NORCROSS, Georgia, September 21, 2021 (GLOBE NEWSWIRE) – Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics targeting galectin proteins, today announced that it has entered into a $ 20 million convertible debt financing agreement with Richard E. Uihlein, chairman of the board and individual shareholder on most important of society. This $ 20 million convertible debt is in addition to a $ 10 million convertible debt financing from Mr. Uihlein concluded in April 2021.
The loan agreement includes two separate $ 10 million convertible notes, the first of which was closed and financed on September 17, 2021 and the second to be closed on or before December 17, 2021. The convertible notes are unsecured and bear interest at a rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if debt and interest are converted into common stock of the Company, at Mr. Uihlein’s option, on or before maturity, which is four years from the date of each loan closing. The debt and interest conversion price is set at 228% above the price per share of the common shares the day before each closing or $ 5.00 per share, whichever is greater.
Richard E. Uihlein, President of Galectin Therapeutics, commented on his $ 20 million investment: “I remain deeply committed to the success of the company and our goal of meeting significant and unmet medical needs. We are the only company to treat NASH cirrhosis using a clinically relevant endpoint to measure efficacy. In addition, the results of a phase 1 trial using belapectin in combination with KEYTRUDA®, a checkpoint inhibitor, were very encouraging, particularly in patients with metastatic melanoma. This funding demonstrates my confidence in our team and our science, and I look forward to moving our programs forward.
“I would like to thank Mr. Uihlein for his unwavering commitment to the Company. The impact of his financial support and leadership as Chairman of the Board cannot be overstated, ”said Joel Lewis, President and CEO of Galectin Therapeutics. “We continue to make progress in our NAVIGATE trial for patients with NASH cirrhosis and we are also exploring how best to move forward in the treatment of metastatic melanoma, where we have seen promising first results from belapectin in combination with KEYTRUDA in the treatment of melanoma. This funding, along with the recent addition of several accomplished and experienced professionals to our leadership team, provides resources that will help us pursue our goals.
Belapectin is a complex carbohydrate drug that targets galectin-3, a protein essential 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, lungs, kidneys, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust therapeutic effects in reversing hepatic fibrosis and cirrhosis. A phase 2 study has shown that belapectin 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), entitled “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 patient randomization in August 2020 and is posted at www.clinicaltrials.gov (NCT04365868). Galectin-3 plays an important role in cancer, and the Company has supported a phase 1b study of the combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and head and neck cancer. This trial provided a strong rationale for moving forward with a Phase 2 development program that the company is considering.
About fatty liver with advanced fibrosis and cirrhosis
Non-alcoholic steatohepatitis (NASH) has become a common liver disease with increasing 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 damage to hepatocytes (bloating) in people who consume little or no alcohol. Over time, patients with NASH may develop excessive fibrosis, or scarring of the liver, and eventually cirrhosis of the liver. It is estimated that 1 to 2 million people in the United States will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. In the United States, approximately 8,890 liver transplants are performed each year. There is no approved drug therapy 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. The flagship drug of galectin, belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic and malignant diseases, for which it has the Fast Track designation by the United States Food and Drug Administration. The main development program is non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of fibrosis associated with NASH. It is the most common liver disease and one of the greatest drug development opportunities available today. Further development programs relate to the treatment of combination immunotherapy for advanced melanoma and other malignant tumors. The advancement of these additional clinical programs largely depends on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve profitable and efficient development. Further 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 belapectin will lead to the first therapy for the treatment of fatty liver with cirrhosis and those regarding the hope that our lead compounds will be successful in immunotherapy. anticancer 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, the fact that the evaluation criteria required by the FDA may not be met; Galectin may not be successful in developing effective treatments and / or obtaining the required approvals for the use of belapectin or one of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemical, manufacturing and control issues; the Company’s current clinical trial and any future clinical studies as amended to meet FDA requirements may not yield positive results in a timely manner, if at all, and may require larger and longer trials, which would take time and be expensive; plans regarding the development, approval and commercialization of any Galectin drug are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of one of its development programs, Galectin may not be successful in developing partnerships with other companies or in raising additional capital that would allow it to further develop and / or finance studies or projects. testing. Galectin has suffered operating losses since its inception, and its ability to successfully develop and market drugs may be affected by its ability to manage costs and finance continuing operations. Global factors such as the coronavirus may continue to impact NASH patient populations worldwide and slow trial recruitment and extend trial duration and significantly impact associated costs. For a discussion of additional factors impacting Galectin’s business, see the company’s annual report on Form 10-K for the year ended December 31, 2020, and subsequent SEC filings. You should not place undue reliance on forward-looking statements. Although subsequent events may change its opinions, management disclaims any obligation to update any forward-looking statements.
Company details :
Jack Callicutt, Chief Financial Officer
Galectin Therapeutics and its associated logo are a registered trademark of Galectin Therapeutics Inc. Belapectin is the name assigned by USAN to the galectin-3 inhibitor GR-MD-02 from Galectin Therapeutics.