Slide 1: Developing Unique Oral Immunotherapies that Fundamentally Change the Paradigms of Care
www.immuron.com For personal use only Immuron Limited Developing Unique Oral Immunotherapies that Fundamentally Change the Paradigms of Care May 2017 ASX:IMC
Slide 2: Forward Looking Statement
Forward Looking 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,” “guida
Slide 3: Free Writing Prospectus Statements
Free Writing Prospectus Statements Immuron Limited (ASX:IMC) For personal use only This presentation contains a “free writing prospectus,” or a portion thereof, required to be filed by us with the Commission or retained by us pursuant to Rule 433 under the Securities Act of 1933, as amended, or the
Slide 4: Offering Summary
Offering Summary Immuron Limited (ASX:IMC) For personal use only Offering Size US$8,750,000 o f American Depository Shares (ADSs) and Warrants Ordinary Shares are listed o n the ASX u nder the symbol IMC Exchange/Ticker Applied to list the ADSs and Warrants o n the NASDAQ Capital Market u nder the s
Slide 5: Investment Highlights
Investment Highlights • Clinical stage biopharmaceutical company targeting inflammatory-‐mediated and For personal use only infectious diseases with oral immunotherapies • Lead program, IMM-‐124E, in Phase 2 development for the treatment of multiple high value indications, including NASH, ASH and
Slide 6: Experienced Management Team
Experienced Management Team For personal use only Thomas Liquard Dan Peres, MD Chief Executive Officer Chief Medical Officer Mr. Liquard spent the majority of his career at Dr. Peres, a surgeon by training, has deep Pfizer in New York in various commercial experience in liver diseases and clinical l
Slide 7: Prominent Scientific Advisory Board and Leading Research Partners
Prominent Scientific Advisory Board and Leading Research Partners For personal use only Advisory Board Dr. Arun Sanyal (MD) Dr. Stephen Harrison (MD) Dr. Manal Abdelmalek (MD) University of Virginia San Antonio Military Medical Center Duke University Medical Center Brooke US Army Medical Center Form
Slide 8: Oral Immunotherapy: Scalable, Disruptive Technology
Oral Immunotherapy: Scalable, Disruptive Technology For personal use only 1 2 3 Vaccines Are Antibodies Are Harvested Broad Therapeutic Effect Developed from Colostrum Induction of • Reduced gut and blood pathogens regulatory responsible for initiating inflammation T-cells • Reduces systemic inflamm
Slide 9: Immuron's Clinical Programs
Immuron’s Clinical Programs Multiple Near-Term Inflection Points For personal use only Development Stage Program Indications Program H ighlights Pre-‐Clinical Phase 1 Phase 2 Phase 3 Anti-‐Inflammatory Programs -‐ Interim data expected 3Q 2017 IMM-‐124E NASH -‐ Topline results expected 4Q 2017
Slide 10: IMM-124E: Revolutionary Treatment for NASH
For personal use only IMM-124E Revolutionary Treatment for NASH
Slide 11: NASH (Non-Alcoholic Fatty Liver) Pathophysiology
NASH (Non-Alcoholic Fatty Liver) Pathophysiology For personal use only 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 (homeostasi
Slide 12: IMM-124E in NASH (Non-Alcoholic Fatty Liver)
IMM-124E in NASH (Non-Alcoholic Fatty Liver) For personal use only • Broad anti-inflammatory mechanism of action - Targeted LPS antibodies - Upstream Effect: LPS-TLR4 pathway - Downstream: Anti-inflammatory through both innate and adaptive immune systems (e.g., the induction of regulatory T-cells to
Slide 13: IMM-124E – Uniquely Positioned to Address Large Unmet Need of $35B Market (2030)
IMM-124E – Uniquely Positioned to Address Large Unmet Need of $35B Market (2030) For personal use only NASH Cirrhosis NAFLD 25M People 1.2M people Up to 145M People F0 F1 F2 F3 F4 • No regulatory 17M People 8M People pathway currently exists for NAFLD • Drug would need to Intercept (OCA) Tobira (CCR
