Immuron Ltd — Investor Presentation 2019

Jun 18, 2019

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FORGING COMMERCIAL & CLINICAL PATHWAYS

TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – JUNE 2019

GARY S. JACOB, Ph.D. CEO

NASDAQ: IMRN ASX: IMC

1

SAFE HARBOR STATEMENT

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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.

Immuron believes the statements are based on reasonable are Although forward-looking assumptions, they 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.

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COMPANY HIGHLIGHTS

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We are a commercial and clinical-stage biopharmaceutical company focusing on infectious diseases with oral immunoglobulin-based therapies.

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Validated Technology Platform – with One Registered Asset, Travelan® Generating Revenue

IMM-124E & IMM-529, in Clinical Development for Treatment of Liver Disease and C. difficile Infections

Plan for Accelerated R egulatory Path to Approval for IMM124E (Travelan®) as Drug to Prevent Travelers’ Diarrhea in USA

PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS

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Toxin
Neutralization
+
Oral
Isolation of
Development Antimicrobial Clearance of
hyperimmune
of Highly
therapeutics targeted gut
antibody-rich
Specific without pathogens
bovine
Vaccines
drawbacks of
colostrum
antibiotics
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DEVELOPMENT PIPELINE: TWO-PRONGED PLAN

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	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	HIGHLIGHTS
	PRE-CLINICAL	PHASE 1	PHASE 2	PHASE 3	MARKET
	ANTI-INFLAMMATORY PROGRAMS
Travelan®	Commercial product - Australia Commercial product - Canada Health Canada NPN 80046016 (2015) TGA ARTG Aust L106709 (2004)
	Commercial product - USA Dietary supplement (2015)
IMM-124E (Travelan®) PLAN TO DEVELOP AS DRUG TO PREVENT TRAVELERS’ DIARRHEA IN USA
IMM-529 TO PREVENT RECURRENCE IN C. DIFFICILE PATIENTS

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US DOD R&D COLLABORATION AGREEMENTS

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Collaboration on Development of a Shigella-Specific Therapeutic

• Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016

• Naval Medical Research Center (NMRC) – August 2016

• Walter Reed Army Institute of Research (WRAIR) – June 2016

• Travelan® binds 180 pathogenic strains of bacteria from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand

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BACKGROUND OF TRAVELAN®: PLAN TO EXPAND USE

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COMMERCIAL PRODUCT

DRUG CANDIDATE IMM-124E

Marketed in Australia, USA and Canada

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Plan to develop IMM-124E as an approved drug to prevent Travelers’ Diarrhea

Status with FDA: IND 14,933*

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*IMM-124E for treatment of NASH

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WHAT IS TRAVELERS’ DIARRHEA?

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• Caused by consuming food or water infected with pathogens. Three or more unformed stools in 24 hours.

• .

• Bacterial pathogens are the predominant risk[1]

• Enterotoxigenic E. coli (ETEC) are the :

• predominant pathogens[2,3]

42% in Latin America

28% in Southeast Asia

• Up to 70% of travelers suffer from travelers’ diarrhea[4] .

• 1 – Steffen, R. 2017 Epidemiology of travelers’ diarrhea. Journal of Travel Medicine 24(1)

• 2 – Leder, K. 2015 Advising Travellers about Management of Travelers’ Diarrhea. Australian Family Physician, vol 44 No. 1-2 Jan. Feb 2015

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• 3 – Castelli et. al., Epidemiology of Travelers’ Diarrhea, J. Travel Medicine 2001; 8 (Suppl2) S26-S30

• 4 – CDC Yellow Book 2018, Chapter 2 Travelers’ Diarrhea.

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TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS

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Immuron Sales

2019 Global market - US $630M Expected to reach US $890M by 2024 at 7% CAGR[1]

1. https://www.marketwatch.com/press-release/at-71-cagrtravelers-diarrhea-therapeutics-market-size-to-reach-usd890-million-by-2024-2019-05-08

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$3,000,000
$2.68M
$2,500,000
$2.01M
$2,000,000
$1.38M
$1,500,000
$1,000,000
$500,000
$0
FY17A FY18A FY19B
AUD
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ANTIBIOTIC RESISTANCE: OPPORTUNITY FOR TRAVELAN®

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: International Society of Travel Medicine, 2017 guidelines for treating Travelers’ Diarrhea included[1]

• Antibiotics should NOT be used routinely, except patients at high risk of complications

• Rifaximin recommended when antibiotic prophylaxis is indicated

• Fluoroquinolones not recommended for prophylaxis[2]

• Insufficient evidence to recommend prebiotics or probiotics

The opportunity: Travelan®, the alternative to antibiotic treatment of TD

• 1 Riddle et al. 2017. Guidelines for the prevention and treatment of travellers’ diarrhea: a graded expert panel report. Journal of Travel Medicine 24(1).

