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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 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.
Galectin Therapeutics (NASDAQ: GALT) reported financial results for Q2 2024 and provided a business update. Key highlights include:
1. The NAVIGATE Phase 2b/3 trial of belapectin for MASH cirrhosis is on track for interim top-line analysis in December 2024.
2. Presented data at EASL 2024 showing no correlation between collagen content in liver biopsies and portal pressure in MASH cirrhotic patients.
3. As of June 30, 2024, the company had $25.6 million in cash and cash equivalents, with an additional $10 million available under a line of credit.
4. Q2 2024 net loss was $12.4 million ($0.20 per share), compared to $9.2 million ($0.15 per share) in Q2 2023.
5. Research and development expenses increased to $9.8 million in Q2 2024 from $7.4 million in Q2 2023.
Galectin Therapeutics (NASDAQ: GALT) has appointed Dr. Khurram Jamil as Chief Medical Officer, effective immediately. Dr. Jamil, who joined the company in March 2024 as VP of Clinical Development and Medical Director, brings over 20 years of experience in hepatology and drug development. He will lead the management of the NAVIGATE clinical trial for belapectin, a potential treatment for MASH cirrhosis.
The company expects interim top-line data from the Phase 2b portion of the NAVIGATE trial in December 2024. This trial is evaluating belapectin's efficacy in preventing esophageal varices in patients with cirrhosis due to MASH. The study has randomized 357 patients across 14 countries on five continents.
Galectin Therapeutics (NASDAQ:GALT) announced its participation in the European Association for the Study of the Liver (EASL) 2024 Congress, held June 5-8 in Milan, Italy. The company will present data from its belapectin program, highlighting the lack of correlation between collagen content in liver biopsies and portal pressure in MASH cirrhotic patients. Chief Medical Officer Pol Boudes emphasized the importance of using endoscopies to detect esophageal varices caused by increased portal pressure, rather than relying on liver biopsies. The presentation, titled 'Evaluating the correlation between portal pressure, collagen proportional area, and α-smooth muscle actin in patients with portal hypertension due to MASH cirrhosis,' will be available for EASL attendees and later on Galectin's website.
Galectin Therapeutics (NASDAQ: GALT) reported its Q1 2024 financial results and provided a business update. The NAVIGATE Phase 2b/3 trial of belapectin in liver cirrhosis due to MASH continues as planned, with an interim top-line readout expected late Q4 2024 after a positive fifth DSMB meeting.
Q1 financials show $23.6M in cash with an additional $10M available from a new line of credit. R&D expenses decreased to $8.1M from $8.8M YoY, while G&A expenses increased slightly to $1.6M from $1.5M. The net loss remained constant at $11.5M or ($0.19) per share YoY.
Corporate updates include the appointment of Dr. Khurram Jamil as VP of Clinical Development. The company mourns the loss of Dr. Stephen A. Harrison, a key figure in the belapectin program.