Uniformed Services University of the Health Sciences

MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases. Following discussion with the US Naval Medical Research Command (NMRC), today the Company can announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC). The results of this clinical trial are unrelated to Travelan® and do not impact Immuron’s plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) with a view to initiating Phase 3 clinical trial(s) of Travelan® in 2H 2025. Nor does this NMRC trial impact on Immuron’s commercialization strategy for Travelan®. This commercialization strategy also includes the results of the Uniformed Services University clinical study (n=866) of Travelan® which is 85% recruited with topline results anticipated in April 2025 (NCT04605783). The details of the trial are available at clinicaltrials.gov/study/NCT06122870 . The trial was funded by the NMRC. Immuron’s involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study. Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. Relatively little is known regarding what constitutes protective immunity against Campylobacter and there is currently no licensed vaccine to prevent disease caused by C. jejuni. C. jejuni is considered an invasive enteric pathogen, but the molecular details of its pathogenesis remain difficult to interpret or understand largely due to the lack of reliable, non-primate animal models of disease. To address this unmet medical need, the NMRC developed a conjugated vaccine using the Campylobacter jejuni capsule crosslinked to the colonization factor antigen 1 (CFA/1) of Enterotoxigenic Escherichia coli (ETEC). These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and CFA/1 (ASX Announcement 9 November 2020). Immuron has been advised by NMRC that the safety and protective efficacy of the product was tested in a controlled human infection-model clinical trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis. A total of 27 volunteers were enrolled in the randomized, placebo-controlled trial and randomly assigned to either the active or placebo arm of the study. The interim results demonstrated 10.4% protective efficacy against moderate to severe campylobacteriosis following challenge with Campylobacter compared to the placebo group. Data analysis by the NRMC continues, including secondary and exploratory endpoints, which may provide insights as to why protective efficacy for CampETEC for was lower than that achieved in similar studies with Travelan®. Immuron is not privy to any further details of the study at this time, pending the presentation of findings described below. Dr Frédéric Poly, the principal Investigator of the study, will present the findings for the NMRC CampETEC clinical study at the 22nd International Workshop on Campylobacter, Helicobacter & Related Organisms (CHRO 2024) which commences on 7 October 2024 at the Perth Convention and Exhibition Centre. A copy of the presentation will be made available on the Company website once it is made available to the Company. Travelan® demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. These studies showed dosing 400 mg three times daily, resulted in 76.7% to 90.9% protection (Otto et al., 2011) and more recently 36.4% protective efficacy in a single daily dose Phase 2 study designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing (ASX Announcement 7 March 2024). This Phase 2 single dose trial also produced clinically relevant secondary endpoints (ASX Announcement 8 August 2024). The vaccine used in CampETEC was a conjugated vaccine for both campylobacter and ETEC. The NMRC recently received U.S. Department of Defense funding to develop a new campylobacter vaccine not conjugated with ETEC as well as new vaccines for shigella and different strains of E.coli. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. NRMC and Walter Reed Army Institute of Research (WRAIR) are now developing an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrheal pathogens (ASX announcement 16 August 2024). Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have had an increasing resistance to commonly prescribed antibiotics. In addition, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases is a high priority objective for the US Military. This release has been authorized by the directors of Immuron Limited. COMPANY CONTACT: Steven LydeamoreChief Executive OfficerPh: +61 (0)3 9824 5254steve@immuron.com About Travelan® Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tableted preparation of hyperimmune 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 gastrointestinal 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 Diarrhea Traveler’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. Campylobacter spp. are also responsible for a significant proportion of cases. The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the causative agent of cholera) are often confused with Traveler’s Diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable. 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 infectious diseases. For more information visit: http://www.immuron.com 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.