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• 2 Tribble, D. 2017 Resistant pathogens as causes of traveller’s diarrhea globally and impact(s) on treatment failure and recommendations. Journal of Travel Medicine 24(1)

TRAVELAN® AS A DRUG TO PREVENT TRAVELERS’ DIARRHEA

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• Travelan® evaluated in two randomised, double-blind, placeboControlled Human Infection Model challenge clinical trials

Oral challenge with O78 ETEC strain (H10407)

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PLACEBO IMM-124E
400mg TID
15 15
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Diarrhea was defined as passage of two or more unformed stools during 48 hour period within 72 hours of the challenge

• 90 healthy volunteers in Study 1 & 2

• Published in Scandinavian Journal of Gastroenterology

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Otto et al. 2011 Randomized Control Trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by ETEC in volunteers. Scandinavian Journal of Gastroenterology, 2011; 46: 862–868.

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SUMMARY OF RESULTS FROM STUDY 1

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Treatment Group

Treatment Group	Treatment Group	Treatment Group	Treatment Group
Placebo Colostrum_p_
Number of volunteers	15	15
Number of volunteers with diarrhea	11 (73%)	1 (7%)	0.0005
Number of diarrheal stools/volunteer (mean + SEM)	4.4±0.9	0.4±0.4	0.0004
Mean number of diarrheal stools per volunteer with diarrhea (mean and range)	6 (2 – 8)	6 (6)	NS
Abdominal pain	5 (33%)	0 (0%)	0.04
ETEC H10407 isolated from feces after challenge	15 (100%)	12 (80%)	NS

*Fisher’s exact test or Student’s t-test (two-tailed) as appropriate. NS, not significant

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SUMMARY OF RESULTS FROM STUDY 2

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	Treatment Group Group 1: Group 2: Group 3: Group 4: Placebo Colostrum Colostrum Colostrum tid 400 mg tid + buffer 200 mg tid 400 mg tid	Treatment Group Group 1: Group 2: Group 3: Group 4: Placebo Colostrum Colostrum Colostrum tid 400 mg tid + buffer 200 mg tid 400 mg tid	Treatment Group Group 1: Group 2: Group 3: Group 4: Placebo Colostrum Colostrum Colostrum tid 400 mg tid + buffer 200 mg tid 400 mg tid	Treatment Group Group 1: Group 2: Group 3: Group 4: Placebo Colostrum Colostrum Colostrum tid 400 mg tid + buffer 200 mg tid 400 mg tid
Number of volunteers	14	14	14	14
Number of volunteers with diarrhea	12 (86%)	2 (14%),p= 0.0004*	5 (36%),p= 0.02	3 (20%),p= 0.007
Number of diarrheal stools/volunteer (mean + SEM)	3.9±0.8	0.5±0.3,p= 0.0005	1.8±0.8,p= 0.07	0.9±0.5,p= 0.003
Mean number of diarrheal stools per volunteer with diarrhea (mean and range)	5 (3–10)	3.5 (3–4)	5 (2–7)	4.7 (2–7)
Abdominal pain	5 (36%)	0 (0%),p= 0.04	2 (14%),p= 0.04	0 (0%),p= 0.02
ETEC H10407 isolated from feces after challenge	12 (86%)	14 (100%)	14 (100%)	12 (80%)

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*All tests compared results of active treatment with placebo group; calculation by Fisher’s exact test or Student’s t -test (two-tailed)

TRAVELAN®: ORAL CHALLENGE STUDY PREVENTION OF SHIGELLOSIS (BACILLARY DYSENTERY) IN PRIMATES*

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• 12 juvenile rhesus monkeys randomly assigned to Travelan® (n=8) or placebo (high protein milk powder) (n=4) treatment groups

• Travelan® or placebo (500mg) was administered 2x daily for 6-days, starting on day 0

• Each monkey challenged with 2.8 x 10[9] Shigella flexneri 2a intragastrically on day 3

• Travelan® /placebo treatment stopped on day-6. Monkeys monitored through to day 14

• Faecal samples taken 2 x daily and cultured to establish presence/absence of Shigella flexneri

• Animals continually monitored for clinical signs

• *Collaborative animal model study with AFRIMS & WRAIR

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RESULTS OF TRAVELAN® SHIGELLA CHALLENGE STUDY*

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3 x10 [9]
S. flexneri
“Travelan®” x 6 days No Treatment x 8 days
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14
“Placebo” x 6 days
1
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*Collaboration with AFRIMS & WRAIR

= last day of S. flexneri consecutive +ve stool culture

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SUMMARY OF TRAVELAN® SHIGELLA ANIMAL STUDY

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Placebo (high protein milk powder) provided no protection against acute shigellosis

• All (4/4) Placebo treated monkeys developed severe acute enteric shigellosis.

