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BiomX Inc. (PHGE)·Q4 2024 Earnings Summary

Executive Summary

  • BiomX reported Q4 and full-year 2024 results with no product revenue disclosed, higher R&D and G&A spend tied to BX004 and BX211, and a year-end cash and restricted cash balance of $18.0M; subsequent February 2025 financings added $12M gross proceeds, extending runway into Q1 2026 .
  • Q4 2024 EPS was -$1.15 vs consensus -$0.30 (2 ests), indicating a miss amid continued clinical investment; revenue consensus was $0.0 (2 ests) and no Q4 revenue was reported (pre-revenue biotech) (values from S&P Global)*.
  • Clinical execution remains the core catalyst: management flagged BX211 Phase 2 topline by end of March 2025 in the Q4 materials, then announced positive, statistically significant outcomes on March 31; a Phase 2/3 path is being planned pending FDA feedback .
  • BX004 Phase 2b remains on track for topline in Q1 2026 after Q4 2024 manufacturing scale-up delays were resolved; regulatory discussions are expected in H2 2025 .

What Went Well and What Went Wrong

  • What Went Well

    • Positive BX211 Phase 2 topline demonstrated statistical significance in ulcer size reduction (PAR) at week 12 (p=0.046) with >40% separation from placebo by week 10; also significant in ulcer depth and reduced ulcer area expansion, with favorable trends across other clinical parameters .
    • Management signaled Phase 2/3 planning for BX211, framing results as a “watershed moment for phage therapy” and one of the strongest demonstrations of phage efficacy in a chronic bacterial infection .
    • Liquidity improved with $12M February 2025 raises, supporting BX004 Phase 2b through topline and analyses to inform H2 2025 regulatory discussions; cash runway guided into Q1 2026 .
  • What Went Wrong

    • BX004 Phase 2b timeline slipped due to Q4 2024 manufacturing scale-up delays (10L to 50L), shifting topline from earlier guidance to Q1 2026 (from H1 2026 previously) .
    • FY24 operating loss expanded ($44.5M) as R&D rose to $24.7M and G&A to $11.8M, reflecting program advancement and APT integration; impairments (goodwill $0.8M, IPR&D $3.2M, long-lived assets $4.0M) also weighed on operating results .
    • Q4 EPS missed consensus (limited coverage), reflecting continued opex and fair-value/non-cash items (warrant revaluation swings across 2024) (values from S&P Global)* .

Financial Results

EPS vs. Consensus (Q4 2024)

MetricQ4 2024
GAAP EPS (Actual)-$1.15*
GAAP EPS (Consensus)-$0.30*
EPS Estimates (#)2*

Note: Values retrieved from S&P Global.*

Cash & Liquidity (Quarter-end)

MetricQ2 2024Q3 2024Q4 2024
Cash, Short-term Deposits & Restricted Cash ($M)$32.7 $24.7 $18.0
Runway (company estimate)Through Q4 2025 Into Q4 2025 Into Q1 2026 (excludes Feb-25 $12M)

Operating Expenses Trend (Quarterly and Annual)

MetricQ2 2024Q3 2024FY 2023FY 2024
R&D Expense ($M)$6.9 $7.3 $16.7 $24.7
G&A Expense ($M)$2.8 $3.2 $8.7 $11.8
Net Loss ($M)n/an/a$26.2 $17.7

Notes: Company’s Q4 2024 press release provided full-year figures; quarterly Q4 opex not separately disclosed .

Other FY 2024 Items (Selected)

MetricFY 2024
Operating Loss ($M)$44.5
Goodwill Impairment ($M)$0.8
IPR&D Impairment ($M)$3.2
Long-lived Assets Impairment ($M)$4.0

KPIs (Programs/Corporate)

