Immuron Ltd — Regulatory Filings 2023

Aug 13, 2023

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Immuron to present at the Military Health System Research Symposium

Melbourne, Australia, August 14, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that it will be presenting at The Military Health System Research Symposium (MHSRS), in Kissimmee, Florida from the 14[th] to the 17[th] of August 2023.

The MHSRS is the U.S. Department of Defense’s premier scientific meeting that focuses specifically on the unique medical needs of the Warfighter. This annual symposium brings together nearly 3,000 healthcare professionals, researchers, U.S DoD leaders and decision markers as well as various funding bodies and will be a good networking opportunity for the company.

The company will attend the meeting as an Exhibitor and present two posters at the event. One entitled ‘Clinical Evaluation of an Oral prophylactic for prevention of Travelers diarrhea in active-duty military assigned abroad’. The company has also been invited by the Medical Technology Enterprise Consortium (MTEC) to showcase Immuron and its collaborative work with the U.S. Department of Defence including an overview of the current MTEC award entitled ‘Biologics licence application of a bovine immunoglobulin supplement that prevents travelers’ diarrhea caused by enterotoxigenic Escherichia coli (ETEC)’.

The Naval Medical Research Center (NMRC) are also presenting a poster at the symposium on the new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC poster is entitled ‘Research and Development of Hyperimmune Bovine Colostrum Products for the Prevention of Travelers’ Diarrhea’.

Copies of the presentations are available on the Company’s website.

• https://www.immuron.com.au/product science/

Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have demonstrated increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several

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post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.

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 travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers’ diarrhea. 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 Travelers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.

About Travelers’ diarrhea

Travelers’ diarrhea 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 travelers’ diarrhea 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 commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and 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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Clinical Evaluation of Travelan® an Oral Prophylactic for Prevention of Travelers’ Diarrhea in Active Duty Military Service Assigned Abroad.

Joanne L. Casey[1] , Dilara Islam[2,3,4] , Renee M. Laird[2,4] , Vicky Chapman[2,4] , Sandra D. Isidean[2,4] , Kayla Testa[2,4] , Mohamed Al-Ibrahim[5 ] Chad K. Porter[2] , Frédéric Poly[2 ] and Jerry Kanellos[ 1]

1 Immuron Limited. Unit 10, 25-37 Chapman Street, Blackburn North, Victoria 3130, Australia.

2Naval Medical Research Command (NMRC), 503 Robert Grant Ave. Silver Spring, MD 20910.

3 US Army Medical Directorate Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS), Bangkok 10400, Thailand.

4 Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD 20817.

5 Pharmaron Clinical Pharmacology Center, 800 West Baltimore St, Baltimore. MD 21201.

Introduction

Infectious diarrhea is one of the most common illnesses reported by travelers and among deployed US troops visiting developing countries. Travelers’ diarrhea (TD) is often acquired through ingestion of contaminated food and water. TD is predominantly bacterial, with diarrheagenic Escherichia coli , including enterotoxigenic (ETEC) and enteroaggregative E. coli (EAEC), Campylobacter, Shigella , and Salmonella species most common etiology. The morbidity associated with diarrheal illness can result in lost duty days, decreased performance, effects on judgment, decreased morale and reduced operational readiness.

ETEC is the leading cause of TD and represents an undeniable burden for US troops while deployed. TD, is currently managed symptomatically, with antibiotics recommended for more severe disease; however, given the emerging incidence of antibiotic resistance, primary prevention approaches are urgently required. Despite efforts to reduce disease by controlling food and water sources this has only been partially effective, research is focused on developing a vaccine for TD, there are however currently no licensed vaccines available in the United States. New strategies are needed to circumvent ETECattributable TD and a broadly active, safe, and effective oral immunoprophylaxis represents an appealing approach for travelers’ and the military.

Colostrum, the first milk expressed after birthing is rich in antibodies (immunoglobulins) and innate immune components for protection of newborns against infectious agents. Travelan is a hyperimmune bovine colostrum produced by immunization of cows during gestation with a vaccine consisting of antigens derived from multiple ETEC strains known to cause TD. Travelan is a pasteurized, lactosereduced, low-fat, high-protein powder which contains over 80% proteins by weight of which approximately 35% to 45% are antibodies. The manufacturing process involves spray drying of the colostrum to form a powder and tableting in accordance with Good Manufacturing Practices.

