Positive Results Support Travelan progress to Phase 3 Clinical Trials in the US Highlights: Immuron proceeding to Phase 3 registration strategy with the FDA Travelan topline clinical trial results demonstrate protective

Positive Results Support Travelan

progress to Phase 3 Clinical Trials in the US

Melbourne, Australia, March 7, 2024: Immuron

Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim

topline results confirming that a single daily dose of Travelan is effective in prevention of moderate to severe

diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

AU $4.8 (USD $3.43) million funding by the U.S. Department of Defense (ASX Announcement 12 January 2022) to perform a randomized double-blind

placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited

to deployed US troops visiting developing countries. Healthy volunteers were recruited and randomly assigned to receive a single daily

oral dose of 1200 mg of Travelan or placebo. Dosing commenced 2 days prior to challenge with ETEC strain H10407 and continued

for 7 days. ClinicalTrials.gov Identifier: NCT05933525.

This interim analysis summarizes the data for

a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. Last patients last visits

are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.

Having demonstrated protective efficacy in two

published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing

to the current standard recommended treatment of three times daily dosing. To learn more about Phase 2 study design, read: U.S. Food and

Drug Administration Step 3: Clinical Research

IMM-124E (Travelan ) will be the

first product developed with Immuron's platform technology to proceed into Phase 3 clinical trials. The underlying nature of Immuron's

platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block

viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce. More information on

Immuron's platform technology can be found below.

Travelan demonstrated clinical

efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. These studies showed dosing 400 mg three times daily,

resulted in 76.7% (p=0.007) to 90.9% (p=0.0005) protection (Otto et al., 2011).

This trial demonstrated protective efficacy* with

once daily dosing even though the attack rate for this study was much lower than planned. The intended attack rate (percentage of subjects

with ETEC-induced moderate- severe diarrhea) for this study was approximately 70%. The attack rate for the Placebo group of this study

was only 37% (Table 2). Given the lower than planned attack rate, this current study is underpowered to appropriately detect a significant

difference in moderate to severe ETEC attributed diarrhea in the Placebo group compared to the Treatment group. This makes the demonstration

of protective efficacy and reduction in adverse events and diarrheal symptoms particularly noteworthy.

The company will now proceed to hold an end of

Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials

including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine

for Travelers' Diarrhea. A preventative treatment that defends against infectious enteric diseases is a high priority objective

for the U.S. Military.

Immuron is in the process of exploring non-dilutive funding opportunities

for these Phase 3 clinical trials.

Travelan , a first-in-class, oral

antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo.

Studies using the CHIM for a variety of different

enteric pathogens suggest the greatest protection may be against more severe disease and in studies where the disease appears to be predominately

mild, which appears to be the case in this study, the efficacy estimates can be lower than anticipated.

Table 2: Comparison of clinical study data

Immuron is investigating the impact of the lower than expected attack

Immuron has filed a provisional patent application with the U.S. Patent

Office including results from this trial.

Table 1: Summary of current clinical study

1 Fishers exact test and binomial

AE = Adverse event associated with the ETEC challenge

* Intent-to-treat analysis set defined as randomized

subjects who received study medication and were challenged

This release has been authorized by the directors

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 infectious diseases.

About Phase 2 Clinical Trials

researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically

involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial. Instead, Phase 2 studies

provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and

design new Phase 3 research protocols. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

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.

TD is generally defined

as the passage of 3 unformed stools per 24 hours plus at least one additional symptom (such as nausea, vomiting, abdominal cramps,

fever, blood/mucus in the stools, or fecal urgency) that develop while abroad or within 10 days of returning from any resource-limited

destinations (Leung et al., 2006). Diarrhea continues to be the most frequent health problem among travelers to destinations in lower-

and middle-income regions (Steffen, 2017). Deployed US military personnel, essentially representing a long-term traveller population,

are particularly affected given their population dynamics and the context in which they seek care and treatment (Connor et al., 2012).

Diarrhea is the leading infectious disease threat to the overall health and preparedness of deployed US armed forces, with diarrheagenic

E. coli, Campylobacter spp., and Shigella spp. among the most commonly reported etiologies (Riddle et al., 2006).

Immuron Platform Technology

Immuron's proprietary

technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has the capability

of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can withstand the

acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal (GI) tract. Bovine

IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly to the bacteria found

there. The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious

diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize

the toxins they produce.

IMM-124E was developed

using Immuron's platform technology. IMM-124E is produced from the colostrum of birthing cattle that have been immunised during

pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in the vaccine

to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC.

The resultant hyperimmune

colostrum IMM-124E from ETEC vaccinated cows contains significant levels of polyclonal antibodies specific for ETEC antigens LPS, CFA-I

and Flagellin (Sears et al., 2017).

The antibodies produced

in IMM-124E have been found to have a stronger binding and neutralizing activity (than the antibodies of unvaccinated cattle) against

a wide range of LPS antigens including both the variable O-polysaccharide region and the preserved oligosaccharide core R'

region of LPS from the 13 serotypes used in the ETEC vaccine.