Immuron Ltd — Investor Presentation 2017

Aug 6, 2017

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Immuron Presents NASH Interim Results at BioShares Conference

Melbourne, Australia, 7 August 2017: Australian biopharmaceutical company, Immuron Limited (ASX:IMC; NASDAQ:IMRN), is please to provide investors with a copy of its recent presentation slide deck showcased at the 2017 BioShares Biotech Summit conference held in Queenstown, New Zealand.

CEO, Dr Jerry Kanellos, presented clinical data from the Company’s recent interim analysis report from the IMM-124E Phase II study in NASH during the Fibrosis session entitled “Insights to Fibrosis Drug Discovery and Development”.

A copy of the presentation slide deck is appended to this announcement.

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COMPANY CONTACT: US INVESTORS RELATIONS: Jerry Kanellos Jon Cunningham Chief Executive Officer RedChip Companies, Inc. AUS Ph: +61 (0)3 9824 5254 US Ph: +1 (407) 644 4256, (ext. 107) jerrykanellos@immuron.com jon@redchip.com

AUSTRALIA INVESTORS RELATIONS: US PUBLIC RELATIONS: Peter Taylor Eric Fischgrund NWR Communications FischTank - Marketing and PR AUS ph: Ph: +61 (0)4 1203 6231 US Ph: +1 (646) 699 1148 peter@nwrcommunications.com.au eric@fischtankpr.com

ABOUT IMMURON:

Immuron Limited (NASDAQ: IMRN; ASX: IMC), is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the treatment of 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 and its lead clinical candidate, IMM-124E, is in Phase 2 clinical trials for NASH, ASH and Pediatric NAFLD. Immuron’s second clinical stage asset, IMM-529, is targeting C. difficile Infections (CDI). These products together with the Company’s other preclinical immunotherapy pipeline products targeting immunerelated diseases currently under development, will meet a large unmet need in the global immunotherapy market.

For more information visit: http://www.immuron.com

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FORWARD-LOOKING STATEMENTS:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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www.immuron.com
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Developing Therapies that Fundamentally
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2017
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ASX:IMC NASDAQ:IMRN

Oral Immunotherapy: Scalable, Disruptive Technolo gy

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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 inflammation
+ • Lowers organ injury
Clearance of • Not associated with general
Targeted GUT immune suppression
Antigen Specific Antibodies + Adjuvants Pathogens • Generally Regarded as Safe (GRAS)
(IgG and IgG1)
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• Platform capable of spawning multiple drugs  Long-term value creation

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

• Competitive Advantage • Significant hurdles to generic biosimilar entry  No pharmacokinetic baseline; Mixture (e.g., Copaxone)

• Safety established  Generally Regarded As Safe (GRAS)

NASH (Non-Alcoholic Fatty Liver) Pathophysiology

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NASH – Patho h siolo p y gy

• 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 broad 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 – 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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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: 134 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

	•	Timing: topline results by 4Q 2017
	•	NIH funded; sponsored by University of Virginia
ASH	• •	Expected enrollment: 66 patients 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
		7

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

Study

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

Populations

• The Full Analysis Set population had 122 patients who met this criterion.

• 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

Results

• Primary endpoint, change in HFF from Baseline to Week 24 did not show any treatment signals, in either FAS or PP populations

• There was a trend for serum ALT to decrease throughout 24 weeks.

• Exploratory analysis of 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.

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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2000
Analysis showed that the 1200
mg treatment group approached
0 a significant difference to
Placebo and that a dose effect
became evident with the 600 mg
-2000 group
The 1200 mg and 600 mg groups
-4000 were not different from one
another (p=0.3589) but each
approached significant
-6000 difference compared to placebo
(p=0.0036 and p=0.0075)
-8000
Group 1200mg 600mg Placebo
Predicted value adjusted for Baseline ALT
9
Predicted value for ALT AUC
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Thank You

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