Acurx Pharmaceuticals, Inc. · NASDAQ:ACXP
Acurx Pharmaceuticals — IPO Roadshow (June 2021)
22 slides from Acurx Pharmaceuticals's IPO roadshow presentation, Jun 11, 2021
Slide 1: Potentially First in a New Class of Antibiotics Since the 1980s
June 2021 Potentially, we believe, to be First in a New Class of Antibiotics Since the 1980s 1,2 World Health Organization & U.S. Centers for Disease Control and Prevention Priority Pathogens 1,3 Readiness for the next Infectious Disease Pandemic: Antibiotic Resistance Disclosures 1 Centers for Dise
Slide 2: Disclosures
Disclosures DISCLAIMER The Company has filed a registration statement, including a preliminary prospectus, with the SEC (File No . 333 - 256156 ) in connection with the offering to which this presentation relates . Sales of the securities of the Company offered pursuant to the registration statement
Slide 3: Offering Summary and Use of Proceeds
Issuer: Acurx Pharmaceuticals Ticker/Exchange: ACXP/Nasdaq Base Offering size: $15,000,000 Shares offered: 2,500,000 Shares of Common Stock Filing range: $5.00 to $7.00 (Midpoint of $6.00 per share) Over - allotment option: 15% Expected pricing date: 06 - 24 - 21 Underwriters: Alexander Capital, L.P
Slide 4: Corporate highlights
Corporate: Co - Founded July 2017 to develop a new class of antibiotics to address global crisis of antimicrobial resistance in Gram - positive bacteria; initial target - CDI Novel Mechanism of Action: DNA polymerase IIIC inhibitor ▪ Previously unexploited scientific target ▪ Positioned, we believe,
Slide 5: Antimicrobial resistance and readiness for the next pandemic
Disclosures ▪ Antimicrobial resistance occurs when microorganisms (bacteria, fungi, viruses, and parasites) change when exposed to antimicrobial drugs. ▪ WHO Director - General recently warned that growing antimicrobial resistance is as dangerous as the ongoing COVID - 19 pandemic threatens to unwin
Slide 6: Cure and recurrence rates versus other CDI antibiotics
Mechanisms of Action Disclosures Disclosures No new antibiotics in clinical development have shown improvement in either ICR or SCR in comparison to currently marketed antibiotics P roduct C. d iff icile - mITT population % Initial Cure % Sustained Cure % Recurrence * Marketed (Ph 3 results US/CAN)
Slide 7: Antibiotics: Gold Standards to Treat CDI
Disclosures FMT / Microbiologics Vaccines Antibiotics ▪ Current standard of care first - line and first recurrence treatment with established marketed antibiotics (vancomycin, fidaxomicin) recommended by IDSA * ▪ Currently marketed antibiotics achieve relatively high initial cure rate but leave high
Slide 8: Acurx R&D Pipeline
Acur x R&D Pipeline 1 Computational Chemistry Project: Currently “mining” 2 to 4 additional DNA Polymerase IIIC new chemical entities in a computational chemistry modeling program in scientific collaboration with WuXi AppTec to expand pipeline of DNA Pol IIIC inhibitors. Disclosures Disclosures R&D
Slide 9: Mechanism of Action
Mechanisms of Action ▪ Ibezapolstat: We believe this is the only compound currently in clinical trials known to target C. difficile by acting specifically on pol IIIC 1 ▪ Vancomycin : Cell wall biosynthesis inhibitor 2 ; selective RNA Inhibitor ▪ Fidaxomicin : RNA synthesis inhibitor 3 ▪ Ridinilazol
Slide 10: Acurx Market Opportunity
Patients with C. difficile Infection (CDI) ( ibezapolstat ) $500 mm Sales (20% Peak Penetration) ~150,000 Patients Treated (w/ 20 - 40% recurrence rate) 600,000 U.S. Patients/ Yr Incidence (CDC) Patients w/other Gram+ infections ( Staphylococcus, Streptococcus or Enterococcal Infections, including M
Slide 11: C. difficile Market Maintaining Strong Growth
▪ C. difficile is one of most common pathogen s in healthcare associated infections (HAI) in North America ▪ 2 0 % to 40% of cases recurrent ▪ Mortality rate 9.3% $628 $663 $719 $778 $917 $ 1 ,1 2 7 $ 1 ,2 9 5 $ 1 ,4 0 3 $ 1 ,4 9 9 $ 1 ,5 8 8 $ 1 ,6 5 8 2016 2017 2018 2019 2020 2021 2022 2023 Source
