Announcement • Jul 06
Immuron Advances Imm-529 Partnering Strategy and Provides Updates on Clinical Development Immuron Limited engaged Pullan Consulting to provide business development services to assist in securing a strategic partnership for IMM-529. Pullan Consulting specializes in guiding biotechnology and pharmaceutical companies through the partnering process, from strategy development and partner identification to negotiation and transaction execution. Immuron has U.S. Food and Drug administration approval for IMM-529 Investigational New Drug application (IND 32095) for clinical development of IMM-529 as a product to specifically prevent or treat Clostridioides difficile infection in a Phase 2 clinical trial. IMM-529 has a validated biological target. FDA-approved monoclonal antibody Bezlotoxumab was developed as a first-in-class therapy designed to prevent recurrence of Clostridioides difficile infection by neutralizing toxin B, the major driver of recurrent disease. IMM-529’s polyclonal antibodies offer multivalent defense compared with monoclonal single-epitope antibodies. IMM-529 also has an advantage over current standard of care antibiotic treatments that disrupt microbiota. IMM-529 decolonizes the gut facilitating clearance of the pathogen, recovery of the microbiome and prevention of recurrent infection. Immuron has completed an Investigational Brochure and clinical protocol and has secured a principal investigator and three Australian sites. This trial is eligible for Australia’s Clinical Trial Notification scheme, a fast-track method for initiating trials. Immuron has manufactured and released drug product for supply of a clinical trial. The trial protocol is for a randomized, double blind, placebo-controlled clinical study of IMM-529 with Standard of Care for the treatment of Clostridioides difficile infection in subjects with first episode Clostridioides difficile infection or recurrent Clostridioides difficile infection. Up to 60 subjects will be enrolled in the study. Subjects would be randomly assigned to IMM-529 plus Standard of Care or placebo plus Standard of Care in a 2:1 ratio at multiple sites. The primary objective would be to evaluate the safety and tolerability of IMM-529 together with Standard of Care in patients with Clostridioides difficile infection or recurrent Clostridioides difficile infection. Determination of efficacy would be assessed by the measurement and comparison of mortality rate, disease symptoms and recurrence rate for each treatment group. Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It is anticipated that first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to 98,000 patients would be eligible if IMM-529 is positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue for IMM-529 is projected at USD 400 million. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts. The Company is seeking partners to advance clinical development of IMM-529. Under a licensing model, the licensee typically funds development, registration, and commercialization costs. Common licensing agreements include upfront fees upon execution of the document, as well as developmental milestone payments and royalties on product sales. Terms from select historical Clostridioides difficile infection-focused deals that show a range of possible transaction structures are shown below. With upfront payments ranging from USD 1 million to USD 50 million, milestone payments ranging from USD 25 million to USD 570 million, and typical royalties on sales in the mid-to-high single digit percentage range, a successful development partnership for its IMM-529 asset could prove transformational for Immuron. Destiny Pharma licensed NTCD-M3 (nontoxigenic Clostridioides difficile strain, live biotherapeutic) to Sebela Pharmaceuticals with upfront USD 1 million; up to USD 570 million milestones (including USD 19 million development and up to USD 550 million sales) plus royalties. Summit Therapeutics licensed Ridinilazole (small molecule antibiotic) to Eurofarma with USD 2.5 million upfront; up to USD 25 million milestones plus royalties. Assembly Biosciences licensed Microbiome GI programs to Allergan (later AbbVie) with USD 50 million upfront plus milestones and royalties. The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile. Treatment of Clostridioides difficile infection also involves antibiotic use, and the heavy reliance on antibiotics to control Clostridioides difficile does not allow for the gut flora to regenerate and predisposes the patient to relapsing Clostridioides difficile infection. Clostridioides difficile is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States. Clostridioides difficile infection affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. Immuron collaborated with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum that contains antibodies targeting three essential Clostridioides difficile virulence components. IMM-529 targets Toxin B, the spores, and the surface layer proteins of the vegetative cells. This 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). Immuron’s proprietary technology is based on polyclonal immunoglobulins derived from engineered hyper-immune bovine colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and the products are orally active. Bovine immunoglobulins can withstand the acidic environment of the stomach and are resistant to proteolysis by the digestive enzymes found in the Gastrointestinal tract. Bovine immunoglobulins also possess this unique ability to remain active in the human Gastrointestinal 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. Announcement • Dec 05
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 45,472,000
Price\Range: AUD 0.0791
Transaction Features: Subsequent Direct Listing Announcement • Nov 06
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 8,495,080
Price\Range: AUD 0.0756
Transaction Features: Subsequent Direct Listing Announcement • Nov 01
Immuron Limited Announces Clinical Trial Update Immuron Limited provided a clinical trial update on Travelan®? and IMM-529. IMM-529 IND (Clostridioides difficile infection) Immuron announced on October 8, 2025 submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529 to prevent or treat Clostridioidesdifficile Infection. Immuron has received formal acknowledgment of its Investigational New Drug (IND") application from the Center for Biologics Evaluation and Research (CBER), including assignment of a biologic product name and IND number. On October 25th, the U.S. Food and Drug Administration (FDA) informed the company that the IND is currently under active review and issued a request for additional clinical information. In response, Immuron submitted a comprehensive reply addressing the FDA's queries and made minor updates to the clinical trial protocol to incorporate the agency's recommendations ahead of the IND 30-day decision date. Uniformed Services University P2TD study (Incidence of gut health deficiencies) Immuron was expecting the Uniformed Services University to provide topline results from this study by the end of October 2025. The results of the P2TD clinical study, conducted by the Uniformed Services University, will play a pivotal role in shaping Immuron's dosing strategy for its upcoming End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA). Should the study demonstrate favorable outcomes, Immuron intends to propose a twice-daily dosing regimen. IMM-124E (Travelan®?) was developed using Immuron's platform technology. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; 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; and risks relating to pre clinical and clinical testing. IMM-124E®? was developed using Immuron's platforms technology. Factors that could cause real results to differ materially from those current anticipated include: risks relating to its growth strategy; ability to obtain and perform under and maintain financing and Strategic agreements and relationships; risks relating To the results of research and development activity; risks relating to the timing and timing of starting and completing clinical trial; uncertainties relating to preclinical, and clinical testing; risks relating to preclinical andclinical testing; and risks relating to the potential of preclinical and clinical testing. Announcement • Oct 21
Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,133,840
Price\Range: AUD 0.0886
Transaction Features: Subsequent Direct Listing Announcement • Oct 17
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,133,840
Price\Range: AUD 0.0886
Transaction Features: Subsequent Direct Listing Announcement • Jul 22
Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million. Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 32,909,640
Price\Range: AUD 0.0824
Transaction Features: Subsequent Direct Listing Announcement • Jul 16
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 877,440
Price\Range: AUD 0.0722
Transaction Features: Subsequent Direct Listing Announcement • Jun 04
Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million. Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 116,680
Price\Range: AUD 0.0708
Transaction Features: Subsequent Direct Listing Announcement • Jan 15
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,801,680
Price\Range: AUD 0.0847
Transaction Features: Subsequent Direct Listing Announcement • Jan 14
Immuron Announces Travelan Clinical Trial Update Immuron Limited announced that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study and will soon request an end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3. Travelan (IMM-124E) Phase 2 Clinical Study NCT05933525: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC) Immunology: Statistically significant lower levels of IgA and IgG were observed for the subjects who received Travelan compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen. Travelan®? antibodies target and bind to ETEC antigen in the gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers. Clinical data also demonstrated there was a statistically significant reduction in the number of colony forming units (CFUs) in the stools of subjects who received travelan (p =0.0121), measured 48 hours post challenge, indicating faster clearance of the challenge strain from the GI tract. 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 colos trum ofthing 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. dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This 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); 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. Such statements include, but are not limited to, any statements relating to 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 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 growth strategy; 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; risks relating to preclinical and clinical testing; dependence on third-party suppliers; ability to attract, integrate and retain key personnel; the early stage of products under development; need for product development programs and any other statement that are not historical facts. Announcement • Jan 10
Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,579,760
Price\Range: AUD 0.0874
Transaction Features: Subsequent Direct Listing Announcement • Jan 08
Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,579,760
Price\Range: AUD 0.0874
Transaction Features: Subsequent Direct Listing Announcement • Oct 18
Immuron Limited, Annual General Meeting, Nov 18, 2024 Immuron Limited, Annual General Meeting, Nov 18, 2024. Location: the offices of k & l gates, level 25, rialto south tower, 525 collins street melbourne, victoria, Australia Announcement • Oct 04
Immuron Limited Announces NMRC Reports Results for Campylobacter Clinical Study Immuron Limited announced that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC). The results of this clinical trial are unrelated to Travelan and do not impact Immuron's plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) with a view to initiating Phase 3 clinical trial(s) of Travelan in 2H 2025. Nor does this NMRC trial impact on Immuron's commercialization strategy for Travelan. This commercialization strategy also includes the results of the Uniformed Services University clinical study (n=866) of Travelan which is 85% recruited with topline results anticipated in April 2025 (NCT04605783). The trial was funded by the NMRC. Immuron's involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study. Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter Jejuni capsule and CFA/1 (ASX Announcement 9 November 2020). Immuron has been advised by NMRC that the safety and protective efficacy of the product was tested in acontrolled human infection-model clinical trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis. A total of 27 volunteers were enrolled in the randomized, placebo-controlled trial and randomly assigned to either the active or placebo arm of the study. The interim results demonstrated 10.4% protective efficacy against moderate to severe campyl Obacteriosis following challenge with Campylobacter compared to the placebo group. A copy of the presentation will be made available to the Company. Travelan demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the Company's growth strategy; and ability to obtain, perform underand maintain financing and strategic agreements and relationship; risks relating to the Company. Announcement • Jul 04
Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million. Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: At the Market Offering Announcement • Jul 02
Immuron Requests Pre-IND Meeting for IMM-529 with FDA Filing Immuron Limited announced that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529. The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections. To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI. Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This 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 knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease. Announcement • Jun 06
Immuron Limited Appoints Jeannette Joughin as Director Immuron Limited appointed Jeannette Joughin as director, date of appointment is 1 June 2024. Announcement • May 31
Immuron Limited Announces Resignation of Roger Aston as Non-Executive Director Immuron Limited announced that Dr. Roger Aston has resigned from his position as Non-Executive Director effective May 31, 2024. Roger was appointed as a Director in 2012 and served as Non-Executive Chairman from 2012 to 2023. Announcement • Mar 07
