Immuron Ltd — Investor Presentation 2023

Oct 29, 2023

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Immuron CEO, Steven Lydeamore to present at AusBioInvest

Melbourne, Australia, October 30, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to advise our Chief Executive Officer, Steven Lydeamore will be presenting at AusBioInvest 2023 on Monday, October 30th in the 9.40am – 10.35am session (AEST) at the Park Hyatt, Melbourne, Australia.

A copy of the presentation being made at AusBioInvest 2023 is included below.

This release has been authorised by the directors of Immuron Limited.

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COMPANY CONTACT:

Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 info@immuron.com

About Travelan®

Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveller’s diarrhoea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletised preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhoea-causing bacteria and prevent colonisation and the pathology associated with traveller’s diarrhoea. In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Traveller’s Diarrhoea, reduce the risk of minor gastrointestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveller’s Diarrhoea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.

About Traveller’s Diarrhoea

Traveller’s Diarrhoea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of cases. The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the causative agent of cholera) are often confused with Traveller’s Diarrhoea as they may be contracted while travelling and initial symptoms are often indistinguishable.

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About Immuron

Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercialising orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.

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

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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AUSBIOINVEST PRESENTATION 30 OCTOBER, 2023 - Steven Lydeamore CEO NASDAQ: IMRN ASX: IMC

SAFE HARBOR STATEMENT

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.

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

FY2024 results in this presentation are subject to audit review.

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REVENUE GENERATING WITH STRONG PIPELINE

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Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases

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Major Shareholders
Financial Snapshot
Holder Units % of CSO
Shares on Issue 227,798,346
Total Options 14,568,559 BNY Mellon [Asset Management] 78,704,665 34.6 %
Last Traded Price IMC: A$0.075 Management & Board 6,904,554 3.0 %
52 week High/Low IMC: A$0.105 / 0.067 Authentics Australia Pty. Ltd. 6,000,000 2.6 %
IMRN: $3.21 / 1.39
Grandlodge 3,846,712 1.7 %
Market Cap IMC: A$17.08m
Cash & Cash Equivalents A$17.2m
(30 June 2023)
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TECHNOLOGY PLATFORM FOR GUT MEDIATED DISEASES

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Bovine colostrum is the first milk of cows after calving. It is rich in immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, growth factors and bioactive peptides. Colostrum has higher levels of protein, fat, vitamins, and minerals when compared to milk. This enables full development of the newborn calf in addition to immunity against several pathogens.[*]

Immuron’s proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal (“GI”) tract and can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces.

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STEP 1

STEP 2

STEP 3

Development of Highly Isolation of Hyperimmune Oral Antimicrobial Specific Vaccines antibody-rich therapeutics bovine colostrum without drawbacks of antibiotics

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FINAL PRODUCT

Toxin Neutralization + Clearance of targeted gut pathogens

• Reduce occurrence and reduce/relieve diarrhoea

• Reduce/relieve abdominal cramping

• Reduce/relieve gastrointestinal pain

• Assists repair of gastrointestinal/gut wall lining

• Enhance/promote immune defence

• Enhance/promote health liver function

Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)

* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 1- 11, https://doi.org/10.1016/j.nfs.2021.10.001

STRONG PIPELINE WITH NEAR TERM MILESTONES

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Immuron’s Clinical Programs
Compound or Indication Phase Phase Phase Market
brand name I II III
Traveler’s
IMM-124E
Diarrhea ETEC
Travelan®
challenge
Clostridioides
difficile
IMM-529
Infection &
Recurrence
Our Partners’ Clinical Programs
Compound or Partner Phase Phase Phase Market
brand name I II III
Travelan®
Uniformed Services University
CampETEC
Naval Medical
Research Command
Further information on the clinical programs can be found on slide 8 5
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STRONG SALES GROWTH IN ATTRACTIVE MARKET

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Traveller’s Diarrhoea (TD)

Market is large and growing ~7%[3 ] CAGR

Industry tailwinds Travel picking up significantly following COVID lockdowns Frequent 30% - 70% of travelers experience TD[4]

Australia 12 months to July 2023 $83m $50m short term resident Chief Commercial Net Sales Net Sales Based on US annual Based on EU travel returns 77% of those Officer has 20+ year’s FY23: A$1.16 million FY23: A$0.64 million travel numbers and a numbers and a in 2019[1] experience with local 1QFY24: A$1.35 million 1QFY24: A$0.21 million USA and global (Asia, UK) penetration rate of penetration rate of 229% higher than pre- 9% lower than pre15%, the market 15%, the market Total departures commercial leadership pandemic period pandemic period June 2023 99.4% roles with GSK and potential is estimated potential is estimated 1QFY20 1QFY20 of June 2019[2] P&G at $83m[5] at $50m[5]

1. https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departures-australia/latest-release

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2. https://www.trade.gov/sites/default/files/2023-09/US-Outbound-to-World-Regions.xlsx

