Immuron Ltd — Investor Presentation 2019

Apr 15, 2019

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FORGING COMMERCIAL & CLINICAL PATHWAYS

TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – APRIL 2019

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1
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NASDAQ: IMRN ASX: IMC

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.

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2 Lead clinical assets, IMM-124E & IMM-529, in Phase 2 development for the treatment of Liver Disease and C. difficile.

Plan for accelerated regulatory path to approval for IMM-124E (Travelan®) as drug to prevent Travelers’ Diarrhea in USA.

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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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US DOD R&D COLLABORATION AGREEMENTS

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

• Naval Medical Research Center (NMRC) – August 2016

• Walter Reed Army Institute (WRAIR) – June 2016

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WRAIR R&D COLLABORATION – KEY MILESTONES

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• Evaluation of anti-Shigella specific activity of Travelan®

• Travelan® shown to target common bacterial antigens present on ETEC and Shigella.

• Travelan® shown to bind 180 pathogenic strains of bacteria retrieved from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand.

• Travelan® prevented clinical Shigellosis (bacillary dysentery) in non-human primates.

• Development of a Shigella specific Therapeutic

• Three new products developed by Immuron

• • Preclinical testing initiated at WRAIR

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THE POTENTIAL OF POLYCLONAL ANTIBODIES

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US Department of Defense Travelan® immunoreactivity study[1] (2017):

• Travelan® demonstrates broadspectrum antimicrobial properties

• Antibodies in Travelan® able to bind

• & react with all 180 strains of bacteria isolated from infected DoD personnel

Pathogenic bacteria included Campylobacter, Shigella and Entertoxigenic E. coli

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WESTERN BLOT ANALYSIS
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• 1 - Carried out by Armed Forces Research Institute of Medical Sciences (AFRIMS), Walter Reed Army Institute of Research (WRAIR), US Naval Medical Research Centre (NMRC)

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 Commercial product - USA Dietary supplement (2015) Health Canada NPN 80046016 (2015) TGA ARTG Aust L106709 (2004)
IMM-124E (Travelan®)		PLAN TO DEVELOP AS DRUG TO PREVENT TRAVELERS’ DIARRHEA IN USA
IMM-529		TO PREVENT RECURRENCE IN C. DIFFICILE PATIENTS

BACKGROUND OF TRAVELAN®: DIAMOND IN THE ROUGH

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COMMERCIAL PRODUCT

Marketed in Australia, USA and Canada

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DRUG CANDIDATE IMM-124E Status with FDA: IND open and active

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Plan to develop IMM-124E as an approved drug in USA to treat Travelers’ Diarrhea

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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:

42% in Latin America

28% in Southeast Asia

• Up to 70% of travelers suffer from travelers’ diarrhea[2] .

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

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

TRAVELAN® OTC BUSINESS

• A unique OTC targeting Travelers’ Diarrhea in Australia & Canada

• In Australia, TGA listed medicine indicated to:

• Reduce the risk of travelers’ diarrhea

• Reduce the symptoms of minor gastrointestinal disorders

• Dietary supplement in USA

• Significantly reduces the motility of ETEC strains

• Binds to multiple epitopes and antigens on both the bacterial surface and flagella

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Travelan® has considerably greater reactivity against purified ETEC antigens than IgG purified from non-immune colostrum powder

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TRAVELAN® COMMERCIAL PROFILE

• Annual revenues of AUD $2M+; cash flow positive

• Net revenues: 1H2019 +20% vs 1H2018

• Potential WW peak sales: $200M+

• Global market size: US$630M – 2019

• Global market size expected to grow to US$1B

• 2025 (CAGR 7%)

• Pursuing new geographies

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• Potential for new products & formulations (e.g Shigella)

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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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Status with FDA: IND open and active

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

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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

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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). 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 TREAT TRAVELERS’ DIARRHEA

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• Results of Controlled Human Infection Model (CHIM) Studies

Oral challenge with O78 ETEC strain (H10407). Treatment 5 days after challenge with ciprofloxacin 500mg bd for 5 days

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PLACEBO IMM-124E
400mg
15 15
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• Travelan® evaluated in two randomised, double-blind, placebo-controlled challenge clinical trials

• 90 healthy volunteers

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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
•
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• Published in Scandinavian Journal of Gastroenterology

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Otto et al. 2011 RCTs 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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1 15 5

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

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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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= 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 treat Prevent Travelers’ Diarrhea in Travelers to Endemic Areas:

