Immuron Limited · ASX:IMC
Immuron — Non-Deal Roadshow (August 2019)
32 slides from Immuron's roadshow presentation, Aug 16, 2019
Slide 1: Forging Commercial & Clinical Pathways Targeting Infectious Diseases with Oral Immunotherapies
1 1 FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – AUGUST 2019 NASDAQ: IMRN ASX: IMC GARY S. JACOB, Ph.D. CEO
Slide 2: Safe Harbor Statement
2 2 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 similar expressions are intended
Slide 3: Company Highlights
3 3 COMPANY HIGHLIGHTS We are a commercial and clinical - stage biopharmaceutical company focusing on infectious diseases with oral immunoglobulin - based therapies • Validated Technology Platform – with One Registered Asset, Travelan ® Generating Revenue • IMM - 124E & IMM - 529, in Clinical Develo
Slide 4: Development Pipeline: Two-Pronged Plan
4 4 DEVELOPMENT PIPELINE: TWO - PRONGED PLAN DEVELOPMENT STAGE HIGHLIGHTS PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET ANTI - INFLAMMATORY PROGRAMS Travelan ® Commercial product - Australia Commercial product - Canada Commercial product - USA IMM - 124E ( Travelan ®) PLAN TO DEVELOP AS DRUG TO PREV
Slide 5: Platform Overview: Oral Immunoglobulins
5 5 PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS Development of Highly Specific Vaccines Isolation of hyperimmune antibody - rich bovine colostrum Oral Antimicrobial therapeutics without drawbacks of antibiotics Toxin Neutralization + Clearance of targeted gut pathogens
Slide 6: Mechanism of Action - Targeting Enteric Pathogens
6 6 MECHANISM OF ACTION - TARGETING ENTERIC PATHOGENS 6 Pre - Clinical Studies • Delivers high levels of orally active antibodies to specific enteric pathogenic bacteria which colonize the gastrointestinal tract and cause infection and disease. • Biological therapeutics which directly target the maj
Slide 7: US DoD R&D Collaboration Agreements
7 7 US DOD R&D COLLABORATION AGREEMENTS • Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016 • Naval Medical Research Center (NMRC) – August 2016 • Walter Reed Army Institute of Research (WRAIR) – June 2016 • Travelan® binds 180 pathogenic strains of bacteria from infected pers
Slide 8: Background of Travelan: Plan to Expand Use
8 8 BACKGROUND OF TRAVELAN ®: PLAN TO EXPAND USE Marketed in Australia, USA and Canada Status with FDA: IND 14,933* COMMERCIAL PRODUCT DRUG CANDIDATE IMM - 124E Plan to develop IMM - 124E as an approved drug to prevent Travelers’ Diarrhea *IMM - 124E for treatment of NASH
Slide 9: What Is Travelers' Diarrhea?
9 9 WHAT IS TRAVELERS’ DIARRHEA? • Caused by consuming food or water infected with pathogens. Three or more unformed stools in 24 hours. • Bacterial pathogens are the predominant risk 1 . • Enterotoxigenic E. coli (ETEC) are the predominant pathogens 2,3 : 42% in Latin America 28% in Southeast Asia
Slide 10: Antibiotic Resistance: Opportunity for Travelan
10 10 International Society of Travel Medicine, 2017 guidelines for treating Travelers’ Diarrhea included 1 : • Antibiotics should NOT be used routinely, except patients at high risk of complications • Rifaximin recommended when antibiotic prophylaxis is indicated • Fluoroquinolones not recommended
Slide 11: Travelan as a Drug to Prevent Travelers' Diarrhea
11 11 TRAVELAN ® AS A DRUG TO PREVENT TRAVELERS’ DIARRHEA Otto et al. 2011 Randomized Control Trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by ETEC in volunteers. Scandinavian Journal of Gastroenterology, 2011; 46: 862 – 868. Oral challenge with O78 ETE
Slide 12: Summary of Results from Study
12 12 SUMMARY OF RESULTS FROM STUDY 1 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 with diarrhea (mean and range) 6 (2 – 8) 6 (6) NS Abdo
Slide 13: Travelan Oral Challenge Study: Prevention of Shigellosis in Primates
13 13 • 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 for 6 - days, starting on day 0 • Each monkey challenged with 2.8 x 10 9 Shigella flexneri 2a intragastrical
Slide 14: Results of Travelan Shigella Challenge Study
14 14 “ Travelan ®” x 6 days “Placebo” x 6 days 3 x10 9 S. flexneri = last day of S. flexneri consecutive + ve stool culture No Treatment x 8 days RESULTS OF TRAVELAN ® SHIGELLA CHALLENGE STUDY* Travelan ® group Placebo control group DAYS 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 *Collaboration with AFRIMS
Slide 15: IMM-124E Drug Development Plan
15 15 Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea in travelers to endemic areas: IMM - 124E DRUG DEVELOPMENT PLAN Execute Prevention Trial and File Registration Package File IND with Single Double - Blind & Placebo Controlled Trial for Prevention of Travelers’ Diarrhea H
Slide 16: Travelan Commercial Profile: Increasing Sales Addressing Large Markets
16 16 TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS 2019 Global market - US $ 630 M Expected to reach US $ 890 M by 2024 at 7 % CAGR 1 $1.38M $2.01M $2.68M $0 $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000 $3,000,000 FY17A FY18A FY19B Immuron Sales AUD 1. https://www.
