Acurx Pharmaceuticals, Inc. · NASDAQ:ACXP
Acurx Pharmaceuticals — IPO Roadshow (April 2024)
23 slides from Acurx Pharmaceuticals's IPO roadshow presentation, Apr 2, 2024
Slide 1: Advancing a New Class of Antibiotics to Phase 3 Trials Targeting Priority Pathogens
Advancing a New Class of Antibiotics to Phase 3 Trials Targeting “Priority Pathogens” David P. Luci, President & CEO April 2024 – WHO and CDC Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 278028 April 2, 2024
Slide 2: Disclosure
Disclosure 1 FREE WRITING PROSPECTUS This presentation highlights basic information about Acurx Pharmaceuticals, Inc. (the ”Company”) and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should conside
Slide 3: Disclosure (cont'd.) Forward Looking Statements
Disclosure (cont’d.) FORWARD LOOKING STATEMENTS This presentation contains forward - looking statements as defined in the Private Securities Litigation Reform Act of 1995 regardi ng, among other things, development plans, regulatory activities, anticipated milestones, product candidate benefits, com
Slide 4: Offering Summary
3 Offering Summary Issuer Ticker Exchange Proceeds Overallotment Option Sole Bookrunner Acurx Pharmaceuticals ACXP Nasdaq $25m 15% Titan Partners Group LLC, a division of American Capital Partners, LLC Use of Proceeds: Working capital and other general purposes, including, but not limited to, clinic
Slide 5: Executive Summary
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Slide 6: Unmet Medical Need
Unmet Medical Need 5 1 Louie et al, Fidaxomicin vs Vancomycin, Phase 3 study, NEJM, Feb 2011; 2 Vickers et al, Efficacy and Safety of Ridinilazole Compared with Vancomycin for treatment of C. difficile Infection; Ph2 Rand omi zed, Double - blind, Active - controlled, Non - inferiority Study; Lancet,
Slide 7: Antibiotics: Global Standard to Treat CDI
&UHDWHGE\QDUHHUDWMDLNDHZ IURPWKH1RXQ3URMHFW &UHDWHGE\7HPSODWH IURPWKH1RXQ3URMHFW Antibiotics: Global Standard to Treat CDI 6 Antibiotics ▪ Existing standard of care first - line and first recurrence treatment with established marketed antibiotics (vancomycin, fidaxomicin) recommended by IDSA 1 ▪ Cur
Slide 8: R&D Pipeline
Program Target Pathogen Discovery Pre - Clinical Ph 1 Ph 2 Ph 3 Ibezapolstat C. Difficile ACX - 375C Gram - positive Infections CCP 1 Multiple product candidates; Gram - positive infections R&D Pipeline 7 1 Computational Chemistry Project Currently “mining” 2 to 4 additional DNA Polymerase IIIC new
Slide 9: Recent & Upcoming Milestones
Recent & Upcoming Milestones 8 Clinical Lead AB treating CDI - recently completed Ph2b trial ▪ Dec ‘23 : Sustained Clinical Cure Data (30 days after EOT) ▪ Jan ’24: Extended Clinical Cure Data (94 days out) ▪ Jan ‘24 : Microbiome head - to - head comparison to standard of vancomycin Clinical, Regula
Slide 10: Mechanism of Action
Mechanism of Action 9 Ibezapolstat kills C. difficile bacteria by blocking the pol IIIC enzyme thereby not allowing DNA replication of the bacterial cell. 1 Same MOA applies to the ACX - 375C series of compounds ibezapolstat DNA PolC 1. Wei - Chu Xu, et al., Bioorganic & Medicinal Chemistry https://
Slide 11: C. difficile Infection: Large Growing Market
C. difficile Infection: Large Growing Market 10 $192 $289 $43 $39 $56 $78 $123 $731 China Japan UK Spain Italy France Germany United States $348 $455 $73 $68 $98 $131 $206 $1,155 China Japan UK Spain Italy France Germany United States Global Market Current and Forecast (2023 - 2032) 2023 TOTAL $1.5b
Slide 12: Ibezapolstat: Phase 2 Success
