CORAL GABLES, Fla., Aug. 13 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. today reported financial results for the quarter ended June 30, 2007.
Second Quarter 2007 Results
For the quarter ended June 30, 2007, the Company reported a net loss of $1,208,130, or $0.10 loss per basic and diluted share, compared to a net loss of $353,996, or $0.05 loss per basic and diluted share for the same period in 2006. Second quarter 2007 results were impacted by non-cash charges relating to stock-based compensation in the amount of $182,233, compared to $120,562 in the same period in 2006. For the six months ended June 30, 2007, the Company reported a net loss of $2,460,208, or $0.20 loss per basic and diluted share, compared to a net loss of $666,825, or $0.10 loss per basic and diluted share for the same period in 2006. Results for the first six months of 2007 were impacted by non-cash charges relating to stock-based compensation in the amount of $382,601, compared to $241,125 in the same period in 2006.
Research and development expenses for the second quarter of 2007 were $1,002,780, an increase of 271.2% compared to $270,149 in the second quarter of 2006. These include non-cash stock-based compensation of $161,320 and $82,067, respectively. The substantial increase in research and development expenses in the second 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 Company’s 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. Research and development expenses for the six months ended June 30, 2007 were $1,765,300, an increase of 307.9% compared to $432,764 for the first six months of 2006. These include non-cash stock-based compensation of $239,713 and $164,135 respectively.
General and administrative expenses for the second quarter of 2007 totaled $434,208 an increase of 400.2% compared to $86,812 in the second quarter of 2006. These include non-cash stock-based compensation of $20,913 and $38,495, respectively. General and administrative expenses increased significantly in the second quarter of 2007 primarily 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, monitor and oversee upcoming clinical trials and fulfill the requirements related to the Company’s being a publicly-traded company. General and administrative expenses for the first six months of 2007 totaled $1,168,834 an increase of 382.6% compared to $242,194 in the first six months of 2006. These include non-cash stock-based compensation of $142,888 and $76,990, respectively.
As a development stage pharmaceutical company, Catalyst has no revenues to-date.
At June 30, 2007, the Company had cash and cash equivalents totaling $17.6 million and no long-term debt. The Company believes that its existing cash and cash equivalents will be sufficient to meet the Company’s projected operating requirements through the end of 2008.
Commenting on today’s news, Patrick J. McEnany, Catalyst’s Chief Executive Officer, noted, “We continue to move ahead with our clinical development program for CPP-109. In particular, we have initiated our first U.S. Phase II clinical trial, which will evaluate CPP-109 as a treatment for cocaine addiction. We also expect to initiate our U.S. Phase II clinical trial evaluating CPP-109 as a treatment for methamphetamine addiction later in the year.”
Initiation of U.S. Phase II Study of CPP-109 for the Treatment of Cocaine Addiction
On July 10, 2007, Catalyst announced that it has initiated its randomized, double-blind, placebo-controlled U.S. Phase II clinical trial of CPP-109 in patients with cocaine addiction.
The Phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multi-center study to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. The Phase II clinical trial is expected to enroll 180 cocaine dependent patients at 10 leading addiction treatment clinical centers in the United States. Patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up. The primary endpoint of the study is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be cocaine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst will be measuring several secondary endpoints based on reductions of cocaine use.
Bioequivalence Study
On May 9, 2007, Catalyst announced positive initial top-line results from a bioequivalence study demonstrating that CPP-109 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).
About 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.
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 the timing of receipt of necessary approvals by the Institutional Review Boards that operate the clinical trial sites where the cocaine trial described herein will be held, whether the results from the clinical trial conducted by the Company will be positive, whether the results of the trials referred to above will warrant additional clinical trials or warrant submission of an application for regulatory approval of CPP-109, and those other factors described in the Company’s Annual Report on Form 10-K for 2006 and the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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 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.
CATALYST PHARMACEUTICAL PARTNERS, INC. (a development stage company) CONDENSED STATEMENTS OF OPERATIONS (unaudited) For the Three Months For the Six Months Ended June 30, Ended June 30, 2007 2006 2007 2006 Revenues $ - $ - $ - $ - Operating costs and expenses: Research and development 1,002,780 270,149 1,765,300 432,764 General and administrative 434,208 86,812 1,168,834 242,194 Total operating costs and expenses 1,436,988 356,961 2,934,134 674,958 Loss from operations (1,436,988) (356,961) (2,934,134) (674,958) Interest income 228,858 2,965 473,926 8,133 Loss before income taxes (1,208,130) (353,996) (2,460,208) (666,825) Provision for income taxes - - - - Net loss $(1,208,130) $(353,996) $(2,460,208) $(666,825) Loss per share - basic and diluted $(0.10) $(0.05) $(0.20) $(0.10) Weighted average shares outstanding - basic and diluted 12,527,564 6,887,513 12,523,210 6,887,513 CATALYST PHARMACEUTICAL PARTNERS, INC. (a development stage company) CONDENSED BALANCE SHEETS June 30, December 31, 2007 2006 (unaudited) ASSETS Current Assets: Cash and cash equivalents $17,600,170 $20,434,702 Interest receivable 78,517 85,787 Prepaid expenses 498,166 67,333 Total current assets 18,176,853 20,587,822 Property and equipment, net 49,555 20,157 Other assets 20,388 11,500 Total assets $18,246,796 $20,619,479 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $146,383 $448,072 Accrued expenses 272,113 324,774 Total current liabilities 418,496 772,846 Total stockholders’ equity 17,828,300 19,846,633 Total liabilities and $18,246,796 $20,619,479 stockholders’ equity
Catalyst Pharmaceutical Partners
CONTACT: Jack Weinstein, Chief Financial Officer of CatalystPharmaceutical Partners, +1-201-934-4201, jweinstein@catalystpharma.com;Melody Carey of Rx Communications, +1-917-322-2568, mcarey@rxir.com
Web site: http://www.catalystpharma.com/
