Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Rick Zordani was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annonce • May 12
Galectin Therapeutics Inc Announces Publication of Navigate Phase 2B Trial Results for Belapectin Galectin Therapeutics Inc. announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. The manuscript, titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial,” is now available online and available as an open-access publication. The NAVIGATE trial evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. Key markers of fibrosis including Liver Stiffness Measure results were aligned with the clinical finding belapectin was generally safe and well tolerated. The manuscript highlights: Numerical reduction in incidence of new esophageal varices with belapectin 2 mg/kg compared to placebo; Statistically significant reduction in the per-protocol population; Supportive changes in non-invasive markers of portal hypertension and fibrosis including LSM and ELF; Favorable safety and tolerability profile. Belapectin targets galectin-3, a key mediator of fibrosis and inflammation, and is being developed as a potential therapy to address complications of MASH cirrhosis. The full manuscript is available online and can be accessed freely given its open-access status. NAVIGATE was a global, randomized, placebo-controlled Phase 2b trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. The study assessed the development of varices and other clinically relevant outcomes over an 18-month treatment period. Annonce • Mar 18
Galectin Therapeutics Inc. Appoints Henry Brem, M.D. as Independent Director to Board of Directors Galectin Therapeutics Inc. on March 17, 2026 announced it has appointed Henry Brem, M.D., as an independent director to its Board of Directors. Dr. Brem is an internationally recognized neurosurgeon-scientist and leader in translational medicine. He serves as the Henry Brem Professor of Neurosurgery at Johns Hopkins University and previously served as Director of the Department of Neurosurgery and Neurosurgeon-in-Chief at The Johns Hopkins Medical Institutions. He is also Co-Director of the Brain Cancer Program at the Sidney Kimmel Comprehensive Cancer Center. Dr. Brem has helped transform neurosurgical oncology through the development of image-guided surgical techniques and localized drug delivery systems, including Gliadel wafers for brain tumors. He has published more than 416 peer-reviewed papers, holds multiple patents, and has been continuously funded by the NIH for over four decades. He is a member of the National Academy of Medicine and has received numerous honors recognizing his contributions to clinical excellence and translational research. Annonce • Jan 14
Galectin Therapeutics Inc Announces Resignation Of Director Marc Rubin On January 10, 2026, Marc Rubin resigned from the Board of Directors of Galectin Therapeutics Inc. (the “Company”). Mr. Rubin’s resignation is not the result of any disagreement with the Company on any matter relating to its operations, policies or practices. Annonce • Dec 19
Galectin Therapeutics Inc. Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditure Through March 2027 Galectin Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company's previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company's initial request for an in-person or teleconference meeting to a written response. Based on FDA's written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study. Pursuant to the written response from FDA, Galectin Therapeutic will pursue a follow-up Type C meeting to finalize remaining components of the next clinical trial design that were not fully resolved in the written response. This follow-up meeting will also provide an opportunity to present recently generated biomarker data, including findings highlighted at last month's American Association for the Study of Liver Diseases (AASLD) meeting, which could not be incorporated in the original submission due to stated objective of obtaining FDA feedback before the end of 2025. The Company views this next FDA interaction as an important step toward ensuring full clarity as it advances belapectin towards subsequent clinical development in a pivotal Phase 3 clinical trial. Galectin Therapeutics is also encouraged that the planned meeting will allow participation from prominent key opinion leaders, whose insights could not be integrated into the prior written-only exchange. Galectin Therape therape remains committed to advancing belapectin's development for patients with advanced fibrotic liver disease and continues to engage constructively with the FDA as it progresses the program. In connection with this agreement, the maturity dates of all of the Company's convertible lines of credit and convertible notes payable to its chairman have been extended through June 30, 2027. The Company now believes that its cash resources, together with availability under these credit facilities, are sufficient to fund currently expected expenditures through at least March 2027. Annonce • Nov 11
