Neuromuscular Manifestations

Sales Highlights: Global December 2024 Quarter AUD$2.5 million up 70% on prior quarter, up 249% on pcpDecember 2024 Half Year AUD$4.0 million up 70% on pcp Australia December 2024 Quarter AUD$1.9 million up 83% on prior quarter, up 314% on pcpDecember 2024 Half Year AUD$2.9 million up 54% on pcp North America December 2024 Quarter AUD$0.7 million up 43% on prior quarter, up 141% on pcpDecember 2024 Half Year AUD$1.1 million up 130% on pcp MELBOURNE, Australia, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce continued strong sales growth (unaudited) of Travelan®, an over-the-counter immune supplement that targets pathogenic bacteria and the toxins they produce in the gastrointestinal (GI) tract. Flavio Palumbo, Chief Commercial Officer said, “We are achieving strong growth in both Australia and North America reflecting the core ranging we secured in another nine pharmacy banner groups in Australia, distribution in ten pharmacy/grocery retailers in Canada and sales growth on amazon.com in the US.” AustraliaSales of Travelan® increased 90% to AUD $1.851 million during December 2024 Quarter compared to AUD $1.007 million for September 2024 Quarter, a 315% increase on December 2023 Quarter. Sales of Travelan® increased 54% to AUD $2.858 million during December 2024 Half Year compared to AUD $1.853 million for December 2023 Half Year. North AmericaSales of Travelan® increased 43% to AUD $0.652 million in the December 2024 Quarter compared to AUD $0.456 million in the September 2024 Quarter, a 141% increase on December 2023 Quarter. Sales of Travelan® increased 57% to AUD $1.108 million during December 2024 Half Year compared to AUD $0.482 million for December 2023 Half Year. Travelan sales in USA and Canada in the December 2024 Half Year were AUD$0.731 million and AUD$0.376 million respectively. FY25 sales results are unaudited. This release has been authorised by the directors of Immuron Limited. COMPANY CONTACT: Steven LydeamoreChief Executive OfficerPh: +61 (0)3 9824 5254info@immuron.com About Travelan®Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a purified tablet preparation of hyper-immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with traveler’s diarrhea. In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Traveler’s Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveler’s Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection. About Traveler’s diarrheaTraveler’s Diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role. About ImmuronImmuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. For more information visit: https://www.immuron.com.au FORWARD-LOOKING STATEMENTS: This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our 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 our 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 our growth strategy; our 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; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e2265d93-ffff-4413-8da6-fae629615c97

The EMA’s human medicines committee recommended 114 medicines for approval in 2024, marking the highest number of positive opinions issued in 15 years, according to the regulator’s latest report . Of the 114 recommendations, 46 were for new active substances, the EMA’s chief medical officer Steffen Thirstrup said at a press conference on Thursday. Cancer remained the therapeutic area with the most approvals in 2024, followed by immunology, rheumatology, blood and coagulation disorders, and endocrinology, he added. Thirstrup highlighted several positive opinions issued last year that he said helped address unmet needs, including one for Merck’s Welireg for a rare condition called von Hippel-Lindau disease that is characterized by tumors and cysts that can turn cancerous. The agency also recommended ARS Pharmaceuticals’ EURneffy, an EpiPen alternative that’s an adrenaline nasal spray for severe allergic reactions. Although the active substance itself is not new, the green light marks a “major contribution to patients” because the spray format is “much more handy and can be handled by a non-medic,” Thirstrup said. Looking ahead, label expansions for weight loss drugs — as well as new candidates being advanced to offset their muscle loss or sarcopenia side effects — could be key areas of focus. One ongoing discussion at the Committee for Medicinal Products for Human Use centers on whether cardiometabolic indications related to obesity should be added as new indications for GLP-1s or if the clinical data should just be added on to the product label so prescribers are aware of the latest research, Thirstrup said. In December, CHMP said a label expansion of Eli Lilly’s blockbuster diabetes drug Mounjaro into obstructive sleep apnea isn’t necessary. Meanwhile, several companies are testing candidates designed to preserve muscle when used in conjunction with GLP-1 drugs, including Scholar Rock’s myostatin-focused approach and Veru’s oral selective androgen receptor modulator. “I would not exclude that some obesity products could have an action [in other areas such as cancer cachexia] but we need to have, first of all, a clear, identified disease entity and how do we define cachexia and muscle wasting. And then we need the company to demonstrate an effect on desirable endpoints,” Thirstrup said.

