View ValuationImmuron 将来の成長Future 基準チェック /16Immuronの収益は年間13.6%の割合で減少すると予測されていますが、年間収益は年間12.2%で増加すると予想されています。主要情報-13.6%収益成長率n/aEPS成長率Biotechs 収益成長39.5%収益成長率12.2%将来の株主資本利益率n/aアナリストカバレッジLow最終更新日22 Apr 2026今後の成長に関する最新情報更新なしすべての更新を表示Recent updatesNew Risk • Apr 23New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.5m market cap, or US$7.46m). Minor Risk Currently unprofitable and not forecast to become profitable next year (AU$4.4m net loss next year).New Risk • Apr 22New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.8m market cap, or US$7.72m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$3.7m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change).Reported Earnings • Mar 03First half 2026 earnings released: AU$0.007 loss per share (vs AU$0.011 loss in 1H 2025)First half 2026 results: AU$0.007 loss per share (improved from AU$0.011 loss in 1H 2025). Revenue: AU$4.18m (up 4.8% from 1H 2025). Net loss: AU$1.92m (loss narrowed 23% from 1H 2025). Revenue is forecast to grow 30% p.a. on average during the next 2 years, compared to a 7.8% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has fallen by 30% per year, which means it is performing significantly worse than earnings.New Risk • Dec 18New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Market cap is less than US$10m (AU$12.0m market cap, or US$7.96m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$5.9m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Revenue is less than US$5m (AU$7.3m revenue, or US$4.8m).New Risk • Dec 10New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: AU$10.8m (US$7.20m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. Market cap is less than US$10m (AU$10.8m market cap, or US$7.20m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$5.9m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$7.3m revenue, or US$4.8m).お知らせ • Dec 05Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 45,472,000 Price\Range: AUD 0.0791 Transaction Features: Subsequent Direct Listingお知らせ • Nov 07+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.642228 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.642228 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 8,495,080 Price\Range: AUD 0.0756 Transaction Features: Subsequent Direct Listingお知らせ • Nov 06Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 8,495,080 Price\Range: AUD 0.0756 Transaction Features: Subsequent Direct Listingお知らせ • Nov 01Immuron Limited Announces Clinical Trial UpdateImmuron Limited provided a clinical trial update on Travelan®? and IMM-529. IMM-529 IND (Clostridioides difficile infection) Immuron announced on October 8, 2025 submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529 to prevent or treat Clostridioidesdifficile Infection. Immuron has received formal acknowledgment of its Investigational New Drug (IND") application from the Center for Biologics Evaluation and Research (CBER), including assignment of a biologic product name and IND number. On October 25th, the U.S. Food and Drug Administration (FDA) informed the company that the IND is currently under active review and issued a request for additional clinical information. In response, Immuron submitted a comprehensive reply addressing the FDA's queries and made minor updates to the clinical trial protocol to incorporate the agency's recommendations ahead of the IND 30-day decision date. Uniformed Services University P2TD study (Incidence of gut health deficiencies) Immuron was expecting the Uniformed Services University to provide topline results from this study by the end of October 2025. The results of the P2TD clinical study, conducted by the Uniformed Services University, will play a pivotal role in shaping Immuron's dosing strategy for its upcoming End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA). Should the study demonstrate favorable outcomes, Immuron intends to propose a twice-daily dosing regimen. IMM-124E (Travelan®?) was developed using Immuron's platform technology. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; 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; and risks relating to pre clinical and clinical testing. IMM-124E®? was developed using Immuron's platforms technology. Factors that could cause real results to differ materially from those current anticipated include: risks relating to its growth strategy; ability to obtain and perform under and maintain financing and Strategic agreements and relationships; risks relating To the results of research and development activity; risks relating to the timing and timing of starting and completing clinical trial; uncertainties relating to preclinical, and clinical testing; risks relating to preclinical andclinical testing; and risks relating to the potential of preclinical and clinical testing.お知らせ • Oct 21Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,133,840 Price\Range: AUD 0.0886 Transaction Features: Subsequent Direct Listingお知らせ • Oct 17Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,133,840 Price\Range: AUD 0.0886 Transaction Features: Subsequent Direct Listingお知らせ • Oct 10+ 1 more updateImmuron Limited, Annual General Meeting, Nov 11, 2025Immuron Limited, Annual General Meeting, Nov 11, 2025. Location: the offices of grant thornton, collins square, tower 5, level 22, 727 collins street melbourne, vic 3008 AustraliaReported Earnings • Aug 31Full year 2025 earnings released: AU$0.023 loss per share (vs AU$0.03 loss in FY 2024)Full year 2025 results: AU$0.023 loss per share (improved from AU$0.03 loss in FY 2024). Revenue: AU$7.29m (up 49% from FY 2024). Net loss: AU$5.25m (loss narrowed 24% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 31% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings.New Risk • Aug 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (AU$6.5m revenue, or US$4.2m). Market cap is less than US$100m (AU$17.2m market cap, or US$11.0m).New Risk • Jul 24New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (AU$6.5m revenue, or US$4.3m). Market cap is less than US$100m (AU$18.8m market cap, or US$12.4m).お知らせ • Jul 22Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 32,909,640 Price\Range: AUD 0.0824 Transaction Features: Subsequent Direct Listingお知らせ • Jul 18+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.034072 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.034072 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 473,880 Price\Range: AUD 0.0719 Transaction Features: Subsequent Direct Listingお知らせ • Jul 17+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.063351 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.063351 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 877,440 Price\Range: AUD 0.0722 Transaction Features: Subsequent Direct Listingお知らせ • Jul 16Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 877,440 Price\Range: AUD 0.0722 Transaction Features: Subsequent Direct Listingお知らせ • Jun 04Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 116,680 Price\Range: AUD 0.0708 Transaction Features: Subsequent Direct Listingお知らせ • May 30+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.009723 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.009723 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 135,800 Price\Range: AUD 0.0716 Transaction Features: Subsequent Direct ListingNew Risk • May 15New major risk - Revenue and earnings growthEarnings have declined by 2.3% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$6.5m revenue, or US$4.2m). Market cap is less than US$100m (AU$16.4m market cap, or US$10.5m).New Risk • Mar 31New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: AU$15.8m (US$9.85m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Market cap is less than US$10m (AU$15.8m market cap, or US$9.85m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$6.2m net loss next year). Revenue is less than US$5m (AU$6.5m revenue, or US$4.1m).お知らせ • Jan 15Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,801,680 Price\Range: AUD 0.0847 Transaction Features: Subsequent Direct Listingお知らせ • Jan 14Immuron Announces Travelan Clinical Trial UpdateImmuron Limited announced that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study and will soon request an end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3. Travelan (IMM-124E) Phase 2 Clinical Study NCT05933525: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC) Immunology: Statistically significant lower levels of IgA and IgG were observed for the subjects who received Travelan compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen. Travelan®? antibodies target and bind to ETEC antigen in the gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers. Clinical data also demonstrated there was a statistically significant reduction in the number of colony forming units (CFUs) in the stools of subjects who received travelan (p =0.0121), measured 48 hours post challenge, indicating faster clearance of the challenge strain from the GI tract. The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce. IMM-124E was developed using Immuron's platform technology. IMM-124E is produced from the colos trum ofthing cattle that have been immunised during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC. dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); Protection of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross- react with whole cell lysates of many different human strains of C. diff including hypervirulent strains. Such statements include, but are not limited to, any statements relating to 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 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 growth strategy; 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; risks relating to preclinical and clinical testing; dependence on third-party suppliers; ability to attract, integrate and retain key personnel; the early stage of products under development; need for product development programs and any other statement that are not historical facts.お知らせ • Jan 10Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,579,760 Price\Range: AUD 0.0874 Transaction Features: Subsequent Direct Listingお知らせ • Jan 08Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,579,760 Price\Range: AUD 0.0874 Transaction Features: Subsequent Direct Listingお知らせ • Oct 18Immuron Limited, Annual General Meeting, Nov 18, 2024Immuron Limited, Annual General Meeting, Nov 18, 2024. Location: the offices of k & l gates, level 25, rialto south tower, 525 collins street melbourne, victoria, Australiaお知らせ • Oct 04Immuron Limited Announces NMRC Reports Results for Campylobacter Clinical StudyImmuron Limited announced 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 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. 