Highlights (unaudited): Consistent Revenue Growth: Immuron is no longer just a "concept" company. Global H1 FY26 sales grew to AUD$4.2 million, with the U.S. market showing strong momentum (+17% YoY).Cash (AUD $10.0 million) to fund operating activities. Includes AUD $7.3 million (net) raised at an average price of A$0.0803 (IMRN USD$2.0923).Validated Platform: The "Hyper-Immune" platform is versatile. Beyond traveler’s diarrhea (Travelan®), the company is moving into high-value clinical targets like C. dif ...

Group 1: B Riley Financial Inc - B Riley Financial reported earnings of $4.50 per share for the second quarter, a significant improvement from a loss of $14.35 per share in the same period last year [1] - The company's sales surged to $225.302 million, up from $94.885 million year-over-year [1] - Following the earnings report, B Riley Financial shares jumped 25% to $4.65 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Biodexa Pharmaceuticals PLC-ADR gained 51.4% to $7.24 in pre-market trading [4] - Venus Concept Inc surged 31.1% to $2.19 after a decline of over 10% on Monday [4] - Uniqure NV rose 14.1% to $23.30 after gaining 5% on Monday [4] - Adagio Medical Holdings Inc gained 11.7% to $0.93 after a 15% decline on Monday [4] - Sunrise New Energy Co Ltd rose 10.5% to $0.94 after dipping 11% on Monday [4] - Socket Mobile Inc surged 10.3% to $1.29 in pre-market trading [4] - Rain Enhancement Technologies Holdco Inc shares jumped 10.1% to $6.65 in pre-market trading [4] - Organogenesis Holdings Inc gained 9.3% to $5.29 after announcing a planned Type-B meeting with the FDA [4] - Nektar Therapeutics rose 7.8% to $57.50 in pre-market trading [4] Group 3: Stocks Declining in Pre-Market Trading - Radiopharm Theranostics ADR fell 39.8% to $6.40 after a significant jump of 150% on Monday [4] - Saverone 2014 Ltd – ADR tumbled 37.8% to $2.20 after gaining 18% on Monday [4] - Zynex Inc fell 36.6% to $0.42 after a decline of around 10% on Monday [4] - Immuron Ltd – ADR fell 23.8% to $0.74 after a 5% decline on Monday [4] - iRobot Corp fell 23.2% to $0.90 after dipping 73% on Monday due to filing for Chapter 11 bankruptcy [4] - Envirotech Vehicles Inc dipped 17% to $0.93 in pre-market trading [4] - Aldeyra Therapeutics Inc declined 15.7% to $3.36 following a PDUFA extension for Reproxalap NDA [4] - Ascent Solar Technologies, Inc. dipped 15.1% to $3.54 after a 34% jump on Monday [4] - Lightwave Logic Inc dipped 14.5% to $3.22 after announcing a $35 million public offering [4] - Fractyl Health Inc fell 10.4% to $2.00 in pre-market trading [4]

Group 1 - Immuron Limited (NASDAQ:IMRN) is a biotechnology company focused on developing medicines to prevent diarrhea, with a recent setback in its clinical trial for an ETEC hyperimmune bovine colostrum product, which failed to meet its primary endpoint, resulting in a 25.8% drop in share price [2] - The clinical trial was conducted by the Uniformed Services University to assess the product's effectiveness in maintaining gut health during travel and deployment, but Immuron stated that the results do not reflect the performance of its Travelan product due to non-compliance with administration rules and third-party manufacturing [2] - On November 5th, the FDA approved Immuron's IMM-529 drug for a phase 2 clinical trial targeting Clostridioides difficile infection, with the study expected to start in the first half of 2026 and enroll up to 60 participants [3]

