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 months ended March 31, 2015. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission.
“We made excellent progress during the quarter and recent weeks toward the imminent commencement of our Phase 2 program with GR-MD-02 for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis and cirrhosis,” said Peter G. Traber, M.D., president and chief executive officer. “As previously announced, our Phase 2 program consists of studies in two different NASH fibrosis indications, theNASH-CX trial in patients with NASH cirrhosis and the NASH-FX trial in NASH patients with advanced fibrosis, but not cirrhosis. Following communication with the U.S. Food and Drug Administration (FDA) we have a clear design for our program and understanding of the Agency’s current view of the regulatory pathway to bring a new treatment to patients with NASH cirrhosis.
“The NASH-CX trial will enroll 156 patients with NASH cirrhosis and will evaluate 2 mg/kg of GR-MD-02 and 8 mg/kg of GR-MD-02 and placebo, with patients randomized 1:1:1. In collaboration with our contract research organization, we have identified 45 study sites in North America, held an Investigator Meeting, obtained central institutional review board (IRB) approval, and are working to secure site IRB approvals and contracts necessary to begin enrolling subjects. The primary endpoint will be change in hepatic venous pressure gradient (HVPG) compared with placebo, and now secondary endpoints will include fibrosis stage on biopsy as well as the percent of collagen on biopsy at one year of treatment. Correlation of HVPG with liver biopsy will continue to be studied, as planned. Additionally, the HVPG and liver biopsy measurements will be correlated with non-invasive measurements of liver fibrosis and function including FibroScan and 13C-methacetin breath test. We expect to screen the first patients by the end of the second quarter of 2015, with top-line data readout at the end of 2017. We submitted a special protocol assessment (SPA) with the FDA and received very useful feedback for the design of the study and the overall development program. At this time, and in order to move forward as quickly as possible and to take advantage of the myriad preparations in place, we have decided to proceed with the trial as a Phase 2 program, rather than resubmit the SPA to attempt to obtain designation as a Phase 3 trial currently.”
Dr. Traber continued, “The NASH-FX study will be a shorter, four-month trial in 30 NASH patients with advanced fibrosis, but not cirrhosis, randomized 1:1 to either 8 mg/kg of GR-MD-02 or placebo.” This study is entitled “Phase 2 Study to Evaluate Non-Invasive Imaging Methods in Efficacy Assessment of GR-MD-02 for the Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis,” and details can be found here.
“The non-invasive assessments included in this trial include LiverMultiScan (a multi-parametric nuclear magnetic resonance imaging method developed by Perspectum Diagnostics™) as the primary endpoint compared with magnetic resonance elastography and FibroScan as secondary endpoints. This study is expected to begin enrolling patients in July 2015, and will be performed at Brooke Army Medical Center in Fort Sam Houston in Texas, with top-line data readout in the second half of 2016.”
He added, “Our Phase 2 program is supported by data generated with GR-MD-02 in our Phase1b study along with preclinical work. During the first quarter I had the privilege of presenting both our human and preclinical data at the American Association for the Study of Liver Diseases Industry Colloquium. There was a major focus on NASH at the Colloquium, as nearly 28 million Americans are afflicted with NASH, including up to 6 million with advanced fibrosis and a very poor prognosis. Thus there is keen interest from the medical community on drugs that can both halt and reverse fibrosis and cirrhosis.”
Dr. Traber then stated, “In addition to the NASH fibrosis program, we have initiated an exploratory, open-label Phase 2a trial in patients with moderate-to-severe plaque psoriasis. This is based on the known increase in galectin-3 in the skin of psoriatic patients and a patient in the Phase 1 trial with psoriasis who had an apparent remission of psoriasis while receiving GR-MD-02. Determination of future development in this indication will depend on results of this exploratory study.” Details of the trial can be found here.
Dr. Traber concluded, “Immune checkpoint blockade therapies have generated a great deal of interest in recent years, as evidence grows for the efficacy of this approach in oncology, both in blood cancers and in solid tumors. We are excited to be 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 these therapies with this mechanism of action. A Phase 1b study with GR-MD-02 in combination with YERVOY® is ongoing, with successful completion of three patients in the first dosing group, and two patients enrolled in the second dosing group. Another, a Phase 1b study in combination with KEYTRUDA® is expected to be initiated in the coming months. 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, and we look forward to receiving human clinical data.”
For the three months ended March 31, 2015, the Company reported a net loss applicable to common stockholders of $5.1 million, or ($0.22) per share, compared with a net loss applicable to common stockholders of $5.4 million, or ($0.27) per share, for three months ended March 31, 2014. The decrease in net loss applicable to common stockholders is largely due to a decrease in stock-based compensation expense of$0.7 million partially offset by higher research and development expenses related to our clinical programs.
Research and development expense for the three months ended March 31, 2015, was $3.1 million, compared with $2.8 million for three months ended March 31, 2014. The increase primarily relates to increased costs related to preclinical and drug manufacturing costs and in planning activities in preparation for our Phase 2 clinical program.
General and administrative expense for the three months ended March 31, 2015 was $1.7 million, compared with $2.1 million for the three months ended March 31, 2014. The primary reason for the decrease was a reduction in stock-based compensation expense of $0.4 million.
As of March 31, 2015, the Company had $29.3 million of non-restricted cash and cash equivalents available to fund future operations. The Company believes that cash on hand as of March 31, 2015, is sufficient to fund its currently planned operations and research and development activities through September 30, 2016. (Original Source)
Shares of Galectin Therapeutics (GALT) closed last Friday at $2.92 . GALT has a 1-year high of $16.55 and a 1-year low of $2.79. The stock’s 50-day moving average is $3.29 and its 200-day moving average is $3.75.
On the ratings front, MLV & Co. analyst Vernon Bernardino reiterated a Buy rating on GALT, with a price target of $16, in a report issued on March 19. The current price target represents a potential upside of 447.9% from where the stock is currently trading.
According to TipRanks.com, Bernardino has a total average return of -13.2%, a 28.1% success rate, and is ranked #3557 out of 3596 analysts.
Galectin Therapeutics Inc is a clinical stage biopharmaceutical company. The Company is engaged in drug research and development to create new therapies for fibrotic disease and cancer.