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Galectin Therapeutics Inc. (NASDAQ: GALT) is a clinical-stage biopharmaceutical company that leverages its expertise in galectin science and drug development to create groundbreaking therapies for fibrotic diseases and cancer. The company’s flagship drug, belapectin (GR-MD-02), is a galectin-3 inhibitor that has shown promising results in reversing liver fibrosis and cirrhosis in preclinical models.
Galectin Therapeutics utilizes a unique carbohydrate technology to develop drug candidates that target galectin proteins, which are crucial in both biological and pathological processes. These carbohydrate-based compounds are designed to bind and inhibit galectin proteins, thereby providing therapeutic benefits in diseases where galectins play a pathogenic role. The company focuses on serious, life-threatening diseases with limited treatment options, aiming to bring new hope to patients and value to stakeholders.
The company’s lead development program is the NAVIGATE trial, a seamless, adaptive Phase 2b/3 study designed to evaluate belapectin for the prevention of esophageal varices in patients with nonalcoholic steatohepatitis (NASH) cirrhosis. This trial, which completed the randomization of 357 patients in February 2023, is expected to yield interim results in the fourth quarter of 2024. The study's innovative design allows for adaptive modifications, making it a pioneering effort in cirrhosis research.
Financially, Galectin Therapeutics reported a net loss of $9.2 million for the quarter ended June 30, 2023, compared to a net loss of $9.7 million for the same period in 2022. Research and development expenses decreased to $7.4 million, primarily due to the timing of costs related to the NAVIGATE trial. As of June 30, 2023, the company had $18.0 million in cash and cash equivalents, with an additional $30 million available under a $60 million line of credit provided by its chairman.
Additionally, the company is exploring the potential of belapectin in combination with Keytruda© for treating advanced head and neck cancers. Belapectin's unique mechanism of inhibiting galectin-3, a protein involved in multiple inflammatory, fibrotic, and malignant processes, makes it a versatile candidate for various indications.
Galectin Therapeutics continues to build its scientific and clinical team, recently adding key personnel in biostatistics, quality assurance, and clinical operations to manage its expanding portfolio and ongoing trials. The company's commitment to scientific excellence and clinical innovation positions it as a leader in the field of galectin-targeting therapies.
Galectin Therapeutics Inc. (NASDAQ: GALT) announced its participation in the H.C. Wainwright BioConnect Investment Conference on May 2, 2023. CEO Joel Lewis and CMO Dr. Pol F. Boudes will engage in a discussion about the NAVIGATE trial targeting NASH cirrhosis. A live webcast of the event will be available at 10:30 a.m. ET. Belapectin, the company's lead drug, targets galectin-3 and shows promise in reversing liver fibrosis. The NAVIGATE trial, evaluating belapectin's efficacy in preventing esophageal varices in NASH cirrhosis, has completed randomization with results expected in Q4 2024. NASH, affecting up to 28 million U.S. citizens, can lead to cirrhosis, where liver transplants are often the only treatment. The company aims to develop new therapies for chronic liver diseases and cancer.
Galectin Therapeutics, Inc. (NASDAQ: GALT) attended the 2023 Emerging Topic Conference on NASH Cirrhosis, organized by the American Association for the Study of Liver Diseases (AASLD) in Los Angeles on March 25-26, 2023. The conference targeted NASH cirrhosis, emphasizing its growing global health concern and the limitations of current treatment options, primarily liver transplantation. Galectin's NAVIGATE study is under review, focusing on the prevention of esophageal varices using belapectin, a galectin-3 inhibitor aimed at non-alcoholic steatohepatitis (NASH) patients. The conference discussed the critical role of liver macrophages and the challenges of using liver biopsies for diagnosing cirrhosis. Dr. Pol Boudes, Chief Medical Officer, highlighted the urgency of addressing NASH cirrhosis, with projections indicating a potential crisis in liver transplant availability in the U.S.
Galectin Therapeutics, Inc. (NASDAQ: GALT) reported a net loss of $38.9 million for the year ended December 31, 2022, equating to ($0.65) per share, increased from $30.7 million in 2021. This rise is attributed to higher research and development expenses of $31.7 million, primarily for the NAVIGATE trial, up from $23.8 million in 2021. The company has $18.6 million in cash, with $50 million available from a line of credit. The Phase 2b/3 NAVIGATE trial has randomized 357 patients and is expected to yield interim results in Q4 2024. The safety profile of belapectin remains promising, potentially addressing a significant therapeutic gap in NASH cirrhosis.
Galectin Therapeutics (NASDAQ: GALT) announced positive outcomes from its third Data and Safety Monitoring Board (DSMB) meeting for the NAVIGATE study, which evaluates belapectin for preventing esophageal varices in patients with liver cirrhosis due to non-alcoholic steatohepatitis (NASH). The global study includes 357 randomized patients across 14 countries. The DSMB confirmed that the trial can continue without changes, reinforcing confidence in belapectin's safety profile. Interim data from Phase 2b is anticipated in Q4 2024, highlighting the critical need for effective treatments as NASH prevalence rises, contributing to increased liver cirrhosis cases worldwide.
Galectin Therapeutics (NASDAQ: GALT) has completed patient enrollment for its NAVIGATE study, focusing on belapectin for liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The study exceeded its target, randomizing 357 patients across 14 countries, aiming to prevent esophageal varices in patients with portal hypertension. The treatment period for the phase 2b portion spans 18 months, with topline results anticipated in Q4 2024. The Chief Medical Officer expressed optimism regarding the potential benefits of belapectin, while the CEO highlighted the company's focus on efficient execution of its program following this milestone.