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Immuron Ltd Investor Presentation 2017

Aug 14, 2017

35121_rns_2017-08-14_2e0e492c-b581-40db-b9bb-8e82561b5314.pdf

Investor Presentation

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Immuron Commences US Non-Deal Institutional Investor Roadshow

Melbourne, Australia, August 15[th] , 2017: Australian microbiome biopharmaceutical company Immuron Limited (ASX: IMC; NASDQ: IMRN) is pleased to release to shareholders and investors its latest Company Update presentation ahead of a comprehensive roadshow to investment institutions, analysts and shareholders in the United States, where interim-CEO Dr. Jerry Kanellos will be updating on recent trials progress and upcoming milestones.

Dr. Kanellos will be meeting with key US fund managers to highlight the current position and strength of Immuron’s patent portfolio, the Company’s multiple clinical trials which are underway in the areas of NASH, ASH, C Clostridium Difficile Infection, and the increasing traction Immuron’s Travelan product, for the prevention of travellers’ diarrhea, is gaining in both the Australian and US market.

Immuron’s newly appointed Interim-CEO Dr. Jerry Kanellos highlighted;

“We have some very exciting times ahead at Immuron as many of our projects approach critical milestones and targets. Following the initial share price fluctuations after our NASDAQ listing, it’s important than we now firm up our investor base and showcase Immuron’s amazing technology platform to those who are yet to see and understand the Immuron story.

I’m truly honored to be able to present Immuron to the market and explain the Company value proposition to US institutional investors as we move into the next phase of our lifecycle.”

      • END - - -

COMPANY CONTACT: US INVESTORS RELATIONS: Dr. Jerry Kanellos Jon Cunningham Interim-Chief Executive Officer RedChip Companies, Inc. AUS Ph: +61 (0)3 9824 5254 US Ph: +1 (407) 644 4256, (ext. 107) [email protected] [email protected]

AUSTRALIA INVESTORS RELATIONS:

Peter Taylor NWR Communications AUS Ph: +61 (0)4 1203 6231 [email protected]

US PUBLIC RELATIONS:

Eric Fischgrund FischTank - Marketing and PR US Ph: +1 (646) 699 1148 [email protected]

Level 3, 62 Lygon Street Carlton South, Victoria AUSTRALIA 3053

www.immuron.com ABN: 80 063 114 045

Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735

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ABOUT IMMURON:

Immuron Ltd (ASX: IMC) is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the treatment of many gut mediated diseases. Immuron has a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets and sells Travelan® for the prevention of travellers’ diarrhea whilst its lead product candidate IMM-124E is in Phase 2 clinical trials for NASH and ASH. These products together with the Company’s other preclinical immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the market. For more information visit: http://www.immuron.com

FORWARD-LOOKING STATEMENTS:

Certain statements made in this release 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 commercialising 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 release 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 release except as required by law or by any appropriate regulatory authority.

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www.immuron.com
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Immuron Limited
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Changing the
Paradigms of Care
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ASX:IMC NASDAQ:IMRN

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 forwardlooking 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.

Company Highlights

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  • 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)

Experienced Management Team

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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 company.

Dan Peres, MD

Chief Medical Officer

Dr. Peres, a surgeon by training, has deep experience in liver diseases and clinical development including NASH, having worked for leading Medical Devices and Pharma companies since 2008.

.

Travis Robins US Sales Director

Reza Moussakhani

Manufacturing Quality Director

Mr. Robins is an accomplished, motivated leader with progressive years of proven success in dramatically increasing revenues and expanding market shares, while building key relationships.

Mr. Moussakhani has extensive experience in implementation of project/quality and process improvements, including with Hospira and Sigma Pharmaceuticals.

Prominent Scientific Advisory Board and Leadin Research Partners g

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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 PI of Galectin’s GR-MD-02’s Phase II trial.

Dr. Manal Abdelmalek (MD) Duke University Medical Center

Dr. Abdelmalek is a leading investigator in the field of NASH.

Dr. Gerhard Rogler (MD, PhD) Zurich University

Professor Rogler is a leader in the field of Colitis and has authored more than 200 original peer-reviewed articles.

Dr. Miriam Vos (MD) Emory University

Dr. Vos specializes in the treatment of gastrointestinal disease in children as well as fatty liver disease and obesity.

Dr. Dena Lyras (PhD) Monash University

Dr. Lyras is one of the world’s leading experts in C. difficile .

