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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 (GALT) announced a $60 million unsecured line of credit with chairman Richard E. Uihlein, marking the largest financing in the company's history. The funds will cover planned expenditures through 2024 as Galectin progresses its NAVIGATE clinical trial for belapectin, aimed at treating NASH cirrhosis. The credit line allows for borrowings until July 2024 and includes provisions for converting debt into equity at no less than $3.00 per share. CEO Joel Lewis expressed gratitude for Uihlein's support, emphasizing the commitment to align shareholder interests with significant ongoing projects.
Galectin Therapeutics (NASDAQ: GALT) announced two significant scientific presentations employing artificial intelligence to analyze liver biopsies for patients with cirrhosis due to NASH. The data, from a Phase 2 study (NCT02462967), will be shared at the International Liver Congress™ 2022 in London. The first abstract discusses an AI method for detecting liver damage, while the second focuses on machine learning scores predicting portal hypertension complications. These advancements highlight the company's expertise in managing liver disease and the potential impact of belapectin, their leading drug candidate.
Galectin Therapeutics Inc. (NASDAQ: GALT) will present at the H.C. Wainwright Global Investment Conference from May 23-26, 2022, and the 5th Global NASH Congress in London on May 26-27, 2022. Dr. Pol F. Boudes will discuss innovations in NASH cirrhosis and clinical endpoints for NASH trials. Belapectin, Galectin's lead drug targeting galectin-3, shows promise in treating liver fibrosis and cirrhosis, with a Phase 2 study indicating potential to prevent esophageal varices in NASH patients. The NAVIGATE trial is currently enrolling patients to further investigate belapectin's efficacy.
Galectin Therapeutics (NASDAQ: GALT) reported a net loss of $9.9 million, or ($0.17) per share for the quarter ending March 31, 2022, an increase from a net loss of $6.3 million, or ($0.11) per share the previous year. The rise in loss is attributed to heightened research and development costs related to the NAVIGATE trial. As of March 31, 2022, the company had $31.6 million in cash, which is projected to fund operations until May 2023. The firm anticipates needing an additional $40-$45 million for ongoing trials and activities, raising concerns about future financing.
Galectin Therapeutics (NASDAQ: GALT) announced a positive outcome from the first Data and Safety Monitoring Board (DSMB) meeting for its NAVIGATE trial, an adaptive Phase 2b/3 study evaluating belapectin in liver cirrhosis patients with NASH. The DSMB confirmed that belapectin appears safe and well-tolerated, allowing the trial to continue without modifications. The trial aims to prevent esophageal varices, a severe complication that can arise from portal hypertension linked to liver cirrhosis. The initial patients have now reached 18 months of treatment, marking another significant milestone in the study.
Galectin Therapeutics (NASDAQ: GALT) reported a net loss of $30.7 million ($0.52 per share) for 2021, an increase from $23.6 million ($0.41 per share) in 2020. This loss primarily stems from heightened research and development expenses of $23.8 million, driven by the NAVIGATE trial aimed at preventing esophageal varices in NASH cirrhosis patients. Despite enrollment challenges due to COVID-19, progress is evident, especially in the U.S. and Mexico. The company holds $39.6 million in cash, with plans for additional financing of $45-$50 million anticipated for operational needs post-March 2023.
Galectin Therapeutics Inc. (NASDAQ: GALT) will participate in the H.C. Wainwright BioConnect Conference from January 10-13, 2022. CEO Joel Lewis and CMO Dr. Pol F. Boudes will present for the company. The presentation will be available as a webcast at 7:00 a.m. ET on January 10, 2022, and can be accessed on the company's website, with a replay available for 90 days.
Galectin focuses on developing therapies for chronic liver disease and cancer, with its lead drug, belapectin, targeting the galectin-3 protein and receiving Fast Track designation from the FDA for NASH-related fibrosis.
Galectin Therapeutics (NASDAQ: GALT) has successfully closed a second $10 million convertible note, part of a total of $30 million raised through three notes in 2021 from Chairman Richard E. Uihlein. The unsecured notes carry a 2% annual interest, convertible at Uihlein's discretion at a price of $5.00 or 228% above prior share price. The company aims to progress its NAVIGATE trial for NASH cirrhosis and research combining belapectin with KEYTRUDA for head and neck cancer. No drug therapies for liver fibrosis or cirrhosis are currently approved, highlighting the significance of its lead drug belapectin.
Galectin Therapeutics (NASDAQ: GALT) announces that its NAVIGATE trial for NASH cirrhosis is fully underway in all originally selected countries, with full enrollment expected by mid-2022. They have engaged leading experts in oncology to explore new treatments for Head and Neck cancers. Shareholders approved all proposals, including the reelection of the Board of Directors. The company has enhanced its management team and is progressing in its global clinical trials, indicating strong commitment to develop therapies targeting galectin-3.
Galectin Therapeutics (NASDAQ: GALT) announced advancements in its oncology and NASH cirrhosis programs as of November 15, 2021. The Board approved a company-sponsored oncology program for belapectin, with strategic guidance from leading oncology experts. Financially, the company reported a net loss of $8.6 million for Q3 2021, up from $6.0 million in Q3 2020, driven by increased R&D expenses of $6.6 million. Cash reserves stand at $36.6 million, enough to cover operations through March 2023, but an additional $30-$35 million is required by then for ongoing trials.