Key Points Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceedFDA assigned an IND number (032095) for the IMM-529 application IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active MELBOURNE, Australia, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC ...

IMM-529 IND: currently under review, FDA request for Information – minor updates to clinical protocol completed and submitted Travelan® P2TD (n=851) Uniformed Services University study topline data delayed to the end of November due to U.S government shutdown MELBOURNE, Australia, Oct. 31, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company provides a clinical trial update on Travelan® and IMM-529. IMM-529 IND (Clostridioid ...

Core Viewpoint - Emerging Growth Research has initiated coverage on Immuron Limited with a Buy-Extended rating and a 12-month price target of $4.00, indicating over 80% upside potential from the current price of $2.20 [1][2]. Group 1: Company Overview - Immuron Limited is a biopharmaceutical company based in Melbourne, Australia, founded in 1994, focusing on developing oral polyclonal antibodies for gastrointestinal infectious diseases [8]. - The company’s marketed products include Travelan® and Protectyn®, with a pipeline targeting infections such as C. difficile, ETEC, and VRE [8]. Group 2: Product and Revenue Growth - Immuron's flagship product, Travelan®, has shown strong revenue growth, with FY2025 revenue increasing by 49% year-over-year to A$7.29 million [7]. - The company is set to launch a third digestive health product, ProIBS®, in the Australian market in Q4 2025 [7]. Group 3: Clinical Pipeline and Partnerships - Immuron's lead drug candidates, IMM-124E (Travelan®) and IMM-529, are advancing toward pivotal trials in 2026, targeting traveler’s diarrhea and C. difficile infections, respectively [7]. - The company has strategic partnerships with the U.S. Department of Defense, Walter Reed Army Institute of Research, and Monash University to evaluate its antibodies for various applications [7]. Group 4: Financial Position and Market Potential - Immuron maintains a strong balance sheet, remaining debt-free, with product revenues helping to offset R&D costs [7]. - The company is positioned to address multi-billion-dollar global markets in antimicrobial resistance and gastrointestinal therapeutics [7].

Sales Performance - Global Q1 sales reached AUD$2.0 million, representing a 34% increase compared to the prior comparative period (pcp) [1] - Australia Q1 sales were AUD$1.6 million, up 52% on pcp [1] - USA Q1 sales increased to AUD$0.4 million, reflecting a 44% growth on pcp [1] - Canada Q1 sales were AUD$0.0 million, down 92% on pcp [1] Growth Drivers - Continued growth in Australia attributed to increased awareness from digital and social media marketing, same store growth, new store openings, and increased travel from South East Asia [3] - In the U.S., sales growth driven by marketing initiatives including improved online presence on Amazon, local social media pages, and increased paid and organic social media marketing [4] - In Canada, sales are expected to improve as consumer promotions are anticipated towards the end of the calendar year, with efforts to build brand awareness through educational programs and promotions [5] Product Information - Travelan® is an over-the-counter immune supplement designed to reduce the likelihood of travelers' diarrhea caused by pathogenic bacteria [7] - The product is available in Australia as a listed medicine, in Canada as a licensed natural health product, and in the U.S. as a dietary supplement [8]

Core Insights - Immuron Limited has submitted an Investigational New Drug (IND) application to the FDA for the clinical development of IMM-529, aimed at treating Clostridioides difficile infection (CDI) and preventing recurrent CDI [1][8] - The company plans to initiate a Phase 2 clinical trial for IMM-529 in the first half of 2026, targeting individuals with CDI [2] - Market analysis indicates that if proven effective, IMM-529 could be positioned early in the treatment algorithm, with an estimated eligible patient population of approximately 98,000 if introduced at the first recurrence stage [3] Market Potential - The base case annual revenue potential for IMM-529 is projected at approximately US$400 million, considering market size, payer dynamics, competitive landscape, and pricing assumptions [4] - The oral administration route of IMM-529 has been positively received by infectious disease specialists, enhancing its clinical and commercial appeal [4] Industry Context - The rise of antibiotic-resistant 'superbugs' has increased the use of broad-spectrum antibiotics, leading to disruptions in gastrointestinal microbiota and susceptibility to pathogens like C. diff [5] - CDI affects over 400,000 individuals in the US annually, contributing to over 30,000 deaths, highlighting the urgent need for new therapeutics to reduce antibiotic reliance [5] Product Development - IMM-529 is being developed as an adjunctive therapy alongside standard antibiotics for CDI treatment and prevention of recurrence, targeting key virulence components of C. diff [6] - The mechanism of action involves antibodies designed to accelerate the clearance of CDI and support the restoration of healthy gut microbiota [6] - Pre-clinical results show promising efficacy in preventing primary disease (80%), protecting against recurrence (67%), and treating primary disease (78.6%) [7] Unique Positioning - IMM-529 is noted as the only investigational drug to demonstrate therapeutic potential across all three phases of CDI [8]

