We are pleased with the recent addition of
Finally, we are pleased to report that, once again, our Chairman, Mr.
Q4 2023 Belapectin Program Highlights
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis.
NASH Cirrhosis
- The NAVIGATE Phase 2b/3 trial (NCT04365868) evaluating the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis completed randomization of 357 patients in 14 countries on five continents.
- The fourth Data Safety and Monitoring Board (DSMB) meeting authorized the continuation of the trial as designed and without modifications.
- Upcoming milestone remains on track for top-line data readout from NAVIGATE interim analysis in Q4 2024.
- Presented five posters at the Liver Meeting™ 2023 of the
American Association for the Study of Liver Diseases (AASLD) including the safety profile of belapectin and the fact that its pharmacokinetics properties are not affected by the degree of liver impairment.
Corporate Updates
- Appointed
Benjamin S. Carson , Sr., M.D. as a new member of the Board of Directors, following his service as a senior advisor to the Company since 2021.
Full Year 2023 Financial Highlights
- As of December 31, 2023, the Company had $25.7 million of cash and cash equivalents. Additionally, the Company has
$20 million remaining available under a$60 million line of credit provided by its chairman to fund operations and a newly executed$10 million line of credit also provided by our chairman. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2025.
- Research and development expenses for the year ended December 31, 2023 were
$32.1 million compared with$31.7 million for the year endedDecember 31, 2022 . 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, 2023 were
$5.9 million , compared to$6.6 million for the year endedDecember 31, 2022 . The decrease was primarily due to non-cash stock-based compensation expense.
- For the year ended December 31, 2023, the Company reported a net loss applicable to common stockholders of
$44.8 million , or ($0.74 ) per share, compared to a net loss applicable to common stockholders of$38.9 million , or ($0.65 ) per share for the year endedDecember 31, 2022 . The increase is largely due to an increase in noncash interest expense of$1.8 million and a noncash charge related to modification of common stock purchase warrants of$3.6 million .
- 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.
About
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin 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 Fast Track designation by the
Forward Looking Statements
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,” “expect,” “look forward,” “believe,” “hope” 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 MASH, formerly known as NASH, 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 those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing 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 agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended
Company Contact:
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
kgardner@lifesciadvisors.com
ccalabrese@lifesciadvisors.com
Condensed Consolidated Statements of Operations
Year Ended | ||||||
2023 | 2022 | |||||
Operating expenses: | ||||||
Research and development | $ | 32,130 | $ | 31,737 | ||
General and administrative | 5,942 | 6,615 | ||||
Total operating expenses | 38,072 | 38,352 | ||||
Total operating loss | (38,072 | ) | (38,352 | ) | ||
Other income (expense): | ||||||
Interest income | 230 | 52 | ||||
Interest expense | (2,792 | ) | (1,033 | ) | ||
Change in fair value of derivatives | (432 | ) | 557 | |||
Total other income | (2,994 | ) | (424 | ) | ||
Net loss | $ | (41,066 | ) | $ | (38,776 | ) |
Preferred stock dividends | (120 | ) | (97 | ) | ||
Warrant modification | (3,619 | ) | ||||
Net loss applicable to common stock | $ | (44,805 | ) | $ | (38,873 | ) |
Basic and diluted net loss per share | $ | (0.74 | ) | $ | (0.65 | ) |
Shares used in computing basic and diluted net loss per share | 60,159 | 59,391 |
Condensed Consolidated Balance Sheet Data
(in thousands) | ||||||
Cash and cash equivalents | $ | 25,660 | $ | 18,592 | ||
Total assets | 28,200 | 21,285 | ||||
Total current liabilities | 15,676 | 13,012 | ||||
Total liabilities | 88,441 | 53,479 | ||||
Total redeemable, convertible preferred stock | 1,723 | 1,723 | ||||
Total stockholders’ equity (deficit) | $ | (61,964 | ) | $ | (33,917 | ) |
Source:
2024 GlobeNewswire, Inc., source