AI assistant
Immuron Ltd — Investor Presentation 2018
Mar 13, 2018
35121_rns_2018-03-13_918706c1-ed7d-476b-ba45-821aea6a95aa.zip
Investor Presentation
Open in viewerOpens in your device viewer
FWP 1 s109342_fwp.htm FWP
Filed Pursuant To Rule 433 Registration No. 333-215204 March 13, 2018
www.immuron.com Immuron Limited Oral Immunoglobulins Changing the Paradigms of Care March 2018 ASX:IMC NASDAQ:IMRN
Field: Page; Sequence: 3; Options: NewSection
Field: /Page
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 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.
Field: Page; Sequence: 4; Options: NewSection
Field: /Page
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 value indications, Fat Liver Disease and CDI. Excellent safety profile, GRAS by FDA, expedited regulatory review and approval process Well positioned to address high unmet medical need in multiple blockbuster markets High-value peer licensing deals and M&A underscore potential upside Company listed on NASDAQ in 2Q 2017 Experienced Management Team and strong support from leading KOLs and institutions (NIH, DoD) 3
Field: Page; Sequence: 5; Options: NewSection
Field: /Page
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 of Strong anti-toxin properties Targeted GUT Decrease toxin levels results in Pathogens decrease gut damage Antigen Specific Antibodies + Adjuvants Generally Regarded as Safe (IgG and IgG1) (GRAS) Platform capable of producing multiple drug candidates Long-term value creation Bovine IgG possesses a unique ability to remain active in the human GI tract Competitive delivering its full benefits to the bacteria found there Advantage Bovine IgG is capable of withstanding the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes in the GI tract Safety established Not absorbed into the blood 4
Field: Page; Sequence: 6; Options: NewSection
Field: /Page
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-Clinical Phase 1 Phase 2 Phase 3 Anti Inflammatory Programs Anti Infective Programs Program Highlights - Topline results Available - NIH Funded; UVA - Topline results expected 2019 - NIH Funded; Emory University - Topline results expected 4Q 2018 Collaboration with Dr. Rogler, Zurich University Murdoch Childrens Research Institue, La Trobe & RMIT Universities - Phase 1/2 initiated 4Q 2017 - Topline results expected Q1 2019 Collaboration with US Army Collaboration with US Navy 5
Field: Page; Sequence: 7; Options: NewSection
Field: /Page
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 Reduces the symptoms of minor gastro-intestinal disorders Antimicrobial Medsafe (New Not marketed in New Zealand Not marketed in New Zealand Zealand) FDA (USA) Self-affirmed generally Hyperimmune colostrum dietary supplement regarded as safe (GRAS) Dietary supplement. FDA does not review dietary supplements for safety and effectiveness Health Canada Natural Health Product Travelan helps reduce the risk of traveller’s diarrhea. EMA (Europe) Not marketed in Europe Not marketed in Europe ARTG Listing for Travelan http://www.travelanusa.com/ 6
Field: Page; Sequence: 8; Options: NewSection
Field: /Page
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) 7
Field: Page; Sequence: 9; Options: NewSection
Field: /Page
Immuron Limited IMM 124E 2001 NASH Clinical Trial Top Line Results March 2018
Field: Page; Sequence: 10; Options: NewSection
Field: /Page
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 elevated ALT at enrollment Statistically significant reduction in mean AST compared to placebo. Statistically significant effect to reduce CK-18 compared to placebo IMM-124E was shown to remain in the gut and not cross into the bloodstream No effect on liver steatosis 9
Field: Page; Sequence: 11; Options: NewSection
Field: /Page
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 Non-alcoholic fatty liver and the gut microbiota. Stavros B et al. Molecular Metabolism, 2016 Age-Associated Microbial Dysbiosis Promotes Intestinal Permeability, Systemic Inflammation, and Macrophage Dysfunction. Thevaranjan N1, et al. Cell Host Microbe 2017. Hepatic TLR4 signaling in obese NAFLD. Sharifnia T, et al. Am J Physiol Gastrointest Liver Physiol 2015 10
Field: Page; Sequence: 12; Options: NewSection
Field: /Page
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 10% or more macrovesicular steatosis IMM-124E 1200 mg HBA1C of <9.0 11
Field: Page; Sequence: 13; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 14; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 15; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 16; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 17; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 18; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 19; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 20; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 21; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 22; Options: NewSection
Field: /Page
ASPARTATE TRANSAMINASE (AST) LINEAR REGRESSION PREDICTED VALUES P=0.0446 21
Field: Page; Sequence: 23; Options: NewSection
Field: /Page
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
Field: Page; Sequence: 24; Options: NewSection
Field: /Page
PHARMACOKINETICS SERUM BOVINE Ig (n=102) No significant change in any of the arm All curves remain essentially flat 23
Field: Page; Sequence: 25; Options: NewSection
Field: /Page
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 drug 2 Possibly related to study drug: Worsening of Arthraligia - Grade 2 3 Possibly related to study drug: Diarrhea Grade 1 4 Road accident, Unrelated to study drug 24
