Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — LifeSci Corporate Access Event 2025
38 slides from Recce Pharmaceuticals's conference presentation, January 2025
Slide 1: RCE Corporate Presentation
RCE Corporate Presentation LifeSci Corporate Access Event 2025 ASX:RCE | FSE:R9Q January XXXX 2024 2025
Slide 2: Disclaimer
Disclaimer DISCLAIMER This pre sen tation has been pre pared by Recce Pharmaceuticals Ltd (the “Co mp any”). It do es not purpo rt to con tain all the info rmation tha t a prospective investo r may requir e in conne ction with any potential investment in the Company. Yo u shou ld n ot treat the cont
Slide 3: Recce Nearing Commercial Launch
Recce Nearing Commercial Launch Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a new class of Synthetic Anti-Infectives Australian Clinical-Stage Biotech Company RECCE® 327 Gel nearing commercialisation in Diabetic Foot Infections o Indonesian Phase III trial initiated – expected comme
Slide 4: Board and Management Structure
Board and Management Structure Dr John Prendergast – Chairman Michele Dilizia – Executive Director & Chief BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) 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 5: Strong Pipeline
Strong Pipeline Over Various Indications and Upcoming Inflection Points Expected 2026 Commercial Launch Phase III start H1 2025 • Appr ova l re ceived from the Indon esia n Drug an d Food Regula tion Au tho rity, B adan POM, to initiate its Reg istrational Phase 3 clinical trial in Indonesia • ABSS
Slide 6: Independent Study Undertaken on R327 MoA
Independent Study Undertaken on R327 MoA1 By Leading Experts in Bacterial MoA Analysis Stage 1 Stage 2 • 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. R327 arrests cell growth R32
Slide 7: RECCE Activity Against Escherichia coli
RECCE® 327 Activity Against Escherichia coli • E. coli grows fast. Eukaryotic cells healthy Without R327 R327 (3,000 ppm) and not affected. • R327 at 3,000 ppm shown to be highly effective against E. coli without affecting growing, healthy eukaryotic cells. • R327 rapidly and irreversibly shuts down
Slide 8: RECCE Activity Against Staphylococcus aureus
RECCE® 327 Activity Against Staphylococcus aureus • S. aureus bacterial growth slower than E. coli, not Without R327 R327 (2,300 ppm) affecting eukaryotic cells. • R327 at 2,300 ppm shows to be highly effective against S. aureus without affecting growing, healthy eukaryotic cells. • R327 rapidly and
Slide 9: RECCE Maintains Activity
RECCE® 327 Maintains Activity Number of repeats before displaying loss of antibiotic activity Bacteria* 2 4 6 8 10 12 14 16 18 20 22 24 25 Escherichia coli 25 repeats at time of discovery was sufficient for PCT patent applications, with no sign of resistance. Pseudomonas aeruginosa Staphylococcus au
Slide 10: 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 11: RECCE 327 Gel
RECCE® 327 Gel Diabetic Foot Infection & Acute Bacterial Skin and Skin Structure Infection recce.com.au 10
Slide 12: Diabetic Foot Infection Phase III in Indonesia
Diabetic Foot Infection Phase III in Indonesia Significantly Derisks and Accelerate R327 Gel Clinical Development • Phase III Registrational Clinical Trial initiated • Awarded expedited regulatory review status in Indonesia to fast-track progression of Phase 3 trial • Expected launch in 2026 in ASEA
Slide 13: Global Regulatory Strategy
Global Regulatory Strategy Expansion into Indonesia Ongoing IND Preparations • Pursuing similar regulatory pathway in Indonesia • Actively working with leading expert groups to assist in preparing IND application • Approval received from the Indonesian Drug and Food Regulatory Authority, Badan POM a
Slide 14: Recce's Commercialisation Pathway
Recce’s Commercialisation Pathway Indonesia DFI Phase III Clinical Trial NDA Submission Clinical Phase II Interim Programs Data H224 DFI & ABSSSI NDA Phase II Patient Submission Dosing Complete Australia & US ABSSSI/DFI Phase III Clinical Trial 2024 2025 2026 2027 2028 13
Slide 15: Topical Clinical Programs Move into Phase III
Topical Clinical Programs Move into Phase III Phase I/II Clinical Trial – Treatment of Burn Wound Infections • Stage 1 Complete • Patients treated with R327 showed good indications of safety and tolerability • No serious adverse events reported among patients • Clinical investigators are preparing a