Organizations

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Oral Immunoglobulins: Scalable, Disruptive Technolo gy

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Vaccines Are Antibodies Are Harvested Broad Therapeutic Effect Developed from Colostrum

Induction of regulatory T-cells

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regulatory
T-cells
+
Clearance of
Targeted GUT
Antigen Specific Antibodies + Adjuvants Pathogens
(IgG and IgG1)
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  • Reduced gut and blood pathogens responsible for initiating inflammation

  • Reduces systemic inflammation

  • Lowers organ injury

  • Not associated with general immune suppression

  • Generally Regarded as Safe (GRAS)

  • Platform capable of producing multiple drug candidates � Long-term value creation

Competitive Advantage

  • Regulated as biologics by the FDA � 12 years exclusivity in the US for each approval

  • Unique technology offering protection from future generic biosimilar market erosion

  • Safety established � Generally Regarded As Safe (GRAS) by FDA, accelerated approval process

  • Low manufacturing costs � ~ $1 / gram compared with > $100 / gram for MAb

Immuron’s Clinical Programs Multi le Near-Term Inflection Points p

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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 4Q 2017
- NIH Funded; UVA
IMM-124E ASH
- Topline results expected 2018
- NIH Funded; Emory University
IMM-124E Pediatric NAFLD
- Topline results expected 1H 2018
Collaboration with Dr. Rogler, Zurich
IMM-124E Colitis
University
Murdoch Childrens Research
IMM-124E Autism Institue,
La Trobe & RMIT Universities
Anti-Infective Programs
IMM-529 C. difficile Phase 1/2 Expected to start 3Q 2017
IMM-124E / Shigella
Collaboration with US Army
Shigella Vaccine Infections
Campylobacter;
IMM-124E Collaboration with US Navy
ETEC Infections
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IMM-124E

Revolutionary Treatment for NASH

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NASH (Non-Alcoholic Fatty Liver) Pathophysiology

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NASH – Patho h siolo p y gy

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  • 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 tolerance the gut immune system can promote antiinflammatory effect

Source: Adapted from Cohen-Naftaly; Scott L. Friedman, 2011

IMM-124E in NASH (Non-Alcoholic Fatty Liver)

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  • 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 control and inhibit excess inflammation)

  • Strong anti-fibrotic effect demonstrated with CCl4 model

  • Unique competitive profile due to safety/MOA:

  • Addresses multi-factorial nature of NASH

  • Potential for combination use

  • Safety profile supporting of long-term chronic use

  • Potential to expand to mild/moderate populations

  • Market exclusivity (biologics; High barriers to generic biosimilar entry)

IMM-124E – Uniquely Positioned to Address Large Unmet Need of $35B Market (2030)

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NASH Cirrhosis
NAFLD
25M People 1.2M people
Up to 145M People
F0 F1 F2 F3 F4
• 17M People 8M People
No regulatory
pathway currently
exists for NAFLD
• Intercept (OCA)
Drug would need to
Tobira (CCR2/CCR5)
be extremely safe to
Galmed (Aramchol)
be considered for
Genfit (Elafibranor)
trial / approval

NAFLD not
Galectin (GR-MD-02)
available to current
competitors due to IMM-124E
safety profile
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  • • Only asset in development that, due to its safety profile: Up to 50% of the -

  • US population are Can potentially target all spectrum of the disease including mild/moderate patients -

  • thought to have Likely can be used in combination with any other agents currently in development NAFLD - No safety concerns to date that could limit chronic / long-term use

IMM-124E: Fatty-Liver Portfolio – 3 Phase II Trials

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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 (National Institute of Health)
  • Multi-center, double-blinded, placebo controlled trial; 25 sites running in US, Australia and Israel

  • NASH Fully recruited: 133 patients with biopsy proven NASH

    • Primary endpoint: changes in liver fat content confirmed by MRI; changes in ALT (liver enzymes)

    • • 3 arms: placebo, high dose and low dose

    • • Timing: topline results by 4Q 2017

  • NIH funded; sponsored by University of Virginia

  • • Expected enrollment: 66 patients

  • ASH • Endpoint: ALT

  • • Timing: topline results in 2018

  • • NIH funded; sponsored by Emory University

  • Pediatric Expected enrollment: 40 patients NAFLD • Endpoint: ALT; 3 months treatment • Timing: topline results in 1H 2018

IMM-124E – Summary of Data Prevention of Fibrosis and Improvement in Metabolic & Inflammatory Markers

Carbon-Tetrachloride (CCl4) a non-disease related fibrosis model

  • Aim: To demonstrate effects of IMM-124E on Fibrosis caused by Intraperitoneal CCl4

CCl4 Fibrosis Studies

Results:

  • Marked reduction in Liver Fibrosis and Inflammation on Histology

  • Marked reduction on Liver Damage markers (i.e. ALT, Bilirubin etc.)

