Slide 1: Immuron Limited: Oral Immunoglobulins Changing the Paradigms of Care
www.immuron.com Immuron Limited Oral Immunoglobulins Changing the Paradigms of Care March 2018 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 expre
Slide 3: Company Highlights
Company Highlights 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 multiple high va
Slide 4: Platform Overview: Oral Immunoglobulins
Platform Overview: Oral Immunoglobulins 1 2 3 Vaccines Are Antibodies Are Harvested Broad Therapeutic Effect Developed from Colostrum Reduced gut and blood pathogens Induction of responsible for initiating regulatory inflammation T-cells Reduces systemic inflammation + Lowers organ injury Clearance
Slide 5: Immuron's Clinical Programs
Immuron's Clinical Programs Multiple Near-Term Inflection Points Program IMM-124E IMM-124E IMM-124E IMM-124E IMM-124E IMM-529 IMM-124E / Shigella Vaccine IMM-124E Indications NASH ASH Pediatric NAFLD Colitis Autism C. difficile Shigella Infections Campylobacter; ETEC Infections Development Stage Pre
Slide 6: Travelan
TRAVELAN Hyperimmune bovine colostrum powder 200mg (30 caplets, 24 month shelf life) Reduces the risk of TD, reduces the Australian Packaging symptoms of minor GI disorders US Packaging Regulatory Regulatory Pathway Indications Authority TGA Listed Medicine Reduces the risk of travellers’ diarrhoea
Slide 7: Travelan immunoreactivity study
Prominent immune-reactive bands of Campylobacter, ETEC and Shigella isolates from Bhutan, Cambodia, Nepal and Thailand Travelan immunoreactivity study: Armed Forces Research Institute of Medical Sciences (AFRIMS) Walter Reed Army Institute of Research (WRAIR) US Naval Medical Research Centre (NMRC)
Slide 8: IMM-124E 2001 NASH Clinical Trial Top Line Results
Immuron Limited IMM 124E 2001 NASH Clinical Trial Top Line Results March 2018
Slide 9: Summary: IMM-124E Clinical Trial Results
SUMMARY: IMM-124E Clinical Trial Results IMM-124E demonstrated good safety and tolerability on both doses A statistically significant effect of IMM-124E to reduce serum levels of LPS A statistically significant and clinically meaningful effect to reduce ALT levels by 30% or more in patients with ele
Slide 10: LPS Antagonism First in Class MoA
LPS ANTAGONISM FIRST IN CLASS MoA Obesity, Diet and liver disease Dysbiosis "leaky gut" (LPS) Endotoxemia LPS engages TLR4 lipogenesis, inflammation, hepatocyte apoptosis and fibrosis Hyperglycemia drives intestinal barrier dysfunction and risk for enteric infection. Thaiss CA et al. Science, 2018 N
Slide 11: Study Design
STUDY DESIGN IMM-124E-2001 120 patients, 3-arms, Randomized, double Placebo blind, Placebo 2dose, balanced 1:1:1 design Major Inclusion Criteria Histologically proven NASH ( 12 months) SCREENING IMM-124E 600 mg NASH activity score (NAS) 4 45 D FOLLOW UP 4 W Cytologic ballooning score of at least 1 1
Slide 12: Study Endpoints
STUDY ENDPOINTS PRIMARY Safety Hepatic Fat Fraction SECONDARY liver enzymes ALT, AST, GGT Glucose homeostasis and serum lipid profile Serum Bovine Ig Pharmacokinetics Establish recommended dose MoA Lipopolysaccharides (LPS) CK-18 Cytokines Adiponectin and GLP-1 12
Slide 13: Study Populations
STUDY POPULATIONS Patients Screened: N = 237 Screening Failure n = 104 Patients Randomized: N = 133 Early Discont. n = 21 Non-compliance n=8 Major deviations n=2 Study Analysis Sets: PP: 102 FAS: 133 ITT: 133 Definitions: ITT = Intention to Treat FAS = Full analysis set PP = Per Protocol 13
Slide 14: Serum ALT Rate of Subjects with 30% Decrease
SERUM ALANINE AMINO-TRANSFERASE (ALT) RATE OF SUBJECTS WITH 30% DECREASE (n=94)* p=0.107 30.3% 28.6% 14.3% 35% 30% 25% 20% 15% 10% 5% 0% IMM 1200mg IMM 600mg PLB * outlier sites excluded (site recruiting <3 patients) as commonly practiced in clinical trials 14
Slide 15: Serum ALT Rate of Subjects with 30% Decrease (ALT BL >50)
SERUM ALANINE AMINO-TRANSFERASE (ALT) RATE OF SUBJECTS WITH 30% DECREASE* * excluded outlier sites, ALT BL >50 P=0.048 40% 35% 30% 25% 20% 15% 10% 5% 0% 36.4% 27.0% 13.6% IMM 1200mg IMM 600mg PLB 15
Slide 16: Serum LPS Rate of Patients with 15% Decrease
SERUM LIPOPOLYSACCHARIDES (LPS) RATE OF PATIENTS WITH 15% DECREASE* * Outlier sites excluded, Baseline LPS >250 P = 0.0184 70% 60% 50% 40% 30% 20% 10% 0% 64.3% 59.1% 34.5% IMM 1200mg IMM 600mg PLB 16
Slide 17: Serum LPS Overall Response Tertile Analysis
SERUM LPS OVERALL RESPONSE TO TREATMENT TERTILE ANALYSIS Analysis aimed at looking at the entire population Shows an overall beneficial effect across all patients Minimizes risk of cut-off selection bias p=0.0715 (1200mg vs. PLB) 17
