BiomX Inc. (PHGE)·Q1 2025 Earnings Summary

Executive Summary

• BiomX delivered a clean quarter operationally with positive DFO (BX211) Phase 2 efficacy sustained from the March topline readout and financing-driven runway extension into Q1 2026; Q1 EPS loss of ($0.33) modestly beat S&P Global consensus of ($0.36), and EBITDA was less negative than expected (actual ($7.52) vs est. ($10.30) million) .
  Values retrieved from S&P Global.
• Cash and restricted cash increased to $21.2M as of March 31 (from $18.0M at Dec 31) following February financings; management reiterated runway into Q1 2026 and noted additional potential proceeds upon warrant exercises approved in April .
• BX211: management emphasized DFO Phase 2 significance (statistically significant PAR and other endpoints) and said they are planning a Phase 2/3 (potentially pivotal) study pending FDA feedback; discussions with DHA continue after ~$40M in cumulative non‑dilutive support .
• BX004 (CF): Phase 2b topline remains targeted for Q1 2026; CMC issues have been resolved and sites show strong interest; company is preparing RWE analyses and regulatory interactions in 2H25 .

What Went Well and What Went Wrong

• What Went Well

  • Positive BX211 Phase 2 results (stat. sig. PAR at wk12 p=0.046; wk13 p=0.052; improvements in ulcer depth and reduced ulcer area expansion) with strong KOL support; management: “a potential turning point… one of the strongest demonstrations to date of the therapeutic potential of phage therapy” .
  • Financing and shareholder approval supported runway into Q1 2026 and positioned BX004 Phase 2b readout; CEO highlighted support from Deerfield and the Cystic Fibrosis Foundation .
  • Regulatory momentum: planning BX211 Phase 2/3 pending FDA feedback and engaging regulators on BX004 RWE plan in 2H25 .

• What Went Wrong

  • R&D spend increased YoY to $5.3M on BX004 Phase 2b prep, BX211 Phase 2 costs, and facility costs post-APT acquisition (partly offset by higher grants) .
  • Net cash used in operations remained sizable at $8.7M for Q1 (improved vs $11.4M YoY), underscoring continued burn ahead of pivotal catalysts .
  • Continued pre-revenue profile; company provided no product revenue guidance (S&P Global consensus embeds $0 revenue)* .
    Values retrieved from S&P Global.

Financial Results

• P&L and estimates (oldest → newest)

Values retrieved from S&P Global.

• Operating expenses and loss (YoY)

• Liquidity

• KPIs (clinical, BX211 Phase 2)
  • Percent Area Reduction (PAR): p=0.046 at week 12; p=0.052 at week 13 .
  • Ulcer depth improvement at week 13 (bone-at-baseline subgroup): p=0.048 .
  • Reduced expansion of ulcer area: p=0.017 .

Note: No revenue recognized; S&P Global revenue consensus for Q1 2025 was $0.0* .
Values retrieved from S&P Global.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The first quarter of 2025 was a period of exceptional progress… The strength of the positive Phase 2 results from our BX211 program… represent a significant milestone for the field of bacteriophage therapy… We remain focused on… the anticipated Phase 2b readout of BX004 in cystic fibrosis in the first quarter of next year.” — Jonathan Solomon, CEO .
• “We demonstrated safety and tolerability of BX211… sustained and statistically significant percent area reduction… and significant improvement in ulcer depth and ulcer area expansion vs placebo… We are planning a potential Phase II/III trial pending FDA feedback.” — Jonathan Solomon (prepared remarks) .
• “We expect the financing will provide a runway… aligned with the planned top line readout of the Phase IIb study of BX004 in cystic fibrosis… which remains on track.” — Jonathan Solomon .
• “Research and development expenses… were $5.3 million… general and administrative expenses were $2.5 million… Net loss was $7.7 million… Net cash used in operating activities… was $8.7 million.” — Marina Wolfson .

Q&A Highlights

• Regulatory path for BX211: Company gearing up for FDA discussions later this year; exploring breakthrough and orphan designations; potential to move directly to a pivotal study subject to agency alignment .
• BX004 timing and gating factors: Trial “on track”; strong center interest; prior CMC issues resolved; materials ready; expects Q1 2026 topline .
• Safety database considerations: For orphan indications, typical exposure targets near ~300 patients historically; company hopes to use fewer given favorable safety of phage, subject to FDA discussions .
• Physician/KOL engagement: Significant inbound interest across U.S. and Europe; next DFO study envisioned as global .
• Cash/warrants: $12M February proceeds already included in $21M cash; additional ~$12M possible upon warrant exercise approved by shareholders .

Estimates Context

• EPS: Q1 2025 actual ($0.33) vs S&P Global consensus ($0.36)*; modest beat as operating loss and fair‑value warrants effects improved YoY .
  Values retrieved from S&P Global.
• EBITDA: Q1 2025 actual ($7.52)M vs consensus ($10.30)M*, indicating lower‑than‑expected cash burn trajectory this quarter.
  Values retrieved from S&P Global.
• Revenue: No product revenue; consensus modeled $0.0* .
  Values retrieved from S&P Global.
• Where estimates may adjust: Potential upward bias to out‑quarter EBITDA/cash burn expectations if operating discipline persists and non‑dilutive funding continues; clinical timelines unchanged (BX004 Q1’26), so timing estimates likely stable near term .

Key Takeaways for Investors

• Clinical de‑risking: Statistically significant BX211 Phase 2 efficacy supports moving toward a registrational path pending FDA feedback; non‑dilutive DHA support and KOL enthusiasm are notable positives .
• Capital runway: February financings and April warrant approvals extend runway into Q1 2026, enough for BX004 Phase 2b topline; incremental cash possible upon warrant exercises .
• Execution: CMC headwinds for BX004 resolved; site interest strong; regulatory engagement on RWE planned for 2H 2025 .
• Risk profile: Still pre‑revenue; continued quarterly burn and dependency on clinical/regulatory milestones remain core risks .
• Near‑term catalysts: FDA feedback path and trial design for BX211; progress updates on BX004 enrollment/start; continued DHA or other non‑dilutive funding .
• Stock drivers: Concrete FDA alignment on BX211 pivotal strategy and any partnership/DHA funding updates could be the next narrative inflection points ahead of BX004 Q1’26 topline .
• Estimate implications: Slight EPS/EBITDA beats this quarter suggest modestly better burn than modeled; consensus likely remains anchored to binary clinical timelines (BX211 design clarity; BX004 Q1’26) rather than quarterly P&L .
  Values retrieved from S&P Global.

Appendix: Source Highlights

• Q1 2025 press release and 8‑K 2.02 exhibit (financials, program updates, runway): .
• Q1 2025 earnings call (prepared remarks and Q&A): .
• BX211 topline (Mar 31): .
• Financing (Feb 26): .
• Prior quarters (Q3’24 PR/call; Q4’24 PR/call): .