Immuron Limited · ASX:IMC
Immuron — 2nd Australian Biologics Festival 2024
33 slides from Immuron's conference presentation, Feb 21, 2024
Slide 1: Australian Biologics Festival 2024 announcement
Australian Biologics Festival 2024 Melbourne, Australia, February 21, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to advise our Research & Development Manager, Joanne Casey, PhD will be presenting at the Australian
Slide 2: For personal use only
risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform unde
Slide 3: Navigating New Horizons: Travelan Market Expansion into the USA
2ND AUSTRALIAN BIOLOGICS For personal use only FESTIVAL 2024 NAVIGATING NEW HORIZONS: TRAVELAN ® MARKET EXPANSION INTO THE USA STRATEGIC COLLABORATIONS, PARTNERSHIPS AND CLINICAL TRIALS JERRY KANELLOS, PhD Chief Scientific Officer Presented by: JOANNE CASEY, PhD R&D Manager NASDAQ: IMRN ASX: IMC 1
Slide 4: Safe Harbor Statement
SAFE HARBOR STATEMENT C e r ta i n state m e n t s m a d e i n t h i s p re s e nta t i o n a re fo r wa rd - l o o k i n g state m e n t s a n d a re b a s e d o n I m m u ro n ’s c u r re nt ex p e c tat i o n s , e st i m ate s a n d p ro j e c t i o n s . Wo rd s s u c h a s For personal use onl
Slide 5: Topics
TOPICS Introduction For personal use only • Immuron’s Pipeline Technology • Travelan – commercial product Partnering with US Department of Defense (DoD) • History of collaborations • DoD funding Commercial pathway of Travelan® in the US • FDA clinical pathway to BLA • Scale-up Product Development •
Slide 6: Company Overview
Immuron Ltd is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut For personal use only mediated diseases Dual listed (ASX:IMC) (NASDAQ:IMRN) ➢ Platform Technology: capable of producing highly specific orally a
Slide 7: Platform Technology
PLATFORM TECHNOLOGY Bovine colostrum is the first milk of cows after calving. It is rich in immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, growth factors and bioactive peptides. Colostrum has higher levels of protein, fat, vitamins, and minerals when compared to For personal use only milk.
Slide 8: Intellectual Property
INTELLECTUAL PROPERTY Due to the practical nature of the technology used to produce our products, the company retains a significant amount of know- how and other unregistered intellectual property which presents significant hurdles to competitors in producing the same For personal use only products.
Slide 9: Billion Dollar Market
Billion Dollar Market BILLION DOLLAR MARKET Travellers’ diarrhoea treatment market - INDUSTRY OVERVIEW is large and growing at a CAGR of ~7% Industry tailwinds For personal use only Travel picking up significantly following COVID lockdowns Frequent Symptoms 30% - 70% of travelers experience travelle
Slide 10: PLOS ONE research article: Travelan against shigellosis
PLOS ONE RESEARCH ARTICLE Bioactivity and efficacy of a hyperimmune bovine colostrum product - Travelan, against shigellosis in a non- Human primate model (Macaca mulatta). For personal use only Abstract Infectious diarrhea is a World Health Organization public health priority area due to the lack o
Slide 11: Travelan
TRAVELAN® ➢ Travelan® is a pasteurized, lactose-reduced, low-fat, high-protein colostrum powder which contains over 80% proteins by weight. For personal use only ➢ Travelan® is enriched with anti-Enterotoxigenic E.coli (ETEC) antibodies (35-45% w/w), which target ETEC in the gastrointestinal tract A
Slide 12: Travelan Distribution Capability
TRAVELAN DISTRIBUTION CAPABILITY Australia USA Canada Shandex Ontario, Canada For personal use only Distributes to all Retail Pharmacy provinces of Canada B2B Established E-commerce Developing Immuron Ltd Vancouver, BC, Canada Key Commentary Australia • Retail network includes over 3,500 pharmacies
Slide 13: Travelan – Mechanism of Action
TRAVELAN – MECHANISM OF ACTION • Broad spectrum antimicrobial (gram negative bacteria) For personal use only • Protects against bacterial adhesion to host cell intestinal epithelia • Caesin and other colostrum proteins are known to protect the antibodies from the acid Pre-Clinical environment of the
Slide 14: Travelan Manufacturing
TRAVELAN® MANUFACTURING Vaccine ➢ Manufacture involves proprietary shearing technology developed to harvest cell surface antigens from 13 For personal use only Enterotoxigenic E. coli (ETEC) strains known to cause Travelers’ diarrhea ➢ Approved by performing a risk assessment for use in food-produci
Slide 15: Manufacturing Travelan - Drug Substance
For personal use only MANUFACTURING TRAVELAN® - DRUG SUBSTANCE 13
Slide 16: Manufacturing – Travelan Drug Product
MANUFACTURING – TRAVELAN® DRUG PRODUCT ➢ Tablets packaged in unit-dose blister packs containing 200 mg of bovine colostrum For personal use only formulated as a 700 mg solid oral dose tablet with non-novel excipients ➢ All excipients are within regulations of United States Pharmacopeia and National
Slide 17: Travelan Safety and Efficacy
TRAVELAN® SAFETY AND EFFICACY ➢ Randomised, double-blind, placebo-controlled human For personal use only infection model studies ➢ Travelan or placebo 200- 400mg 3 times daily for 7 days ➢ Challenge with ETEC 2 days after dosing 84% to over 90% prophylactic efficacy in the Travelan treatment arm 1O