Galectin Therapeutics Presented Navigate Trial Results At the American Association for the Study of Liver Diseases (Aasld) 2025 Annual Meeting Galectin Therapeutics Inc. announced new biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg. Using established criteria for clinically meaningful worsening, a lower proportion of patients treated with belapectin 2 mg /kg experienced 30% or 5 kPa increases in liver stiffness (LSM) by FibroScan®? compared with placebo, indicating slowing of fibrosis progression and stabilization of liver function. Across all ELF fibrosis risk categories, belapectin2 mg/kg showed a lower incidence of new varices compared with placebo, with the largest benefit in patients with ELF > 11.3 (22.7% vs 42.9%), representing those at highest risk for liver complications. Pro-C3 biomarker analysis demonstrated a >50% reduction from baseline at 18 months with belapectin 2 u/kg compared with placebo, supporting the therapy's antifibrotic and disease-modifying potential in compensated MASH cirrhosis with portal hypertension. Analysis of YKL-40, a biomarker associated with Galectin-3 upregulation in fibrotic liver disease, demonstrated a 20% reduction in a higher proportion of patients treated with bel apectin 2 mg/kg compared with placebo, providing additional mechanistic evidence of belapectin's antifibrotic activity. Patients were randomized 1:1:1 to receive intravenous belapectin at 2 mg/kg or 4 mg/kg of lean body mass or placebo every other week for 18 months (78 weeks). When patients were stratified using FDA-approved Enhanced Liver Fibrosis (ELF) score cutoffs, belapectin 2 mg-kg demonstrated a consistently lower incidence of new varices across all fibrosis categories, with the largest reduction observed among patients with ELF >11.3, representing those at highest risk for Liver complications (22.7% vs42.9% for placebo). A total of 57 subjects completed 36 months of therapy in NAVIAGTE. At 36 months, the cumulative incidence of new varices in the study was 23.4%, 12.4% and 16.7% respectively, in placebo, 2 mg/kg, and 4 mg/kg cohorts. As in prior trials, the safety profile of belapectin remains highly encouraging with incidence of adverse events and serious adverse events comparable across the three cohorts. As in prior trials. Raj Vuppalanchi, M.D., serves as Professor of Medicine and Director of Hepatology at Indiana University School of Medicine, stated "The long-term NAVIGATE data presented at AASLD provide important insights into the potential of Galectin-3 inhibition in advanced fibrosis. Galectin's lead drug belapectin is a carbohydrate-based drug that inhibits thegalectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company's current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin's drugs are subject to change at any time based on the changing needs of the Company's current clinical trial; and the Company's current clinical trial. Annonce • Oct 23
Galectin Therapeutics Inc., Annual General Meeting, Dec 03, 2025 Galectin Therapeutics Inc., Annual General Meeting, Dec 03, 2025. Annonce • Jul 09
Galectin Therapeutics Inc. announced that it expects to receive $10 million in funding Galectin Therapeutics, Inc. announced that it has entered into a material definitive agreement for a line of credit of up to $10,000,000 on December 19, 2017. The transaction included participation the lender from Richard E. Uihlein. The Company may draw upon the Line of Credit through April 30, 2026. Each advance made pursuant to the July 2025 Supplemental Line of Credit Agreement shall be evidenced by an unsecured, convertible promissory note, and bear interest at the Applicable Federal Rate for short term loans (currently 4.05%), plus two (2%) percent. Principal and interest on the Promissory Notes are due on or before September 30, 2026. Only with the consent of the Lender, may the Promissory Notes be prepaid, in whole or in part, at any time without premium or penalty, but with interest on the amount or amounts prepaid. The Company agreed to issue the Lender warrants to purchase up to an aggregate of 200,000 shares of the Company’s common stock, par value $0.001 per share. The Company shall issue to the Lender Warrants to purchase up to the remaining 200,000 shares of the Company’s common stock, ratably, upon borrowings under the July 2025 Supplemental Line of Credit Agreement, with exercise prices equal to 150% of the closing price of the Company’s common Stock on the date of the Promissory Note evidencing such draw, but in no event more than $10.00 per share nor less than $3.00 per share. The Warrants expire on July 31, 2029. Annonce • May 12
