Galectin Therapeutics(GALT) - 2022 Q1 - Quarterly Report

Product Development - Galectin Therapeutics is focused on developing therapies for fibrotic diseases, cancer, and other conditions, utilizing proprietary complex carbohydrates targeting galectin proteins[54] - The lead product candidate, belapectin, has shown potential in reversing liver fibrosis and cirrhosis, with completed Phase 1 and Phase 2 clinical studies demonstrating its efficacy[55] - A global Phase 2b/3 clinical trial, NAVIGATE, is currently underway to evaluate belapectin for preventing esophageal varices in NASH cirrhosis patients, with patient enrollment starting in Q2 2020[56] - The company has established a joint venture, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding treatment options beyond belapectin[58] - A Phase 2 trial is planned for advanced or metastatic head and neck cancer using belapectin in combination with a PD-1 inhibitor, following previous successful collaborations[59] Clinical Trials - The NASH-FX trial, a Phase 2a pilot study, involved 30 patients and did not meet its primary endpoint but indicated that belapectin was safe and well tolerated[67] - Belapectin has been shown to reduce liver fat, inflammation, and portal pressure in preclinical models, supporting its development for NASH cirrhosis[63] - The NASH-CX trial involved 162 patients with well-compensated NASH cirrhosis and portal hypertension, randomized to receive either belapectin or placebo[68] - In the total patient population, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose of belapectin, compared to a 0.3 mm Hg change in placebo[69] - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01)[70] - The belapectin 2 mg/kg LBM group had a 0% incidence of new varices, compared to 18% in the placebo group, indicating a significant reduction in the development of esophageal varices[72] - Belapectin demonstrated a statistically significant improvement in hepatocyte ballooning and a reduction in new esophageal varices development (p=0.02) compared to placebo[73] - The NAVIGATE trial is designed to evaluate belapectin's efficacy in preventing esophageal varices in NASH cirrhosis patients, with a primary endpoint focused on the incidence of new varices[76] - The NAVIGATE trial will compare two belapectin doses (2 mg/kg LBM and 4 mg/kg LBM) against placebo, with an interim analysis planned to select the optimal dose[76] - Approximately 140 clinical trial sites have been activated across 15 countries for the NAVIGATE trial[84] - The Company has commenced a Hepatic Impairment Study involving 40 patients to evaluate the effects of cirrhosis on serum belapectin levels[85] - Promising results from a Phase 1b trial combining belapectin with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients[88] Financial Performance - The company has incurred significant operating losses since inception and relies on external capital for continued development[54] - Research and development expenses increased to $8,058,000 for the three months ended March 31, 2022, compared to$4,899,000 in the same period of 2021, representing a 64% increase[92] - Clinical activities accounted for $6,869,000 of the research and development expenses, up from$4,283,000, indicating a significant rise in clinical trial costs[92] - The company had $31.6 million in unrestricted cash and cash equivalents as of March 31, 2022, to fund future operations[96] - Net cash used in operations rose by$1,660,000 to $8,042,000 for the three months ended March 31, 2022, compared to$6,382,000 in the same period of 2021[97] - The company anticipates requiring an additional $40-$45 million to cover costs related to the NAVIGATE Phase 2b/3 clinical trial, expected to reach interim analysis in mid-2024[96] - General and administrative expenses decreased to $1,418,000 for the three months ended March 31, 2022, from$1,877,000 in the same period of 2021, a reduction of 32%[95] - The increase in general and administrative expenses was primarily due to a rise in non-cash stock-based compensation expenses of approximately $446,000[95] - The company has raised a net total of$234.5 million from public and private offerings since its inception[96] - The company has operated at a loss since inception and anticipates that losses will continue for the foreseeable future[96] - The company does not have any off-balance sheet arrangements that could materially affect its liquidity or capital resources[98] Regulatory Environment - The FDA has provided guidance on the NAVIGATE trial, which is designed to confirm previous Phase 2 data and evaluate the risk/benefit of belapectin[56] - Galectin Therapeutics is subject to extensive regulation by the FDA and other authorities, which could impact the commercialization of its product candidates[54]