Immuron Limited · ASX:IMC
Immuron — Shareholder Meeting (November 2019)
28 slides from Immuron's shareholder meeting presentation, Nov 6, 2019
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: 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 6: 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 7: 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 8: 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 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: 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 11: 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 12: 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 13: 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 14: 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 15: 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 16: Neutralizing Clostridium difficile, While Sparing the Microbiome: IMM-529
For personal use only NEUTRALIZING CLOSTRIDIUM DIFFICILE, WHILE SPARING THE MICROBIOME IMM-529 16
Slide 17: 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 18: 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 19: The 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 20: 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 21: 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 22: 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 23: 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 24: US Department of Defense Reports Final Results from Travelan Shigellosis Challenge Study
US Department of Defense Reports Final Results from Travelan® For personal use only Shigellosis Challenge Study Key Highlights: • Travelan® shigellosis challenge studies in non-human primates successfully completed • Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan®
Slide 25: 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 26: 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 27: New U.S. Department of Defense Research Collaboration with Immuron
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 28: 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