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Acurx Pharmaceuticals, Inc. (ACXP)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 narrowed net loss to $2.15M ($0.11/share) driven by deliberate cost cuts in both R&D and G&A; cash increased to $4.64M following ~$3.6M gross proceeds raised during the quarter .
  • Regulatory de-risking advanced: EMA scientific advice aligned with FDA on Phase 3 design and CMC, confirming the path to MAA filing upon successful Phase 3; Phase 3 start remains funding-dependent .
  • Evidence base strengthened: two NIAID/NCI/NCATS-supported non-clinical studies highlighted IBZ’s microbiome-preserving profile versus vancomycin/metronidazole and differentiated from fidaxomicin; Phase 2 data accepted for publication in Lancet Microbe (in press at the time of the call) .
  • Funding runway bolstered post-quarter via a $12M equity line with Lincoln Park Capital; management reiterated aggressive cost control until Phase 3 funding is secured, with multiple non-dilutive avenues being pursued (PASTEUR, BARDA, ARCH, European sources) .

What Went Well and What Went Wrong

What Went Well

  • Cost discipline: R&D fell to $0.60M (from $1.56M y/y) on lower manufacturing and consulting; G&A fell to $1.55M (from $2.82M y/y) on lower professional fees and share-based comp; net loss shrank to $2.15M ($0.11/share) from $4.38M ($0.28/share) .
  • Regulatory clarity: EMA guidance aligned with FDA on Phase 3 program and confirmed an MAA pathway after successful Phase 3, positioning ACXP to commence an international Phase 3 upon funding .
  • Differentiation data and visibility: Non-clinical studies showed narrower microbiome disruption versus vancomycin/metronidazole and differentiation from fidaxomicin; Phase 2 clinical results accepted (in press) for Lancet Microbe publication, supporting potential anti-recurrence advantages .

Management quotes:

  • “With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.”
  • “We’ve done some dramatic cost cutting… and I would expect both our G&A and our R&D cost to continue to go down… until we start the Phase III program.”
  • “We continue to identify and pursue funding opportunities for our Phase III… we have several initiatives underway…”

What Went Wrong

  • Phase 3 timing remains uncertain: Management will not guide to a start date given funding not yet secured; the company is “treading water” until financing closes .
  • No product revenue; operating model remains expense-only with reliance on external capital (ATM previously, registered directs, and new equity line) .
  • Legislative/grant visibility remains limited near term: No specific update on PASTEUR Act timing; non-dilutive options under evaluation (BARDA, ARCH, Europe) but no awards yet .

Financial Results

P&L and Cash (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Cash and Equivalents ($M)$5.76 $3.71 $4.64
Research & Development Expense ($M)$1.20 $0.80 $0.60
General & Administrative Expense ($M)$1.62 $2.00 $1.55
Net Loss ($M)$2.82 $2.8 $2.15
Basic & Diluted EPS ($)$(0.17) $(0.16) $(0.11)
Shares Outstanding (period-end, M)16.77 17.03 22.40

Notes: No product revenue line disclosed in the quarterly statements of operations; company reports operating expenses and net loss only .

Results vs S&P Global Consensus (Q1 2025)

MetricActualConsensusSurprise
EPS Normalized ($)-2.2*-2.8*+0.6
Revenue ($M)0.0*0.0*0.0

Values marked with * were retrieved from S&P Global.

Drivers of variance: The loss narrowed on lower consulting and manufacturing costs (R&D) and reduced professional fees and share-based comp (G&A), consistent with management’s cost-cutting effort .