Galectin Therapeutics Presented Navigate Trial Results At the European Association for the Study of the Liver 2025 Congress Galectin Therapeutics announced that Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®?, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. A total of 355 patients were randomized in a 1:1:1 ratio to receive intravenous belapectin at either 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg LBM (n=118), or placebo (n=118) every other week for 18 months. The primary endpoint was the prevention of varices, assessed as a composite clinical outcome that included patients who developed any varices, experienced intercurrent events, or lacked an endoscopy or intercurrent events at 18 months. The study evaluated both the intent-to-treat (ITT) population (N=355) and a pre-defined per-protocol population or completer population (PPP, N=287), the latter comprising patients who completed 18 months of treatment with upper endoscopies performed at both baseline and after 18 months of treatment. Rates of discontinuation, adverse events (AEs), and serious adverse events (SAEs) were comparable to placebo, with no drug-related SAEs reported in the NAVIGATE trial. Annonce • Apr 02
Galectin Therapeutics Inc. Auditor Raises 'Going Concern' Doubt Galectin Therapeutics Inc. filed its 10-K on Mar 31, 2025 for the period ending Dec 31, 2024. In this report its auditor, Cherry Bekaert LLP - Cherry, Bekaert & Holland, LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern. Annonce • Feb 20
Galectin Therapeutics Reports Significant Reduction in New Varices with Belapectin in U.S. Patient Population from the NAVIGATE Trial Galectin Therapeutics Inc. announced additional results showing a statistically significant reduction in new varices in per-protocol patients (completers) enrolled in the U.S. from the NAVIGATE trial for belapectin in patients with Metabolic Dysfunction-Associated SteatoHepatitis (MASH) cirrhosis and portal hypertension. The NAVIGATE trial top-line results showed that while the incidence of varices at 18 months was 43.2% lower in patients treated with belapectin 2 mg vs placebo, the composite endpoint did not reach statistical significance in the intent-to-treat population (N=355). However, in the completer population of 287 patients (revised), the incidence of varices was reduced by 49.3% in patients treated with belapectin 2 mg vs placebo (nominal p-value = 0.04 (revised)). Following the favorable trend observed in the completers, the Company further analyzed the two thirds of the completer patients in the NAVIGATE trial enrolled in the U.S. (n=186). The incidence of varices in this population was significantly reduced by 68.1% (p=0.02) in patients treated with belapectin 2 mg (4 out of 60) vs placebo (13 out of 62) in the U.S. While all three cohorts of patients in the U.S. had a higher percentage use of GLP-1 and statins than the rest of the world, the belapectin cohorts performed much better than placebo in the U.S. Annonce • Dec 20
Galectin Therapeutics Announces Top-Line Results of Navigate Clinical Trial Evaluating Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Mash Galectin Therapeutics Inc. announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis and portal hypertension. The NAVIGATE trial (NCT04365868) is a global, multicenter, randomized, double-blind, placebo-controlled study conducted in over 130 sites in 5 continents, across 15 countries including the U.S., Canada, Mexico, Australia, U.K, France, Germany, Korea and Israel. 355 patients were randomized 1:1:1 to receive intra-venously either belapectin 2mg/kg of lean body mass (LBM) (n=119), belapectin 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months. All enrolled subjects transitioned into a 36-month treatment period, with approximately 50 subjects completing the full 36 months to date. The company are still analyzing the extensive data from the trial and anticipate providing multiple clinical updates from the subjects completing 36-month therapy, as well as additional biomarker data in First Quarter 2025. Based on results from previous clinical and preliminary nonclinical studies, as well as preliminary data from the NAVIGATE trial, the lack of increased efficacy at the 4 mg dose of belapectin is likely due to saturable binding dynamics and interactions with Galectin-3 proteins. Once available, Galectin will provide clinical updates and determine next steps for belapectin development. Galectin's lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. Factors that could cause actual performance to difference materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company's current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly. Annonce • Nov 15
Galectin Therapeutics Inc., Annual General Meeting, Jan 23, 2025 Galectin Therapeutics Inc., Annual General Meeting, Jan 23, 2025. Annonce • Aug 02
