On August 14, 2023 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2023 (Press release, Galectin Therapeutics, AUG 14, 2023, View Source [SID1234634380]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said:
"We are increasingly optimistic as we oversee and manage our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis, which completed randomization of 357 patients in February 2023. To help manage NAVIGATE and prepare for the interim analysis from the phase 2b portion, which is expected in the fourth quarter of 2024, we have added several key staff members over the past few months in the areas of biostatistics, quality assurance and clinical operations. The Company’s results will be the first, and as of now, the only data generated from a late-stage trial focusing on compensated cirrhosis caused by NASH that has progressed to portal hypertension. Currently, this patient population has no curative option, other than a liver transplantation.

Additionally, we are continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination with Keytruda© in patients with advanced head and neck cancers. Our team is fully committed to maximizing the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Compared to pre-cirrhotic NASH stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression of the disease to portal hypertension and, ultimately, liver failure. We are pleased by the continued apparent safety and tolerance profile of belapectin in the NAVIGATE patient population, and we remain encouraged that the NAVIGATE results can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate liver transplantation as a therapeutic option."

Financial Results

For the three months ended June 30, 2023, the Company reported a net loss applicable to common stockholders of $9.2 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $9.7 million, or ($0.16) per share for the three months ended June 30, 2022. The decrease is largely due to a decrease in 2023 research and development expenses related to the timing of certain costs related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended June 30, 2023, were $7.4 million compared with $8.1 million for the three months ended June 30, 2022. The decrease was primarily due to timing of certain costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2023, were $1.6 million, compared to $1.6 million for the three months ended June 30, 2022.

As of June 30, 2023, the Company had $18.0 million of cash and cash equivalents. Additionally, the Company has $30 million remaining available under a $60 million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.

The Company expects that it will require more cash to fund operations after December 31, 2024, and believes it will be able to obtain additional financing as needed. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH when it has progressed to the liver cirrhosis stage as well as advanced cancers. Galectin-3 is produced by activated macrophages, a key inflammatory cell, and plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart, as well as in the cancerous tumor microenvironment. Belapectin binds to galectin-3 and disrupts its function. Belapectin, because of its unique structure, is also captured by activated macrophages and exerts its activity directly at the source of galectin-3 production. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis associated with liver cirrhosis, a disease that is characterized by an invasion of activated macrophages into the liver parenchyma. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis," completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, in making the tumor microenvironment resistant to immunological treatment, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and Keytruda in advanced melanoma and in head and neck cancers. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.