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Acurx Pharmaceuticals, Inc. (ACXP)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was operationally focused: EMA scientific advice aligned with FDA, confirming Phase 3 readiness for ibezapolstat; management expects a two-year timeline from first patient to top-line data and will run ~150 sites with ~50% in Europe .
  • EPS beat vs S&P Global consensus: Primary EPS actual was -$3.20* vs -$3.50* estimate (beat by $0.30*) for Q4 2024; revenue consensus remained $0.00*, consistent with development-stage status*.
  • Expense discipline improved YoY: R&D fell to $0.80M (from $1.90M), G&A to $2.00M (from $3.20M), net loss narrowed to $2.80M (from $5.10M) . Cash ended at $3.71M; 2024 ATM raised $6.6M in gross proceeds .
  • Funding remains the key catalyst: management is pursuing government/quasi-government support, territorial partnerships, royalty financing, and may run the two Phase 3 trials sequentially; no interim look planned, and Nasdaq listing risk monitored with ATM suspended in January .

What Went Well and What Went Wrong

What Went Well

  • EMA guidance confirmed alignment with FDA across manufacturing, non-clinical, and clinical aspects, positioning the company to commence international Phase 3 registration trials; “complete agreement in all regards from both agencies” .
  • Strengthened scientific and IP differentiation: new microbiome and bile acid analyses reinforced ibezapolstat’s selective microbiome profile; additional patents (USPTO July 2024; JPO Feb 2025) extend protection and bolster ACX-375C development .
  • Expense control YoY: R&D and G&A decreased materially in Q4 vs prior year, driving narrower net loss; drivers included lower consulting and share-based comp .

What Went Wrong

  • Cash balance declined to $3.71M from $7.47M YoY and $5.76M QoQ, highlighting near-term financing dependence to initiate Phase 3 .
  • Continued operating losses: net loss of $2.80M, EPS -$0.16; management underscored the need for external funding (government, partnerships, royalty finance) to start enrollment .
  • Listing and financing optics: ATM suspended in January and management acknowledged Nasdaq listing risk; while confident, market turmoil complicates timelines .

Financial Results

Quarterly comparison vs prior periods and estimates (company-reported)

MetricQ4 2023Q3 2024Q4 2024
R&D Expenses ($USD Millions)$1.90 $1.20 $0.80
G&A Expenses ($USD Millions)$3.20 $1.62 $2.00
Net Loss ($USD Millions)$5.10 $2.82 $2.80
Diluted EPS ($USD)-$0.37 -$0.17 -$0.16
Shares Outstanding (Millions)14.47 16.77 17.03
Cash and Equivalents ($USD Millions)$7.47 $5.76 $3.71

Trend across last three quarters (company-reported)

MetricQ2 2024Q3 2024Q4 2024
R&D Expenses ($USD Millions)$1.83 $1.20 $0.80
G&A Expenses ($USD Millions)$2.30 $1.62 $2.00
Net Loss ($USD Millions)$4.12 $2.82 $2.80
Diluted EPS ($USD)-$0.26 -$0.17 -$0.16
Cash and Equivalents ($USD Millions)$6.36 $5.76 $3.71

Estimates comparison (S&P Global)

MetricQ2 2024Q3 2024Q4 2024
Primary EPS Consensus Mean ($)-$4.40*-$3.80*-$3.50*
Primary EPS Actual ($)-$5.20*-$3.40*-$3.20*
Surprise ($)-$0.80*+$0.40*+$0.30*
Revenue Consensus Mean ($USD)$0.00*$0.00*$0.00*

Values retrieved from S&P Global.*

Segment breakdown: Not applicable (no commercial revenues) .

KPIs (operational/financing):