Travelan® provided 75% protection against acute shigellosis

• 2 of 8 (25%) Travelan®-treated monkeys developed severe acute enteric shigellosis

• 6 of 8 (75%) Travelan®- treated monkeys survived Shigella flexneri challenge

• S. flexneri was undetectable in consecutive faecal samples by day-7 in 4 of 6 (67%) survivors and by day 9 in the remaining 2 (33%) survivors

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IMM-124E DRUG DEVELOPMENT PLAN

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Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea in travelers to endemic areas:

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File IND with
Hold Pre-IND Single Double- Execute
Assimilate Data
Meeting to Blind & Placebo Prevention Trial
to Support
Discuss Merits of Controlled Trial and File
Literature-Based
505(b)(2) for Prevention of Registration
FDA Submission
Application Travelers’ Package
Diarrhea
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US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG TO PREVENT TD

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MARKET POTENTIAL FOR TRAVELAN® SALES:

Market potential figure derived from:

2014 figures of US citizens traveling to high risk destinations for TD (44.3 million)[1] and obtaining pretravel advice (22.2 million)[2] . Sources of pre-travel advice include primary care provider, travel medicine specialist, company doctors, pharmacist, and travel agencies[2] . Our forecast utilizes a very conservative estimate for % of US citizens purchasing Travelan® after seeking pre-travel advice.

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1. U.S. Department of Commerce, International Trade Administration, National Travel and Tourism Office. U.S. Citizen Traffic to Overseas Regions, Canada & Mexico 2014. Monthly Statistics, U.S.Outbound Travel by World Regions. 2014. Available at: http://travel.trade.gov/view/m-2014-O-001/index.html. Accessed June 26, 2015.

2. Mathyas Wang , MD , Thomas D. Szucs , MD, MBA, MPH, LLM , and Robert Steffen , MD. Economic Aspects of Travelers ’ Diarrhea. Journal of Travel Medicine, Volume 15, Issue 2, 2008, 110–118

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COMPETITOR MARKET ANALYSIS – ANTI-DIARRHEAL DRUGS

Drug	Indication	Dosing	Ave cost – 2 week trip	Revenue USD Millions (Year)
FDA APPROVED DRUG TREATMENTS FOR DIARRHEA
PEPTO BISMOL (BSS)	Relief for heartburn, nausea, indigestion, upset stomach and diarrhea.	2 tabs QID	$20.971	82.6 (2013)2
IMMODIUM	Decrease the frequency of diarrhea in TD, gastroenteritis, inflammatory bowel disease, and short bowel syndrome.	2 tabs (2 mg)	$17.331 (48 caplets)	82.5 (2013)2
CIPROFLOXACIN (FLUOROQUINOLINE)	Bacterial infections.	500 mg	$44.523	40.8 (2015)3
RIFAXIMIN	Treatment of Travellers’ Diarrhea.	3 caps (200 mg) TID	$6574
PRESENTLY, THERE IS NO FDA APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA
TRAVELAN®	Dietary Supplement.	3 caps (200 mg) TID	$30 – 30 caplets	0.77 (2018)5

1. Amazon.com

2. Top 10 OTC brands for digestives by revenue in the USA in 2013

3. Almalki et. al., Utilization, spending & price trends for quinolones in the US, Pharmacoecon Open 2017 Jun: 1(2): 123-131

4. Drugs.com Xifaxan (rifaximin) price guide. Cost of Xifaxan oral tablet 200 mg ~$657 for 30 tablets

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1. US Sales for Travelan – FY2018

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NEUTRALIZING CLOSTRIDIUM DIFFICILE , WHILE SPARING THE MICROBIOME

IMM-529

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CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY

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Clostridium difficile ( C. difficile ) is a bacterium that causes diarrhea and more serious intestinal conditions such as colitis

• Therapeutic market expected to grow from USD $630 million in 2016 to over $1.7 billion by 2026 – CAGR 15%[1]

• Leading cause of gastroenteritis-associated mortality in U.S.[2]

• Approx. 44,500 patients[3] died in 2014 from C. difficile infections (U.S.)

