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BiomX Inc. (PHGE)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was primarily a regulatory and pipeline update quarter: EPS modestly beat consensus, while net loss widened year over year due to warrant fair value changes; cash runway remains guided into Q1 2026 . EPS was -$0.29 vs Wall Street consensus of -$0.32, a $0.03 beat*.
  • The FDA placed a U.S. clinical hold on the BX004 Phase 2b trial focused on a third‑party nebulizer; BiomX expects imminent feedback and noted continued enrollment/dosing in Europe per protocol .
  • Positive FDA feedback outlined potential Phase 3 development pathways for BX004 and confirmed a clear clinical development path for BX011 in diabetic foot infections, enabling a Phase 2a plan subject to resources .
  • Near‑term stock reaction catalysts: resolution of the BX004 U.S. clinical hold and any additional FDA guidance on Phase 3 pathway; medium‑term catalyst remains BX004 Phase 2b topline expected in Q1 2026 .

What Went Well and What Went Wrong

What Went Well

  • FDA provided supportive guidance for BX004, recognizing unmet need in CF patients on CFTR modulators and outlining potential Phase 3 pathways, including population enrichment and optimized design . “The FDA outlined potential Phase 3 development pathways…reflect recognition of the significant unmet need among cystic fibrosis patients treated with CFTR modulators.” — Jonathan Solomon .
  • Positive FDA feedback confirmed a clear clinical path for BX011 in DFI with no additional non‑clinical studies required; BiomX planning a Phase 2a trial, subject to financing .
  • Continued European enrollment/dosing for BX004 despite U.S. hold; topline timing remains Q1 2026, sustaining momentum in CF program .

What Went Wrong

  • U.S. FDA clinical hold on BX004 Phase 2b paused screening/enrollment stateside due to nebulizer device queries, increasing execution risk until resolved .
  • Net loss of $9.2M vs net income of $9.6M in Q3 2024, driven mainly by warrant fair value changes; highlights sensitivity of bottom line to non‑cash market inputs .
  • Decreased grant funding and increased leasehold depreciation contributed to R&D and G&A cost dynamics, partially offsetting overall expense reductions from workforce and rent changes .

Financial Results

Results vs Prior Periods and Estimates

MetricQ1 2025Q2 2025Q3 2025
Research & Development expenses, net ($USD Millions)$5.25 $5.01 $6.12
General & Administrative expenses ($USD Millions)$2.51 $2.42 $2.41
Net loss ($USD Millions)$7.66 $6.04 $9.17
Basic loss per share ($)$0.33 $0.19 $0.29
Cash and restricted cash, period end ($USD Millions)$21.07 (20.116 + 0.953) $15.03 (14.046 + 0.979) $7.91 (6.923 + 0.985)

Notes:

  • Loss per share figures presented as reported; line item is “Basic loss (earnings) per share of Common Stock.”

Q3 2025 Actual vs Wall Street Consensus

MetricConsensusActualDelta
EPS ($)-$0.32*-$0.29*+$0.03 (beat)*
Revenue ($USD Millions)$0.00*$0.00*$0.00 (in line)*

Values marked with * retrieved from S&P Global.

Year-over-Year Highlights

  • Net loss swung to -$9.17M in Q3 2025 vs net income of $9.64M in Q3 2024, primarily due to warrant fair value changes .
  • R&D decreased YoY to $6.12M from $7.28M, driven by workforce reductions, lower rent post 2024 impairment, and lower CF manufacturing costs, partially offset by accelerated leasehold depreciation and lower grants .
  • G&A decreased YoY to $2.41M from $3.25M on lower salary/share‑based comp and legal/professional fees, partially offset by accelerated leasehold depreciation .

Segment Breakdown

  • Not applicable; BiomX is a clinical-stage company without commercial revenue or reportable operating segments in these periods .

KPIs

KPIQ1 2025Q2 2025Q3 2025
Net cash used in operating activities (YTD, $USD Millions)$8.7 $14.8 (6M) $22.0 (9M)
BX004 Phase 2b patient target~60 patients (design) ~60 patients (design) ~60 patients (design)
BX004 topline timingQ1 2026 Q1 2026 Q1 2026
Cash runway guidanceInto Q1 2026 Into Q1 2026 Into Q1 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough Q1 2026Into Q1 2026 (Q1, Q2) Into Q1 2026 Maintained
BX004 Phase 2b toplineQ1 2026Q1 2026 (Q1, Q2) Q1 2026 Maintained
BX004 U.S. clinical hold statusNear-termNot applicable (Q1); Hold disclosed in Aug with expectation to resolve “Feedback expected imminently” New update (resolution expected)
BX004 Phase 3 pathwayFutureInitiating real-world evidence discussions H2 2025 FDA outlined Phase 3 development pathways Clarified/advanced
BX011 clinical plan2026-Planning Phase 2a subject to resources Planning Phase 2a; FDA positive feedback; no additional non‑clinical required Clarified/advanced