3. Research Reports World, 28 May 2021: Global Traveler’s Diarrhea Therapeutics Industry Research Report, Growth Trends and Competitive Analysis 2021-2027

4. Centers for Disease Control and Prevention Yellow Book

5. IMC Company Report - Travelan Market Analysis 2019

VALUABLE SALES POTENTIAL FOR PIPELINE PRODUCTS

• › Infectious disease experts reacted favorably to the IMM-529 MOA, and its unique ability to target three elements of the rCDI infection – the spores, vegetative cells, and Toxin B

• › Non-microbiome approaches (such as IMM-529) are still appealing to experts, who noted that clinical trial efficacy (reduction in relapse rate) and cost/access will be the key drivers of clinical use in recurrent patients, not mechanism of action

• › Immuron’s development of IMM-124E (hyperimmune bovine colostrum) as a prescription medication has the potential to address this unmet need

• › Primary care physicians (PCP)s impressed with clinical efficacy endpoint targets demonstrating > 80% protection against the development of diarrhea.

• › If base case efficacy targets are reached, IMM-124E would mostly be used by travelers going to the highest risk areas (e.g., rural Central America/Asia/Africa).

Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue in USA for IMM-529 is conservatively projected at US$93M for the target patient population (limited to 2nd recurrence and later based on trial design and payer coverage)

›

• › Based on the estimated market size and pricing, the base case yearly revenue in USA for IMM-124E is projected at US$102M .

• › Reaching higher efficacy goals could broaden use.

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• › Positioning IMM-529 earlier than second recurrence and/or efficacy targets could lead to higher uptake.

Compound or brand name

Indication

Phase I

Phase II

Phase III Market

IMM-124E - Travelan®

IMM-529

Traveler’s Diarrhea ETEC challenge

Clostridioides difficile Infection & Recurrence

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Lumanity, a leading lifescience consulting company: https://lumanity.com/company/our-story/ Clostridioides difficile infections (CDI) to grow to almost $1.7 billion by 2026, according to GlobalData

NEAR TERM MILESTONES ANTICIPATED TO DRIVE VALUE Travelan® • FDA IND1approved for single daily dose IMM-124E ETEC2 CHIM3clinical trial • IRB Approval4 • Initiated IMM-124E ETEC2CHIM3 clinical trial • 100% of patients enrolled • Completion of In-patient phase ETEC2CHIM3clinical trial • Topline results for IMM-124E ETEC2clinical trial • Clinical Study Report CampETEC • Submitted Response Letter to FDA Clinical Hold • Immuron sponsored Toxicology study - completed • Toxicology Study Report • FDA IND1approved (Clinical Hold released) • Institutional Review Board approval of NMRC5CampETEC Campylobacter CHIM3clinical trial protocol • FDA approval of IND amendment for change to protocol • Initiate NMRC5CampETEC Campylobacter CHIM3clinical trial • Completion of In-patient phase CampETEC Campylobacter CHIM3clinical trial IMM-529 • 600 mg solid dose active formulation development • IMM-529 cGMP manufacture • IMM-529 (CDI)7Pre-IND1 submission Travelan® • USU6P2TD IMM-124E field clinical trial recruitment commencement • ~50% of 868 participants recruited • Completion of enrollment • Completion of in-patient phase 2H 2022 1H 2023 2H 2023 1H 2024

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Completed; 1. Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Institutional Review Board; 5. Naval Medical Research Command; 6. Uniformed Health Services University of the Health Sciences; 7. Clostridioides Difficile

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STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:

EMAIL: STEVE@IMMURON.COM PHONE: AUSTRALIA: +613 8892 4854

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SCIENTIFIC REFERENCES

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Travelan® (IMM-124E)

	Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90% of volunteers Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI: 10.3109/00365521.2011.574726
	Clinical Evaluation of Travelan® an Oral Prophylactic for Prevention of Travelers’ Diarrhea in Active Duty Military Service Assigned Abroad. Military Health System Research Symposium 14-17 Aug 2023_Abstract 1
	Travelan as a broad Spectrum anti-bacterial Immuron Limited, 29 April, 2011
	Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad potential for prevention of traveler’s diarrhea US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 4 September, 2019
	Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared to placebo and demonstrated a significant clinical benefit US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 5 September, 2018
	Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and Shigella US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 30 January, 2017
	Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), and bioactivity of HBC against common enteric pathogens Islam et al., 2020. Submitted to mSphere, American Society for Microbiology
	Bioactive Immune Components of Travelan® Clin Vaccine Immunol 24:e00186-16. https://doi.org/10.1128/CVI.00186-16
	Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM-124E) has a non-detrimental effect on gut microbial communities in unchallenged mice Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya, Elisa L Hill-Yardin, Ashley E Franks
	Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine Colitis Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797, https://doi.org/10.1093/ecco-jcc/jjy213
	IMM-529
	10 Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5