Slide 17: US Sales Forecast for Travelan
17 17 US SALES FORECAST FOR TRAVELAN ®: IF APPROVED AS DRUG TO PREVENT TD MARKET POTENTIAL FOR TRAVELAN® SALES: 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 million) 2 . Sources of p
Slide 18: Competitor Market Analysis - Anti-Diarrheal Drugs
18 18 COMPETITOR MARKET ANALYSIS – ANTI - DIARRHEAL DRUGS Drug Indication Dosing Ave cost – 2 week trip Revenue USD Millions (Year) FDA APPROVED DRUG TREATMENTS FOR DIARRHEA PEPTO BISMOL (BSS) Relief for heartburn, nausea, indigestion, upset stomach and diarrhea. 2 tabs QID $20.97 1 82.6 (2013) 2 IM
Slide 19: Neutralizing Clostridium difficile While Sparing the Microbiome: IMM-529
19 19 NEUTRALIZING CLOSTRIDIUM DIFFICILE , WHILE SPARING THE MICROBIOME IMM - 529
Slide 20: Clostridium Difficile Market Opportunity
20 20 CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY 1. https//www.globaldata.com/global - clostridium - difficle - infection - market - approach - 2016 - 2026 2. Jagai , et.al., BMC Gastroenterology, 2014:14:211 Trends in gastroenteritis - associated mortality in the USA. 3. K. Desai, BMC Infect. Dis., 2
Slide 21: The Unmet Need
21 21 THE UNMET NEED • Current standard of care for C. difficile includes vancomycin, metronidazole & fidaxomicin • Therapies plagued by significant CDI recurrences ( * 1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments • Growing resistance to vancomycin treatment • Some trea
Slide 22: IMM-529 Opportunity
22 22 • 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 IMM - 529 OPPORTUNITY Toxin B
Slide 23: The C. difficile Prevention of Recurrent CDI Mouse Model
23 23 D a y - 10 - 1 0 A n t i b i o t i c s i n d ri n k i n g w a t e r t o i ndu c e s u s c e p t i b i l i t y t o C. d i ff i c il e C. d i ff i c il e c h a ll e n g e ( 10 3 s po r e s ) C 57 B L / 6 m i c e 6 – 7 w ee ks THE C. DIFFICILE PREVENTION OF RECURRENT CDI MOUSE MODEL * + 8 Adminis
Slide 24: IMM-529 Animal Model Recurrence Study
24 24 0 2 4 6 8 10 12 14 16 18 20 0 10 20 30 40 50 60 70 80 90 100 110 Survival Days after vancomycin treatment ceased P e r c e n t s u r v i v a l Infected + SOC Infected + SOC + IMM-529 ** p=0.0027 IMM - 529 ANIMAL MODEL ‘RECURRENCE’ STUDY All studies statistically significant Demonstrated ~80% s
Slide 25: The C. difficile Prevention Mouse Model
25 25 Monitor: • Weight loss • Physiological appearance • Activity • Diarrhoea D a y - 10 - 3 0 A n t i b i o t i c s i n d ri n k i n g w a t e r t o i ndu c e s u s c e p t i b i l i t y t o C. d i ff i c il e C. d i ff i c il e c h a ll e n g e ( 10 3 s po r e s ) C 57 B L / 6 m i c e 6 – 7 w ee
Slide 26: IMM-529 Animal Model Study
26 26 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 0 20 40 60 80 100 Survival hours post infection P e r c e n t s u r v i v a l Uninfected, No treatment Infected, No treatment Infected, Non-immune IgG treatment Infected, IMM-529 treatment Infected, Vancomycin treatment IMM - 529 ANIMAL MODEL STUDY All studi
Slide 27: IMM-529 Drug Development Plan
27 27 Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium difficile Infection: IMM - 529 DRUG DEVELOPMENT PLAN Execute recurrence prevention trial File IND with plan for placebo controlled trial for prevention of disease recurrence Hold pre - IND meeting to discuss cl
Slide 28: Competitor Market Analysis - CDI
28 28 COMPETITOR MARKET ANALYSIS – CDI Company Drug Type Status Reduce recurrence of CDI Zinplava ( bezlotoxumab ) IV Monoclonal Antibody FDA approved 2016 SER - 109 Oral microbiome therapeutic Phase 3 CP101 Oral microbiome therapeutic Phase 2 Treatment of Primary CDI Ridinilazole Oral antibiotic Ph
Slide 29: Key Milestones Expected to Drive Value
29 29 KEY MILESTONES EXPECTED TO DRIVE VALUE Results from US Army trials expected 2019/2020 2H 2019 1H 2020 2H 2020 1H 2021 • Pre - IND Meeting to Discuss IMM - 124E Literature - Based 505(b)(2) • IMM - 124E ASH Clinical Trial Top Line Results • Initiate Phase 3 Clinical Trial on IMM - 124E TD preve
Slide 30: Management
30 30 MANAGEMENT • Chief Executive Officer of Immuron Limited since November 16, 2018. • 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. • Co - invento
Slide 31: Board of Directors - Chairman & Executive Vice Chairman
31 31 BOARD OF DIRECTORS – CHAIRMAN & EXECUTIVE VICE CHAIRMAN 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 acquisition of Mayne Limited in 2009. He has extensive experie
Slide 32: Company Capitalization
32 32 COMPANY CAPITALIZATION Immuron Limited Ordinary Shares ADS Equivalent 1 Shares 176,780,906 4,419,523 Options 2 44,683,744 1,117,094 Warrants 3 27,760,000 694,000 Total 249,224,650 6,230,617 1. 1 ADS represents 40 ordinary shares 2. Options - Exercise price range: AUD $0.468 to $1.944 (Expiring