Biomx Inc - PHGE STOCK NEWS

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.

BiomX (NYSE: PHGE) announced its Q4 and full year 2024 financial results, highlighting key developments in its phage therapy programs. The company secured $12 million in financing in February 2025 to support its Phase 2b study of BX004. Key financial metrics include:

- Cash balance of $18.0 million as of December 31, 2024
- R&D expenses increased to $24.7 million in 2024
- Net loss decreased to $17.7 million in 2024
- Operating cash burn of $37 million in 2024

Clinical Updates:

• BX211 Phase 2 topline results for diabetic foot osteomyelitis expected by end of March 2025
• BX004 Phase 2b topline results for cystic fibrosis anticipated in Q1 2026
• Received $36.8 million in non-dilutive funding from DHA for BX211 trial

BiomX Inc. (NYSE American: PHGE), a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria, has announced it will release its fourth quarter and full year 2024 financial results on March 25, 2025.

The financial results will be accessible through a press release in the Investors section of BiomX's website. The company plans to host a conference call and audio webcast at a later date, which will coincide with the announcement of initial topline results from its Phase 2 trial investigating treatments for subjects with diabetic foot osteomyelitis.

BiomX Inc. (NYSE American: PHGE) has secured $12 million in financing through a series of offerings, including a registered direct offering and concurrent private placement. The funding will support the advancement of their BX004 program through Phase 2b study in cystic fibrosis patients, with topline results expected in Q1 2026.

The offerings were led by Deerfield Management Company with significant participation from the Cystic Fibrosis Foundation and Nantahala Capital. The financing includes the purchase of 3,633,514 shares of common stock at $0.9306 per share, along with warrants for additional shares. The company will also analyze real-world evidence exploring the relationship between P. aeruginosa reduction and clinical outcomes in CF patients.

BiomX Inc. (NYSE American: PHGE), a clinical-stage company focusing on phage therapies targeting specific pathogenic bacteria, announced that it has received a written notification from NYSE American , dated December 10, 2024. The notification confirms that BiomX has regained compliance with all NYSE American continued listing standards. This compliance rectifies the deficiencies noted on May 23, 2024, as outlined in Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. NYSE American verified that BiomX has met the continued listing standards for two consecutive quarters, in accordance with Section 1009(f) of the Company Guide.

BiomX announced Q3 2024 financial results and clinical program updates. Patient enrollment for BX211 Phase 2 trial in Diabetic Foot Osteomyelitis is complete, with topline results expected in Q1 2025. The BX004 Phase 2b study in Cystic Fibrosis faced manufacturing delays, now resolved, with results expected in H1 2026. Cash balance was $24.7M as of September 30, 2024. R&D expenses increased to $7.3M from $5.6M year-over-year. The company reported net income of $9.6M compared to a net loss of $7.9M in Q3 2023, mainly due to changes in warrant fair value. Cash runway extends into Q4 2025.

BiomX Inc. (NYSE American: PHGE), a clinical-stage company focused on natural and engineered phage therapies, has scheduled a conference call and webcast for November 14, 2024, at 8:00 a.m. ET. The event will cover the company's third quarter 2024 financial results, business updates, and program developments. Participants can join via phone at 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.

BiomX Inc. (NYSE American: PHGE), a clinical-stage company developing phage therapies targeting specific pathogenic bacteria, has announced a mandatory separation of its units (PHGE.U). Each unit consists of one share of Common Stock and one warrant to purchase one-half of a share of Common Stock. The separation will occur on or about October 25, 2024, after which the units will no longer trade on the NYSE American.

Key points:

• Unit holders will receive the underlying shares of Common Stock and Warrants
• The separation is automatic, requiring no action from unit holders
• Warrants will expire on October 28, 2024
• Each warrant allows purchase of one-half share at $115 per share
• Post-separation, Common Stock will trade under the symbol PHGE

BiomX Inc. (NYSE American: PHGE) will present updated data from its Phase 1b/2a study of BX004 for treating cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections at the North American Cystic Fibrosis Conference in Boston. The findings will be showcased in a poster session on September 27, 2024, and discussed in a workshop on September 28, 2024.

Key results include:

• Greater reduction in P. aeruginosa colony-forming units in subjects receiving BX004-A compared to placebo
• 14% of BX004-A recipients had negative P. aeruginosa sputum culture at treatment end, versus 0% for placebo
• Improved lung function (FEV1) in a subgroup of BX004-A recipients (+5.66%) compared to placebo (-3.23%)

The study's six-month follow-up has been completed for all subjects.