Slide 1: Key Opinion Leader Event
Key Opinion Leader Event Clinical Data Milestones: The Recce Innovation Journey ASX:RCE | FSE:R9Q
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: Event Agenda
Event Agenda James Graham Prof Eugene Athan BCom, GAICD MBBS, MD, FRACP, MPH Managing Director & Chief Executive Officer Director, Department of Infectious Diseases Recce Pharmaceuticals Ltd Principle Investigator of Phase II Clinical Trial of R327G Barwon Health Dr Alan W Dunton MD Dr Sohinee Sarka
Slide 4: Phase II RECCE 327 Topical Gel
Phase II RECCE® 327 Topical Gel Acute Bacterial Skin and Skin Structure Infections Professor Eugene Athan OAM MBBS, FRACP (Infec Dis), MPH, MD Principle Investigator of Phase II Clinical Trial of RECCE® 327 Topical Gel
Slide 5: Introduction
Introduction Professor Eugene Athan MBBS, FRACP (Infec Dis), MPH, MD • OAM for service to Infectious Diseases Medicine • Professor of Medicine, School of Medicine Deakin University • Co-Director of the Centre for Innovation in Infectious Disease and Immunology Research at Deakin University • Infecti
Slide 6: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Diabetic Foot Infections (DFIs)
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Diabetic Foot Infections (DFIs) ABSSSI & DFI – Unmet clinical needs • Diabetic foot ulcers and infections are common complications that can lead to amputations. • About 50%–60% of ulcers develop infection which is the leading pathology
Slide 7: Current Therapy for Treating DFIs and ABSSSIs
Current Therapy for Treating DFIs and ABSSSIs • ABSSSIs are a significant healthcare concern, encompassing indications such as DFIs, necrotizing fasciitis, and post-operative wound infections. • No placebo-controlled studies as international regulators deem it unethical to withhold appropriate treat
Slide 8: Phase II RECCE 327 Topical Gel
Phase II RECCE® 327 Topical Gel Clinical Trial Overview • The Phase II clinical trial is an Open-label, Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of R327 Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections. • Teste
Slide 9: Phase II ABSSSI Clinical Trial
Phase II ABSSSI Clinical Trial Achieved all Endpoints • 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 infected area • The study enrol
Slide 10: FDA Accepted Diagnosis Tools
FDA Accepted Diagnosis Tools Assesses Severity of Patient Wounds Endpoints • To evaluate the efficacy of RECCE® 327 topical gel on ABSSSI • To evaluate the potential for systemic bioavailability of single and multiple doses of RECCE® 327 topical gel applied once daily for 7 or 14 days to infected AB
Slide 11: Potential of RECCE 327 Gel for Future Applications
Potential of RECCE® 327 Gel for Future Applications No Serious Adverse Events demonstrated with R327G Results demonstrate the potential of R327G to address the ABSSSI market – ABSSSIs present a considerable challenge to healthcare system – Those are high risk of skin infections and poor outcomes
Slide 12: References
References • https://www.sciencedirect.com/science/article/pii/S0168822721000851 • https://www1.racgp.org.au/ajgp/2020/may/diabetic-foot-ulcer • https://pmc.ncbi.nlm.nih.gov/articles/PMC7919962/ • https://jfootankleres.biomedcentral.com/articles/10.1186/s13047-020-00406-y?utm_source=chatgpt.com • ht
Slide 13: Clinical Overview & Phase 3 Implications
Clinical Overview & Phase 3 Implications Dr Alan W Dunton BSc (BioChem) Hons, M.D. (NYU) Chief Medical Advisor & Non-Executive Director Recce Pharmaceuticals
Slide 14: Recce Pharmaceuticals Ltd. Pipeline 2025
Recce Pharmaceuticals Ltd. Pipeline 2025 Over Various Indications and Upcoming Inflection Points Phase III start H1 2025 • Approval received from the Indonesian Drug and Food Regulation Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial in Indonesia • ABSSSI includes postope
Slide 15: Phase II ABSSSI Clinical Trial
Phase II ABSSSI Clinical Trial Study Highlights • Successful Phase II clinical trial assessing efficacy and safety of once daily RECCE® 327 topical gel (R327G) in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including patients with Diabetic Foot Infections (DFI) • Primar
Slide 16: RECCE Topical Gel: Phase III in DFI
RECCE® 327 Topical Gel: Phase III in DFI Multicentre Indonesia • Double blind, Placebo-controlled, Parallel group Study in Patients with DFI • Drug to be administered once daily for up to 14 days • N=300 patients (200 active, 100 placebo) • Primary endpoint is “clinical response” – per standard used
