CORAL GABLES, Fla., April 2 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. today reported financial results for the year ended December 31, 2006.
“During 2006, we achieved a number of important milestones,” stated Patrick J. McEnany, Chief Executive Officer of Catalyst Pharmaceutical Partners. “In November, we completed our initial public offering raising net proceeds of approximately $17.6 million, which we expect will allow us to fund the advancement of CPP-109 through two U.S. Phase II clinical trials to evaluate CPP-109s effectiveness for the treatment of cocaine addiction and methamphetamine addiction and a U.S. Phase III clinical trial to evaluate CPP- 109’s effectiveness for the treatment of cocaine addiction. In addition, we have completed the production of sufficient clinical trial quantities of CPP- 109 for use in our upcoming clinical trials. Finally, the FDA has granted us ‘Fast Track’ status with respect to CPP-109 to treat cocaine addiction.”
“Also, during the year, we have strengthened our Company by adding several key members to our management team and scientific advisory board. We believe that their individual as well as collective expertise will serve us well as we push forward with the clinical development and ultimate commercialization of CPP-109 for the treatment of both cocaine addiction and methamphetamine addiction,” concluded Mr. McEnany.
Financial Results
For the year ended December 31, 2006, the net loss was $2,729,454, or $0.36 per basic and diluted share, compared to a net loss of $1,805,380, or $0.29 per basic and diluted share, in the prior year. Results for 2006 and 2005 include non-cash charges relating to stock-based compensation of $1,220,739 and $1,172,750, respectively.
Research and development expenses for 2006 were $989,144, compared to $1,330,515 in 2005. This includes stock-based compensation for 2006 and 2005 of $344,649 and $881,000, respectively.
General and administrative expenses for 2006 were $1,913,183, compared to $491,653 in 2005. This includes stock-based compensation for 2006 and 2005 of $876,090 and $291,750, respectively. General and administrative expenses increased significantly in 2006 compared to 2005 due to the Company expanding its staff in preparation for its product development efforts and its IPO.
For the fourth quarter of 2006, the net loss was $741,241, or $0.07 per basic and diluted share, compared to a net loss of $255,937 or $0.04 per basic and diluted share, for the same period in 2005. Results for the fourth quarters of 2006 and 2005 include non-cash charges relating to stock-based compensation of $150,795 and $79,687, respectively.
As a development stage pharmaceutical company, Catalyst had no revenues during 2006 and 2005.
In November 2006, Catalyst completed its IPO. In the IPO, the Company sold 3,350,000 shares of its common stock at an initial public offering price of $6.00 per share and received net proceeds from the offering of approximately $17.6 million.
At December 31, 2006 the Company had cash and cash equivalents totaling $20.4 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.
Company Development Update
In January 2007, Company reported that it would conduct two U.S. Phase II clinical trials, one to evaluate the use of CPP-109 in the treatment of cocaine addiction and the other to evaluate the use of CPP-109 in the treatment of methamphetamine addiction. Each clinical trial is expected to be a double-blind, randomized, placebo-controlled study with approximately 150 patients.
While the protocols for these contemplated U.S. Phase II clinical trials are not yet finalized, the Company expects, based on currently available information, that it will commence its U.S. Phase II clinical trial evaluating CPP-109 for the treatment of cocaine addiction during the second quarter of 2007 and its U.S. Phase II clinical trial evaluating CPP-109 for the treatment of methamphetamine addiction during the third quarter of 2007.
The Company expects to receive the results of the first of its Phase II clinical trials evaluating the use of CPP-109 in the treatment of cocaine addiction in the second quarter of 2008 and the results of its second U.S. Phase II clinical trial evaluating the use of CPP-109 in the treatment of methamphetamine addiction sometime shortly thereafter.
In March 2007, the Company completed the production of clinical trial quantities of CPP-109 and commenced a study to demonstrate that CPP-109 is bioequivalent to “Sabril” (registered trademark of Sanofi-Aventis), which could provide data potentially linking CPP-109 to the extensive body of published clinical literature on vigabatrin. The Company expects to have the results of its bioequivalence study in the second quarter of 2007.
In addition, the Company is supporting, through an unrestricted grant to the New York University School of Medicine, an investigator-sponsored clinical trial to take place in Mexico. The study is being undertaken by a member of the Company’s Scientific Advisory Board, Jonathan Brodie, Ph.D., M.D., a Professor of Psychiatry at New York University School of Medicine, and by Emilia Figueroa, M.D., an addiction physician specialist who directs several addiction clinics in Mexico. The clinical trial is a double-blind, randomized, placebo-controlled trial involving approximately 100 patients selected from a pool of cocaine-dependent prison parolees who meet specific clinical diagnostic standards for cocaine dependence. Enrollment for the study commenced in the first quarter of 2007.
About Catalyst Pharmaceutical Partners, Inc.
Catalyst Pharmaceutical Partners 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 is CPP-109, which is based on the compound gamma-vinyl-GABA. 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 those described in the Annual Report on Form 10-K 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, 2006, 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.
CATALYST PHARMACEUTICAL PARTNERS, INC. CONDENSED STATEMENTS OF OPERATIONS Year Ended December 31, 2006 2005 Revenues $ - $ - Operating costs and expenses: Research and development 989,144 1,330,515 General and administrative 1,913,183 491,653 Total operating expenses 2,902,327 1,822,168 Loss from operations (2,902,327) (1,822,168) Interest income 172,873 16,788 Loss before income taxes (2,729,454) (1,805,380) Provision for income taxes - - Net loss $(2,729,454) $(1,805,380) Basic and diluted net loss per share $ (0.36) $ (0.29) Weighted average shares outstanding - basic and diluted 7,687,630 6,204,918 CATALYST PHARMACEUTICAL PARTNERS, INC. CONDENSED BALANCE SHEETS December 31, 2006 2005 ASSETS Current Assets: Cash and cash equivalents $ 20,434,702 $ 771,127 Interest receivable 85,787 - Prepaid expenses 67,333 440 Total current assets 20,587,822 771,567 Property and equipment, net 20,157 4,031 Deposits 11,500 13,852 Total assets $ 20,619,479 $ 789,450 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $ 448,072 $ 67,753 Accrued expenses 324,774 275,235 Total current liabilities 772,846 342,988 Total stockholders’ equity 19,846,633 446,462 Total liabilities and stockholders’ equity $ 20,619,479 $ 789,450
Catalyst Pharmaceutical Partners, Inc.
CONTACT: Jack Weinstein of Catalyst Pharmaceutical Partners, Inc., ChiefFinancial Officer, +1-201-934-4201; or Melody Carey for Rx Communications,+1-917-322-2571
Web site: http://www.catalystpharma.com/