Ibezapolstat: Phase 2 Success 11 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). No drug related SAE’s SCC (Sustained Clinical Cures) All 15 ibezapolstat - treated patients in Phase 2b who achieved Clinical Cure (CC) at end of treat
Slide 13: Ibezapolstat Preserves & Enhances the Microbiome
Ibezapolstat Preserves & Enhances the Microbiome 12 Ibezapolstat restores the microbiome by enhancing Actinobacteria in the microbiome while suppressing regrowth of Proteobacteria ; reducing the likelihood of recurrence 1 PHYLUM ANTIBIOTIC ACTIVITY ibezapolstat vancomycin (oral) Actinobacteria No Ye
Slide 14: Ibezapolstat Clinical Trial Designs for CDI
Ibezapolstat Clinical Trial Designs for CDI 13 Segment 2A Open - Label Segment 2B Double - Blind Active - Controlled A Phase 3 Double - Blind Vancomycin - Controlled Trial (IBZ - ASPIRE - 1 and IBZ - ASPIRE - 2) Ibezapolstat for Oral Treatment of C. difficile Infection ▪ Phase 2 dose (450 mg BID) ▪
Slide 15: Key Factors For Potential Phase 3 Success
Key Factors For Potential Phase 3 Success 14 Nonclinical ▪ Bactericidal potency vs C. difficile ▪ Effective against MDR strains including vanco resistant and Fidax resistant strains ▪ Does not trigger sporulation or toxin release ▪ Reduced flagellar movement ▪ Active in biofilms ▪ Preserves and rest
Slide 16: ACX-375C Highlights
ACX - 375C Highlights 15 VRE hospital infections exceeded carbapenem - resistant (CR) Acinetobacter, MDR Pseudomonas aeruginosa and CR Enterobacteriaceae infections combined 2 Second DNA Pol IIIC Inhibitor ACX - 375C Oral and I.V. formulation targets treatment of Staphylococcus, Streptococcus and En
Slide 17: ACX-375C Highlights
ACX - 375C Highlights 16 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
Slide 18: Capitalization Summary
Capitalization Summary 17 Common Shares Outstanding Warrants (WAEP: $3.28) Stock Options (WAEP: $5.64) Fully D iluted S hares O utstanding 14,468,229 6,195,456 2,985,000 23,648,685 Cap Table as of 12/31/23 Cash & Cash Equivalents Total Assets Total Debt Shareholders’ Equity $7.5 $7.7 $0 $4.7 Balance
Slide 19: Experienced Senior Executive Management
Experienced Senior Executive Management 18 David P. Luci, CPA, Esq Co - Founder & CEO Robert J. DeLuccia Co - Founder & Executive Chairman Robert G. Shawah CPA, Co - Founder & CFO Former CEO of Dipexium Pharmaceuticals (Nasdaq: DPRX), Abeona Therapeutics (Nasdaq: ABEO), MacroChem (OTC BB: MACM), and
Slide 20: Strategic Alternatives
Strategic Alternatives 19 In parallel with Ph3 trial preparation, explore strategic alternatives OBJECTIVE &UHDWHGE\$OLFH'HVLJQ IURPWKH1RXQ3URMHFW Ph 3 trial preparation PLAN 1A PLAN 1B Partnering / M&A initiative Enroll Ph3 & build out pipeline
Slide 21: Proposed Pathway To Commercialization
Proposed Pathway To Commercialization 20 Current Data Library International Ph3 Trials Regulatory Approvals U.S. Food & Drug Administration Health Canada European Medicines Agency UK Medicines & Healthcare Product Agency Japan: Pharmaceuticals and Medical Devices Agency + =
Slide 22: Recent M&A Transactions
Recent M&A Transactions 21 June 2023 Shionogi buys Qpex Pharma, an early - stage developer of beta lactamase inhibitor for drug resistant gram - negative bacterial infections. Deal terms - $100 million upfront and up to $40 million in downstream milestones. Lead antibiotic candidate is in Ph1b . Mar
Slide 23: Non-Executive Members of the Board of Directors
Non - Executive Members of the Board of Directors 22 ▪ 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 , C