Message #1 From:
Jason Date: May 29, 2007 08:17:06 AM
CPRX, Catalyst Pharmaceutical Partners Reports First Quarter 2007 Financial Results
Company Successfully Completes Bioequivalence Study
Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX Drugstocks) today reported financial results for the quarter ended March 31, 2007.
First Quarter 2007 Results
For the quarter ended March 31, 2007, the Company reported a net loss of $1,252,078, or $0.10 loss per basic and diluted share, compared to a net loss of $312,829, or $0.05 loss per basic and diluted share for the same period in 2006. First quarter 2007 results were impacted by non-cash charges relating to stock-based compensation in the amount of $200,368, compared to $120,563 in the same period in 2006.
Research and development expenses for the first quarter of 2007 were $762,520, an increase of 368.9% compared to $162,615 in the first quarter of 2006. These include non-cash stock-based compensation of $78,393 and $82,068, respectively. The substantial increase in research and development expenses in the first quarter of 2007 is primarily the result of costs incurred relating to the Company's development and production of CPP-109 clinical trial material, expenses related to the two upcoming U.S. Phase II clinical trials, expenses relating to the Company's recently reported bioequivalence study and support by the Company during the quarter for a clinical trial in Mexico that is being conducted by a member of the Company's Scientific Advisory Board.
General and administrative expenses for the first quarter of 2007 totaled $734,626 an increase of 372.8% compared to $155,382 in the first quarter of 2006. These include non-cash stock-based compensation of $121,975 and $38,495, respectively. General and administrative expenses increased significantly in the first quarter of 2007 due to the Company's recent additions to its management team so that the Company has the executive management to execute its product development efforts, upcoming clinical trials and fulfill the requirements related to the Company now being a publicly-traded company. As a development stage pharmaceutical company, Catalyst has no revenues to- date.
At March 31, 2007, the Company had cash and cash equivalents totaling $19.1 million and no long-term debt. The Company believes that its existing cash and cash equivalents will be sufficient to meet its projected operating requirements through the next 24 months.
Commenting on today's news, Patrick J. McEnany, Catalyst's Chief Executive Officer, noted, 'We are pleased with our operational progress for the quarter. We continue to move ahead with our clinical development program for CPP-109. In particular, we are on track to commence our U.S. Phase II clinical trial evaluating CPP-109 as a treatment for cocaine addiction at the end of the second quarter of 2007, to be followed in the third quarter by the commencement of our U.S. Phase II clinical trial evaluating CPP-109 as a treatment for methamphetamine addiction. Further, we recently announced positive top-line results from our bioequivalence study of CPP-109 compared to Sabril(R) Tablets.'
Mr. McEnany continued, 'During the quarter, we also welcomed two new members to our Scientific Advisory Board -- Dr. Thomas Kosten and Dr. Richard Rawson. Both Dr. Kosten and Dr. Rawson bring to Catalyst invaluable clinical experience in the area of drug addiction. We look forward to their extensive contributions to the Company. We also appointed Steven R. Miller, Ph.D. as Vice President of Pharmaceutical Development and Project Management. All of these appointments serve to significantly strengthen our team and position us solidly for the commencement of Phase II trials and the ultimate commercialization of CPP-109.'
Bioequivalence Study
On May 9, 2007, Catalyst announced that it has received initial top-line results from a bioequivalence study demonstrating that CPP-109 (Catalyst's Vigabatrin Tablets) is bioavailable and bioequivalent to Sabril(R) Tablets, the version of vigabatrin marketed in Europe by Sanofi Aventis. These data potentially provide a basis for linking CPP-109 to the extensive body of published pre-clinical and clinical literature on Sabril(R).
As previously stated, CPP-109 has been formulated and manufactured to the Company's specifications and clinical trial materials are available for use in the upcoming U.S. Phase II studies for cocaine and methamphetamine addiction.
About CPRX Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the development and commercialization of prescription drugs for the treatment of addiction. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents and four patents pending in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions. Catalyst has also been granted rights to Brookhaven's vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company's initial product candidate based on vigabatrin is CPP-109. CPP-109 has been granted 'Fast Track' status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs. For more information about the Company, go to www.catalystpharma.com.
