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Galectin Therapeutics Inc. (Nasdaq:GALT), a developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported financial results for the year ended December 31, 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.
For the year ended December 31, 2014, the Company reported a net loss applicable to common stockholders of $17.0 million, or ($0.78) per share, compared with a net loss applicable to common stockholders of $21.9 million, or ($1.30) per share, for 2013. The decrease in net loss applicable to common stockholders is largely due to an $8.8 million or ($0.53) per share one-time, non-cash charge related to the modification of certain warrants recorded in the second quarter of 2013 and an unrelated one-time, non-cash stock compensation charge of $1.0 million or ($0.06) per share recorded in the third quarter of 2013, which were partially offset by increased research and development expenses primarily related to our clinical program.
Research and development expense for the 2014 was $8.4 million, compared with $5.7 million for 2013. The increase primarily relates to increased costs for our Phase 1 clinical trial, which was completed in 2013, and increases in preclinical and drug manufacturing costs, and in planning activities in preparation for our Phase 2 clinical program.
General and administrative expense for 2014 was $7.0 million, compared with $6.4 million for 2013. The primary reasons for the increase were related to increased legal and insurance expense.
As of December 31, 2014, the Company had $29.1 million of non-restricted cash and cash equivalents available to fund future operations. In January and February of 2015, the Company received $4.1 million in net proceeds from the issuance of common shares through its At-the-Market stock issuance program. The Company believes that cash on hand of $29.7 million as of March 13, 2015, is sufficient to fund its operations and research and development activities through September 30, 2016.