Slide 12: Ibezapolstat: Phase 2a Success
ACX - 362E Highlights ▪ Patients with mild to moderate CDI treated with orally administered ibezapolstat given 450mg twice daily for 10 days ▪ A ll 10 patients (100%) met the study's primary and secondary efficacy endpoints of Initial Cure and Sustained Cure ▪ Ibezapolstat very well tolerated; no tr
Slide 13: Ibezapolstat Enhances Actinobacteria
1 Garey, Late - Breaker Presentation, Ibezapolstat Clinical Update, 8 th Annual International C . diff . Virtual Conference, Nov 18 , 2020 PHYLUM ANTIBIOTIC ACTIVITY ibezapolstat vancomycin (oral) Actinobacteria No Yes Bacteroidetes No Yes Firmicutes Yes Yes Fusobacteria No No Proteobacteria No No I
Slide 14: ACX-375C Highlights
ACX - 375C Highlights Second DNA Pol IIIC Inhibitor ACX - 375C : Oral and I.V. formulation targets treatment of Staphylococcus, Streptococcus and Enterococcal infections , including vancomycin - resistant enterococcus (VRE), Methicillin - resistant staph (MRSA) and other resistant G+ bacterial infec
Slide 15: Microbiome: Ibezapolstat vs. Vancomycin
Microbiome comparison to vancomycin Vancomycin ▪ 2 to 3 log reduction in healthy bacteria Ibezapolstat ▪ No appreciable reduction ▪ Poorly soluble in the gut ▪ Free concentrations of ibezapolstat high enough, we believe, to kill C. difficile but too low, we believe, to kill healthy bacteria like Bac
Slide 16: Ibezapolstat Phase 2/3 Clinical Trial Design
Ibezapolstat Ph 2, Ph 3 Clinical Trial Design Segment 2A Open - Label Segment 2B Double - Blind Active - Controlled ▪ Phase 2 dose (450 mg BID) ▪ n = 20 ▪ 6 sites (US) ▪ After first 10 patients had completed treatment, Trial Oversight Committee will assess ibezapolstat safety profile relative to tre
Slide 17: Expectation of Success in Phase 2b
▪ In Vitro potency vs C. difficile ▪ In Vivo efficacy hamster model (industry standard) ▪ Excellent human safety profile to date ▪ High human fecal concentrations (>100 - fold above MIC 50 in patient samples) ▪ Favorable microbiome effects (healthy volunteers and patients; recurrence) ▪ Ph2A patient
Slide 18: External positive drivers: PASTEUR Act and AMR Action Fund
Disclosures There is no guarantee that any specific objective will be achieved. Acurx Pharmaceuticals, LLC products are in development, a nd there is no guarantee that this development will have a successful outcome. Clinical trials are in the early stages. Pre - Clinical trials are tested on animal
Slide 19: Experienced Senior Executive Management
Experienced Senior Executive Management ▪ David P. Luci, CPA, Esq., Former CEO Dipexium Pharmaceuticals ( Nasdaq:DPRX ); Abeona Therapeutics, MacroChem , Bioenvision . Raised capital in several public offerings and private placements; sold 3 public companies from “C” suite ▪ Robert J. DeLuccia, Form
Slide 20: Experienced Senior Management Team
Experienced Senior Management Team ▪ Michael Silverman , MD, FACP, Medical Director KPMG Health Care Consulting, Biopure Corp, Sandoz, Sterling - Winthrop (Kodak - Sanofi) and clinical practice of medicine ▪ Les Johnson , Manufacturing Director Clear Path Development, Salamandra , Celsis , Cambrex ,
Slide 21: Timeline
Timeline Disclosures Disclosures Novel ACX - 375 Analogs: Antibacterial Agents Targeting DNA Pol IIIC ACX - 362E Highlights Disclosures Disclosures Microbiome comparison to vancomycin Disclosures 1H 2021 2H 2020 2H 2021 - 1H 2022 ▪ Completed Ph2a trial of ibezapolstat in CDI ▪ Complete “crossover” f
Slide 22: Disclosures Disclosures ACX - 362E Highlights Disclosures Disclosures Microbiome comparison to vancomycin Disclosures…
Disclosures Disclosures ACX - 362E Highlights Disclosures Disclosures Microbiome comparison to vancomycin Disclosures Christopher Carlin Alexander Capital, LP ccarlin@alexandercapitallp.com (646) 787 - 8890 June 2021