Slide 1: Forging Commercial & Clinical Pathways
For personal use only FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – NOVEMBER, 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: Company Highlights
COMPANY HIGHLIGHTS We are a commercial and clinical-stage biopharmaceutical company For personal use only focusing on infectious diseases with oral immunoglobulin-based therapies • Validated Technology Platform – with One Registered Asset, Travelan® Generating Revenue • IMM-124E & IMM-529, in Clinic
Slide 4: Development Pipeline: Three-Pronged Plan
DEVELOPMENT PIPELINE: THREE-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) Travelan® Commercial product - Canada Dieta
Slide 5: 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 5
Slide 6: Mechanism of Action - Targeting Enteric Pathogens
MECHANISM OF ACTION - TARGETING ENTERIC PATHOGENS • Delivers high levels of orally active antibodies to specific enteric pathogenic bacteria which colonize the For personal use only gastrointestinal tract and cause infection and disease. • Biological therapeutics which directly target the major path
Slide 7: US DOD R&D Collaboration Agreements
US DOD R&D COLLABORATION AGREEMENTS For personal use only Collaboration on Development: 1) Shigella-Specific Target – US Army 2) Campylobacter-specific Target – US Navy • Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016 • Naval Medical Research Center (NMRC) – August 2016 • W
Slide 8: New US DoD Research Collaboration to Develop Campylobacter Therapeutic
For personal use only New U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic against Campylobacter Key Highlights: • AU $5.5 (USD $3.7) million funding approved by the U.S. Department of Defense to develop and clinically evaluate a new
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 S
Slide 11: 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 12: 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 13: Summary of Results From Study
SUMMARY OF RESULTS FROM STUDY 1 For personal use only Treatment Group Placebo Colostrum p Number of volunteers 15 15 Number of volunteers with diarrhea 11 (73%) 1 (7%) 0.0005 Number of diarrheal stools/volunteer (mean + SEM) 4.4 ± 0.9 0.4 ± 0.4 0.0004 Mean number of diarrheal stools per volunteer wi
Slide 14: Travelan Oral Challenge Study: Prevention of Shigellosis 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 f
Slide 15: Results of Travelan Shigella Challenge Study
RESULTS OF TRAVELAN® SHIGELLA CHALLENGE STUDY* 3 x109 S. flexneri For personal use only Travelan® group S. flexneri was undetectable in consecutive fecal samples by day 7 in 4 of 6 (67%) survivors and by day “Travelan®” x 6 days No Treatment x 8 days 9 in the remaining 2 (33%) survivors DAYS 1 2 3 4
Slide 16: IMM-124E Drug Development Plan
IMM-124E DRUG DEVELOPMENT PLAN Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea (TD) in For personal use only travelers to endemic areas: File IND with Plan for Double- Execute Assimilate Data Hold Pre-IND Blind, Placebo Prevention Trial to Support IND Meeting to Controll
Slide 17: Travelan Commercial Profile: Increasing Sales Addressing Large Markets
TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS For personal use only Global Immuron Sales - AUD $2.6M $3,000,000 2019 Global market - US $630M $2,500,000 $2.01M Expected to reach US $890M by $2,000,000 $1.38M 2024 at 7% CAGR 1 $1,500,000 $1,000,000 $500,000 $- FY17A FY18A FY
Slide 18: Immuron North American Revenue Surges by 52% in FY19
Immuron North American revenue surges by 52% in FY19 For personal use only Key Highlights: • Immuron FY19 revenue surged by 52% in North America, reaching $1.16M. • In the USA, FY19 Travelan® sales exceeded the $1M AUD milestone for the first time and grew by +32% to $1.02M AUD. • In May 2019, USA T
Slide 19: Immuron North American Q1 Sales Up 111% YoY
Immuron North American Q1 Sales Up 111% YoY For personal use only Key Highlights: • First Quarter of FY2020 (Q1) North American sales grew by 111% YoY to $269K AUD • Q1 US Travelan® sales increased by +81% YoY to $232K AUD • Global Immuron sales continued an upward trend in Q1 with a +54% YoY sales
Slide 20: Global Travelan Sales (AUD)
GLOBAL TRAVELAN® SALES (AUD) For personal use only Global Immuron Sales - AUD • FY19 YoY revenue1 growth: 23% • Q1 FY20 YoY revenue1 growth: 54% $2.6M $3,000,000 $2,500,000 $2.01M $2,000,000 $1.38M Sales by region $1,500,000 CANADA 6% $1,000,000 USA 40% $500,000 AU 54% $- FY17A FY18A FY19A USA AU CA
Slide 21: FY20 Marketing Overview: USA
FY20 MARKETING OVERVIEW: USA TRAVEL CLINICS CONSUMER MARKETING For personal use only FY19 REVIEW • Increased sales in 190 Passport • USA website launched June 2019. Health Clinics across the USA. • Travel blogger & influencer • Training & incentive program for collaborations to target travellers (28
Slide 22: US Sales Forecast for Travelan if Approved as Drug
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 23: 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 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 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 26: 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 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: 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 29: IMM-529 Animal Model Recurrence Study
IMM-529 ANIMAL MODEL ‘RECURRENCE’ 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 rat
Slide 30: The C. difficile Prevention Mouse Model
THE C. DIFFICILE PREVENTION MOUSE MODEL For personal use only C57BL/6 mice 6–7 weeks Vancomycin or 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 •
Slide 31: IMM-529 Animal Model Study
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 32: 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 difficile Infection: File IND with Hold pre-IND plan for placebo Develop clinical meeting to controlled trial Execute registration discuss clinical for prevention o
Slide 33: 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 34: Key Milestones Expected to Drive Value
KEY MILESTONES EXPECTED TO DRIVE VALUE For personal use only 2H 1H 2H 2019 2020 2020 2021 • Pre-IND Meeting to • Initiate Phase 3 • Phase 3 IMM- • Plan to File BLA Discuss IMM-124E Clinical Trial on 124E TD for IMM-124E Phase 3 Clinical IMM-124E TD Clinical Data TD prevention Development prevention
Slide 35: 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 36: Board of Directors - Chairman & Executive Vice Chairman
BOARD OF DIRECTORS – CHAIRMAN & EXECUTIVE VICE CHAIRMAN For personal use only Dr Roger Aston CHAIRMAN - B. Sc. (Hons), PhD. Dr Aston has more than 20 years experience in the pharmaceutical and biotech industries. He was Chief Executive Officer of Mayne Pharma Group Limited, after leading HalcyGen’s