Get instant alerts when news breaks on your stocks. Claim your one week free trial for StreetInsider Premium here.
NORCROSS, Ga., Dec. 21 2021 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin protein-targeting therapeutics, today announced that it has closed the second $10 million convertible note under a September 2021 financing agreement with Richard E. Uihlein, president and CEO of the company. largest individual shareholder. In total, the Company received $30 million in three convertible notes from Mr. Uihlein in 2021.
The convertible notes are unsecured and bear interest at the rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if the debt and interest are converted into common shares of the Company, at Mr. Uihlein’s election, on or before maturity, which is four years from the date of each closing of the loan. The debt and interest conversion price is set at 228% above the price per common share on the day before each closing or $5.00 per share, whichever is greater.
Richard E. Uihlein, President of Galectin Therapeutics, said, “As I have said many times, I remain deeply committed to the success of the company and our goal of addressing significant unmet medical needs. I am proud of our progress in 2021 and look forward to achieving further milestones in 2022 and beyond. I have confidence in our team and our science, and look forward to continuing our programs.
“I thank Mr. Uihlein for his outstanding commitment to the Company. As I have said before, the impact of his financial support and leadership as Chairman cannot be overstated,” said Joel Lewis, President and CEO of Galectin Therapeutics. “We plan to continue to make significant progress in our NAVIGATE trial for patients with NASH cirrhosis, and we are also exploring how best to move forward in the treatment of advanced head and neck cancer, where we have seen the promising first results of belapectin in combination with KEYTRUDA. Earlier this month, following our annual meeting of shareholders, I presented our achievements in 2021 and our objectives for 2022, which you can consult on https://investor.galectintherapeutics.com/node/16661/html. We look forward to reporting on our progress in 2022.”
Belapectin is a complex carbohydrate drug that targets galectin-3, a key protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve organ scarring, including fibrotic disorders of the liver, lungs, kidneys, heart, and vascular system. Belepectin binds to galectin-3 and disrupts its function. Preclinical animal data have shown that belepectin has robust therapeutic effects in reversing liver fibrosis and cirrhosis. A Phase 2 study has shown that belepectin can prevent the development of esophageal varices in NASH cirrhosis, and these results form the basis for conducting the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), titled “An international multicenter, double-blind, randomized, placebo-controlled, adaptive transparent study evaluating the efficacy and safety of belepectin (GR-MD-02) for the prevention of esophageal varices in cirrhosis NASH began randomizing patients in August 2020, and is published on www.clinicaltrials.gov (NCT04365868). Galectin-3 plays an important role in cancer and the Company supported a phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided strong justification for moving to a Phase 2 development program that the company is considering.
About fatty liver disease with advanced fibrosis and cirrhosis
Non-alcoholic steatohepatitis (NASH) has become a common liver disease with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the United States. It is characterized by the presence of excess fat in the liver as well as inflammation and hepatocyte damage (swelling) in people who consume little or no alcohol. Over time, patients with NASH may develop excessive fibrosis, or liver scarring, and eventually liver cirrhosis. It is estimated that up to 1 to 2 million people in the United States will develop cirrhosis as a result of NASH, for which liver transplantation is the only available cure. Approximately 8,890 liver transplants are performed each year in the United States. There are no approved drug therapies for the treatment of liver fibrosis or cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing new therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s primary drug, belapectin (formerly known as GR-MD-02), is a carbohydrate drug that inhibits the protein galectin-3 which is directly implicated in multiple inflammatory, fibrotic and malignant diseases, for which it has Fast Track designation by the US Food and Drug Administration. The main development program focuses on non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH-related fibrosis. It is the most common liver disease and one of the greatest drug development opportunities available today. Additional development programs focus on combination immunotherapy treatment for advanced melanoma and other malignancies. The advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. Additional information is available at www.galectintherapeutics.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and use words such as “may”, “estimate”, “could”, “wait” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belepectin will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy. and in other therapeutic indications. Factors that could cause actual performance to differ materially from that discussed in the forward-looking statements include, among others, that the trial endpoints required by the FDA may not be achieved; Galectin may fail to develop effective treatments and/or obtain required approvals for the use of belapectin or any of its other drugs in development; the Company may fail to scale up manufacturing and meet requirements related to chemistry, manufacturing and control issues; the Company’s current clinical trial and any future clinical studies as amended to meet FDA requirements may not produce positive results in a timely manner, if at all, and may require larger and longer trials, which would be time consuming and costly; plans regarding the development, approval and commercialization of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company, as determined by management and regulatory bodies. regulatory; regardless of the results of any of its development programs, Galectin may not succeed in developing partnerships with other companies or in raising additional capital that would allow it to further develop and/or finance studies or trials. Galectin has incurred operating losses since its inception, and its ability to successfully develop and commercialize drugs may be affected by its ability to manage costs and fund continuing operations. Global factors such as the coronavirus may continue to impact NASH patient populations around the world and slow trial recruitment and extend trial duration and significantly impact costs. associates. For a discussion of additional factors affecting Galectin’s business, see the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update any forward-looking statements.
Jack Callicutt, Chief Financial Officer (678) [email protected]
Galectin Therapeutics and its associated logo are registered trademarks of Galectin Therapeutics Inc. Belapectin is the USAN name for Galectin Therapeutics’ Galectin-3 GR-MD-02 inhibitor.
Source: Galectin Therapeutics Inc.