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

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Drug	Indication	Dosing	Ave cost – 2 week trip	Revenue USD Millions (Year)
FDA APPROVED OTC DRUG TREATMENT FOR DIARRHEA
PEPTO BISMAL (BSS)	Relief for heartburn, nausea, indigestion, upset stomach and diarrhea.	2 tabs QID	$14.56	97.8 (2018) 82.6 (2013)
IMMODIUM	Decrease the frequency of diarrhea in TD, gastroenteritis, inflammatory bowel disease, and short bowel syndrome.	2 tabs (2 mg)	$11.48 (48 caplets)	82.5 (2013)
CIPROFLOXACIN (FLUOROQUINOLINE)	Bacterial infections.	500 mg	$44.52	40.8 (2015)
RIFAXIMIN	Treatment of Travellers’ Diarrhea.	3 caps (200 mg) TID	$246.96 - $493.92
NO FDA APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA
TRAVELAN®	Dietary Supplement.	3 caps (200 mg) TID	$30 – 30 caplets	0.77 (2018)

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TRAVELAN® UNIQUELY POSITIONED FOR SUBSTANTIAL GROWTH - NO FDA APPROVED DRUG TO PREVENT TD

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• Therapeutic market is expected to grow from US$630 million in 2019 to over $1 billion by 2025

• Market Opportunity – CAGR 7%.

• 44.3 million US Citizens travel to high risk destinations each year 30 to 70% will get TD.

• 22.2 million US Citizens seek pretravel health advice.

• Antibiotic Chemoprophylaxis can provide up to 90% protection against TD – NOT Recommended due to emerging resistance to this class of drug.

Unmet Need

• Bismuth Subsalicyclate (BSS) shown to provide up to 65% protection against TD not commonly used as prophylaxis for TD due to adverse effects, salicylate toxicity, inconvenient dosing (2 tablets 4X a day) and low compliance.

• Vaccines – No current products targeting TD registered in the USA.

• Highly differentiated – Neutralizes ETEC but does not impact microbiome.

Travelan® Positioning

• Targets many isolates (Campylobacter, ETEC, Klebsiella, Salmonella, Shigella).

• Listed medicine in Australia over 600,000 packets sold WW.

• There is also growing resistance to antibiotic treatments.

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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® Travelan® 1	Commercial product - Australia Commercial product - Canada Commercial product - USA DEVELOP AS DRUG TO TREAT TRAVELERS’ DIARRHEA Dietary supplement (2015) Health Canada NPN 80046016 (2015) TGA ARTG Aust L106709 (2004)
	IMM-529 2	PREVENT RECURRENCE IN _C. DIFFICILE_PATIENTS

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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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• Therapeutic market expected to grow from US$360 million in 2014 to over $1.7 billion by 2024 – CAGR 15%

• Nearly 30,000 patients die each year from C. difficile infections (US)

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

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Sources: GlobalData, Decision Resources, CDC

THE UNMET NEED

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• Current standard of care for C. difficile includes vancomycin and metronidazole, accounting for 80% of patient share (US)

• 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

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IMM-529 OPPORTUNITY

• IMM-529 highly differentiated – neutralizes C. difficile but does not impact microbiome

• Targets not only toxin B but also spores and vegetative cells responsible for recurrence

• Potential use in combination with standard of care

• Targets many isolates

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IMM-529 TARGETS

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Ingestion of spores

Germination of spores Colonisation by vegetative cells

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Toxin B production Infection

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IMM-529 UNIQUE MOA IN CDI

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SPORES - Infectious particles – Heat, ethanol & UV resistant. Survive gastric acid, adhere to cells in the colon & germinate. IMM-529 antibodies bind to surface antigens on spores & prevent adherence to host cells & limit germination.

VEGETATIVE CELLS – Fimbriae & other surface layer proteins (SLP) contribute to bacterial colonization. Fimbriae are used to adhere to other bacteria & to host cells. Fimbriae one of the primary mechanisms of virulence. IMM-529 antibodies bind to SLP on vegetative cells & limit colonization.

TOXIN B – is essential for virulence. Toxin B disrupts the cytoskeleton and tight junctions of intestinal epithelial cells. IMM-529 antibodies neutralise toxin B, inhibiting toxin mediated epithelial cell apoptosis & limit toxin translocation into the systemic circulation & inflammatory signal cascades.

