On November 8, 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 three and nine months ended September 30, 2016 (Filing, Q3, Galectin Therapeutics, 2016, NOV 8, 2016, View Source [SID1234516417]). These results are included in the Company’s Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Summary of Key Development Programs, Updates and Anticipated Milestones
• At The Liver Meeting in Boston, Massachusetts on November 11-15, 2016, Dr. Peter Traber, president, chief executive officer and chief medical officer of Galectin Therapeutics and co-investigator of these studies, will present two posters that demonstrate the use of alternative non-invasive tests on the progression of cirrhosis and fibrosis in patients with nonalcoholic steatohepatitis (NASH), highlighting the potential utility of non-invasive imaging methods in the development of novel therapies in this patient population and adding momentum in this area of medicine.
• In the recently completed NASH-FX study, GR-MD-02 was found to be safe and well tolerated among the patient population with no serious adverse events.
• In August, the Company reported on a study that demonstrated clinically meaningful results in a human disease with GR-MD-02, where four patients who received 24 weeks of therapy experienced an average of 48% improvement in their plaque psoriasis. In October, a fifth patient reached 72% improvement at his 13th infusion visit with one more assessment to be completed by the end of November. Dr. Stephen Harrison, the co-chief investigator in our NASH-CX trial, stated that he was especially encouraged that GR-MD-02 has demonstrated an improved clinical effect in moderate-to-severe psoriasis, suggesting the compound has activity in a human disease that can occur in association with NASH.
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• The full report of our Phase 1 study in NASH patients with advanced fibrosis, which demonstrated GR-MD-02 was safe and defined dosing for Phase 2 trials, was published on October 25, 2015 in the peer-reviewed scientific journal, Alimentary Pharmacology and Therapeutics (http://bit.ly/2f3Znq3).
• In support for continued funding of the NASH-CX trial, a private placement financing for $1.5 million was secured from a single source.
• Dr. William L. Redmond, Ph.D., of Earle A. Chiles Research Institute of Providence Portland Medical Center will present pre-clinical and clinical data regarding use of GR-MD-02 in combination with immunotherapy, specifically with Yervoy and Ketruda, at the GTCbio 9th Immunotherapeutics & Immunomonitoring Conference, to be held on February 6-7, 2017 in San Diego, CA.
Management Commentary
"As noted by our co-lead investigators, Dr. Stephen Harrison and Dr. Naga Chalasani, it is important to complete our ongoing NASH-CX Phase 2b trial focused on the treatment of NASH cirrhosis as one year may provide an appropriate length of therapy and the endpoints may serve as a surrogate for outcomes for registration trials in this patient population," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "NASH cirrhosis has always been, and remains, the lead indication for GR-MD-02. Presently, we are the only company with a compound for NASH cirrhosis in an active Phase 2 clinical trial.
"The market seemingly recognizes the concerns about the rising incidence of NASH and the need for therapies to counter a potential health epidemic as Allergan’s $1.7 billion purchase of Tobira appears to have been motivated by a NASH drug in clinical trials.
"The NASH-CX trial is a one-year of treatment, multi-center trial in patients with NASH cirrhosis that is being conducted at 36 outstanding liver centers in the United States. It completed enrollment one month early with 162 well-compensated patients with NASH cirrhosis (Child-Pugh-Turcotte Class A) with elevated portal pressure (HVPG ³ 6 mmHg). Only five patients of the 162 enrolled have dropped out of the trial thus far,
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with this low attrition rate highlighting the importance, urgency, and need for patients suffering from NASH-cirrhosis to find an effective medical treatment. And, a total of 2,240 drug infusions (including placebo) have been given in this trial, representing 53% of the total number of infusions in the entire trial. So we are quite pleased that this study is well along in its development and on track for reporting of top-line results in December of 2017.
"As a company, Galectin Therapeutics’ attention has always been focused on completing the NASH-CX clinical trial and reporting results in a timely fashion. With an outstanding safety profile, inhibition of galectin-3 with GR-MD-02 remains a potential treatment of NASH cirrhosis and provides us encouragement about our continuation of the NASH-CX clinical trial."
Financial Results
For the three months ended September 30, 2016, the Company reported a net loss applicable to common stockholders of $5.6 million, or $0.19 per share, compared with a net loss applicable to common stockholders of $6.2 million, or $0.26 per share, for the three months ended September 30, 2015. The decrease is largely due to lower non-cash stock based compensation expense and timing of research and development expenses related to the Phase 2 clinical program in NASH.
Research and development expense for the three months ended September 30, 2016 was $3.3 million, compared with $4.4 million for the three months ended September 30, 2015. The decrease primarily relates to timing of research and development expenses related to the Phase 2 clinical program in NASH.
General and administrative expense for this quarter was $1.2 million, compared with $1.4 million for the prior year, with the decrease being primarily related to non-cash stock compensation. As of September 30, 2016, the Company had $16.1 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 August 2017.
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