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Immuron Limited (NASDAQ: IMRN) is a pioneering Australian biopharmaceutical company that specializes in oral immunotherapy. The company focuses on developing and commercializing therapies utilizing polyclonal antibody products that target the human gut immune system and microbiome. Immuron's cutting-edge technology platform is designed to create orally stable therapeutics, offering potential 'oral targeted therapy' for a variety of immune-mediated and inflammatory disorders, including non-alcoholic steatohepatitis (NASH), diabetes, colitis, arthritis, inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), liver fibrosis, and other chronic conditions influenced by the immune system.
These disorders represent growing areas of unmet medical need, where oral targeted therapy drugs could provide significant benefits due to their high safety profiles and minimal absorption. Immuron has successfully brought one product to market, serving as proof of concept for its oral immune technology platform. Additionally, the company boasts a robust pipeline of products in various stages of clinical development.
One of Immuron's prominent products is IMM-124E, a proprietary immunomodulatory agent aimed at treating gastrointestinal immune-mediated diseases, including fatty liver diseases. The company operates in two primary segments: Research and Development, and Hyperimmune Products.
Recent developments highlight Immuron's progress in the market. The company has reported increased sales of its travel-related product, Travelan®, especially in markets such as the USA and Canada. Notably, sales in the USA have exceeded expectations following the product’s launch on Amazon. The company is also exploring non-dilutive funding opportunities for its Phase 3 clinical trials and has filed a provisional patent application with the U.S. Patent Office to protect its innovative findings.
Immuron's strategy involves continuing to harness its unique oral immunotherapy platform to address significant medical needs, focusing on partnerships and collaborations to enhance its product offerings and market reach.
Immuron Limited has secured AU $4.8 million (USD $3.43 million) from the U.S. Department of Defense for its product Travelan. Additionally, the company received AU $1.4 million (USD $1.02 million) from the U.S. Naval Medical Research Center to support Travelan's clinical development. The total funding of AU $6.2 million (USD $4.45 million) will be used to test a single larger dosing regimen for military applications. A clinical trial involving 60 volunteers will assess the efficacy of Travelan against Enterotoxigenic Escherichia coli.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a clinical trial program to evaluate the efficacy of Travelan® and two non-antibiotic OTC products for Travelers' Diarrhea. The Uniformed Services University (USU) commenced manufacturing investigational products in November 2021, anticipating enrollment to start in April 2022. The trial aims to enroll 1,336 participants over 18 months, assessing three nutraceuticals against a placebo. This initiative involves collaboration with USU’s Infectious Diseases Clinical Research Program and other organizations to enhance health strategies for travel risk.
Immuron Limited has announced the successful completion of its investigational medical product manufacturing for the US Naval Medical Research Centre (NMRC) after a year-long hiatus due to COVID-19. The company plans to submit an IND application to the U.S. FDA in Q1 2022 to initiate two human Phase II trials. One trial aims to prevent infectious diarrhea caused by ETEC, while the second focuses on campylobacteriosis. Both trials will take place at Johns Hopkins Bloomberg School of Public Health, with the first expected to commence in H1 2022.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a significant advancement in its antiviral research with the publication of findings regarding its product IMM-124E. Conducted by Hadassah Medical Center, the study, titled Augmented antiviral T cell immunity by oral administration of IMM-124E, outlines results from a preclinical mouse model and a phase I/IIa clinical trial. The research indicated that IMM-124E promotes antiviral T cell responses against various viral strains, including SARS-CoV-2 and Hepatitis B. The company has also filed an international patent application for IMM-124E.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced the resignation of Peter Anastasiou, effective immediately. Anastasiou, who joined the Board in 2015 and served as Vice Executive Chairman, cited the missed opportunity to invest in a significant Covid vaccine asset as a reason for his departure. Despite this, he expressed confidence in the company's technology and financial standing. The Board commended Anastasiou for his contributions, stating that the company has a strong cash reserve and an exciting project pipeline.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced the termination of its proposed acquisition of a private biotechnology firm focused on vaccine development due to ASX regulatory concerns. The planned acquisition, aimed at enhancing shareholder value and providing a COVID-19 vaccine candidate, was deemed infeasible as the ASX did not find sufficient information to meet its listing requirements. Consequently, Immuron will resume trading from September 24, 2021, and incur approximately $450k in professional fees related to this unsuccessful endeavor.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a research update on its SARS-CoV-2 program in collaboration with Monash University's Biomedicine Discovery Institute. The study focuses on IMM-124E, showing potential inhibitory activity against the virus, distinct from current vaccine approaches. This suggests a complementary therapeutic option. Additionally, Dr. Dan Peres has been appointed as Chief Medical Officer to lead clinical programs, primarily targeting COVID-19.
Immuron Limited has announced the recommencement of its IMM-124E IND Program and a clinical study for Travelers' Diarrhea (TD) in collaboration with the Uniformed Services University. The Phase III clinical trial will assess the efficacy of nutraceutical products, including IMM-124E, in preventing TD for individuals traveling to high-risk regions. Additionally, the company has engaged Professor Teena Chopra to explore gastrointestinal issues linked to COVID-19, emphasizing their innovative, non-antibiotic solutions for gut health.
Immuron (ASX: IMC; NASDAQ: IMRN) announced the closing of a registered direct offering of 1,066,668 American Depositary Shares (ADSs) at $18.75 per ADS, totaling approximately $20 million in gross proceeds. The funds will be utilized for research and development, clinical programs, marketing for its flagship product Travelan, and general working capital. The offering was overseen by H.C. Wainwright & Co., and a registration statement was declared effective by the SEC. This offering aims to enhance the company's financial positioning and support its ongoing projects.
Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a registered direct offering of 1,066,668 American Depositary Shares (ADSs) at $18.75 per ADS, expected to generate approximately $20.0 million in gross proceeds.
This funding will support clinical programs, enhance marketing for Travelan, and provide ongoing working capital. The offering is being managed by H.C. Wainwright & Co. and will close around July 23, 2020, subject to customary conditions.
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