Galectin Therapeutics Inc Stock Price, News & Analysis

Galectin Therapeutics (NASDAQ: GALT) has reported its 2024 financial results and provided updates on its belapectin program for MASH cirrhosis treatment. The NAVIGATE trial's per-protocol analysis showed promising results, with a 68% reduction in new varices incidence in U.S. patients and a 49% reduction in the overall per-protocol population at 2mg dose.

The company reported a net loss of $47.2 million ($0.76 per share) for 2024, compared to $44.5 million in 2023. R&D expenses increased to $36.6 million from $32.1 million in 2023. The company has $15.1 million in cash, plus access to $11 million in credit lines, providing runway through August 2025.

Additional biomarker data is expected in Q2 2025, as the company prepares for discussions with potential partners and the FDA regarding belapectin's development path forward.

Galectin Therapeutics (NASDAQ: GALT) has reported additional results from its NAVIGATE trial for belapectin in patients with MASH cirrhosis and portal hypertension. The analysis revealed a statistically significant 68.1% reduction (p=0.02) in new varices incidence with belapectin versus placebo in U.S. per-protocol patients.

While the trial's initial composite endpoint didn't reach statistical significance in the intent-to-treat population (N=355), the completer population of 287 patients showed a 49.3% reduction in varices incidence (p=0.04). The U.S. subset analysis (n=186) demonstrated stronger results, with only 4 out of 60 belapectin-treated patients developing varices compared to 13 out of 62 in the placebo group.

With an estimated 3 million U.S. adults affected by MASH cirrhosis and clinically significant portal hypertension, for which no FDA-approved therapies exist, the company continues analyzing data, including results from approximately 50 patients who completed 36-months of therapy. Additional data is expected by Q1 2025.

Galectin Therapeutics (NASDAQ: GALT) has announced that the top-line results of their NAVIGATE trial, focusing on patients with MASH cirrhosis and portal hypertension, will be presented at the 2025 MASH-TAG Conference in Park City, Utah, from January 9-11, 2025.

The presentation, titled "Belapectin administered at 2mg/kg/LBW for 18 months reduced the incidence of varices development in patients with MASH cirrhosis and portal hypertension: Top line results from the NAVIGATE trial," will be delivered by Dr. Naim Alkhouri, Chief Medical Officer of Arizona Liver Health, on January 10, 2025, at 11:25 AM MST.

Additionally, the company's executive leadership will host one-on-one meetings in San Francisco during the JP Morgan Healthcare Conference from January 13-16, 2025, to discuss NAVIGATE topline results and future steps for the belapectin program with external stakeholders.

Galectin Therapeutics (NASDAQ: GALT) announced results from its NAVIGATE clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension. In the per-protocol population, the 2mg/kg dose showed a statistically significant 48.9% reduction in esophageal varices development compared to placebo (p<0.05). However, in the intent-to-treat population, while showing a 43.2% reduction, the primary endpoint did not achieve statistical significance.

The global trial involved 355 patients across 130 sites in 15 countries, randomized to receive either 2mg/kg belapectin, 4mg/kg belapectin, or placebo. The drug demonstrated a favorable safety profile with no significant adverse events. Additional data from patients completing 36-month therapy will be presented in early 2025.

Galectin Therapeutics (NASDAQ: GALT) presented three posters at AASLD 2024 Liver Meeting regarding their ongoing NAVIGATE trial for belapectin in MASH cirrhosis patients with portal hypertension. Key findings include: approximately one-third of screened patients had esophageal varices, demonstrating the importance of screening. The company established an effective centralized evaluation system for assessing esophageal and gastric varices in clinical research. The NAVIGATE trial readout remains on schedule for December 2024.

Galectin Therapeutics (NASDAQ: GALT) reported Q3 2024 financial results and provided updates on its NAVIGATE trial for belapectin in MASH cirrhosis patients. The company expects to present top-line results in December 2024. As of September 30, 2024, cash and cash equivalents stood at $27.1 million, with an additional $6 million available through a credit line. Q3 net loss was $11.2 million ($0.18 per share), compared to $14.0 million ($0.24 per share) in Q3 2023. R&D expenses were $7.6 million, slightly down from $7.7 million in the previous year. The company estimates sufficient funding through May 2025.

Galectin Therapeutics (NASDAQ: GALT) announced the acceptance of three abstracts from its ongoing Phase 2b/3 NAVIGATE trial for presentation at the American Association for the Study of Liver Diseases (AASLD) 2024 Liver Meeting. The trial focuses on patients with MASH cirrhosis and portal hypertension. The posters will be presented on November 18, 2024, during the 'Portal Hypertension and Other Complications of Cirrhosis' session.

The accepted abstracts cover:

• Evaluation of esophageal and gastric varices in cirrhotic patients
• Baseline patient characteristics from the NAVIGATE trial
• Identification of esophageal varices in patients with compensated MASH cirrhosis

The abstracts will be available on the AASLD website and in the October supplement of the AASLD journal, Hepatology.

Galectin Therapeutics (NASDAQ: GALT), a leader in developing galectin protein-targeting therapeutics, has announced its participation in the upcoming H.C. Wainwright MASH Investor Conference on October 7, 2024. Joel Lewis, CEO, and Dr. Khurram Jamil, CMO, will be attending the event.

Dr. Jamil is scheduled to present at 10:00 AM ET on October 7, 2024, providing the latest updates on the company's clinical programs and pipeline advancements. Interested parties can access the presentation webcast through a provided link or via the Events & Presentation page in the investors section of the Galectin Therapeutics website.

This conference participation underscores Galectin Therapeutics' commitment to keeping investors informed about their progress in developing innovative therapeutics targeting galectin proteins.

Galectin Therapeutics (NASDAQ: GALT), a leader in galectin protein-targeted therapeutics, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024 in New York, NY.

Key highlights:

• Joel Lewis, CEO, and Dr. Khurram Jamil, CMO, will attend the conference
• Dr. Jamil will deliver a company presentation on September 9, 2024, at 12:00 PM ET
• The presentation will be accessible via webcast on the company's website
• Galectin's management team will be available for one-on-one meetings with interested investors

This conference provides Galectin Therapeutics an opportunity to showcase its progress and engage with potential investors in the biotechnology sector.