Slide 16: Phase I/II DFI Clinical Trial – Achieved Primary Endpoints
Phase I/II DFI Clinical Trial – Achieved Primary Endpoints • Patients recruited had mild skin and soft tissue DFI including multidrug-resistant Gram-positive and Gram-negative pathogens • Study met all primary end points • R327 well-tolerated in all patients; DFI’s resolved/cured *Patient was on sys
Slide 17: Phase II ABSSSI Clinical Trial – Dosing in Final Stages
Phase II ABSSSI Clinical Trial – Dosing in Final Stages Efficacy Data and Safety Approval Received NOT FOR RELEASE TO US WIRE SERVICES OR DISTRIBUTION IN THE UNITED STATES • Non-Data Safety Monitoring Board unanimously agree R327G is safe and well-tolerated in patients – demonstrating highly encoura
Slide 18: 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 19: 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 20: 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 21: 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 22: 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 23: 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 24: RECCE Intravenous
RECCE® 327 Intravenous Urinary Tract Infection / Urosepsis recce.com.au 23
Slide 25: 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 26: 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 27: 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 10.00 have a fast (near minutes) effect against E. coli 9.00 and irreversible Viable Bacteria (log CFU/ml) 8.00 • Bacteria could not be revived post-treatment •
Slide 28: Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial
Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial R327 has achieved multiple ‘fast infusion’ time stamps in line with intended future regulatory submissions Clinical Trial Complete • Assessing R327 at faster administration rates (<1 hour) 15 minutes • Trial aimed at positioning R327 as first pa
Slide 29: 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 Expiry Expiry Expiry Expiry Filed Family 1 Family 2 Family 3 Family 4 Family 1 group relates to the Company’s Unique an
Slide 30: 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 31: Company Overview
Company Overview Recce Pharmaceuticals Ltd is a clinical-stage biotech company with a new class of novel synthetic anti-infectives Capital Structure – January 2025 RCE Share Price and Volume Chart – 12 Months (price shown in AUD) ASX & FSE Code RCE, R9Q 2,500,000 $0.80 Share Price USD $0.30 $0.70 2,
Slide 32: Summary – Significant Opportunities Ahead
Summary – Significant Opportunities Ahead Proprietary first-in-class, broad-spectrum anti-infectives against bacteria, protected by Composition of Matter Patent. Fast development plans targeting: Sepsis, UTI/Urosepsis, Burn Wounds and Acute Bacterial Skin and Skin Structure Infections (ABSSSI), incl
Slide 33: Thank you
Thank you @0@ = recce.com.au
Slide 34: Appendix
Appendix @0@ = recce.com.au
Slide 35: RECCE Activity Against Multiple Bacterial Infections
RECCE® 327 Activity Against Multiple Bacterial Infections Recce’s Anti-Infective Research (AIR) Unit – Located within Murdoch Children’s Research Institute, one of the top three children’s research institutes worldwide – Ongoing pre-clinical programs, exploring new research development opportunities
Slide 36: Sepsis – it's a big problem!
Sepsis – it’s a big problem! Sepsis is a life-threatening inflammatory response to infection that has spread in the body. Is the most expensive condition to 48.9 Cases of sepsis treat in the last 8 years5. Double the average cost per stay across all other million recorded worldwide1 conditions5. Kil
Slide 37: Sepsis Patient Journey
Sepsis Patient Journey Patient Presents at the Hospital Current Treatment Paradigm • Mortality from sepsis increases by as much as 8% for • Introducing broad-spectrum antibiotic (s) every hour that treatment is delayed. • Running antibiograms • Cost of sepsis care for inpatient admissions and skille
Slide 38: Large Addressable Market
Large Addressable Market The global diabetic foot infection (DFI) and sepsis market is worth in excess of $US9.5 billion NOT FOR RELEASE TO US WIRE SERVICES OR DISTRIBUTION IN THE UNITED STATES Global Diabetic Foot Infections (DFI) Market • The DFI treatment market is estimated to be worth ~US$5.2 b
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