Immuron Limited · ASX:IMC
Immuron — Investor Presentation (November 2019)
35 slides from Immuron's investor presentation, Nov 6, 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 – NOVEMBER, 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: Three-Pronged Plan
4 4 DEVELOPMENT PIPELINE: THREE - 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 PR
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: New U.S. Department of Defense Research Collaboration with Immuron
8 8 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 oral therapeutic
Slide 9: Background of Travelan: Plan to Expand Use
9 9 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 10: What Is Travelers' Diarrhea?
10 10 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 Asi
Slide 11: Antibiotic Resistance: Opportunity for Travelan
11 11 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 12: Travelan as a Drug to Prevent Travelers' Diarrhea
12 12 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 13: Summary of Results from Study
13 13 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 14: Travelan Oral Challenge Study: Prevention of Shigellosis in Primates
14 14 • 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 15: Results of Travelan Shigella Challenge Study
15 15 “ 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 AFR
Slide 16: IMM-124E Drug Development Plan
16 16 Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea (TD) in travelers to endemic areas: IMM - 124E DRUG DEVELOPMENT PLAN Execute Prevention Trial and File Registration Package File IND with Plan for Double - Blind, Placebo Controlled Trial for Prevention of Travelers’ Diar
Slide 17: Travelan Commercial Profile: Increasing Sales Addressing Large Markets
17 17 TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS 2019 Global market - US $630M Expected to reach US $890M by 2024 at 7% CAGR 1 AUD 1. https://www.marketwatch.com/press - release/at - 71 - cagr - travelers - diarrhea - therapeutics - market - size - to - reach - usd - 890
Slide 18: Immuron North American Revenue Surges by 52% in FY19
18 18 Immuron North American revenue surges by 52% in FY19 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 Travelan® sales a
Slide 19: Immuron North American Q1 Sales Up 111% YoY
19 19 Immuron North American Q1 Sales Up 111% YoY 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 increase, reachi
Slide 20: FY20 Marketing Overview: USA
20 20 • Increased sales in 190 Passport Health Clinics across the USA. • Training & incentive program for travel clinic nurses. FY20 MARKETING OVERVIEW: USA • USA website launched June 2019. • Travel blogger & influencer collaborations to target travellers (28 globally). • 2 podcast campaigns to sti
Slide 21: US Sales Forecast for Travelan if Approved as Drug
21 21 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
Slide 22: Competitor Market Analysis - Anti-Diarrheal Drugs
22 22 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 23: Neutralizing Clostridium difficile, While Sparing the Microbiome: IMM-529
23 23 NEUTRALIZING CLOSTRIDIUM DIFFICILE , WHILE SPARING THE MICROBIOME IMM - 529
Slide 24: Clostridium Difficile Market Opportunity
24 24 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 25: The Unmet Need
25 25 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 26: IMM-529 Opportunity
26 26 • 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 27: The C. difficile Prevention of Recurrent CDI Mouse Model
27 27 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 28: IMM-529 Animal Model Recurrence Study
28 28 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 29: The C. difficile Prevention Mouse Model
29 29 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 30: IMM-529 Animal Model Study
30 30 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 31: IMM-529 Drug Development Plan
31 31 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 32: Competitor Market Analysis - CDI
32 32 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 33: Key Milestones Expected to Drive Value
33 33 KEY MILESTONES EXPECTED TO DRIVE VALUE Results from US Army Shigella animal studies expected in 2020 2H 2019 1H 2020 2H 2020 2021 • Pre - IND Meeting to Discuss IMM - 124E Phase 3 Clinical Development • Initiate Phase 3 Clinical Trial on IMM - 124E TD prevention study • Phase 3 IMM - 124E TD C
Slide 34: Management
34 34 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 35: Board of Directors - Chairman & Executive Vice Chairman
35 35 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