Biomx Inc Stock Price, News & Analysis

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.