Galectin Therapeutics(GALT) - 2025 Q1 - Quarterly Results

Executive Summary and Business Update Galectin Therapeutics reported Q1 2025 financial results and a business update, highlighting positive clinical findings for belapectin from the NAVIGATE trial Report Overview Galectin Therapeutics reported its financial results and provided a business update for the three months ended March 31, 2025, focusing on the advancement of its lead therapeutic, belapectin - Galectin Therapeutics (NASDAQ: GALT) reported Q1 2025 financial results and a business update[1] - The company is a leading developer of therapeutics targeting galectin proteins[1] CEO and CMO Commentary CEO Joel Lewis and CMO Khurram Jamil highlighted positive feedback and significant clinical findings for belapectin from the NAVIGATE trial, presented at EASL. Key results include a clinically significant response in liver stiffness (Fibroscan®) and a reduction in new varices, particularly medium and large ones, reinforcing belapectin's potential as a treatment for MASH-associated liver cirrhosis and portal hypertension - CEO Joel Lewis emphasized continued focus on advancing belapectin analyses and positive feedback from EASL[2] - CMO Khurram Jamil noted that approximately double the number of patients on placebo showed worsening liver stiffness compared to belapectin[4] - The 2 mg/kg dose of belapectin led to a significantly lower incidence of new varices compared to placebo, primarily driven by a reduction in medium and large varices[2][4] - Belapectin has Fast Track Designation, supporting its potential as the first targeted treatment for MASH cirrhosis and portal hypertension[5] Belapectin Program Details This section details belapectin's mechanism of action, the design of the NAVIGATE Phase 2b/3 trial, and comprehensive clinical results demonstrating its efficacy Drug Mechanism and Development Status Belapectin is a carbohydrate-based drug designed to inhibit galectin-3, a protein central to the pathogenesis of MASH and fibrosis. It holds Fast Track designation from the FDA for MASH with cirrhosis - Belapectin is a complex carbohydrate drug targeting galectin-3, a protein critical in MASH and fibrosis pathogenesis[6] - Belapectin has Fast Track designation by the U.S. Food and Drug Administration for MASH with cirrhosis[15] NAVIGATE Phase 2b/3 Trial Design The NAVIGATE trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled Phase 2b/3 study. It evaluates the efficacy and safety of intravenous belapectin (2 mg/kg or 4 mg/kg LBM) administered every other week for 18 months to prevent esophageal varices in MASH cirrhosis patients - NAVIGATE is a global, randomized, double-blind, placebo-controlled Phase 2b/3 trial[7] - The trial evaluates belapectin (2 mg/kg or 4 mg/kg LBM) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis[7] Detailed Clinical Results Detailed analysis of the NAVIGATE trial, including biomarker data presented at EASL, showed statistically significant reductions in liver stiffness (LSM) from baseline in the belapectin 2 mg/kg arm at Weeks 26, 52, and 78. The 2 mg/kg group also demonstrated significantly fewer patients experiencing worsening liver stiffness compared to placebo, with a notable reduction in the incidence of new varices - Statistically significant reductions in liver stiffness from baseline were observed in the belapectin 2 mg/kg treatment arm at Week 26, Week 52, and Week 78[7] - Belapectin 2 mg/kg treatment may lead to regression of liver stiffness in high-risk MASH populations, while placebo-treated patients showed no improvement[8] - Significantly fewer patients (51% fewer) in the belapectin 2 mg/kg group experienced >30% worsening in liver stiffness compared to placebo (p=0.03)[10] Liver Stiffness Worsening (NAVIGATE Trial) | | placebo | 2 mg/kg belapectin | 4mg/kg belapectin | |---|---|---|---| | N= | 88 | 94 | 87 | | >10 increase in kPa from baseline | 11 (12.5%) | 4 (4.3%) | 9 (10.3%) | | >30% increase from baseline | 21 (23.9%) | 11 (11.7%) | 13 (14.9%) | | >10 kPa + 30% increase from baseline | 10 (11.4%) | 4 (4.3%) | 9 (10.3%) | LSM Mean Change from Baseline (Belapectin 2 mg/kg) | Time Point | LSM Mean Change from Baseline | p-value | |---|---|---| | Week 26 | -3.48 | 0.005 | | Week 52 | -4.60 | < 0.0001 | | Week 78 | -2.72 | 0.0197 | Financial Performance This section provides an overview of Galectin Therapeutics' Q1 2025 financial results, including a reduced net loss, detailed statements of operations, and key balance sheet data Q1 2025 Financial Summary Galectin Therapeutics reported a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share, for Q1 2025, an