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Immuron Ltd Investor Presentation 2020

Oct 28, 2020

35121_rns_2020-10-28_603163ba-2225-4efe-b63b-ee02f0b6655a.pdf

Investor Presentation

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FORGING COMMERCIAL & CLINICAL PATHWAYS

TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – OCTOBER, 2020

JERRY KANELLOS, Ph.D. CEO

NASDAQ: IMRN ASX: IMC

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DEVELOPMENT PIPELINE

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TRAVELAN® COMMERCIAL PROFILE:

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Global Immuron Sales (Gross) - AUD

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$2.7M
$2.6M
$3,000,000
$2,500,000
$2.01M
$2,000,000
$1.38M
$1,500,000
$1,000,000
$500,000
$-
FY17A FY18A FY19A FY20A
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AUD

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IMM-124E DRUG DEVELOPMENT PLAN

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Plan to register Travelan® as a drug in the USA with the FDA to reduce the risk of Travelers’ Diarrhea (TD) in travelers to endemic areas:

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✓ ✓ File IND with
Plan for Double- Execute
Assimilate Data Hold Pre-IND
Blind, Placebo Prevention Trial
to Support IND Meeting to Controlled Trial and File
Submission to Discuss Merits of
for Prevention of Registration
FDA to Prevent Application to Travelers’ Package
TD Prevent TD
Diarrhea
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US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG

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MARKET POTENTIAL FOR TRAVELAN® SALES:

USD >$100 MILLION

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

  3. 15, Issue 2, 2008, 110–118

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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY OF NON-ANTIBIOTIC OTC PRODUCTS IN TRAVELERS’ DIARRHEA (TD) PREVENTION (P4TD)

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CURRENT STATUS – PLAN TO C0MMENCE ENROLMENT JUNE 2021

Primary Objective:

To evaluate the clinical efficacy of Travelan®, Florastor® and Bimuno® vs. placebo for maintenance of Gastrointestinal Health (GH) focusing on a 10 day window of prophylaxis during travel.

STUDY DESIGN

This is a randomized (1:1:1:1 allocation), double-blind, placebo controlled multicenter clinical trial comparing three dietary supplements, Travelan®, Florastor® and Bimuno®, individually against placebo to determine efficacy for maintenance of GH.

A total of 1320 subjects (330/arm) will be enrolled from the following populations: active duty US and UK military personnel, US DoD beneficiaries and US civilians deploying or traveling to intermediate or high GH disruption risk destinations.

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US NAVEL MEDICAL RESEARCH CENTRE DRUG DEVELOPMENT PLAN

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Two Human Clinical Trials Planned: New Drug to Reduce the risk of Infectious Diarrhea Caused by Campylobacter and by ETEC

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✓ ✓ File IND with
Plans for two
Assimilate Data Hold Pre-IND
Double-Blind, Execute
to Support IND Meeting to
Placebo Prevention Trials
Submission to Discuss Merits
Controlled
FDA to Prevent of Application to
Prevention Trials
TD Prevent TD
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IMM-529 DRUG DEVELOPMENT PLAN

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Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridiodes difficile 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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Immuron Reports Neutralizing activity Against SARS-CoV-2

Key Points

  • Immuron’s Hyper-immune Bovine Colostrum used to manufacture Travelan® and Protectyn®

  • demonstrates antiviral activity against the COVID-19 virus in laboratory studies

  • Immuron’s technology platform offers a potential new oral therapeutic approach to target SARS-CoV-2 in the GI Tract

Melbourne, Australia, July 21, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that the hype-Immune bovine colostrum used to manufacture the company’s flag ship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn® has demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19.

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IMM-124E SARS-COV-2 RESEARCH & DEVELOPMENT PROPOSAL

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CURRENT STATUS

RESEARCH & DEVELOPMENT

Reached out to local, national, and international potential research collaborators to advance this work and assist in the further characterization of the neutralization activity of SARS-CoV-2 observed with IMM-124E

  • Research Services Agreements

  • ➢ To identify the inhibitory substance/s in IMM-124E

  • Preclinical Development

  • ➢ Access application form for a contract research project – submitted

  • ➢ The project aims to assess the effect of IMM-124E in ex-vivo and animal models infected with SARS-CoV-2

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IMM-124E SARS-COV-2 RESEARCH & DEVELOPMENT PROPOSAL

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CURRENT STATUS

CLINICAL PROPOSALS

  • Consultancy agreement executed with Professor Teena Chopra, Professor of Medicine Wayne State University School of Medicine, Detroit

  • ➢ Professor Chopra is building a registry of the patients presenting with gastrointestinal events to better understand this cohort and the unique medical challenges they present

  • Clinical protocol development

  • ➢ Reviewing several proposals to assess the efficacy of IMM-124E to treat patients with COVID-19

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