  • Non-dilutive funding to date for BX211: $36.8M
  • February 2025 equity/related financings: $12M gross proceeds
  • Reverse 1-for-10 stock split effective Aug 26, 2024; unit separation/warrants expired Oct 28, 2024; NYSE American compliance regained Dec 16, 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BX211 Phase 2 topline (Week 13)Program timelineQ1 2025 “By end of March 2025” (achieved Mar 31 with positive results) Maintained/Tightened window
BX211 next stepsDevelopment planNot specifiedPlan Phase 2/3 pending FDA feedback New detail
BX004 Phase 2b toplineProgram timelineQ3 2025 (prior) H1 2026 (Q3’24); refined to Q1 2026 (Q4) Lowered/pushed out, then narrowed
Cash runwayLiquidityThrough Q4 2025 Into Q1 2026 (ex-Feb 2025 $12M noted separately) Extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
BX211 efficacy/readoutEnrollment complete; Week-13 topline expected Q1’25 Positive, statistically significant topline announced Mar 31; planning Phase 2/3 Strong positive inflection
BX004 manufacturing/CMCFDA meeting positive; preparing Phase 2b Q4 mfg delays resolved; topline now Q1’26; real-world evidence analyses ahead of H2’25 FDA talks Delay resolved; timeline extended but clarified
Funding mix (non-dilutive + equity)Q2 financing $50M; guided runway to Q4’25 $12M Feb-25 raise; BX211 DHA non-dilutive totals $36.8M Supportive of milestones
Regulatory strategyPreparing BX004 Phase 2b; FDA meeting held BX004 regulatory discussions expected H2’25; BX211 Phase 2/3 pending FDA feedback Increasing engagement
Listing/complianceReverse split; unit separation/warrants expiration Regained NYSE American compliance (Dec-24) Improved corporate footing

Management Commentary

  • “We believe these data represent one of the strongest demonstrations to date of the therapeutic potential of phage therapy.” – Jonathan Solomon, on BX211 Phase 2 results and Phase 2/3 planning .
  • “Patients treated with BX211 demonstrate sustained and statistically significant PAR… separation from placebo starting at week 7 with a difference greater than 40% by week 10.” – Management on efficacy magnitude .
  • “During the fourth quarter of 2024, BiomX encountered manufacturing delays… These challenges have since been resolved, supporting continued progress [for BX004].” .
  • “Aggregate gross proceeds were approximately $12 million… [supporting] topline results of its Phase 2b study of BX004 in the first quarter of 2026.” .

Q&A Highlights

  • Non-dilutive funding outlook: DHA/Navy support tied to resistant infections and battlefield wound care; management sees ongoing interest in phage, potentially providing “substantial non-dilutive funding” .
  • Placebo performance and trajectory: Placebo improvement early reflects standard-of-care debridement/antibiotics and trial attention; separation emerged after week ~6–7 as phage effect compounded (biofilm, accessibility), consistent with expected ~40% placebo ulcer shrinkage baseline .
  • Dosing learnings: Response dynamics differ by route/site (lungs vs bone/soft tissue); DFO showed gradual improvement consistent with biofilm breakdown; rigorous screening ensured phage susceptibility .
  • Statistical robustness: Week 12 PAR significant (p=0.046), week 13 near-threshold; depth and ulcer worsening endpoints also significant, reinforcing totality of evidence .

Estimates Context

  • Q4 2024 EPS: -$1.15 vs -$0.30 consensus; Revenue consensus $0.0 (2 estimates each). Coverage is limited and volatility in warrant fair-value remeasurement can impact GAAP results (values from S&P Global).*
  • Implications: Street models may adjust expense run-rate and timing assumptions for BX004 (shift to Q1’26 topline) and incorporate accelerated BX211 path post-positive data (trial design, timing) .

Key Takeaways for Investors

  • BX211 is now a validated clinical asset with statistically significant Phase 2 efficacy and safety; Phase 2/3 planning is underway—FDA feedback is the next value inflection .
  • BX004’s Phase 2b path is intact post-manufacturing resolution; timeline is pushed to Q1’26 with H2’25 FDA interactions—watch for RWE analyses that could inform endpoints and regulatory dialogue .
  • Liquidity is adequate into Q1’26, bolstered by the Feb-25 $12M raise and prior $50M financing; non-dilutive BX211 support ($36.8M to date) is strategically important .
  • Corporate risk profile improved with NYSE American compliance regained and cap structure cleanup (reverse split, unit separation/warrant expiry) .
  • Near-term trading catalysts: detailed BX211 dataset presentations, FDA guidance on Phase 2/3, BX004 regulatory interactions in H2’25; medium-term: BX004 Phase 2b execution toward Q1’26 topline .

Footnote: *Values retrieved from S&P Global.