Galectin Therapeutics Inc. Appoints Khurram Jamil to Chief Medical Officer Galectin Therapeutics Inc. announced the appointment of Khurram Jamil, M.D., an accomplished senior executive with expertise in liver disease to Chief Medical Officer effective immediately. After joining in March 2024 as Vice President Clinical Development and Medical Director, Khurram has quickly integrated himself into team and has led the management of NAVIGATE clinical trial of belapectin. Khurram is well known in the hepatology community and has over 20 years of experience. After completing his general surgery residency at Seton Hall University, Khurram had several roles with increasing responsibility in biotechnology and pharmaceutical companies where he designed and led many clinical trials, several of which resulted in new drug approvals in the United States and other countries around the world. New Risk • Apr 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 11% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$33m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-US$60m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$63m net loss in 3 years). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Annonce • Mar 30
Galectin Therapeutics Inc. Appoints Benjamin S. Carson as Member of the Board of Directors Galectin Therapeutics Inc. appointed Benjamin S. Carson, Sr., M.D. as a new member of the Board of Directors, following his service as a senior advisor to the Company since 2021. New Risk • Feb 08
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €91.8m (US$99.0m) This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-US$36m free cash flow). Negative equity (-US$51m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$50m net loss in 3 years). Share price has been volatile over the past 3 months (7.9% average weekly change). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Market cap is less than US$100m (€91.8m market cap, or US$99.0m). New Risk • Nov 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.1% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-US$36m free cash flow). Negative equity (-US$51m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$50m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Shareholders have been diluted in the past year (4.1% increase in shares outstanding). Annonce • Oct 07
Galectin Therapeutics Inc., Annual General Meeting, Dec 07, 2023 Galectin Therapeutics Inc., Annual General Meeting, Dec 07, 2023, at 11:00 Eastern Standard Time. Agenda: To elect the eleven 11 nominees for director named in the proxy statement accompanying this notice to serve until our 2024 annual meeting of stockholders; to ratify the selection by the audit committee of the board of directors of cherry bekaert llp as our independent registered public accounting firm for the fiscal year ending December 31, 2023; to approve an amendment to our 2019 omnibus equity incentive plan to reserve an additional 3,000,000 shares for issuance under the plan; and to to transact such other business as may properly come before the meeting or any adjournments of the 2023 annual meeting. Annonce • Oct 05
Galectin Therapeutics, Inc. Reports the Positive Outcome of the Fourth Data and Safety Monitoring Board Meeting for NAVIGATE Galectin Therapeutics Inc. reported the positive outcome of its fourth data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with portal hypertension caused by non-alcoholic steatohepatitis (NASH) liver cirrhosis. NAVIGATE is the first study of its kind and is a global effort that randomized 357 patients in 14 countries on five continents. The main efficacy objective is the primary prevention of esophageal varices. Interim topline data from the Phase 2b portion of NAVIGATE is expected in the fourth quarter of 2024. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver cirrhosis. The objective of this fourth independent DSMB was to further review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications. The study is fully randomized, and it will be continuing to collect a large amount of safety data, including patients who have completed up to 36 months of treatment. This fourth recommendation further strengthens its confidence that belapectin can offer a beneficial risk-benefit profile. Because of the cirrhotic process and the multiple co-morbidities of the metabolic syndrome, such as hypertension, type 2 diabetes and obesity, NAVIGATE patients are generally on multiple medications and at risk of severe complications, including infectious events triggered by an immune deficient state. In this medically complex environment, a candidate drug designed for cirrhotic patients must be safe and well- tolerated. Currently, patients with decompensated liver cirrhosis have no hope other than to receive a liver transplantation. A liver transplantation is a complex and expensive procedure, requiring life-long immunosuppression and specialized follow-up and is dramatically rationed by a global shortage of organs and a lack of access creating unwanted disparities throughout North America and the rest of the world. With the NASH/MASH epidemy and the resulting increasing number of patients that will suffer from liver cirrhosis, the liver organ shortage is only going to get worse, further highlighting the urgent need for new treatments. Board Change • Oct 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 5 highly experienced directors. Independent Director Rick Zordani was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annonce • Jan 06