Core Insights - Immuron Limited has reported record sales for the financial year ending June 30, 2025, and is on track to exceed first quarter sales for FY24, with results expected in mid-October 2025 [3][10]. Sales Performance - The company achieved record sales up to the end of FY25 and anticipates surpassing FY24 first quarter sales [3]. - Travelan, a dietary supplement imported into the U.S., is not expected to be affected by new tariffs on pharmaceutical products [3][10]. Clinical Trial Updates - Immuron is developing three therapeutic products: IMM-124E (Travelan), IMM-529, and IMM-986 [4]. - Topline results for the Travelan clinical study are expected in October 2025, with the final patient visit anticipated in July 2025 [5][10]. - The company plans to request an end of Phase 2 meeting with the FDA for IMM-124E following the trial results, which will lead to a Phase 3 clinical program [6]. Revenue Projections - The base case yearly revenue for IMM-124E in the U.S. is projected at approximately US$102 million [7]. - The market for IMM-529 is estimated to reach peak revenues of around US$400 million [9]. Regulatory Milestones - Immuron plans to submit an Investigational New Drug (IND) application for IMM-529 to the FDA by mid-October 2025, which is necessary for starting a Phase 2 clinical program [8][10]. - The company is also progressing with initial pre-clinical studies for IMM-986, targeting Vancomycin-resistant enterococci (VRE), with completion expected by the end of 2025 [10][15]. Product Launch Plans - The launch of ProIBS, a treatment for Irritable Bowel Syndrome (IBS), is anticipated in Q4 of 2025, with a full launch planned for Q1 of 2026 [11][12]. - The IBS treatment market in Australia is projected to generate around A$221 million in 2025, with an annual growth rate of 3.28% [12].

Core Insights - Immuron Limited (NASDAQ:IMRN) reported a 49% growth in global revenue for fiscal year 2025, primarily driven by strong sales of its flagship product, Travelan [1][2] - The company achieved a net loss reduction of 24% year-over-year, with a loss per share of A$0.023 for FY2025, an improvement from A$0.03 in FY2024 [2] - Gross margins remained robust at 65.4%, indicating strong profitability despite the losses [2] Revenue Performance - North American sales for Travelan increased by 76% to A$2 million, attributed to growth in Amazon and Canadian retail [1] - Australian sales rose 40% to A$5.3 million, supported by the introduction of new pharmacy channels [1] Financial Position - At year-end, Immuron held AU$2.83 million in cash, a decrease from AU$11.66 million the previous year [2] - Shareholders' equity decreased to AU$8 million from AU$12.7 million in 2024, reflecting a decline in overall financial strength [2] - The company maintained minimal long-term debt, indicating a stable balance sheet [2]

