Slide 1: Forging Commercial & Clinical Pathways
For personal use only FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – APRIL 2019 NASDAQ: IMRN ASX: IMC 1
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT For personal use only 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”
Slide 3: Company Highlights
COMPANY HIGHLIGHTS For personal use only We are a commercial and clinical-stage biopharmaceutical company focusing on infectious diseases with oral immunoglobulin-based therapies. Plan for accelerated regulatory path to approval for IMM-124E 2 Lead clinical assets, (Travelan®) as drug to IMM-124E &
Slide 4: Platform Overview: Oral Immunoglobulins
PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS For personal use only Toxin Neutralization Isolation of Oral + Development Antimicrobial Clearance of hyperimmune of Highly therapeutics targeted gut antibody-rich Specific without pathogens bovine Vaccines drawbacks of colostrum antibiotics 4
Slide 5: US DOD R&D Collaboration Agreements
US DOD R&D COLLABORATION AGREEMENTS For personal use only • Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016 • Naval Medical Research Center (NMRC) – August 2016 • Walter Reed Army Institute (WRAIR) – June 2016 5
Slide 6: WRAIR R&D Collaboration – Key Milestones
WRAIR R&D COLLABORATION – KEY MILESTONES For personal use only • Evaluation of anti-Shigella specific activity of Travelan® • Travelan® shown to target common bacterial antigens present on ETEC and Shigella. • Travelan® shown to bind 180 pathogenic strains of bacteria retrieved from infected personn
Slide 7: The Potential of Polyclonal Antibodies
THE POTENTIAL OF POLYCLONAL ANTIBODIES For personal use only US Department of Defense Travelan® immunoreactivity study1 (2017): Campy single prominent ETEC prominent immune- Shigella prominent immune- immune-reactive band reactive bands reactive bands • Travelan® demonstrates broad- spectrum antimic
Slide 8: Development Pipeline: Two Pronged Plan
DEVELOPMENT PIPELINE: TWO PRONGED PLAN DEVELOPMENT STAGE For personal use only HIGHLIGHTS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET ANTI-INFLAMMATORY PROGRAMS TGA ARTG Aust L106709 (2004) Commercial product - Australia Health Canada NPN 80046016 (2015) Commercial product - Canada Travelan® Dietary
Slide 9: Background of Travelan: Diamond in the Rough
BACKGROUND OF TRAVELAN®: DIAMOND IN THE ROUGH For personal use only COMMERCIAL PRODUCT DRUG CANDIDATE IMM-124E Marketed in Australia, USA Status with FDA: and Canada IND open and active Plan to develop IMM-124E as an approved drug in USA to treat Travelers’ Diarrhea 9
Slide 10: What Is Travelers' Diarrhea?
WHAT IS TRAVELERS’ DIARRHEA? For personal use only • Caused by consuming food or water infected with pathogens. Three or more unformed stools in 24 hours. • Bacterial pathogens are the predominant risk1. • Enterotoxigenic E. coli (ETEC) are the predominant pathogens: 42% in Latin America 28% in Sout
Slide 11: Travelan OTC Business
TRAVELAN® OTC BUSINESS For personal use only • A unique OTC targeting Travelers’ Diarrhea in Australia & Canada • In Australia, TGA listed medicine indicated to: - Reduce the risk of travelers’ diarrhea - Reduce the symptoms of minor gastrointestinal disorders • Dietary supplement in USA • Significa
Slide 12: Travelan Commercial Profile
TRAVELAN® COMMERCIAL PROFILE For personal use only • Annual revenues of AUD $2M+; cash flow positive • Net revenues: 1H2019 +20% vs 1H2018 • Potential WW peak sales: $200M+ • Global market size: US$630M – 2019 • Global market size expected to grow to US$1B – 2025 (CAGR 7%) • Pursuing new geographies
Slide 13: Background of Travelan: Plan to Expand Use
BACKGROUND OF TRAVELAN®: PLAN TO EXPAND USE For personal use only COMMERCIAL PRODUCT DRUG CANDIDATE IMM-124E Marketed in Australia, USA Status with FDA: and Canada IND open and active Plan to develop IMM-124E as an approved drug to treat Travelers’ Diarrhea 13
Slide 14: Antibiotic Resistance: Opportunity for Travelan