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 acontrolled 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 campyl Obacteriosis following challenge with Campylobacter compared to the placebo group. A copy of the presentation will be made available to the Company. Travelan demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the Company's growth strategy; and ability to obtain, perform underand maintain financing and strategic agreements and relationship; risks relating to the Company.Reported Earnings • Oct 03Full year 2024 earnings released: AU$0.03 loss per share (vs AU$0.017 loss in FY 2023)Full year 2024 results: AU$0.03 loss per share (further deteriorated from AU$0.017 loss in FY 2023). Revenue: AU$4.90m (up 172% from FY 2023). Net loss: AU$6.94m (loss widened 83% from FY 2023). Revenue is forecast to grow 60% p.a. on average during the next 2 years, compared to a 8.0% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings.Reported Earnings • Aug 31Full year 2024 earnings released: AU$0.03 loss per share (vs AU$0.017 loss in FY 2023)Full year 2024 results: AU$0.03 loss per share (further deteriorated from AU$0.017 loss in FY 2023). Revenue: AU$4.90m (up 172% from FY 2023). Net loss: AU$6.94m (loss widened 83% from FY 2023).お知らせ • Jul 04Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Transaction Features: At the Market Offeringお知らせ • Jul 02Immuron Requests Pre-IND Meeting for IMM-529 with FDA FilingImmuron Limited announced that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529. The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections. To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI. Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01)and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains. To knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease.お知らせ • Jun 06Immuron Limited Appoints Jeannette Joughin as DirectorImmuron Limited appointed Jeannette Joughin as director, date of appointment is 1 June 2024.お知らせ • May 31Immuron Limited Announces Resignation of Roger Aston as Non-Executive DirectorImmuron Limited announced that Dr. Roger Aston has resigned from his position as Non-Executive Director effective May 31, 2024. Roger was appointed as a Director in 2012 and served as Non-Executive Chairman from 2012 to 2023.分析記事 • Mar 08We're Not Very Worried About Immuron's (ASX:IMC) Cash Burn RateJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...お知らせ • Mar 07Immuron Limited Announces Positive Results Support Travelan Progress to Phase 3 Clinical Trials in the USImmuron Limited announced the interim topline results confirming that a single daily dose of Travelan is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC). Immuron was awarded USD 4.8 million funding by the U.S. Department of Defense to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries. This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024. Having demonstrated protective efficacy in two published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. IMM-124E (Travelan) will be the first product developed with Immuron's platform technology to proceed into Phase 3 clinical trials. The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious diseases. This makes the demonstration of protective efficacy and reduction in adverse events and diarrhea particularly noteworthy. The company will now proceed to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine for Travelers' Diarrhea. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the U.S. Military. Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials. Topline results: Travelan, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo. ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan group compared to the placebo group; Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate; 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan Group compared to the placebo group; Statistically significant reduction of 83.3% in the subjects in the Travelan groups requiring early antibody treatment post challenge compared to the placebo group; For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group; 55.6% reduction in the number of subjects experiencing adverse events and diarrhea. 55.6% reduction in The number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan group compared to the randomized double-blind placebo group; 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan group compared to the Placebo group.お知らせ • Dec 22Immuron Limited Clinical Trials UpdateImmuron Limited provided shareholders and the market with an update on the company's clinical development portfolio. The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. The clinical study is being led by Principal Investigator Dr. Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024. Headline results from the clinical trial are anticipated to be reported in second half of 2024. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. Immuron's manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529 drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells of Clostridioides DiffICile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical Services to conduct a GLP compliant toxicity study inrodents. The study protocol has been submitted and approved by the Animal Ethics Committee and the study is planned to commence in first quarter of 2024. The company is working towards submitting a Pre-IND information package to the U.S. Food and Drug Administration (FDA) in first quarter of 2024.お知らせ • Dec 04Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical StudyImmuron Limited announced that the US Naval Medical Research Command (NMRC) has initiated the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter. The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870. The dosing, challenge and the in-patient stage of the study is anticipated to be completed by the third week of December 2023. The estimated study completion date (last participant, last visit) is June 2024 with headline results from the clinical trial expected to be reported in 2H 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 demonstrated 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 (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.お知らせ • Oct 23Immuron Limited, Annual General Meeting, Nov 21, 2023Immuron Limited, Annual General Meeting, Nov 21, 2023, at 10:00 AUS Eastern Standard Time. Location: offices of the Offices of K & L Gates, Level 25 Rialto South Tower, 525 Collins Street Melbourne Malbourne Victoria Australia Agenda: To consider Adoption of Remuneration Report; to consider Re-election of Dr. Roger Aston; to consider Approval of increased placement capacity; to consider Approval to Amend Constitution - Employee share scheme provisions; to consider Approval of Omnibus Incentive Plan; and to consider Approval of the Issue of Options to Mr. Paul Brennan.お知らせ • Oct 19Immuron Limited Announces Travelan® Clinical Study Cohort 2 CommencesImmuron Limited announced the second cohort of 34 participants have commenced the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan® or placebo. The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial are anticipated to be reported in June 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 demonstrated 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 (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.Reported Earnings • Oct 01Full year 2023 earnings released: AU$0.017 loss per share (vs AU$0.013 loss in FY 2022)Full year 2023 results: AU$0.017 loss per share (further deteriorated from AU$0.013 loss in FY 2022). Revenue: AU$1.80m (up 136% from FY 2022). Net loss: AU$3.79m (loss widened 33% from FY 2022). Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings.Reported Earnings • Aug 30Full year 2023 earnings released: AU$0.017 loss per share (vs AU$0.013 loss in FY 2022)Full year 2023 results: AU$0.017 loss per share (further deteriorated from AU$0.013 loss in FY 2022). Revenue: AU$1.80m (up 136% from FY 2022). Net loss: AU$3.79m (loss widened 33% from FY 2022). Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings.お知らせ • Jul 26Immuron Limited Announces First Patients Enrolled in Travelan® Clinical StudyImmuron Limited announced the first cohort of 30 participants have been enrolled into the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort of 30 participants is anticipated to complete dosing and the in-patient stage of the study by the first week of August 2023. The final 30 participants are anticipated to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. The U.S. Department of Defense Uniformed Services University is also running a randomized clinical trial with Travelan® in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783. The USU has reported that to date it has successfully enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study. USU has extended the enrolment period and now expects to complete clinical trial enrolment in Second Quarter 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 demonstrated increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.お知らせ • May 31Immuron Limited Initiates Recruitment of Travelan Clinical StudyImmuron Limited announced that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan(R) to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022). Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment. The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan®? compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. The first cohort of 30 participants is anticipated to be enrolled and dosed by the end of July 2023. The final 30 participants are anticipated to be enrolled into the study in October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. This is one of four clinical trials Immuron has, or is soon to, initiate. The U.S. Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan(R) in up to 868 participants. The U.S. department of Defense Uniformed Services University are running a randomized clinical trial of travelan(R) in up To 868 participants. The U.,S. Department of Defense Uniforming Services University is running a randomizedclinical trial of Travelan®? in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783.