  • Marked reduction in Liver Activated Macrophages (F4/80 high)

Model represents the Metabolic syndrome

  • Aim: To demonstrate the effect of IMM-124E or anti-LPS IgG (derived from IMM-124E)

Results:

Ob-Ob Mice

  • Anti-LPS IgG considerable reduces ALT level

  • Improved metabolic status for IG and IMM-124E treated mice (i.e. TG, Fasting Glucose and OGTT)

  • Anti-inflammatory shift: Decreased TNF- α and increase splenic NKT cells

Aim: To show safety and efficacy of IMM-124E Biopsy Proven NASH Patients

Population: 10 subjects with biopsy proven NASH and Type 2 Diabetes

Phase 1/2 Clinical Studies

Results:

  • Improved Metabolic status (e.g. HbA1c, HOMA OGTT) GLP1 and Adiponectin

  • Improved Liver status (e.g. ALT)

  • Proof of concept: increase in Circulatory Regulatory T-Cell

IMM-124E in NASH (Non-Alcoholic Fatty Liver)

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Liver:
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• 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 suppress • TNF-α ↓
inflammation (NKT, DC, • IL-2, IL-6, IL-10, IL-12
macrophages)
• Treg ↑ (CD4, CD25, FoxP3)
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Animal Models: IMM-124E Improves Fibrosis and Inflammatory Markers

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Decrease Portal Inflammation

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Group A: Group B: Naïve
Control anti LPS
Group C: Group D:
Treated Treated
3
2.4 p<0.02
2.5 ^^ p<0.01
2
1.4 1.33
1.5
0.66
1
0.5
0
A B C D
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Improved Metavir Fibrosis Score

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Group A: Group B: Naïve
Control anti LPS
Group C: Group D:
Treated Treated
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4
3.5 3.4 p<0.0009
^^ p<0.0003
3
2.5
1.8
2
1.5 1
1
0.5
0
0
A B C D
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Mizrahi M. 2013, AASLD; Hepatology 751A

Animal Models: Macroscopy – Prevents Fibrosis

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Fibrotic Liver CCl4 (carbon tetrachloride)

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IMM-124E Treated Liver CCl4 (carbon tetrachloride)

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Treatment with IMM-124E Prevents Fibrosis and Inflammation

Mizrahi M. 2013, AASLD; Hepatology 751A

Suppression of F4/80High Macrophages

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Marked Reduction in Liver Activated Macrophages (F4/80 high)

Phase 1/2: Improves Liver Function and Reduces Insulin Resistance

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Results of a Phase 1/2a clinical trial; N=10 30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED

Improved HBA1C, OGTT and HOMA

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Improved Liver Enzymes

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Improved Metabolic Status (e.g. HbA1c, HOMA OGTT) GLP1, and Adiponectin and Liver Function (e.g. ALT)

Mizrahi M, J Inflamm Res. 2012;5:141-50

Phase 1/2: Improves Inflammatory Biomarkers

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Increased CD4+CD25+FOXP3+ TREGS

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Day 1 Day 30
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Increased GLP1 and Adiponectin

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Proof of Concept: Increase in Circulatory Regulatory T-Cell

Mizrahi M. J Inflamm Res. 2012

IMM-124E: NASH Phase II Trial

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IMM-124E-2001 Interim Analysis – No Safety Issues Reported

  • The study has 12 scheduled visits over the study duration of 28 weeks (24 weeks treatment and 4 weeks follow-up.

  • NASH • The interim analysis was triggered when 80 patients ( two thirds of the planned study population) had

  • Study completed the entire 24-week treatment period and had verified Baseline and week 24 MRI data. • The purpose of the interim analysis was to determine whether any signals exist regarding; safety of the study treatment and to search for signals of efficacy from primary, secondary and exploratory endpoints.

