BiomX Inc. (PHGE)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 was operationally constructive (BX004 Phase 2b dosing began; BX211 Phase 2 data reiterated), while financials reflected a typical pre‑revenue biotech profile: net loss of $6.0M and basic loss per share of $0.19; cash and restricted cash of $15.2M, with runway into Q1 2026 .
• Results outperformed Wall Street consensus: EPS beat by $0.07 (actual −$0.19 vs −$0.26 consensus) and EBITDA was better than expected (actual −$7.14M vs −$8.80M consensus). Revenue remains $0.0, as the company has not yet generated sales. Bolded beats below .
• Clinical catalysts: BX004 Phase 2b topline expected Q1 2026; FDA feedback on a real‑world evidence strategy expected H2 2025; BX211 planning moves toward a potential registrational study pending FDA feedback .
• Subsequent event (potential stock overhang): on Aug 19, 2025 the FDA placed a clinical hold on the third‑party nebulizer used to deliver BX004 in the U.S.; EU enrollment continues; BiomX submitted additional device data to resolve the hold .
• Note: We found and read the Q2 2025 8‑K press release and 10‑Q; no Q2 2025 earnings call transcript was available. Prior quarters’ Q1 2025 and Q4 2024 press releases and calls were read for trend analysis .

What Went Well and What Went Wrong

What Went Well

• BX211 Phase 2 trial in diabetic foot osteomyelitis (DFO) showed sustained, statistically significant ulcer size reduction; separation from placebo by week 7 and >40% difference by week 10; improvements in ulcer depth and reduced ulcer area expansion; favorable safety profile. “Positive Phase 2 results for BX211 … over 40% reduction … favorable safety profile” — CEO Jonathan Solomon .
• BX004: Nature Communications publication indicated ~500‑fold (2.7 log10) greater bacterial reduction vs placebo, with no detectable resistance; Phase 2b dosing successfully initiated in July 2025 .
• Grants and cost discipline helped lower R&D and G&A y/y in Q2; BiomX recognized ~$1.0M of MTEC and IIA grants in Q2 2025, supporting lower net R&D spend y/y .

What Went Wrong

• U.S. FDA clinical hold (Aug 19) paused U.S. enrollment for BX004 due to questions about the third‑party nebulizer device (not the drug); potential to create timeline risk despite EU enrollment continuing .
• Operating loss remained sizable given program activity (−$7.4M in Q2), and net loss was $6.0M, driven partly by reduced non‑cash warrant FV change y/y (less of a tailwind vs Q2 2024) .
• Going‑concern disclosure persists: management indicates substantial doubt about the ability to continue as a going concern absent additional capital beyond the current runway into Q1 2026 .

Financial Results

P&L comparison vs prior year and prior quarter (oldest → newest)

Note: Company states it has not yet generated sales; revenue is $0.0 .

Estimates vs actuals (Q2 2025)

• EPS beat: actual −$0.19 vs consensus −$0.26 (Δ +$0.07).
• EBITDA better than expected: actual −$7.14M vs −$8.80M consensus (Δ +$1.66M).
  Values with asterisks are retrieved from S&P Global.

Balance sheet liquidity snapshot (oldest → newest)

Segment breakdown

• BiomX operates a single segment; CODM reviews consolidated operating and net loss .

KPIs and operational metrics

• Net cash used in operating activities (6M) ($USD Millions): −$14.8 .
• Grants recognized (MTEC + IIA) in Q2 ($USD Millions): ~$1.0 .
• BX004 Phase 2b dosing commenced (Jul 2025); topline results targeted Q1 2026 .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q2 2025 call transcript found. We benchmark narrative trends using Q4 2024 and Q1 2025 calls vs current period.