お知らせ • May 09Immuron Limited Announces US Food and Drug Administration Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves Way for Clinical Trial InitiationImmuron Limited announced that the US Naval Medical Research Center has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli developed in collaboration with Immuron. The FDA has removed a clinical hold on the Investigational New Drug application allowing the NMRC to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by Campylobacter and ETEC which is now active. The safety and protective efficacy of the product will be tested utilising two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomized, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models. The first clinical study will be conducted at the Johns Hopkins University Center for Immunization Research Inpatient Unit, located at the Johns Hopkins Bayview Medical Campus. The study population will include 30 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years. Commencement is subject to ethics approval from the Institutional Review Board.Reported Earnings • Mar 03First half 2023 earnings released: AU$0.009 loss per share (vs AU$0.008 loss in 1H 2022)First half 2023 results: AU$0.009 loss per share (further deteriorated from AU$0.008 loss in 1H 2022). Net loss: AU$1.98m (loss widened 9.2% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings.お知らせ • Jan 25Immuron US DoD Naval Medical Research Center Responds to FDA Clinical Hold for New Campylobacter ETEC TherapeuticImmuron Limited announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application. The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following a subsequent meeting on 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.お知らせ • Dec 23Immuron Limited Receives FDA Approval for Travelan IND ApplicationImmuron Limited announced that it has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active. As a result of this approval the company will proceed with the planned clinical trial in the United States. The safety and protective efficacy of Travelan will be tested utilizing a controlled human infection- model clinical trial design. Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC Inc. at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA. The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023. 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.お知らせ • Dec 05Immuron Limited Submits IND Application To FDA for TravelanImmuron Limited announced that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for Travelan®. The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC Inc. at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA . Dr. Mohamed Al-Ibrahim, MB, ChB, FACP will be the Principal Investigator for the study with recruitment planned to commence in 1H 2023 subject to FDA approval with headline results from the clinical trial expected to be reported by year end 2023. 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Oct 14Immuron Limited, Annual General Meeting, Oct 28, 2022Immuron Limited, Annual General Meeting, Oct 28, 2022.Reported Earnings • Sep 02Full year 2022 earnings released: AU$0.013 loss per share (vs AU$0.038 loss in FY 2021)Full year 2022 results: AU$0.013 loss per share (up from AU$0.038 loss in FY 2021). Net loss: AU$2.85m (loss narrowed 66% from FY 2021). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings.お知らせ • Aug 19Immuron Limited Provides Update on IMM-124E SARS-CoV-2 ResearchImmuron Limited announced that it has deprioritized SARS-CoV-2 research to focus on the clinical development of more advanced stage therapeutic drug candidates. Immuron has previously reported IMM-124E research investigations demonstrating neutralizing activity against SARS-CoV-2. The company has been pursuing the antiviral activities of IMM-124E, focusing on establishing a better understanding of the mechanism of action associated with these initial observations. CSIRO conducted Quantitative Mass Spectrometry analysis (LC-MS/MS) to identify potential antiviral agents that are significantly enriched in IMM-124E. Quantitative proteomics identified at least 53 proteins that are significantly overexpressed in IMM-124E compared to the Milk Powder control samples. This included 17 immunoglobulin-like proteins that appear to be enriched between two- to nine-fold in Immuron Colostrum drug substance and several small antimicrobial proteins known to function in defense against bacterial infections. Immuron has dedicated significant resources to interrogate the mechanism of SARS-CoV-2 protection, however, the mechanism of how IMM-124E provides protection against SARS-CoV-2 viral infection remains unclear.お知らせ • Jul 26Immuron Limited Provides Update on IND Application for Campylobacter ETEC TherapeuticImmuron Limited announced that the US Naval Medical Research Center (NMRC) has received feedback from the US Food and Drug Administration following a review of the Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC. The Agency has specified that the IND does not contain sufficient information required under 21 CFR 312.23 to assess the risk to subjects in the proposed clinical studies. The IND has been placed on Clinical Hold until the FDA have received and reviewed a response from the NMRC justifying dosing, safety monitoring and a risk mitigation plan. The NMRC has previously filed and had IND applications approved by the FDA on similar colostrum-based products without being requested for supporting pharmacology/toxicology data. The NMRC are currently addressing the clinical hold comments and will seek a Type A meeting with the FDA to discuss the clinical hold and the necessary protocol amendments. The meeting will be scheduled in 30 calendar days from receipt of the NMRC meeting request and background information package.お知らせ • May 12Immuron US DoD Naval Medical Research Center Submits IND Application for New Campylobacter ETEC TherapeuticImmuron Limited announced that the US Naval Medical Research Center (NMRC) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. NMRC is preparing to commence the first of two planned clinical trials in the United States following approval of the application. The safety and protective efficacy of the product will be tested utilizing two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the studies and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models. Infectious diarrhea is the most common illness reported by travelers visiting developing countries and amongst 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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. The development of an oral immunotherapy preventative treatment that protects against endemic diarrheal diseases, is a high priority objective for the US Military.お知らせ • May 09Immuron Limited Provides Update on the Planned Clinical Trial to Evaluate the Efficacy of Travelan and Two Third Party Non-Antibiotic Products in Travelers' DiarrheaImmuron Limited provided shareholders and the market with a progress update on the planned clinical trial to evaluate the efficacy of Travelan® and two third party non-antibiotic products in Travelers' Diarrhea USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of three commercially available nutraceutical products for TD and inform strategies for Defense Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783)All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm). USU have completed the manufacture of the first batches of investigational medicinal products and shipment of these to the first clinical trial sites is now complete. USU are anticipating recruitment of study participants to commence in June 2022 and expect to complete clinical trial enrolment in approximately 18 months. The clinical protocol has also been amended to extend the treatment period from 13 days to 22 days to cover the COVID-19 quarantine period still required by some countries. The extended time is necessary as those travelers required to quarantine upon arrival who may be still at risk of diarrhea symptoms during this period. The protocol amendment has now been submitted to the ethics board for approval and recruitment will commence once approval has been granted. The Problem: Travelers' diarrhea (TD) remains a highly prevalent disease that impacts operational readiness of military personnel and is also debilitating civilian travel. In addition to its acute morbidity, TD is associated with acquisition of antimicrobial resistance genes and long-term sequelae. Current mitigation strategies including pre-travel counseling and antibiotics for prevention and treatment have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention. The Approach: Prebiotics, probiotics and passive immunotherapy may offer safe and relatively inexpensive preventive strategies by promoting gut resistance to enteropathogens, and potentially lessening the use of antibiotics. USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for TD prevention and inform strategies for Force Health Protection.お知らせ • May 06+ 1 more updateImmuron Limited Appoints Steven Lydeamore as Chief Executive Officer, effective June 27, 2022Immuron Limited announced the appointment of Steven Lydeamore as Chief Executive Officer (CEO) of the Company effective 27 June 2022. Mr. Lydeamore has 30 years international pharmaceutical experience, working in Australia, Canada and USA. Mr. Lydeamore brings valuable international experience having spent eleven years working at Canadian global pharmaceutical company Apotex Inc., and four years for Mayne Pharma (USA) Limited. This includes valuable experience in mergers and acquisitions, finance, business development, sales and marketing, manufacturing, and research and development. Mr. Lydeamore was most recently Chief Executive Officer (CEO) of Anatara Lifesciences Limited, during which time the company successfully transitioned from a preclinical to a clinical company following development of a gastrointestinal tract delivery technology from which two products have commenced human clinical trials.Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Apr 19Immuron Limited Announces Work on the Investigational New Drug Application to Evaluate the Efficacy of A Single Dose Regimen of TravelanImmuron Limited announced that work on the Investigational New Drug application to evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) clinical study using the enterotoxigenic Escherichia coli (ETEC) strain H10407 is progressing well. The Company has been working with regulatory consultants to address the FDA's guidance and feedback received following the Type B meeting with the agency and Navy Medical Research Centre (NMRC) associates have completed the Travelan ETEC Clinical trial Synopsis. A mutual Confidentiality Disclosure Agreement has been executed with a qualified Contract Research Organization and discussions have been initiated to discuss costs and timelines for the proposedTravelan clinical study. Up to 60 volunteers will be enrolled in the CHIM clinical study and will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® or placebo. Infectious diarrhea is the most common illness reported by travelers visiting developing countries and amongst 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.Reported Earnings • Mar 01First half 2022 earnings: Revenues and EPS in line with analyst expectationsFirst half 2022 results: AU$0.008 loss per share (up from AU$0.026 loss in 1H 2021). Net loss: AU$1.81m (loss narrowed 68% from 1H 2021). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings.分析記事 • Jan 20We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, although...Reported Earnings • Oct 04Full year 2021 earnings released: AU$0.038 loss per share (vs AU$0.017 loss in FY 2020)Full year 2021 results: Net loss: AU$8.38m (loss widened 186% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 22% per year, which means it is performing significantly worse than earnings.Executive Departure • Oct 03Executive Vice Chairman Peter Anastasiou has left the companyOn the 24th of September, Peter Anastasiou's tenure as Executive Vice Chairman ended after 6.4 years in the role. As of June 2021, Peter still personally held 1.82m shares (AU$472k worth at the time). Peter is the only executive to leave the company over the last 12 months.分析記事 • Oct 01We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...Board Change • Sep 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • May 15Immuron Limited Provides Monash University Research Update on SARS-CoV-2 ProgramImmuron Limited to provide shareholders and the market with an update on the anti-viral activity of IMM124E used to manufacture the company’s commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn®. Monash University Scientists at the Biomedicine Discovery Institute have developed and optimized two new immunologically based assays utilizing two recombinant reagents, the SARS-CoV-2 Spike protein and a receptor binding domain protein obtained from Melbourne’s Peter Doherty Institute for Infection and Immunity. Preliminary findings previously reported investigating IMM-124E demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. Further studies now undertaken, by Monash suggest that the SARS-CoV-2 inhibitory activity is novel and does not bind to the spike protein or the receptor binding domain that the virus uses to dock to the cells it infects. SARS-CoV-2 and Bovine Corona viruses (BCoV) are closely related phylogenetically. Different studies have demonstrated the existence of cross-reactive immunity through shared sites/epitopes between the bovine and human viruses. Thus, it appears that the immunological homology in highly conserved structures between the two viruses may be the cause of the reported inhibition. Immune recognition of viral structural proteins M and S2, by anti-BCoV antibodies present in IMM-124E could cause the inactivation of the SARS-COV-2 virus. This antiviral effect differs from most Vaccines currently under development which directly target the spike protein. The mode of action may offer a complementary treatment regime using therapeutics targeting the virus.分析記事 • Mar 30We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, Immuron ( ASX:IMC...Reported Earnings • Mar 02First half 2021 earnings released: AU$0.026 loss per share (vs AU$0.009 loss in 1H 2020)First half 2021 results: Net loss: AU$5.74m (loss widened 277% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings.分析記事 • Feb 05Have Insiders Been Selling Immuron Limited (ASX:IMC) Shares This Year?It is not uncommon to see companies perform well in the years after insiders buy shares. The flip side of that is that...Is New 90 Day High Low • Feb 02New 90-day low: AU$0.21The company is down 5.0% from its price of AU$0.22 on 04 November 2020. The Australian market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 4.0% over the same period.Is New 90 Day High Low • Jan 04New 90-day low: AU$0.21The company is down 14% from its price of AU$0.25 on 06 October 2020. The Australian market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period.お知らせ • Dec 15Immuron Limited Provides Update on Progress of the Anti-Viral Activity of IMM-124EImmuron Limited provide shareholders and the market with an update on progress made for the further development of the anti-viral activity of IMM-124E. The company has been actively engaging with local, national, and international research collaborators to advance this work and assist in the further characterization of the neutralization activity of SARS-CoV-2 observed with Immuron's commercial hyper-immune colostrum used to manufacture the company's flag ship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn®. The company has executed a new Research Agreement with Monash University to develop new assays to evaluate the efficacy of IMM-124E, the active pharmaceutical ingredient used to manufacture Travelan® and Protectyn® to further the understanding of the inhibitory substance/s in the commercial products. The research team will be led by Dr Melanie Hutton and Professor Dena Lyras, Deputy Director, Biomedicine Discovery Institute and Deputy Head, Department of Microbiology who will utilize two new recombinant reagents, the SARS-CoV-2 Spike protein, a receptor binding domain protein as well as an antibody positive human serum sample obtained from Melbourne's Peter Doherty Institute for Infection and Immunity.お知らせ • Nov 12Immuron Limited Announces That the Naval Medical Research Center Has Completed the Characterisation of the Colostrum Harvested from Cows Immunized with the Experimental Vaccine Developed to Target Campylobacter and Enterotoxigenic E.ColiImmuron Limited announced that the Naval Medical Research Center (NMRC) has completed the characterisation of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC). 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 Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemoglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year. PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020. Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug administration (FDA) in First Quarter 2021. The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Second Quarter and Third Quarter 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models. Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for their prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia. The major goal of this research effort is to lay the scientific foundation for development of a multi-pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.お知らせ • Nov 09Immuron Limited Announces US DoD NMRC Reports Positive Response to VaccineImmuron Limited to announce that the Naval Medical Research Center (NMRC) has completed the characterisation of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC). 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 Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemoglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year. PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020. Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug administration (FDA) in First Quarter 2021. The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Second Quarter and Third Quarter 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models. Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for their prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia. The major goal of this research effort is to lay the scientific foundation for development of a multi- pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.Is New 90 Day High Low • Nov 02New 90-day low: AU$0.23The company is down 37% from its price of AU$0.38 on 04 August 2020. The Australian market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 3.0% over the same period.お知らせ • Oct 13Immuron Limited Provides Shareholders and the Market with an Update on the Planned Clinical Programs in Travelers’ DiarrheaImmuron Limited provided shareholders and the market with an update on the planned clinical programs in Travelers’ Diarrhea (TD). The Board of Immuron has approved company plans to recommence the CMC related activities regarding its investigational drug IMM-124E required to support an investigational new drug (IND) application to the FDA and the proposed phase III clinical study in TD. The company has recently been advised by the Uniformed Services University (USU) that it has recommenced the planned clinical trial program to evaluate the efficacy of non-antibiotic OTC products in Travelers’ Diarrhea and will provide a purchase order for IMM-124E. USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for TD and inform strategies for Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: a prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region. All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).お知らせ • Jul 24+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of $20.000025 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of $20.000025 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,066,668 Price\Range: $18.75 Discount Per Security: $1.40625 Transaction Features: Registered Direct Offering分析記事 • Jun 20Peter Anastasiou Is The Executive Vice Chairman of Immuron Limited (ASX:IMC) And They Just Sold 100% Of Their SharesWe wouldn't blame Immuron Limited (ASX:IMC) shareholders if they were a little worried about the fact that Peter...分析記事 • Jun 16Do Directors Own Immuron Limited (ASX:IMC) Shares?If you want to know who really controls Immuron Limited (ASX:IMC), then you'll have to look at the makeup of its share...業績と収益の成長予測ASX:IMC - アナリストの将来予測と過去の財務データ ( )AUD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数6/30/20279-5N/A-416/30/20268-4N/A-5112/31/20257-5-5-5N/A9/30/20257-5-5-5N/A6/30/20257-5-6-6N/A3/31/20257-6-7-7N/A12/31/20247-7-8-8N/A9/30/20246-7-7-7N/A6/30/20245-7-6-6N/A3/31/20244-5-5-5N/A12/31/20234-4-4-4N/A9/30/20233-4-3-3N/A6/30/20232-4-3-3N/A3/31/20231-3-2-2N/A12/31/20221-3-2-2N/A9/30/20221-3-2-2N/A6/30/20221-3-3-3N/A3/31/20221-4-3-3N/A12/31/20210-4-4-4N/A9/30/20210-6-4-4N/A6/30/20210-8-4-4N/A3/31/20211-8N/AN/AN/A12/31/20201-7-4-4N/A9/30/20202-5-4-4N/A6/30/20203-3-3-3N/A3/31/20203-4N/AN/AN/A12/31/20193-5-3-3N/A9/30/20193-5N/A-2N/A6/30/20192-5N/A-2N/A3/31/20192-4N/A-1N/A12/31/20182-3N/A-1N/A9/30/20182-3N/A-2N/A6/30/20182-3N/A-4N/A3/31/20182-4N/A-6N/A12/31/20172-5N/A-8N/A9/30/20172-6N/A-8N/A6/30/20171-7N/A-7N/A3/31/20171-8N/A-5N/A12/31/20161-6N/A-4N/A9/30/20161-6N/A-5N/A6/30/20161-7N/A-5N/A3/31/20161-5N/A-5N/A12/31/20151-4N/A-5N/A9/30/20151-4N/A-4N/A6/30/20151-3N/A-3N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: IMC今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: IMC今後 3 年間、利益が出ない状態が続くと予測されています。高成長収益: IMC今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: IMCの収益 ( 12.2% ) Australian市場 ( 6.1% ) よりも速いペースで成長すると予測されています。高い収益成長: IMCの収益 ( 12.2% ) 20%よりも低い成長が予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: IMCの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/10 05:14終値2026/06/10 00:00収益2025/12/31年間収益2025/06/30データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Immuron Limited 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Karen SterlingEmerging Growth Research LLCRaghuram SelvarajuH.C. Wainwright & Co.