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IN VITRO CHARACTERISATION OF C. DIFFICILE IMM-529 ANTIBODIES

SPORE, VEGETATIVE CELL AND TOXIN B

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IMM-529 ANTIBODIES CROSS-REACT WITH C. DIFFICILE SPORES

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1 2 3 4 5 6 7 8
250 kDa
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Non-immune

Exosporium

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IMM-529B#1

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IMM-529 B#2

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250 kDa
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250 kDa
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1. KI (A[+] B[+] ) Strain used to generate product

2. M7404 (A[+] B[+] )

3. VPI10463 (A[+] B[+] )

4. GE (A[+] B[+] )

5. MDU2992 (A[-] B[+] )

6. JGS6133 (A[+] B[+] ) 7. AI35 (A[-] B[+] ) 8. -1470 (A[-] B[+] )

IMM-529 contains antibodies that are cross-reactive with the exoporium layer of spores from variety of isolates (human and animal)

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IMM-529 ANTIBODIES CROSS-REACT WITH CELL LYSATES FROM C. DIFFICILE VEGETATIVE CELLS

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Animal Human
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
75 kDa
50 kDa
37 kDa
25 kDa
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Strainused to generate product

IMM-529 contains antibodies that are cross-reactive with vegetative cell whole cell lysates from a variety of human and animal C. difficile isolates

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IMM-529 ANTIBODIES CROSS-REACT AGAINST TOXIN B

FROM DIFFERENT C. DIFFICILE STRAINS

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1 2 3 4 5 6 7 8 9 10 11
250 kDa
Non-immune
250 kDa
IMM-529 B#1
250 kDa
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1. KI (A[+] B[+] )

2. M7404 (A[+] B[+] )

3. VPI10463 (A[+] B[+] )

4. GE (A[+] B[+] )

5. MDU2992 (A[-] B[+] )

6. JGS6133 (A[+] B[+] )

7. AI35 (A[-] B[+] )

8. 8-1470 (A[-] B[+] )

9. CD37 (A[-] B[-] )

10. PurifiedToxin B (commercial)

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IMM-529 B#2

IMM-529 contains antibodies specific to Toxin B from a variety of human and animal isolates

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IMM-529 ANTIBODIES NEUTRALIZE TOXIN B FROM HISTORICAL AND HYPERVIRULENT STRAINS

H y p e rv iru le n t T o xin B

C o m m e rcia l p u rifie d T o xin B

H isto rical T o xin B

(strain K I)

(stra in V P I1 0 4 6 3 )

(strain 6 3 0 )

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_____ * __ __ *** ____
-- *** __
1 0 0 1 0 0 1 0 0
7 5 7 5 7 5
5 0 5 0 5 0
2 5 2 5 2 5
0 0 0
N o N o n - immune IM M - 5 2 9 B 1 N o No n - im m u n e IM M - 5 2 9 B 1 N o No n - im m u n e IM M - 5 2 9 B 1
A n tib o d y A n tib o d y A n tib o d y
% c e ll d e a th % c e ll d e a th % c e ll d e a th
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****Indicates P < 0.0001.

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***Indicates P < 0.001

Hutton et al. Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative. Scientific Reports | 7: 3665 | DOI:10.1038/s41598-017-03982-5 (June 2017)

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THE C. DIFFICILE PREVENTION MOUSE MODEL

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C57BL/6mice 6–7 weeks

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IMM-529administration

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Day -10 -3 -2 -1 0
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Monitor:

• Weight loss

Antibiotics in drinkingwater to induce susceptibility to C. difficile

C. difficile challenge (10[3] spores)

• Physiological appearance

• Activity

• Diarrhoea

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THE C. DIFFICILE RELAPSE MOUSE MODEL

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C57BL/6mice 6–7 weeks

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C. difficile challenge
(10 [3] spores)
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Administration of water or IMM-529

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Day -10 -1 0
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+8
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Antibiotics in drinkingwater to induce susceptibility to C. difficile

Monitor:

Vancomycin treatment ceases

• Weight loss

• Physiological appearance

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

• Activity

• Diarrhoea

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IMM-529 ANIMAL MODEL STUDY

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All studies
statistically
significant
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Prevention Study
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
0
0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0
h o u rs p o s t in fe c tio n
P e rc e n t s u rv iv a l
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Demonstrated 80% efficacy without use of antibiotics

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IMM-529 ANIMAL MODEL STUDY

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

Demonstrated ~90% survival rate vs. 22% survival rate in control group

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IMM-529 ANIMAL MODEL STUDY

Treatment Study

All studies statistically significant

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S u rv iv a l

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1 0 0
U n in fe c te d , N o tre a tm e n t
In fe c te d , N o tre a tm e n t
8 0
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
In fe c te d , IM M -5 2 9 tre a tm e n t
6 0
In fe c te d , V a n c o m y c in tre a tm e n t
4 0
2 0
0
0 1 2 3 4
D a y s p o s t in fe c tio n
P e rc e n t s u rv iv a l
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Demonstrated 80% efficacy without use of antibiotics

