Exhibit 99.1
FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES MAY 2019 GARY S. JACOB, Ph.D. CEO NASDAQ: IMRN ASX: IMC 1
SAFE HARBOR STATEMENT 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 to identify forward-looking statements. Although Immuron believes the forward-looking statements are based on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ from those expressed or forecasted in the forward-looking statements. The forward-looking statements made in this presentation relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority. 2
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-inventor of TRULANCE® (plecanatide), an FDA approved drug to treat chronic GI disorders. Raised over USD $500 million of capital in the public markets to support Synergy from founding to approval of TRULANCE® in 2017. Ph.D. in Biochemistry; University of Wisconsin-Madison and BS in Chemistry from the University of Missouri. Former Acting CEO of Immuron Ltd. Over twenty years’ experience in pharmaceutical and biotechnology industries. Former Chief Operating Officer of TransBio Ltd. Responsible for strategic identification, development and maintenance of global commercial partnerships, along with development, management and IP portfolio, R&D and technology transfer. Leadership roles in business development, project management, IP portfolio management, R&D, senior management. Consultant to academic institutes, private and publicly listed companies and government departments specializing in development and commercialization strategies. PhD in medicine from the University of Melbourne. 3
BOARD OF DIRECTORS CHAIRMAN & EXECUTIVE VICE CHAIRMAN 4
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 Development for Treatment of Liver Disease and C. difficile Infections Plan for Accelerated R egulatory Path to Approval for IMM- 124E (TravelanR) as Drug to Prevent Travelers’ Diarrhea in USA 5
PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS Toxin Neutralization Oral + Isolation of Development Antimicrobial Clearance of hyperimmune of Highly therapeutics targeted gut antibody-rich Specific without pathogens bovine Vaccines drawbacks of colostrum antibiotics 6
US DOD R&D COLLABORATION AGREEMENTS 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) June 2016 Travelan® binds 180 pathogenic strains of bacteria from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand 7
DEVELOPMENT PIPELINE: TWO-PRONGED PLAN DEVELOPMENT STAGE HIGHLIGHTS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET ANTI-INFLAMMATORY PROGRAMS TGA ARTG Aust L106709 (2004) Commercial product - Australia Travelan® Health Canada NPN 80046016 (2015) Commercial product - Canada Dietary supplement (2015) Commercial product - USA PLAN TO DEVELOP AS DRUG TO IMM-124E (Travelan®) PREVENT TRAVELERS’ DIARRHEA IN USA TO PREVENT RECURRENCE IN IMM-529 C. DIFFICILE PATIENTS 8
BACKGROUND OF TRAVELAN®: PLAN TO EXPAND USE 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
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 Asia Up to 70% of travelers suffer from travelers’ diarrhea 4 . 1 Steffen, R. 2017 Epidemiology of travelers’ diarrhea. Journal of Travel Medicine 24(1) 2 Leder, K. 2015 Advising Travellers about Management of Travelers’ Diarrhea. Australian Family Physician, vol 44 No. 1-2 Jan. Feb 2015 3 Castelli et. al., Epidemiology of Travelers’ Diarrhea, J. Travel Medicine 2001; 8 (Suppl2) S26-S30 4 CDC Yellow Book 2018, Chapter 2 Travelers’ Diarrhea. 10
TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS Immuron Sales $3,000,000 $2.68M $2,500,000 2019 Global market - US $630M $2.01M $2,000,000 Expected to reach US $890M by $1.38M $1,500,000 2024 at 7% CAGR 1 $1,000,000 $500,000 $0 FY17A FY18A FY19B 1. https://www.marketwatch.com/press-release/at-71-cagr-travelers-diarrhea-therapeutics-market-size-to-reach-usd- AUD 890-million-by-2024-2019-05-08 11
