Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (March 2024)
35 slides from Recce Pharmaceuticals's investor presentation, March 2024
Slide 1: RCE Corporate Presentation
RCE Corporate Presentation ASX:RCE | FSE:R9Q March 2024
Slide 2: Disclaimer
Disclaimer DISCLAIMER This presentation has been prepared by Recce Pharmaceuticals Ltd (the “Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not treat the contents of this pre
Slide 3: About Recce Pharmaceuticals Ltd
About Recce Pharmaceuticals Ltd • Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a new class of Synthetic Anti-Infectives, protected by Composition of Matter Patent • Australian clinical-stage biotech company, with a United States presence • Strong pre-clinical data package demonstrati
Slide 4: Board and Management Structure
Board and Management Structure Dr John Prendergast – Chairman Michele Dilizia – Executive Director & Chief Scientific BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM US-based, current Chairman and Co-founder of Palatin Technologies,
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 – March 2024 RCE Share Price and Volume Chart – 12 Months (price shown in AUD) ASX & FSE Code RCE, R9Q $0.80 6,000,000 Share Price AUD $0.44 $0.70 5,00
Slide 6: The Need for a New Class of Antibiotics: Synthetic Anti-Infectives
The Need for a New Class of Antibiotics: Synthetic Anti-Infectives • NO pre-formed natural superbugs. • Entirely man-made and designed with purpose. • Universal Mechanism of Action - does not succumb to resistance. • Broad Spectrum capability and maintains its activity even with repeated use. • Empo
Slide 7: Strong Pipeline
Strong Pipeline Over Various Indications and Upcoming Inflection Points *AIR – Anti infective Research Unit 6
Slide 8: 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. 48.9 11 1 in 3 million million Patients who die in Cases of sepsis Sepsis related hospital have sepsis3 recorded worldwide1 deaths recorded2 Is the most expensive Kills more peop
Slide 9: Sepsis Patient Journey
Sepsis Patient Journey Patient Presents at the Hospital The Infection • Mortality from sepsis increases by as much as 8% for • The most common pathogen causing Urinary every hour that treatment is delayed. Tract Infections (UTIs) is E. coli with 90% • Cost of sepsis care for inpatient admissions and
Slide 10: Independent Study Undertaken on R327 MoA
Independent Study Undertaken on R327 MoA1 By Leading Experts in Bacterial MoA Analysis Stage 1 Stage 2 R327 arrests cell growth and R327 disrupts bacterial cellular • Novel mechanism which targets rapid access to permeabilizes cell membranes energetics, depleting ATP and shut down of bacterial energ
Slide 11: 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 12: 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 13: 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 14: Bactericidal Effect of RECCE on ESKAPE Pathogens
Bactericidal Effect of RECCE® 327 on ESKAPE Pathogens Control Control Control Control Control Control • Average time-kill curves of R327 at various concentrations against strains of ESKAPE pathogens (tested in duplicate) • Time-kill study was performed to determine the bacterial killing effect of R3
Slide 15: R327 Faster Acting Than Existing Antibiotics
R327 Faster Acting Than Existing Antibiotics No Prolonged Exposure Needed • R327 kills pathogenic bacteria at a faster rate. • R327 designed to work faster than all existing antibiotics, reinforced by MoA work undertaken by experts in their field. “R327 kills bacteria in conditions where other antib
Slide 16: Phase I Human Clinical Trial - Complete
Phase I Human Clinical Trial - Complete 120x dose amount* 6,000 mg ✓ • Study to assess IV infusion of RECCE® 327 in healthy male subjects as a single ascending dose. 80x dose amount* 4,000 mg ✓ • Randomized, double-blind, placebo-controlled, safety, tolerability and pharmacokinetics study. 60x dose
Slide 17: RECCE - Intravenous formulation – Phase I
RECCE® 327 - Intravenous formulation – Phase I Summary of Results – All Primary Endpoints Achieved ü No serious adverse events (SAEs) or deaths were reported in this study. ü No clinically significant changes were noted in any hematology parameter(s) in any cohort during the course of the study. ü N
Slide 18: RECCE Concentrates Safely in the Urine
