Acurx Pharmaceuticals, Inc. · NASDAQ:ACXP
Acurx Pharmaceuticals — Investor Presentation (September 2025)
23 slides from Acurx Pharmaceuticals's investor presentation, September 2025
Slide 1: Advancing a New Class of Antibiotics to Phase 3 Trials
Advancing a New Class of Antibiotics to Phase 3 Trials Targeting WHO/CDC “Priority Pathogens” While addressing Antimicrobial Resistance (AMR) September 2025 David P. Luci, President & CEO
Slide 2: Disclosure
Disclosure This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, development plans, regulatory activities, anticipated milestones, product candidate benefits, competitive position, business strategies,
Slide 3: Executive Summary
Executive Summary ▪ Corporate. Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) incorporated in July 2017, acquired its lead antibiotic (AB) program to treat C. difficile Infection (CDI) in February 2018 (ibezapolstat or IBZ) ▪ Novel Mechanism of Action (MOA): Targets the polymerase IIIC enzyme, a previou
Slide 4: Mechanism of Action
Mechanism of Action ▪ Ibezapolstat kills C. difficile bacteria by blocking the pol IIIC enzyme thereby not allowing DNA DNA replication of the bacterial cell1 ibezapolstat ▪ Same MOA for ACX-375C series of compounds PoI IIlC ▪ Meets four criteria of innovation: New chemical class, new target, new MO
Slide 5: Unmet Medical Need
Unmet Medical Need No new antibiotics in clinical development showing improvement in either IC or SCC C. difficile Infection – mITT population Product % Sustained Clinical % Initial Cure % without recurrence Cure* Marketed vancomycin (n-309) 86 75 61 (Ph3 Results US/CAN)1 fidaxomicin (n=287) 88 85 7
Slide 6: Antibiotics: Global Standard to Treat CDI
Antibiotics: Global Standard to Treat CDI Antibiotics Live Biotherapeutic Products (LBPs)/Fecal Microbiota ▪ Existing standards of care first-line and first recurrence Transplant (FMT) treatment with established marketed antibiotics ▪ Two LBP treatments approved (U.S. Only) for recurrent CDI (rCDI)
Slide 7: R&D Pipeline
R&D Pipeline Program Target Pathogen Discovery Pre-Clinical Ph 1 Ph 2 Ph 3 Ibezapolstat C. Difficile ACX-375C Gram-positive QIDP/Fast Track Infections Eligible Anthrax Multiple product QIDP/Fast Track candidates; Eligible Gram-positive infections 1 Computational Chemistry Project Currently “mining”
Slide 8: Upcoming Milestones
Upcoming Milestones IBEZAPOLSTAT R&D * Open-Label Pilot Study (n=20) to evaluate IBZ in patients with multiple recurrences of CDI and resistant to standards of care (vancomycin/fidaxomicin). 1Q26 - 4Q2026 * University of Houston laboratory study (humanized mouse model); to address the critical need
Slide 9: C. difficile Infection: Large Growing Market
C. difficile Infection: Large Growing Market Global Market Current and Forecast (2023-2032) 2023 TOTAL $1.5bil 2032 TOTAL $2.3bil $1,155 China $731 $192 $348 Japan China UK Japan $289 UK Spain $455 Spain Italy Italy France France $43 $73 Germany Germany United States United States $39 $68 $56 $98 $7
Slide 10: Ibezapolstat: Phase 2 Success
Ibezapolstat: Phase 2 Success EOT (End of Treatment) 25/26 (96%) of evaluable patients were cured at EOT (10 of 10 in Ph2a and 15 of 16 in Ph2b). Well tolerated. No drug related SAE’s SCC (Sustained Clinical Cures) Regulatory/Patent Exclusivity treatment All 15 ibezapolstat-treated patients in Phase
Slide 11: Ibezapolstat Preserves & Enhances the Microbiome
Ibezapolstat Preserves & Enhances the Microbiome Ibezapolstat restores the microbiome by enhancing Actinobacteria in the microbiome while suppressing regrowth of Proteobacteria; reducing the likelihood of recurrence1 PHYLUM ANTIBIOTIC ACTIVITY ibezapolstat vancomycin (oral) Actinobacteria No Yes Bac
Slide 12: FDA / EMA Approved Phase 3 Trial Design