• • Potential orphan disease (7 years market exclusivity and premium pricing)

• https//www.globaldata.com/global-clostridium-difficle-infectionmarket-approach-2016-2026

• Jagai, et.al., BMC Gastroenterology, 2014:14:211 Trends in gastroenteritis-associated mortality in the USA.

• K. Desai, BMC Infect. Dis., 2016,16:303

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THE UNMET NEED

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• Current standard of care for C. difficile includes vancomycin, metronidazole & fidaxomicin

• Therapies plagued by significant CDI recurrences ( 1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments

• Growing resistance to vancomycin treatment

• Some treatments are administered intravenously rather than via the gut where C. difficile resides

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• *Isobel Ramsay, Nicholas Brown and David Enoch. Recent Progress for the Effective Prevention and Treatment of Recurrent Clostridium difficile Infection. Infectious Diseases: Research and Treatment Volume 11: 1–4 (2018). DOI: 10.1177/1178633718758023

THE C. DIFFICILE PREVENTION OF RECURRENT CDI MOUSE MODEL*

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C57BL/6mice 6–7 weeks

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C. difficile challenge
(10 [3] spores)
Day -10 -1 0
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Administration of water or IMM-529 +8 Vancomycin treatment ceases

Antibiotics in drinkingwater to induce susceptibility to C. difficile

Monitor:

• Weight loss

• Physiological appearance

Administration of vancomycin alone or vancomycin + IMM-529 12 hour post infection

• Activity

• Diarrhoea

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*Collaboration with Prof. Dena Lyras, Monash University, Australia

IMM-529 ANIMAL MODEL ‘RECURRENCE’ STUDY

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Relapse Study

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S u rv iv a l
1 1 0
In fe c te d + S O C
1 0 0
9 0 ** In fe c te d + S O C + IM M -5 2 9
8 0 p=0.0027
7 0
6 0
5 0
4 0
3 0
2 0
1 0
0
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 tre a tm e n t c e a s e d
P e rc e n t s u rv iv a l
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All studies
statistically
significant
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Demonstrated ~80% survival rate (7/9) vs. ~10% survival rate in control group (1/9)

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THE C. DIFFICILE PREVENTION MOUSE MODEL

C57BL/6mice 6–7 weeks

Vancomycin or IMM-529administration

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Day -10 -3 -2 -1 0
Antibiotics in drinkingwater to C. difficile challenge
induce susceptibility to C. difficile (10 [3] spores)
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Monitor:

Antibiotics in drinkingwater to induce susceptibility to C. difficile

• Weight loss

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• Physiological appearance

• Activity

• Diarrhoea

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*Collaboration with Prof. Dena Lyras, Monash University, Australia

IMM-529 ANIMAL MODEL ‘PREVENTION’ STUDY

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All studies
statistically
significant
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Prevention Study statistically
significant
S u rv iv a l
1 0 0
U n in fe c te d , N o tre a tm e n t
8 0 In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
6 0 In fe c te d , IM M -5 2 9 tre a tm e n t
In fe c te d , V a n c o m y c in tre a tm e n t
4 0
2 0
Demonstrated
00 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0 80% efficacy
h o u rs p o s t in fe c tio n without use of
antibiotics
P e rc e n t s u rv iv a l
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IMM-529 DRUG DEVELOPMENT PLAN

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Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium difficle Infection:

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File IND with
Hold pre-IND
Develop clinical plan for placebo
meeting to Execute
registration controlled trial
discuss clinical recurrence
strategy for FDA for prevention of
protocol and prevention trial
submission disease
strategy
recurrence
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COMMERCIAL & PRODUCT DEVELOPMENT PIPELINE

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PROGRAM	INDICATIONS	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	DEVELOPMENT STAGE	PROGRAM HIGHLIGHTS
		PRE-CLINICAL	PHASE 1	PHASE 2	PHASE 3	MARKET
		ANTI-INFLAMMATORY PROGRAMS
Travelan® Travelers’ Diarrhea Travelan® Travelers’ Diarrhea Travelan® Travelan® (IMM-124E) Travelers’ Diarrhea Travelan® (IMM-124E) NASH		Commercial product Australia Commercial product Canada Commercial product USA Plan for FDA submission Top Line Results Reported March 2018 Dietary supplement (2015) Health Canada NPN 80046016 (2015) TGA ARTG Aust L106709 (2004)
IMM-124E ASH IMM-124E Pediatric NAFLD		NIH Funded U of Virginia Topline results expected 2H 2019 NIH Funded; Emory University Topline results expected 1Q 2020
IMM-529 C. Difficile WRAIR Shigella		Developing to prevent recurrence in C. difficile patients Walter Reed Army Institute of Research