KPIs and Capital

  • Gross proceeds raised in Q1 2025: ~$3.6M via two registered direct offerings .
  • Post-quarter financing: $12M equity line of credit with Lincoln Park Capital (closed May 2025) .
  • Weighted-average shares in Q1 2025: 20.04M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Formal financial guidance (Revenue/EPS/OpEx)FY/QtrNone providedNone providedMaintained (no guidance)
Phase 3 start timing (ibezapolstat)2025Phase 3 ready; timing subject to fundingTiming still funding-dependent; aggressive cost control until launch; new $12M ELOC added Maintained
Regulatory pathwayPhase 3/MAAFDA-aligned, Phase 3 readyEMA confirmed alignment and MAA pathway post-successful Phase 3 Improved visibility
Non-dilutive funding2025Evaluating optionsPursuing PASTEUR/“PASTEUR-lite,” BARDA, ARCH, European sources; no awards yet Ongoing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Phase 3 readiness & CMCSubmitted CMC meeting request; Phase 3 roadmap presented; FDA Phase 3 readiness confirmed EMA guidance aligned with FDA; MAA path confirmed; Phase 3 start remains funding-dependent Regulatory visibility up; timing tied to funding
Funding strategyATM and registered direct usage; cash $5.8M (Q3) to $3.7M (YE) ~$3.6M gross raised in Q1; $12M equity line closed post-quarter; cutting OpEx to extend runway Liquidity options broadened
Microbiome differentiationPhase 2b data presented at IDWeek; bile acid findings vs vancomycin Two non-clinical studies show narrower microbiome alteration vs VAN/MET and differentiation vs FDX; Lancet Microbe publication in press Strengthening evidence base
IP/PatentsNew USPTO patent (reducing recurrence, microbiome health) New patents granted in Japan and India for pol IIIC inhibitors (exp. 2039) IP estate expanding
Non-dilutive pathwaysNoted exploration (Anthrax program planning) PASTEUR/BARDA/ARCH/European interest discussed; no specifics yet Active exploration, timing uncertain
OpEx trajectoryR&D ~$1.2M, G&A ~$1.6M in Q3 R&D $0.6M, G&A $1.55M; management expects further declines until Phase 3 start Downward pre-Phase 3

Management Commentary

  • Prepared remarks emphasized regulatory convergence and evidence strength: “With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.”
  • On cost trajectory and funding-dependent Phase 3: “We’ve done some dramatic cost cutting… I would expect… G&A and R&D… to continue to go down… until we start the Phase III program… we did close on the equity line of $12 million… we are in a decent position… to tread water until one of these funding opportunities comes through.”
  • On differentiation and publication: Phase 2 results “accepted for publication in… Lancet Micro[be]… high rates of clinical cure… no recurrence… preservation of key health-promoting bacteria… another important mechanism to prevent recurrent CDI.”
  • On pursuit of non-dilutive options: “There’s also traditional BARDA grants… application to ARCH… a European… group has taken some interest… we’ve got a lot of lines in the water… waiting to get a bite.”

Q&A Highlights

  • Microbiome endpoints in Phase 3: Preservation/restoration already a secondary endpoint; management exploring further differentiation opportunities in light of recent publications .
  • OpEx and Phase 3 timing: Expect further OpEx declines until Phase 3; start remains contingent on external funding; ELOC provides flexibility while pursuing financing .
  • Policy/grants: No specific PASTEUR update; BARDA/ARCH/European avenues under active discussion but not finalized .
  • Regulatory flexibility: Team evaluating comments about “plausible mechanism” pathways; first-of-kind for antibiotics would be novel if applicable .

Estimates Context

  • Q1 2025 EPS (normalized) beat S&P Global consensus: actual -2.2 vs -2.8 consensus (+$0.6). Revenue in line at $0.0. Values retrieved from S&P Global.*
  • Given management’s continued cost reductions and absence of Phase 3 spend, near-term loss expectations may drift lower; however, any Phase 3 initiation would likely re-accelerate OpEx and widen losses vs current run-rate .

Values marked with * were retrieved from S&P Global.

Key Takeaways for Investors

  • Operating discipline is working: materially lower OpEx narrowed losses and extended runway; management signaled more cost reduction until Phase 3 starts .
  • Regulatory de-risking progressed with EMA/FDA alignment and MAA path confirmation, which could be a value inflection once funding is secured .
  • Differentiation narrative is strengthening versus standard-of-care and fidaxomicin, with peer-reviewed visibility increasing (Lancet Microbe acceptance) .
  • Liquidity optionality improved via $12M ELOC, but Phase 3 remains dependent on external financing; non-dilutive sources (PASTEUR/BARDA/ARCH/Europe) are key watch items .
  • Near-term trading catalysts: non-dilutive funding updates, publication timing/readthroughs, any Phase 3 financing announcement or start, and policy developments on PASTEUR/BARDA .
  • Estimate revisions: S&P Global EPS (normalized) likely moves modestly higher (less negative) near-term on lower OpEx; reversal if Phase 3 begins given trial spend.*
  • Risk balance: financing execution risk and timing remain central; however, regulatory clarity and scientific differentiation mitigate development risk relative to peers .

Appendices (source details)

  • Q1 2025 8-K/Press release and financials .
  • Q1 2025 earnings call transcript (prepared remarks and Q&A) .
  • Q4 2024 and Q3 2024 prior quarter updates .
  • Related press releases (call notice; financing and regulatory items) .

Values marked with * were retrieved from S&P Global.