On March 15, 2016 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, reported financial results for the year ended December 31, 2015 (Filing, Annual, Galectin Therapeutics, 2015, MAR 15, 2016, View Source [SID:1234509541]). 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.

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Management Commentary
"Numerous clinical advancements during 2015 with our lead compound GR-MD-02 form the basis for a productive 2016, and we look forward to reporting on a number of important development milestones throughout the year," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Of particular note, during 2015 we began two Phase 2 studies with GR-MD-02 in non-alcoholic steatohepatitis, or NASH, a disease that has been gaining considerable awareness not only among clinicians, but also among the general population. NASH is a significant and growing problem, and treatment will require considerable healthcare resources. Our compound is being investigated in NASH with cirrhosis in our NASH-CX trial, and in NASH with advanced fibrosis in our NASH-FX trial. We expect to report top-line data from our NASH-FX trial by the end of September of this year. Enrollment in our NASH-CX trial is on schedule and we expect to report top-line data by the end of 2017. We are very excited about the potential for GR-MD-02 in the treatment paradigm of a global market estimated to reach $35 billion by the middle of the next decade."

Dr. Traber continued, "In addition to data from the NASH-FX trial, we expect to report data from a 10-patient Phase 2 open-label study with GR-MD-02 in moderate-to-severe plaque psoriasis in September 2016. Also, our partners at the Providence Portland Cancer Center are studying GR-MD-02 in combination with the checkpoint inhibitors Yervoy and Keytruda in two separate Phase 1b studies in advanced metastatic melanoma. We look forward to initial data from select cohorts in both studies later this year, but are dependent on the Providence Portland Cancer Center to conduct and fund these trials. Preclinical work in cancer models with GR-MD-02 added to checkpoint inhibitors showed a boost in anti-tumor immunity, a reduction in tumor size and increased survival, and we are eager to learn if this activity will be duplicated in humans.

"We strengthened our U.S. patent position during 2015 and more recently obtained an extension of coverage for method of use patents of pectin compounds in a number of fibrotic diseases, including pulmonary fibrosis. We are formulating plans to leverage our intellectual property. Also in recent weeks we named lead independent director Marc Rubin, M.D. as chairman of our board of directors. Dr. Rubin is a leading bioscience industry executive with more than 25 years of senior management and board experience in the development and commercialization of pharmaceuticals.

"In January 2016, we announced that the United States District Court for Northern Georgia had dismissed all claims against it and certain officers, directors and shareholder 10X Fund L.P. alleged in a Consolidated Securities Class Action originally filed in July 2014 and all claims against certain officers and directors alleged in a Consolidated Shareholder Derivative Action originally filed in August 2014. The Court entered final judgments of dismissals in both actions, that is, dismissals "with prejudice", based on the Court’s finding that any further amendment of the complaints would be futile. Plaintiffs have filed notice of intent to appeal in both matters. On March 3, 2016, the Nevada State Court dismissed a shareholder derivative complaint filed against the Company’s officers and directors in Nevada and entered a final judgment in favor of the defendants. The plaintiff has 30 days to appeal after the final judgment order. We are pleased that these matters appear very close to final resolution in favor of the Company and our officers and directors.

"In summary, we believe that Galectin is in a solid position from clinical, financial and leadership perspectives. I look forward to continuing consistent outreach to the investment community via frequent CEO Perspective blog postings and conference participation, among other activities to keep our shareholders informed of our plans, accomplishments and milestones," Dr. Traber concluded.

Financial Results
For the year ended December 31, 2015, the Company reported a net loss applicable to common stockholders of $21.1 million, or $0.88 per share, compared with a net loss applicable to common stockholders of $17.0 million, or $0.78 per share, for 2014. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program.

Research and development expense for 2015 was $13.1 million, compared with $8.4 million for 2014. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.

General and administrative expense for 2015 was $7.0 million, compared with $7.0 million for 2014.

As of December 31, 2015, the Company had $25.8 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2017.