Slide 18: Travelan Safety
TRAVELAN® SAFETY For personal use only • Travelan® is well tolerated and has been administered orally in over 500 subjects in clinical trials with doses up to 4.8 g per day for 28 days with no treatment related Serious adverse events (SAEs) • Clinically evaluated in Children (6 to 19 years of age) •
Slide 19: New Horizons: Expansion into the US
NEW HORIZONS EXPANSION INTO THE US For personal use only 1. Collaboration with the US Department of Defense (DOD) 2. FDA Clinical Pathway to approval of a listed medicine 3. Immuron distribution and expansion plans 17
Slide 20: Travelers' Diarrhea and the US Military
TRAVELERS’ DIARRHEA AND THE US MILITARY For personal use only 18
Slide 21: Travelers' Diarrhea – Current Management in the US
TRAVELERS’ DIARRHEA – CURRENT MANAGEMENT IN THE US For personal use only • The literature indicates that overall, ~50% of US travelers to remote or less developed countries seek pre-travel guidance. Advice from physicians, travel clinics, pharmacists, or other source. • Physicians’ standard protocol
Slide 22: US Military – Travel and Risk
US MILITARY – TRAVEL AND RISK For personal use only Key Commentary • US Military Infectious Diseases Research Program (MIDRP) • The mission of the MIDRP is to plan, coordinate and oversee for the US DOD requirements-driven medical solutions that PREVENT, PREDICT, and TREAT infectious diseases threat
Slide 23: US DOD R&D Collaborative Agreements
US DOD R&D COLLABORATIVE AGREEMENTS NMRC AFRIMS WRAIR For personal use only Travelan®(ETEC) Campylobacter Established Shigella Developing Key Commentary ARMED FORCES RESEARCH INSTITUTE OF ▪ Immuron history of collaboration with NMRC since 2015 MEDICAL SCIENCES (AFRIMS) ▪ R&D focused on diarrheal inf
Slide 24: US DOD R&D Collaborations
US DOD R&D COLLABORATIONS Current clinical programs NMRC AFRIMS WRAIR For personal use only Travelan® MTEC military grant (USD$3.4M) phase 2 clinical study NCT05933525 Travelan®(ETEC) Campylobacter Established Travelan® - Uniformed Services University field study 868 participants including deployed
Slide 25: Partnering with US Department of Defense
PARTNERING WITH US DEPARTMENT OF DEFENSE • Join funding consortiums like MTEC which the U.S. Army Medical Research and Development Command (USAMRDC) and other DoD agencies offer funding opportunities to members through solicitations called Requests for Prototype Proposals (RPPs): https://mtec-sc.org
Slide 26: Travelan: Market Expansion in the US
TRAVELAN®: MARKET EXPANSION IN THE US Supported (in part) by MTEC DRUG CANDIDATE For personal use only ➢ Immuron is pursuing a regulatory pathway to TRAVELAN® license Travelan® with the FDA via a Biologics Status with FDA: License Application (BLA) with a proposed IND 14933 indication to prevent TD
Slide 27: Travelan Drug Development Plan
TRAVELAN® DRUG DEVELOPMENT PLAN Travelan® current position Milestone B. For personal use only MTEC funded due to High Technology Readiness Level (TRL) rating. The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Depart
Slide 28: Overview of FDA Licensure Pathway
OVERVIEW OF FDA LICENSURE PATHWAY Pre-IND 2019 Pre-IND/IND submission COVID For personal use only IND 2022 approval in 30 Days Military Regulatory approval 3+ months PHASE 2 TRIAL-MTEC IRB approval/ Clinical Trial commenced May 2023 Optimal dosing strategy Clinical data June 2024 End of Phase 2 meet
Slide 29: Company Competencies & Manufacturing and Distribution Expansion Plans
COMPANY COMPETENCIES & MANUFACTURING AND DISTRIBUTION EXPANSION PLANS For personal use only ✓ Immuron is the sole proprietary of the Travelan® product and associated intellectual property ✓ Strong US DoD collaboration ✓ Immuron has an international distribution network to ensure prompt delivery to d
Slide 30: Competitor Market Analysis (US)
COMPETITOR MARKET ANALYSIS (US) Average cost: Drug Indication Dosing 2-week trip For personal use only PRESENTLY, THERE IS NO FDA-APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA 3 caps (200 mg) $29.57 – 30 TRAVELAN® Dietary supplement TID caplets 5 FDA-APPROVED DRUG TREATMENTS FOR DIARRHEA PEPTO BISMOL
Slide 31: US Sales Forecast for Travelan: If FDA Approved
US SALES FORECAST FOR TRAVELAN®: IF FDA APPROVED MARKET POTENTIAL FOR TRAVELAN® SALES: Regulatory Regulatory Indications For personal use only Authority Pathway USD >$100 MILLION Australia Australian Register for • Reduces the risk of travelers’ Therapeutic Therapeutic Goods (ARTG) diarrhea Goods •
Slide 32: Thank You
THANK YOU For personal use only Collaborators: Immuron team ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES NAVAL MEDICAL UNIFORMED RESEARCH SERVICES COMMAND UNIVERSITY Funding support 30
Slide 33: Scientific References
SCIENTIFIC REFERENCES Travelan® (IMM-124E) Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90% Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI: For personal use only of volunteers 10.3109/00365521.2011.574726 Clinical Evaluation of