Slide 18: Serum CK-18 Rate of Patients with 15% Decrease
SERUM CYTOKERATINE-18 (CK-18) RATE OF PATIENTS WITH 15% DECREASE (n=94)* * excluded outliers sites P = 0.0494 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 38.9% 18.2% 15.2% IMM 1200mg IMM 600mg PLB 18
Slide 19: Serum CK-18 Overall Response Tertile Analysis
SERUM CK-18 OVERALL RESPONSE TO TREATMENT TERTILE ANALYSIS Analysis aimed at looking at the entire population Shows an overall beneficial effect across all patients Minimizes risk of cut-off selection bias 19
Slide 20: Serum AST Rate of Subjects with Decrease
SERUM ASPARTATE-AMINOTRANSFERASE AST RATE OF SUBJECTS WITH AST DECREASE* >30% (n=94)* * excluded outlier sites 35% 30% 25% 20% 15% 10% 5% 0% P=0.107 30. 14.3% 14.3% IMM 1200mg IMM 600mg PLB 20
Slide 21: AST Linear Regression Predicted Values
ASPARTATE TRANSAMINASE (AST) LINEAR REGRESSION PREDICTED VALUES P=0.0446 21
Slide 22: Hepatic Fat Fraction
HEPATIC FAT FRACTION (n=102) No effect seen in any of the arms Since IMM-124E is no anti-steatotic 0.0 -0.5 -1.0 -2.5 0 -1.5 -2.0 Change in HFF (%) from Day 1200mg 600mg Group Placebo LS Mean Std Err 22
Slide 23: Pharmacokinetics Serum Bovine Ig
PHARMACOKINETICS SERUM BOVINE Ig (n=102) No significant change in any of the arm All curves remain essentially flat 23
Slide 24: Safety Results
SAFETY RESULTS (n=133) All Adverse Events Grade 3-4 subjects (events) SAE1 Events Rx stopped due to AE Death Total 572 28 6 2 1 Placebo n=44 [n(%)] 167 6 (6) 3 0 1 4 600mg IMM124E n=43 [n(%)] 192 6 (12) 1 1 2 0 1200mg IMM124E n=46 [n(%)] 213 5 (10) 2 1 3 0 1 SAE - None determined related to study dr
Slide 25: Summary
SUMMARY IMM-124E demonstrates an outstanding safety profile IMM-124E shows a significant decrease in serum LPS making it the first ever LPS-antagonist drug candidate IMM-124E reduces Liver enzymes IMM-124E demonstrates a significant reduction in CK-18 No change in Hepatic Fat Fraction was demonstrat
Slide 26: IMM-529: Neutralizing Clostridium difficile, while Sparing the Microbiome
IMM-529 Neutralizing Clostridium difficile, while Sparing the Microbiome
Slide 27: IMM-529 in Clostridium difficile Infection (CDI)
IMM-529 in Clostridium difficile Infection (CDI) 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 microbiome - Compellin
Slide 28: IMM-529 for the Treatment of CDI
IMM-529 for the Treatment of CDI Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5 Market billion by 2024 CAGR 15% Opportunity Nearly 30,000 patients die each year from C. difficile infections (US) Potential orphan disease (7 years market exclusivity and premium prici
Slide 29: Triple Action MOA
Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome 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 adheres to host cells and germinat
Slide 30: Results of Pre-Clinical Studies
Results of Pre-Clinical Studies S u r v iv a l 1 0 0 U n in fe c te d , N o tr e a tm e n t Demonstrated ~70% l 8 0 In fe c te d , N o tr e a tm e n t a v i In fe c te d , N o n -im m u n e Ig G tre a tm e n t survival rate without rv All studies 6 0 In fe c te d , IM M -5 2 9 tr e a tm e n t u t s
Slide 31: Phase 1/2 Study Design in CDI
Phase 1/2 Study Design Phase Study in CDI Initiated 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 subjects to be enrolled within the first 72 hours)
Slide 32: NASH and C. difficile Comps Indicate Potential for Substantial Growth
NASH and C. difficile Comps Indicate Potential for Substantial Growth 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 Phase 2 US$42
Slide 33: Capital Profile
Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN) Rank Holder Name Current Qty % Current Top 10 Shareholders 1 HSBC CUSTODY NOM AUST LTD (ADR Program) 19,531,706 14.97% 2 * GRANDLODGE PL 9,056,682 6.94% 3 AUTHENTICS AUST PL 8,624,999 6.61% 4 RETZOS EXECUTIVE PL 3,800,000 2.91% 5 * ANASTASIOU PET
Slide 34: Key Milestones Expected to Drive Value
Key Milestones Expected to Drive Value 4Q 1Q 2018 2019 2017 2018 IMM-124E IMM-124E IMM-124E IMM-124E - NASH Phase 2 study - NASH Phase 2 - NASH centric - ASH Phase 2 topline closed topline results transaction results - Pediatric NAFLD Phase 2 topline IMM-529 IMM-529 results - Initiation of Phase - T
Slide 35: Thank You
Thank You We have filed a registration statement with the Securities and Exchange Commission, or SEC, for the offering to which this communication relates. Before you invest, you should read the prospectus dated June 9, 2017 and the prospectus supplements dated November 2, 2017 and January 18, 2018