On March 31, 2022 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, 2021 (Press release, Galectin Therapeutics, MAR 31, 2022, View Source [SID1234611240]). 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, "Reiterating my comments from our shareholders meeting in December, I am proud of our team and their accomplishments during 2021. It was a challenging year for many companies, particularly in biotech and drug development. Our experienced new team coalesced in identifying and addressing pertinent issues with a prescience that was indicative of their accumulated experience and extensive backgrounds. While we are always cognizant of the ultimate goal of registering a new drug, our primary focus throughout 2021 and now continues to be the enrollment of our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis. Many clinical trials in the past two years have experienced difficulties in enrollment, and we have been no exception. For several reasons, the pandemic makes enrolling patients for the NAVIGATE trial more challenging than most trials. Patients eligible for the NAVIGATE trial have liver cirrhosis and, as such, are at a greater health risk of complications from COVID-19. Additionally, our patient population tends to display other comorbidities, including diabetes and obesity. It is also important to consider the safety of our candidate participants first, as cirrhotic patients with portal hypertension are immunocompromised. We believe that as we continue to emerge from the COVID-19 pandemic, site recruitment and patient enrollment will accelerate and we have experienced increases in enrollment, particularly in the U.S and Mexico. However, we have not seen the enrollment in Europe that we anticipated, and conditions there remain uncertain. Consequently, we have activated multiple sites in Latin America and believe this will overcome our challenges in Europe. This decision was made in advance of current conditions. At this time, while we continue to target enrollment completion for June 30, 2022, ultimately it may require an additional quarter to complete."
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Mr. Lewis continued, "Late in 2021, we engaged three noted physicians – Dr. Chetan Bettegowda, from Johns Hopkins, and Dr. Nishant Agrawal and Dr. Ari Rosenberg, both from University of Chicago Medical Center – as consultants to help define the path forward in oncology. In consultation with our oncology experts, we have now selected the treatment of recurrent or metastatic head and neck cancer as the lead indication to pursue for belapectin in combination with Keytruda, an immune checkpoint inhibitor. The decision is notably based on the lack of available treatments for these patients, the low response rates of monotherapy, the limited number of therapies in development, and the resulting very high medical need. We are currently working to compile an Investigational New Drug (IND) package, including the development of a phase 2 trial protocol, with the objective for the Company to file an IND with the FDA oncology division."
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Dr. Pol Boudes, Chief Medical Officer stated, "I continue to be confident that the NAVIGATE trial will be fully enrolled despite the challenges we have seen related to the COVID-19 pandemic. Additionally, I am pleased to report we recently completed enrollment in a Hepatic Impairment Study, a very important study to include in our New Drug Application (NDA) dossier. The Hepatic Impairment Study was being conducted at four sites and involved 38 subjects (divided amongst normal healthy volunteers, and patients with mild, moderate, and severe hepatic impairment). Each subject received a single infusion of belapectin (4 mg/kg LBM) and their serum belapectin levels were monitored for up to approximately two weeks to define the effects of various stages of cirrhosis on belapectin pharmacokinetics. The tolerance and safety of belapectin are also being evaluated."
Financial Results
For the year ended December 31, 2021, the Company reported a net loss applicable to common stockholders of $30.7 million, or ($0.52) per share, compared to a net loss applicable to common stockholders of $23.6 million, or ($0.41) per share for the year ended December 31, 2020. The increase is largely due to an increase in 2021 research and development expenses related to the Company’s NAVIGATE trial.
Research and development expenses for the year ended December 31, 2021, was $23.8 million compared with $18.0 million for the year ended December 31, 2020. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the year ended December 31, 2021, were $6.4 million, compared to $5.5 million for the year ended December 31, 2020. The increase was primarily due to non-cash stock-based compensation expense and insurance expense.
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As of December 31, 2021, the Company had $39.6 million of cash and cash equivalents. On December 20, 2021, the Company received $10 million in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company received a total of $30 million in unsecured promissory notes from Mr. Uihlein in 2021. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least March 31, 2023.
The Company expects that it will require more cash to fund operations after March 31, 2023, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $45-$50 million to cover costs of the NAVIGATE trial to reach the planned interim analysis estimated to occur around the end of the first quarter of 2024, along with drug manufacturing and other research and development activities and general and administrative costs. 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.
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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," began enrolling patients in June 2020, 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) 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.