Slide 17: Diabetic Foot Infection Phase III in Indonesia
Diabetic Foot Infection Phase III in Indonesia Significantly Derisks and Accelerate R327 Gel Clinical Development • IND/ Phase III Registrational Clinical Trial approved • Awarded expedited regulatory review status in Indonesia to fast-track progression of Phase 3 trial • Expected launch in 2026 in
Slide 18: Large Addressable Market
Large Addressable Market The global diabetic foot infection (DFI) and sepsis market is worth in excess of $US9.5 billion Global Diabetic Foot Infections (DFI) Market • The DFI treatment market is estimated to be worth ~US$5.2 billion1 US$5.2B • Initially targeting Indonesian market valued at ~US$189
Slide 19: Insights from Dr Yukiko Nakatani
Insights from Dr Yukiko Nakatani WHO Assistant Director-General for Antimicrobial Resistance on the State of Antibacterial Development June 14, 2024 “Antimicrobial resistance is only getting worse yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly
Slide 20: WHO Global Priority Pathogens List
WHO Global Priority Pathogens List Antibiotic-Resistant Bacteria (2024) Priority 1 - CRITICAL Carbapenem-resistant: K. pneumoniae & A. baumannii • Carbapenem-resistant organisms are commonly resistant to all beta-lactam antibiotics including the broad-spectrum carbapenem drugs: meropenem, imipenem,
Slide 21: Global Regulatory Strategy
Global Regulatory Strategy Expansion into ASEAN • Phase 3 ready, aiming to complete recruitment by end 2025 and read-out in early 2026 with expected approval in early 2026 (agreed accelerated approval) Ongoing IND Preparations • Indonesian approval will facilitate regulatory approval for R327 Gel ac
Slide 22: Lung Study data
Lung Study data Dr Sohinee Sarkar BSc (Biotech), Adv Masters(Biotech), PhD Senior Postdoctoral Fellow Infection, Immunity & Global Health (Respiratory) Murdoch Children's Research Institute
Slide 23: Recce is at the forefront of tackling antimicrobial resistance
Recce is at the forefront of tackling antimicrobial resistance Focus on non-tuberculous mycobacteria (NTM) • NTM comprise mycobacterial spp. other than those causing tuberculosis & leprosy • Opportunistic pathogens increasing in global prevalence • Increasing incidence of NTM in conflict zones due t
Slide 24: Mycobacterium abscessus: A Cystic fibrosis superbug
Mycobacterium abscessus (M. abscessus): A Cystic fibrosis superbug Background • Cystic fibrosis is an inherited disorder; defect in the CFTR gene (chloride channel) • Multi-organ disease affecting primarily the lungs & digestive system • Lungs: repeated infections and resulting inflammation leading
Slide 25: Preclinical validation of R327 against M. abscessus
Preclinical validation of R327 against M. abscessus Uninfected macrophages R327 outperforms clarithromycin No host cell cytotoxicity detected Infected macrophages
Slide 26: Nebulised Delivery of R327
Nebulised Delivery of R327 Against M. abscessus lung infection TNF-𝛂𝛂 deficient mice
Slide 27: R327 Delivery to the Lungs is Safely Tolerated
R327 Delivery to the Lungs is Safely Tolerated With no adverse effects in mouse lung infection model
Slide 28: Nebulised R327 retains its efficacy in the mouse lung
Nebulised R327 retains its efficacy in the mouse lung Saline Placebo R327 Azithromycin nebulised intranasal
Slide 29: R327 efficacy against M. abscessus skin infection
R327 efficacy against M. abscessus skin infection Keratinocyte cell line
Slide 30: R327 efficacy against M. abscessus skin infection
R327 efficacy against M. abscessus skin infection
Slide 31: R327 efficacy against M. abscessus skin infection
R327 efficacy against M. abscessus skin infection
Slide 32: R327: A Promising Candidate For Treating NTM Infections
R327: A Promising Candidate For Treating NTM Infections Nontuberculous mycobacteria (NTM) cause a wide spectrum of infections ranging from skin/soft tissue infections to tuberculosis-like lung disease • R327 shows promising efficacy against both lung and skin infections caused by M. abscessus, one o
Slide 33: Company Update
Company Update James Graham Managing Director & Chief Executive Officer Recce Pharmaceuticals
Slide 34: 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 35: 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 36: 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 37: 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 38: Thank you
Thank you @0@ = recce.com.au