BiomX (PHGE) Q4 2024 & Study Result earnings summary

Executive summary

• BX211 achieved statistically significant efficacy and safety in a phase II trial for diabetic foot osteomyelitis (DFO), with >40% ulcer area reduction and no severe adverse events, marking a milestone for phage therapy in chronic bacterial infection.

• BX004 and BX211 are lead phage therapy candidates for chronic infections, both showing positive late-stage clinical results and advancing in development.

• BX004 achieved 14.3% culture conversion in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa 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; 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 raised in February 2025 through financings to support ongoing clinical programs and extend runway into Q1 2026.

• 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.

• Net cash used in operating activities for 2024 was $37M, up from $21.3M in 2023.

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.

• Preparation for regulatory discussions on BX004 is underway, with meetings expected later this year.

• A virtual KOL event is scheduled to discuss BX211 phase II results and broader implications.