Immuron Limited · ASX:IMC
Immuron — Biotech Showcase San Francisco 2018
34 slides from Immuron's conference presentation, January 2018
Slide 1: Immuron Limited: Oral Immunoglobulins Changing the Paradigms of Care
www.immuron.com Immuron Limited Oral Immunoglobulins Changing the Paradigms of Care January 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
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 Clea
Slide 5: Immunotherapy Targeting Pathogenic Bacteria
Immunotherapy Targeting Pathogenic Bacteria Technology Platform Capable of Producing High Levels of Antibodies against specific pathogenic and antigenic determinants Targeting Virulence Factors; Antigens Important For; • Spores • Outer Membrane Stability • Lipopolyscaccarride • Host Immune Evasion E
Slide 6: Proprietary Technology to "Weed" Harmful Bacteria
Immunotherapy Targeting Pathogenic Bacteria Proprietary Technology to “Weed” Harmful Bacteria Direct Protective MOA Indirect Protective MOA • Toxin Neutralization • Inhibition of Toxin Induced Inflammatory Signal Cascades • Suppression of Germination • Anti-Inflammatory Effect via • Suppression of A
Slide 7: Immuron's Clinical Programs
Immuron’s Clinical Programs Multiple Near-Term Inflection Points Development Stage Program Indications Program Highlights Pre-Clinical Phase 1 Phase 2 Phase 3 Anti-Inflammatory Programs - Interim data reported 2Q 2017 IMM-124E NASH - Topline results expected 1Q 2018 - NIH Funded; UVA IMM-124E ASH -
Slide 8: 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’ diar
Slide 9: Novel Approaches Targeting Pathogenic Gut Bacteria
Novel Approaches Targeting Pathogenic Gut Bacteria • Travelan contains high levels of specific antibodies which have been generated against 13 strains of Enterotoxigenic E.coli bacteria, the most common cause of Travellers’ Diarrhea. • The active pharmaceutical ingredient is bovine colostrum powder
Slide 10: Novel Approaches Targeting Pathogenic Gut Bacteria
Novel Approaches Targeting Pathogenic Gut Bacteria Formulated with 13 Strains of Proven to Be Cross-Reactive (binds) to Other E-Coli E-Coli Strains and Gram-Negative Bacteria Serotype Strains # • ETEC strain M452C1 [serotype O20:H-] • ETEC strain T0225-C4 [O75:H4] ETEC O6: H16 B2C • ETEC strain 83-5
Slide 11: Novel Approaches Targeting Pathogenic Gut Bacteria
Novel Approaches Targeting Pathogenic Gut Bacteria • Significantly reduces adherence of CFA/I producing ETEC strains to a cell-line that mimics the human small intestinal epithelium • Significantly reduces the motility of ETEC strains through soft agar Pre-Clinical Studies • Binds to both the bacter
Slide 12: Novel Approaches Targeting Pathogenic Gut Bacteria
Novel Approaches Targeting Pathogenic Gut Bacteria • Travelan has undergone clinical testing in two patient randomised, double-blind, placebo-controlled clinical trials (90 healthy volunteers) • Methodology: Study 1: 30 participants in total, 15 randomised to Clinical treatment and 15 to placebo Stu
Slide 13: IMM-124E: Revolutionary Treatment for Fatty Liver Disease
IMM-124E Revolutionary Treatment for Fatty Liver Disease
Slide 14: NASH (Non-Alcoholic Fatty Liver) Pathophysiology
NASH (Non-Alcoholic Fatty Liver) Pathophysiology 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 hepatic
Slide 15: IMM-124E in NASH
IMM-124E in NASH (Non-Alcoholic Fatty Liver) Liver: • 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 Innate system to supp
Slide 16: IMM-124E: Fatty-Liver Portfolio – Phase II Trials