ANTIBIOTIC RESISTANCE: OPPORTUNITY FOR TRAVELAN® For personal use only International Society of Travel Medicine, 2017 guidelines for treating Travelers’ Diarrhea included1: • Antibiotics should NOT be used routinely, except patients at high risk of complications • Rifaximin recommended when antibiot
Slide 15: Travelan as a Drug to Treat Travelers' Diarrhea
TRAVELAN® AS A DRUG TO TREAT TRAVELERS’ DIARRHEA For personal use only • Results of Controlled Human Infection Model STUDY 1: 30 participants Oral challenge with O78 (CHIM) Studies ETEC strain (H10407). • Travelan® evaluated in two randomised, Treatment 5 days after double-blind, placebo-controlled
Slide 16: Travelan Oral Challenge Study: Shigellosis Prevention in Primates
TRAVELAN®: ORAL CHALLENGE STUDY PREVENTION OF SHIGELLOSIS (BACILLARY DYSENTERY) IN PRIMATES For personal use only • 12 juvenile rhesus monkeys randomly assigned to Travelan® (n=8) or placebo (high protein milk powder) (n=4) treatment groups • Travelan® or placebo (500mg) was administered 2x daily fo
Slide 17: Results of Travelan Shigella Challenge Study
RESULTS OF TRAVELAN® SHIGELLA CHALLENGE STUDY 3 x109 S. flexneri For personal use only Travelan® group “Travelan®” x 6 days No Treatment x 8 days DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 “Placebo” x 6 days Placebo control group 1 = last day of S. flexneri consecutive +ve stool culture 17
Slide 18: Summary of Travelan Shigella Animal Study
SUMMARY OF TRAVELAN® SHIGELLA ANIMAL STUDY For personal use only Placebo (high protein milk powder) provided no protection against acute shigellosis • All (4/4) Placebo treated monkeys developed severe acute enteric shigellosis. Travelan® provided 75% protection against acute shigellosis • 2 of 8 (2
Slide 19: IMM-124E Drug Development Plan
IMM-124E DRUG DEVELOPMENT PLAN Revamp Travelan® for FDA approval as drug to treat Prevent Travelers’ Diarrhea in For personal use only Travelers to Endemic Areas: File IND with Hold Pre-IND Single Double- Assimilate Data Blind & Placebo Execute Meeting to to Support Controlled Trial Prevention Trial
Slide 20: US Sales Forecast for Travelan
US SALES FORECAST FOR TRAVELAN® IF APPROVED AS DRUG FOR TD For personal use only MARKET POTENTIAL FOR TRAVELAN® SALES: USD >$100 MILLION Market potential figure derived from: 2014 figures of US citizens traveling to high risk destinations for TD (44.3 million)1 and obtaining pretravel advice (22.2 m
Slide 21: Competitor Market Analysis – Anti-Diarrheal Drugs
COMPETITOR MARKET ANALYSIS – ANTI-DIARRHEAL DRUGS Ave cost – 2 For personal use only Drug Indication Dosing Revenue USD Millions (Year) week trip FDA APPROVED OTC DRUG TREATMENT FOR DIARRHEA PEPTO BISMAL (BSS) Relief for heartburn, nausea, indigestion, upset 2 tabs QID $14.56 97.8 (2018) stomach and
Slide 22: Travelan Uniquely Positioned for Substantial Growth
TRAVELAN® UNIQUELY POSITIONED FOR SUBSTANTIAL GROWTH - NO FDA APPROVED DRUG TO PREVENT TD For personal use only • Therapeutic market is expected to grow from US$630 million in 2019 to over $1 billion by 2025 Market Opportunity – CAGR 7%. • 44.3 million US Citizens travel to high risk destinations ea
Slide 23: Development Pipeline: Two Pronged Plan
DEVELOPMENT PIPELINE: TWO PRONGED PLAN DEVELOPMENT STAGE For personal use only PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET HIGHLIGHTS ANTI-INFLAMMATORY PROGRAMS TGA ARTG Aust L106709 (2004) Commercial product - Australia Health Canada NPN 80046016 (2015) Commercial product - Canada Travelan® Dietary
Slide 24: Neutralizing Clostridium Difficile, While Sparing the Microbiome: IMM-529
For personal use only NEUTRALIZING CLOSTRIDIUM DIFFICILE, WHILE SPARING THE MICROBIOME IMM-529 24
Slide 25: Clostridium Difficile Market Opportunity
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY For personal use only • Therapeutic market expected to grow from US$360 million in 2014 to over $1.7 billion by 2024 – CAGR 15% • Nearly 30,000 patients die each year from C. difficile infections (US) • Potential orphan disease (7 years market exclusivity and