  • • A total of 133 patients have been randomized into the study.

  • Patient To be included in the interim analysis patients were required to have attended one post baseline visit. • The Full Analysis Set population had 122 patients who met this criterion.

  • Populations • To be included in the Per Protocol population patients had to complete the 24-week treatment period, have valid Baseline and Week 24 MRI values. A total of 69 patients met this criteria.

    • Baseline participant characteristics across the 3 treatment groups are similar

    • Baseline LPS 1000 – 10,000 times level reported for healthy blood donors

    • Interim Analysis report achieves main goals – Safety, Tolerability and Futility

  • Results There was a significant decrease in serum ALT and AST throughout 24 weeks, Changes in ALT values taking into account all time points by calculating area under the curve and correcting for baseline values demonstrated a dose-related effect.

    • IMM-124E demonstrated a systemic effect decreasing liver injury and it’s potential to treat NASH as a non-absorbable drug

IMM-124E Interim analysis

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  • 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:

  • Excellent Safety

  • Treatment well tolerated at both doses

  • No Futility

  • Significant change in ALT and AST at 24W

  • Significant reduction in ALT and AST over time compared to placebo

  • Dose response

  • Non-absorbable

Phase II: Interim Analysis Report - Improves Liver Function

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  • Change in ALT by treatment group and visit (FAS population)Results of a Phase IIa clinical trial; N=133

24 Week Treatment; NO SAFETY ISSUES REPORTED

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Change in ALT (U/L) from Day 0
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  • When comparing the 24W values of serum ALT to baseline all arms demonstrate a significant reduction

  • However the change over time is different across the study arms

Phase II: Interim Analysis Report - Improves Liver Function

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Box plot for predicted ALT AUC from ANCOVA (FAS population) Results of a Phase IIa clinical trial; N=133 24 Week Treatment; NO SAFETY ISSUES REPORTED Improved Liver Enzymes

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  • Using logarithmic regression the predicted value was used

  • Both 1200 mg and 600 mg arms demonstrated significant change over placebo (p=0.0036 and p=0.0075)

  • but were not different from one another (p=0.3589)

IMM-124E Key Milestones

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  • • •

  • 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 - - topline results SanyalBio Duke

    • ASH Phase 2 topline results
  • Results of colitis pre-clinical studies: ~~2017/2018~~

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IMM-529

Neutralizing Clostridium difficile , while Sparing the Microbiome

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IMM-529 in Clostridium difficile Infection (CDI)

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  • 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)

IMM-529 for the Treatment of CDI

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  • 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 Positioning

  • Only asset that targets not only toxin B but also the spores and the vegetative cells responsible for recurrence

  • Can be used in combination with standard of care

  • Targets many isolates

Sources: GlobalData, Decision Resources, CDC

Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome

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Spores – Infectious Particles

IMM-529 antibodies bind to multiple epitopes on surface antigens on spores and prevent adheres to host cells and limit germination.

Heat, ethanol and UV resistant. Survive gastric acid, adhere to cells in the colon and germinate.

Vegetative Cells

Fimbriae and other surface layer proteins (SLP) contribute to bacterial colonization. Fimbriae are used to adhere to other bacteria and to host cells and is one of the primary mechanisms of virulence

IMM-529 antibodies bind to multiple epitopes on the surface layer proteins (SLP) on vegetative cells and limit colonization.

Toxin B

IMM-529 antibodies bind to multiple epitopes effectively neutralize toxin B, inhibiting toxin mediated epithelial cell apoptosis and limit toxin translocation into the systemic circulation and inflammatory cascades.

Toxin B is essential for virulence. Toxin B disrupt the cytoskeleton and tight junctions of intestinal epithelial cells.

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1
2
3
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Results of Pre-Clinical Studies

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Survival
100 Uninfected, No treatment
Infected, No treatment
80 Infected, Non-immune IgG treatment
60 Infected, IMM-529 treatment
Infected, Vancomycin treatment
40
20
0
0 1 2 3 4
Days post infection
Percent survival
Prevention Studies
Treatment Studies
Relapse Studies
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Demonstrated ~70% survival rate without use of antibiotics vs. 0% for control group (P<0.0001)

Demonstrated ~80% survival rate without use of antibiotics vs. <7% in control group (P<0.0001)

Demonstrated ~20% relapse rate vs. ~89% relapse rate in control group (P<0.0027)