RECCE® 327 Concentrates Safely in the Urine Concentration of R327 in Ratio Urine Compared to Urine/Plasma - Plasma 16x 17x 14x 9x In over 60 healthy 21x subjects 16x – R327 primary route of elimination appears to be through – Opportunities for therapeutic in array of UTIs (uncomplicated the kidney t
Slide 19: RECCE Kills Quickly in the Urine
RECCE® 327 Kills Quickly in the Urine E. coli ATCC 25922 Treated with RECCE® 327 in Urine 10.00 • R327 in the presence of human urine was able to 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 V
Slide 20: 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 • Assessing R327 at faster administration rates (<1 hour) R327 at 3,000mg now tested at • Trial aimed at positioning R327 as first patient
Slide 21: Topical Clinical Programs
Topical Clinical Programs 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 new protocol of nex
Slide 22: Phase I/II DFI Clinical Trial – Achieving Primary Endpoints
Phase I/II DFI Clinical Trial – Achieving 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 • Additional clini
Slide 23: Phase I/II DFI Clinical Trial – Patient Summaries
Phase I/II DFI Clinical Trial – Patient Summaries Patient 2 (Second Daily) – Infection Resolved/Cured Patient 1 (Daily) – MRSA Infection (S. aureus, mixed skin flora and Coliforms) • 235kg, 32-year-old male with a four-year history of Type • 55-year-old male with a 23-year history of Type 2 Diabetes
Slide 24: Phase I/II DFI Clinical Trial – Patient Summaries
Phase I/II DFI Clinical Trial – Patient Summaries Patient 3 (Second Daily) – Infection Patient 4 (Daily) – Infection Patient 5 (Daily) – Infection Resolved/Cured (S. aureus, mixed Resolved/Cured in half the Resolved/Cured (Mixed skin skin flora and mixed coliforms) treatment time (Mixed skin flora)
Slide 25: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Day 0 Day 0 Day 0 Day 1 Day 30 Day 0 – Recce treatment Day 0 – Recce treatment Day 0 – Recce treatment Day 1 – Recce treatment Day 30 – Recce treatment Pre-treatment infection First Recce gel applied Gel application complete Post treatment Po
Slide 26: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Pre-Treatment 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 Initial redness and swelling No signs of infection, no signs of pus Wound impr
Slide 27: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Pre-Treatment Day 7 Day 14 Day 21 Day 0 – Pre-treatment wound swab Day 7 – Recce treatment Day 14 – Recce treatment Day 21 – Recce treatment Growing culture of Gram-positive and Initial redness and swelling of the No signs of bacterial growth
Slide 28: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Pre-Treatment Day 3 Day 7 Significant bacterial infection Redness and swelling Left femoral Day 0 – Pre-treatment Day 3 – Recce treatment Day 7 – Recce treatment Significant bacterial infection, redness and Initial redness and swelling minimi
Slide 29: Patient Case Study – TGA Special Access Scheme Category A
Patient Case Study – TGA Special Access Scheme Category A Pre-Treatment Day 3 Day 7 Day 1 – Pre-treatment Day 3 – Recce treatment Day 7 – Recce treatment Osteomyelitis (serious infection of the bone), signs of Wound drying up with infection clearing, toe Wound completely dried up, no signs of biofil
Slide 30: 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 opportuniti
Slide 31: 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 Australia ✓ 2028 ✓ 2037 ✓ 2037 ✓ 2041 Family 1 gr
Slide 32: Strategic Partnership in South-East Asia to Accelerate Clinical Program
Strategic Partnership in South-East Asia to Accelerate Clinical Program • Memorandum of Understanding (MoU) signed with leading Indonesian biomedical organisation PT Etana Biotechnologies. • MoU aims to facilitate late-stage clinical trials in Indonesia, supporting the Indonesian Government’s access
Slide 33: 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 taking approx. 1 hour, 500 doses produced per automated run • This in-house pilot facility provides
Slide 34: Multiple Upcoming Clinical Milestones
Multiple Upcoming Clinical Milestones Topical R327 Burn Wounds Burn Wounds H1: Initiate Phase I/II Burn Q1 24: Initiate Stage 2 of Phase I/II Burn Wound Infection Trial Wound Infection Clinical Trial - Completed DFI DFI H1: Initiate Phase I/II Q1 24: Initial readout of Phase I/II DFI Trial DFI Clini
Slide 35: Thank you
Thank you @0@ recce.com.au
Recce Pharmaceuticals — Investor Presentation (March 2024) on 6ix