Executive Summary

Q3 2024 was operationally focused: Acurx announced CMC readiness for Phase 3 following successful pre-meeting FDA correspondence, advanced international regulatory preparations, and highlighted additional supportive Phase 2b microbiome and bile acid data .
Financially, net loss narrowed year over year to $(2.82) million and basic/diluted loss per share to $(0.17), with R&D down slightly and G&A lower versus Q3 2023; cash ended at $5.76 million after ~$1.6 million gross ATM proceeds in the quarter .
Guidance/timing shifted: management now targets earliest Phase 3 trial start in Q1 next year vs Q2’s hope to start in Q4 2024, contingent on financing; EMA scientific advice is expected late Q4 or more likely Q1 .
Stock reaction catalysts near term: formal EMA/UK/Canada/Japan regulatory interactions, any territorial licensing or government non‑dilutive funding, and clarity on Phase 3 start/sequencing (single vs sequential trials) .

What Went Well and What Went Wrong

What Went Well

Achieved CMC readiness for Phase 3 without a formal FDA meeting, enabling progression to Phase 3 protocol execution and international filings; “we're delighted to announce CMC readiness for Phase III” .
Strengthened scientific case: Phase 2b data presented at IDWeek showed ibezapolstat’s favorable bile acid profile and microbiome preservation, with 5/5 IBZ patients followed for 3 months post‑EOT experiencing no recurrence; “these exciting results demonstrate two properties… which may contribute to the anti‑recurrence effect” .
Protection strategy: new USPTO patent covering treatment of CDI while reducing recurrence and improving gut microbiome health, expiring June 2042, supporting a durable competitive moat .

What Went Wrong

Phase 3 timing slipped: Q2 commentary targeted Q4 2024 start “if funded,” Q3 updated to earliest Q1, reflecting funding and regulatory sequencing constraints (EMA advice before EU enrollment) .
Financing mix remains unresolved: management prefers non‑dilutive paths (government, territorial licenses, royalty financing) but still raised capital via ATM ($1.6M gross in Q3), and lacks firm commitments; dilution risk persists if equity is needed .
Estimate benchmarking unavailable: Wall Street consensus via S&P Global could not be retrieved in this session, limiting beat/miss analysis and the degree of investor validation vs Street expectations (note below) [functions.GetEstimates errors].

Financial Results

Quarterly P&L and Cash Progression

Metric	Q1 2024	Q2 2024	Q3 2024
Cash And Equivalents ($USD)	$8,920,926	$6,360,858	$5,762,564
Research & Development ($USD)	$1,555,011	$1,825,582	$1,198,184
General & Administrative ($USD)	$2,822,878	$2,296,244	$1,623,413
Total Operating Expenses ($USD)	$4,377,889	$4,121,826	$2,821,597
Net Loss ($USD)	$(4,377,889)	$(4,121,826)	$(2,821,597)
Loss per Share (Basic/Diluted)	$(0.28)	$(0.26)	$(0.17)
Weighted Avg Shares	15,472,507	15,824,654	16,363,473
Shares Outstanding (Quarter End)	15,757,102	15,996,168	16,770,378
ATM Proceeds (Gross, period)	$4.4M in Q1	~$0.3M in Q2 PR; CFO cited ~$3.0M on call (discrepancy)	~$1.6M in Q3

Notes: The Q2 ATM proceeds discrepancy (press release ~$0.3M vs call ~$3.0M) should be reconciled with management; we treat press release values as primary .

Year-over-Year Comparison (Q3 2024 vs Q3 2023)

Metric	Q3 2023	Q3 2024	YoY Change
Research & Development ($USD)	$1,348,985	$1,198,184	$(150,801)
General & Administrative ($USD)	$1,765,996	$1,623,413	$(142,583)
Total Operating Expenses ($USD)	$3,114,981	$2,821,597	$(293,384)
Net Loss ($USD)	$(3,114,981)	$(2,821,597)	$293,384
Loss per Share (Basic/Diluted)	$(0.24)	$(0.17)	$0.07
Weighted Avg Shares	13,005,128	16,363,473	+3,358,345

Results vs Estimates

Wall Street consensus estimates via S&P Global were unavailable during this session due to access limits; thus EPS/revenue beat/miss cannot be determined (see Estimates Context below) [functions.GetEstimates errors].

Segment breakdown

Not applicable; Acurx is a development-stage biopharma with no reported product revenues in the period .

KPIs (Operating and Financing)

