
PHGE
New Projects/Investments
Guidance Update
  • BiomX received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed clinical developmental pathway for BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections (DFI).
  • The FDA's guidance supports a path toward a potential Biologics License Application (BLA) for BX011, with no additional non-clinical studies expected.
  • BiomX plans to initiate a Phase 2a clinical trial in DFI for BX011, a decision driven by a broader patient population, a large commercial opportunity, and a clear regulatory path.
  • The development of phage therapies for S. aureus has been supported by approximately $40 million in non-dilutive funding from the U.S. DHA and Department of Navy.
Nov 4, 2025, 1:40 PM
BiomX Provides BX004 Clinical Trial Update and New FDA Feedback
PHGE
New Projects/Investments
Guidance Update
  • BiomX believes it has fully addressed the FDA's queries related to the third-party nebulizer used to deliver BX004, with the FDA not raising any concerns regarding the BX004 drug product itself.
  • Despite the U.S. clinical hold, European enrollment and dosing for the BX004 Phase 2b trial are progressing faster than expected, and topline results remain on track for the first quarter of 2026.
  • The FDA has provided new written feedback, recognizing a significant unmet need for therapies addressing chronic Pseudomonas aeruginosa infection in cystic fibrosis patients and outlining potential development pathways for BX004, including strategies for Phase 3 study population enrichment.
Oct 17, 2025, 12:30 PM