Galectin Therapeutics Inc. develops therapeutics that target galectin proteins, with its lead program focused on belapectin, a carbohydrate-based galectin-3 inhibitor for MASH cirrhosis and portal hypertension. Company updates commonly cover NAVIGATE clinical-trial results, biomarker analyses, medical-conference presentations, journal publications, and FDA communications related to the belapectin development program.
News also includes financial results, research and development spending, cash-resource updates, credit financing, board composition, and investor or key-opinion-leader events. Galectin has also described additional development interests in combination immunotherapy for advanced head and neck cancers and other malignancies.
Galectin Therapeutics (NASDAQ: GALT) reported its Q2 2020 financial results with a net loss of $6.2 million, or ($0.11) per share, up from $3.1 million, or ($0.06) per share, in Q2 2019. The increase was primarily due to $4.7 million in research and development expenses for the NASH-RX trial. The company is optimistic about the trial's potential for accelerated FDA approval and plans to enroll 315 patients across 130 sites globally. As of June 30, 2020, cash and equivalents totaled $40.8 million, with a $10 million line of credit available, sufficient to fund operations through September 2021.
Galectin Therapeutics (NASDAQ: GALT) has initiated the NASH-RX trial, targeting NASH cirrhosis patients at risk of esophageal varices. This international Phase 2b/3 trial assesses the efficacy of belapectin (GR-MD-02), previously shown to prevent varice development in earlier studies. With 315 patients expected across 130 sites, the trial features an adaptive design allowing seamless transitions between phases. An interim analysis will evaluate safety and efficacy after 78 weeks of treatment. Successful outcomes may enable accelerated FDA approval and partnerships, addressing a critical unmet need in liver disease.
Galectin Therapeutics has initiated patient enrollment for the NASH-RX trial, focusing on belapectin as a treatment for nonalcoholic steatohepatitis (NASH) cirrhosis. This adaptively-designed Phase 2b/3 trial targets patients at risk of developing esophageal varices, with a total enrollment of approximately 315 participants across 130 sites in 12 countries. Success in this trial could lead to accelerated FDA approval and partnership opportunities, addressing a significant unmet medical need in the treatment of NASH.
Galectin Therapeutics Inc. (NASDAQ: GALT) reported its Q1 2020 financial results, showing a net loss of $3.6 million ($0.06 per share), an improvement from $9.1 million ($0.20 per share) in Q1 2019. The company has filed a new protocol for its NASH-RX clinical trial with the FDA, aiming to begin patient enrollment in Q2 2020. The trial intends to assess the efficacy of belapectin for treating NASH cirrhosis. Additionally, a $100 million shelf registration statement has been filed with the SEC to facilitate future financing needs as ongoing costs for the clinical program are estimated at $125 million.
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