8-K: Galectin Therapeutics Announces 2024 Financial Results and Provides Business Update

Galectin Therapeutics reported its 2024 financial results, highlighting progress with its belapectin program and securing additional funding.

Summary

• Galectin Therapeutics reported its financial results for the year ended December 31, 2024.
• The company is developing belapectin, a drug targeting galectin-3 for the treatment of MASH cirrhosis.
• Topline data from the NAVIGATE Phase 2b/3 trial showed a 43.2% reduction in varices incidence at 18 months in patients treated with belapectin 2 mg vs placebo, though it didn't reach statistical significance in the intent-to-treat population.
• In the per-protocol population, the incidence of varices was reduced by 49.3% with belapectin 2 mg vs placebo (p=0.04).
• Among U.S. patients in the per-protocol population, belapectin 2 mg reduced varices incidence by 68.1% (p=0.02).
• 57 subjects completed 36 months of treatment, showing a sustained positive trend for the 2 mg cohort with a lower incidence of varices compared to placebo (13.0% vs 20.0%).
• The company had $15.1 million in cash and cash equivalents as of December 31, 2024, and an additional $11 million available through lines of credit with their chairman.
• Galectin believes it has sufficient cash to fund operations through August 2025.
• Research and development expenses for 2024 were $36.6 million, compared to $32.1 million in 2023.
• The net loss applicable to common stockholders for 2024 was $47.2 million, or ($0.76) per share, compared to $44.5 million, or ($0.74) per share in 2023.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company reported a net loss, there are promising clinical results for belapectin, particularly in the U.S. per-protocol population. The additional funding provides some financial stability, but the limited cash runway remains a concern.

Positives

• Belapectin shows promise in reducing varices incidence in MASH cirrhosis patients, particularly in the U.S.
• The 2 mg dose of belapectin continues to show positive trends in long-term data.
• The company has secured additional funding to extend its cash runway.
• The NAVIGATE trial did not observe any drug related Serious Adverse Events (SAE).

Negatives

• The composite endpoint in the NAVIGATE trial did not reach statistical significance in the intent-to-treat population.
• The company reported a net loss of $47.2 million for 2024.
• The company believes it has sufficient cash to fund currently planned operations and research and development activities only through August 2025.

Risks

• The full analysis of the NAVIGATE trial data may not produce positive data.
• Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin.
• The company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters.
• The company's clinical trials may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly.
• Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital.
• Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations.

Future Outlook

The company anticipates sharing additional biomarker data from the NAVIGATE trial in the second quarter of 2025 and plans to collaborate with potential partners and medical experts to define the next steps in belapectin's development. They believe they have sufficient cash to fund operations through August 2025.

Management Comments

• Joel Lewis, CEO, highlighted the urgent need for new treatments for MASH cirrhosis and portal hypertension.
• Joel Lewis, CEO, noted the 68% reduction in new varices in the NAVIGATE trials per-protocol analysis in U.S. patients.
• Khurram Jamil, CMO, expressed encouragement with the 2 mg belapectin data and its potential as a therapeutic option.
• Khurram Jamil, CMO, believes the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients who currently do not have any treatment options.

Industry Context

Galectin Therapeutics is focused on developing treatments for MASH cirrhosis, a significant and growing medical need. The company's belapectin program targets galectin-3, a protein involved in fibrosis. The company hopes that belapectin MASH program, which has a Fast Track Designation, will ultimately provide the first targeted treatment option for the increasing number of patients affected by MASH-associated liver cirrhosis.

Comparison to Industry Standards

• It's difficult to directly compare Galectin's results to industry standards without knowing the specific endpoints and patient populations of other MASH cirrhosis trials.
• However, companies like Intercept Pharmaceuticals (OCA for PBC) and Madrigal Pharmaceuticals (resmetirom for MASH) are developing treatments for liver diseases, and their clinical trial results and regulatory pathways could provide some context.
• The 68% reduction in varices incidence in the U.S. per-protocol population is a notable result that could differentiate belapectin if confirmed in larger trials.

Related Party Transactions

• Richard Uihlein, the chairman, provided an additional $5 million line of credit.

Stakeholder Impact

• Shareholders: The clinical trial results and financial performance will impact shareholder value.
• Patients: Positive clinical trial results offer hope for a new treatment option for MASH cirrhosis.
• Employees: The company's financial stability and development progress affect job security and opportunities.

Next Steps

• Conducting full analysis of the NAVIGATE trial data.
• Sharing additional biomarker data in the second quarter of 2025.
• Collaborating with potential partners and leading medical experts to define the optimal next steps in belapectin's development.
• Discussing NAVIGATE results with potential partners and the FDA.

Key Dates

Keywords

belapectin, MASH cirrhosis, Galectin Therapeutics, NAVIGATE trial, varices, portal hypertension, financial results, clinical trial, galectin-3