Fabio Dorigotti brings over 25 years of clinical development experienceJoins Actimed following retirement of Frank Misselwitz London, UK – 16 January 2025. Actimed Therapeutics, a UK based clinical stage speciality pharmaceutical company focused on bringing innovation to the treatment of cancer cachexia and other muscle wasting disorders, announces the appointment of Dr Fabio Dorigotti as Chief Medical Officer (CMO) following the retirement of previous CMO, Frank Misselwitz MD. Prior to joining Actimed, Dr Dorigotti was CMO of Swiss biopharmaceutical company Quercis Pharma. He brings over 25 years of pharmaceutical industry experience spanning the full breadth of the clinical development process. Robin Bhattacherjee, Actimed CEO, commented: “I am very pleased to welcome Fabio as our new Chief Medical Officer as we focus on advancing our lead candidate ACM001.1 (S-pindolol benzoate) for cancer cachexia into late-stage clinical development. Fabio brings a wealth of relevant knowledge and experience and a proven track record of success. I would also like to take this opportunity to thank our retiring CMO Frank Misselwitz for his invaluable contribution to Actimed over the last several years and am delighted that he will retain his role as a Non-Executive Director on the Board of the company.” During his career, Dr Dorigotti has held inhouse roles of Head of Global Medical Affairs for CSL Vifor and Medical Affairs Director at Astrazeneca, and as Chief Strategy Officer and President of Global Clinical for Worldwide Clinical Trials, a full-service global contract research organization (CRO). He brings a strong track record of successful clinical development and product marketing approvals, alongside a deep understanding of FDA, EMA and other regulatory agencies. Dr Dorigotti commented: “Joining Actimed as CMO provides me with an exciting opportunity to bring my skills and experience to bear in the further development of products that could fill an unmet medical need and benefit patients with serious muscle wasting disorders. I look forward to collaborating with the excellent team at Actimed to help drive the further progress of this exciting candidate and the company.” *** About Actimed Therapeutics Actimed Therapeutics is a clinical stage speciality pharmaceutical company focused on bringing innovation to the treatment of muscle wasting disorders to transform the care of an underserved and vulnerable patient population. The lead area of focus for Actimed is specifically in cachexia. Cachexia is a wasting disease that is associated with cancer and other serious chronic illnesses and with significant morbidity and mortality. A significant number of cancer patients suffer from cachexia1 and it is estimated that cachexia is responsible for up to 20% of all cancer deaths2. A recent meta-analysis demonstrated that cachexia was associated with an 82% higher relative risk of mortality in patients with NSCLC versus no cachexia3. Despite its prevalence and devastating clinical effects, there is no globally approved drug for the treatment or prevention of cancer-related cachexia. The lead product of Actimed, S-pindolol benzoate (ACM-001.1) targets multiple pathways that drive cachexia and has generated promising proof of concept Phase 2a clinical data in cachexia patients, with further clinical studies in preparation. Actimed is currently preparing for further clinical studies in cancer cachexia having received an Investigational New Drug (IND) approval from FDA for S-pindolol benzoate in August 2023 for the treatment of cancer cachexia. Actimed also owns the global rights to its second asset, S-oxprenolol (ACM-002), which is being developed by the Company for the muscle wasting seen in amyotrophic lateral sclerosis (ALS) where loss of body mass and muscle wasting may impact survival⁴. Actimed was granted Orphan Drug Designation to S-oxprenolol for the treatment of ALS by the FDA in 2024. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for cancer cachexia and any other indications outside of ALS to US company Faraday Pharmaceuticals. FOR MORE INFORMATIONActimed Therapeuticswww.actimedtherapeutics.com MEDiSTRAVA Frazer Hall, Erica HollingsworthTel: +44 (0)203 928 6900Email: actimed@medistrava.com ___________________________[1] Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 242 Argilés JM et al, Nat Rev Cancer 2014; 14:754-623 Bonomi P. et al. The mortality burden of cachexia in patients with non-small-cell lung cancer: A meta-analysis; International Conference of Sarcopenia, Cachexia and Wasting Disorders, June 17 – 18 2023, Stockholm, abstract 2-18, page 139⁴ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293