Slide 26: The Unmet Need
THE UNMET NEED • Current standard of care for C. difficile includes vancomycin and metronidazole, accounting for 80% of For personal use only patient share (US) • Therapies plagued by significant CDI recurrences (1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments • Growing re
Slide 27: IMM-529 Opportunity
IMM-529 OPPORTUNITY For personal use only • IMM-529 highly differentiated – neutralizes C. difficile but does not impact microbiome • Targets not only toxin B but also spores and vegetative cells responsible for recurrence • Potential use in combination with standard of care • Targets many isolates
Slide 28: IMM-529 Targets
IMM-529 TARGETS For personal use only Ingestion of Due to unique character of C. spores difficile bacterium, it is difficult to reduce its recurrence with antibiotics. Germination of spores Toxin B production Colonisation by vegetative cells Infection 28
Slide 29: IMM-529 Unique MOA in CDI
IMM-529 UNIQUE MOA IN CDI For personal use only SPORES - Infectious particles – Heat, ethanol & UV resistant. Survive gastric acid, adhere to cells in the colon & germinate. IMM-529 antibodies bind to surface antigens on spores & prevent adherence to host cells & limit germination. VEGETATIVE CELLS
Slide 30: In Vitro Characterisation of C. difficile IMM-529 Antibodies
For personal use only IN VITRO CHARACTERISATION OF C. DIFFICILE IMM-529 ANTIBODIES SPORE, VEGETATIVE CELL AND TOXIN B 30
Slide 31: IMM-529 Antibodies Cross-React with C. difficile Spores
IMM-529 ANTIBODIES CROSS-REACT WITH C. DIFFICILE SPORES For personal use only 1 2 3 4 5 6 7 8 250 kDa Exosporium Non-immune 250 kDa *Strain used to generate product 1. KI (A+B+)* 2. M7404 (A+B+) 3. VPI10463 (A+B+) IMM-529 B#1 4. GE (A+B+) 5. MDU2992 (A-B+) 250 kDa 6. JGS6133 (A+B+) 7. AI35 (A-B+) 8.
Slide 32: IMM-529 Antibodies Cross-React with Vegetative Cell Lysates
IMM-529 ANTIBODIES CROSS-REACT WITH CELL LYSATES FROM C. DIFFICILE VEGETATIVE CELLS For personal use only Animal Human 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Strain used to generate product 75 kDa 50 kDa 37 kDa 25 kDa IMM-529 contains antibodies that are cross-reactive with vegetative cell whole cel
Slide 33: IMM-529 Antibodies Cross-React Against Toxin B
IMM-529 ANTIBODIES CROSS-REACT AGAINST TOXIN B FROM DIFFERENT C. DIFFICILE STRAINS For personal use only 1 2 3 4 5 6 7 8 9 10 11 250 kDa 1. KI (A+B+) 2. M7404 (A+B+) Non-immune 3. VPI10463 (A+B+) 4. GE (A+B+) 5. MDU2992 (A-B+) 250 kDa 6. JGS6133 (A+B+) IMM-529 B#1 7. AI35 (A-B+) 8. 8-1470 (A-B+) 9.
Slide 34: IMM-529 Antibodies Neutralize Toxin B
IMM-529 ANTIBODIES NEUTRALIZE TOXIN B FROM HISTORICAL AND HYPERVIRULENT STRAINS For personal use only C o m m e r c ia l p u r ifie d T o x in B H is t o r ic a l T o x in B H y p e r v ir u le n t T o x in B (s t r a in V P I1 0 4 6 3 ) (s t ra in 6 3 0 ) (s t ra in K I) _____ **** __ __ *** **** _
Slide 35: The C. difficile Prevention Mouse Model
THE C. DIFFICILE PREVENTION MOUSE MODEL For personal use only C57BL/6 mice 6–7 weeks IMM-529 administration Day -10 -3 -2 -1 0 Monitor: Antibiotics in drinking water to C. difficile challenge • Weight loss induce susceptibility to C. difficile (103 spores) • Physiological appearance • Activity • Dia
Slide 36: The C. difficile Relapse Mouse Model
THE C. DIFFICILE RELAPSE MOUSE MODEL For personal use only C57BL/6 mice 6–7 weeks C. difficile challenge Administration of water (103 spores) or IMM-529 Day -10 -1 0 +8 Monitor: Antibiotics in drinking water to induce susceptibility to C. difficile Vancomycin treatment • Weight loss ceases • Physiol
Slide 37: IMM-529 Animal Model Study: Prevention
IMM-529 ANIMAL MODEL STUDY All studies For personal use only Prevention Study statistically significant S u r v iv a l 100 U n in f e c t e d , N o t r e a t m e n t 80 In f e c t e d , N o t r e a t m e n t P e r c e n t s u r v iv a l In fe c t e d , N o n - im m u n e Ig G t r e a t m e n t 60 In
Slide 38: IMM-529 Animal Model Study: Relapse
