UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

November 16, 2010

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED)

Commission File No. 001-33057

 

 

CATALYST PHARMACEUTICAL

PARTNERS, INC.

(Exact Name Of Registrant As Specified In Its Charter)

 

 

 

Delaware		76-0837053
(State Or Other Jurisdiction Of Incorporation Or Organization)		(IRS Employer Identification No.)

355 Alhambra Circle, Suite 1370

Coral Gables, Florida 33134

(Address Of Principal Executive Offices)

(305) 529-2522

(Registrant’s Telephone Number, Including Area Code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 8.01

Other Events

On November 16, 2010, the Company issued a press release announcing its third quarter 2010 financial and operational results. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

99.1		Press release issued by the Company on November 16, 2010

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: November 16, 2010

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Exhibit Index

 

Exhibit No.		Description
99.1		Press release issued by the Company on November 16, 2010

 

Exhibit 99.1

 

NEWS RELEASE		FOR IMMEDIATE RELEASE
For Further Information Contact:
Jack Weinstein		Melody Carey
Catalyst Pharmaceutical Partners		Rx Communications Group
Chief Financial Officer		Co-President
(201) 934-4201		(917) 322-2571
jweinstein@catalystpharma.com		mcarey@rxir.com

Catalyst Pharmaceutical Partners Announces

Third Quarter 2010 Financial and Operational Results

CORAL GABLES, FL, November 16, 2010 — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) today announced its financial and operational results for the third quarter and nine months ended September 30, 2010. Highlights for the third quarter of 2010 and subsequent events include:

 

•

Reported positive results of CPP-115 non-clinical trials in the fourth quarter of 2010.

 

•

Raised $1.5 million in the third quarter of 2010 through a registered direct offering of common stock to a major fundamental healthcare investor.

 

•

Received a $488,958 grant under the Qualifying Therapeutic Discovery Projects Program (section 48D of the Internal Revenue Code) in the fourth quarter of 2010.

 

•

Appointed Dr. Richard B. Silverman to the Company’s Scientific Advisory Board in the fourth quarter of 2010. Dr. Silverman is the inventor of Pfizer’s $3 billion pain medication, Lyrica®. Dr. Silverman is also the inventor of CPP-115, Catalyst’s newest GABA aminotransferase inhibitor.

 

•

Expect to initiate a registration-directed CPP-109 U.S. Phase II(b) cocaine trial this quarter, with top-line results from this trial expected in the second quarter of 2012.

 

•

Expect a CPP-109 investigator sponsored cocaine/alcohol co-morbidity study to commence at the University of Pennsylvania during the first quarter of 2011.

“We are pleased with the recently reported positive results of our CPP-115 non-clinical program,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “We expect to begin the remaining non-clinical studies shortly to enable us to file an IND for CPP-115 by the middle of next year. Our CPP-109 U.S. Phase II(b) cocaine trial in partnership with the National Institute on Drug Addiction (NIDA) and the U.S. Veterans Administration is on track to commence in the fourth quarter of 2010. We are also excited by the addition of Dr. Silverman to our Scientific Advisory Board, and we expect that Dr. Silverman will help us explore new ways to maximize the potential of his discoveries that we in-licensed from Northwestern University last year.”

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Third Quarter and Nine Months 2010 Results

For the three months ended September 30, 2010, the Company reported a net loss of $903,985, or $0.05 per basic and diluted share compared to a net loss of $1,286,720, or $0.09 per basic and diluted share, for the same period in 2009. For the nine months ended September 30, 2010, the Company reported a net loss of $3,277,569, or $0.18 loss per basic and diluted share, compared to a net loss of $6,079,808, or $0.43 loss per basic and diluted share, for the same period in 2009.

Research and development expenses for the third quarter of 2010 were $500,091, compared to $850,998 in the third quarter of 2009. Research and development expenses for the nine months ended September 30, 2010 were $1,737,613 compared to $4,549,883 for the first nine months of 2009. Expenses for research and development for the three and nine month periods ended September 30, 2010 decreased compared to amounts expended in the same periods in 2009 resulting from the completion in the third quarter of 2009 of the Company’s Phase II(a) clinical trial evaluating CPP-109 as a treatment of cocaine addiction and its proof-of-concept study evaluating CPP-109 as a treatment of methamphetamine addiction. The Company expects that costs related to research and development activities will increase for the remainder of 2010 and into 2011 as the Company expects to conduct additional non-clinical trials and a Phase I human clinical trial of CPP-115, and initiates the NIDA/VA U.S. Phase II(b) clinical trial evaluating CPP-109 as a treatment for cocaine addiction.

General and administrative expenses for the third quarter of 2010 totaled $408,374, compared to $441,316 in the third quarter of 2009. General and administrative expenses for the first nine months of 2010 totaled $1,554,396 compared to $1,555,786 in the first nine months of 2009.

As a development stage pharmaceutical company, Catalyst has no revenues to-date.

At September 30, 2010, the Company had cash and cash equivalents of $6.2 million and no debt.

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. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions and obsessive-compulsive disorders. Catalyst is also developing CPP-115, another GABA aminotransferase inhibitor that is more potent than vigabatrin and has 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. CPP-115 has been granted orphan-drug designation for the treatment of infantile spasms by the FDA. 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.

 

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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, the Company’s ability to fund current and anticipated clinical and non-clinical trials from its available working capital, the Company’s ability to obtain the financing required to complete the necessary studies to file an Investigational New Drug Application (IND) for CPP-115 and to fund a Phase I human clinical trial of CPP-115 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.

 

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CATALYST PHARMACEUTICAL PARTNERS, INC.

(a development stage company)

CONDENSED STATEMENTS OF OPERATIONS (unaudited)

 

		For the Three Months Ended September 30,								For the Nine Months Ended September 30,
		2010				2009				2010				2009
Revenues		$	—			$	—			$	—			$	—
Operating costs and expenses:
Research and development			500,091				850,998				1,737,613				4,549,883
General and administrative			408,374				441,316				1,554,396				1,555,786
Total operating costs and expenses			908,465				1,292,314				3,292,009				6,105,669
Loss from operations			(908,465	)			(1,292,314	)			(3,292,009	)			(6,105,669	)
Interest income			4,480				5,594				14,440				25,861
Loss before income taxes			(903,985	)			(1,286,720	)			(3,277,569	)			(6,079,808	)
Provision for income taxes			—				—				—				—
Net loss		$	(903,985	)		$	(1,286,720	)		$	(3,277,569	)		$	(6,079,808	)
Loss per share – basic and diluted		$	(0.05	)		$	(0.09	)		$	(0.18	)		$	(0.43	)
Weighted average shares outstanding – basic and diluted			18,821,881				14,065,385				18,305,735				14,065,385

 

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CATALYST PHARMACEUTICAL PARTNERS, INC.

(a development stage company)

CONDENSED BALANCE SHEETS

 

		September  30, 2010				December 31, 2009
		(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents		$	6,247,177			$	7,779,277
Prepaid expenses			108,567				108,147
Total current assets			6,355,744				7,887,424
Property and equipment, net			49,133				68,447
Deposits			10,511				10,511
Total assets		$	6,415,388			$	7,966,382
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable		$	241,271			$	249,635
Accrued expenses and other liabilities			154,795				44,517
Total current liabilities			396,066				294,152
Accrued expenses and other liabilities, non-current			18,771				54,370
Total liabilities			414,837				348,522
Total stockholders’ equity			6,000,551				7,617,860
Total liabilities and stockholders’ equity		$	6,415,388			$	7,966,382

 

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