On March 30, 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 year ended December 31, 2022 (Filing, 3 mnth, DEC 31, Galectin Therapeutics, 2023, MAR 30, 2023, View Source [SID1234629586]). These results are included in the Company’s Annual Report on Form 10-K, 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:
"As previously reported, we completed recruitment in late December 2022 and randomization by the end of February 2023 in our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis with a total of 357 patients. We randomized more patients than we had anticipated, potentially adding power to the study. From the beginning of December until the end of February, we randomized more than 5 patients per week, notwithstanding the holiday season. Typically, clinical trials become more efficient as time elapses over the screening window.

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We look forward to managing this trial and obtaining interim analysis results from the Phase 2b portion in the fourth quarter of 2024. The Company’s results will be the first, and as of now, the only late-stage trial in compensated cirrhosis that has advanced to include portal hypertension caused by NASH. This patient population has no current therapeutic option, other than a liver transplantation.

Additionally, we are furthering our efforts by 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 maximize the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Compared to NASH pre-cirrhotic 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 to portal hypertension and, ultimately, liver failure. As recently announced, the third Data Safety Monitoring Board ("DSMB") evaluation of NAVIGATE was positive, and the study can continue as planned. This is a significant milestone for us because with 357 patients randomized we now have a large database of patient exposure to belapectin, and some of these patients have received more than a year and a half of treatment. The safety and tolerance of candidate drugs can be a significant problem for cirrhotic patients who are compromised by their liver disease and may have difficulty metabolizing drugs. We are very encouraged by the developing safety profile of belapectin, and we to continue to be optimistic that the results of NAVIGATE can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate a liver transplantation as a therapeutic option."

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Financial Results

For the year ended December 31, 2022, the Company reported a net loss applicable to common stockholders of $38.9 million, or ($0.65) per share, compared to a net loss applicable to common stockholders of $30.7 million, or ($0.52) per share for the year ended December 31, 2021. The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the year ended December 31, 2022, were $31.7 million compared with $23.8 million for the year ended December 31, 2021. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities, including hiring additional employees. General and administrative expenses for the year ended December 31, 2022, were $6.6 million, compared to $6.4 million for the year ended December 31, 2021. The increase was primarily due to non-cash stock-based compensation expense partially offset by decreases in legal and insurance expenses.

As of December 31, 2022, the Company had $18.6 million of cash and cash equivalents. Additionally, the Company has $50 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 and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. 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 (GR-MD-02) 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, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.