NMRC and USAMD-AFRIMS are working with Immuron Ltd on a Research and Clinical Development Program, the focus is on understanding, developing, and informing strategies for the protection of Defense Force personnel against infectious diarrhea. While previous clinical efficacy data with Travelan have demonstrated protection in Controlled human infection model studies (CHIM), such a regimen is cumbersome for military deployed in austere environments, as miltary field studies have shown that compliance is low with products dosed more than once per day. We present our recent in vitro and in vivo data characterizing the antibodies in Travelan and our plans to investigate a dosing regime more suitable for the military in remote locations.

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Objectives

Cross-reactivity of Travelan in vitro and in vivo: Laboratory research studies have demonstrated antibodies in Travelan are reactive against ETEC strains other than those present in the bovine vaccine. Here we describe studies designed to further characterize Travelan cross reactivity and to measure the pre-clinical efficacy of Travelan in a Shigella challenge model in vivo.

Clinical study to assess the protective efficacy of Travelan : Travelan has demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two controlled human infection model (CHIM) studies. These studies showed dosing at 200 mg or 400 mg three times a day, resulted in 84%- to over 90% protection (Otto et al., 2011). A CHIM study with a dosing schedule better suited to the military is planned to assess the efficacy of Travelan against moderate-to- severe diarrhea following challenge with ETEC strain H10407.

Materials and Methods

Immunoreactivity of Travelan antibodies with isolated TD pathogens: Whole cell lysates of 60 ETEC, 60 Shigella and 60 Campylobacter clinical isolates from several countries (Bhutan, Cambodia, Nepal and Thailand) were analyzed by western blotting by probing with Travelan. A skim milk solution was used as a control to probe replicate membranes. A similar study was performed with whole cell lysates of 71 clinical isolates of Vibrio cholera from Bangladesh, Cambodia and Thailand.

Efficacy of Travelan in a Shigella challenge model: Travelan (500 mg) was delivered intragastrically twice daily over 6 days to 8 naïve juvenile rhesus macaques (NJRM; Macca mulatta ). Control animals (n=4) received a skim milk solution as placebo using the same dosing schedule. All animals were challenged with Shigella flexneri 2a and monitored for symptoms for up to 13 days post-challenge. Blood and fecal samples were collected daily, bacterial shedding was monitored and histological analysis of the gastrointestinal (GI) tract was performed on euthanized animals.

A randomized double-blind placebo-controlled Phase 2 clinical study:

Full details of the study plan will be presented.

Results

Travelan cross-reactive immunoreactivity with gram negative clinical isolates: Travelan demonstrated reactivity with all 60 ETEC isolates with variable staining intensity and staining patterns of reactive bands across isolates. Travelan was also reactive with all 60 Shigella isolates and demonstrated a dominant single reactive band in all Campylobacter isolates. All isolates of Vibrio cholera showed reactive bands when probed with Travelan compared with no staining reactivity for any of the clinical isolates when probed with skim milk.

Travelan prevents clinical shigellosis: All placebo-treated NJRMs experienced dysentery within 24 – 36 hours of challenge, whilst only 2 of the 8 (25%) Travelan-treated group developed dysentery. These results demonstrate a 75% efficacy in this in vivo Shigella challenge model (p <0.05). Histopathological analysis revealed that all animals in the placebo-treated group displayed severe inflammation in different parts of the GI tract. These animals also had very high levels of inflammatory cytokines (IL-1b, IL-6 and IL-8) in fecal samples collected throughout the study. The inflammation seen in the GI tract and the increase in inflammatory cytokines in the feces closely correlated with the observed dysenteric clinical outcomes. Three Travelan-treated animals had signs of inflammation in the GI tract, and only 2 of those had high levels of inflammatory cytokines in fecal samples. All other animals in the Travelan-treated group were clinically healthy and did not excrete any inflammatory cytokines.

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Clinical ETEC CHIM Travelan study: The status and results of the study at the time of this Symposium will be presented.

Conclusions

Travelan demonstrated wide immunoreactivity with over 200 clinical field isolates of gram-negative bacteria . This has significant implications for the use of Travelan in military (and other travelling populations) for the prevention of TD caused by multiple strains of ETEC, Shigella, Campylobacter and Cholera Spp . ETEC

The results from the Shigella challenge study results suggests that Travelan is functionally cross-reactive and may have some prophylactic activity against Shigellosis. Overall, these findings provide implications for protection of the war fighter in the field and the potential for long-term humanitarian protection and treatment for endemic populations in an outbreak of these diarrheal-pathogens. Furthermore if the dosing schedule of Travelan used in the clinical study provide implications for demonstrates protective efficacy in the ETEC-challenge study, this could lead to significant positive impacts for the future protection against TD for military units.

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