Announcement • 21h
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 
