CORAL GABLES, FL, August 13, 2010 -- Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) today announced its financial results for the second quarter and six months ended June 30, 2010.
Second Quarter 2010 Results
The Company reported a net loss of $1,328,541, or $0.07 per basic and diluted share, compared to a net loss of $1,761,887, or $0.13 per basic and diluted share, for the same period in 2009. For the six months ended June 30, 2010, the Company reported a net loss of $2,373,584, or $0.13 loss per basic and diluted share, compared to a net loss of $4,793,088, or $0.34 loss per basic and diluted share, for the same period in 2009.
Research and development expenses for the second quarter of 2010 were $797,935, compared to $1,238,253 in the second quarter of 2009. Research and development expenses for the six months ended June 30, 2010 were $1,237,522 compared to $3,698,885 for the first six months of 2009. The reduction is the result of decreased clinical trial activity in the first half of 2010 as compared to the prior year. The Company expects that research and development expenses will increase during the balance of 2010.
General and administrative expenses for the second quarter of 2010 totaled $535,197, compared to $530,559 in the second quarter of 2009. General and administrative expenses for the first six months of 2010 totaled $1,146,022 compared to $1,114,470 in the first six months of 2009.
As a development stage pharmaceutical company, Catalyst has no revenues to-date.
At June 30, 2010, the Company had cash and cash equivalents of $5.6 million and no debt. Based on the registered direct stock offering that Catalyst completed on August 9, 2010, cash and cash equivalents at June 30, 2010 totaled $7.1 million on a pro-forma basis. The Company believes it has sufficient capital to fund its ongoing CPP-109 and CPP-115 research and development activities and to continue its operations through at least the first quarter of 2012.
Second Quarter Accomplishments
? Signed a definitive Clinical Trial Agreement with the National Institute on Drug Abuse (NIDA) to collaborate on a U.S. Phase II(b) clinical trial evaluating CPP-109 for the treatment of cocaine addiction. The Company expects to enroll 200 subjects at 12 sites across the United States. ? Presented data from Catalyst’s recently completed Phase II(a) cocaine addiction trial at the American Society of Addiction Medicine Annual Medical-Scientific Conference. ? Presented CPP-109 data at the College on Problems of Drug Dependence which supports its continued development as a treatment for cocaine and methamphetamine addiction. ? Commenced non-clinical safety and efficacy studies for CPP-115.
Significant Recent and Upcoming Events
? In August, raised $1.5 million in a registered direct offering of common stock with two mutual funds. ? Expect to commence the CPP-109 U.S. Phase II(b) cocaine trial in the fall of 2010, with top-line results from this trial expected in the first quarter of 2012. ? Expect to report results of CPP-115 non-clinical trials in the third quarter of 2010. ? Expect to commence a CPP-109 investigator sponsored cocaine/alcohol co-morbidity study at the University of Pennsylvania by year-end.
“We are very pleased to have completed our $1.5 million registered direct offering which was completed at the market price of our common stock on the day we entered into the agreement to sell the shares,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “We expect that this financing will provide sufficient capital for Catalyst to operate through the announcement of top-line results for the CPP-109 U.S. Phase II(b) cocaine trial. In addition, CPP-115 non-clinical studies are well underway evaluating safety and efficacy in animal models for addiction, epilepsy and neuropathic pain. We expect to report the results of these studies by the end of the third quarter. Based upon the results of those studies, we hope to explore partnering opportunities for CPP-115, as well as to seek non-dilutive financing in various forms.”
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting addiction and diseases of the central nervous system, such as epilepsy and neuropathic pain. Catalyst has two products in development, and is currently evaluating the lead product candidate, CPP- 109 (vigabatrin, a GABA aminotransferase inhibitor) for the treatment of cocaine addiction. CPP-109 has been granted “Fast Track” status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction, which 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 an unmet medical need. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions and obsessive- compulsive disorders. Catalyst is also in the early stages of developing CPP-115, another GABA aminotransferase inhibitor that could be more potent than vigabatrin but may have reduced side effects (e.g., visual field defects, or VFDs) from those associated with vigabatrin. Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy and neuropathic pain. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to GABA aminotransferase. For more information about the Company, go to www.catalystpharma.com.
Forward-Looking Statements
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 anticipated timing of the completion of the studies described in this press release and the other factors described in the Company’s filings 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 Ended June 30, For the Six Months Ended June 30, 2010 2009 2010 2009
venues.............................................. $ - $ - $ - $ -
erating costs and expenses: search and development.................. 797,935 1,238,253 1,237,522 3,698,885 neral and administrative................... 535,197 530,559 1,146,022 1,114,470 tal operating costs and expenses..... 1,333,132 1,768,812 2,383,544 4,813,355 ss from operations ............................ (1,333,132) (1,768,812) (2,383,544) (4,813,355) erest income ..................................... 4,591 6,925 9,960 20,267 ss before income taxes..................... (1,328,541) (1,761,887) (2,373,584) (4,793,088) ovision for income taxes ................... - - - - t loss................................................. $ (1,328,541) $ (1,761,887) $ (2,373,584) $ (4,793,088) ss per share – basic and diluted....... $ (0.07) $ (0.13) $ (0.13) $ (0.34) eighted average shares standing – basic and diluted........... 18,043,385 14,065,385 18,043,385 14,065,385
CATALYST PHARMACEUTICAL PARTNERS, INC. (a development stage company)
CONDENSED BALANCE SHEETS
June 30, 2010
December 31, 2009 (unaudited) ASSETS Current Assets: Cash and cash equivalents................................... $ 5,608,368 $ 7,779,277 Prepaid expenses ................................................. 236,728 108,147 Total current assets .......................................... 5,845,096 7,887,424 Property and equipment, net................................. 55,367 68,447 Deposits ................................................................ 10,511 10,511 Total assets ...................................................... $ 5,910,974 $ 7,966,382
LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable.................................................. $ 251,969 $ 249,635 Accrued expenses and other liabilities.................. 199,224 44,517 Total current liabilities....................................... 451,193 294,152 Accrued expenses and other liabilities, non-current 47,370 54,370 Total liabilities 498,563 348,522
Total stockholders’ equity ........................................ 5,412,411 7,617,860 Total liabilities and stockholders’ equity................... $ 5,910,974 $ 7,966,382
