Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30, 2020, and Provides Business Update

NORCROSS, Ga., Aug. 10, 2020 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the quarter ended June 30, 2020. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, “We are excited to have initiated the NASH-RX trial, having enrolled our first patient in June and continuing to enroll patients at several of our sites in our clinical trial of belapectin targeting cirrhotic NASH patients. If the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a pharmaceutical company. Later this quarter, we plan to host a conference call with the Investment Community for a more thorough discussion of the NASH-RX trial, its current status, our updated strategy, and to take questions.”Richard E. Uihlein, Chairman of the Board, added, “The protocol of the NASH-RX trial has been designed to provide belapectin with the best chance to demonstrate efficacy and safety, and I am very pleased this trial is now underway. Belapectin is targeting NASH cirrhosis patients, those who can no longer expect to benefit from increased exercise or an improved diet as may benefit many of those with earlier stages of NASH. And, belapectin (formerly known as GR-MD-02) is the first drug that has been shown to prevent the development of esophageal varices in patients with compensated NASH cirrhosis. If confirmed, these results would constitute a significant benefit for patients. Consequently, we believe our drug targets NASH at a very critical point of its development, as it represents an opportunity to prevent the progression of liver damage, and thereby save lives.”The NASH-RX trial will use an adaptive design to confirm dose selection and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component. In June 2020, we enrolled our first patients in the NASH-RX trial. NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.Galectin plans to host a conference call with the investment community in the third quarter to provide a more comprehensive description and update on the status of the trial and to take questions. The date and time of the call and how to participate will be published in advance of the planned call.Financial ResultsFor the three months ended June 30, 2020, the Company reported a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share, compared to a net loss applicable to common stockholders of $3.1 million, or ($0.06) per share for the three months ended June 30, 2019. The increase is due to 2020 research and development expense related to the Company’s NASH-RX trial.About Belapectin (GR-MD-02)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” 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 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 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 currently planned clinical trial and any future clinical studies as modified to meet the requirements of the FDA 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. Global factors such as coronavirus may limit access to NASH patient populations around the globe and slow trial enrollment and prolong the duration of the trial 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, 2019, 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 forward-looking statements.Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.comGalectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor GR-MD-02
Condensed Consolidated Statements of Operations
Condensed Consolidated Balance Sheet Data