Recent Insider Transactions Derivative • Jul 01
Chief Medical Officer notifies of intention to sell stock Khurram Jamil intends to sell 68k shares in the next 90 days after lodging an Intent To Sell Form on the 26th of June. If the sale is conducted around the recent share price of US$5.00, it would amount to US$341k. As of today, Khurram currently holds no shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$2.9m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jun 23
Galectin Therapeutics Reaches Agreement with Fda on Primary Endpoint and Regulatory Path Forward for Belapectin in Patients with Mash Cirrhosis and Portal Hypertension Galectin Therapeutics Inc. announced positive feedback from its recent in person Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. Galectin Therapeutics has reached agreement with the FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin. The company intends to file the Phase 3 protocol in the third quarter of 2026 and is actively exploring strategic and financial partnership opportunities to support the continued development and commercialization of belapectin. The Phase 3 trial will assess the safety and efficacy of belapectin for the prevention of disease progression in a randomized, double-blind, placebo-controlled design in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. Alignment was reached on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices (>5 mm), a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. The company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study. FDA accepted the company's proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure standardized, objective, and consistent assessment of endoscopic outcomes across study sites. Galectin recently published details of the central review methodology and operational framework developed for NAVIGATE, highlighting the rigor and reproducibility of the process in a large multinational clinical trial. Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The company believes that the planned Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension. Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, the company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial. Consistent with FDA guidance, the company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA's recent communication regarding use of a single, adequate and well-controlled confirmatory trial for marketing approval, the company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis. Galectin Therapeutics is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the third quarter of 2026. 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). 