IMM-529 ANIMAL MODEL STUDY Relapse Study All studies For personal use only statistically S u r v iv a l significant 110 100 In f e c t e d + S O C 90 ** In f e c t e d + S O C + IM M - 5 2 9 P e r c e n t s u r v iv a l p= 0 .0 0 27 80 70 60 50 40 30 20 Demonstrated 10 0 ~90% survival 0 2 4 6 8 10 1
Slide 39: IMM-529 Animal Model Study: Treatment
IMM-529 ANIMAL MODEL STUDY Treatment Study All studies For personal use only statistically significant S u r v iv a l 100 U n in f e c t e d , N o t r e a t m e n t In f e c t e d , N o t r e a t m e n t 80 P e r c e n t s u r v iv a l In fe c t e d , N o n - im m u n e Ig G t r e a t m e n t In f e
Slide 40: Ongoing Phase I/IIa C. difficile Trial
ONGOING PHASE I/IIA C. DIFFICILE TRIAL • Randomized, double blind, placebo-controlled clinical study of IMM-529 for treatment of CDI For personal use only • 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20 subjects to be enrolled within the first 72 hours) • Subje
Slide 41: IMM-529 Drug Development Plan
IMM-529 DRUG DEVELOPMENT PLAN Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium For personal use only difficle Infection: File IND with Hold pre-IND double-blind, Develop clinical placebo meeting to registration controlled trial Execute discuss clinical strategy for
Slide 42: IMM-529 for the Treatment of CDI
IMM-529 FOR THE TREATMENT OF CDI For personal use only • Therapeutic market is expected to grow from US$360 million in 2014 to over $1.7 billion by Market Opportunity 2024 – CAGR 15% • Nearly 30,000 patients die each year from C. difficile infections (US) • Potential orphan disease (7 years market e
Slide 43: Competitor Market Analysis – CDI
COMPETITOR MARKET ANALYSIS – CDI For personal use only Company Drug Type Status Reduce recurrence of CDI Zinplava (bezlotoxumab) IV Monoclonal Antibody FDA approved 2016 Phase 3 SER-109 Oral microbiome therapeutic CP101 Oral microbiome therapeutic Phase 2 Treatment of Primary CDI Ridinilazole Phase
Slide 44: Commercial & Product Development Pipeline
COMMERCIAL & PRODUCT DEVELOPMENT PIPELINE DEVELOPMENT STAGE For personal use only PROGRAM INDICATIONS PROGRAM HIGHLIGHTS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET ANTI-INFLAMMATORY PROGRAMS Commercial product Australia. Travelan® Travelers’ Diarrhea TGA ARTG Aust L106709 (2004) Health Canada NPN 8
Slide 45: IMM-124E: Fatty-Liver Portfolio
IMM-124E: FATTY-LIVER PORTFOLIO Two ongoing NIH funded Phase 2 Programs currently underway: ASH and Pediatric NAFLD For personal use only ASH • NIH funded; sponsored by University of Virginia • Lead Principal Investigator: Arun Sanyal; Former President of AASLD (American Association for the Study of
Slide 46: US Department of Defense Commissioned Pre-Clinical Studies
US DEPARTMENT OF DEFENSE COMMISSIONED PRE-CLINICAL STUDIES For personal use only Collaboration with: • Department of Enteric Diseases (DED) • Armed Forces Research Institute of Medical Sciences (AFRIMS) • A overseas laboratory of the Walter Reed Army Institute of Research (WRAIR) • 60 clinical isola
Slide 47: US DOD Preclinical Studies
US DOD PRECLINICAL STUDIES For personal use only Armed Forces Research Institute of Medical Sciences (AFRIMS) • Travelan® protective efficacy against shigellosis in a juvenile Rhesus macaque challenge model. • Travelan® prevented clinical shigellosis in 75% of Travelan® treated NHPs compared to plac
Slide 48: US DOD – Shigella Specific Therapeutics
US DOD – SHIGELLA SPECIFIC THERAPEUTICS For personal use only Walter Reed Army Institute of Research (WRAIR) • Immuron has produced three Shigella specific therapeutic products utilizing vaccines developed by the Walter Reed Army Institute of Research (WRAIR). • The hyperimmune products from the stu
Slide 49: Key Milestones Expected to Drive Value
KEY MILESTONES EXPECTED TO DRIVE VALUE For personal use only 2H 1H 2H 1H 2019 2020 2020 2021 • Pre-IND Meeting • Initiate Phase 3 • Phase 3 IMM- • File to Discuss IMM- Clinical Trial on 124E TD 505(b)(2) NDA 124E Literature- IMM-124E TD Clinical Data for IMM-124E Based 505(b)(2) prevention study Ava