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ONGOING PHASE I/IIA C. DIFFICILE TRIAL

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• Randomized, double blind, placebo-controlled clinical study of IMM-529 for 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 standard-of-care (vancomycin/metronidazole)

• Follow-up: 3 months overall

• Primary objective: To evaluate safety and tolerability of IMM-529 plus standard-of-care (SOC) combination in patients with CDI

• Secondary objective: To evaluate the effectiveness of IMM-529/SOC combo to treat patients with CDI

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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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----- Start of picture text -----

File IND with
Hold pre-IND double-blind,
Develop clinical
meeting to placebo
registration Execute
discuss clinical controlled trial
strategy for FDA prevention trial
protocol and for prevention of
submission
disease
strategy
recurrence
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IMM-529 FOR THE TREATMENT OF CDI

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• Therapeutic market is expected to grow from US$360 million in 2014 to over $1.7 billion by 2024 – CAGR 15%

• Market 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 current standard of care - 80% of patient share in U.S.

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

• Unmet Need underscoring need for new treatments

• • 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 spores and vegetative cells responsible for recurrence

• • Can be used in combination with standard of care

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Sources: GlobalData, Decision Resources, CDC

COMPETITOR MARKET ANALYSIS – CDI

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Company		Drug	Type	Status
Reduce recurrence of CDI
Zinplava (bezlotoxumab) IV Monoclonal Antibody FDA approved 2016
SER-109 Oral microbiome therapeutic Phase 3
CP101 Oral microbiome therapeutic Phase 2
Treatment of Primary CDI
Ridinilazole Oral antibiotic Phase 3
Cadazolid Oral antibiotic Failed Phase 3
SER-262 Oral microbiome therapeutic Phase 1b

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*As of March 25, 2019

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 2Q 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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4 44 4

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 University of Virginia

• 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

• Endpoint: Serum endotoxin/ lipopolysaccharide (LPS) levels

• Timing: topline results in 2Q2019

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 1Q 2020

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US DEPARTMENT OF DEFENSE COMMISSIONED PRE-CLINICAL STUDIES

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Collaboration with:

• Department of Enteric Diseases (DED)

• Armed Forces Research Institute of Medical Sciences (AFRIMS)

• A overseas laboratory of the Walter Reed Army Institute of Research (WRAIR)

• 60 clinical isolates of each bacteria, Campylobacter , ETEC, and Shigella , (180 in total) were tested by Western blot analysis.

• The clinical isolates were collected from infected patients located in Bhutan, Cambodia, Nepal and Thailand between 1993 and 2016, allowing researchers to measure the impact of Travelan[] antibodies on infectious bacterial strains in the field.

• When compared to the controls, researchers found that the antibodies within Travelan[] were reactive to all 180 clinical isolates from these infected individuals.

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US DOD PRECLINICAL STUDIES

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Armed Forces Research Institute of Medical Sciences (AFRIMS)

• Travelan® protective efficacy against shigellosis in a juvenile Rhesus macaque challenge model.

• Travelan® prevented clinical shigellosis in 75% of Travelan® treated NHPs compared to placebo. Overall results strongly suggest that Travelan® is functionally cross-reactive and an effective prophylactic tool against Shigellosis.

• These results provide an alternative approach of non-antibiotic interventions which could lead to a new preventative modality for the US DoD.

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US DOD – SHIGELLA SPECIFIC THERAPEUTICS

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Walter Reed Army Institute of Research (WRAIR)

• Immuron has produced three Shigella specific therapeutic products utilizing vaccines developed by the Walter Reed Army Institute of Research (WRAIR).

• The hyperimmune products from the study have been processed and shipped to the WRAIR for preclinical assessment.

• Under the current terms of the Cooperative Research Agreement, the WRAIR will fund the evaluation of the anti-Shigella therapeutics and assess their protective capacity in a head to head comparison with Travelan® in established small animal models.

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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 • Initiate Phase 3 • Phase 3 IMM• File to Discuss IMMClinical Trial on 124E TD 505(b)(2) NDA 124E LiteratureIMM-124E TD Clinical Data for IMM-124E Based 505(b)(2) prevention study Available TD prevention study • IMM-124E ASH • Pediatric NAFLD Clinical Trial Top Top Line Results Line Results • Results from US Army and US Navy trials Opening additional expected 2019/2020 CDI clinical sites for IMM-529 Trial

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