Welcome to our dedicated page for Biomx news (Ticker: PHGE), a resource for investors and traders seeking the latest updates and insights on Biomx stock.
BiomX Inc. (PHGE) generates frequent news flow as a clinical-stage company developing natural and engineered bacteriophage therapies targeting specific pathogenic bacteria. Company press releases and Form 8-K filings describe how BiomX advances phage cocktails and personalized phage treatments for chronic conditions, including cystic fibrosis-related lung infections and diabetic foot disease. News coverage often centers on clinical trial progress, regulatory feedback, financing transactions and strategic updates that can influence the outlook for PHGE stock.
A major theme in BiomX news is the development of its phage product candidates. For BX004, a fixed multi-phage cocktail for cystic fibrosis patients with chronic Pseudomonas aeruginosa infections, the company has reported Phase 1b/2a data, FDA Fast Track and Orphan Drug designations, initiation of a Phase 2b trial, an FDA clinical hold related to a third-party nebulizer device, and ultimately the discontinuation of the Phase 2b study after internal review and Data Monitoring Committee feedback. Separate updates detail European enrollment, FDA correspondence on potential Phase 3 pathways, and safety reviews.
News items also highlight BiomX’s diabetic foot programs. The company has announced statistically significant positive topline Phase 2 results for BX211 in diabetic foot osteomyelitis and subsequent FDA feedback supporting the development pathway for BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus in diabetic foot infections. Releases describe the rationale for prioritizing DFI, the incorporation of proprietary phages, and the role of non-dilutive funding from U.S. Defense Health Agency and Department of Navy-related sources.
Investors following PHGE can also expect updates on corporate and financial events, such as reverse stock split decisions, private placements of Series Y Convertible Preferred Stock and warrants, lease terminations at subsidiaries, and cost-cutting measures including workforce reductions. Together, these disclosures provide a detailed, evolving picture of BiomX’s clinical pipeline, regulatory interactions, capital structure and strategic alternatives. Bookmark this page to review new PHGE press releases, trial milestones and SEC-reported events as they are published.
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.
BiomX (NYSE American: PHGE) reported significant clinical progress and Q2 2025 financial results. The company achieved positive Phase 2 results for BX211 in diabetic foot osteomyelitis, demonstrating >40% wound size reduction versus placebo. Their BX004 program showed promising results with a ~500-fold bacterial reduction in cystic fibrosis patients, as published in Nature Communications.
The company has initiated patient dosing in the Phase 2b trial of BX004, with topline results expected in Q1 2026. Financial highlights include a cash balance of $15.2 million as of June 30, 2025, with funding runway into Q1 2026. Q2 2025 showed reduced operating expenses, with R&D expenses at $5.0 million (down from $6.9M) and net loss of $6.0 million.
BiomX (NYSE American: PHGE), a clinical-stage company focused on developing phage therapies targeting specific pathogenic bacteria, has scheduled its second quarter 2025 financial results and program updates announcement for August 13, 2025, before U.S. markets open.
The company will host a conference call and audio webcast at 8:00 AM ET on the same day. Participants are advised to register at least 5 minutes before the call begins. Those not planning to ask questions are encouraged to join via the webcast, which will be available both live and archived in the Investors section of BiomX's website.
BiomX (NYSE American: PHGE) has initiated patient dosing in its Phase 2b trial of BX004, a phage therapy targeting antibiotic-resistant Pseudomonas aeruginosa infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will evaluate approximately 60 patients over an 8-week treatment period.
The trial follows promising Phase 1b/2a results where 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment. The company expects topline results in Q1 2026 and anticipates FDA feedback in H2 2025 regarding the use of real-world evidence linking bacterial reduction to clinical outcomes. BX004 has already received Fast Track and Orphan Drug designations.
BiomX (NYSE American: PHGE) has published Phase 1b/2a Part 1 trial results of its phage cocktail BX004 in Nature Communications, demonstrating significant efficacy against antibiotic-resistant P. aeruginosa infections in cystic fibrosis patients.
The study revealed a remarkable 500-fold (2.7 log₁₀) bacterial reduction compared to placebo, with no emerging resistance. Key findings include a strong safety profile, successful bacterial reduction achieved at day 15, and therapeutic phages reaching and persisting at infection sites. The treatment demonstrated favorable microbiome composition shifts and maintained efficacy where traditional antibiotics often fail.
BiomX is currently advancing its Phase 2b trial of BX004, with topline results expected in Q1 2026.
BiomX (NYSE American: PHGE) announced that CEO Jonathan Solomon will present at the Biomed Israel 2025 conference in Tel Aviv, Israel, from May 20-22, 2025. The presentation will focus on the company's positive topline Phase 2 results for BX211, a phage therapy targeting Staphylococcus aureus in Diabetic Foot Osteomyelitis (DFO). Solomon will deliver an oral presentation titled "Precision Phage Therapy for Chronic Diabetic Foot Infections" during the Immunology & Inflammation session on May 21, 2025, at the InterContinental David Tel Aviv.
BiomX (NYSE: PHGE) reported significant progress in Q1 2025, highlighted by positive Phase 2 trial results for BX211 in treating diabetic foot osteomyelitis (DFO). The trial demonstrated statistically significant improvements in ulcer size reduction and depth compared to placebo. BX211's development has been supported by $40 million in non-dilutive funding from the U.S. Defense Health Agency.
The company's BX004 Phase 2b study in Cystic Fibrosis remains on track for topline results in Q1 2026. In April 2025, shareholders approved warrant exercises from $12 million in financings announced in February 2025. The company's cash balance stood at $21.2 million as of March 31, 2025, with runway expected through Q1 2026. Q1 2025 financial results showed a net loss of $7.7 million, improved from $17.3 million in Q1 2024.
BiomX Inc. (NYSE American: PHGE), a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria, has scheduled its first quarter 2025 financial results conference call and webcast for Thursday, May 15, 2025, at 2:00 p.m. ET. During the call, the company will discuss Q1 2025 financial performance and provide updates on its business operations and programs. Interested participants can join via phone by dialing 1-877-407-0724 (U.S.) or +1 201-389-0898 (International). The webcast will be accessible through the Investors section of BiomX's website at www.biomx.com, where it will also be archived for future viewing.
BiomX Inc. (NYSE American: PHGE), a clinical-stage company focused on phage therapies, has disclosed that its independent registered public accounting firm included a going concern qualification in their audit opinion for the fiscal year ended December 31, 2024. This disclosure, which was previously included in the Company's annual report on Form 10-K filed on March 25, 2025, is being announced separately to comply with NYSE American Company Guide Sections 401(h) and 610(b). The company emphasizes that this announcement does not represent any changes or amendments to their 2024 audited financial statements or annual report.
BiomX (NYSE: PHGE) announced positive topline results from its Phase 2 trial of BX211 for treating Diabetic Foot Osteomyelitis (DFO). The trial demonstrated that BX211 was safe and well-tolerated, producing statistically significant improvements in multiple areas:
- Sustained reduction in ulcer size (PAR) with p=0.046 at week 12
- Significant improvements in ulcer depth at week 13 (p=0.048)
- Reduced expansion of ulcer area (p=0.017)
The study involved 41 patients randomized at a 2:1 ratio, with 26 receiving BX211 and 15 receiving placebo. Treatment showed separation from placebo starting at week 7, with a difference greater than 40% by week 10. The company is now planning for a Phase 2/3 trial, pending FDA feedback.