Core Insights - Immuron Limited is advancing its clinical trials for Travelan and IMM-529, with significant updates on both products [1][2][3] IMM-529 IND (Clostridioides difficile infection) - On October 8, 2025, Immuron submitted an Investigational New Drug (IND) application to the FDA for IMM-529 aimed at preventing or treating Clostridioides difficile infection [2] - The FDA has acknowledged the IND application and is currently reviewing it, having requested additional clinical information [3] - Immuron has responded to the FDA's queries and made minor updates to the clinical trial protocol ahead of the 30-day decision date [3] Travelan Clinical Trials - The Uniformed Services University was expected to provide topline results from the Travelan P2TD study by the end of October 2025, but results are now delayed until the end of November 2025 due to a government shutdown [4][8] - The outcomes of the P2TD clinical study will influence Immuron's dosing strategy for its End-of-Phase 2 meeting with the FDA, with a potential proposal for a twice-daily dosing regimen if results are favorable [5] - Immuron has conducted multiple Travelan clinical trials, with varying dosing regimens and significant results in protecting against diarrhea [6][7] Travelan Product Information - Travelan is an orally administered passive immunotherapy designed to reduce the likelihood of travelers' diarrhea caused by pathogenic bacteria [12] - It is available in Australia as a listed medicine and in Canada as a licensed natural health product, while in the U.S., it is marketed as a dietary supplement [12] IMM-529 Development - IMM-529 is being developed as an adjunctive therapy with standard antibiotics for recurrent Clostridioides difficile infection, targeting multiple virulence components of the bacteria [19][20] - Pre-clinical studies have shown promising results, including an 80% prevention rate for primary disease and a 67% protection rate against disease recurrence [21]

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 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]

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 achieved record sales of A$7 million for the current financial year, a significant increase from A$4.9 million in the previous year [3][10] - Sales momentum continued into April, driven by holiday periods and seasonal breaks in North America [3] Clinical Trial Updates - Immuron is developing three therapeutic products: IMM-124E for traveler's diarrhea, IMM-529 for Clostridioides difficile infection, and IMM-986 for Vancomycin-resistant enterococci [4] - Recruitment for the IMM-124E field study has been completed, with topline results expected in October 2025 [5][10] - The company plans to request an end of Phase 2 meeting with the FDA for IMM-124E, with projected annual revenue in the USA estimated at US$102 million [6] - IMM-529 is progressing towards an IND submission to the FDA, anticipated in August 2025, with peak revenues projected at approximately US$400 million [7][8] Product Launch Plans - Immuron is preparing to launch ProIBS® in Australia, with a product delivery expected in Q3 2025 and launch in Q1 2026 [11][10] - The IBS treatment market in Australia is projected to generate around A$221 million in 2025, with an annual growth rate of 3.28% [11] Pre-clinical Research - Immuron is collaborating with Monash University on IMM-986, targeting Vancomycin-resistant enterococci, with pre-clinical research results expected in August 2025 [12][10] - The estimated national cost to treat infections from antimicrobial resistance in the U.S. exceeds $4.6 billion annually [12]

Sales Performance - Immuron Limited has achieved record sales exceeding AUD$5 million in a fiscal year, marking the highest sales in the company's history [1][2] - For the March 2025 quarter, global sales reached AUD$1.3 million, a 2% increase compared to the prior year, while year-to-date sales amounted to AUD$5.3 million, reflecting a 46% increase [1][2] - In Australia, year-to-date sales were AUD$3.7 million, up 34% year-over-year, with the March 2025 quarter sales at AUD$0.5 million, a 28% increase [1][2] - North American sales for the year-to-date reached AUD$1.6 million, an impressive 86% increase compared to the previous year [1][2] Product Overview - Travelan® is an over-the-counter immune supplement designed to target pathogenic bacteria and their toxins in the gastrointestinal tract, reducing the likelihood of travelers' diarrhea [1][4] - 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 [4] Market Position - Travelan® has been ranked 1 by market share change, 2 by SKU, and 3 by brand in the Anti-diarrheal category in Australia [2] - The company has seen strong sales growth due to its travel activation program and expanded pharmacy agreements, particularly in the lead-up to peak travel seasons [2]