Immuron Limited Announces Positive Results Support Travelan Progress to Phase 3 Clinical Trials in the US Immuron Limited announced 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). Immuron was awarded USD 4.8 million funding by the U.S. Department of Defense 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. 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. 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. This makes the demonstration of protective efficacy and reduction in adverse events and diarrhea 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. Topline results: Travelan, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo. ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan group compared to the placebo group; Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate; 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan Group compared to the placebo group; Statistically significant reduction of 83.3% in the subjects in the Travelan groups requiring early antibody treatment post challenge compared to the placebo group; For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group; 55.6% reduction in the number of subjects experiencing adverse events and diarrhea. 55.6% reduction in The number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan group compared to the randomized double-blind placebo group; 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan group compared to the Placebo group. Announcement • Dec 22
Immuron Limited Clinical Trials Update Immuron Limited provided shareholders and the market with an update on the company's clinical development portfolio. The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. The clinical study is being led by Principal Investigator Dr. Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024. Headline results from the clinical trial are anticipated to be reported in second half of 2024. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. Immuron's manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529 drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells of Clostridioides DiffICile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical Services to conduct a GLP compliant toxicity study inrodents. The study protocol has been submitted and approved by the Animal Ethics Committee and the study is planned to commence in first quarter of 2024. The company is working towards submitting a Pre-IND information package to the U.S. Food and Drug Administration (FDA) in first quarter of 2024. Announcement • Dec 04
Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical Study Immuron Limited announced that the US Naval Medical Research Command (NMRC) has initiated the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter. The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870. The dosing, challenge and the in-patient stage of the study is anticipated to be completed by the third week of December 2023. The estimated study completion date (last participant, last visit) is June 2024 with headline results from the clinical trial expected to be reported in 2H 2024. 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, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military. Announcement • Oct 23
Immuron Limited, Annual General Meeting, Nov 21, 2023 Immuron Limited, Annual General Meeting, Nov 21, 2023, at 10:00 AUS Eastern Standard Time. Location: offices of the Offices of K & L Gates, Level 25 Rialto South Tower, 525 Collins Street Melbourne Malbourne Victoria Australia Agenda: To consider Adoption of Remuneration Report; to consider Re-election of Dr. Roger Aston; to consider Approval of increased placement capacity; to consider Approval to Amend Constitution - Employee share scheme provisions; to consider Approval of Omnibus Incentive Plan; and to consider Approval of the Issue of Options to Mr. Paul Brennan. Announcement • Oct 19
Immuron Limited Announces Travelan® Clinical Study Cohort 2 Commences Immuron Limited announced the second cohort of 34 participants have commenced the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan® or placebo. The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial are anticipated to be reported in June 2024. 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, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military. Announcement • Jul 26
Immuron Limited Announces First Patients Enrolled in Travelan® Clinical Study Immuron Limited announced the first cohort of 30 participants have been enrolled into the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort of 30 participants is anticipated to complete dosing and the in-patient stage of the study by the first week of August 2023. The final 30 participants are anticipated to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. The U.S. Department of Defense Uniformed Services University is also running a randomized clinical trial with Travelan® in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783. The USU has reported that to date it has successfully enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study. USU has extended the enrolment period and now expects to complete clinical trial enrolment in Second Quarter 2024. 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 post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military. Announcement • May 31
Immuron Limited Initiates Recruitment of Travelan Clinical Study Immuron Limited announced that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan(R) to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022). Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment. The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan®? compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. The first cohort of 30 participants is anticipated to be enrolled and dosed by the end of July 2023. The final 30 participants are anticipated to be enrolled into the study in October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. This is one of four clinical trials Immuron has, or is soon to, initiate. The U.S. Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan(R) in up to 868 participants. The U.S. department of Defense Uniformed Services University are running a randomized clinical trial of travelan(R) in up To 868 participants. The U.,S. Department of Defense Uniforming Services University is running a randomizedclinical trial of Travelan®? in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783. Announcement • May 09
Immuron Limited Announces US Food and Drug Administration Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves Way for Clinical Trial Initiation Immuron Limited announced that the US Naval Medical Research Center has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli developed in collaboration with Immuron. The FDA has removed a clinical hold on the Investigational New Drug application allowing the NMRC to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by Campylobacter and ETEC which is now active. The safety and protective efficacy of the product will be tested utilising two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomized, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models. The first clinical study will be conducted at the Johns Hopkins University Center for Immunization Research Inpatient Unit, located at the Johns Hopkins Bayview Medical Campus. The study population will include 30 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years. Commencement is subject to ethics approval from the Institutional Review Board. Announcement • Jan 25
Immuron US DoD Naval Medical Research Center Responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic Immuron Limited announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application. The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following a subsequent meeting on 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.