ANTIBIOTIC RESISTANCE: OPPORTUNITY FOR TRAVELAN® 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 for prophylaxis 2 Insufficient evidence to recommend prebiotics or probiotics The opportunity: Travelan®, the alternative to antibiotic treatment of TD 1 Riddle et al. 2017. Guidelines for the prevention and treatment of travellers’ diarrhea: a graded expert panel report. Journal of Travel Medicine 24(1). 2 Tribble, D. 2017 Resistant pathogens as causes of traveller’s diarrhea globally and impact(s) on treatment failure and recommendations. Journal of Travel Medicine 24(1) 12
TRAVELAN® AS A DRUG TO PREVENT TRAVELERS’ DIARRHEA 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 defined as 90 healthy volunteers in Study 1 & 2 passage of two or more 400mg TID unformed stools during 48 Published in Scandinavian Journal of hour period within 72 hours 15 15 of the challenge Gastroenterology RESULTS: Travelan® provided over 90% prophylactic efficacy against diarrhea due to infection by the major strain of E.coli that causes TD 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. 13
RESULTS OF TRAVELAN® SHIGELLA CHALLENGE STUDY* 3 x10 9 S. flexneri Travelan® group “TravelanR” 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 *Collaboration with AFRIMS & WRAIR = last day of S. flexneri consecutive +ve stool culture 14
IMM-124E DRUG DEVELOPMENT PLAN 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 Meeting to Blind & Placebo Prevention Trial to Support Discuss Merits of Controlled Trial and File Literature-Based 505(b)(2) for Prevention of Registration FDA Submission Application Travelers’ Package Diarrhea 15
US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG TO PREVENT TD 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 (22.2 million) 2 . Sources of pre-travel advice include primary care provider, travel medicine specialist, company doctors, pharmacist, and travel agencies 2 . Our forecast utilizes a very conservative estimate for % of US citizens purchasing Travelan® after seeking pre-travel advice. 1. U.S. Department of Commerce, International Trade Administration, National Travel and Tourism Office. U.S. Citizen Traffic to Overseas Regions, Canada & Mexico 2014. Monthly Statistics, U.S.Outbound Travel by World Regions. 2014. Available at: http://travel.trade.gov/view/m-2014-O-001/index.html. Accessed June 26, 2015. 2. Mathyas Wang , MD , Thomas D. Szucs , MD, MBA, MPH, LLM , and Robert Steffen , MD. Economic Aspects of Travelers ‘ Diarrhea. Journal of Travel Medicine, Volume 15, Issue 2, 2008, 110 118 16
COMPETITOR MARKET ANALYSIS ANTI-DIARRHEAL DRUGS Ave cost 2 Drug Indication Dosing Revenue USD Millions (Year) week trip 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 IMMODIUM Decrease the frequency of diarrhea in TD, gastroenteritis, inflammatory bowel disease, and $17.33 1 2 tabs (2 mg) 82.5 (2013) 2 short bowel syndrome. (48 caplets) CIPROFLOXACIN Bacterial infections. (FLUOROQUINOLINE) 500 mg $44.52 3 40.8 (2015) 3 RIFAXIMIN Treatment of Travellers’ Diarrhea. 3 caps (200 mg) $657 4 TID PRESENTLY, THERE IS NO FDA APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA TRAVELAN® Dietary Supplement. 3 caps (200 mg) $30 30 0.77 (2018) 5 TID caplets 1. Amazon.com 2. Top 10 OTC brands for digestives by revenue in the USA in 2013 3. Almalki et. al., Utilization, spending & price trends for quinolones in the US, Pharmacoecon Open 2017 Jun: 1(2): 123-131 4. Drugs.com Xifaxan (rifaximin) price guide. Cost of Xifaxan oral tablet 200 mg ~$657 for 30 tablets 5. US Sales for Travelan FY2018 17
NEUTRALIZING CLOSTRIDIUM DIFFICILE , WHILE SPARING THE MICROBIOME IMM-529 18
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY Clostridium difficile ( C. difficile ) is a bacterium that causes diarrhea and more 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 Leading cause of gastroenteritis-associated mortality in U.S. 2 Approx. 44,500 patients 3 died in 2014 from C. difficile infections (U.S.) Potential orphan disease (7 years market exclusivity and premium pricing) 1. https//www.globaldata.com/global-clostridium-difficle-infections-market- approach-1-7-billion-2026/ www.globaldata.com/globalostridium-difficileinfections-market-approach-1-7-billion-2026/ 2. Jagai, et.al., BMC Gastroenterology, 2014:14:211 Trends in gastroenteritis-associated mortality in the USA. 3. K. Desai, BMC Infect. Dis., 2016,16:303 19
