Immuron Limited · ASX:IMC
Immuron — 2nd Australian Biologics Festival 2024
31 slides from Immuron's conference presentation, Feb 21, 2024
Slide 1: Navigating New Horizons: Travelan Market Expansion into the USA
1 2 ND AUSTRALIAN BIOLOGICS FESTIVAL 2024 NASDAQ: IMRN ASX: IMC 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
Slide 2: Safe Harbor Statement
Certain statements made in this presentation are forward - looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,” “ intends,” “ plans,” “ believes,” “ seeks,” “estimates,” “guidance” and s imilar expressions are intended
Slide 3: Topics
TOPICS 3 Introduction • 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 • Current status and
Slide 4: Company Overview
Immuron Ltd is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases Company Overview » Platform Technology: capable of producing highly specific orally active immunoglobulins to any enteric path
Slide 5: Platform Technology
5 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 milk. This enables full d
Slide 6: Intellectual Property
6 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 products. The company has a
Slide 7: Billion Dollar Market - Industry Overview
7 BILLION DOLLAR MARKET - INDUSTRY OVERVIEW Billion Dollar Market Travellers’ diarrhoea treatment market is large and growing at a CAGR of ~7% Industry tailwinds Travel picking up significantly following COVID lockdowns Frequent Symptoms 30% - 70% of travelers experience travellers’ diarrhoea 1 • Th
Slide 8: PLOS ONE Research Article: Travelan against shigellosis in non-human primates
8 PLOS ONE RESEARCH ARTICLE Bioactivity and efficacy of a hyperimmune bovine colostrum product - Travelan, against shigellosis in a non - Human primate model ( Macaca mulatta ). Abstract Infectious diarrhea is a World Health Organization public health priority area due to the lack of effective vacci
Slide 9: Travelan
9 » Travelan® is a pasteurized, lactose - reduced, low - fat, high - protein colostrum powder which contains over 80% proteins by weight. » Travelan® is enriched with anti - Enterotoxigenic E.coli (ETEC) antibodies (35 - 45% w/w), which target ETEC in the gastrointestinal tract » Travelan® is a biol
Slide 10: Travelan Distribution Capability
TRAVELAN DISTRIBUTION CAPABILITY • Retail network includes over 3,500 pharmacies • Online sales of both Travelan® and Protectyn® • Protectyn® is distributed by Osborne Health Supplies USA • Travelan® is sold to travel medicine clinics and on our own amazon.com shopfront (launched July 2023) Canada •
Slide 11: Travelan - Mechanism of Action
• Broad spectrum antimicrobial (gram negative bacteria) • Protects against bacterial adhesion to host cell intestinal epithelia • Caesin and other colostrum proteins are known to protect the antibodies from the acid environment of the stomach • Binds to surface layer proteins preventing bacterial co
Slide 12: Manufacturing Travelan - Drug Substance
Vaccine » Manufacture involves proprietary shearing technology developed to harvest cell surface antigens from 13 Enterotoxigenic E. coli (ETEC) strains known to cause Travelers’ diarrhea » Approved by performing a risk assessment for use in food - producing animals with the Australian Pesticides an
Slide 13: Manufacturing Travelan - Drug Substance
MANUFACTURING TRAVELAN® - DRUG SUBSTANCE 13
Slide 14: Manufacturing - Travelan Drug Product
» Tablets packaged in unit - dose blister packs containing 200 mg of bovine colostrum formulated as a 700 mg solid oral dose tablet with non - novel excipients » All excipients are within regulations of United States Pharmacopeia and National Formulary » Product specifications include i) IgG content
Slide 15: Travelan Safety and Efficacy
15 » Randomised, double - blind, placebo - controlled human infection model studies » Travelan or placebo 200 - 400 mg 3 times daily for 7 days » Challenge with ETEC 2 days after dosing TRAVELAN ® SAFETY AND EFFICACY 84% to over 90% prophylactic efficacy in the Travelan treatment arm 1 Otto W, Najni
Slide 16: Travelan Safety
