Galectin Therapeutics Q1 2024 Financial Results and Business Update

Galectin Therapeutics, Inc. (NASDAQ: GALT), a leading developer of therapies targeting galectin proteins, has released its financial results and provided a business update for the quarter ending March 31, 2024. The company's main focus has been on advancing the NAVIGATE Phase 2b/3 trial of belapectin, a drug that targets galectin-3 proteins. This trial is aimed at treating liver cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH).

Joel Lewis, the Chief Executive Officer and President of Galectin Therapeutics, highlighted the company’s commitment to the NAVIGATE trial, which has received Fast Track Designation from the U.S. Food & Drug Administration. The recent fifth meeting of the independent Data and Safety Monitoring Board (DSMB) resulted in a recommendation to continue the trial without any modifications, emphasizing belapectin’s positive safety profile. The top-line interim analysis from the Phase 2b portion of the NAVIGATE trial is expected in the fourth quarter of 2024.

The company also mourned the recent passing of Dr. Stephen A. Harrison, who was integral to the belapectin clinical program from its beginning. Dr. Harrison was the coordinating investigator of the NAVIGATE trial and had significantly influenced the design of clinical research in cirrhotic patients. He notably advocated for the prevention of esophageal varices as a clinical outcome, which is considered more relevant to real-world clinical settings than liver biopsies.

Belapectin is a complex carbohydrate drug that targets galectin-3, which plays a crucial role in the development of MASH and fibrosis. The NAVIGATE Phase 2b/3 trial (NCT04365868) is evaluating the efficacy and safety of belapectin in preventing esophageal varices in MASH across 357 patients in 14 countries. The DSMB's fifth meeting endorsed the continuation of the trial as planned. An interim top-line data readout from the Phase 2b portion is anticipated late in the fourth quarter of 2024.

In corporate updates, Khurram Jamil, M.D., was appointed as Vice President of Clinical Development. Financially, Galectin Therapeutics reported having $23.6 million in cash and cash equivalents as of March 31, 2024. Additionally, the company has $10 million available from a $60 million line of credit provided by its chairman of the board and another $10 million from a recently executed line of credit also provided by the chairman. The company believes it has enough funds to support current operations and research activities through May 15, 2025.

Research and development expenses totaled $8.1 million for the quarter ended March 31, 2024, compared to $8.8 million for the same period in the previous year. The decrease was mainly due to the timing of expenditures related to the NAVIGATE trial. General and administrative expenses were $1.6 million, up slightly from $1.5 million in the same quarter of 2023. The net loss applicable to common stockholders was $11.5 million, or ($0.19) per share, consistent with the net loss for the same period in 2023.

Galectin Therapeutics is committed to developing new therapies for chronic liver disease and cancer. Their lead drug, belapectin, is a carbohydrate-based drug that inhibits galectin-3, involved in various inflammatory, fibrotic, and malignant diseases. The lead development program focuses on MASH with cirrhosis. Liver cirrhosis remains a significant medical challenge and opportunity for drug development. Other development programs include treatments for advanced head and neck cancers and other malignancies, for which the company seeks suitable partners to advance these initiatives.

Galectin aims to leverage its scientific and development expertise along with external alliances to achieve cost-effective and efficient development.