Biomx Inc Stock Price, News & Analysis

BiomX (NYSE American: PHGE) announced on December 8, 2025 that it will discontinue the Phase 2b trial of nebulized phage therapy BX004 in cystic fibrosis after an internal review and recommendations from the independent Data Monitoring Committee following unusually high rates of adverse events.

The company said it will implement cost‑cutting measures, including a significant workforce reduction, and review strategic alternatives while refocusing development efforts on its bacteriophage program BX011 for Staphylococcus aureus diabetic foot infections, subject to available resources.

BiomX (NYSE American: PHGE) said the FDA is continuing to evaluate the nebulizer device used in its BX004 Phase 2b cystic fibrosis trial and the company is working with the device manufacturer to provide requested information to lift the clinical hold. An independent Data Monitoring Committee (DMC) completed a safety review after adverse events and recommended the study continue with adjusted dosing. BiomX will update the protocol and now expects topline results in Q2 2026, with U.S. enrollment to resume once device questions are resolved.

BiomX (NYSE:PHGE) will effect a 1-for-19 reverse stock split of its common stock, to trade on a split-adjusted basis when markets open on November 25, 2025. The company will file a Certificate of Amendment in Delaware and the new CUSIP after the split will be 09090D 509.

The split was approved by stockholders on October 16, 2025 and the Board fixed the final ratio on November 13, 2025. Outstanding shares are expected to be reduced from approximately 29,006,165 to approximately 1,526,640, with proportional adjustments to equity awards, warrants, convertible preferred stock and plan share pools. No fractional shares will be issued; holders entitled to fractions will be rounded up to the next whole share. Recordholders with certificates will receive instructions from Continental Stock Transfer & Trust Company; street-name holders need take no action.

BiomX (NYSE:PHGE) reported third quarter 2025 results and clinical updates on Nov 12, 2025. Key clinical points: positive FDA feedback on BX011 (S. aureus in diabetic foot infections) with a planned Phase 2a and FDA guidance outlining potential Phase 3 pathways for BX004 (P. aeruginosa in cystic fibrosis). The FDA has placed a U.S. clinical hold on the BX004 Phase 2b trial related to a third-party nebulizer; enrollment and dosing outside the U.S. continue and U.S. feedback is expected imminently. The company expects topline Phase 2b results in Q1 2026.

Financial highlights: cash and restricted cash $8.1M (Sept 30, 2025), sufficient to fund operations into Q1 2026; R&D $6.1M and G&A $2.4M in Q3; net loss $9.2M in Q3. Net cash used in operations was $22.0M for the nine months ended Sept 30, 2025.

BiomX (NYSE American: PHGE) will report third quarter 2025 financial results and program updates before U.S. market open on Wednesday, November 12, 2025. The company will host a conference call and live audio webcast at 8:30 AM ET to discuss results and program progress.

Registration is recommended at least 5 minutes before the call; the webcast will be live and archived on the company website.

BiomX (NYSE American: PHGE) received positive FDA feedback on the clinical development pathway for BX011, a fixed multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections (DFI), and plans a Phase 2a trial in DFI subject to funding.

The FDA support includes a path toward a potential BLA, no additional non‑clinical studies expected, and CMC comments consistent with BiomX’s manufacturing strategy. BX011 uses multiple proprietary phages, including one evaluated in the prior BX211 Phase 2 DFO study, which reported statistically significant topline ulcer-size reductions. BiomX has received about $40 million in non-dilutive U.S. defense funding for its S. aureus phage program.

BiomX (NYSE American: PHGE) provided a program update on BX004 and new FDA feedback on Oct 17, 2025. The company says it has responded to the FDA's limited technical clarifications about the third‑party nebulizer used to deliver BX004 and believes those queries are fully addressed. The FDA did not raise concerns about the BX004 drug product.

Key points: European enrollment and dosing continued ahead of plan; all European nebulizer components are CE marked; the Phase 2b study remains on track to report topline results in Q1 2026. The FDA also provided written feedback recognizing unmet need in chronic Pseudomonas aeruginosa infection and outlined potential Phase 3 enrichment and development pathways.

BiomX (NYSE American: PHGE) announced that CEO Jonathan Solomon will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8th, 2025, from 4:30 - 5:00 PM ET at the Lotte New York Palace Hotel in New York City.

The presentation, titled "Phage Therapy: A Novel Approach to Chronic Diabetic Foot Infections," will highlight the positive topline results from the company's Phase 2 trial of BX211 for treating Diabetic Foot Osteomyelitis (DFO). Investors can request one-on-one meetings through H.C. Wainwright representatives.

BiomX (NYSE American: PHGE) announced that the FDA has placed a clinical hold on the Phase 2b trial of BX004, their cystic fibrosis treatment. The hold specifically concerns the third-party nebulizer device used for drug delivery, with no issues raised about the BX004 drug candidate itself.

The company has already submitted additional requested data from the nebulizer manufacturer to the FDA. While U.S. patient screening and enrollment are temporarily paused, the European trial continues unaffected as the nebulizer components are CE marked and meet EU regulatory requirements.