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IMM-124E: FATTY-LIVER PORTFOLIO

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Two ongoing NIH funded Phase 2 Programs currently underway: ASH and Pediatric NAFLD

ASH

• NIH funded; sponsored by Virginia Commonwealth University

• 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)

• Fully recruited: 56 patients

• Endpoints: Clinical Safety; Serum endotoxin (LPS) levels

• Timing: topline results expected in 2H2019

PEDIATRIC NAFLD

• NIH funded; sponsored by Emory University

• Lead Principal Investigator: Miriam Vos;

• Current enrollment: 23/40 patients

• Endpoint: ALT; 3 months treatment

• Timing: topline results in 1H 2020

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KEY MILESTONES EXPECTED TO DRIVE VALUE

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2H 1H 2H 1H 2019 2020 2020 2021 • Pre-IND Meeting to • Initiate Phase 3 • Phase 3 IMM• File Discuss IMM-124E Clinical Trial on 124E TD 505(b)(2) NDA Literature-Based IMM-124E TD Clinical Data for IMM-124E 505(b)(2) prevention study Available TD prevention study • • • IMM-124E ASH Pre-IND Meeting Initiate U.S. Clinical Trial Top Line on IMM-529 C. Phase 2 trial Results difficile program on IMM-529 to Results from US Army trials expected treat recurrent • Pediatric NAFLD 2019/2020 CDI Top Line Results

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MANAGEMENT

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• Chief Executive Officer of Immuron Limited since November 16, 2018.

• Over 30 years of experience in pharmaceutical and biotechnology - including R&D, operations, business development and capital financing.

• Co-founder and founding CEO of Synergy Pharmaceuticals.

• Co-inventor of TRULANCE® (plecanatide), an FDA approved drug to treat chronic GI disorders.

• Raised over USD $500 million of capital in the public markets to support Synergy from founding to approval of TRULANCE® in 2017.

• Ph.D. in Biochemistry; University of Wisconsin-Madison and BS in Chemistry from the University of Missouri.

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• Former Acting CEO of Immuron Ltd. Over twenty years’ experience in pharmaceutical and biotechnology industries.

• Former Chief Operating Officer of TransBio Ltd. Responsible for strategic identification, development and maintenance of global commercial partnerships, along with development, management and IP portfolio, R&D and technology transfer.

• Leadership roles in business development, project management, IP portfolio management, R&D, senior management.

• Consultant to academic institutes, private and publicly listed companies and government departments specializing in development and commercialization strategies.

• PhD in medicine from the University of Melbourne.

BOARD OF DIRECTORS – CHAIRMAN & EXECUTIVE VICE CHAIRMAN

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Dr Roger Aston

CHAIRMAN - B. Sc. (Hons), PhD.

Dr Aston has more than 20 years experience in the pharmaceutical and biotech industries. He was Chief Executive Officer of Mayne Pharma Group Limited, after leading HalcyGen’s acquisition of Mayne Limited in 2009. He has extensive experience with FDA and EU product registration, clinical trials, global licensing, private placement fundraising and prospectus preparation. Dr Aston has held numerous other board positions in the sector including with Clinuvel Limited, HalyGen Limited and Ascent Pharma Health Limited, recently acquired by Watson.

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Peter Anastasiou

EXECUTIVE VICE CHAIRMAN - BBSc

Mr. Anastasiou has extensive business experience in a wide range of organisations. He has been a successful entrepreneur from and early age with his first biotech venture, Neuro Developments Australia, seeded at age 24. Mr. Anastasiou was the founder of Investment Group Grandlodge, and ACS International both of which have generated significant wealth through Investment and Management

NON-EXECUTIVE DIRECTORS

• Dr Gary Jacob

• Stephen Anastasiou

• Daniel Pollock

• Professor Ravi Savarirayan

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• Richard Jay Berman

COMPANY CAPITALIZATION

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Immuron Limited Ordinary Shares ADS Equivalent [1]
Shares 163,215,706 4,080,393
Options [2] 44,823,800 1,120,595
Warrants [3] 27,760,000 694,000
Total 235,799,506 5,894,988
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Information prepared as at 18 June 2019

Share Price (18 June 2019): AUD $0.135

1. 1 ADS represents 40 ordinary shares

2. Options - Exercise price range: AUD $0.468 to $1.944 (Expiring from 27 Nov 2019 to 15 March 2023) 3. Exercise price of USD $10.00 per ADS (Expiring 13 June 2022)

Market Capitalization: AUD $22 Million

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