Slide 14: IMM-124E: Fatty-Liver Portfolio – Phase 2 Trials
IMM-124E: Fatty-Liver Portfolio – 3 Phase 2 Trials For personal use only Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD • Lead Principal Investigator: Arun Sanyal; Former President of AASLD (American Association for the Study of Liver Diseases) and current Chair of the Liver Study Sec
Slide 15: IMM-124E – Summary of Data
IMM-124E – Summary of Data Prevention of Fibrosis and Improvement in Metabolic/Inflammatory Markers For personal use only • Carbon-Tetrachloride (CCl4) a non-disease related fibrosis model • Aim: To demonstrate effects of IMM-124E on Fibrosis caused by Intraperitoneal CCl4 CCl4 Fibrosis • Results: S
Slide 16: IMM-124E in NASH (Non-Alcoholic Fatty Liver)
IMM-124E in NASH (Non-Alcoholic Fatty Liver) Liver: For personal use only • Activated Kupffer cells ↓ IMM-124E (F4/80 macrophages) • Fibrosis and inflammation ↓ Gut: Serum: • Insulin resistance ↓ • Intestinal LPS ↓ • Circulating LPS ↓ • Intestinal permeability ↓ • TGF-β ↑ • Tolerance – Activation of
Slide 17: Animal Models: IMM-124E Improves Fibrosis and Inflammatory Markers
Animal Models: IMM-124E Improves Fibrosis and Inflammatory Markers For personal use only Decrease Portal Inflammation Improved Metavir Fibrosis Score Group A: Group B: Naïve Group A: Group B: Naïve Control anti LPS Control anti LPS Group C: Group D: Group C: Group D: Treated Treated Treated Treated
Slide 18: Animal Models: Macroscopy – Prevents Fibrosis
Animal Models: Macroscopy – Prevents Fibrosis For personal use only Fibrotic Liver IMM-124E Treated CCl4 (carbon tetrachloride) Liver CCl4 (carbon tetrachloride) IMM-124E Treatment with IMM-124E Prevents Fibrosis and Inflammation Mizrahi M. 2013, AASLD; Hepatology 751A 18
Slide 19: Suppression of F4/80High Macrophages
Suppression of F4/80High Macrophages For personal use only Marked Reduction in Liver Activated Macrophages (F4/80 high) 19
Slide 20: Phase 1/2: Improves Liver Function and Reduces Insulin Resistance
Phase 1/2: Improves Liver Function and Reduces Insulin Resistance For personal use only Results of a Phase 1/2a clinical trial; N=10 30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED Improved HBA1C, OGTT and HOMA Improved Liver Enzymes Improved Metabolic Status (e.g. HbA1c, HOMA OGTT) GLP1,
Slide 21: Phase 1/2: Improves Inflammatory Biomarkers
Phase 1/2: Improves Inflammatory Biomarkers For personal use only Increased CD4+CD25+FOXP3+ TREGS Increased GLP1 and Adiponectin Day 1 Day 30 Proof of Concept: Increase in Circulatory Regulatory T-Cell Mizrahi M. J Inflamm Res. 2012 21
Slide 22: IMM-124E Key Milestones
IMM-124E Key Milestones For personal use only 3Q 4Q 2018 2017 2017 • NASH Phase 2 interim • NASH Phase 2 Topline • NASH-centric transaction analysis Results after NASH Phase 2 • Results of MOA studies: • Results of MOA studies: • Pediatric NAFLD Phase 2 - SanyalBio - Duke topline results • ASH Phase
Slide 23: IMM-529: Neutralizing Clostridium difficile, but Sparing the Microbiome
For personal use only IMM-529 Neutralizing Clostridium difficile, but Sparing the Microbiome
Slide 24: IMM-529 in Clostridium difficile Infection (CDI)
IMM-529 in Clostridium difficile Infection (CDI) For personal use only • Biologic with unique triple mechanism of action - Antibodies neutralize the toxin B, the spores and the vegetative cells • Potential to redefine the standard-of-care (SOC) therapy for CDI - Current antibiotic treatments exacerb
Slide 25: IMM-529 for the Treatment of CDI
IMM-529 for the Treatment of CDI For personal use only • Therapeutic market is expected to grow from $356.3 million in 2014 to over $1.5 billion Market by 2024 – CAGR 15% Opportunity • Nearly 30,000 patients die each year from C. difficile infections (US) • Potential orphan disease (7 years market e
Slide 26: Triple Action MOA
Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome For personal use only Spores – Infectious Particles IMM-529 antibodies bind to Heat, ethanol and UV multiple epitopes on surface resistant. Survive gastric acid, antigens on spores and adhere to cells in the colon prevent adherence
Slide 27: Results of Pre-Clinical Studies
Results of Pre-Clinical Studies For personal use only Prevention Studies S u r v iv a l 100 80 U n in f e c t e d , N o t r e a t m e n t In f e c t e d , N o t r e a t m e n t Demonstrated ~70% P e r c e n t s u r v iv a l 60 In fe c t e d , N o n - im m u n e Ig G t r e a t m e n t In f e c t e d
Slide 28: Phase 1/2 Study Design
Phase 1/2 Study Design For personal use only Phase 1/2 Study in CDI Expected to Commence 2Q 2017 • 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 subject
Slide 29: IMM-529 Key Milestones
IMM-529 Key Milestones For personal use only 2Q 2018 2017 • Clinical supplies manufacturing • Topline results expected from Phase 1/2 study in CDI • Initiation of Phase 1/2 Trial in CDI 29
Slide 30: Corporate and Financial Overview
For personal use only Corporate and Financial Overview
Slide 31: Robust IP and Extended Market Protection
Robust IP and Extended Market Protection For personal use only • 6 patent families offering composition and/or method of treatment claims Strong Patent • Approved / pending in major geographies including US, Europe, Japan and China Portfolio • Granted patent terms ending between 2024 and 2030 with p
Slide 32: Recent High-Value NASH LM&A Highlights
Recent High-Value NASH LM&A Highlights Potential for Significant Upside For personal use only • Focused on advancing IMM-124E and IMM-529 through key clinical inflection points while pursuing partnering opportunities • Recent licensing and M&A partnerships in NASH underscores potential of IMM-124E •
Slide 33: NASH and C. difficile Comps Indicate Potential for Substantial Growth
NASH and C. difficile Comps Indicate Potential for Substantial Growth For personal use only 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-‐
Slide 34: Company Capitalization – Pre-Offering
Company Capitalization – Pre-Offering For personal use only Pre-‐Offering Pre-‐Offering Immuron Limited Ordinary Shares “ADSs Equivalent”1 Shares 103,641,417 2,591,035 Options2 33,177,523 829,438 Warrants 0 0 Total 136,818,940 3,420,473 1. Each ADS is equal to 40 ordinary shares 2. Options -‐ Wei
Slide 35: Use of Funds – Net of Raise Fees
Use of Funds – Net of Raise Fees For personal use only Programs Use of Funds IMM-‐124E – Advance the clinical development of IMM-‐124E for the treatment of fatty-‐liver diseases. Funds sufficient to complete our $3,000,000 Phase 2 clinical programs in NASH, ASH and Pediatric NASH IMM-‐529 – Adva
Slide 36: Travelan OTC/Business
Travelan OTC/Business A unique Preventative Treatment for Traveler’s Diarrhea For personal use only • Travelan/OTC: unique value proposition that is valued by consumers and customers - Up to 90% effective in preventing traveler’s diarrhea - Significantly reduces the motility of ETEC strains - Binds
Slide 37: Key Milestones Expected to Drive Value
Key Milestones Expected to Drive Value For personal use only 2Q 3Q 4Q 2018 2017 2017 2017 • IMM-529 • IMM-124E • IMM-124E • IMM-124E - Clinical supplies - NASH Phase 2 - NASH Phase 2 - NASH centric transaction manufacturing interim analyses topline results - Pediatric NAFLD Phase 2 - Initiation of P
Slide 38: Investment Highlights
Investment Highlights For personal use only ü Targeting inflammatory-‐mediated and infectious diseases with oral immunotherapies ü Lead program, IMM-‐124E, in Phase 2 with key data readouts before year end ü Phase 1/2 study IMM-‐529 for treatment of CDI expected to commence 2Q 2017 ü Well pos
Slide 39: Thank You
For personal use only Thank You