Will Firdapse Prove Beneficial For Catalyst Pharmaceutical Partners Inc. (NASDAQ:CPRX)?
Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX), a specialty pharmaceutical company, announced its third quarter results for the year 2013, ended September 30, 2013. For the quarter, the company reported a GAAP net loss of $5,912,059, or $0.13 per basic and diluted share, versus a GAAP net loss of $2,621,535, or $0.08 per basic and diluted share, for the same period in 2012.
Non-GAAP net loss was $3,235,458 or $0.07 per share, compared with non-GAAP net loss of $1,280,969, or $0.04 per share, in the same period of 2012.
As a development-stage specialty pharma company, Catalyst had no revenues in either the third quarter of 2013.
Recently, Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX) closed a registered direct public offering with net proceeds of about $14.1 million. FD granted the “Breakthrough Therapy Designation” status to the company’s Firdapse, for the treatment of LEMS.
Patient screening activity is actively taking place at 19 trial sites. The company expects to add six more sites soon. The Phase 3 trial, which is being overseen by the Data Monitoring Committee, has been recommended the continuation of the trial as planned.
At September 30, the company had total $27.7 million in cash and cash equivalents, certificates of deposit and short-term investments. It is a debt free company. According to the company, the existing capital resources will be sufficient to meet Catalyst’s anticipated working capital requirements through the end of 2014.
Research and development expenses will remain substantial during the rest of 2013 and 2014, principally as a result of the Firdapse ongoing development projects.
“Significant progress has been made towards initiating new clinical trial sites and enrolling patients in our Phase 3 clinical trial for Firdapse to treat patients with Lambert-Eaton Myasthenic Syndrome (LEMS). We continue to believe that we will complete enrollment around the end of the year and be in a position to announce top-line data from the double-blind portion of our trial during the second quarter of 2014,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “The Catalyst team is focused on all critical activities to successfully complete our Phase 3 registration trial and has begun its pre-commercialization efforts for Firdapse.”