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available in our document catalog search (Sep–Dec 2025). We read Q1 2025 call for trend context –.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Regulatory feedback (FDA)Planning FDA interactions for BX211; exploring breakthrough/orphan pathways Planning for BX211 registrational path; awaiting real‑world evidence feedback for BX004 in H2 2025 FDA outlined Phase 3 pathways for BX004; positive BX011 pathway; BX004 U.S. hold feedback expected imminently Accelerating clarity
CF BX004 executionQ2b on track; enthusiasm at sites; CMC issues behind Dosing initiated; Phase 2b design reiterated; topline Q1 2026 EU dosing continues; U.S. hold; topline Q1 2026 unchanged Operational progress with U.S. gating item
Diabetic foot (BX211/BX011)Strong Phase 2 DFO data; considering pivotal design; KOL support; DHA backing Planning potential registrational study; continued DHA discussions Shift to DFI with BX011; FDA confirms path; Phase 2a planning Broadening to earlier-stage indication
Funding/runway$12M financing; warrants approved; runway to Q1 2026 Runway guided to Q1 2026 Runway guided to Q1 2026; cash $8.1M (incl. restricted) at Q3 end Stable guidance; lower cash balance
Device/manufacturingCMC issues “behind us” (Q1 tone) Not specifically notedNebulizer device queries drive U.S. hold; BiomX believes issues addressed Device focus increases

Management Commentary

  • “This past quarter was defined by significant advancements in our regulatory discussions with the Food and Drug Administration (FDA) across our pipeline.” — Jonathan Solomon, CEO .
  • On BX004: “The FDA outlined potential Phase 3 development pathways, including opportunities for population enrichment and optimized trial design… Feedback on the U.S. clinical hold of BX004 is expected imminently.” .
  • On BX011: “We…received positive feedback from the FDA on the proposed clinical development pathway… BiomX is currently planning a Phase 2a trial for BX011… with no additional non‑clinical studies required, pending sufficiency of financial resources.” .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available in our search window (Sep–Dec 2025). From Q1 2025 call, notable themes included: plans for pivotal design in DFO/BX211 with potential breakthrough/orphan considerations ; BX004 Phase 2b execution on track with strong site enthusiasm ; runway extended via $12M financing and warrant approvals .

Estimates Context

  • Q3 2025 EPS: actual -$0.29 vs consensus -$0.32 (beat $0.03); Q2 2025 EPS: actual -$0.19 vs consensus -$0.26; Q1 2025 EPS: actual -$0.33 vs consensus -$0.36*. Revenue consensus was $0.00 for Q1–Q3, in line with actual pre‑commercial status*. Values retrieved from S&P Global.
MetricQ1 2025Q2 2025Q3 2025
EPS Consensus ($)-$0.36*-$0.26*-$0.32*
EPS Actual ($)-$0.33*-$0.19*-$0.29*
Revenue Consensus ($USD Millions)$0.00*$0.00*$0.00*

Values marked with * retrieved from S&P Global.

Implications: Modest EPS beats across 2025 despite zero revenue reflect cost controls (G&A and R&D down YoY) and volatility from warrant fair value; Street estimates likely to watch device resolution and regulatory clarity more than fundamentals for near‑term adjustments .

Key Takeaways for Investors

  • EPS modestly beat consensus in Q3; however, net loss widened sequentially and YoY on warrant fair value changes—non‑cash but impactful to reported results .
  • The BX004 U.S. clinical hold centers on a third‑party nebulizer; BiomX believes it has addressed FDA queries, with European dosing ongoing—resolution is a key near‑term catalyst .
  • Regulatory momentum improved: FDA outlined Phase 3 pathways for BX004 and confirmed BX011’s clinical path, supporting trial planning and eventual registrational strategies .
  • Cash runway guided into Q1 2026, aligning with BX004 Phase 2b topline timing; liquidity is tight (Q3 cash + restricted $8.1M), making timely milestones and potential financing or non‑dilutive support important .
  • Program prioritization: shifting lead regulatory focus to DFI (BX011) broadens addressable population and may streamline approval path relative to DFO (BX211) .
  • Trading setup: stock likely to react to any FDA communication lifting the BX004 U.S. hold or further clarifying Phase 3 strategy; downside if feedback is further delayed or requires device changes .
  • Medium‑term thesis: value inflection tied to BX004 Phase 2b efficacy and BX011 Phase 2a initiation—monitor grant flows (DHA), device resolution, and operational burn trajectory .

Citations:

  • Q3 2025 8‑K/Press release and financial statements
  • Q2 2025 press release/8‑K and financials – –
  • Q1 2025 press release/8‑K and financials – –
  • BX004 Phase 2b initiation and FDA feedback articles – –
  • BX004 U.S. clinical hold update –
  • Q1 2025 earnings call transcript –