New Risk • May 17
New major risk - Revenue and earnings growth Earnings have declined by 7.2% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Negative equity (-US$126m). Earnings have declined by 7.2% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable next year (US$24m net loss next year). Announcement • May 12
Galectin Therapeutics Inc Announces Publication of Navigate Phase 2B Trial Results for Belapectin Galectin Therapeutics Inc. announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. The manuscript, titled “Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in Patients with MASH Cirrhosis: The Randomized, Placebo-Controlled NAVIGATE Trial,” is now available online and available as an open-access publication. The NAVIGATE trial evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. Results demonstrated that belapectin 2 mg/kg was associated with a numerical reduction in the development of new varices compared to placebo in the full analysis set, with a statistically significant reduction observed in the per-protocol population. Key markers of fibrosis including Liver Stiffness Measure results were aligned with the clinical finding belapectin was generally safe and well tolerated. The manuscript highlights: Numerical reduction in incidence of new esophageal varices with belapectin 2 mg/kg compared to placebo; Statistically significant reduction in the per-protocol population; Supportive changes in non-invasive markers of portal hypertension and fibrosis including LSM and ELF; Favorable safety and tolerability profile. Belapectin targets galectin-3, a key mediator of fibrosis and inflammation, and is being developed as a potential therapy to address complications of MASH cirrhosis. The full manuscript is available online and can be accessed freely given its open-access status. NAVIGATE was a global, randomized, placebo-controlled Phase 2b trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension without esophageal varices at baseline. The study assessed the development of varices and other clinically relevant outcomes over an 18-month treatment period. New Risk • Apr 01
New major risk - Revenue and earnings growth Earnings have declined by 11% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$31m free cash flow). Negative equity (-US$124m). Earnings have declined by 11% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$23m net loss in 2 years). 