improvement from $11.5 million, or ($0.19) per share, in Q1 2024. The company had $7.4 million in cash and equivalents and access to an additional $11 million in credit, sufficient to fund operations through August 2025. Research and development expenses decreased due to the timing of NAVIGATE trial expenditures Q1 2025 Financial Highlights (in millions) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | |---|---|---|---| | Cash and Cash Equivalents | $7.4 | N/A | N/A | | R&D Expenses | $6.5 | $8.1 | -$1.6 (Decrease) | | G&A Expenses | $1.4 | $1.6 | -$0.2 (Decrease) | | Net Loss Applicable to Common Stockholders | $9.6 | $11.5 | -$1.9 (Improvement) | | Basic and Diluted Net Loss Per Share | ($0.15) | ($0.19) | $0.04 (Improvement) | - The company believes it has sufficient cash to fund planned operations and R&D activities through August 2025, supplemented by $11 million available under lines of credit[11] - The decrease in R&D expenses was primarily due to the timing of expenditures related to the NAVIGATE clinical trial[11] Condensed Consolidated Statements of Operations The condensed consolidated statements of operations show a reduced net loss for Q1 2025 compared to Q1 2024, driven by lower operating expenses and a decrease in interest expense and change in fair value of derivatives Condensed Consolidated Statements of Operations (Three Months Ended March 31, in thousands) | Metric (in thousands) | 2025 | 2024 | |---|---|---| | Research and development | $6,485 | $8,054 | | General and administrative | $1,412 | $1,594 | | Total operating expenses | $7,897 | $9,648 | | Total operating loss | ($7,897) | ($9,648) | | Interest income | $35 | $80 | | Interest expense | ($1,744) | ($869) | | Change in fair value of derivatives | ($25) | ($1,052) | | Total other income (expense) | ($1,734) | ($1,841) | | Net loss | ($9,631) | ($11,489) | | Preferred stock dividends | $26 | ($8) | | Net loss applicable to common stock | ($9,605) | ($11,497) | | Basic and diluted net loss per share | ($0.15) | ($0.19) | | Shares used in computing basic and diluted net loss per share | 63,204 | 61,976 | Condensed Consolidated Balance Sheet Data As of March 31, 2025, the company's cash and cash equivalents decreased significantly from December 31, 2024. Total assets also declined, while total current liabilities saw a substantial increase Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2025 | December 31, 2024 | |---|---|---| | Cash and cash equivalents | $7,431 | $15,120 | | Total assets | $9,528 | $17,495 | | Total current liabilities | $110,840 | $35,409 | | Total liabilities | $121,789 | $120,565 | | Total redeemable, convertible preferred stock | $1,723 | $1,723 | | Total stockholders' equity (deficit) | ($113,984) | ($104,793) | Corporate Information This section provides an overview of Galectin Therapeutics, outlines the nature of forward-looking statements, and lists key company contacts About Galectin Therapeutics Galectin Therapeutics is dedicated to developing novel therapies for chronic liver disease and cancer, with belapectin as its lead drug targeting galectin-3 for MASH cirrhosis. The company seeks partnerships for its additional clinical programs in cancer immunotherapy - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer[15] - Belapectin, the lead drug, inhibits the galectin-3 protein involved in inflammatory, fibrotic, and malignant diseases[15] - Additional development programs in cancer immunotherapy are largely dependent on finding suitable partners[15] Forward-Looking Statements The report contains forward-looking statements regarding future events and financial performance, which are subject to risks and uncertainties. These include the potential for belapectin to become the first MASH cirrhosis therapy, success in cancer immunotherapy, and the ability to secure partnerships or additional capital. Actual results may differ materially due to various factors, and management disclaims any obligation to update these statements - Statements regarding future events and financial performance are forward-looking and subject to risks and uncertainties[17] - Factors that could cause actual performance to differ include trial data not being positive, failure to obtain approvals, manufacturing challenges, and inability to secure partnerships or capital[17] Company Contacts Contact information for the company's Chief Financial Officer and Investor Relations is provided for inquiries - Company contact: Jack Callicutt, Chief Financial Officer (678) 620-3186, ir@galectintherapeutics.com[18] - Investor Relations contact: Kevin Gardner, kgardner@lifesciadvisors.com[18]