Galectin Therapeutics Inc. Announces the End of Enrollment of Navigate, Its Seamless, Adaptive Phase 2B/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis Galectin Therapeutics Inc. announced that in late December 2022, it ended enrollment of NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its kind and is a global effort that recruited patients in 14 countries and on five continents. The main efficacy objective is the primary prevention of esophageal varices. Patients enrolled in the study have cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed dilated veins in the esophagus known as esophageal varices, a complication of portal hypertension. Portal hypertension is the consequence of the unrelented inflammatory and fibrotic process occurring in the liver and dramatically increases the risk of developing esophageal varices, a potentially life-threatening complication of liver cirrhosis. About Belapectin. Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis,” is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring. About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis. Non-alcoholic steatohepatitis (NASH) has become a common d sease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis. Annonce • Oct 18
Galectin Therapeutics Inc., Annual General Meeting, Dec 01, 2022 Galectin Therapeutics Inc., Annual General Meeting, Dec 01, 2022, at 11:00 US Eastern Standard Time. Agenda: To consider and elect the eleven nominees for director named in the accompanying proxy statement to hold office until the 2023 annual meeting of stockholders; to consider and ratify the selection by the Audit Committee of the Board of Directors of Cherry Bekaert LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; to consider and vote on a non-binding advisory resolution to approve executive compensation; to consider and transact such other business as may properly come before the meeting or any adjournments of the 2022 Annual Meeting. Annonce • Oct 13
Galectin Therapeutics Receives FDA Approval to Proceed with Combination Immunotherapy Trial in Head and Neck Cancer Galectin Therapeutics Inc. announced that its Investigational New Drug (IND) application for belapectin in combination with a checkpoint inhibitor for the treatment of Head and Neck cancer has been filed with the U.S. Food and Drug Administration (FDA) Oncology division. Galectin Therapeutics also received a Study May Proceed letter for a Phase 2 clinical trial entitled A Phase 2 Study of the Efficacy and Safety of Belapectin in Combination with Pembrolizumab (Keytruda®) as First-Line Treatment in subjects with Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck. Annonce • Oct 07
Galectin Therapeutics, Inc. Reports the Positive Outcome of the Second Data and Safety Monitoring Board Meeting for NAVIGATE Galectin Therapeutics Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its kind and is a global effort that recruits patients in over 15 countries and five continents. The main efficacy objective is the primary prevention of esophageal varices. Patients enrolled in the study have liver cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed esophageal varices as a complication of portal hypertension. Portal hypertension is the consequence of the unrelented inflammatory and fibrotic process occurring in the liver and dramatically increases the risk of developing esophageal varices, a potentially life-threatening complication of liver cirrhosis. The objective of this second independent DSMB was to further review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE can continue as designed, without modifications. Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring. About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis: Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis. Annonce • Jun 22
