Galectin Therapeutics (GALT) Narrows Loss in FY14; Provides Update

Galectin Therapeutics (NASDAQ: GALT) reported financial results for the year ended December 31, 2014. 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.

The company posted FY14 loss of $0.78 per share, from a loss of $1.30 per share reported in the prior year. Cash and equivalents was $29.13 million at the end of 2014.

"I am pleased with our many accomplishments during 2014 as we continue to advance programs with GR-MD-02 for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis. We completed a successful Phase 1 clinical trial and announced final data in January 2015 that were supportive of our plans to begin a Phase 2 program with GR-MD-02 in advanced fatty liver disease, or NASH with fibrosis and cirrhosis," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "As announced last month, we submitted the Phase 2 clinical trial protocol to the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis, the primary endpoint being to determine the change in the hepatic venous pressure gradient (HVPG) as compared with placebo. The FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. We submitted a request for a Special Protocol Assessment with the clinical protocol for this trial. Additionally, we are planning to conduct a separate, shorter Phase 2 trial in NASH patients with advanced fibrosis. We expect to begin enrolling patients in both trials during the second quarter of 2015."

Dr. Traber continued, "We are also supporting independent research with GR-MD-02 in combination with two commercial melanoma drugs, as preclinical research has shown our compound enhances the efficacy of immune checkpoint blockade therapies. Currently GR-MD-02 is in a Phase 1b study in combination with Yervoy®, and a Phase 1b study in combination with Keytruda® is expected to be initiated in the second quarter of 2015. Preclinical work in mouse cancer models with GR-MD-02 added to checkpoint inhibitors shows a boost in anti-tumor immunity, a reduction in tumor size and increased survival.

"We have an exciting year ahead of us, and we look forward to advancing GR-MD-02 through various clinical trials with the goal of providing a new treatment to the nearly 28 million Americans afflicted with NASH, of which up to 6 million have advanced fibrosis," Dr. Traber concluded.

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