• 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) • Pharmacovigilance has reported no pro
Slide 17: New Horizons Expansion into the US
NEW HORIZONS EXPANSION INTO THE US 17 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
Slide 18: Travelers' Diarrhea and the US Military
TRAVELERS’ DIARRHEA AND THE US MILITARY 18
Slide 19: Travelers' Diarrhea - Current Management in the US
• 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 for a patient traveling to a high - risk area is the prescription of a
Slide 20: US Military - Travel and Risk
US MILITARY – TRAVEL AND RISK US Military Map – worldwide risk to US forces, APIS/I - 92 MONITOR data (trade.gov) 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 solut
Slide 21: US DoD R&D Collaborative Agreements
US DOD R&D COLLABORATIVE AGREEMENTS ▪ Immuron history of collaboration with NMRC since 2015 ▪ R&D focused on diarrheal infectious agents: Campylobacter, enterotoxigenic Escherichia coli (ETEC) and Shigella ▪ Historically focused on human vaccine development ▪ Several vaccines are in clinical evaluat
Slide 22: US DoD R&D Collaborations
US DOD R&D COLLABORATIONS Key Highlights ▪ Immuron partnered with AFRIMS, NMRC & WRAIR to analyze Travelan® specificity against Campylobacter, ETEC, Shigella and Vibrio cholera field samples (2016) ▪ Travelan® reacts with 180 pathogenic strains of bacteria from infected personnel deployed in Bhutan,
Slide 23: Partnering with US Department of Defense
23 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 - s
Slide 24: Travelan: Market Expansion in the US
24 TRAVELAN ® : MARKET EXPANSION IN THE US DRUG CANDIDATE TRAVELAN® Status with FDA: IND 14933 IND 15675 / IND 17066 » US DOD financial support (US$3.4M) to fund part of this initiative and develop a dosing regimen acceptable for use by the military Plan to develop Travelan as an approved biologic i
Slide 25: Travelan Drug Development Plan
25 TRAVELAN® DRUG DEVELOPMENT PLAN Travelan® current position Milestone B. 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 Department of the Army, D
Slide 26: Overview of FDA Licensure Pathway
OVERVIEW OF FDA LICENSURE PATHWAY PHASE 3 (PIVOTAL) FIELD STUDY 50% efficacy 20% travelers’ diarrhea rate 10% drop - out rate Placebo group n=293 Travelan® group n=293 Pre - IND/IND submission PHASE 3 (PIVOTAL) FIELD STUDY 50% efficacy 20% travelers’ diarrhea rate 10% drop - out rate Placebo group n
Slide 27: Company Competencies & Manufacturing and Distribution Expansion Plans
x Immuron is the sole proprietary of the Travelan® product and associated intellectual property x Strong US DoD collaboration x Immuron has an international distribution network to ensure prompt delivery to deployed US military if necessary x All Immuron’s commercial operations involve suitably, qua
Slide 28: Competitor Market Analysis (US)
COMPETITOR MARKET ANALYSIS (US) 28 Average cost: 2 - week trip Dosing Indication Drug PRESENTLY, THERE IS NO FDA - APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA $29.57 – 30 caplets 5 3 caps (200 mg) TID Dietary supplement TRAVELAN® FDA - APPROVED DRUG TREATMENTS FOR DIARRHEA $20.94 1 2 tabs QID Relie
Slide 29: US Sales Forecast for Travelan if FDA Approved
US SALES FORECAST FOR TRAVELAN®: IF FDA APPROVED 1. U.S. Department of Commerce, International Trade Administration: U.S. International Air Travel Statistics (I - 92 data), Monthly U.S. Outbound Data, U.S. Outbound Travel to World Regions. Available at: https://www.trade.gov/us - international - air
Slide 30: Thank You
THANK YOU Immuron team NAVAL MEDICAL RESEARCH COMMAND UNIFORMED SERVICES UNIVERSITY ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES Funding support Collaborators: 30
Slide 31: Scientific References
3 1 31 SCIENTIFIC REFERENCES Travelan® (IMM - 124E) Scandinavian Journal of Gastroenterology, 46:7 - 8, 862 - 868, DOI: 10.3109/00365521.2011.574726 Travelan® has been shown to reduce both the incidence and severity of ETEC - induced diarrhea in up to 90% of volunteers Military Health System Researc