Galectin Therapeutics Announces 2 Liver Cirrhosis Scientific Presentations at the EASL International Liver Congress(TM) 2022 Galectin Therapeutics Inc. announced two scientific presentations regarding the use of artificial intelligence to analyze liver biopsies of patients affected with cirrhosis of the liver due to Nonalcoholic Steatohepatitis (NASH). The data originates from the Company's phase 2 study (NCT02462967) that evaluated its proprietary drug candidate belapectin in patients with NASH cirrhosis who have developed portal hypertension. Portal hypertension is a severe clinical complication of the disease that marks a significant progression towards liver failure and for which, currently, no treatment is registered. The presentations will be delivered by Dr. Mazen Noureddin of the Division of Digestive and Liver Diseases, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA, United States, during the International Liver Congress(TM) 2022 hosted by the European Association for the Study of the Liver (EASL) on June 22-26, 2022 in London, U.K. The first abstract (FRI509) focuses on the use of second-harmonic generation microscopy for automated detection of septa and nodules in liver biopsies of NASH cirrhosis patients. As current staging systems oversimplify all degrees of cirrhosis into one category, artificial intelligence can be used to develop more sophisticated algorithms to correlate with the natural history of the disease, including the development of portal hypertension. The second abstract (FRI 516) focuses on derivation of machine learning histologic scores that correlate with portal pressures and the development of esophageal varices. Esophageal varices represent a severe clinical complication of portal hypertension, as they can bleed and, consequently, be immediately life-threatening. The Machine Learning algorithm used could predict the degree of portal hypertension and the development of varices in patients with portal hypertension. Annonce • Apr 16
Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis Galectin Therapeutics Inc. reported the positive outcome of its first data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its kind and is a global effort that recruits patients over 15 countries and five continents. The study main efficacy objective is the primary prevention of esophageal varices. Patients enrolled in the study have liver cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed esophageal varices as a complication of portal hypertension. Portal hypertension is the consequence of the unrelented inflammatory and fibrotic process occurring in the liver and dramatically increases the risk of developing esophageal varices, a potentially life-threatening complication of liver cirrhosis.The objective of this first independent DSMB was to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE can continue as designed, without modifications. Annonce • Dec 22
Galectin Therapeutics Inc. announced that it has received $20 million in funding On December 21, 2021, Galectin Therapeutics Inc. closed the transaction. The company received $10,000,000 in its second and final tranche. The company has received $20,000,000 in the transaction so far. Executive Departure • Mar 02
Chief Medical Officer has left the company On the 28th of February, Pol Boudes' tenure as Chief Medical Officer ended after less than a year in the role. We don't have any record of a personal shareholding under Pol's name. Pol is the only executive to leave the company over the last 12 months. Is New 90 Day High Low • Jan 29
New 90-day low: €1.62 The company is down 25% from its price of €2.16 on 30 October 2020. The German market is up 20% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 13% over the same period. Recent Insider Transactions • Jan 20
Independent Director recently sold €107k worth of stock On the 11th of January, Gilbert Amelio sold around 60k shares on-market at roughly €1.79 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €65k more than they bought in the last 12 months. Is New 90 Day High Low • Jan 05
New 90-day low: €1.79 The company is down 21% from its price of €2.26 on 07 October 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is flat over the same period. Is New 90 Day High Low • Dec 11
New 90-day low: €2.08 The company is down 15% from its price of €2.44 on 11 September 2020. The German 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 down 8.0% over the same period. Is New 90 Day High Low • Sep 29
New 90-day high: €3.06 The company is up 18% from its price of €2.60 on 01 July 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annonce • Sep 03
Galectin Therapeutics, Inc. Announces Management Changes Galectin Therapeutics Inc. announced the appointment of current board member, Joel Lewis, to the position of Chief Executive Officer and President. In this position, Mr. Lewis will set corporate strategy and oversee operations, most importantly the Company’s global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapectin (GR-MD-02). Dr. Harold Shlevin, who is retiring from the CEO position, has signed a consulting agreement through which he has agreed to devote significant effort to advancing the NASH-RX trial. Dr. Shlevin and Mr. Lewis will retain their positions on Galectin’s Board of Directors. On the subject of the Board, because Joel will assume the role of CEO and President, he can no longer serve as Chairman of the Audit Committee.