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All studies statistically significant

Potentially only therapeutic (approved or in development) that can treat all phases of the disease:

1.Prophylaxis

2.Treatment

3.Recurrence

Phase 1/2 Study Design

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Phase 1/2 Study in CDI Expected to Commence 3Q 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

IMM-529 Key Milestones

  • Clinical supplies manufacturing

  • Topline results expected from Phase 1/2 study in CDI

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  • Initiation of Phase 1/2 Trial in CDI

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Corporate and Financial Overview

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Robust IP and Extended Market Protection

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  • 6 patent families offering composition and/or method of treatment claims

  • • Approved / pending in major geographies including US, Europe, Japan and

  • Strong Patent China

  • Portfolio • Granted patent terms ending between 2024 and 2030 with possible extensions

  • Extended Immuron’s drugs are considered “biologics” by the FDA Market • In the US, this is expected to confer Immuron’s new drugs 12 years of

  • Exclusivity market exclusivity, offering investors a long revenue tail • Immuron’s drug not absorbed in the blood

  • Generic • No baseline for PK studies

  • Protection • This results in lengthy process for biosimilar manufacturers

Recent High-Value NASH LM&A Highlights Potential for Si nificant U side g p

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  • 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

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  • 2016: Licensed preclinical • 2015: Acquired Phenex

  • NASH asset

  • NASH asset in Phase 2

  • ~$50M upfront + other undisclosed milestones • Total deal value $470M

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  • 2015: Acquired Pharmaxis

  • 2014: Acquired Lumena

  • 2 Phase 2 assets for NASH and cholestatic liver disease

  • NASH asset in Phase 1

  • $39M upfront – Total deal value $600M • Total deal value $260M

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  • 2014: Acquired Nimbus

  • 2016: Acquired Tobira

  • Preclinical assets and platform

  • ~ $530M (5x market cap at •

  • time of announcement), in a $400M upfront in a deal deal valued at up to $1.7B valued at $1.2B

NASH and C. difficile Comps Indicate Potential for Substantial Growth

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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
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Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)

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Current Top 10 Shareholders

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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 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
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Current Company Market Capitalization

AUD$23.4M ≈ USD$18.6M (8[th] Aug 2017)

Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)

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130,440,462 Issue Shares (Fully Paid)
Issued Capital
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)
9,937,629 Unlisted Options exercisable at various prices
Recent Share IMC Expands Agreement with US Army - 3 Additional Therapeutics
Price Activity
Travelan Increases Industry Presence
Positive Results of IMM-124E in Acute Colitis Studies
NASDAQ Listing
NASH Phase II Interim Analysis Success
Close of Recruitment of Phase II NASH Trial
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Travelan OTC/Business A unique OTC targeting Traveler’s Diarrhea

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  • 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 substantially greater reactivity against purified ETEC flagella antigen than IgG purified from nonimmune colostrum powder

  • Annual Revenues of AU$1M+; Cash flow positive

  • Net revenues: 1H2017 +41% vs 1H2016

  • Pursuing new geographies

  • Potential WW peak sales: $20M+

  • Multiple ways to keep growing OTC business:

  • Continued penetration of current markets

  • Geographic expansions

  • New products / New formulations (e.g., shigella)

Key Milestones Expected to Drive Value

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  • IMM-529IMM-124EIMM-124EIMM-124E

          • Clinical supplies NASH Phase 2 NASH Phase 2 NASH centric transaction -
  • manufacturing interim analyses topline results Pediatric NAFLD Phase 2 - - SanyalBio – NASH Duke – NASH MOA topline results -

  • MOA ASH Phase 2 topline results

  • IMM-529 - Initiation of Phase 1/2 Trial in CDI • IMM-529 - Topline results expected from Phase 1/2 study in CDI

  • Results from colitis preclinical studies and Army and US Navy trials expected 2017/2018

Investment Highlights

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  • Well positioned to address high unmet medical need in multiple blockbuster markets

  • Two clinical assets, 4 phase 2 clinical trials on going

  • Robust R&D pipeline

  • High-value peer licensing deals and M&A underscore potential upside ( Current Market Capitalization = USD$18.6M, 6 August 2017)

  • Validated technology platform – with one registered asset generating growing revenue

  • Listed on NASDAQ in 2Q 2017

  • Experienced Management Team with strong support from leading KOLs and institutions

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Thank You

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