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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 (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.
Immuron (ASX: IMC; NASDAQ: IMRN) has announced a new $3.5 million (USD $2.3 million) research award from the U.S. Department of Defense to advance the development of Travelan®. The funding is for the Naval Medical Research Command (NMRC) and Walter Reed Army Institute of Research (WRAIR) to develop an enhanced formulation of Travelan, potentially expanding its coverage as a therapeutic measure against endemic military-relevant diarrheal pathogens.
The research will target key protective antigens of major enteric bacterial pathogens not present in the current product formulation. Immuron will negotiate a sub-award for collaboration with NMRC and WRAIR. This builds on the DoD's long-standing relationship with Immuron to evaluate Travelan's effectiveness against diarrheal pathogens, addressing a high-priority objective for the US Military in preventing infectious enteric diseases.
Immuron (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company, announces CEO Steven Lydeamore's upcoming presentation at the Emerging Growth Conference on August 22nd, 2024. The interactive presentation, scheduled for 3:40 PM Eastern time and lasting 12 minutes, invites investors, advisors, and analysts to attend.
Participants can submit questions in advance to Questions@EmergingGrowth.com or during the event. Registration is required to attend and receive updates. If unable to join live, an archived webcast will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel.
Immuron (ASX: IMC; NASDAQ: IMRN) has announced an upcoming investor webinar on MarketOpen Direct Connect. The event is scheduled for Thursday, August 8, 2024, at 11:00 AM AEST (9:00 AM AWST). CEO Steven Lydeamore will provide an update on additional data analysis of the IMM-124E (Travelan®) Phase 2 trial and discuss next steps.
The webinar will include a moderated Q&A session allowing attendees to ask questions directly to Mr. Lydeamore. Interested parties can register for free via the provided Zoom link. A recorded version of the webinar will be made available after the event.
Immuron (ASX: IMC; NASDAQ: IMRN) has reported record global sales for its over-the-counter immune supplement Travelan® in FY 2024. Global sales reached AUD$4.9 million, up 174% from the previous year. Australia led with AUD$3.7 million in sales, a 223% increase, while the USA achieved record sales of AUD$1.1 million, up 74%. The June 2024 quarter saw significant growth, with global sales up 253% year-over-year to AUD$1.3 million.
The company attributes this success to increased brand awareness investments and plans further growth in North America through increased brand investment and distribution. The sales surge aligns with rising international travel, as reported by the Australian Bureau of Statistics and the U.S. International Trade Administration.
Immuron (ASX: IMC; NASDAQ: IMRN) has filed a pre-IND application with the FDA for IMM-529, aimed at treating recurrent Clostridioides difficile infections (CDI). CDI affects over 400,000 people annually in the U.S., causing over 30,000 deaths. IMM-529 is being developed as an adjunct therapy to standard antibiotics, targeting Toxin B, spores, and vegetative cells of C. diff. Pre-clinical studies have shown promising results, including 80% prevention of primary disease and 67% protection against recurrence. The projected base case yearly revenue for IMM-529 is US$93 million, with potential expansion to US$141 million if used for first recurrence patients. The drug's oral dosing is considered advantageous over current complex treatments. Immuron is working with Monash University to produce antibodies from bovine colostrum. The PR highlights the urgent need for new CDI treatments due to rising antibiotic resistance.
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