Slide 1: Immuron Limited: Changing the Paradigms of Care
Immuron Limited August 2017 Changing the Paradigms of Care www.immuron.com ASX:IMC NASDAQ:IMRN
Slide 2: Forward Looking Statement
Forward Looking 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 ex
Slide 3: Company Highlights
Company Highlights 3 • Clinical stage biopharmaceutical company targeting inflammatory - mediated and infectious diseases with oral immunotherapies • Validated technology platform – with one registered asset generating revenue • 2 Lead clinical assets in Phase 2 development for the treatment of mult
Slide 4: Experienced Management Team
Experienced Management Team 4 Jerry Kanellos, PhD Chief Executive Officer Dr. Kanellos has over 20 years of experience in the pharmaceutical and biotech industries including CMC, operations and BD. He has held senior roles at CSL and was CEO of Avipep Pty Ltd a privately owned oncology biotech compa
Slide 5: Advisory Board
Advisory Board Dr. Arun Sanyal (MD) University of Virginia Former President of the AASLD. Current Chair of the Liver Study Section at the NIH. IMM - 124E lead PI. Dr. Stephen Harrison (MD) San Antonio Military Medical Center Brooke US Army Medical Center Internationally renowned expert in NASH. Lead
Slide 6: Oral Immunoglobulins: Scalable, Disruptive Technology
Oral Immunoglobulins: Scalable, Disruptive Technology 6 1 Vaccines Are Developed 2 Antibodies Are Harvested from Colostrum Antigen Specific Antibodies (IgG and IgG1) Adjuvants + 3 Broad Therapeutic Effect + • Reduced gut and blood pathogens responsible for initiating inflammation • Reduces systemic
Slide 7: Immuron's Clinical Programs: Multiple Near-Term Inflection Points
Immuron’s Clinical Programs Multiple Near - Term Inflection Points 7 Program Indications Development Stage Program Highlights Pre - Clinical Phase 1 Phase 2 Phase 3 Anti - Inflammatory Programs IMM - 124E NASH - Interim data reported 2Q 2017 - Topline results expected 4Q 2017 IMM - 124E ASH - NIH Fu
Slide 8: IMM-124E: Revolutionary Treatment for NASH
IMM - 124E Revolutionary Treatment for NASH
Slide 9: NASH Pathophysiology
NASH (Non - Alcoholic Fatty Liver) Pathophysiology 9 NASH – Pathophysiology • Blood derived antigens (including circulating LPS) determines tolerance vs. inflammation • Kupffer cells play a key role in liver inflammation and fibrosis • Tregs hold a key role in tolerance (homeostasis) • Much like hep
Slide 10: IMM-124E in NASH
IMM - 124E in NASH (Non - Alcoholic Fatty Liver) 10 • Targeted antibodies mediate broad anti - inflammatory mechanism of action - Upstream Effect: LPS - TLR4 pathway - Downstream: Anti - inflammatory through both innate and adaptive immune systems (e.g., the induction of regulatory T - cells to cont
Slide 11: IMM-124E: Uniquely Positioned to Address Large Unmet Need
Cirrhosis 1.2 M people F4 IMM - 124E – Uniquely Positioned to Address Large Unmet Need of $35B Market (2030) 11 NAFLD Up to 145M People • No regulatory pathway currently exists for NAFLD • Drug would need to be extremely safe to be considered for trial / approval • NAFLD not available to current com
Slide 12: IMM-124E: Fatty-Liver Portfolio – Phase II Trials
IMM - 124E: Fatty - Liver Portfolio – 3 Phase II Trials 12 Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD NASH • 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 t
Slide 13: IMM-124E – Summary of Data
IMM - 124E – Summary of Data Prevention of Fibrosis and Improvement in Metabolic & Inflammatory Markers 13 CCl4 Fibrosis Studies • Carbon - Tetrachloride (CCl4) a non - disease related fibrosis model • Aim: To demonstrate effects of IMM - 124E on Fibrosis caused by Intraperitoneal CCl4 • Results: -
Slide 14: IMM-124E in NASH: Mechanism
IMM - 124E in NASH (Non - Alcoholic Fatty Liver) 14 Liver: Serum: • Intestinal LPS ↓ • Intestinal Permeability ↓ • Tolerance – Activation of Innate system to suppress inflammation (NKT, DC, macrophages) Gut: • Insulin resistance ↓ • Circulating LPS ↓ • TGF - β ↑ • TNF - α ↓ • IL - 2 , IL - 6 , IL -
