Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (September 2025)
38 slides from Recce Pharmaceuticals's investor presentation, September 2025
Slide 1: RCE Corporate Presentation
RCE Corporate Presentation ASX:RCE | FSE:R9Q September 2025 0
Slide 2: Disclaimer
Disclaimer DISCLAIMER FUTURE MATTERS This pre sen tation has been pre pared by Recce Pharmaceuticals Ltd (the “Co mp any”). It do es This pre sen tation contains r efe rence to certain intentions, expecta tion s, future pla ns, strategy and prospects of not purpor t to contain all the info rmatio n
Slide 3: Company Overview
Company Overview
Slide 4: Recce Pharmaceuticals – Company Overview
Recce Pharmaceuticals – Company Overview An Australian clinical-stage biotech with a United States presence, developing a New Class of Synthetic Anti-infectives with a unique mechanism of action for a broad spectrum of infections including serious/life-threatening indications. • Publicly-traded on t
Slide 5: Board and Management Structure
Board and Management Structure Dr John Prendergast – Chairman BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) Michele Dilizia – Executive Director & Chief Scientific Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM US-based, current Chairman and Co-founder of Palatin Tech nologies,
Slide 6: 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 3 in Indonesia of lead asset RECCE® 327 Gel for the treatment of Diabetic Foot Infections – Expected launch in 2026 a
Slide 7: Company Overview
Company Overview Recce Pharmaceuticals Ltd is a clinical-stage biotech company with a new class of novel synthetic anti-infectives Capital Structure – September 2025 RCE Share Price and Volume Chart – 12 Months (price shown in AUD) ASX & FSE Code RCE, R9Q 3,000,000 $0.60 Share Price AUD $0.4200 2,50
Slide 8: 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 9: 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 10: Program Pipeline for 2025
Program Pipeline for 2025 Various indications and upcoming inflection points • Approval received from the Indonesian Drug and Food Regulation Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial in Indonesia • ABSSSI includes postoperative infection, wound infections and diabe
Slide 11: 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 Phase II Acute Bacterial Skin and Launch Registrational Phase III Treatment of Burn Wound Infections Skin Structure Infections
Slide 12: Commercialisation Pathway in DFI and ABSSSI
Commercialisation Pathway in DFI and ABSSSI Positive Phase II and Special Access Scheme data ➔ Start Phase 3 in DFI DFI & Phase II ABSSSI Data 2H24 Clinical Programs Indonesia: NDA DFI Phase 3 Clinical Trial Submission Australia & US: NDA ABSSSI/DFI Phase 3 Clinical Trial Submission US: IND & Clinic
Slide 13: RECCE 327 Synthetic Anti-Infective
RECCE® 327 Synthetic Anti-Infective 12
Slide 14: Independent Study Undertaken on RECCE 327 MoA
Independent Study Undertaken on RECCE® 327 MoA1 Linnaeus Biosciences MoA studies of R327 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 2 Stage 4 Stage 1 Stage 3 R327 target
Slide 15: RECCE 327 Maintains Activity
RECCE® 327 Maintains Activity 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 of antibiotic act
Slide 16: Bactericidal Effect of RECCE on ESKAPE Pathogens
Bactericidal Effect of RECCE® 327 on ESKAPE Pathogens 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 curv es of R327 at various conc ent rat ions against strains of ESKAPE pathog
Slide 17: RECCE 327 Topical Gel
RECCE® 327 Topical Gel 16
Slide 18: Strategic Opportunity in South-East Asia
Strategic Opportunity in South-East Asia Awarded expedited regulatory review status in Indonesia to fast-track progression of Phase 3 trial Significant • In Indonesia, DFIs are severe in 67.1% of hospitalised medical need cases and result in amputation in 46.9% of patients1. • In-hospital treatment
Slide 19: Topical Clinical Programs Move into Phase 3
Topical Clinical Programs Move into Phase 3 Phase I/II • Interim data results released – primary endpoints achieved Clinical Trial • Patients supported by in-home (out-patient) nurses trained in Diabetic Foot R327 treatment protocols Infections (DFI) • Appointment of leading out-patient nursing grou
Slide 20: Phase II ABSSSI Clinical Trial
Phase II ABSSSI Clinical Trial Achieved all Endpoints Successful clinical response • This Phase II study achieved all primary and secondary endpoints as an open-label clinical trial evaluating the safety and tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the in
