$CPRX $4.84+ 8%
Baker Bros own over 11% of company
May 11, 2015
Catalyst Pharmaceuticals Announces First Quarter 2015 Financial Results and Provides Corporate Update
CORAL GABLES, Fla., May 11, 2015 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), (Catalyst Pharmaceuticals), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the first quarter ended March 31, 2015.
"This quarter we have been working to advance regulatory and commercial affairs and are moving closer to initiating the submission of our rolling NDA to the FDA next quarter for Firdapse® for the symptomatic treatment of LEMS," said Patrick J. McEnany, Catalyst's Chief Executive Officer. "This past quarter we made important strides on our commercial infrastructure, significant progress with our pipeline, and also strengthened our cash position."
Mr. McEnany added, "We recently reported that we held a productive pre-NDA meeting with the FDA and believe that our full clinical and non-clinical data packages provide acceptable support for a complete submission of an NDA for Firdapse®. We are working closely with the FDA on a pathway to include certain types of Congenital Myasthenic Syndromes (CMS) in the initial label upon approval in LEMS and also continuing our ongoing expanded access program which provides access to Firdapse® for patients with LEMS and CMS at no cost."
2015 Business Achievements to Date:
Confirmatory pre-NDA meeting with FDA regarding Firdapse® for LEMS
Raised $34.9 million, net of expenses, in a public offering of shares of common stock
Orphan Drug Designation of Firdapse® for treatment of Congenital Myasthenic Syndromes
Richard J. Daly and Donald A. Denkhaus appointed to Board of Directors
Development and advancement of comprehensive commercialization and pre-launch plan
Enrollment in expanded access program which allows LEMS and CMS patients early access to Firdapse®
Recently presented Phase 3 trial results at the annual meeting of the American Academy of Neurology (AAN) in Washington, D.C.
Upcoming 2015 Milestones:
Initiate rolling NDA for Firdapse for the treatment of LEMS in Q3 with anticipated completion of NDA submission during Q4
Announce topline results from a Phase 1(b) multiple dose safety and tolerance study for CPP-115 in Q3
Top-line results during this quarter expected from Mt. Sinai academic investigator sponsored study evaluating CPP-109 (Vigabatrin), as a surrogate for CPP-115, for the treatment of Tourette's disorder
Financial Results
For the quarter ended March 31, 2015, Catalyst reported a GAAP net loss of $5,410,259, or 7 cents per basic and diluted share, compared to a GAAP net loss of $3,811,119, or 7 cents per basic and diluted share, for the same period in 2014. Excluding non-cash expense of $1,180,278 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $4,229,981 or 6 cents per basic and diluted share for the first quarter of 2015. In comparison, Non-GAAP1 net loss for the first quarter of 2014 was $3,475,605, or 6 cents per basic and diluted share, which excludes non-cash expense of $335,514 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the first quarter of 2015 were $2,349,552 compared to $2,748,683 in the first quarter of 2014. Research and development expenses decreased when compared to the same period in 2014 as we decreased activities related to our completed Phase 3 trial for Firdapse®. However, we expect that our research and development spend for the rest of the year will increase significantly as we prepare for and submit our NDA for Firdapse® and as we increase activities in other ongoing studies and trials.
General and administrative expenses for the first quarter of 2015 totaled $1,942,363 compared to $759,682 in the first quarter of 2014. The increase when compared to the same period in 2014 is primarily due to an increase in pre-commercialization expenses and headcount, as we prepare for the future commercialization of Firdapse®.
As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the first quarter of 2015 or the first quarter of 2014.
At March 31, 2015, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $71.5 million and no debt. This includes proceeds from our February 2015 offering in which we sold 11.5 million shares of our common stock, and raised net proceeds of approximately $34.9 million. We believe that these resources give us sufficient runway through anticipated approval and subsequent product launch of Firdapse®, assuming approval in 2016.
More detailed financial information and analysis may be found in the Company's Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC), May 11, 2015.
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