Slide 15: Animal Models: IMM-124E Improves Fibrosis and Inflammatory Markers
Animal Models: IMM - 124E Improves Fibrosis and Inflammatory Markers 15 Group A: Control Group D: Treated Group B: Naïve anti LPS Group C: Treated 2.4 0.66 1.4 1.33 0 0.5 1 1.5 2 2.5 3 A B C D *p< 0.02 ^^ p< 0.01 Group A: Control Group D: Treated Group B: Naïve anti LPS Group C: Treated 0 1 1.8 3.4
Slide 16: Animal Models: Macroscopy – Prevents Fibrosis
IMM - 124 E Animal Models: Macroscopy – Prevents Fibrosis 16 Fibrotic Liver CCl 4 (carbon tetrachloride) IMM - 124 E Treated Liver CCl 4 (carbon tetrachloride) Treatment with IMM - 124 E Prevents Fibrosis and Inflammation Mizrahi M. 2013 , AASLD; Hepatology 751 A
Slide 17: Suppression of F4/80 High Macrophages
Suppression of F 4 / 80 High Macrophages 17 Marked Reduction in Liver Activated Macrophages (F 4 / 80 high)
Slide 18: Phase 1/2: Improves Liver Function and Reduces Insulin Resistance
Phase 1 / 2 : Improves Liver Function and Reduces Insulin Resistance 18 Results of a Phase 1 / 2 a clinical trial; N= 10 30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED Improved Liver Enzymes Improved HBA 1 C, OGTT and HOMA Mizrahi M, J Inflamm Res . 2012 ; 5 : 141 - 50 Improved Metabolic
Slide 19: Phase 1/2: Improves Inflammatory Biomarkers
Phase 1 / 2 : Improves Inflammatory Biomarkers 19 Increased CD 4 +CD 25 +FOXP 3 + TREGS Day 1 Day 30 Mizrahi M. J Inflamm Res. 2012 Increased GLP 1 and Adiponectin Proof of Concept: Increase in Circulatory Regulatory T - Cell
Slide 20: IMM-124E NASH Phase II Trial Interim Analysis
IMM - 124 E: NASH Phase II Trial 20 IMM - 124 E - 2001 Interim Analysis – No Safety Issues Reported NASH Study • The study has 12 scheduled visits over the study duration of 28 weeks ( 24 weeks treatment and 4 weeks follow - up. • The interim analysis was triggered when 80 patients ( two thirds of t
Slide 21: IMM-124E Interim Analysis
IMM - 124 E Interim analysis 21 • Goal: Validate Safety and test for futility • Analysis was not powered for efficacy due to sample size • Design: interim analysis initiated when 80 patients reached 24 W and have 2 MRI • Execution: Performed by an independent Committee to keep Company Blinded • Resu
Slide 22: Phase II Interim Analysis Report - Improves Liver Function
Phase II: Interim Analysis Report - Improves Liver Function 22 Results of a Phase IIa clinical trial; N= 133 24 Week Treatment; NO SAFETY ISSUES REPORTED Change in ALT by treatment group and visit (FAS population) • When comparing the 24 W values of serum ALT to baseline all arms demonstrate a signi
Slide 23: Phase II Interim Analysis Report - Improves Liver Function
Phase II: Interim Analysis Report - Improves Liver Function 23 Results of a Phase IIa clinical trial; N= 133 24 Week Treatment; NO SAFETY ISSUES REPORTED Box plot for predicted ALT AUC from ANCOVA (FAS population) Improved Liver Enzymes • Using logarithmic regression the predicted value was used • B
Slide 24: IMM-124E Key Milestones
• NASH Phase 2 interim analysis • Results of MOA studies: - SanyalBio • NASH Phase 2 Topline Results • Results of MOA studies: - Duke • NASH - centric transaction after NASH Phase 2 • Pediatric NAFLD Phase 2 topline results • ASH Phase 2 topline results IMM - 124 E Key Milestones 24 3 Q 2017 4 Q 201
Slide 25: IMM-529: Neutralizing Clostridium difficile, while Sparing the Microbiome
IMM - 529 Neutralizing Clostridium difficile , while Sparing the Microbiome
Slide 26: IMM-529 in Clostridium difficile Infection (CDI)
IMM - 529 in Clostridium difficile Infection (CDI) 26 • Biologic with unique triple mechanism of action - Targets and neutralizes the toxin B, the spores and the vegetative cells • Potential to redefine the standard - of - care (SOC) therapy for CDI - Stops virulence, without impacting the microbiom
Slide 27: IMM-529 for the Treatment of CDI: Market Opportunity
IMM - 529 for the Treatment of CDI 27 Market Opportunity • Therapeutic market is expected to grow from US$ 356.3 million in 2014 to over $ 1.5 billion by 2024 – CAGR 15 % • Nearly 30 , 000 patients die each year from C. difficile infections (US) • Potential orphan disease ( 7 years market exclusivit
