Sign in
AP

Acurx Pharmaceuticals, Inc. (ACXP)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 focused on advancing ibezapolstat to Phase III: FDA CMC review request submitted with a meeting anticipated in Q4 2024; management now targets earliest Phase III first-patient dosing in Q1 2025, shifting from prior Q4 2024 readiness due to regulatory sequencing across geographies .
  • Cash was $6.36M at quarter-end, with R&D $1.83M, G&A $2.30M, net loss $4.12M ($0.26/share), broadly consistent with Q1 operating intensity while cash declined as the company prepared for Phase III and IP strengthening .
  • Strategic financing options advanced: multiple confidentiality agreements with larger pharma, exploration of territorial licensing and royalty financing; management estimates Phase III costs at $25M per trial ($50M total), favoring nondilutive structures and sequencing trials to mitigate equity dilution .
  • A new USPTO patent on ibezapolstat’s CDI treatment, recurrence reduction, and microbiome benefits extends U.S. patent protection to June 2042, strengthening competitive positioning ahead of Phase III and potential partnering .

What Went Well and What Went Wrong

What Went Well

  • Phase III readiness and regulatory momentum: FDA End-of-Phase II confirmed Phase III entry and NDA pathway; CMC meeting request submitted with target in Q4 2024, enabling EU submission thereafter .
  • Strengthened IP: USPTO granted a new patent covering CDI treatment, reduced recurrence, and microbiome health, expiring June 2042; management emphasized its unusual nature and strategic advantage .
  • Active BD pipeline: Management reported robust inbound interest, multiple signed CAs (5–12), and openness to M&A, royalty financing, and territorial licensing to reduce dilution and accelerate Phase III .

What Went Wrong

  • Phase III timing pushed: From “ready to start Q4 2024 subject to funding” in Q1 to “earliest Q1 2025” in Q2, reflecting the need to conclude FDA CMC review and coordinate EMA submission before international enrollment; modest schedule slippage is a watch item .
  • Operating burn increased y/y: G&A rose to $2.30M vs $1.71M y/y; net loss widened to $4.12M vs $3.45M y/y, driven by higher professional fees and share-based comp, plus R&D manufacturing costs .
  • Disclosure discrepancy: Press release/8-K indicated ~$0.3M ATM gross proceeds in Q2, while the call stated ~$$3M; investors should rely on the furnished press release/8-K figures vs. .

Financial Results

Quarterly financials vs prior periods and estimates

MetricQ4 2023Q1 2024Q2 2024
Cash And Equivalents ($USD Millions)$7.47 $8.92 $6.36
Research and Development ($USD Millions)$1.90 $1.56 $1.83
General and Administrative ($USD Millions)$3.20 $2.82 $2.30
Total Operating Expenses ($USD Millions)N/A$4.38 $4.12
Net Loss ($USD Millions)$5.10 $4.38 $4.12
Diluted EPS ($USD)$0.37 $0.28 $0.26
Shares Outstanding (period end)14,468,229 15,757,102 15,996,168

Revenue and EPS vs estimates (S&P Global)

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)— (pre-revenue) — (pre-revenue) — (pre-revenue)
Diluted EPS (Actual, $USD)$0.37 $0.28 $0.26
EPS Consensus (S&P Global)N/A*N/A*N/A*
Revenue Consensus (S&P Global)N/A*N/A*N/A*
*Estimates unavailable via S&P Global at time of retrieval. Values would be retrieved from S&P Global.

KPIs and capital actions

KPIQ4 2023Q1 2024Q2 2024
ATM Shares Sold (period)—1,121,793 133,066
ATM Gross Proceeds ($USD Millions)—$4.4 $0.3
Warrants Outstanding (count; WAE $/sh)——6.1M; $3.28 WAE
Patent: new USPTO grant (date; expiry)——Jul 16, 2024; Jun 2042

Note: CFO call commentary referenced ~$3.0M ATM proceeds in Q2; press release/8-K furnished ~$0.3M; investors should rely on press release/8-K vs. .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA CMC meeting timing2H 2024Preparing for Phase III; manufacturing update; no CMC date disclosed CMC meeting request submitted; anticipate meeting in Q4 2024 Clarified timing (scheduled in Q4)
Phase III first-patient dosingStart windowReady to start Q4 2024 subject to funding Earliest Q1 2025 given CMC/EMA sequencing Lowered/pushed out
Phase III designProgramTwo registration trials; noninferiority vs vancomycin; mITT population ~450 per trial Confirmed same: two trials; 450 ITT; 1:1 vs vancomycin Maintained
Phase III cost estimateBudget~$50–$60M if independent ~$25M per trial; ~$50M total Tightened estimate
Funding approachStrategyRobust interest; pursue nondilutive (partnering/royalty) Signed multiple CAs; exploring royalty financing, territorial deals, grants Advanced optionality