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 treatments are administered intravenously rather than via the gut where C. difficile resides * Isobel Ramsay, Nicholas Brown and David Enoch. Recent Progress for the Effective Prevention and Treatment of Recurrent Clostridium difficile Infection. Infectious Diseases: Research and Treatment Volume 11: 1 4 (2018). DOI: 10.1177/1178633718758023 20
IMM-529 TARGETS 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
THE C. DIFFICILE PREVENTION OF RECURRENT CDI MOUSE MODEL* C57BL/6 mice 6 7 weeks C. difficile challenge Administration of water (10 3 spores) or IMM-529 Day -10 -1 0 +8 Antibiotics in drinkingwater to Monitor: induce susceptibility to C. difficile Vancomycin treatment Weight loss ceases Physiological appearance Administration of vancomycin alone or Activity vancomycin + IMM-529 12 hour post infection Diarrhoea *Collaboration with Prof. Dena Lyras, Monash University, Australia 22
IMM-529 ANIMAL MODEL STUDY Relapse Study All studies statistically S u r v iv a l significant 1 1 0 In f e c te d + S O C 1 0 0 l 9 0 ** In fe c te d + S O C + IM M -5 2 9 a 8 0 p=0.0027 iv v 7 0 r u 6 0 t s 5 0 n e 4 0 c r 3 0 e P 2 0 Demonstrated ~80% 1 0 survival rate (7/9) vs. 0 ~10% survival rate in 0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0 control group (1/9) D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d 23
IMM-529 DRUG DEVELOPMENT PLAN Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium difficle Infection: File IND with Hold pre-IND Develop clinical plan for placebo meeting to Execute registration controlled trial discuss clinical recurrence strategy for FDA for prevention of protocol and prevention trial submission disease strategy recurrence 24
COMMERCIAL & PRODUCT DEVELOPMENT PIPELINE 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 80046016 (2015) Commercial product Canada Travelan® Travelers’ Diarrhea Commercial product USA Travelan® Dietary supplement (2015) Travelan® Travelers’ Diarrhea Plan for FDA submission (IMM-124E) Travelan® NASH Top Line Results Reported March 2018 (IMM-124E) NIH Funded VCU IMM-124E ASH Topline results expected 2H 2019 NIH Funded; Emory University IMM-124E Pediatric NAFLD Topline results expected 1Q 2020 Developing to prevent recurrence in C. IMM-529 C. Difficile difficile patients WRAIR Shigella Walter Reed Army Institute of Research 25
IMM-124E: FATTY-LIVER PORTFOLIO 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 the Study of Liver Diseases) and current Chair of the Liver Study Section at the NIH (National Institute of Health) Fully recruited: 56 patients Endpoints: Clinical Safety; Serum endotoxin (LPS) levels Timing: topline results expected in 2H2019 PEDIATRIC NAFLD NIH funded; sponsored by Emory University Lead Principal Investigator: Miriam Vos; Current enrollment: 23/40 patients Endpoint: ALT; 3 months treatment Timing: topline results in 1H 2020 26
KEY MILESTONES EXPECTED TO DRIVE VALUE 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 Available TD prevention study IMM-124E ASH Pre-IND Meeting Initiate U.S. Clinical Trial Top Line on IMM-529 C. Phase 2 trial Results difficile program on IMM-529 to Results from US Army trials expected treat recurrent 2019/2020 Pediatric NAFLD CDI Top Line Results 27
COMPANY CAPITALIZATION Immuron Limited Ordinary Shares ADSs Shares 128,565,106 366,265* Options 1 44,823,800 N/A Warrants 2 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 prepared as 2. Exercise price of AUD $10.00 per ADS (1 ADS represents 40 ordinary at 1 May 2019 shares*) [Expiring 13 June 2022] 28