Field: Page; Sequence: 26; Options: NewSection
Field: /Page
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 demonstrated in any study arm Pharmacokinetics shows no IMM-124E translocation into blood 25
Field: Page; Sequence: 27; Options: NewSection
Field: /Page
IMM-529 Neutralizing Clostridium difficile, while Sparing the Microbiome
Field: Page; Sequence: 28; Options: NewSection
Field: /Page
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 - Compelling data in all three phases of the disease including (1) prevention of primary disease, (2) treatment of primary disease and (3) prevention of recurrence - Orally administrated, safe >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate in control groups Potential orphan disease designation; Potential breakthrough / fast track designations Market exclusivity (biologics; High barriers to generic biosimilar entry) 27
Field: Page; Sequence: 29; Options: NewSection
Field: /Page
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 pricing) Vancomycin and metronidazole are the current standard of care, accounting for 80% of patient share (US) Unmet Need However, therapies are plagued by significant CDI recurrences (1st relapse: 25%; 2nd: 40%; 3rd: 50%) underscoring need for new treatments There is also growing resistance to vancomycin treatment Highly differentiated Neutralizes C. difficile but does not impact microbiome IMM-529 Only asset that targets not only toxin B but also the spores and the vegetative cells responsible for recurrence Positioning Can be used in combination with standard of care Targets many isolates Sources: GlobalData, Decision Resources, CDC 28
Field: Page; Sequence: 30; Options: NewSection
Field: /Page
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 germinate. 1 Vegetative Cells IMM-529 antibodies bind to Fimbriae and other surface 2 multiple epitopes on the layer proteins (SLP) contribute surface layer proteins (SLP) to bacterial colonization. on vegetative cells and limit Fimbriae are used to adhere to colonization. other bacteria and to host cells 3 and is one of the primary Toxin B IMM-529 antibodies bind to Toxin B is essential for multiple epitopes effectively virulence. Toxin B disrupt the neutralize toxin B, inhibiting toxin cytoskeleton and tight mediated epithelial cell apoptosis junctions of intestinal epithelial and limit toxin translocation into cells. the systemic circulation and inflammatory cascades
Field: Page; Sequence: 31; Options: NewSection
Field: /Page
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 In fe c te d , V a n c o m y c in tr e a tm e n t n use of antibiotics vs. e 4 0 statistically c r e P 2 0 0% for control group significant Prevention Studies (P<0.0001) Potentially only S u r v iv a l therapeutic 1 0 0 U n in fe c te d , N o tr e a tm e n t Demonstrated ~80% In fe c te d , N o tr e a tm e n t (approved or in l 8 0 a In fe c te d , N o n -im m u n e Ig G tre a tm e n t v i survival rate without v In fe c te d , IM M -5 2 9 tr e a tm e n t development) that r 6 0 u t s In fe c te d , V a n c o m y c in tr e a tm e n t use of antibiotics vs. n can treat all e 4 0 rc e <7% in control group P 2 0 phases of the Treatment Studies (P<0.0001) disease: 1. Prophylaxis S u r v iv a l 1 1 0 In f e c te d + S O C 2. Treatment 1 0 0 l 9 0 ** In fe c te d + S O C + IM M -5 2 9 Demonstrated ~20% a 8 0 p=0.0027 iv 3. Recurrence rv 7 0 relapse rate vs. u s 6 0 t 5 0 n ~89% relapse rate in e 4 0 rc e 3 0 P 2 0 control group 1 0 (P<0.0027) 0 Relapse Studies 0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0 D a y s a fte r v a n c o m y c in tr e a tm e n t c e a s e d 30
Field: Page; Sequence: 32; Options: NewSection
Field: /Page
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) Subjects randomized to IMM-529 or placebo in a 2:1 ratio Treatment duration: 28 days on top of SOC (vancomycin / metronidazole) Follow-up: 3 months overall Primary objective: To evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with CDI Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to treat patients with CDI 31
Field: Page; Sequence: 33; Options: NewSection
Field: /Page
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$423M SMMT SMT19969 Phase 1 US$143M ASMB ABI-M101 Preclinical US$419M As of May 4, 2017 32
Field: Page; Sequence: 34; Options: NewSection
Field: /Page
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 PETER + K P 2,907,236 2.23% 6 INVERAREY PL 2,731,632 2.09% 7 * FIFTY-FIFTH LEPRECHAUN PL 2,645,983 2.03% 8 INSYNC INV PL 2,500,000 1.92% 9 SBI INV PR LLC 2,000,000 1.53% 10 ADVANCE PUBLICITY PL 2,000,000 1.53% TOTAL TOP 20 SHAREHOLDERS 55,798,238 42.76% BALANCE OF SHARES 74,642,224 57.24% TOTAL SHARE ON ISSUE 130,440,462 100.00% * Denotes a Director Related Entity Current Company AUD$51.2M USD$39.5M (9 th Mar 2018) Market Capitalization 33
Field: Page; Sequence: 35; Options: NewSection
Field: /Page
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 - Topline results expected 1/2 Trial in CDI from Phase 1/2 study in CDI Results from colitis preclinical studies and US Army and US Navy trials expected 2018 34
Field: Page; Sequence: 36; Options: NewSection
Field: /Page
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 and the other documents that we have filed with the SEC for more complete information about us and this offering. You may get these documents for free by visiting EDGAR on the SEC web site at www.sec.gov .
Thank You
Field: Page; Sequence: 1; Options: Last
Field: /Page