On March 29, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the year ended December 31, 2017 (Press release, Galectin Therapeutics, MAR 29, 2018, View Source [SID1234525800]). 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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"In 2017 we achieve a major milestone in establishing GR-MD-02 as the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "We believe this is the first randomized clinical trial of any drug to demonstrate clinically meaningful positive effects, including reducing portal hypertension, facilitating an improvement in liver cell death (a key component of NASH), and reducing the development of new esophageal varices, in this important group of patients. The drug has also always proven to be safe and well tolerated.
"In May 2018, we will be meeting with the Food and Drug Administration to present the results of our NASH-CX clinical trial. We hope to come to an agreement with the FDA on a plan for a Phase 3 clinical trial. In addition, we have submitted an application for Breakthrough Therapy Designation for GR-MD-02. We are also encouraged by the recent findings of a Phase 1 clinical trial of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA) on melanoma patients, which may represent another path forward for GR-MD-02 into the significant market for evolving new cancer therapies. The positive results of the various trials conducted over the course of the past year have demonstrated that GR-MD-02 has potential in a variety of applications, from NASH to Immunotherapy and Skin Disease. In addition, through our strong intellectual property program, we are protecting the value of our asset and opening additional opportunities on a global basis. The management team at Galectin is dedicated to advancing our trials to unlock the full value of our potential."
Expected Upcoming Milestones
The Company will be meeting with the FDA in early May 2018 to present the results of its NASH-CX clinical trial. The purpose of the meeting is to seek agreement on a plan for a Phase 3 clinical trial
The Company has filed a request with the Food and Drug Administration to grant GR-MD-02 Breakthrough Therapy Designation as therapy for patients with NASH Cirrhosis without esophageal varices.
The Company has been selected to make an oral presentation at the International Liver Meeting in April 2018 in Paris. The presentation, which will be made by Dr. Naga Chalasani, one of the principal NASH-CX clinical trial investigators, is entitled, "A multicenter, randomized, double-blind, PLB-controlled trial of Galectin-3 inhibitor (GR-MD-02) in patients with NASH cirrhosis and portal hypertension."
The Company continues to remain in ongoing discussions with a number of pharmaceutical companies about potential partnerships.
Summary of Key Development Programs and Updates
The Company, in partnership with Providence Cancer Institute, presented preclinical and early clinical data from an investigator-initiated Phase 1 clinical trial of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA). According to one of the principal investigators at the Providence Cancer Institute, the objective response rate of five out of eight patients (62.5%) in this trial with advanced melanoma, including two complete responses, is very encouraging and compares favorably with the known response rates with pembrolizumab alone (ORR of ~ 33%).
The company has begun enrolling cohort 3 (GR-MD-02 8 mg/kg), of the pembrolizumab, combination immunotherapy clinical trial, which will include at least 10 patients with melanoma, to provide a larger group of patients to evaluate. It is hoped additional data can be reported in mid-2018 when we anticipate a decision on progressing to phase 2.
The Company announced it has received two new patents in China and two new patents in Japan for the Company’s lead compound, GR-MD-02.
The Company announced it entered into a $10 million unsecured line of credit facility with stockholder and new director Richard E. Uihlein in December 2017.
Dr. Peter G. Traber, M.D., Chaired the Anti-Fibrotic Drug Development Summit 2017, which is dedicated to the translation of fibrotic mechanisms into clinically effective therapeutics.
Financial Results
For the year ended December 31, 2017, the Company reported a net loss applicable to common stockholders of $17.5 or $0.49 per share, compared to a net loss applicable to common stockholders of $22.4 million, or $0.76 per share, for 2016. The decrease is largely due to lower preclinical, clinical, legal, and stock-based compensation expenses.
Research and development expense for 2017 was $11.7 million, compared with $15.3 million, for 2016. The decrease primarily relates to a reduction in costs for the NASH-CX Phase 2 clinical trial as it winds down and lower preclinical costs.
General and administrative expense for 2017 was $4.5 million, compared to $6.2 million, for 2016, primarily due to a decrease in legal and stock-based compensation expenses.
As of December 31, 2017, the Company had $3.1 million of cash and cash equivalents. In December 2017, the Company entered into a $10 million line of credit and received $4.5 million in proceeds in January 2018 from common stock warrant exercises. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least March 31, 2019.
Positive Results in NASH Cirrhosis
GR-MD-02, a proprietary polysaccharide pharmaceutical preparation that inhibits galectin proteins, recently completed a Phase 2b clinical trial (NASH-CX). There were statistically significant and clinically relevant positive effects of GR-MD-02 on HVPG and other parameters in patients with NASH cirrhosis without esophageal varices following one year of therapy. Patients without esophageal varices comprise about 50 percent of the total population of patients
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with NASH cirrhosis, and is estimated to be 2.5 million people in the United States. This group of patients is readily diagnosed by endoscopy which is already part of the standard of care for patients with suspected NASH. The drug was well tolerated during this one-year trial. The Company believes that this is the first randomized clinical trial of any drug to demonstrate clinically meaningful positive effects in this important group of patients. Full details of Galectin’s NASH-CX trial can be found in a supplemental slide deck of our corporate presentation on the home page of our website.
Encouraging Results in Cancer Immunotherapy
GR-MD-02 also showed encouraging Phase 1b results in combination with pembrolizumab (KEYTRUDA) to treat advanced melanoma. In the first two cohorts of this study, five out of eight patients (62.5 percent) with advanced melanoma had objective responses, with two complete and three partial responses, which compares favorably with the known response rates with pembrolizumab alone (~33 percent). The study continues with additional results expected in Summer 2018. Full details on Galectin’s combination cancer immunotherapy program can be found in a supplemental slide deck to our corporate presentation on the home page of our website.