FDA / EMA Approved Phase 3 Trial Design* 1:1 CDI Patients R A 450 mg BID N Treatment PRIMARY EFFICACY ENDPOINT: CC at TOC (visit D Ibezapolstat O n=237 OBJECTIVE: evaluate (Day 12): survival and Blinded 10 days M Non- Follow-up efficacy of IBZ and VAN resolution of diarrhea by I Z Inferiority 125 mg
Slide 13: Key IBZ Factors For Potential Phase 3 Success
Key IBZ Factors For Potential Phase 3 Success Clinical Nonclinical ▪ Clinical Cure Rate 96% (25 of 26 ▪ Bactericidal potency vs C. difficile patients) in Ph2 trials ▪ Effective against MDR strains including ▪ Sustained Clinical Cure Rate of 100% vanco resistant and FDX resistant strains 30 days afte
Slide 14: ACX-375C Highlights
ACX-375C Highlights Second DNA Pol IIIC Inhibitor ACX-375C – Targets MRSA and B. anthracis (anthrax) ▪ Oral and I.V. formulation targets treatment of Staphylococcus, Streptococcus and Enterococcal infections, including vancomycin-resistant enterococcus (VRE), Methicillin-resistant staph (MRSA) and o
Slide 15: ACX-375C Highlights
ACX-375C Highlights Potential Clinical Indications: (QIDP/Fast Track eligible); ABSSSI (MRSA + other G+) ▪ Follow-on: community-acquired bacterial pneumonia, hospital and/or ventilator-associated bacterial pneumonia; bacteremia with or w/o infectious endocarditis, bone/joint infections and diabetic
Slide 16: Experienced Senior Executive Management
Experienced Senior Executive Management David P. Luci, CPA, Esq Robert J. DeLuccia Robert G. Shawah Co-Founder & CEO Co-Founder & Executive Chairman Co-Founder & CFO Former CEO of Dipexium Pharmaceuticals Former Chairman of Dipexium Former Chief Accounting Officer (Nasdaq: DPRX), Abeona Therapeutics
Slide 17: R&D Team
R & D Team Bob DeLuccia, Co-founder & Executive Chairman (see prior slide) Michael Silverman, MD, FACP: Acurx Medical Director >35 years’ experience clinical research/product development; KPMG Health Care Consulting; Biopure Corp, Sandoz, Sterling- Winthrop (Kodak-Sanofi) and clinical practice of me
Slide 18: Scientific / Corporate Advisors
Scientific / Corporate Advisors SCIENTIFIC Jack H. Dean, Ph.D., Former Director, Worldwide Pre-Clinical Research at Sanofi; Research Professor, Univ of Arizona (Pharmacology & Toxicology) Richard Ellison, MD, Professor of Medicine, UMass Medical School (Microbiology Kevin Garey, PharmD*, Professor,
Slide 19: Strategic Alternatives
Strategic Alternatives OBJECTIVE In parallel with Ph3 trial preparation, explore strategic alternatives Enroll Ph3 & proceed PLAN 1A with build out strategy Ph 3 trial preparation PLAN 1B Partnering & M&A initiatives 18
Slide 20: Proposed Pathway To Commercialization
Proposed Pathway To Commercialization U.S. Food & Drug Administration Health Canada Current Data Library + International Ph3 Trials = Regulatory Approvals European Medicines Agency UK Medicines & Healthcare Product Agency Japan: Pharmaceuticals and Medical Devices Agency 19
Slide 21: Board of Directors
Board of Directors ▪ Jack H. Dean, Ph.D., Former Director, Worldwide Pre-Clinical Research at Sanofi; Research Professor, Univ of Arizona (Pharmacology & Toxicology) ▪ James Donohue, Vice President of Charles River Associates (Nasdaq: CRAI) ▪ Thomas Harrison, Chairman Emeritus of the Diversified Age
Slide 22: Capitalization Summary
Capitalization Summary Cap Table as of 06/30/25 Balance Sheet as of 06/30/25 ($mm) Common Shares Cash & Cash $6.1 1,470,352 Equivalents Outstanding Warrants (WAEP: Total Assets $6.2 306,812 $65.60) Total Debt $0 Stock Options (WAEP: 194,000 $101.00) Total Liabilities $2.6 Fully Diluted Shares 1,971,
Slide 23: Advancing a New Class of Antibiotics to Phase 3 Trials
Advancing a New Class of Antibiotics to Phase 3 Trials Targeting WHO/CDC “Priority Pathogens” While addressing Antimicrobial Resistance (AMR) September 2025 David P. Luci, President & CEO
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