Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (April 2025)
32 slides from Recce Pharmaceuticals's investor presentation, April 2025
Slide 1: RCE Corporate Presentation
RCE Corporate Presentation ASX:RCE | FSE:R9Q XXXX April 2024 2025
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: 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 4: Board and Management Structure
Board and Management Structure 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 Tech nologies,
Slide 5: Company Overview
Company Overview Recce Pharmaceuticals Ltd is a clinical-stage biotech company with a new class of novel synthetic anti-infectives Capital Structure – February 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 AUD $0.36 $0.70 2
Slide 6: Recce Products are Dramatically Differentiated
Recce Products are Dramatically Differentiated Selective activity against prokaryotic cells and not Unprecedented, broad-spectrum activity against against eukaryotic cells Gram +ve and Gram -ve bacteria, tested against over 400 clinical strains Multiple formulations – intravenous solution (can be us
Slide 7: Recce Pharmaceuticals Ltd. Pipeline 2025
Recce Pharmaceuticals Ltd. Pipeline 2025 Over Various Indications and Upcoming Inflection Points • Approval received from the Indonesian Drug and Food Regulation Aut hority, Badan PO M, to i ni tiat e i ts Regist rat ional Phase 3 c linical tri al i n Indonesia • ABSSSI includes postoperativ e i nfe
Slide 8: 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 9: 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 10: 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 shown to be highly effective against S. aureus without affecting growing, healthy eukaryotic cells. • R327 rapidly and
Slide 11: RECCE 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 12: 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 13: Strategic Opportunity in South-East Asia to Accelerate Clinical Program
Strategic Opportunity in South-East Asia to Accelerate Clinical Program Phase 3 • Approval received from the Indonesian Drug Registrational and Food Regulatory Authority, Badan POM, Clinical Trial in to initiate Registrational Phase 3 clinical trial Indonesia • Human Research Ethics Committee approv
Slide 14: Topical Clinical Programs Move into Phase III
Topical Clinical Programs Move into Phase III Phase I/II • Interim data results released – primary endpoints achieved Clinical Trial • Patients supported by in-home (out-patient) nurses trained in R327 Diabetic Foot treatment protocols Infections (DFI) • Appointment of leading out-patient nursing gr
Slide 15: 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 16: 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 17: 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 18: 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 19: 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 20: 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 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 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: Significant Value Creation Potential
Significant Value Creation Potential • Novel, Synthetic, Broad-Spectrum, Rapid-Acting, Anti-Infectives: demonstrated against >400 clinical isolates; no signs of resistance • Highly successful Phase 2 with Phase 3 clinical trial approved to begin for ASEAN; Australia and beyond expected to follow • >
Slide 32: Thank you
Thank you @0@ = recce.com.au
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