BiomX (PHGE) Q4 2024 & Study Result earnings summary

Executive summary

• BX211 achieved statistically significant efficacy and safety in phase II trials for diabetic foot osteomyelitis (DFO), with over 40% ulcer size reduction versus placebo and efficacy across methicillin-susceptible and resistant strains; this marks the first well-controlled, double-blind, placebo-controlled trial to show significant phage therapy efficacy in chronic bacterial infection.

• BX004 and BX211 are lead candidates for chronic infections, both showing positive late-stage clinical results and advancing in development for cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and DFI/DFO.

• BX004 achieved 14.3% culture conversion in CF patients with chronic Pseudomonas aeruginosa lung infections in Phase 1b/2a; Phase 2b topline results expected Q1 2026.

• BX211 Phase 2 topline results in DFO expected by end of March 2025, with preparation for Phase 2/3 pending FDA feedback.

• Addressable markets estimated at >$1.5B for BX004 and >$2.5B for BX211 worldwide.

Financial highlights

• $18.0 million in cash and cash equivalents as of December 31, 2024, excluding $12M gross proceeds from February 2025 financing.

• $12 million in new financing raised in February 2025 to support ongoing clinical programs and regulatory preparations.

• Research and development expenses for 2024 were $24.7M, up from $16.7M in 2023, mainly due to BX004 and BX211 trial costs and APT acquisition.

• Net loss for 2024 was $17.7M, improved from $26.2M in 2023, mainly due to change in fair value of warrants.

• BX211 program supported by $36.8M in non-dilutive funding, including milestone payment from U.S. Defense Health Agency.

Outlook and guidance

• BX004 Phase 2b topline results anticipated Q1 2026; regulatory discussions planned for H2 2025.

• BX211 Phase 2 topline results expected by end of March 2025; advancing to Phase 2/3 pending FDA feedback.

• Cash, cash equivalents, and short-term deposits expected to fund operations into Q1 2026.

• A virtual event with key opinion leaders is scheduled to discuss BX211 phase II results and implications.