Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (March 2025)
35 slides from Recce Pharmaceuticals's investor presentation, March 2025
Slide 1: Commercialising a New Class of Synthetic Anti-Infectives
Commercialising a New Class of Synthetic Anti-Infectives RECCE PHARMACEUTICALS LIMITED | (ASX:RCE)(FSE:R9Q) CORPORATE PRESENTATION | MARCH 2025 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 1
Slide 2: Disclaimer
Disclaimer Disclaimer Future Matters This presentation has been prepared by Recce Pharmaceuticals Ltd (the “Company”). It does not This presentation contains reference to certain intentions, expectations, future plans, strategy and purport to contain all the information that a prospective investor m
Slide 3: Company Overview
Company Overview 3 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 3
Slide 4: Leading, Australian Anti-Infective Company
Leading, Australian Anti-Infective Company Near-term commercialisation pathway expected to launch in 2026 Products address the global healthcare crisis of antibiotic resistance Phase III in Indonesia of lead asset RECCE® 327 Gel for the treatment of Diabetic Foot Infections - Launch in 2026 and open
Slide 5: Synthetic Anti-Infectives
Synthetic Anti-Infectives The need for a new class of antibiotics On-track to be the only global clinical stage company whose drug is shown to be efficacious against the full suite of ESKAPE pathogens NO pre-formed natural Very broad-spectrum coverage Universal Mechanism of Action superbugs of bacte
Slide 6: Large Addressable Market
Large Addressable Market The global diabetic foot infection (DFI) and sepsis market is worth over $US9.1 billion • The DFI treatment market is estimated to be worth ~US$5.2 billion1 • Initially targeting Indonesian market valued at ~US$189 million where US$5.2B DFI impacts 11% of the population2 Est
Slide 7: Program Pipeline for 2025
Program Pipeline for 2025 Various indications and upcoming inflection points Program Indications Discovery Pre-clinical Phase I Phase II Phase III Market • Approval received from the Indonesian Drug and Diabetic Foot Infections Phase III starts H1 2025 Food Regulation Authority, Indonesia (ASEAN) Ba
Slide 8: Multiple Clinical Milestones – Achieved and Upcoming
Multiple Clinical Milestones – Achieved and Upcoming Significant milestones anticipated in 2025 Pre FY2025 Previous 12 Months 2025 and 2026 Phase I/II Clinical Trial for the Treatment Phase II Acute Bacterial Skin and Skin Launch Registrational Phase III trial for of Burn Wound Infections Phase I St
Slide 9: Commercialisation Pathway in DFI and ABSSSI
Commercialisation Pathway in DFI and ABSSSI: Positive Phase II and SAS data → Start Phase III in DFI DFI & ABSSSI Phase II Clinical Data 2H24 Programs Indonesia: NDA DFI Phase III Clinical Trial Submission Australia & US: NDA ABSSSI/DFI Phase III Clinical Trial Submission US: IND & Clinical Trials 2
Slide 10: Experienced Board of Directors
Experienced Board of Directors Dr John Prendergast – Chairman Michele Dilizia – Executive Director & Chief Scientific Officer BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM US-based, current Chairman and Co-founder of Palatin Technologies,
Slide 11: Company Overview: Recce Pharmaceuticals Ltd
Company Overview: Recce Pharmaceuticals Ltd A clinical-stage Australian biotech company with a new class of synthetic anti-infectives Capital Structure – March 2025 Share Price & Volume – March 2025 ASX & FSE Code RCE, R9Q $0.80 2,500,000 Share Price AUD $0.43 $0.70 2,000,000 3-Month Average Daily V
Slide 12: R327 Solution
R327 Solution 12 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 12
Slide 13: Independent Study Undertaken on RECCE MoA
Independent Study Undertaken on RECCE® 327 MoA1 Linnaeus Biosciences MoA studies of R327 Recce products work via a NOVEL MECHANISM which targets rapid access to and shut down of bacterial energy production (ATP), which results in bacterial death of both active and resting bacteria Stage 1 Stage 2 St
Slide 14: R327 Faster Acting Than Existing Antibiotics
R327 Faster Acting Than Existing Antibiotics No prolonged exposure needed R327 is faster-acting against bacteria than other antibiotics – works quickly, without prolonged cellular exposure times required of other antibiotics (extended exposures commonly associated with systemic toxicity) Because of
Slide 15: RECCE 327 – Global Recognition
RECCE® 327 – Global Recognition R327 added to WHO’s list of antibacterial products in clinical development Number of compounds by antibiotic class Global recognition by the World Health Organization (WHO): Inclusion underscores Cell wall inhibitors 15 significance of R327 in combating antimicrobial
Slide 16: RECCE 327 – No Resistance on Serial Passaging
RECCE® 327 – NO RESISTANCE on Serial Passaging Amoxicillin loses activity after a maximum of 8 repeats; RECCE® 327 remains active for more than 25 repeats 25 repeats at time of discovery was sufficient for PCT patent applications, with no sign of resistance Number of repeats before displaying loss o
Slide 17: Broad-Spectrum Coverage of RECCE in vitro against ESKAPE Pathogens
Broad-Spectrum of Coverage of RECCE® 327 in vitro against ESKAPE Pathogens-Bactericidal Effect E. faecium ATCC 19434 S. aureus ATCC 29213 K. pneumoniae ATCC 43816 A. baumannii ATCC 17978 P. aeruginosa ATCC 27853 Enterobacter cloacae ATCC 13047 • Average time-kill curves of R327 at various concentrat
Slide 18: R327 Active Against all Tested Clinical Drug-Resistant Species