Financial Performance - The company reported net losses of A$5,215,987, A$6,936,957, and A$3,786,507 for the fiscal years ended June 30, 2025, 2024, and 2023, respectively, with an accumulated deficit of A$82,443,205 as of June 30, 2025[51]. - As of June 30, 2025, the company had A$2,830,526 in cash and cash equivalents, indicating a need for additional financing to support ongoing research and development activities[52]. - The company expects to receive Research and Development Tax Incentive refunds of A$1,110,577 and A$764,981 for the fiscal years ended June 30, 2025 and 2024, respectively, which provides a 43.5% refundable tax offset on eligible expenditures[61]. - As of June 30, 2025, the company's cumulative operating losses have a total potential tax benefit of A$15,722,291 at local tax rates[143]. - Immuron Limited has never declared or paid dividends on its ordinary shares and does not anticipate paying dividends in the foreseeable future, intending to retain all available funds for operations and growth[179]. Product Development and Pipeline - The company is currently focused on advancing its product candidates, IMM-124E for Traveler's Diarrhea and IMM-529 for C. difficile, through clinical trials[51]. - The company has only two product candidates in clinical trials, with all other candidates still in preclinical development, highlighting the early stage of its product pipeline[42]. - The company has two lead drug candidates in clinical development targeting Clostridioides difficile infections and Enterotoxigenic Escherichia coli infections[195]. - The company plans to launch ProIBS® in Australia in Q1 2026, expanding its digestive health portfolio[194]. - The company aims to seek FDA approval for Travelan as a preventative treatment for travelers' diarrhea, which could significantly increase commercial opportunities in the U.S.[206]. - The company plans to hold an end of Phase 2 meeting with the FDA to discuss Phase 3 registration strategy for Travelan[226]. - The company plans to file an IND application for IMM-529 in the second half of 2025, following a Phase 2 trial for recurrent CDI[211]. Clinical Trials and Research - Clinical trials are lengthy and costly, often taking several years to complete, with uncertain outcomes impacting product development timelines[68]. - The company relies on third parties for conducting preclinical studies and clinical trials, which may lead to delays if these parties do not meet deadlines[70]. - Delays in clinical trial programs could adversely affect the company's business and future commercialization opportunities[72]. - The company has completed enrollment of 866 participants in a clinical trial evaluating Travelan's efficacy in travelers' diarrhea, with topline results expected in October 2025[209]. - A clinical study showed a 43.8% reduction in diarrhea in the Travelan group, approaching statistical significance (p=0.066)[206]. - IMM-529 demonstrated 80% efficacy in preventing primary Clostridioides difficile infections (CDI) without antibiotics, and 90% survival rate in relapse studies compared to 22% in the control group[211]. Market and Competition - The company faces significant risks related to competition, regulatory approvals, and the successful commercialization of its product candidates[35]. - The company competes with numerous entities in the biotechnology and pharmaceutical sectors, which may develop superior technologies or products[84]. - Market acceptance of the company's products is uncertain, and failure to achieve it could negatively impact revenue generation[86]. - The potential market size for product indications may differ significantly from initial estimates, affecting business plans and financial performance[90]. - The global market for CDI therapeutics is projected to grow from USD 630 million in 2016 to USD 1.7 billion by 2026, with a CAGR of 10.2%[215]. Regulatory and Compliance Risks - Regulatory approval processes can take many years and require substantial resources, with no guarantee of success[139]. - The FDA and foreign regulatory authorities have substantial discretion in the approval process, which can lead to delays or denials[138]. - The company may face significant restrictions on the marketing and use of its products even after obtaining regulatory approval[141]. - The company is subject to various federal and state fraud and abuse laws, which could impact its operations and financial condition[129]. - The company may face significant penalties if found liable for violations of the U.S. Foreign Corrupt Practices Act, which could adversely affect its financial condition and cash flows[147]. Intellectual Property - The company’s success is heavily dependent on its ability to protect its intellectual property, including obtaining and maintaining patents for its products and technologies[152]. - The company is focused on protecting its intellectual property portfolio, including securing composition of matter patents on its biologics[201]. - The company may encounter difficulties in protecting its intellectual property rights in certain jurisdictions, which could diminish the value of its intellectual property[159]. - The expiration of patents for the company's product candidates could lead to increased competition and reduced ability to recover development costs[158]. Operational Challenges - The company may need to curtail or cease operations if it fails to secure additional funding, which would adversely affect its business and financial condition[52]. - The company relies on a sole manufacturer for its lead compound, which poses risks of significant costs and delays if a replacement is needed[38]. - The company has not yet secured manufacturing capabilities for commercial quantities of its product candidates, which could hinder commercialization efforts[112]. - The company has limited large-scale manufacturing experience, which may negatively impact its ability to produce sufficient quantities of product candidates for clinical trials[95]. - The company may not be able to transition from laboratory-scale to commercial production, which could impede its ability to scale up manufacturing processes[96]. Employee and Talent Management - Retaining key personnel and fostering academic collaborations are critical for the company's research and development success[82]. - The company faces intense competition for qualified employees, which may impact its ability to attract and retain essential talent[83]. Financial and Market Risks - Currency fluctuations may adversely affect the price of the company's ordinary shares and ADS, particularly with the Australian dollar weakening against the U.S. dollar[178]. - The market price of the company's American Depositary Shares (ADS) may be volatile and subject to fluctuations due to economic conditions beyond its control[167]. - The dual listing of the company's ordinary shares and ADS may adversely affect liquidity and value, potentially impairing the development of an active trading market for the ADS in the U.S.[169]. Security and Compliance - The company has implemented information security measures to protect sensitive data, but remains vulnerable to cyber-attacks and breaches that could harm its reputation and operations[117]. - The company has faced risks related to compliance with the Sarbanes-Oxley Act, which could impact its stock price and capital raising efforts[172]. - The company is exempt from certain SEC disclosure requirements as a foreign private issuer, resulting in potentially less publicly available information[171].

Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases [5] - The company is listed on both the ASX (ASX: IMC) and NASDAQ (NASDAQ: IMRN) [5] Recent Developments - Immuron has entered into a partnership with InvestorHub to enhance direct engagement with investors through an interactive investor hub [1][2] - The investor hub will serve as a platform for content and communication, including videos, educational materials, interviews, and corporate research [2] Upcoming Milestones - CEO Steven Lydeamore highlighted the importance of improving communication with shareholders, especially with several near-term milestones approaching [3] - Immuron anticipates the submission and approval of the FDA for the IMM-529 Investigational New Drug (IND) and the release of topline results for the Travelan® (IMM-124E) clinical trial by the end of the calendar year [3] Product Information - Travelan® is an orally administered passive immunotherapy designed to reduce the likelihood of travelers' diarrhea, which is caused by pathogenic bacteria [6] - The product is available in Australia as a listed medicine and is sold as a dietary supplement in the U.S. for digestive tract protection [6] Technology Platform - Immuron's proprietary technology is based on polyclonal immunoglobulins derived from engineered hyper-immune bovine colostrum, allowing for the development of medicines targeting a wide range of infectious diseases [9] - The platform can effectively block viruses or bacteria at mucosal surfaces and neutralize toxins produced by these pathogens [9] Clinical Development - IMM-529 is being developed as an adjunctive therapy for the prevention and treatment of recurrent Clostridioides difficile infection (CDI) [12] - The product targets multiple components of C. diff virulence, showing promising results in pre-clinical models for preventing primary disease and protecting against disease recurrence [14][15] Market Insights - The IBS treatment market in Australia is part of the broader "Digestives & Intestinal Remedies" market, projected to generate approximately AU$221.14 million in 2025, with an annual growth rate of 3.28% [18]

Sales Performance - Immuron Limited reported annual sales of AUD$7.3 million, representing a 49% increase compared to the previous year [1][3] - For the June 2025 quarter, sales reached AUD$2.0 million, up 55% year-over-year [1] - In Australia, annual sales were AUD$5.2 million, a 40% increase from the prior year, with June 2025 quarter sales of AUD$1.5 million, up 58% [1][3] - North American sales totaled AUD$2.0 million, reflecting a 76% increase year-over-year, with June 2025 quarter sales of AUD$0.5 million, up 49% [1][3] Product Overview - Travelan is an over-the-counter immune supplement designed to target pathogenic bacteria and their toxins in the gastrointestinal tract [1][4] - It is an orally administered passive immunotherapy that helps reduce the likelihood of travelers' diarrhea, caused primarily by enterotoxigenic Escherichia coli (ETEC) [4][5] - Travelan is recognized as a listed medicine in Australia and a licensed natural health product in Canada, while in the U.S., it is marketed as a dietary supplement [4] Strategic Focus - The company aims to position Travelan as an essential product for travelers, with a clear growth strategy supporting its sales increase [3] - Immuron plans to invest further in North America while maintaining momentum in the Australian market [3]