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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 (NASDAQ:GALT) announced it will present six abstracts at The Liver Meeting™ 2021, focusing on belapectin, a galectin-3 inhibitor targeting NASH cirrhosis. Key findings include new insights into belapectin’s mechanism to inhibit galectin-3, its pharmacokinetic profile in hepatic insufficiency patients, and its innovative NAVIGATE phase 2b/3 study design aimed at preventing esophageal varices in NASH cirrhosis patients. The research highlights correlations between liver tests and portal hypertension, emphasizing the profound impact of NASH cirrhosis on quality of life.
Galectin Therapeutics (NASDAQ: GALT) announced the presentation of six scientific abstracts at The Liver Meeting™ 2021 from November 12-15. These abstracts cover new insights into belapectin, a galectin-3 inhibitor targeting NASH cirrhosis, showcasing its mechanism of action, pharmacokinetic profile in hepatic insufficiency, and innovative NAVIGATE trial design aimed at preventing esophageal varices. The research highlights the correlation between liver tests and portal hypertension, and emphasizes the impact of NASH cirrhosis on patients' quality of life.
Galectin Therapeutics (NASDAQ: GALT) announced its participation in the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021. Dr. Pol F. Boudes, Chief Medical Officer, will engage in a fireside chat with analyst Ed Arce at 11:00 AM ET. The event aims to discuss the company's lead drug, Belapectin, which targets galectin-3 for treating liver fibrosis associated with NASH. The NAVIGATE trial is ongoing to evaluate Belapectin's efficacy in preventing esophageal varices in NASH cirrhosis patients. Live webcast will be available on the company's website.
Galectin Therapeutics Inc. (NASDAQ: GALT) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference, scheduled for September 13-15, 2021. The company’s management will present and conduct 1-on-1 investor meetings. Investors can access the presentation starting September 13 at 7:00 A.M. ET through an online link. Galectin's leading drug, belapectin (GR-MD-02), targets galectin-3 and shows promise in treating non-alcoholic steatohepatitis (NASH) and related liver fibrosis. Belapectin is involved in ongoing clinical studies, including the NAVIGATE trial.
Galectin Therapeutics (NASDAQ:GALT) announced a $20 million convertible debt financing with Chairman Richard E. Uihlein, enhancing financial support following a $10 million deal in April. The arrangement includes two $10 million notes, the first funded on September 17, 2021, and the second by December 17, 2021. The 2% interest rate accrues additional payments based on potential share conversion. Uihlein expressed commitment to addressing unmet medical needs, specifically in NASH cirrhosis and advanced melanoma treatments, bolstered by positive Phase 1 trial results with belapectin and KEYTRUDA.
Galectin Therapeutics, Inc. (NASDAQ: GALT) announced that its management will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The virtual conference will include a presentation starting at 7:00 A.M. (ET) on September 13, along with 1-on-1 meetings with investors. Galectin's lead drug, belapectin, targets galectin-3, which is linked to diseases such as NASH and fibrosis. The NAVIGATE trial for belapectin in preventing esophageal varices in NASH cirrhosis is ongoing. More details can be found on their official website.
Galectin Therapeutics (NASDAQ:GALT) announced key leadership appointments to strengthen its management team, including Dakshina Reddy as Executive Director of Regulatory Affairs and Ezra R. Lowe, Ph.D., as Executive Director of Clinical and Preclinical Pharmacology. These changes aim to enhance the company's efforts in cancer immunotherapy and NASH cirrhosis treatments. CEO Joel Lewis emphasized that these experienced hires will facilitate advancement in clinical trials, particularly for their lead drug, belapectin, which targets galectin-3 and is involved in pivotal studies like the NAVIGATE trial.
Galectin Therapeutics Inc. (NASDAQ: GALT) announced a net loss of $8.5 million for Q2 2021, an increase from $6.2 million in Q2 2020. The rise is attributed to increased R&D expenses primarily for the NAVIGATE trial in NASH cirrhosis, totaling $6.5 million this quarter. Despite these challenges, positive results in ongoing cancer immunotherapy trials enhance the rationale for a larger Phase 2 study. The company has $31.6 million in cash as of June 30, 2021, and anticipates needing an additional $30-$35 million by late 2023 to support ongoing trials.
Galectin Therapeutics Inc. (NASDAQ:GALT) announced promising results from its extension cohort of a Phase 1b clinical trial investigating Belapectin combined with KEYTRUDA® in patients with metastatic melanoma and head and neck cancer. The trial demonstrated a 56% cancer control rate in melanoma and 40% in head and neck cancer. Notably, no toxicities related to Belapectin were reported, and adverse effects were mild. Researchers expressed optimism over the data, suggesting a rationale for a larger Phase 2 randomized controlled study to further explore this combination therapy.
Galectin Therapeutics (NASDAQ: GALT) reported a net loss of $6.3 million for Q1 2021, increasing from $3.6 million in Q1 2020, primarily due to heightened R&D expenses of $4.9 million attributed to the NAVIGATE trial for NASH cirrhosis. The company raised $10 million in convertible debt financing and launched NAVIGATEnash.com to educate stakeholders on NASH. Recent peer-reviewed results showed promising outcomes in a cancer immunotherapy trial combining belapectin with pembrolizumab, underscoring the potential of its galectin-3 inhibitor in oncology.
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