New Risk • Apr 23New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.5m market cap, or US$7.46m). Minor Risk Currently unprofitable and not forecast to become profitable next year (AU$4.4m net loss next year).
New Risk • Apr 22New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$10.8m market cap, or US$7.72m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$3.7m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change).
Reported Earnings • Mar 03First half 2026 earnings released: AU$0.007 loss per share (vs AU$0.011 loss in 1H 2025)First half 2026 results: AU$0.007 loss per share (improved from AU$0.011 loss in 1H 2025). Revenue: AU$4.18m (up 4.8% from 1H 2025). Net loss: AU$1.92m (loss narrowed 23% from 1H 2025). Revenue is forecast to grow 30% p.a. on average during the next 2 years, compared to a 7.8% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has fallen by 30% per year, which means it is performing significantly worse than earnings.
New Risk • Dec 18New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Market cap is less than US$10m (AU$12.0m market cap, or US$7.96m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$5.9m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Revenue is less than US$5m (AU$7.3m revenue, or US$4.8m).
New Risk • Dec 10New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: AU$10.8m (US$7.20m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. Market cap is less than US$10m (AU$10.8m market cap, or US$7.20m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$5.9m net loss in 2 years). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$7.3m revenue, or US$4.8m).
お知らせ • Dec 05Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 3.596835 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 45,472,000 Price\Range: AUD 0.0791 Transaction Features: Subsequent Direct Listing
お知らせ • Nov 07+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.642228 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.642228 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 8,495,080 Price\Range: AUD 0.0756 Transaction Features: Subsequent Direct Listing
お知らせ • Nov 06Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.642228 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 8,495,080 Price\Range: AUD 0.0756 Transaction Features: Subsequent Direct Listing
お知らせ • Nov 01Immuron Limited Announces Clinical Trial UpdateImmuron Limited provided a clinical trial update on Travelan®? and IMM-529. IMM-529 IND (Clostridioides difficile infection) Immuron announced on October 8, 2025 submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529 to prevent or treat Clostridioidesdifficile Infection. Immuron has received formal acknowledgment of its Investigational New Drug (IND") application from the Center for Biologics Evaluation and Research (CBER), including assignment of a biologic product name and IND number. On October 25th, the U.S. Food and Drug Administration (FDA) informed the company that the IND is currently under active review and issued a request for additional clinical information. In response, Immuron submitted a comprehensive reply addressing the FDA's queries and made minor updates to the clinical trial protocol to incorporate the agency's recommendations ahead of the IND 30-day decision date. Uniformed Services University P2TD study (Incidence of gut health deficiencies) Immuron was expecting the Uniformed Services University to provide topline results from this study by the end of October 2025. The results of the P2TD clinical study, conducted by the Uniformed Services University, will play a pivotal role in shaping Immuron's dosing strategy for its upcoming End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA). Should the study demonstrate favorable outcomes, Immuron intends to propose a twice-daily dosing regimen. IMM-124E (Travelan®?) was developed using Immuron's platform technology. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; 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; and risks relating to pre clinical and clinical testing. IMM-124E®? was developed using Immuron's platforms technology. Factors that could cause real results to differ materially from those current anticipated include: risks relating to its growth strategy; ability to obtain and perform under and maintain financing and Strategic agreements and relationships; risks relating To the results of research and development activity; risks relating to the timing and timing of starting and completing clinical trial; uncertainties relating to preclinical, and clinical testing; risks relating to preclinical andclinical testing; and risks relating to the potential of preclinical and clinical testing.
お知らせ • Oct 21Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,133,840 Price\Range: AUD 0.0886 Transaction Features: Subsequent Direct Listing
お知らせ • Oct 17Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.100458 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,133,840 Price\Range: AUD 0.0886 Transaction Features: Subsequent Direct Listing
お知らせ • Oct 10+ 1 more updateImmuron Limited, Annual General Meeting, Nov 11, 2025Immuron Limited, Annual General Meeting, Nov 11, 2025. Location: the offices of grant thornton, collins square, tower 5, level 22, 727 collins street melbourne, vic 3008 Australia
Reported Earnings • Aug 31Full year 2025 earnings released: AU$0.023 loss per share (vs AU$0.03 loss in FY 2024)Full year 2025 results: AU$0.023 loss per share (improved from AU$0.03 loss in FY 2024). Revenue: AU$7.29m (up 49% from FY 2024). Net loss: AU$5.25m (loss narrowed 24% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 31% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings.
New Risk • Aug 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (AU$6.5m revenue, or US$4.2m). Market cap is less than US$100m (AU$17.2m market cap, or US$11.0m).
New Risk • Jul 24New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (AU$6.5m revenue, or US$4.3m). Market cap is less than US$100m (AU$18.8m market cap, or US$12.4m).
お知らせ • Jul 22Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 2.711754 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 32,909,640 Price\Range: AUD 0.0824 Transaction Features: Subsequent Direct Listing
お知らせ • Jul 18+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.034072 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.034072 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 473,880 Price\Range: AUD 0.0719 Transaction Features: Subsequent Direct Listing
お知らせ • Jul 17+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.063351 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.063351 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 877,440 Price\Range: AUD 0.0722 Transaction Features: Subsequent Direct Listing
お知らせ • Jul 16Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.063351 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 877,440 Price\Range: AUD 0.0722 Transaction Features: Subsequent Direct Listing
お知らせ • Jun 04Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.008261 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 116,680 Price\Range: AUD 0.0708 Transaction Features: Subsequent Direct Listing
お知らせ • May 30+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.009723 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.009723 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 135,800 Price\Range: AUD 0.0716 Transaction Features: Subsequent Direct Listing
New Risk • May 15New major risk - Revenue and earnings growthEarnings have declined by 2.3% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 2.3% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$6.5m revenue, or US$4.2m). Market cap is less than US$100m (AU$16.4m market cap, or US$10.5m).
New Risk • Mar 31New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: AU$15.8m (US$9.85m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Market cap is less than US$10m (AU$15.8m market cap, or US$9.85m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$6.2m net loss next year). Revenue is less than US$5m (AU$6.5m revenue, or US$4.1m).
お知らせ • Jan 15Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.152602 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,801,680 Price\Range: AUD 0.0847 Transaction Features: Subsequent Direct Listing
お知らせ • Jan 14Immuron Announces Travelan Clinical Trial UpdateImmuron Limited announced that it has submitted the Clinical Study Report to the U.S. Food and Drug Administration (FDA) for the recently completed Phase 2 study and will soon request an end of Phase 2 meeting which is a pre-cursor to proceeding to Phase 3. Travelan (IMM-124E) Phase 2 Clinical Study NCT05933525: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC) Immunology: Statistically significant lower levels of IgA and IgG were observed for the subjects who received Travelan compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen. Travelan®? antibodies target and bind to ETEC antigen in the gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers. Clinical data also demonstrated there was a statistically significant reduction in the number of colony forming units (CFUs) in the stools of subjects who received travelan (p =0.0121), measured 48 hours post challenge, indicating faster clearance of the challenge strain from the GI tract. The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce. IMM-124E was developed using Immuron's platform technology. IMM-124E is produced from the colos trum ofthing cattle that have been immunised during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC. dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); Protection of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross- react with whole cell lysates of many different human strains of C. diff including hypervirulent strains. Such statements include, but are not limited to, any statements relating to 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 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 growth strategy; 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; risks relating to preclinical and clinical testing; dependence on third-party suppliers; ability to attract, integrate and retain key personnel; the early stage of products under development; need for product development programs and any other statement that are not historical facts.