Slide 21: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 0 Day 1 Day 30 Day 0 – Recce treatment Day 0 – Recce treatment Day 1 – Recce treatment Day 30 – Recce treatment Pre-treatment infection First Recce gel applied Post treatment Post treatment • Patient A unresponsive to 4x daily Cepha
Slide 22: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 7 Day 10 Day 14 Day 0 – Recce treatment Day 7 – Recce treatment Day 10 – Recce treatment Day 14 – Recce treatment Significant bacterial infection Wound drying up Post treatment Wound improved, well tolerated • Pre-treatment of R327G
Slide 23: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 7 Day 14 Day 21 Day 0 – Pre-treatment wound swab Day 7 – Recce treatment Day 14 – Recce treatment Day 21 – Recce treatment • Pre-treatment wound swab on Day 0 showed a growing culture ✓ Day 21 post-treatment, the wound had of both G
Slide 24: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 3 Day 7 Significant bacterial infection Redness and swelling Day 0 – Pre-treatment Day 3 – Recce treatment Day 7 – Recce treatment • Pre-treatment of R327G showed significant bacterial infection, ✓ Day 7 post-treatment showed wound
Slide 25: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 3 Day 7 Day 0 – Pre-treatment Day 3 – Recce treatment Day 7 – 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, wit
Slide 26: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 5 Significant bacterial infection Day 0 – Pre-treatment Day 5 – Recce treatment • Significant bacterial infection – septic ankle arthritis, peri- ✓ The discharge has cleared, and with no signs Left femoral prosthetic joint infection
Slide 27: RECCE 327 Clinical Programs
RECCE® 327 Clinical Programs 26
Slide 28: 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). R327 desig
Slide 29: RECCE 327 Summary Results – Phase I – Complete
RECCE® 327 Summary Results – Phase I – Complete Double-blind, Placebo-controlled, Single Ascending-dose, Safety and Pharmacokinetic Study in Healthy Participants ✓ Safe and well tolerated at doses up to 6,000mg given as a 1-hour intravenous infusion; ✓ No Serious Adverse Events; – All AE’s mild or m
Slide 30: RECCE Concentrates Safely in the Urine
RECCE® 327 Concentrates Safely in the Urine Concentration of R327 Ratio Urine/Plasma in Urine Compared to Plasma 16x 17x 14x 9x In over 60 21x healthy subjects 16x – R327 primary route of elimination appears to be through – Opportunities for therapeutic in array of UTIs (uncomplicated the kidney to
Slide 31: 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 10.00 a fast (near minutes) effect against E. coli and irreversible 9.00 • Bacteria could not be revived post-treatment Viable Bacteria (log CFU/ml) 8.00 •
Slide 32: 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’ Clinical Trial Complete R327 has achieved multiple ‘fast infusion’ time stamps in line with intended future Assessment Assessing R327 at faster administration r
Slide 33: Intellectual Property & Manufacturing
Intellectual Property & Manufacturing 32
Slide 34: Robust Worldwide Intellectual Property Portfolio
Robust Worldwide Intellectual Property Portfolio Recce’s patent portfolio contains over 40 patents and patent applications in the world’s major markets. Patent Patent Patent Patent Filed Expiry Expiry Expiry Expiry Family 1 Family 2 Family 3 Family 4 Family 1 group relates to the Company’s Unique an
Slide 35: Manufacturing & Scalability
Manufacturing & Scalability Manufacturing facility in Sydney’s Macquarie Park • Raw materials plentiful and cheap – few $/Kg • No expensive waste – 99.9% product yield • Automated manufacture process – completing 5,000 doses a week under GMP • This in-house pilot facility provides clear benefits in
Slide 36: RECCE 327 – Global Recognition
RECCE® 327 – Global Recognition R327 added to World Health Organization’s List of Antibacterial Products in Clinical Development • Global recognition by the World Health Organization (WHO) – inclusion underscores significance of R327 in combating antimicrobial resistance. • Unique Mechanism of Actio
Slide 37: Summary
Summary Significant value creating opportunities Novel, Synthetic, Broad-Spectrum, Indonesian Phase 3 registrational Upon completion of Phase 3 Rapid-Acting, Anti-Infectives: clinical trial data read-out and registrational clinical trial, demonstrated against >500 regulatory submission enables Recce
Slide 38: Thank you
Thank you @0@ recce.com.au
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