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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 (IMRN) reported strong sales growth for its over-the-counter immune supplement Travelan® in the December 2024 quarter. Global sales reached AUD$2.5 million, marking a 70% increase from the previous quarter and a 249% rise year-over-year.
In Australia, quarterly sales hit AUD$1.9 million, up 83% from the previous quarter and 314% year-over-year, while half-year sales reached AUD$2.9 million, a 54% increase. The growth reflects expanded distribution across nine additional pharmacy banner groups.
In North America, quarterly sales reached AUD$0.7 million, up 43% quarter-over-quarter and 141% year-over-year. Half-year sales grew to AUD$1.1 million, with USA contributing AUD$0.731 million and Canada AUD$0.376 million, benefiting from distribution across ten pharmacy/grocery retailers in Canada and growing amazon.com sales.
Immuron (NASDAQ: IMRN) has announced a new research collaboration with Monash University to develop therapeutic drug candidates targeting antimicrobial resistant pathogens. The collaboration involves two key projects: one focusing on bacterial DNA transfer mechanisms to develop broad-spectrum therapeutics, and another specifically targeting Vancomycin-resistant enterococci (VRE).
The research will utilize Immuron's technology platform and will be led by Professor Dena Lyras at the Biomedicine Discovery Institute. The collaboration requires no additional funding beyond Immuron's existing research budget. After initial results, both parties will negotiate potential joint development or commercialization terms.
The initiative addresses a critical healthcare challenge, with antimicrobial resistance (AMR) treatment costs exceeding $4.6 billion annually in the U.S. The global antibiotics market is projected to reach $57.0 billion by 2026, growing at a 4.0% CAGR.
Immuron (NASDAQ: IMRN) has submitted a Clinical Study Report to the FDA for its completed Travelan® (IMM-124E) Phase 2 trial, with plans to request an end of Phase 2 meeting before proceeding to Phase 3. The study demonstrated statistically significant results in both immunology and microbiome responses.
The trial showed lower IgA and IgG levels in Travelan®-treated subjects compared to placebo, indicating reduced ETEC antigen exposure. There was also a significant reduction in colony forming units in subjects' stools after 48 hours (p=0.0121), suggesting faster pathogen clearance.
Microbiome analysis revealed that the Travelan® group maintained more stable gastrointestinal microbiota, with improved richness and diversity compared to placebo. The treatment group showed increased levels of beneficial bacteria and reduced inflammation-associated bacteria.
Additionally, a separate Uniformed Services University field study has randomized 776 subjects, with final enrollments expected in March 2025 and follow-up completion around June 2025.
Immuron (NASDAQ: IMRN) announces CEO Steven Lydeamore's upcoming presentation at the Small Cap Growth Virtual Investor Conference on December 5th, 2024, at 2:30 PM EST. The interactive online event allows real-time investor questions and will be archived for later viewing.
Recent highlights include a 172% increase in global sales to $4.90 million in FY24, with record Travelan® sales of $4.86 million. October 2024 saw record monthly sales of A$1.49 million. The company reports ~90% recruitment for the Travelan® Uniformed Services University Phase 4 trial and is planning a Phase 2 trial for IMM-529 following positive FDA pre-IND feedback.
Immuron (ASX: IMC; NASDAQ: IMRN) announced that CEO Steven Lydeamore delivered a presentation at the 21st Virtual Investor Summit Microcap Event on November 21. The company has made the presentation materials available on their corporate website under the presentations section.
Immuron (NASDAQ:IMRN) has announced its participation in the upcoming Q4 Virtual Investor Summit Microcap Event on November 21st. The company, which specializes in gut mediated diseases with one commercial product and two pipeline assets across three clinical programs, will deliver a presentation from 10:30am to 11:00am ET. The event features 40 micro-cap companies with catalysts and/or strong market performance. One-on-one meetings will be available throughout the day, and qualified investors can attend the event complimentarily, which includes live Q&A sessions.
Immuron (ASX: IMC; NASDAQ: IMRN) has announced that its Chief Executive Officer, Steven Lydeamore, will participate in a fireside chat at the Maxim Virtual Healthcare Conference on Wednesday, 16th October 2024, at 4:30 PM U.S. Eastern time. The company has made available a copy of the presentation covering the information to be discussed during the event on their official website. Interested parties can access the presentation materials at https://www.immuron.com.au/corporate-presentations/. This announcement has been authorized by Immuron 's board of directors.
Immuron (ASX: IMC; NASDAQ: IMRN) has reported strong sales growth for its over-the-counter immune supplement Travelan® in the September 2024 Quarter. Global sales reached AUD$1.5 million, up 13% from the previous quarter. In Australia, sales increased by 3% to AUD$1.007 million, while North American sales saw a significant jump of 48% to AUD$0.456 million.
Chief Commercial Officer Flavio Palumbo highlighted the company's achievements, including securing core ranging in nine additional Australian pharmacy banner groups, achieving the strongest monthly sales on amazon.com in the US, and expanding distribution to ten pharmacy/grocery retailers in Canada. These developments have contributed to Immuron's continued growth in both the Australian and North American markets.
Immuron (ASX: IMC; NASDAQ: IMRN) announced the completion of an interim analysis by the US Naval Medical Research Command (NMRC) for a clinical trial evaluating a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC). The trial, unrelated to Travelan®, showed 10.4% protective efficacy against moderate to severe campylobacteriosis. This result does not impact Immuron's plans for Travelan®, including the upcoming end of Phase 2 meeting with the FDA and potential Phase 3 trials in 2H 2025.
The study, funded by NMRC, involved 27 volunteers in a randomized, placebo-controlled trial. Immuron's role was to produce a hyperimmune bovine colostrum product using NMRC's campylobacter/ETEC vaccine. The findings will be presented at the 22nd International Workshop on Campylobacter, Helicobacter & Related Organisms (CHRO 2024) on October 7, 2024.
Immuron continues to collaborate with NMRC and Walter Reed Army Institute of Research (WRAIR) on developing new hyperimmune products targeting various pathogens, aiming to address the high-priority need for preventative treatments against enteric diseases in the US Military.
Immuron (ASX: IMC; NASDAQ: IMRN) has received positive feedback from the FDA on its pre-IND package for IMM-529, a potential treatment for Clostridioides difficile infection (CDI). The company plans to file an IND application in the first half of 2025, followed by a Phase 2 trial. IMM-529 targets three C. diff virulence components and has shown promising results in pre-clinical models, including prevention of primary disease, protection against recurrence, and treatment of primary disease.
CDI affects over 400,000 people annually in the US, contributing to over 30,000 deaths. Market assessment indicates potential yearly revenue of US$93M for IMM-529 if positioned for second recurrence treatment, with potential for up to US$141M if used after first recurrence. The oral dosing of IMM-529 is viewed favorably by infectious disease experts.
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