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Immuron Ltd Investor Presentation 2023

Jun 6, 2023

35121_rns_2023-06-06_29463eaa-d204-4fbd-a336-8b6acc79d7eb.pdf

Investor Presentation

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Immuron CEO, Steven Lydeamore presents at LD Micro

Melbourne, Australia, June 7, 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, presented at the LD Micro Invitational XIII conference at the Luxe Sunset Boulevard Hotel, Los Angeles, California, United States on June 6[th] at 2pm (Pacific Time) (7am June 7 AEST) in Track 2.

Registration details for this conference can be found here.

A copy of the presentation made at LD Micro Invitational XIII conference 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 [email protected]

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.

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.

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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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LD MICRO PRESENTATION

7 JUNE, 2023

S t e v e n Lyd e amo re - C EO NASDAQ: IMRN ASX: IMC

1

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.

YTD FY2023 results in this presentation are subject to audit review.

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CEO UPDATE & CORPORATE SNAPSHOT

Strengthening executive Flavio brings over 20 Strong sales for Travelan® well team – New Chief year’s experience with above pre-pandemic levels, may Commercial Officer local and global (Asia, UK) result in short term stock outages Flavio Palumbo commercial leadership in some wholesalers and roles with GSK and P&G pharmacies in June 2023

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USA Market:

Immuron’s own shopfront on amazon.com will be introduced during FY23 Re-entry into retail pharmacies will be explored in FY23

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Canadian Market:

Working towards relaunch into retail pharmacy in FY24

Market Expansion:

Shareholder Base:

  • Evaluating options to enter • Large retail shareholder base in US and Australia Asian and European • BNY Mellon Asset Management (American markets through Depository Shares) holds 34% stake distributors • Board and management aligned with shareholders,

  • • Evaluating options to add to holding 3% stake marketed products portfolio in FY24

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Financial Snapshot

Shares on Issue 227,798,346
Total Options 12,879,720
Last Traded Price IMC: A$0.084
52 week High/Low IMC: A$0.105/0.067
IMRN: $3.21/1.39
Market Cap IMC: A$19.1m
Cash & Cash Equivalents (as at
31 Dec 22)
A$18.5m

Major Shareholders

Holder Units % of CSO
BNY Mellon Asset Management 77,903,505 34.2 %
Management & Board 6,904,554 3.0 %
Authentics Australia Pty. Ltd. 6,000,000 2.6 %
Grandlodge 3,846,712 1.7 %

as of 30 May 2023

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EXECUTIVE SUMMARY

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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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|---|---|---|
|•|Two commercially available oral immunotherapeutic products – Travelan® and Protectyn®|
|•|
|4 clinical programs – Travelan® (Sponsor: Immuron), CampETEC, IMM-529, Travelan® (Sponsor: US Department of Defense)|
|Company|
|•|
|Market capitalisation of A$19.1m as of 30 May 2023 with cash & cash equivalates balance of $18.5 million as of 31 Dec 2022|
|Overview|
|•|Flagship product Travelan® demand surged faster than current supply capability|
|•|
|Travelan® (IMM-124E) IND filed with and approved by FDA|[a]|
|•|
|Travelan® (IMM-124E) Phase 2 clinical trial initiated|[g]|
|Business|
|•|
|CampETEC IND approved (released from Clinical Hold)|[f]|
|•|
|Update|Travelan® Uniformed Health Services University P2TD IMM-124E field clinical trial recruited 300 (35% of target 868)|[e]|
|•|
|FY23 H1 revenue of $584k, up 153% on pcp|
|•|
|FY23 YTD 14 April 2023 revenue of A$1.78m, up 233% YTD on pcp|
|Results &|•|
|Evaluating options to enter Asian and European markets through distributors|
|Outlook|•|Evaluating options to add to marketed products portfolio in FY24|

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TECHNOLOGY PLATFORM

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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

Development of Highly Specific Vaccines

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STEP 2

STEP 3

Isolation of Hyperimmune Oral Antimicrobial 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

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STATUS OF PRODUCT PORTFOLIO AND KEY MILESTONES

US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military[b]