Slide 28: Triple Action MOA: Neutralizing C. difficile; Sparing the Microbiome
Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome 28 Spores – Infectious Particles IMM - 529 antibodies bind to multiple epitopes on surface antigens on spores and prevent adheres to ho st cells and limit germination. Heat, ethanol and UV resistant. Survive gastric acid, adhere to
Slide 29: Results of Pre-Clinical Studies
Results of Pre - Clinical Studies 29 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 Prevent
Slide 30: Phase 1/2 Study Design
Phase 1 / 2 Study Design 30 • Phase 1 / 2 , randomized, double blind, placebo - controlled clinical study of IMM - 529 for the treatment of CDI • 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20 subjects to be enrolled within the first 72 hours) • Subjects randomi
Slide 31: IMM-529 Key Milestones
• Clinical supplies manufacturing • Initiation of Phase 1/2 Trial in CDI • Topline results expected from Phase 1/2 study in CDI IMM - 529 Key Milestones 31 2 Q/ 3 Q 2017 2018
Slide 32: Corporate and Financial Overview
Corporate and Financial Overview
Slide 33: Robust IP and Extended Market Protection
Robust IP and Extended Market Protection 33 Strong Patent Portfolio • 6 patent families offering composition and/or method of treatment claims • Approved / pending in major geographies including US, Europe, Japan and China • Granted patent terms ending between 2024 and 2030 with possible extensions
Slide 34: Recent High-Value NASH Licensing and M&A Highlights
• 2016 : Licensed preclinical NASH asset • ~$ 50 M upfront + other undisclosed milestones Recent High - Value NASH LM&A Highlights Potential for Significant Upside 34 • Focused on advancing IMM - 124 E and IMM - 529 through key clinical inflection points while pursuing partnering opportunities • Rec
Slide 35: NASH and C. difficile Comps Indicate Potential for Substantial Growth
NASH and C. difficile Comps Indicate Potential for Substantial Growth 35 Company Ticker Program Development Stage Market Cap* Program in NASH ICPT Obeticholic acid Phase 3 US$2.9B GNFT Elafibranor Phase 3 US$1.1B CNAT ENCORE - LF Phase 2 US$195M Program in C. Difficile MCRB SER - 109; SER - 262 Phas
Slide 36: Capital Profile: Current Top Shareholders
Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN) 36 Current Top 10 Shareholders Current Company Market Capitalization AUD$ 23.4 M ≈ USD$ 18.6 M ( 8 th Aug 2017 ) Rank Holder Name Current Qty % 1 HSBC CUSTODY NOM AUST LTD (ADR Program) 19,531,706 14.97% 2 * GRANDLODGE PL 9,056,682 6.94% 3 AUTHEN
Slide 37: Capital Profile: Issued Capital and Share Price Activity
Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN) Issued Capital Recent Share Price Activity 130 , 440 , 462 Issue Shares (Fully Paid) 25 , 289 , 894 Listed Options exercisable at AUD$ 0.55 on or before 30 Nov 2019 701 , 500 Warrants exercisable at USD$ 10 on or before 13 June 2022 ( 40 : 1 ) 9
Slide 38: Travelan OTC/Business
Travelan OTC/Business A unique OTC targeting Traveler’s Diarrhea • Travelan/OTC: Unique value proposition that is valued by consumers and customers - Significantly reduces the motility of ETEC strains - Binds to multiple epitopes and antigens on both the bacterial surface and flagella - Has substant
Slide 39: Key Milestones Expected to Drive Value
Key Milestones Expected to Drive Value 39 • IMM - 529 - Clinical supplies manufacturing • IMM - 124E - NASH Phase 2 interim analyses - SanyalBio – NASH MOA • IMM - 529 - Initiation of Phase 1/2 Trial in CDI • IMM - 124E - NASH Phase 2 topline results - Duke – NASH MOA • IMM - 124E - NASH centric tra
Slide 40: Investment Highlights
Investment Highlights 40 x Well positioned to address high unmet medical need in multiple blockbuster markets x Two clinical assets, 4 phase 2 clinical trials on going x Robust R&D pipeline x High - value peer licensing deals and M&A underscore potential upside ( Current Market Capitalization = USD$
Slide 41: Thank You
Thank You —re