Recce Pharmaceuticals Ltd. · ASX:RCE
Recce Pharmaceuticals — Investor Presentation (September 2023)
39 slides from Recce Pharmaceuticals's investor presentation, September 2023
Slide 1: Corporate Presentation
Corporate Presentation ASX:RCE | FSE:R9Q September 2023
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 BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) US-based, current Chairman and Co-founder of Palatin Technologies, Inc. (NYSE: PTN) Michele Dilizia – Executive Director & Chief Scientific Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Jou
Slide 5: Platform Technology
Platform Technology Recce’s products will treat systemic and local infections caused by ESKAPE pathogens, other resistant organisms or when the etiology of the infection is unknown • Very broad-spectrum coverage of bacteria with no signs of resistance • Extremely rapid onset of effect – measured in
Slide 6: Strong Pipeline
Strong Pipeline Over Various Indications and Upcoming Inflection Points Asset and Indications Discovery Pre-Clinical Phase I Phase II Phase III Market Route of Administration Serious/life threatening bacterial infections including sepsis Urinary tract infections R327 Intravenous* including urosepsis
Slide 7: Sepsis – it's a big problem!
Sepsis – it’s a big problem! 2 What is Sepsis? Economic Impact Social Impact Sepsis is a life-threatening Is the most expensive Kills more people in the US inflammatory response to condition to treat in the than prostate, breast cancer infection that has spread in last 8 years5. and HIV/AIDS combine
Slide 8: Sepsis Patient Journey
Sepsis Patient Journey Patient Presents at the Hospital Early treatment with an effective antibiotic is key to improving patient outcome • 1/3 of patients present non-specific symptoms, leading to delayed treatment and high mortality rate. MENINGITIS • Mortality from sepsis increases by as much as 8
Slide 9: Urinary Tract Infections and Urosepsis
Urinary Tract Infections and Urosepsis The Infection In approximately 30% of all septic patients the • Urinary tract infection (UTI) is one of the most common infectious focus is localised in the urogenital tract infectious diseases • The most common pathogen causing UTIs is E. coli with 90% • More
Slide 10: 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 11: 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 permeabilizes cell membranes energetics, depleting ATP • Novel mechanism which targets rapid access to and shut down of bacterial energ
Slide 12: 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 13: 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 14: 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 15: 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 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 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 18: 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 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: Topical RECCE – Phase I/II
Topical RECCE® 327 – Phase I/II Patient examples from ongoing Burn Wound trial • Patients suffered major burn injury. • Multiple bacterial species in and surrounding wound. • Growth swabs with organisms including pathogens from the ESKAPE group of bacteria. Pre-treatment, significant Post R327 treat
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 0 After 24 hours After 30 days Pre-treatment First Recce Gel Application Post Treatment Post Treatment infection Gel Applied Complete • Patient Y unresponsive to 4 x daily Cephalexin for 10 days – Infection spreading and hospi
Slide 22: 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 23: 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 24: 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 25: 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 26: Phase I/II Diabetic Foot Ulcer (DFU) Clinical Trial
Phase I/II Diabetic Foot Ulcer (DFU) Clinical Trial Clinical Trial Overview Outpatient Nurses Appointed • Human Research Ethics approval received • Patients enrolled in Phase I/II now supported • Phase I/II to assess safety and efficacy of R327 by in-home (out-patient) nurses trained in on mild skin
Slide 27: 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 Expiry Expiry Expiry Filed Family 1 Family 2 Family 3 Family 1 group relates to the Company’s Unique and Highly Australia ✓ 20
Slide 28: Pre-Clinical Study Outlook
Pre-Clinical Study Outlook • Recce’s new Anti-Infective Research (AIR) Unit – Located within Murdoch Children’s Research Institute, one of the top three children’s research institutes worldwide – Fit-for-purpose laboratory space with a dedicated Murdoch Children’s team with access to infectious dise
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 taking approx. 1 hour, 500 doses produced per automated run • This in-house pilot facility provides
Slide 30: Multiple Upcoming Clinical Milestones
Multiple Upcoming Clinical Milestones Topical R327 Burn Wounds Key inflection points Burn Wounds H1: Initiate Phase I/II Q4 23: Readout of Burn Wound Infection Phase I/II Burn Wound Clinical Trial- Initiated Infection Trial DFU DFU Q4 23: Readout of Phase H1: Initiate Phase I/II DFU I/II DFU Trial C
Slide 31: Investment Highlights
Investment Highlights Recce Pharmaceuticals Ltd is a clinical-stage biotech company with a new class of novel synthetic anti-infectives Proprietary first-in-class, broad-spectrum anti-infectives against bacteria Multiple clinical indications and formulations in Phase I and II addressing unmet medica
Slide 32: Thank you
Thank you James Graham Managing Director and Chief Executive Officer Recce Pharmaceuticals Ltd ASX:RCE; FSE:R9Q +61 2 9256 2505 [email protected] recce.com.au
Slide 33: Appendix
eve recce.com.au Appendix 32
Slide 34: Empowering Clinicians with a New Class of Antibiotics
Empowering Clinicians with a New Class of Antibiotics The need for new antibiotics has never been greater Physician perspectives on R327 • Initial resistance to use new approved drugs due to antibiotic resistance “We have so few options when patients have difficult pathogens. • “New antibiotics, abl
Slide 35: Recently Approved Antibiotics – Benchmark for Pricing
Recently Approved Antibiotics – Benchmark for Pricing Anticipated Pricing Benchmarks1 USD $25,000 – $30,000 • Though Xigris (activated protein C) was pulled from the market in 2011, its pricing represents a potential premium benchmark for a novel sepsis agent • Fetroja, a recently approved agent for
Slide 36: Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase
Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase Case studies: Other antibiotic companies Price (US$) Volume (m) • Positive top line results from a global, pivotal Oct 2015: Ann. mixed results Phase III clinical trial of solithromycin oral $2 50.00 from 2nd
Slide 37: Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase
Successfully Completing a Clinical Trial Phase Can Lead to Significant Share Price Increase Case studies: Other antibiotic companies Price (US$) Volume (m) • In December 2016, Achaogen announces $3 0.00 60 .0 positive results in Phase III cUTI and CRE clinical trials of Plazomicin. $2 5.00 50 .0 • E
Slide 38: Large strategics are also paying attention
Large strategics are also paying attention Case studies: Partnering antibiotic assets creates value GSK and Spero Therapeutics announce exclusive licence US$66 million upfront and Up to US$525 million in potential agreement for late-stage antibiotic that may treat complicated UTIs milestones plus ro
Slide 39: Many recent deals within the anti-infectives space
Many recent deals within the anti-infectives space have seen larger companies with an entrenched presence acquiring smaller Biotech's Key Recent Deals in Infectious Disease Companies Involved Deal Details Total Value Key Takeaways • Amplyx was developing therapies for patients with • Deal Date: Apri
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