Immuron’s Clinical Programs

  • Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM-124E (Travelan®)[c]

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

  • IMM-124E (Travelan®) IND was approved by the FDA in 2H2022[a]

  • Clinical trial initiated May 2023[g]

  • Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529[d]

  • 600mg solid dose active formulation development completed

  • Project strategy and budget to be approved by the Immuron Board before initiating clinical trials

  • Travelan® - Uniformed Services University has recruited more than 35% of participants in a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region[e]

Our Partners’ Clinical Programs

  • Estimated Study Primary Completion Date – 30 July 2023

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Compound or Partner Phase Phase Phase Market
brand name I II III
Travelan® Uniformed Services
University
CampETEC Naval Medical
Research Center
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  • Estimated Study Completion Date – 31 December 2023

Naval Medical Research Center Clinical Trials of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC)

  • Animal ethics approval for Toxicology study – 22 November 2022

  • Immuron sponsored Toxicology study - completed 20 December 2022

  • FDA Removed Clinical Hold on Campylobacter ETEC – 8 May 2023[f]

a ,b,c,d,e,f ,g ASX Release links in appendix

*Further information on the clinical programs can be found on slide 7

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6

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KEY MILESTONES ANTICIPATED TO DRIVE VALUE
2H 2022 1H 2023 2H 2023 1H 2024
• FDA IND [1] approved for • IRB Approval [4] • Completion of In-patient • Topline results for IMM-
Travelan® single daily dose IMM-124E • Initiated IMM-124E ETEC [2] phase ETEC [2] CHIM [3] clinical 124E ETEC [2] clinical trial
ETEC [2] CHIM [3] clinical trial [a] CHIM [3] clinical trial [g] trial • Clinical Study Report
• Submitted Response Letter • Toxicology Study Report • Initiate NMRC [5] CampETEC • Topline results for NMRC [5]
to FDA Clinical Hold • FDA IND [1] approved (Clinical ETEC [2] CHIM clinical trial CampETEC ETEC [2] CHIM [3]
• Immuron sponsored Hold released) [f] clinical trial
CampETEC
Toxicology study - • Initiate NMRC [5] CampETEC
completed Campylobacter CHIM [3]
clinical trial
• 600 mg solid dose active • Project strategic planning • IMM-529 cGMP • IMM-529 IND [1] submission [6]
formulation development and budget development manufacture [6] • Initiate IMM-529 Phase 2
IMM-529
• IMM-529 IND [1] Pre-IND CDI [8] clinical trial [6]
submission [6]
• USU [7] P2TD IMM-124E field • 35% of 868 participants • Primary Study Completion • Study Completion
Travelan® clinical trial recruitment recruited
commencement [e]
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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 Center; 6. Project strategy and budget to be approved by the Immuron Board; 7. Uniformed Health Services University of the Health Sciences; 8. Clostridioides Difficile;[a,e,f ,g ] ASX Release links in appendix

7

IMMURON’S CLINICAL PROGRAMS – OPPORTUNITY ASSESSMENT

  • › 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/

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8

DISTRIBUTION CAPABILITY

Australia USA Canada Retail Pharmacy Established B2B E-commerce Developing

Key Commentary

  • The Australian retail network includes over 3,500 pharmacies

  • In the USA, the key B2B customer is Passport Health - the largest network of travel medicine clinics

  • Immuron’s own shopfront on amazon.com will be introduced in the USA during FY23

  • Re-entry into retail pharmacies in USA will be explored in FY24

  • In Canada, we are working towards a relaunch into retail pharmacy in FY24

  • We are exploring options to expand B2B business in airlines, cruise ships, health & wellness segments

  • We are evaluating options to enter Asian and European markets through distributors

ANB Canada Ontario, Canada Distributes to all provinces of Canada

Immuron Limited Vancouver, BC, Canada

RJW Logistics Chicago, USA Distributes to all states of USA

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Immuron Limited

Melbourne, Australia Distributes to all states of Australia and to distributors in USA and Canada

