Research Update

For your convenience, here is a link to updated research by Henslow Research following the USU study results announcement which is available to wholesale and professional investors: https://henslow.com/news/research/immuron/

The USU study results do not stop Immuron from proceeding with the planned End-of-Phase 2 meeting with the FDA. The USU continues to conduct subset analysis, the results of which will provide Immuron further input for this meeting. Background information on this study dates back to 2020. Information that addresses questions you may have relating to this can be found at the bottom of this update.

You may have read that Immuron was #22 in Deloitte's Tech Fast 50 with a growth rate of 304% (calculated based on tech-based operating revenue over 3 years =FY25-FY23/Y23):

https://www.deloitte.com/au/en/Industries/tmt/about/technology-fast-50.html

This reflects the strong growth in Travelan®sales. At the AGM, Immuron reported continued sales growth with FY2026 Q1 sales of AUD$2.0 million up 34% on FY2025 Q1. Immuron continues progression towards EBITDA (ex-R&D) breakeven (Earnings before Interest, Taxes, Depreciation and Amortisation; ex-R&D: add back research & development, less R&D Tax Incentive and R&D grants).

The USU study results have overshadowed the significant value of the recent FDA approval of Immuron's IND application for IMM-529 which allows Immuron to proceed with Phase 2 clinical studies in clostridioides difficile infection.

https://investors.immuron.com.au/announcements/7245857

Immuron advised at the AGM that it anticipated initiating the IMM-529 Phase 2 trial in 1H 2026. The Immuron team is busy working towards that goal. Near term activities planned include manufacture of investigational product, agreements with principal investigator/contract research organisation and, initiation of trial sites.

As noted in the announcement, IMM-529 has sales potential of US$400 million in the US alone.

IMM-529 has a unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including:

(1) Prevention of primary disease (80% P =0.0052);

(2) Protection of disease recurrence (67%, P<0.01) and

(3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC).

Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains.

To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease.

https://www.nature.com/articles/s41598-017-03982-5

There is a significant unmet need. Current first-line antibiotic treatments, despite their efficacy in achieving clinical cure, fail to address fundamental drivers of recurrence. Despite decades of research, no CDI vaccine has achieved FDA approval for clinical use. Multiple vaccine candidates have failed at advanced stages of development. No approved prophylactic interventions exist for primary prevention of CDI in high-risk populations (elderly patients, hospitalized individuals, antibiotic users). While microbiota-based therapies show promise for secondary prevention (preventing rCDI after initial infection), they are not approved or studied for primary prevention in asymptomatic individuals or those at risk of acquiring CDI from healthcare environments.

Background to the USU study

The protocol for this study was first published in October 2020. Historic protocols can be found here: https://clinicaltrials.gov/study/NCT04605783?intr=travelan&rank=3&tab=history

This study was originally proposed to be a 4-way study with IMM-124E (the active drug substance in Travelan) one of 3 products being evaluated in a placebo-controlled trial. USU manufactured investigational product for all arms of the trial so that they were indistinguishable. See Immuron announcement of May 2022: https://investors.immuron.com.au/announcements/4150060. This is the reason the dosage form was not the same as Travelan. The reason for twice-daily dosing is because the U.S. DoD would prefer less frequent dosing for military personnel while on deployment. This was also the reason the most recent Phase 2 study was dosed once-daily in a trial that reported positive outcomes: https://investors.immuron.com.au/announcements/6235395).

There was significant upside if this trial was successful. It may have allowed Travelan entry to guidelines for prevention of traveler's diarrhea. This would have opened additional sales channels within the U.S. market (health practitioner channel) where the product is currently sold as a dietary supplement without label claims (Immuron has such claims in Australia and Canada).

Wishing you all a safe, happy and health holiday period.

If you are traveling to a country which is a high-risk area for traveler's diarrhea, don't forget your Travelan®

https://www.travelan.com.au/prevent-travellers-diarrhoea

Best Regards,

Steve Lydeamore

Chief Executive Officer