Uniformed Services University to Release Topline Data Highlights: Primary Endpoint did not reach statistical significance Investigational product was manufactured by a third party and was not administered in accordance w

Uniformed Services University to Release Topline

Melbourne, Australia, December 10, 2025: Immuron

Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company announces that the Uniformed Services

University has released topline results from its clinical trial evaluating the effectiveness of a third party manufactured product containing

enterotoxigenic E. coli (ETEC) hyperimmune bovine colostrum (IMM-124E) in maintaining gut health during deployment and travel.

On October 31, 2025, Immuron announced that the

Uniformed Services University (USU) completed the P2TD study (NCT04605783). This study was not conducted under an Investigational New

Drug (IND) Application approved by the FDA. The investigational drug product, contract manufactured for USU by a third party, was formulated

as 600 mg of powder in sachets and administered twice daily in a randomized, placebo controlled trial.

It is important to note that this product was

not administered in accordance with Travelan directions for use. Travelan is administered before meals,

USU Study can be found on clincaltrials.gov; ClinicalTrials.gov ID: NCT04605783.

As Immuron did not manufacture the investigational

product and given the differences in administration, Immuron does not consider the results of this trial to reflect the performance of

Travelan when taken in compliance with directions for use.

Immuron previously indicated that the results

of this study would inform its dosing recommendation to the FDA at the upcoming End-of-Phase 2 meeting. If the study demonstrated satisfactory

outcomes, the company would have considered proposing a twice-daily dosing regimen. However, the data failed to show superiority over

prior clinical trial results supporting superiority of the current three-times-daily regimen for Travelan caplets. Immuron

will propose the established and clinically validated dosage form and three-times-daily dosing schedule.

Immuron has identified several factors that may

have influenced the primary endpoint outcome, including:

These insights, together with a comprehensive

review of the clinical study report, will guide the design of future clinical programs. Importantly, the findings from the USU study provide

an input to refining trial design prior to Immuron's planned End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

Background on Travelan Clinical Trials

Immuron has conducted multiple Travelan clinical

trials which are summarized in the Table below. It is important to note that dosing in the Uniformed Services University P2TD study (NCT04605783)

is 600mg taken as 1 sachet twice daily. The dosage form and administration differ from our commercial product, Travelan for

which directions for use are to take one to two caplets before each meal (i.e., three times daily). Immuron recently completed

a Travelan Phase 2 clinical trial (NCT05933525) during which 6 caplets (1200mg) were taken once daily.

Clinical trial 1 and 2 published in Otto et al.,

2011. Clinical trial 3 recently completed once daily dosing Clinical trial 4 USU study. *Statistically significant; 1

range covers all diarrhea to severe diarrhea cases; 2 For the USU study the formulation is a powdered-form of Travelan also

known as IMM-124E, which is the active component of Travelan .

As announced on August 16, 2024, the Naval Medical

Research Command and the Walter Reed Army Institute of Research, in collaboration with Immuron, are progressing the development of novel

vaccines targeting Campylobacter and Shigella. Under a recently executed collaborative research agreement with the Henry

M. Jackson Foundation, vaccine preparations against these pathogens will be developed and formulated at the military research institutes

and subsequently provided to Immuron. Utilizing its proprietary technology platform, Immuron will produce two hyper-immune bovine colostrum

products for pre-clinical evaluation, with the objective of advancing a combined colostrum-based therapeutic specifically designed for

Immuron has also advanced discussions with the

Department of Enteric Diseases at the Armed Forces Research Institute of Medical Sciences (AFRIMS) to conduct testing of Travelan

against Enteroaggregative Escherichia coli (EAEC) and Enteropathogenic Escherichia coli (EPEC) strains. This would inform Immuron as to

whether another vaccine should be added to the manufacturing process for IMM-124E to increase the overall protective efficacy of a military-relevant

Immuron continues to market Travelan assertively

in its progression towards EBITDA (ex R&D) breakeven as outlined at the Annual General Meeting (AGM) of November 11, 2025. At the

AGM, Immuron advised that it had cost effectively raised capital necessary to proceed with a Phase 2 clinical trial for IMM-529 in Clostridioides

difficile infection, following approval of the IMM-529 IND by the FDA. Immuron announced on December 4, 2025, that it had issued 45.472

million shares at A$0.07910 which raised A$3.5 million. This has exhausted the At-The-Market Facility. These funds will be deployed towards

meeting these objectives.

This release has been authorised 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.

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 (Travelan )

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.

IMM-124E is manufactured

into a tablet form referred to as Travelan .

Connor P, Porter CK,

Swierczewski B and Riddle MS. Diarrhea during military deployment: current concepts and future directions. Curr Opin Infect Dis. 25(5):

Hutton, M.L., Cunningham,

B.A., Mackin, K.E. et al. 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