Presentation to update the advanced development of BIO 300, an orally available medical countermeasure for Warfighters, to prevent toxicities due to radiation exposure. MINNEAPOLIS--(BUSINESS WIRE)--Updates on the development of Humanetics Corporation’s (Humanetics) new drug candidate, BIO 300, were presented at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29 th in Kissimmee, Florida. MHSRS is the foremost scientific meeting of the U.S. Department of Defense (DOD), focusing on the unique medical needs of warfighters. BIO 300 was originally developed as a radioprotectant by researchers at the Armed Forces Radiobiology Research Institute (AFRRI) in Bethesda, Maryland. It was exclusively licensed to Humanetics for advanced development and commercialization. Collaborative studies continue with DOD scientists to develop BIO 300 as an oral drug that warfighters can take to provide protection against the effects of radiation from a radiological or nuclear event. Key Highlights of the Presentation: Novel Formulation: An overview of the BIO 300, an orally available drug designed for ease of use and rapid administration in various military and commercial settings. Efficacy and Safety: Insights into the nonclinical studies demonstrating the compound’s ability to protect against Acute Radiation Syndrome (ARS) and its safety in animal models. Clinical Development Pathway: An outline of clinical data supporting BIO 300’s safety and efficacy, including the proposed plan for human dose conversion under the FDA animal rule. Ongoing Development Activities: A detailed overview of ongoing and future development activities to support planned regulatory submissions. This work highlighted on BIO 300 research has positioned it as one of the most advanced prophylactic medical countermeasures currently under development for ARS. Developing countermeasures that protect individuals, especially military personnel, against ARS is paramount, considering the current geopolitical environment fueling the real and increasing threat of nuclear or radiological events. “We are thrilled to share our progress on the advanced development of BIO 300,” said Michael Kaytor, Ph.D., Vice President of Research and Development at Humanetics. “This drug could transform our ability to protect the men and women who serve our country, and anyone who may be at risk of intentional or accidental radiation exposure.” In addition to its military applications, BIO 300 is being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce inflammatory lung damage (e.g., COVID-19, Idiopathic Pulmonary Fibrosis, acute respiratory distress syndrome). The research presented was supported in part by grants from the US Department of Defense’s Congressionally Directed Medical Research Program and an Other Transaction Authority agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND). The views expressed herein are those of Humanetics and may not reflect the official policy or position of the Department of Defense or the US Government. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. About Humanetics Corporation Humanetics Corporation is a clinical-stage pharmaceutical company engaged in the accelerated discovery, development and commercialization of proprietary drugs in markets with urgent and unmet needs with a focus on radiation modulators for oncology and medical countermeasures. For more information, visit . Contacts Michael Kaytor VP – Research and Development mkaytor@humaneticscorp.com

Amy Emerson, Lykos' founding leader, stepping down as CEO Pharma veteran and Lykos Chief Operating Officer Michael Mullette appointed as interim CEO Dr. David Hough named Chief Medical Officer SAN JOSE, Calif., Sept. 5, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, today announced key changes to the company's senior management. Amy Emerson, who has led Lykos for the past decade since its founding in 2014, will step down as Chief Executive Officer ("CEO"). She will transition into a senior advisor role through the end of the year and will serve as an Observer on the Lykos Board. Michael Mullette, who has served as Chief Operating Officer ("COO") since early 2022 following over two decades with Sanofi and Moderna, will become the company's interim CEO. "Mike is a highly experienced leader with the right background and skills to steer Lykos as we engage with the FDA and work to bring this pioneering treatment to patients in need," said Jeff George, Chairman of the Lykos Board of Directors. "Mike has been highly impactful in his role as COO and has a deep understanding of the path ahead. He brings a wealth of knowledge and an impressive track record from over two decades in pharmaceuticals and is well-equipped to lead Lykos as we look to the future." Mr. Mullette joined Lykos after more than two decades in the pharmaceutical industry, most recently heading North America for Moderna, where he oversaw commercialization of the company's COVID-19 vaccine during the height of the pandemic. Prior to this, he spent nearly 20 years with Sanofi, where he held management and leadership roles across the U.S., France, Japan, Australia, and Canada, including as GM and Country Chair of Sanofi Canada and as GM of Sanofi Pasteur in Japan. Amy Emerson departs her role at Lykos after nearly 10 years. She began work on the midomafetamine program in 2003 and was appointed to lead Lykos (then MAPS PBC) upon its formation in 2014. "We founded Lykos with a deep belief in the need for innovation in mental health, and I am deeply grateful for the privilege of leading our efforts," said Ms. Emerson. "While we are not at the finish line, the past decade of progress has been monumental. Mike has been an outstanding partner and is well prepared to step in and lead our next steps. I know he will continue to pursue Lykos' mission of helping patients with unwavering dedication and resolve." "Amy's contributions to Lykos, and to innovation in the field of mental healthcare more broadly, cannot be overstated," Mr. George