BiomX Ltd.

Company and focus

• Clinical-stage product discovery company developing phage (bacteriophage) therapies to target and kill specific harmful bacteria linked to chronic diseases.
• Combines natural and engineered phages through synthetic biology to create phage-based therapies for large-market conditions.

Product types and platform

• Fixed cocktail therapy: a single product containing a fixed set of phages designed to cover a broad range of bacterial strains. Built via high-throughput screening, directed evolution, and bioinformatics to form an optimal cocktail.
• Personalized therapy: a large phage library from which a single optimal phage is matched to a specific patient using proprietary phage-susceptibility testing and targeting to enable rapid turnaround.
• Platform capabilities include computational biology, microbiology, synthetic phage engineering, production biology, bioanalytical assays, manufacturing, and formulation to support rapid development of natural or engineered phage cocktails.

Lead and ongoing programs

• BX011: Fixed multi-phage cocktail for diabetic foot infections (DFI) caused by Staphylococcus aureus. Plans for a Phase 2a in DFI; previously reported positive signals in related DFO studies.
• BX211: Personalized phage therapy for diabetic foot osteomyelitis (DFO) caused by S. aureus. Phase 2 trial in DFO completed (March 2025 readout showed safety and efficacy signals in ulcer healing and depth, with favorable trends vs. placebo); strategy targeted to DFO, with potential expansion to DFI.
• BX004: Cystic fibrosis program for chronic Pseudomonas aeruginosa infections; discontinued in December 2025 after an FDA clinical hold and DMC feedback on dosing/regimen feasibility.
• BX005: Topical phage therapy for atopic dermatitis aimed at reducing S. aureus to shift the skin microbiome toward a pre-flare state; FDA IND approved in 2022; development discontinued in 2024.

Regulatory and trial activity

• BX011 and BX211 are in clinical development; BX004 was discontinued after strategic review and safety/regulatory considerations.
• NIH-supported cystic fibrosis study in Pseudomonas aeruginosa using phage therapy (Phase 1b/2; multicenter, randomized, blinded; US-initiated under FDA Emergency IND).
• No products approved for sale; all programs remain in clinical development.

Intellectual property and collaborations

• Patent portfolio: one patent family (US, Canada, EPO, China, Japan) related to treating implantable device infections caused by S. aureus, owned by APT.
• Licenses and collaborations:
  • Walter Reed Army Institute of Research (WRAIR) license: nonexclusive worldwide license to approximately 100 WRAIR Materials (phages) to develop and commercialize phage products against target bacteria; includes royalties and milestones; term generally 10 years for materials; first-patient dosing requirement tied to the license.
  • Grants from the Medical Technology Enterprise Consortium (MTEC) with U.S. DoD partners; aggregate grants of about $5.8 million received from 2019–2025 (including after the acquisition of APT in 2024).
• IP risks include reliance on third-party licenses, potential license termination, post-grant challenges to patents (e.g., inter partes review), and the need to protect trade secrets.

Corporate structure and offices

• Operates as a virtual company; mailing address: 850 New Burton Road, Suite 201, Dover, DE 19904.
• Historically operated in Israel (Ness Ziona) and Maryland (Gaithersburg). BiomX Ltd., the Israeli subsidiary, commenced insolvency proceedings in December 2025, which materially impacted operations and workforce.
• Employees: 20 full-time employees as of December 31, 2025.

Financial position and capital structure

• Revenue: No product sales revenue to date.
• Operating loss: $41.5 million (2025); $44.5 million (2024).
• Accumulated deficit: $216.9 million as of December 31, 2025.
• Cash and liquidity: $5.0 million in cash, cash equivalents, and restricted cash as of December 31, 2025.
• Fundraising and liquidity events:
  • 2023: Form S-3 shelf registered; ATM financing potential up to $1.766 million.
  • March 15, 2024: Acquisition of APT and private placement of $50 million.
  • February 2025: Registered direct offering and concurrent private placement; combined gross proceeds about $12 million.
  • December 26, 2025: 2025 Second SPA with an investor to issue 3,300 shares of Series Y Convertible Preferred Stock ($1,000 stated value, initial conversion price $2.00) and warrants to purchase up to 3,300,000 common shares, for aggregate gross proceeds of $3.0 million. This investor could become the control holder subject to stockholder approval; required approval within 60 days of closing under the SPA.
  • January 13, 2026: Private placement of preferred stock and warrants under the 2025 Second SPA with gross proceeds of $3.0 million.
• Commitments and related obligations: royalty obligations under the WRAIR license, potential sublicense royalties, ongoing performance obligations, and regulatory and manufacturing costs.
• Going concern and strategic status: public-facing going-concern disclosure due to continued operating losses, limited cash, and dependence on securing additional financing. The Israeli subsidiary’s insolvency and the potential change of control under the 2025 Second SPA create execution risk and may affect program advancement.

Market and competition

• The field is competitive, with larger pharmaceutical companies and other phage-focused firms. Competitive factors include efficacy, safety, time-to-market, manufacturing, cost, and IP protection.
• BX011 and BX211 target Staphylococcus aureus in diabetic infections and osteomyelitis, with broader implications for phage-based therapies.

Summary

BiomX is a clinical-stage phage therapy company pursuing both fixed-cocktail and personalized phage approaches. BX011 (DFI) and BX211 (DFO) are the lead programs. The company operates through collaborations and licensing, including WRAIR, and has received DoD-related grants. As of December 31, 2025, the company had 20 full-time employees, $5.0 million in cash, an accumulated deficit of $216.9 million, and ongoing operating losses. Recent financing structures, the insolvency of the Israeli subsidiary, and potential changes in ownership under the 2025 Second SPA create material liquidity and execution risks while the company seeks additional funding to support its clinical programs and platform development.