CORAL GABLES, Fla., March 27 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. , a biopharmaceutical company that acquires, in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, today reported financial results for the fourth quarter and year ended December 31, 2008.
"Catalyst made significant progress in 2008," said Patrick J. McEnany, Chief Executive Officer of Catalyst Pharmaceutical Partners. "During the year, we initiated two U.S. multi-center, Phase II, double-blind, placebo-controlled trials evaluating CPP-109 as a potential treatment for cocaine and methamphetamine addiction. In September we executed a successful equity financing for $4.5 million just prior to the deterioration of the capital markets and the economy. This equity raise, combined with the recently announced change in our clinical development program, provides Catalyst with sufficient working capital through 2010. Furthermore, once we report initial top-line results for our U.S. Phase II cocaine trial, our strengthened balance sheet should allow us to engage potential corporate partners and explore a variety of transactions on terms that may prove to be more favorable to our shareholders. Concurrently, we are actively pursuing government funding from agencies that operate under the National Institutes of Health umbrella to further our development plans for large-scale clinical trials using CPP-109 to treat cocaine and methamphetamine addiction, as well as pilot studies for other addictions, such as alcohol and nicotine abuse, and obsessive-compulsive disorders, including binge eating."
Financial Results
For the year ended December 31, 2008, the Company's net loss was $10,564,597, or $0.81 per basic and diluted share, compared to a net loss of $4,139,493, or $0.33 per basic and diluted share, in the prior year. Results for 2008 and 2007 include non-cash charges relating to stock-based compensation of $717,568 and $556,343, respectively.
Research and development expenses for 2008 were $8,710,441 compared to $3,040,659 in 2007. These expenses include non-cash stock-based compensation for 2008 and 2007 of $458,289 and $365,107, respectively.
General and administrative expenses for 2008 were $2,183,504, compared to $1,986,470 in 2007. These expenses include non-cash stock-based compensation for 2008 and 2007 of $259,279 and $191,236, respectively.
For the fourth quarter of 2008, the Company's net loss was $3,747,750, or $0.27 per basic and diluted share, compared to a net loss of $944,938, or $0.08 per basic and diluted share, for the same period in 2007. Results for the fourth quarters of 2008 and 2007 include non-cash charges relating to stock-based compensation of $226,391 and $79,260, respectively.
As a development stage pharmaceutical company, Catalyst had no revenues during 2008 and 2007.
At December 31, 2008, the Company had cash and cash equivalents of $11.8 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 2010.
Clinical Development Update
In January 2008, Catalyst initiated enrollment of subjects for its U.S. Phase II clinical trial evaluating the use of CPP-109 for the treatment of cocaine addiction. The Phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multi-center trial to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. Under the trial protocol, subjects will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary objective of the trial is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects are cocaine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst will be measuring a number of secondary endpoints based on reductions of cocaine use and craving. In January 2009, Catalyst completed enrollment for this trial, having enrolled 186 subjects at 11 addiction centers around the United States. Initial top-line results for the cocaine trial are expected at the end of the second quarter of 2009.
In June 2008, Catalyst initiated enrollment of subjects for its randomized, double-blind, placebo-controlled U.S. Phase II clinical trial evaluating CPP-109 for the treatment of methamphetamine addiction using a trial protocol that is almost identical to the cocaine trial. On March 3, 2009, in order to conserve cash and to focus its development efforts on evaluating CPP-109 for the treatment of cocaine addiction, Catalyst announced that it had halted enrollment in the methamphetamine trial. Instead, the methamphetamine trial has been converted into a smaller proof-of-concept study with the 57 subjects who had already been enrolled. Initial results for the methamphetamine proof-of-concept study are expected in the third quarter of 2009.
About Catalyst Pharmaceutical Partners, Inc.
Catalyst Pharmaceutical Partners 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. 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 is CPP-109, which is the Company's finished dosage form of vigabatrin, also referred to in the literature as gamma-vinyl-GABA or GVG. CPP-109 has been granted "Fast Track" status by the 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 those described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2008 that the Company has filed with the U.S. Securities and Exchange Commission ("SEC") reporting its financial position and results of operations as of and for the year ended December 31, 2008, could adversely affect the Company's ability to obtain these results. Copies of the Company's filings with the SEC are available from the SEC 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 of Catalyst
Pharmaceutical Partners, +1-201-934-4201, jweinstein@catalystpharma.com; or
Melody Carey of Rx Communications Group, +1-917-322-2571, mcarey@rxir.com,
for Catalyst Pharmaceutical Partners
Web site: http://www.catalystpharma.com/
