Immuron Ltd — Investor Presentation 2021

Dec 15, 2021

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FORGING COMMERCIAL & CLINICAL PATHWAYS

TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – DECEMBER, 2021

JERRY KANELLOS, Ph.D. CEO

NASDAQ: IMRN ASX: IMC

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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

• Review of Strategic Plan

• Review of R&D Project Pipeline

• Travelan US Drug Development Plan

• o NMRC Drug Development Plan

• o IMM-529 US Drug Development Plan

• o IMM-124E SARS-COV-2 R&D

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DEVELOPMENT PIPELINE

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TRAVELAN[®] : PLAN FOR EXPANDED USE WITH PARTIAL SUPPORT BY US DOD FOR DOSE FINDING

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• Immuron is pursuing a regulatory pathway to license Travelan® with the FDA via a Biologics License Application (BLA) with a proposed indication to prevent TD induced by ETEC

DRUG CANDIDATE IMM-124E Status with FDA: IND 14,933 IND 15675 / IND 17066

• We are seeking financial support to fund part of this initiative and develop a dosing regimen acceptable for use by the military

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Plan to develop IMM-124E as an approved biologic in the USA targeting travelers’ diarrhea

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TRAVELAN® DRUG DEVELOPMENT PLAN

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Travelan® for FDA approval as biologic to reduce the risk of travelers’ diarrhea (TD) in travelers to endemic areas:

DoD-supported challenge trial





File IND with Plan for DoubleExecute Field Assimilate Data Hold Pre-IND Blind, PlaceboTrial and File Controlled Field to Support IND Meeting to Registration Trial in Travelers Submission to Discuss Merits of Package to TD-Endemic FDA Application Areas

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RATIONALE OF PHASE 2 TO BE SUPPORTED BY US DOD

• Travelan® efficacy studies were performed using two different doses (200 mg and 400 mg) 3 times a day

• Such a regimen is cumbersome for military troops deployed in austere environments and military field studies have shown that compliance is low with products dosed more than once per day[1]

• We propose herein to test the efficacy of one large dose per day in a controlled human infection model (CHIM) trial using ETEC H10407 to inform the decision to move forward with a once per day dosing regimen in a Phase 3 study

1Srivastava K, Arora A, Kataria A, Cappelleri JC, Sadosky A, Peterson AM. Impact of reducing dosing frequency on adherence to oral therapies: a literature review and meta-analysis. Patient Prefer Adherence . 2013;7:419-434 https://doi.org/10.2147/PPA.S44646

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STUDY DESIGN & TIMELINE OF THE PHASE 2

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• Randomized (1:1), double-blind, placebo-controlled trial in 60 healthy, adult subjects

• Admission to inpatient facility (two repetitive cohorts)

• Once daily dosing of Travelan®/placebo

• Challenge with 2x10[7] CFU of ETEC strain H10407 after two days of dosing

• Follow subjects in an inpatient setting for primary endpoint of moderate-severe diarrhea

• All subjects treated with antibiotics (ciprofloxacin) 5 days post-challenge (or earlier)

Product N Travelan® (IMM-124E), 30 one dose (1.2 mg) Placebo 30

• Discharged when symptoms resolved/resolving and no longer shedding challenge organism

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1H 2022 2H 2022 FEB 2023
24-hour surveillance for moderate-
severe diarrhea; all subjects treated with
24-hour surveillance for moderate-
antibiotics 5 days after challenge
severe diarrhea; all subjects treated with
FY22 antibiotics 5 days after challenge FY23
FY22 FY23
IND Submission Database Lock Final Clinical Study Report
and
FDA Filings Cohort 1 Cohort 2 6-Month Follow-Up Analysis Reporting
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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 COMMENCE ENROLMENT APRIL 2022

Primary Objective:

To evaluate the clinical efficacy of Travelan®, Florastor® and Bimuno® vs. placebo for maintenance of GH as measured by the combined endpoint of incidence of GH deficiencies (defined as 3 or more unformed stools in a 24hour period OR 2 or more unformed stools and one or more associated symptoms in a 24-hour period) or antibiotic treatment for diarrhea per subject report, 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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THE EFFICACY OF NON-ANTIBIOTIC OTC PRODUCTS IN TRAVELERS’ DIARRHEA (TD) PREVENTION (P4TD)

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• The study products used in the clinical trial are considered dietary supplements

• not medicines approved by the FDA

• Clinical Trial Design approved by IRB not FDA

• Each product will be purchased commercially and packaged in sachets similar to placebo – subjects will be instructed to take 1 sachet twice a day with meals.

• Travelers and deployed personnel will be enrolled prior to departure and will begin taking the study product 3 days prior to arrival at destination, continuing for 10 days during travel.

• Enrollment will occur over a 24-month period

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NMRC CAMPETEC DRUG DEVELOPMENT PLAN

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Two Human Clinical Trials Planned: To evaluate the efficacy of the New Drug in Infectious Diarrhea Caused by ETEC and Moderate To Severe Camylobacteriosis

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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 of Application Prevention Trials
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NMRC CAMPETEC DRUG DEVELOPMENT PLAN

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CURRENT STATUS

• cGMP DRUG PRODUCT Manufacture

• Completed

• CLINICAL STUDY

• IND Application – In progress

• FDA Review and Approval of IND – Q1 CY22

• ETEC Study Initiation at John Hopkins – Q2 CY22

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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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IMM-529 DRUG DEVELOPMENT PLAN

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CURRENT STATUS

• COLOSTRUM PRODUCTION

• Completed

• DRUG SUBSTANCE

• cGMP manufacture – Q1 CY22

• DRUG PRODUCT

• cGMP manufacture – Q2 CY22

• CLINICAL DEVELOPMENT

• Clinical Protocol - Completed

• Clinical Sites & Principal Investigators – Identified

• Engaging with suitable CROs to support Clinical Development – In progress

• REGULATORY

• Pre-IND Meeting on IMM-529 – 2H CY22

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

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CURRENT STATUS

RESEARCH & DEVELOPMENT

• Monash Research Services Agreement – Completed

• Research Agreement with Doherty Institute - Executed

• The Aims of this work are as follows:

• Testing of the neutralizing activity of the various fractions isolated by Monash University against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in the cytopathic effect inhibition cellbased assay to be performed by The Doherty Institute – Study initiated December 2021 

• R&D Work to be expanded to include variants of concern – Draft protocols In progress

• Murine mouse model for preclinical evaluation – Draft protocols in development

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KEY MILESTONES EXPECTED TO DRIVE VALUE

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1H 2H 1H 2H 2022 2022 2023 2023 • NMRC IND Submission • Topline Results • Topline Results • IMM-124E Infectious diarrhea (Q1 CY22) NMRC ETEC Study NMRC pivotal field clinical study • Initiate NMRC Phase Campylobacter • Initiate NMRC Phase 2 2 Campylobacter Study ETEC challenge study challenge study • • (Q2CY22) Initiate IMC Phase 2 Topline Results ETEC challenge study IMM-124E ETEC • IMM-124E IND Submission • Pre-IND Meeting on Study Results from • IMM-529 cGMP IMM-529 US Grant application & COVID-19 • • Manufacture IMM-529 IND Initiate Phase 2 Research Program expected YE2021 Submission CDI clinical study

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THANK YOU

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Dr Jerry Kanellos – Chief Executive Officer

• 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.

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