added. "She has helped pioneer the pathway for this FDA-designated breakthrough therapy program since its infancy. We are deeply grateful for her leadership and service." In addition to Mr. Mullette's appointment, Dr. David Hough, who was recently announced as Lykos' senior medical advisor, formally joins the company as Chief Medical Officer. In his expanded role, Dr. Hough will continue to oversee Lykos' clinical development program and its regulatory engagement with FDA regarding the resubmission of midomafetamine. Dr. Hough previously spent 17 years with Johnson & Johnson, where he oversaw the Spravato® (esketamine) Phase 3 development and approval in two indications across multiple markets. "Charting a path toward FDA approval will require seasoned leadership and expertise," said Suprotik (Protik) Basu, Lykos board director and managing partner at Helena, Lykos's lead investor. "I've gotten to know both Mike and Dave over the past year, and I have deep conviction in their ability and commitment to bringing this treatment, if approved, to the millions who are waiting with great hope." Michael Mullette is an experienced pharmaceutical industry leader who joined Lykos as Chief Operating Officer in March 2022 following over two decades with Sanofi and Moderna. He most recently served as Vice President of North America commercial operations for Moderna, where he oversaw commercialization of the company's COVID-19 vaccine during the pandemic. Before joining Moderna, he spent nearly 20 years with Sanofi working in commercial, business development, operations, strategy, planning, marketing, and sales roles of increasing responsibility including leadership roles across the U.S., France, Japan, Australia, and Canada. Mike earned his Bachelor of Business Administration from Villanova University and M.B.A. from Lehigh University. David Hough, M.D., is a board-certified psychiatrist and pharmaceutical executive with deep expertise in central nervous system (CNS) drug development. He previously served as Vice President of Research and Development at J&J Innovative Medicine (a Johnson & Johnson company) and other leadership roles over the course of 17 years. He was the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, and INVEGA TRINZA as well as for SPRAVATO® (esketamine nasal spray), where he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program. Prior to his work at J&J, Dr. Hough graduated from West Point and served as an Army officer before attending medical school at the Uniformed Services University of the Health Sciences (USUHS). He completed his residency training in Psychiatry at Walter Reed Medical Center and subsequently served for 10 years as an Army psychiatrist, where he treated soldiers, retirees, and family members with a variety of behavioral health issues, including many with trauma and PTSD. He is board certified in both Adult and Geriatric Psychiatry, and he previously held an Adjunct Assistant Professor of Psychiatry position at USUHS. He has authored numerous publications in peer reviewed journals, is a reviewer for several journals, and was an examiner for the American Board of Psychiatry and Neurology. Midomafetamine capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications. About Midomafetamine-Assisted Therapy Midomafetamine (MDMA) is commonly known to mental health professionals. In the 1970s and early 1980s, MDMA was used in conjunction with talk therapy by mental health providers to help enhance patients' access, processing and communication of difficult emotions and experiences.1 MDMA is an entactogen— a class of psychoactive compounds that are differentiated from classic psychedelics (i.e., psilocybin, mescaline and LSD) and are defined based on their mechanism and demonstrated effects of increasing self-awareness leading to introspection and personal reflection.2,3 In 1985, the U.S. Drug Enforcement Administration ("DEA") made MDMA a Schedule I drug under the Controlled Substances Act, preventing it from being used for recreational or medical use.4 Since then, research has suggested that MDMA may have potential as a catalyst to support psychotherapy by helping diminish the brain's fear response, allowing people to access and process painful memories without being overwhelmed.5 Lykos was the first company to pioneer randomized, double-blind, placebo-controlled clinical trials evaluating the efficacy and safety of MDMA-assisted therapy as an investigational modality using midomafetamine (MDMA) in combination with psychological intervention and submit an NDA to the FDA seeking approval for the treatment of PTSD in adults. Lykos Therapeutics At Lykos Therapeutics, a public benefit corporation ("PBC") founded by the Multidisciplinary Association for Psychedelic Studies ("MAPS"), our mission is to transform mental healthcare. We're applying decades of evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are relentlessly exploring and reimagining novel approaches to address unmet needs in the mental healthcare space, with an initial focus on PTSD. As a PBC, we are focused on delivering positive impact on our people, communities and society. To learn more visit us at and on LinkedIn, X, Instagram and Facebook. 1 Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. J Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712 2 Nichols, David E. Entactogens: How the name for a novel class of psychoactive agents originated. Frontiers in Psychiatry. 2022 Mar 25;13:863088. doi:10.3389/fpsyt.2022.863088 3 Vollenweider, Franz X.,Dialogues Clin Neurosci. 2001 Dec; 3(4): 265–279.doi: 10.31887/DCNS.2001.3.4/fxvollenweider 4 National Institute on Drug Abuse (NIDA) (nih.gov) What is the history of MDMA? . Accessed, January 17, 2024. What is the history of MDMA? | National Institute on Drug Abuse (NIDA) (nih.gov) 5 Yazar-Klosinski B, Mithoefer MC. Potential psychiatric uses for MDMA. Clinical Pharmacology & Therapeutics. 2017 Feb;101(2):194-196. doi: 10.1002/cpt.565 SOURCE Lykos Therapeutics