  • ATM gross proceeds in 2024: $6.6M .
  • EMA/FDA alignment and Phase 3 readiness communicated (protocol, endpoints, sample size, mITT analysis) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 3 CMC readinessQ4 2024FDA CMC meeting expected in Q4 2024 FDA CMC readiness achieved; EMA guidance aligned Raised (milestone achieved)
Phase 3 Trial Design2025+Two global Phase 3 NI trials; ~450 pts per trial, 1:1 vs vancomycin ~150 clinical sites; ~50% Europe; no interim look; ~2 years FPI to topline Clarified (geography/timeline)
Funding approachNear-termPursue partnerships, territorial licenses, grants, royalty finance Emphasis on government/quasi-government support; sequential trial option; ATM suspended Jan Maintained/clarified
Financial guidance (Revenue/Margins/OpEx)Q4 2024NoneNoneMaintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Regulatory (FDA/EMA)End-of-Phase 2 success; CMC meeting planned; Phase 3 readiness CMC readiness announced; EMA scientific advice planned EMA guidance aligned with FDA; Phase 3 registration readiness reiterated Strengthening alignment
Phase 3 design & timelinesTwo NI trials; ~450 pts each; 1:1 vs vancomycin International sites; sequential option ~150 sites, ~2 years FPI to topline; no interim look Greater specificity
Funding/partnershipsTerritorial licenses, royalty finance, grants Active dialogues incl. M&A; government programs (PASTEUR Act) Focus on government/quasi-government; Capitol Hill outreach; ATM suspended Intensifying
Microbiome/bile acidsPhase 2 selective microbiome; upcoming presentations New predictive model; poster data Additional studies (in-silico; germ-free mouse) differentiate vs VAN/MET/FDX Expanding data
IP/PatentsUSPTO patent (microbiome/recurrence) Continued filings; diagnostic potential JPO patent (DNA pol IIIC inhibitors) granted Broader protection
ACX-375C/Anthrax—Anthrax in vitro activity; program planning JPO patent supports ACX-375C development Progressing preclinical
Treasury strategy——Board approved up to $1M Bitcoin as treasury reserve New initiative

Management Commentary

  • “There’s a complete agreement in all regards from both agencies” (FDA and EMA alignment on Phase 3) – David Luci .
  • “We’re going to start out with 150 clinical trial sites… maybe 30% of the sites in the U.S. compared to 50% in Europe” – David Luci .
  • “We decided against the interim look… it adds like 10% to the required number of patients… two years from first patient enrolled to top line data” – David Luci .
  • “We continue to identify and pursue funding opportunities… potential partnerships with various groups… government and quasi government agencies” – David Luci .
  • “We suspended the ATM in connection with the offering… no sense internally that we’ll let the Nasdaq listing go” – Robert Shawah .

Q&A Highlights

  • EMA/FDA alignment: management confirmed identical expectations across agencies, reducing regulatory risk for Phase 3 .
  • Trial geography and scale: ~150 sites globally with heavier European footprint; sequential trial option to manage funding .
  • Timeline and design: no interim analysis; ~2 years from first patient to topline; endpoints consistent with Phase 2b .
  • Funding strategy: priority on non-dilutive capital (government/quasi-government, royalty finance), territorial partnerships; ATM currently suspended .
  • Nasdaq listing: management confident in maintaining listing, working on measures to support compliance .

Estimates Context

  • Q4 2024 Primary EPS beat vs S&P Global consensus: actual -$3.20* vs -$3.50* estimate (+$0.30* beat). Revenue estimate $0.00*, consistent with no commercial sales*.
  • Prior quarters: Q3 2024 actual -$3.40* vs -$3.80* estimate (+$0.40* beat); Q2 2024 actual -$5.20* vs -$4.40* estimate (-$0.80* miss).
  • Implications: Expense reductions and operating discipline support improving EPS trajectory on S&P’s basis; estimates likely to focus on cash runway and Phase 3 start timing*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Regulatory de-risking: EMA scientific advice aligns with FDA CMC/clinical plans; Phase 3 readiness and mITT analysis framework are set, lowering execution risk .
  • Funding is the gating factor: expect catalysts around government/quasi-government awards, territorial partnerships, or royalty finance to trigger Phase 3 initiation; sequential trial approach reduces upfront capital needs .
  • Operating discipline: Q4 YoY reductions in R&D and G&A narrowed net loss, a positive signal for burn-rate management ahead of Phase 3 .
  • Trial plan clarity: ~150 sites, ~50% Europe, no interim look, two-year timeline to topline; clear path for data readout once funding is secured .
  • Scientific differentiation: expanding microbiome/bile acid evidence and new patents bolster ibezapolstat’s potential anti-recurrence profile and competitive positioning vs VAN/MET/FDX .
  • Watch listing/treasury optics: ATM suspended; management confident on Nasdaq listing; Bitcoin treasury reserve adds non-core volatility but no impact on development plans .
  • Near-term trading lens: headlines on funding/partnership awards and Phase 3 start dates are likely stock movers; EMA/FDA alignment reduces regulatory uncertainty while cash trajectory frames timing .