TEL AVIV, Israel, Nov. 12, 2014 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed”), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, today announced select third quarter 2014 and recent corporate highlights, as well as financial results for the nine months ended September 30, 2014.
Select Third Quarter 2014 and Recent Corporate Highlights:
- Galmed’s Investigational New Drug application, or IND, for aramchol for the treatment of fatty liver disorders, filed with the U.S. Food and Drug Administration, or FDA, become effective, thereby permitting Galmed to conduct clinical studies for the targeted indication and additional proof-of-concept studies in the United States in the future. Galmed was subsequently granted Fast Track Designation by the FDA for aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.
- Successfully completed two, six-month chronic toxicology studies of aramchol without observable significant adverse events, thereby supporting Galmed’s planned Phase IIb clinical trial of aramchol in NASH patients suffering from obesity and insulin resistance, which Galmed intends to initiate during the fourth quarter of 2014. The Phase IIb trial will be conducted in the European Union, Israel and Latin America. These two studies will continue into December 2014 to satisfy an initial FDA requirement to complete nine-month pre-clinical toxicology studies of aramchol prior to conducting clinical trials in the United States.
- Published the results of its Phase IIa clinical trial of aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology journal.
- Announced the purchase of 60 EndoPAT devices and accessories from Itamar Medical Ltd. to assess endothelial, or arterial, function in NASH patients suffering from obesity and insulin resistance participating in its planned Phase IIb clinical trial of aramchol.
Financial Summary for the Nine Months Ended September 30, 2014 and 2013:
- Reported a net loss of $7.1 million, or $0.71 per share, for the nine months ended September 30, 2014, compared with a net loss of $2.2 million, or $0.44 per share, for the comparable prior year period, primarily attributable to increased research and development activities.
- Reported research and development expenses of $5.5 million for the nine months ended September 30, 2014, compared with $1.9 million for the comparable prior year period, primarily resulting from increases in research and development subcontractor expenses in preparation for the initiation of Galmed’s clinical trials initiated or to be initiated following the end of the period, as well as an increase in salaries and benefits due to an increase in clinical staff.
- Reported general and administrative expenses of $1.6 million for the nine months ended September 30, 2014, compared with $333,000 for the comparable prior year period, resulting from an increase in professional services, salaries and benefits, including non-cash stock-based compensation.
- Reported cash and cash equivalents of $35.3 million at September 30, 2014, compared with $137,000 at December 31, 2013 as a result of the net proceeds from Galmed’s initial public offering in March 2014. Galmed currently expects that this existing cash balance will be sufficient to maintain its current operations through 2017.
“I am pleased to report that we have completed all of the short-term milestones that we set for the first three quarters of 2014 at the time of our initial public offering,” stated Allen Baharaff, Galmed’s Chief Executive Officer.
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