CORAL GABLES, Fla., May 14 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. today reported financial results for the first quarter ended March 31, 2009.
First Quarter 2009 Results
For the quarter ended March 31, 2009, the Company reported a net loss of $3,031,201, or $0.22 per basic and diluted share, compared to a net loss of $1,584,047, or $0.13 per basic and diluted share, for the same period in 2008. First quarter 2009 results included non-cash charges relating to stock-based compensation in the amount of $142,274, compared to $263,404 in the same period in 2008.
Research and development expenses for the first quarter of 2009 were $2,322,632, compared to $1,084,359 in the first quarter of 2008. These expenses include non-cash stock-based compensation of $71,700 and $174,556, respectively. General and administrative expenses for the first quarter of 2009 totaled $721,911, compared to $639,673 in the first quarter of 2008. These expenses include non-cash stock-based compensation of $70,574 and $88,848, respectively. As a development stage pharmaceutical company, Catalyst has no revenues to-date.
At March 31, 2009, the Company had cash and cash equivalents of $8.9 million and no long-term debt. The Company believes that its existing cash and cash equivalents will be sufficient to complete the Company's currently ongoing cocaine clinical trial and methamphetamine proof-of-concept study and to continue its operations through the end of 2010 without the need to obtain additional funding.
Product Development Update
Patrick J. McEnany, Catalyst's Chief Executive Officer, stated: "We expect to report the top-line results from our 186-patient randomized, double-blind, placebo-controlled study evaluating the use of CPP-109 for the treatment of cocaine addiction by the end of the second quarter of 2009. Assuming positive data, we will likely seek to meet with the FDA and begin designing the Phase III 'pivotal' cocaine trial during the second half of 2009 that we believe will be required in order to meet our ultimate goal of filing an NDA for CPP-109. In addition, we also expect to have the top-line results of our 57-patient proof-of-concept study evaluating the use of CPP-109 in the treatment of methamphetamine addiction during the third quarter of 2009. Furthermore, we believe that our strengthened balance sheet will enable us to engage prospective corporate partners and explore a variety of potential transactions on terms that may prove to be favorable to our stockholders."
"Additionally, we are actively exploring opportunities to obtain government funding from agencies that operate under the National Institutes of Health umbrella to further our development plans, which include developing large-scale clinical trials using CPP-109 to treat cocaine and methamphetamine addiction, as well as pilot studies for other addictions including alcohol and nicotine dependence."
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company focused on the development and commercialization of prescription drugs for the treatment of addiction and obsessive-compulsive disorders. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions and obsessive-compulsive disorders . 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.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause the Company's actual results in future periods to differ materially from forecasted results. A number of factors, including our ability to successfully complete the clinical trials required for us to file a new drug application for CPP-109, our ability to complete such trials on a timely basis within the budgets we establish for such trials, our ability to protect our intellectual property and those other factors described in the Company's Annual Report on Form 10-K for 2008 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 that the Company has filed with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect the Company. Copies of the Company's filings with the SEC are available from the SEC, may be found on the Company's website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.
CONTACT: Jack Weinstein, Chief Financial Officer, +1-201-934-4201,
jweinstein@catalystpharma.com, or Melody Carey, Rx Communications,
+1-917-322-2568, mcarey@rxir.com
Web site: http://www.catalystpharma.com/