R327 Active Against all Tested Clinical Drug-Resistant Species # of strains resistant to # of strains resistant to Test Bacteria Antibiotic comparator abx R327 Total # of Comparator abx (+/-) strains Klebsiella pneumoniae 1 levofloxacin 66 52 0 Klebsiella pneumoniae 2 imipenem 35 13 0 Acinetobacter
Slide 19: R327: Clinical Programs
R327: Clinical Programs 19 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 19
Slide 20: RECCE 327 Phase I: Safety & PK Intravenous Study
RECCE® 327 Phase I: Safety & PK Intravenous Study Double-blind, placebo-controlled, single ascending-dose, in 80 healthy participants • Safe and well tolerated at doses up to 4,000mg given as a 1-hour intravenous infusion • No Serious Adverse Events: All AE’s mild or moderate (some irritation, disco
Slide 21: RECCE Excreted Safely in High Concentration in Urine
RECCE® 327 Excreted Safely in High Concentration in Urine Concentration of R327: Human Urine Concentration of R327: Human Plasma 3,000 200 • R327 primary route of elimination appears to be through the kidney to 2,500 the ureters and bladder 160 High concentrations of R327 noted in R327 Concentration
Slide 22: Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial
Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial UTI’s are responsible for about 30% of all sepsis infections, defined as ‘Urosepsis’ R327 has achieved multiple ‘fast infusion’ time stamps in line with intended future regulatory submissions Clinical Trial Complete Assessing R327 at faster admi
Slide 23: RECCE Kills Quickly in the Urine
RECCE® 327 Kills Quickly in the Urine E. coli ATCC 25922 Treated with RECCE® 327 in Urine • R327 in the presence of human urine was able to have a 10.00 fast (near minutes) effect against E. coli and irreversible 9.00 • Bacteria could not be revived post-treatment Viable Bacteria Cells (log(CFU/ml)
Slide 24: R327: Topical Spray and Gel
R327: Topical Spray and Gel 24 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 24
Slide 25: Patient Case Study – TGA Special Access Scheme
Patient Case Study – TGA Special Access Scheme Day 0: Day 0: Day 1: Day 30: Pre-treatment First Recce gel applied Post treatment Post treatment Patient unresponsive to 4x daily Cephalexin for 10 days: No pre-treatment wound debridement Infection spreading and hospital ready No stinging at any point
Slide 26: Patient Case Study – TGA Special Access Scheme
Patient Case Study – TGA Special Access Scheme Infection with Biofilm Day 0: Day 3: Day 7: Pre-treatment Recce treatment Recce treatment Pre-treatment (Day 0) X-rays showed infection deep within the Day 7 post R327G treatment showed wound underlying bone, tissue and around the nail, with signs of in
Slide 27: Phase II DFI / ABSSSI Clinical Trial – Achieved all Endpoints
Phase II DFI / ABSSSI Clinical Trial – Achieved all Endpoints Confirms approach for Phase III trials and commercialisation progress in Australia • This Phase II study achieved all primary and secondary endpoints as an open-label Successful clinical response clinical trial evaluating the safety and t
Slide 28: RECCE Topical Gel: Phase III Registration Trial in DFI
RECCE® 327 Topical Gel: Phase III Registration Trial in DFI R327G Multicenter study in Indonesia • Double blind, Placebo-controlled, Parallel group Study in Patients with DFI • Drug to be administered once daily at the clinic for up to 14 days • N=300 patients (200 active, 100 placebo) • Planned enr
Slide 29: Commercialisation Opportunity
Commercialisation Opportunity Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 29
Slide 30: Recce Global Growth Strategy
Recce Global Growth Strategy Expansion Global Expansion into Expansion to across Approvals ASEAN Australia/NZ USA/DoD Gel IV Aerosol New Products DFI Gel IV cUTI Aerosol HAP / VAP and New ABSSSI Gel IV Sepsis Aerosol non-TB Indications Burn Gel IV HAP & VAP Mycobacteria IV Single Dose UTI Intranasal
Slide 31: Strategic Partnership in SE Asia to Accelerate Clinical Program
Strategic Partnership in SE Asia to Accelerate Clinical Program Phase III • Approval received from the Indonesian Drug and Registrational Food Regulatory Authority, Badan POM, to initiate Clinical Trial in registrational Phase III clinical trial Indonesia • Human Research Ethics Committee approval T
Slide 32: Manufacturing & Scalability for Commercialisation
Manufacturing & Scalability for Commercialisation • Key raw ingredient made in the USA • Clinical Phase I-II and preclinical product produced at RECCE Macquarie Park facility in Australia • GMP Manufacturing facility in Australia for Phase III/Scale up • Exploring US manufacturing opportunities for
Slide 33: Robust Worldwide Intellectual Property Portfolio
Robust Worldwide Intellectual Property Portfolio Patent portfolio of 40+ patents and patent applications in the world’s major markets Patent Patent Patent Patent • Family 1 group relates to the Filed Family 1 Expiry Family 2 Expiry Family 3 Expiry Family 4 Expiry Company’s Unique and Highly Australi
Slide 34: Summary
Summary Significant value creating opportunities Novel, Synthetic, Broad-Spectrum, Indonesian Phase III registrational Upon completion of Phase III Rapid-Acting, Anti-Infectives: clinical trial data read-out and registrational clinical trial, enables demonstrated against >500 clinical regulatory sub
Slide 35: Thank You
Thank You James Graham Managing Director and Chief Executive Officer Recce Pharmaceuticals Ltd ASX:RCE; FSE:R9Q T: +61 2 9256 2505 E: james.graham@recce.com.au 35 Recce Pharmaceuticals Limited (ASX:RCE) | Corporate Presentation | 35
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