CORAL GABLES, Fla., Aug. 7 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today reported financial results for the second quarter and six months ended June 30, 2009.
Second Quarter 2009 Results
For the quarter ended June 30, 2009, the Company reported a net loss of $1,761,887, or $0.13 per basic and diluted share, compared to a net loss of $2,377,440, or $0.19 per basic and diluted share for the same period in 2008. Second quarter 2009 results included non-cash charges relating to stock-based compensation in the amount of $64,532, compared to $123,208 in the same period in 2008. For the six months ended June 30, 2009, the Company reported a net loss of $4,793,088, or $0.34 loss per basic and diluted share, compared to a net loss of $3,961,487, or $0.32 loss per basic and diluted share, for the same period in 2008. Results for the first six months of 2009 included non-cash charges relating to stock-based compensation in the amount of $206,806, compared to $386,612 in the same period in 2008.
Research and development expenses for the second quarter of 2009 were $1,376,253 compared to $1,902,144 in the second quarter of 2008, including non-cash stock-based compensation of $48,440 and $99,532, respectively. Research and development expenses for the six months ended June 30, 2009 were $3,698,885 compared to $2,986,503 for the first six months of 2008, including non-cash stock-based compensation of $120,140 and $274,088, respectively.
General and administrative expenses for the second quarter of 2009 totaled $392,559 compared to $561,533 for the second quarter of 2008, including non-cash stock-based compensation of $16,092 and $23,676, respectively. General and administrative expenses for the first six months of 2009 totaled $1,114,470 compared to $1,201,206 in the first six months of 2008, including non-cash stock-based compensation of $86,666 and $112,524, respectively.
As a development stage biopharmaceutical company, Catalyst has no revenues to-date. At June 30, 2009, the Company had cash and cash equivalents totaling $6.3 million and no long-term debt.
"We have sufficient cash to complete the analysis of the results from our cocaine trial and methamphetamine study and to continue our operations through the end of 2010 without additional funding," said Patrick J. McEnany, Catalyst's Chief Executive Officer. "We believe that our financial and human resources are sufficient to pursue a variety of strategies, which we will discuss in detail as they are developed. We are encouraged in that regard by renewed investors' appetite for investing in our industry. While there can be no assurance, we hope, if we obtain positive results from the analysis of our trial data, that we will be able to attract new capital from investors and/or through potential strategic alliances that will allow us to pursue future clinical and non-clinical trials of CPP-109."
"We are currently evaluating the data from our Phase II clinical trial evaluating the use of CPP-109 for the treatment of cocaine addiction and our proof-of-concept study evaluating the use of CPP-109 for the treatment of methamphetamine addiction," continued Mr. McEnany. "We expect to report the results of the cocaine trial and methamphetamine proof-of-concept study by the end of the third quarter of 2009. Based on the results of this analysis, we will evaluate what measures, if any, could be applied to improve the outcome of future studies and will also determine the next steps to be taken regarding the development of CPP-109, including the clinical and non-clinical trials that will be required for us to file an NDA for CPP-109. We will report our future product development plans once they are developed."
McEnany concluded, "Catalyst, along with leading addiction clinicians across the U.S., continues to seek governmental grants from the National Institutes of Health ("NIH"), the National Institute on Drug Abuse, and other agencies that operate under the NIH umbrella, for future vigabatrin addiction trials and to provide a portion of the required funding for our future clinical and non-clinical trials."
Publication of Phase II Mexican Cocaine Trial Results
A paper describing the positive results obtained in an investigator-initiated Phase II trial conducted in Mexico in 2007 was published on August 3, 2009 in the online edition of The American Journal of Psychiatry, a world leading peer-reviewed medical journal. The paper, entitled "Randomized, Double-Blind, Placebo-Controlled Trial of Vigabatrin for the Treatment of Cocaine Dependence in Mexican Parolees," was authored by Jonathan D. Brodie, M.D., Ph.D., Brady G. Case, M.D., Emilia Figueroa, M.D., Stephen L. Dewey, Ph.D., James A. Robinson, M.Ed., Joseph A. Wanderling, M.A. and Eugene M. Laska, Ph.D. The paper suggests that vigabatrin may be effective in the treatment of cocaine addiction. An abstract of the paper can be accessed by clicking here.
"We are extremely pleased that the results of this important trial have been published by a medical journal of this caliber," commented Mr. McEnany. "Catalyst is pleased to have provided financial support for this trial."
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 June 30, 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.
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, -------------- -------------- 2009 2008 2009 2008 ---- ---- ---- ---- Revenues $- $- $- $- Operating costs and expenses: Research and development 1,376,253 1,902,144 3,698,885 2,986,503 General and administrative 392,559 561,533 1,114,470 1,201,206 ------- ------- ------- ------- Total operating costs and expenses 1,768,812 2,463,677 4,813,355 4,187,709 ------- ------- ------- ------- Loss from operations (1,768,812) (2,463,677) (4,813,355) (4,187,709) Interest income 6,925 86,237 20,267 226,222 ------- ------- ------- ------- Loss before income taxes (1,761,887) (2,377,440) (4,793,088) (3,961,487) Provision for income taxes - - - - ------- ------- ------- ------- Net loss $(1,761,887) $(2,377,440) $(4,793,088) $(3,961,487) ======= ======= ======= ======= Loss per share- basic and diluted $(0.13) $(0.19) $(0.34) $(0.32) Weighted average shares outstanding - basic and diluted 14,065,385 12,567,226 14,065,385 12,560,085 ======= ======= ======= ======= CATALYST PHARMACEUTICAL PARTNERS, INC. (a development stage company) CONDENSED BALANCE SHEETS June 30, December 31, 2009 2008 -------- ------------ (unaudited) ASSETS Current Assets: Cash and cash equivalents $6,265,577 $11,766,629 Interest receivable - 12,153 Prepaid expenses 124,673 136,374 ------- ------- Total current assets 6,390,250 11,915,156 Property and equipment, net 80,537 96,376 Deposits 10,511 21,436 ------ ------ Total assets $6,481,298 $12,032,968 ========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $275,663 $332,707 Accrued expenses and other liabilities 195,282 1,097,410 ------- --------- Total current liabilities 470,945 1,430,117 Accrued expenses and other liabilities, non-current 36,420 42,636 ------ ------ Total liabilities 507,365 1,472,753 Total stockholders' equity 5,973,933 10,560,215 --------- ---------- Total liabilities and stockholders' equity $6,481,298 $12,032,968 ========== ===========
|SOURCE Catalyst Pharmaceutical Partners, Inc.|
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