Management Commentary

• “BiomX achieved several significant milestones that advance our pipeline and further validate our phage therapy platform… With BX004’s Phase 2b trial now underway, FDA feedback on our real‑world evidence plan expected later this year, and planning for a potential registrational BX211 study in progress, BiomX is positioned for multiple value‑driving catalysts over the next 12 months.” — Jonathan Solomon, CEO .
• “Positive Phase 2 results for BX211… sustained, statistically significant improvements in wound size reduction, with over 40% reduction in ulcer size compared to placebo, and a favorable safety profile.” — Jonathan Solomon .
• “Earlier in July, Nature Communications published new findings… approximately 500‑fold (2.7 log10) bacterial reduction compared with placebo… no bacterial resistance to BX004 was detected.” .
• On BX211 clinical importance: management emphasized stat‑sig endpoints (PAR, ulcer depth) and favorable trends (infection resolution, CRP reduction, Wagner scale), and potential for a pivotal study pending FDA input .

Q&A Highlights

(From Q1 2025 call; no Q2 2025 transcript available)

• BX211 next steps: Company preparing for FDA interactions later in 2025; potential to seek breakthrough and orphan designations; considering a pivotal design given safety and efficacy .
• BX004 trial execution: Centers are eager; CMC issues resolved; Phase 2b remains on track with Q1 2026 topline .
• Safety database sizing: Management suggested orphan settings may allow below ~300 patient exposures, aided by favorable phage safety profile (subject to FDA discussions) .
• Cash/runway: Q1 cash $21.2M includes February financing; warrants could add ~$12M upon exercise .

Estimates Context

• Q2 2025 results vs consensus: EPS −$0.19 vs −$0.26 consensus (beat); revenue $0.0 vs $0.0 consensus (in line for pre‑revenue); EBITDA −$7.14M vs −$8.80M consensus (better). This may prompt modest upward revisions to near‑term EPS/EBITDA trajectories, though pre‑revenue status limits top‑line changes .
  Values with asterisks are retrieved from S&P Global.

Key Takeaways for Investors

• BX211 appears to have clinically meaningful and statistically significant activity in DFO with favorable safety, supporting a potential accelerated path to registrational development pending FDA feedback; watch for pivotal design clarity and any designation (breakthrough/orphan) later this year .
• BX004 Phase 2b execution is progressing (EU dosing continues), but the U.S. nebulizer device hold introduces timeline risk; monitor resolution status and any impact on the Q1 2026 topline target .
• Financial profile remains typical for pre‑revenue biotech: operating loss of ~$7.4M in Q2 and net loss of $6.0M; EPS/EBITDA beats reflect expense control and grants; runway into Q1 2026 supports near‑term catalysts without immediate financing, but going‑concern language underscores medium‑term capital needs .
• Grants and defense partnerships (MTEC/DHA) are strategic tailwinds that reduce net R&D costs and may facilitate BX211 development pathways; continued KOL engagement strengthens external validation .
• Trading setup: Near‑term stock moves likely hinge on (1) resolution of the U.S. BX004 device hold, (2) visibility into BX211 pivotal strategy/design, and (3) any regulatory feedback on RWE; positive updates could re‑rate pipeline value, while extended device hold would be a headwind .
• Estimate revisions: Expect modest upward adjustments to EPS/EBITDA following Q2 beats; revenue remains $0 until partnering or milestone revenue emerges .
• Risk‑reward: Clinical efficacy signals plus non‑dilutive support vs. device/regulatory risks and funding needs beyond Q1 2026; position sizing should reflect binary catalyst dynamics and financing optionality .

Values with asterisks are retrieved from S&P Global.

Supporting Documents Read

• Q2 2025 8‑K and press release (Aug 13, 2025) .
• Q2 2025 10‑Q (Aug 13, 2025) .
• Other relevant press releases in/around Q2 2025 (Nature Communications; BX004 dosing; program updates; Aug 19 nebulizer device clinical hold) .
• Prior quarters: Q1 2025 press release and 8‑K (May 15, 2025) ; Q1 2025 call transcript ; Q4 2024 press release and 8‑K (Mar 25, 2025) ; investor event/DFO data call (Mar 31, 2025) .

We searched for a Q2 2025 earnings call transcript and found none within July–September; Q1 2025 and Q4 2024 call materials were used for trend context .