KPI	Q1 2024	Q2 2024	Q3 2024
Cash ($USD)	$8.92M	$6.36M	$5.76M
Patent milestone	—	New USPTO patent granted, expires 2042	Patent reiterated as competitive advantage
Regulatory readiness	End-of-Phase 2 agreement with FDA	Preparing CMC FDA meeting submission	CMC readiness achieved via pre‑meeting correspondence
International filings	EMA SME designation	Preparing EU/UK/JP/CA submissions	EMA meeting targeted late Q4 or Q1
ATM usage (gross)	~$4.4M	~$0.3M PR; call ~$3.0M (discrepancy)	~$1.6M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 3 first patient in	Timing	Hope to start Q4 2024 “if funded”	Earliest start Q1 next year; EMA advice likely Q1	Lowered/Delayed
Phase 3 program design	Program	Two international Phase 3 registration trials; ~450 MITT per trial, 1:1 vs vancomycin	Unchanged; ~150 sites; 450 patients per trial; sequential option highlighted	Maintained
CMC status	Regulatory	CMC meeting request submitted; anticipated Q4	CMC readiness achieved without formal meeting	Raised
International regulatory	EU/UK/JP/CA	Preparing submissions post-FDA clarity	EMA meeting late Q4/early Q1; proceed to UK, Canada, Japan thereafter	Raised (more concrete timing)
Cash runway	Liquidity	With ATM, likely mid-2026; without, mid-2025 (call commentary)	Not updated in Q3 call PR; cash ended Q3 at $5.76M	Maintained (no formal update)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2024)	Previous Mentions (Q2 2024)	Current Period (Q3 2024)	Trend
Regulatory readiness (FDA)	End-of-Phase 2 agreement; Phase 3 design set	CMC meeting requested for Q4	CMC readiness achieved; Phase 3 plan reaffirmed	Strengthening
International filings (EMA, etc.)	EMA SME designation	Preparing EU/UK/JP/CA guidance requests	EMA meeting targeted Q4/Q1; then UK, Canada, Japan	Advancing
Funding strategy	Strategic transactions; non‑dilutive preferred	Royalty financing, territorial deals; grants; ATM used	Government “tech watch” meeting; multiple dialogues; non‑dilutive emphasis	Active, multi‑track
Phase 3 design/timing	Two pivotal, 450 MITT each; 18–24 months	Target Q4 start if funded	Earliest Q1 start; 150 sites; sequential option	Slight delay; scope clarified
Microbiome/bile acids	Outperformance vs vancomycin; preservation	ESCMID oral presentation	IDWeek poster: favorable bile acid profile; no recurrence in 5/5 IBZ	Reinforced
Diagnostic predictive model	Not highlighted	Not highlighted	Patent filed; stool metrics predictive by day 3; monitoring in Phase 3	Emerging initiative
ACX‑375/Anthrax	Not highlighted	Not highlighted	In vitro activity incl. ciprofloxacin‑resistant Anthrax; planning preclinical program	New optionality
Policy (PASTEUR Act, BARDA)	Priority review discussed	PASTEUR unlikely in year; potential BARDA expansion	PASTEUR “more prominent”; continued pursuit of government support	Ongoing advocacy

Management Commentary

“We're delighted to announce CMC readiness for Phase III in addition to FDA agreement on our clinical plan forward for Phase III.” – David Luci .
“The trial design is 2 Phase III registration trials… about 150 trial sites, 450 patients per trial… 1:1 randomized against oral vancomycin for a 10‑day treatment period.” – David Luci .
“These exciting results demonstrate two properties of ibezapolstat which may contribute to the anti‑recurrence effect… preservation and restoration of beneficial bacterial classes… and persistent secondary bile acids.” – Dr. Kevin Garey (quoted in PR) .
“We prefer anything that's non‑dilutive… government along with territorial license and co‑development partners… active dialogue now in Europe and Japan and South America.” – David Luci .
“We will continue to evaluate what we call our predictive model… could be a diagnostic… to reduce the $2.8 billion per year cost burden for recurrent C. difficile infection.” – David Luci .

Q&A Highlights

Predictive diagnostic model: proprietary stool-based metrics by day 3 may predict reinfection risk; patent filed; will be evaluated in Phase 3 .
International regulatory plan: EMA meeting late Q4/early Q1, then UK, Canada, Japan; sequencing tied to finalized FDA CMC position .
Funding options: preference for non‑dilutive sources—government (incl. October tech watch meeting), territorial licenses, royalty financing; PASTEUR Act seen as more promising near term .
Phase 3 design and timing: two trials, 900 patients total; sequential execution possible given exclusivity; earliest start Q1 next year .
ACX‑375/Anthrax program: preclinical stage; potential government stockpiling markets rather than traditional commercial sales .

Estimates Context

S&P Global consensus estimates for Q3 2024 EPS and revenue were unavailable during this session due to access limitations, so beat/miss analysis vs Street cannot be provided at this time [functions.GetEstimates errors].
Given the company’s development stage and lack of reported product revenue, Street comparisons are typically focused on EPS/loss per share and cash runway; we recommend updating this section once SPGI access is restored.

Key Takeaways for Investors

Regulatory de‑risking improved: CMC readiness plus prior End‑of‑Phase 2 agreement lowers execution risk going into Phase 3; watch for EMA advice to greenlight EU sites .
Funding is the gating factor: multiple non‑dilutive pathways are active (government, royalty financing, territorial licenses); equity dilution risk remains if those fall short; monitor near‑term deal announcements .
Phase 3 start appears modestly delayed: earliest Q1 next year vs earlier Q4 hope; this likely shifts timelines but sequential trial option mitigates capital intensity .
Scientific differentiation: favorable microbiome/bile acid profile and anti‑recurrence signals support potential clinical and economic value in CDI; new USPTO patent to 2042 strengthens moat .
Optionality beyond CDI: ACX‑375 Anthrax findings create a potential government‑funded asset path; risk/reward depends on preclinical/animal data and BARDA-type support .
Trading implications (near term): stock likely sensitive to funding headlines (royalty/territorial/government), EMA meeting timing, and Phase 3 site activation; dips on timeline slippage may reverse on financing clarity .
Medium‑term thesis: If Phase 3 confirms non‑inferiority with anti‑recurrence profile, ibezapolstat could compete for frontline CDI use, with durable protections (QIDP/Fast Track, exclusivity, patent) supporting commercialization prospects .

Sources: Q3 2024 press release and 8‑K furnishing (including full financial tables and highlights) ; Q3 2024 earnings call transcript ; Q2/Q1 2024 press releases and calls for trend analysis ; IDWeek/Oct 21 PR on bile acids and microbiome .

Acurx Pharmaceuticals, Inc. (ACXP)·Q3 2024 Earnings Summary