CORAL GABLES, Fla., April 2, 2013 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases and disorders, today reported financial results for the fourth quarter and year ended December 31, 2012.
Patrick J. McEnany, CEO of Catalyst, commented, "2012 was a very challenging and yet transformational year for our company. Clearly the Catalyst team was very disappointed with the results of our Phase IIb clinical trial for CPP-109 as a potential treatment for cocaine addiction. We had high expectations to be able to deliver the first effective drug therapy for this horrific, intractable disease. We want to thank all the patients, patients' families, physicians, investigators and our partner, the National Institute on Drug Abuse, for their support and involvement in this project."
Mr. McEnany continued, "On the bright side, during the fourth quarter of 2012 we completed a strategic alliance with BioMarin Pharmaceutical Inc., where we acquired the North American rights to Firdapse™, a late stage Phase III program to treat Lambert-Eaton Myasthenic Syndrome, (LEMS), a rare autoimmune, neuromuscular disease with the primary symptoms of progressive muscle weakness and fatigue. Also, as part of the transaction, BioMarin made a $5 million equity investment in Catalyst, resulting in a 16.6% stake in the Company. CPP-115 has successfully completed a Phase Ia, first-in-man study. The near-term advancement of CPP-115 for the Infantile Spasm indication will require a strategic partner or grant funding. We have recently augmented our management team in the areas of regulatory and clinical operations and expect to add a senior commercial operations person in the second quarter of this year. Finally, we ended 2012 with a healthy balance sheet and have sufficient cash and cash equivalents, certificates of deposits and short-term investments to fund our research and development activities for Firdapse™ and other operations through the first quarter of 2014."
Financial Results
For the year ended December 31, 2012, Catalyst's net loss was $4,076,386, or $0.14 per basic and diluted share, compared to a net loss of $6,391,062, or $0.29 per basic and diluted share, in the prior year. Research and development expenses for 2012 were $2,659,597, compared to $3,383,965 in 2011. General and administrative expenses for 2012 were $2,561,543, compared to $2,698,174 in 2011. Change in fair value of warrants liability, a non-cash item, resulted in a gain of $1,129,778 for 2012, as compared to a loss of $319,908 for 2011.
For the fourth quarter of 2012, Catalyst's net loss was $76,585, or $0.00 per basic and diluted share, compared to a net loss of $2,351,934, or $0.10 per basic and diluted share, for the same period in 2011.
At December 31, 2012, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $15.4 million and no debt. Catalyst believes that its existing cash and investments will be sufficient to meet its projected operating requirements through the first quarter of 2014.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc., is a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases and disorders, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette's Syndrome. Catalyst's lead candidate, Firdapse™ for the treatment of LEMS, is currently undergoing testing in a global, multi-center, pivotal phase III trial. Catalyst is also developing a potentially safer and more potent vigabatrin analog (designated CPP-115) to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder, Tourette's Syndrome, and movement disorders associated with the treatment of Parkinson's Disease.
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 whether the Phase III trial will be successful, whether the Phase III trial will be completed on the expected timeline, whether any of the Company's product candidates will ever be approved for commercialization, as well as those 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) STATEMENTS OF OPERATIONS |
|||
| Year Ended December 31, | |||
| 2012 | 2011 | 2010 | |
| Revenues – government grant | $ -- | $ -- | $ 488,958 |
| Operating costs and expenses: | |||
| Research and development | 2,659,597 | 3,383,965 | 2,306,781 |
| General and administrative | 2,561,543 | 2,698,174 | 2,206,358 |
| Total operating costs and expenses | 5,221,140 | 6,082,139 | 4,513,139 |
| Loss from operations | (5,221,140) | (6,082,139) | (4,024,181) |
| Interest income | 14,976 | 10,985 | 17,858 |
| Change in fair value of warrants liability | 1,129,778 | (319,908) | -- |
| Loss before income taxes | (4,076,386) | (6,391,062) | (4,006,323) |
| Provision for income taxes | -- | -- | -- |
| Net loss | $ (4,076,386) | $ (6,391,062) | $ (4,006,323) |
| Net loss per share - basic and diluted |
$ (0.14) |
$ (0.29) | $ (0.22) |
| Weighted average shares outstanding – basic and diluted | 30,033,108 | 21,728,292 | 18,580,223 |
|
CATALYST PHARMACEUTICAL PARTNERS, INC. (a development stage company) CONDENSED BALANCE SHEETS |
||
| December 31, | ||
| 2012 | 2011 | |
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 1,409,939 | $ 6,029,067 |
| Certificates of deposit | 6,502,825 | -- |
| Short-term investments | 7,504,444 | -- |
| Prepaid expenses | 1,309,470 | 199,116 |
| Total current assets | 16,726,678 | 6,228,183 |
| Property and equipment, net | 53,679 | 12,186 |
| Deposits | 8,888 | 8,888 |
| Total assets | $ 16,789,245 | $ 6,249,257 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 1,365,663 | $ 263,934 |
| Accrued expenses and other liabilities | 281,002 | 569,867 |
| Total current liabilities | 1,646,665 | 833,801 |
| Accrued expenses and other liabilities, non-current | 21,878 | 9,518 |
| Warrants liability, at fair value | 498,587 | 1,645,240 |
| Total liabilities | 2,167,130 | 2,488,559 |
| Total stockholders' equity | 14,622,115 | 3,760,698 |
| Total liabilities and stockholders' equity | $ 16,789,245 | $ 6,249,257 |