お知らせ • Jan 10Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,579,760 Price\Range: AUD 0.0874 Transaction Features: Subsequent Direct Listing
お知らせ • Jan 08Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of AUD 0.225471 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,579,760 Price\Range: AUD 0.0874 Transaction Features: Subsequent Direct Listing
お知らせ • Oct 18Immuron Limited, Annual General Meeting, Nov 18, 2024Immuron Limited, Annual General Meeting, Nov 18, 2024. Location: the offices of k & l gates, level 25, rialto south tower, 525 collins street melbourne, victoria, Australia
お知らせ • Oct 04Immuron Limited Announces NMRC Reports Results for Campylobacter Clinical StudyImmuron Limited announced 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 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. 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 acontrolled 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 campyl Obacteriosis following challenge with Campylobacter compared to the placebo group. A copy of the presentation will be made available to the Company. Travelan demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies. The plan is to develop new hyperimmune products which specifically target each of these pathogens in collaboration with Immuron. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to growth strategy; ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the Company's growth strategy; and ability to obtain, perform underand maintain financing and strategic agreements and relationship; risks relating to the Company.
Reported Earnings • Oct 03Full year 2024 earnings released: AU$0.03 loss per share (vs AU$0.017 loss in FY 2023)Full year 2024 results: AU$0.03 loss per share (further deteriorated from AU$0.017 loss in FY 2023). Revenue: AU$4.90m (up 172% from FY 2023). Net loss: AU$6.94m (loss widened 83% from FY 2023). Revenue is forecast to grow 60% p.a. on average during the next 2 years, compared to a 8.0% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings.
Reported Earnings • Aug 31Full year 2024 earnings released: AU$0.03 loss per share (vs AU$0.017 loss in FY 2023)Full year 2024 results: AU$0.03 loss per share (further deteriorated from AU$0.017 loss in FY 2023). Revenue: AU$4.90m (up 172% from FY 2023). Net loss: AU$6.94m (loss widened 83% from FY 2023).
お知らせ • Jul 04Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million.Immuron Limited has filed a Follow-on Equity Offering in the amount of $2.069083 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Transaction Features: At the Market Offering
お知らせ • Jul 02Immuron Requests Pre-IND Meeting for IMM-529 with FDA FilingImmuron Limited announced that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529. The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections. To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI. Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01)and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains. To knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease.
お知らせ • Jun 06Immuron Limited Appoints Jeannette Joughin as DirectorImmuron Limited appointed Jeannette Joughin as director, date of appointment is 1 June 2024.
お知らせ • May 31Immuron Limited Announces Resignation of Roger Aston as Non-Executive DirectorImmuron Limited announced that Dr. Roger Aston has resigned from his position as Non-Executive Director effective May 31, 2024. Roger was appointed as a Director in 2012 and served as Non-Executive Chairman from 2012 to 2023.
分析記事 • Mar 08We're Not Very Worried About Immuron's (ASX:IMC) Cash Burn RateJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
お知らせ • Mar 07Immuron Limited Announces Positive Results Support Travelan Progress to Phase 3 Clinical Trials in the USImmuron Limited announced the interim topline results confirming that a single daily dose of Travelan is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC). Immuron was awarded USD 4.8 million funding by the U.S. Department of Defense to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries. This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024. Having demonstrated protective efficacy in two published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. IMM-124E (Travelan) will be the first product developed with Immuron's platform technology to proceed into Phase 3 clinical trials. The underlying nature of Immuron's platform technology enables the development of medicines across a large range of infectious diseases. This makes the demonstration of protective efficacy and reduction in adverse events and diarrhea particularly noteworthy. The company will now proceed to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine for Travelers' Diarrhea. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the U.S. Military. Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials. Topline results: Travelan, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo. ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan group compared to the placebo group; Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate; 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan Group compared to the placebo group; Statistically significant reduction of 83.3% in the subjects in the Travelan groups requiring early antibody treatment post challenge compared to the placebo group; For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan group; 55.6% reduction in the number of subjects experiencing adverse events and diarrhea. 55.6% reduction in The number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan group compared to the randomized double-blind placebo group; 55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan group compared to the Placebo group.
お知らせ • Dec 22Immuron Limited Clinical Trials UpdateImmuron Limited provided shareholders and the market with an update on the company's clinical development portfolio. The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. The clinical study is being led by Principal Investigator Dr. Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024. Headline results from the clinical trial are anticipated to be reported in second half of 2024. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. Immuron's manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529 drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells of Clostridioides DiffICile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical Services to conduct a GLP compliant toxicity study inrodents. The study protocol has been submitted and approved by the Animal Ethics Committee and the study is planned to commence in first quarter of 2024. The company is working towards submitting a Pre-IND information package to the U.S. Food and Drug Administration (FDA) in first quarter of 2024.
お知らせ • Dec 04Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical StudyImmuron Limited announced that the US Naval Medical Research Command (NMRC) has initiated the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC has prioritized the clinical development of the study to evaluate the efficacy of the new therapeutic product to prevent infectious diarrhea caused by Campylobacter. The clinical study is being led by Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870. The dosing, challenge and the in-patient stage of the study is anticipated to be completed by the third week of December 2023. The estimated study completion date (last participant, last visit) is June 2024 with headline results from the clinical trial expected to be reported in 2H 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 demonstrated 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 (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.
お知らせ • Oct 23Immuron Limited, Annual General Meeting, Nov 21, 2023Immuron Limited, Annual General Meeting, Nov 21, 2023, at 10:00 AUS Eastern Standard Time. Location: offices of the Offices of K & L Gates, Level 25 Rialto South Tower, 525 Collins Street Melbourne Malbourne Victoria Australia Agenda: To consider Adoption of Remuneration Report; to consider Re-election of Dr. Roger Aston; to consider Approval of increased placement capacity; to consider Approval to Amend Constitution - Employee share scheme provisions; to consider Approval of Omnibus Incentive Plan; and to consider Approval of the Issue of Options to Mr. Paul Brennan.
お知らせ • Oct 19Immuron Limited Announces Travelan® Clinical Study Cohort 2 CommencesImmuron Limited announced the second cohort of 34 participants have commenced the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan® or placebo. The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial are anticipated to be reported in June 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 demonstrated 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 (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.
Reported Earnings • Oct 01Full year 2023 earnings released: AU$0.017 loss per share (vs AU$0.013 loss in FY 2022)Full year 2023 results: AU$0.017 loss per share (further deteriorated from AU$0.013 loss in FY 2022). Revenue: AU$1.80m (up 136% from FY 2022). Net loss: AU$3.79m (loss widened 33% from FY 2022). Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings.
Reported Earnings • Aug 30Full year 2023 earnings released: AU$0.017 loss per share (vs AU$0.013 loss in FY 2022)Full year 2023 results: AU$0.017 loss per share (further deteriorated from AU$0.013 loss in FY 2022). Revenue: AU$1.80m (up 136% from FY 2022). Net loss: AU$3.79m (loss widened 33% from FY 2022). Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings.
お知らせ • Jul 26Immuron Limited Announces First Patients Enrolled in Travelan® Clinical StudyImmuron Limited announced the first cohort of 30 participants have been enrolled into the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort of 30 participants is anticipated to complete dosing and the in-patient stage of the study by the first week of August 2023. The final 30 participants are anticipated to be enrolled into the study and complete the in-patient stage of the study by the end of October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. The U.S. Department of Defense Uniformed Services University is also running a randomized clinical trial with Travelan® in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783. The USU has reported that to date it has successfully enrolled 347 participants into the clinical study following the initiation of enrolment and approximately 260 have completed the study. USU has extended the enrolment period and now expects to complete clinical trial enrolment in Second Quarter 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 demonstrated increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.