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023)Previous Mentions (Q1 2024)Current Period (Q2 2024)Trend
Regulatory readinessPreparing for End-of-Phase II; target Q4 2024 enrollment FDA agreed Phase III readiness and NDA pathway CMC meeting requested; anticipate Q4 2024; EU submission thereafter Progressing
Phase III timingTarget Q4 2024 start Ready Q4 2024 subject to funding Earliest Q1 2025 start to align CMC/EMA Slight delay
Funding/BDStrategic alternatives, ATM facility Robust partner interest; nondilutive preference Multiple CAs signed; royalty, territorial, M&A explored Intensifying
IP/microbiome—Favorable microbiome data vs vancomycin New patent granted; expires 2042 Strengthening
AMR policy—PASTEUR unlikely in 2024; possible HHS program expansion; BARDA funding angle Engagement at AMR conferences; highlighting need for new classes Neutral to improving advocacy

Management Commentary

  • “Following our successful end of Phase II... we submitted our request to FDA for a... CMC... We anticipate FDA to bring up the meeting in the fourth quarter.”
  • “Two required Phase III registration studies... 450 patients... randomized to either ibezapolstat or oral vancomycin.”
  • “The two together should be $25 million a piece... together... $50 million... run the trials consecutively... with positive data from the first Phase III... raise money at much higher prices...”
  • “We have a number of confidentiality agreements signed, north 5, maybe less than 12... interest is more than I anticipated... antibiotic space picking up steam.”
  • “With the ATM, we probably have sufficient funds without any trials going on until like the middle of ’26. Without the ATM, it’s probably the middle of ’25.”
  • “New patent... treatment of C. difficile infection... reducing reinfection... restoring the healthy microbiome.”

Q&A Highlights

  • Phase III design and cost: Management reiterated two international NI trials (ibezapolstat vs vancomycin), ~450 ITT each, ~$25M per trial; sequencing consecutively to minimize dilution .
  • Start timing and regulatory sequencing: Earliest first-patient dosing in Q1 2025 following Q4 2024 FDA CMC and EMA submission; intent to align U.S./EU approvals and sites .
  • Funding optionality: Active discussions with larger pharma; exploring royalty financing ($20–$25M nondilutive potential), territorial licensing (EU/Japan/South America), and grants; M&A remains on the table .
  • Capital structure: 6.1M warrants outstanding; WAE $3.28; ATM use continues opportunistically .
  • Market/policy context: Antibiotics seeing renewed urgency; management points to AMR conferences and potential gov’t programs to support late-stage antibiotics .

Estimates Context

  • Wall Street consensus (S&P Global) for quarterly EPS and revenue was unavailable at time of retrieval; ACXP remains pre-revenue, and investor focus is on operating burn, cash runway, regulatory milestones, and partnership optionality rather than near-term revenue/EPS prints. Values would be retrieved from S&P Global if available.
  • Given modest schedule shift (Phase III earliest Q1 2025) and strengthened IP, estimates—where they exist—may need to adjust timing assumptions for major catalysts and cash runway sensitivity.

Key Takeaways for Investors

  • Phase III start modestly delayed (Q1 2025 earliest) due to regulatory sequencing; CMC meeting in Q4 2024 is a key near-term catalyst .
  • Strong BD momentum (multiple CAs, royalty/territorial/M&A paths) and new patent through 2042 increase odds of nondilutive financing and de-risk commercial positioning ahead of Phase III .
  • Operating burn is rising y/y (G&A up; R&D manufacturing spend), but cash runway extends into mid-2026 with ATM (mid-2025 without), giving time to secure strategic capital .
  • Watch disclosure consistency: rely on press release/8-K for ATM proceeds ($0.3M) vs. call commentary ($3M) .
  • Trial design remains straightforward (NI vs vancomycin; 450 ITT per trial), with potential for superiority analyses; simultaneous international sites should aid enrollment .
  • Near-term trading: Patent grant + CMC scheduling + BD updates could drive sentiment; downside risk if funding dilutes materially or if regulatory timelines slip further .
  • Medium-term thesis: Novel class with microbiome-sparing profile and recurrence reduction potential in a sizeable CDI market under AMR tailwinds; execution on financing and Phase III enrollment is paramount .

Citations: Q2 2024 press release and furnished 8-K ; Q2 2024 call transcript ; Prior quarters Q1 2024 press/call ; Q4 2023 call ; USPTO patent press release .