Galectin Therapeutics Inc Stock Price, News & Analysis

Galectin Therapeutics (NASDAQ: GALT) announced positive results from its second independent Data and Safety Monitoring Board (DSMB) meeting regarding the NAVIGATE trial. This phase 2b/3 study evaluates belapectin for preventing esophageal varices in patients with NASH-related liver cirrhosis. The DSMB concluded belapectin showed a favorable safety profile, allowing the trial to proceed without changes. With 258 patients randomized and an additional 74 in screening, full enrollment is anticipated by year-end. This milestone reinforces the urgent need for new treatments for liver cirrhosis amidst rising NASH cases.

Galectin Therapeutics Inc. (NASDAQ: GALT) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. Dr. Pol F. Boudes, Chief Medical Officer, will present on September 13 at 11:00 AM ET. The company is focused on developing therapies targeting galectin proteins, particularly belapectin, for conditions like liver fibrosis and cirrhosis. Notably, belapectin shows promise in treating Non-alcoholic Steatohepatitis (NASH) and has Fast Track designation from the FDA. A live webcast of the presentation will be available on their website.

Galectin Therapeutics, Inc. (NASDAQ: GALT) reported financial results for Q2 2022, revealing a net loss of $9.7 million, or $0.16 per share, compared to a loss of $8.5 million, or $0.15 per share in Q2 2021. Major developments include securing a $60 million line of credit to fund the Phase 2b NAVIGATE trial and progress on an Investigational New Drug (IND) application for belapectin in treating recurrent head and neck cancer. The firm is on track to complete enrollment of the NAVIGATE trial by Q4 2022 and had $24.2 million in cash as of June 30, 2022.

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.