Slide 1: Forging Commercial & Clinical Pathways
For personal use only FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – MAY 2019 GARY S. JACOB, Ph.D. CEO 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: Management
MANAGEMENT • Chief Executive Officer of Immuron Limited since November 16, 2018. For personal use only • Over 30 years of experience in pharmaceutical and biotechnology - including R&D, operations, business development and capital financing. • Co-founder and founding CEO of Synergy Pharmaceuticals.
Slide 4: Board of Directors – Chairman & Executive Vice Chairman
BOARD OF DIRECTORS – CHAIRMAN & EXECUTIVE VICE CHAIRMAN For personal use only 4
Slide 5: Company Highlights
COMPANY HIGHLIGHTS We are a commercial and clinical-stage biopharmaceutical company focusing on For personal use only infectious diseases with oral immunoglobulin-based therapies. Validated Technology Platform – with One Registered Asset, Travelan® Generating Revenue IMM-124E & IMM-529, in Clinical
Slide 6: 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 6
Slide 7: US DoD R&D Collaboration Agreements
US DOD R&D COLLABORATION AGREEMENTS For personal use only Collaboration on Development of a Shigella-Specific Therapeutic • Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016 • Naval Medical Research Center (NMRC) – August 2016 • Walter Reed Army Institute of Research (WRAIR) –
Slide 8: Development Pipeline: Two-Pronged Plan
DEVELOPMENT PIPELINE: TWO-PRONGED PLAN For personal use only DEVELOPMENT STAGE 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: 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 14,933* Plan to develop IMM-124E as an *IMM-124E for treatment approved drug to prevent Travelers’ of NASH 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 pathogens2,3: 42% in Latin America 28% in A
Slide 11: Travelan Commercial Profile: Increasing Sales Addressing Large Markets
TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS For personal use only Immuron Sales $3,000,000 $2.68M $2,500,000 2019 Global market - US $630M $2,000,000 $2.01M Expected to reach US $890M by $1,500,000 $1.38M 2024 at 7% CAGR 1 $1,000,000 $500,000 $0 FY17A FY18A FY19B 1. https
Slide 12: 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 13: Travelan as a Drug to Prevent Travelers' Diarrhea
TRAVELAN® AS A DRUG TO PREVENT TRAVELERS’ DIARRHEA For personal use only • Travelan® evaluated in two STUDY 1: 30 participants Oral challenge with O78 randomised, double-blind, placebo- ETEC strain (H10407) Controlled Human Infection Model challenge clinical trials PLACEBO IMM-124E Diarrhea was defi
Slide 14: 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 *Collaboration w
Slide 15: IMM-124E Drug Development Plan
IMM-124E DRUG DEVELOPMENT PLAN For personal use only Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea in travelers to endemic areas: File IND with Hold Pre-IND Single Double- Execute Assimilate Data Blind & Placebo Meeting to Prevention Trial to Support Controlled Trial Discu
Slide 16: US Sales Forecast for Travelan
US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG TO PREVENT 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
Slide 17: Competitor Market Analysis – Anti-Diarrheal Drugs
COMPETITOR MARKET ANALYSIS – ANTI-DIARRHEAL DRUGS Ave cost – 2 Drug Indication Dosing Revenue USD Millions (Year) week trip For personal use only FDA APPROVED DRUG TREATMENTS FOR DIARRHEA PEPTO BISMOL (BSS) Relief for heartburn, nausea, indigestion, upset stomach and diarrhea. 2 tabs QID $20.97 1 82
Slide 18: IMM-529: Neutralizing Clostridium difficile, While Sparing the Microbiome
For personal use only NEUTRALIZING CLOSTRIDIUM DIFFICILE, WHILE SPARING THE MICROBIOME IMM-529 18
Slide 19: Clostridium Difficile Market Opportunity
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY Clostridium difficile (C. difficile) is a bacterium that causes diarrhea and more For personal use only serious intestinal conditions such as colitis • Therapeutic market expected to grow from USD $630 million in 2016 to over $1.7 billion by 2026 – CAGR 15%1
Slide 20: The Unmet Need
THE UNMET NEED • Current standard of care for C. difficile includes vancomycin, metronidazole & fidaxomicin For personal use only • Therapies plagued by significant CDI recurrences (*1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments • Growing resistance to vancomycin treatme
Slide 21: 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 21
Slide 22: C. difficile Prevention of Recurrent CDI Mouse Model
THE C. DIFFICILE PREVENTION OF RECURRENT CDI 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
Slide 23: IMM-529 Animal Model Study
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 ~80% 10 survival rate (7/9) vs. 0
Slide 24: IMM-529 Drug Development Plan
IMM-529 DRUG DEVELOPMENT PLAN For personal use only Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium difficle Infection: File IND with Hold pre-IND plan for placebo Develop clinical meeting to controlled trial Execute registration discuss clinical for prevention of
Slide 25: Commercial & Product Development Pipeline
COMMERCIAL & PRODUCT DEVELOPMENT PIPELINE For personal use only DEVELOPMENT STAGE 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 80
Slide 26: IMM-124E: Fatty-Liver Portfolio
IMM-124E: FATTY-LIVER PORTFOLIO For personal use only Two ongoing NIH funded Phase 2 Programs currently underway: ASH and Pediatric NAFLD ASH • NIH funded; sponsored by Virginia Commonwealth University • Lead Principal Investigator: Arun Sanyal; Former President of AASLD (American Association for th
Slide 27: 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 to • Initiate Phase 3 • Phase 3 IMM- • File Discuss IMM-124E Clinical Trial on 124E TD 505(b)(2) NDA Literature-Based IMM-124E TD Clinical Data for IMM-124E 505(b)(2) prevention study Avail
Slide 28: Company Capitalization
COMPANY CAPITALIZATION For personal use only Immuron Limited Ordinary Shares ADSs Shares 128,565,106 366,265* Options1 44,823,800 N/A Warrants2 N/A 694,000 Total 173,388,906 1,060,265 1. Options - Exercise price range: AUD $0.300 to $1.944 (Expiring from 28 May 2019 to 15 March 2023) Information pre