IMM-124E: Fatty-Liver Portfolio – 3 Phase II Trials 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 Section at the NIH (Nati
Slide 17: IMM-124E Interim analysis
IMM-124E Interim analysis • 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 24W and have 2 MRI • Execution: Performed by an independent Committee to keep Company Blinded • Results: •
Slide 18: Phase II: Interim Analysis Report - Improves Liver Function
Phase II: Interim Analysis Report - Improves Liver Function Box plotResults for predicted ALT AUC of a Phase IIafrom ANCOVA clinical trial; (FAS population) N=133 Improved 24 Week Treatment; Liver ISSUES NO SAFETY EnzymesREPORTED 2000 • Using logarithmic regression the predicted value was used 0 • B
Slide 19: IMM-124E Key Milestones
IMM-124E Key Milestones 3Q 4Q 2018 2017 2017 • NASH Phase 2 interim • NASH Phase 2 Closed • NASH Phase 2 Topline analysis Results • Results of MOA studies: - Duke • Pediatric NAFLD Phase 2 topline results - Sanyal Biotechnology • ASH Phase 2 topline results • Results of colitis & US DoD pre-clinical
Slide 20: IMM-529: Neutralizing Clostridium difficile, while Sparing the Microbiome
IMM-529 Neutralizing Clostridium difficile, while Sparing the Microbiome
Slide 21: 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 - Compe
Slide 22: 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 premi
Slide 23: 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 germin
Slide 24: IMM-529 antibodies cross-reactive with exosporium layer of C. difficile spores
IMM-529 antibodies are cross-reactive with the exosporium layer from C. difficile spores exosporium 1 2 3 4 5 6 7 8 250 kDa Non-immune 1 KI (A+B+) 250 kDa 2 M7404 (A+B+) 3 VPI10463 (A+B+) IMM-529 #1 4 GE (A+B+) 5 MDU2992 (A-B+) 250 kDa 6 JGS6133 (A+B+) 7 AI35 (A-B+) IMM-529 #2 8-1470 (A-B+) IMM-529
Slide 25: IMM-529 antibodies cross-reactive with Toxin B from different strains
IMM-529 antibodies are cross- reactive with Toxin B from different C. difficile strains 1 2 3 4 5 6 7 8 9 10 11 1 KI (A+B+) 2 M7404 (A+B+) 250 kDa 3 VPI10463 (A+B+) Non-immune 4 GE (A+B+) 5 MDU2992 (A-B+) 6 JGS6133 (A+B+) 7 AI35 (A-B+) 250 kDa 8-1470 (A-B+) IMM-529 #1 9CD37 (A-B-) 10Purified Toxin B
Slide 26: IMM-529 antibodies neutralize Toxin B from historical and hypervirulent strains
IMM-529 antibodies neutralize Toxin B from historical and hypervirulent strains C o m m e r c ia l p u r ifie d T o x in B H is t o r ic a l T o x in B H y p e r v ir u le n t T o x in B (s t r a in V P I1 0 4 6 3 ) (s t ra in 6 3 0 ) (s t ra in K I) **** *** **** *** **** **** 100 100 100 75 75 % c
Slide 27: Results of Pre-Clinical Studies
Results of Pre-Clinical Studies 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 , IM M - 5 2 9 t r e a
Slide 28: Phase 1/2 Study Design
Phase 1/2 Study Design Phase 1/2 Study in CDI Initiated 4Q 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
Slide 29: IMM-529 Key Milestones
IMM-529 Key Milestones 3Q/4Q 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: 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 31: Capital Profile Immuron Limited
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 32: 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 33: Key Milestones Expected to Drive Value
Key Milestones Expected to Drive Value 2Q 3Q 4Q 2018 2017 2017 2017 • IMM-529 • IMM-124E • IMM-124E • IMM-124E - Clinical supplies - NASH Phase 2 - NASH Phase 2 study - NASH Phase 2 topline manufacturing interim analyses closed results - NASH MOA - NASH centric transaction - Pediatric NAFLD Phase 2
Slide 34: Thank You
Thank You ——