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Immuron Inc. New York, USA

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9

ADDRESSABLE MARKET & INDUSTRY OVERVIEW

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Billion Dollar Market

Travelers diarrhea treatment market is large and growing at a CAGR of ~7%

Industry tailwinds

Travel picking up significantly following COVID lockdowns

Frequent Symptom

30% - 70% of travelers experience traveler’s diarrhea***

~$15b+ ~7% CAGR $83m $50m $1.7b Immuron’s products Travelers diarrhea Travelan® has large Based on US annual Based on EU travel Clostridioides difficile are a subset of the treatment market is market potential travel numbers and a numbers and a infections (CDIs) to global digestive health large and growing at a given that acute penetration rate of penetration rate of grow to almost $1.7 market, which a multiCAGR of ~7% over diarrhea affects 15%, the market 15%, the market billion by 2026, billion-dollar market 2019-2022 millions of travelers potential is estimated potential is estimated according to at $83m at $50m**** GlobalData each year

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* IQVIA Consumer Health Category QuickView MAT Q1 2019

** IMC Company Report - Travelan Market Analysis 2019

10

*** Centers for Disease Control and Prevention Yellow Book

BUSINESS POSITIONED FOR ORGANIC GROWTH AND NEW M&A STRATEGY

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Organic Growth Strategy

Focus on commercialised products and near-term development extensions, including:

01 Travelan®:

  • Sales expansion across target geographies

  • Growth in distribution network and sales & marketing initiatives

  • Product development (new formulations including once daily dosing) e.g. FDA approval

  • 02 Protectyn®:

  • Sales expansion across target geographies

  • • Growth in distribution network and sales & marketing initiatives

  • • Product development and broader applications

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M&A Strategy

By pursuing growth through M&A of a fragmented market, IMC believes that it will be able to increase market geographies, sales channels and penetration driving revenue growth and ultimately shareholder value

Our M&A Key Criteria focusses on:

01 Expand market verticals & product offering 02 Expand existing customer base

03 Cost & Earnings Synergies

04 Strength of IP and Management

05 Distribution network and sales & marketing by each product

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STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:

EMAIL: [email protected] PHONE: AUSTRALIA: +613 8892 4854

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|---|---|
|SCIENTIFIC REFERENCES|
|Travelan® (IMM-124E)|
|Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90% of|Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI:|
|volunteers|10.3109/00365521.2011.574726|
|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|US Department of Defense, Armed Forces Research Institute of Medical|
|for prevention of traveler’s diarrhea|Sciences (AFRIM), 4 September, 2019|
|Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared to|US Department of Defense, Armed Forces Research Institute of Medical|
|placebo and demonstrated a significant clinical benefit|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|Islam et al., 2020. Submitted to mSphere, American Society for Microbiology|
|bioactivity of HBC against common enteric pathogens|
|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|Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya,|
|effect on gut microbial communities in unchallenged mice|Elisa L Hill-Yardin, Ashley E Franks|
|Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine|Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797,|
|Colitis|https://doi.org/10.1093/ecco-jcc/jjy213|
|IMM-529|
|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|

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13

ASX RELEASES REFERENCED

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Ref Slide statement ASX Release a Travelan® (IMM-124E) IND filed with and approved by FDA Immuron Receives FDA Approval for Travelan IND Application b US Department of Defense grant of US$4.45 million to examine a dosing Immuron awarded A$6.2 million US DoD regimen for Travelan® more suited for use by the military funding for Travelan c Market evaluation by Lumanity confirms the Traveler’s Diarrhea market AGM Presentation opportunity for IMM-124E (Travelan®) d Market evaluation by Lumanity confirms the Clostridioides difficile market AGM Presentation opportunity for IMM-529 e Travelan® - Uniformed Services University has recruited more than 20% of US DOD Travelan Clinical Recruitment participants in a randomized clinical trial with Travelan® to evaluate the Milestone effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region f Immuron Announces FDA Removed Clinical Hold on New Campylobacter FDA Removed Clinical Hold on ETEC Therapeutic Paves Way for Clinical Trial Initiation Campylobacter ETEC Therapeutic g Immuron Initiates Recruitment of Travelan® Clinical Study Immuron Initiates Recruitment of Travelan Clinical Study

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