お知らせ • May 31Immuron Limited Initiates Recruitment of Travelan Clinical StudyImmuron Limited announced that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan(R) to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022). Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment. The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan®? compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. The first cohort of 30 participants is anticipated to be enrolled and dosed by the end of July 2023. The final 30 participants are anticipated to be enrolled into the study in October 2023. Headline results from the clinical trial expected to be reported in 1H 2024. This is one of four clinical trials Immuron has, or is soon to, initiate. The U.S. Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan(R) in up to 868 participants. The U.S. department of Defense Uniformed Services University are running a randomized clinical trial of travelan(R) in up To 868 participants. The U.,S. Department of Defense Uniforming Services University is running a randomizedclinical trial of Travelan®? in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783.
お知らせ • May 09Immuron Limited Announces US Food and Drug Administration Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves Way for Clinical Trial InitiationImmuron Limited announced that the US Naval Medical Research Center has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli developed in collaboration with Immuron. The FDA has removed a clinical hold on the Investigational New Drug application allowing the NMRC to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by Campylobacter and ETEC which is now active. The safety and protective efficacy of the product will be tested utilising two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomized, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models. The first clinical study will be conducted at the Johns Hopkins University Center for Immunization Research Inpatient Unit, located at the Johns Hopkins Bayview Medical Campus. The study population will include 30 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years. Commencement is subject to ethics approval from the Institutional Review Board.
Reported Earnings • Mar 03First half 2023 earnings released: AU$0.009 loss per share (vs AU$0.008 loss in 1H 2022)First half 2023 results: AU$0.009 loss per share (further deteriorated from AU$0.008 loss in 1H 2022). Net loss: AU$1.98m (loss widened 9.2% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings.
お知らせ • Jan 25Immuron US DoD Naval Medical Research Center Responds to FDA Clinical Hold for New Campylobacter ETEC TherapeuticImmuron Limited announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application. The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following a subsequent meeting on 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.
お知らせ • Dec 23Immuron Limited Receives FDA Approval for Travelan IND ApplicationImmuron Limited announced that it has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active. As a result of this approval the company will proceed with the planned clinical trial in the United States. The safety and protective efficacy of Travelan will be tested utilizing a controlled human infection- model clinical trial design. Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC Inc. at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA. The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023. 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.
お知らせ • Dec 05Immuron Limited Submits IND Application To FDA for TravelanImmuron Limited announced that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for Travelan®. The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC Inc. at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA . Dr. Mohamed Al-Ibrahim, MB, ChB, FACP will be the Principal Investigator for the study with recruitment planned to commence in 1H 2023 subject to FDA approval with headline results from the clinical trial expected to be reported by year end 2023. 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.
Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Oct 14Immuron Limited, Annual General Meeting, Oct 28, 2022Immuron Limited, Annual General Meeting, Oct 28, 2022.
Reported Earnings • Sep 02Full year 2022 earnings released: AU$0.013 loss per share (vs AU$0.038 loss in FY 2021)Full year 2022 results: AU$0.013 loss per share (up from AU$0.038 loss in FY 2021). Net loss: AU$2.85m (loss narrowed 66% from FY 2021). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings.
お知らせ • Aug 19Immuron Limited Provides Update on IMM-124E SARS-CoV-2 ResearchImmuron Limited announced that it has deprioritized SARS-CoV-2 research to focus on the clinical development of more advanced stage therapeutic drug candidates. Immuron has previously reported IMM-124E research investigations demonstrating neutralizing activity against SARS-CoV-2. The company has been pursuing the antiviral activities of IMM-124E, focusing on establishing a better understanding of the mechanism of action associated with these initial observations. CSIRO conducted Quantitative Mass Spectrometry analysis (LC-MS/MS) to identify potential antiviral agents that are significantly enriched in IMM-124E. Quantitative proteomics identified at least 53 proteins that are significantly overexpressed in IMM-124E compared to the Milk Powder control samples. This included 17 immunoglobulin-like proteins that appear to be enriched between two- to nine-fold in Immuron Colostrum drug substance and several small antimicrobial proteins known to function in defense against bacterial infections. Immuron has dedicated significant resources to interrogate the mechanism of SARS-CoV-2 protection, however, the mechanism of how IMM-124E provides protection against SARS-CoV-2 viral infection remains unclear.
お知らせ • Jul 26Immuron Limited Provides Update on IND Application for Campylobacter ETEC TherapeuticImmuron Limited announced that the US Naval Medical Research Center (NMRC) has received feedback from the US Food and Drug Administration following a review of the Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC. The Agency has specified that the IND does not contain sufficient information required under 21 CFR 312.23 to assess the risk to subjects in the proposed clinical studies. The IND has been placed on Clinical Hold until the FDA have received and reviewed a response from the NMRC justifying dosing, safety monitoring and a risk mitigation plan. The NMRC has previously filed and had IND applications approved by the FDA on similar colostrum-based products without being requested for supporting pharmacology/toxicology data. The NMRC are currently addressing the clinical hold comments and will seek a Type A meeting with the FDA to discuss the clinical hold and the necessary protocol amendments. The meeting will be scheduled in 30 calendar days from receipt of the NMRC meeting request and background information package.
お知らせ • May 12Immuron US DoD Naval Medical Research Center Submits IND Application for New Campylobacter ETEC TherapeuticImmuron Limited announced that the US Naval Medical Research Center (NMRC) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. NMRC is preparing to commence the first of two planned clinical trials in the United States following approval of the application. The safety and protective efficacy of the product will be tested utilizing two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the studies and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled human infection models. Infectious diarrhea is the most common illness reported by travelers visiting developing countries and amongst 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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. The development of an oral immunotherapy preventative treatment that protects against endemic diarrheal diseases, is a high priority objective for the US Military.
お知らせ • May 09Immuron Limited Provides Update on the Planned Clinical Trial to Evaluate the Efficacy of Travelan and Two Third Party Non-Antibiotic Products in Travelers' DiarrheaImmuron Limited provided shareholders and the market with a progress update on the planned clinical trial to evaluate the efficacy of Travelan® and two third party non-antibiotic products in Travelers' Diarrhea USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of three commercially available nutraceutical products for TD and inform strategies for Defense Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783)All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm). USU have completed the manufacture of the first batches of investigational medicinal products and shipment of these to the first clinical trial sites is now complete. USU are anticipating recruitment of study participants to commence in June 2022 and expect to complete clinical trial enrolment in approximately 18 months. The clinical protocol has also been amended to extend the treatment period from 13 days to 22 days to cover the COVID-19 quarantine period still required by some countries. The extended time is necessary as those travelers required to quarantine upon arrival who may be still at risk of diarrhea symptoms during this period. The protocol amendment has now been submitted to the ethics board for approval and recruitment will commence once approval has been granted. The Problem: Travelers' diarrhea (TD) remains a highly prevalent disease that impacts operational readiness of military personnel and is also debilitating civilian travel. In addition to its acute morbidity, TD is associated with acquisition of antimicrobial resistance genes and long-term sequelae. Current mitigation strategies including pre-travel counseling and antibiotics for prevention and treatment have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention. The Approach: Prebiotics, probiotics and passive immunotherapy may offer safe and relatively inexpensive preventive strategies by promoting gut resistance to enteropathogens, and potentially lessening the use of antibiotics. USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for TD prevention and inform strategies for Force Health Protection.
お知らせ • May 06+ 1 more updateImmuron Limited Appoints Steven Lydeamore as Chief Executive Officer, effective June 27, 2022Immuron Limited announced the appointment of Steven Lydeamore as Chief Executive Officer (CEO) of the Company effective 27 June 2022. Mr. Lydeamore has 30 years international pharmaceutical experience, working in Australia, Canada and USA. Mr. Lydeamore brings valuable international experience having spent eleven years working at Canadian global pharmaceutical company Apotex Inc., and four years for Mayne Pharma (USA) Limited. This includes valuable experience in mergers and acquisitions, finance, business development, sales and marketing, manufacturing, and research and development. Mr. Lydeamore was most recently Chief Executive Officer (CEO) of Anatara Lifesciences Limited, during which time the company successfully transitioned from a preclinical to a clinical company following development of a gastrointestinal tract delivery technology from which two products have commenced human clinical trials.
Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Apr 19Immuron Limited Announces Work on the Investigational New Drug Application to Evaluate the Efficacy of A Single Dose Regimen of TravelanImmuron Limited announced that work on the Investigational New Drug application to evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) clinical study using the enterotoxigenic Escherichia coli (ETEC) strain H10407 is progressing well. The Company has been working with regulatory consultants to address the FDA's guidance and feedback received following the Type B meeting with the agency and Navy Medical Research Centre (NMRC) associates have completed the Travelan ETEC Clinical trial Synopsis. A mutual Confidentiality Disclosure Agreement has been executed with a qualified Contract Research Organization and discussions have been initiated to discuss costs and timelines for the proposedTravelan clinical study. Up to 60 volunteers will be enrolled in the CHIM clinical study and will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® or placebo. Infectious diarrhea is the most common illness reported by travelers visiting developing countries and amongst 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 an increasing resistance to commonly prescribed antibiotics. In addition, travelers' 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.
Reported Earnings • Mar 01First half 2022 earnings: Revenues and EPS in line with analyst expectationsFirst half 2022 results: AU$0.008 loss per share (up from AU$0.026 loss in 1H 2021). Net loss: AU$1.81m (loss narrowed 68% from 1H 2021). Revenue was in line with analyst estimates. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 25% per year, which means it is performing significantly worse than earnings.
分析記事 • Jan 20We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, although...
Reported Earnings • Oct 04Full year 2021 earnings released: AU$0.038 loss per share (vs AU$0.017 loss in FY 2020)Full year 2021 results: Net loss: AU$8.38m (loss widened 186% from FY 2020). Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 22% per year, which means it is performing significantly worse than earnings.
Executive Departure • Oct 03Executive Vice Chairman Peter Anastasiou has left the companyOn the 24th of September, Peter Anastasiou's tenure as Executive Vice Chairman ended after 6.4 years in the role. As of June 2021, Peter still personally held 1.82m shares (AU$472k worth at the time). Peter is the only executive to leave the company over the last 12 months.
分析記事 • Oct 01We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
Board Change • Sep 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. Independent Non-Executive Director Ravi Savarirayan was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • May 15Immuron Limited Provides Monash University Research Update on SARS-CoV-2 ProgramImmuron Limited to provide shareholders and the market with an update on the anti-viral activity of IMM124E used to manufacture the company’s commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn®. Monash University Scientists at the Biomedicine Discovery Institute have developed and optimized two new immunologically based assays utilizing two recombinant reagents, the SARS-CoV-2 Spike protein and a receptor binding domain protein obtained from Melbourne’s Peter Doherty Institute for Infection and Immunity. Preliminary findings previously reported investigating IMM-124E demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. Further studies now undertaken, by Monash suggest that the SARS-CoV-2 inhibitory activity is novel and does not bind to the spike protein or the receptor binding domain that the virus uses to dock to the cells it infects. SARS-CoV-2 and Bovine Corona viruses (BCoV) are closely related phylogenetically. Different studies have demonstrated the existence of cross-reactive immunity through shared sites/epitopes between the bovine and human viruses. Thus, it appears that the immunological homology in highly conserved structures between the two viruses may be the cause of the reported inhibition. Immune recognition of viral structural proteins M and S2, by anti-BCoV antibodies present in IMM-124E could cause the inactivation of the SARS-COV-2 virus. This antiviral effect differs from most Vaccines currently under development which directly target the spike protein. The mode of action may offer a complementary treatment regime using therapeutics targeting the virus.
分析記事 • Mar 30We Think Immuron (ASX:IMC) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, Immuron ( ASX:IMC...
Reported Earnings • Mar 02First half 2021 earnings released: AU$0.026 loss per share (vs AU$0.009 loss in 1H 2020)First half 2021 results: Net loss: AU$5.74m (loss widened 277% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings.
分析記事 • Feb 05Have Insiders Been Selling Immuron Limited (ASX:IMC) Shares This Year?It is not uncommon to see companies perform well in the years after insiders buy shares. The flip side of that is that...
Is New 90 Day High Low • Feb 02New 90-day low: AU$0.21The company is down 5.0% from its price of AU$0.22 on 04 November 2020. The Australian market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 4.0% over the same period.
Is New 90 Day High Low • Jan 04New 90-day low: AU$0.21The company is down 14% from its price of AU$0.25 on 06 October 2020. The Australian market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period.
お知らせ • Dec 15Immuron Limited Provides Update on Progress of the Anti-Viral Activity of IMM-124EImmuron Limited provide shareholders and the market with an update on progress made for the further development of the anti-viral activity of IMM-124E. The company has been actively engaging with local, national, and international research collaborators to advance this work and assist in the further characterization of the neutralization activity of SARS-CoV-2 observed with Immuron's commercial hyper-immune colostrum used to manufacture the company's flag ship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn®. The company has executed a new Research Agreement with Monash University to develop new assays to evaluate the efficacy of IMM-124E, the active pharmaceutical ingredient used to manufacture Travelan® and Protectyn® to further the understanding of the inhibitory substance/s in the commercial products. The research team will be led by Dr Melanie Hutton and Professor Dena Lyras, Deputy Director, Biomedicine Discovery Institute and Deputy Head, Department of Microbiology who will utilize two new recombinant reagents, the SARS-CoV-2 Spike protein, a receptor binding domain protein as well as an antibody positive human serum sample obtained from Melbourne's Peter Doherty Institute for Infection and Immunity.
お知らせ • Nov 12Immuron Limited Announces That the Naval Medical Research Center Has Completed the Characterisation of the Colostrum Harvested from Cows Immunized with the Experimental Vaccine Developed to Target Campylobacter and Enterotoxigenic E.ColiImmuron Limited announced that the Naval Medical Research Center (NMRC) has completed the characterisation of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC). 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 Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemoglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year. PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020. Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug administration (FDA) in First Quarter 2021. The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Second Quarter and Third Quarter 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models. Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for their prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia. The major goal of this research effort is to lay the scientific foundation for development of a multi-pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.
お知らせ • Nov 09Immuron Limited Announces US DoD NMRC Reports Positive Response to VaccineImmuron Limited to announce that the Naval Medical Research Center (NMRC) has completed the characterisation of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC). 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 Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemoglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year. PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020. Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug administration (FDA) in First Quarter 2021. The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Second Quarter and Third Quarter 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models. Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for their prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia. The major goal of this research effort is to lay the scientific foundation for development of a multi- pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.
Is New 90 Day High Low • Nov 02New 90-day low: AU$0.23The company is down 37% from its price of AU$0.38 on 04 August 2020. The Australian market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 3.0% over the same period.
お知らせ • Oct 13Immuron Limited Provides Shareholders and the Market with an Update on the Planned Clinical Programs in Travelers’ DiarrheaImmuron Limited provided shareholders and the market with an update on the planned clinical programs in Travelers’ Diarrhea (TD). The Board of Immuron has approved company plans to recommence the CMC related activities regarding its investigational drug IMM-124E required to support an investigational new drug (IND) application to the FDA and the proposed phase III clinical study in TD. The company has recently been advised by the Uniformed Services University (USU) that it has recommenced the planned clinical trial program to evaluate the efficacy of non-antibiotic OTC products in Travelers’ Diarrhea and will provide a purchase order for IMM-124E. USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for TD and inform strategies for Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: a prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region. All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).
お知らせ • Jul 24+ 1 more updateImmuron Limited has completed a Follow-on Equity Offering in the amount of $20.000025 million.Immuron Limited has completed a Follow-on Equity Offering in the amount of $20.000025 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 1,066,668 Price\Range: $18.75 Discount Per Security: $1.40625 Transaction Features: Registered Direct Offering
分析記事 • Jun 20Peter Anastasiou Is The Executive Vice Chairman of Immuron Limited (ASX:IMC) And They Just Sold 100% Of Their SharesWe wouldn't blame Immuron Limited (ASX:IMC) shareholders if they were a little worried about the fact that Peter...
分析記事 • Jun 16Do Directors Own Immuron Limited (ASX:IMC) Shares?If you want to know who really controls Immuron Limited (ASX:IMC), then you'll have to look at the makeup of its share...