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 14, 2011
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 1500
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 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01 | Other Events |
Appointment of Richard P. Rieger as Vice President, Commercial Operations
On November 14, 2011, Richard P. Rieger began employment as the Company’s Vice President, Commercial Operations. In this capacity, Mr. Rieger will be primarily responsible for the creation of co-development, in-and out-licensing agreements and co-marketing and co-promotion partnerships.
Prior to his employment with the Company, from March 2011 to November 2011, Mr. Rieger served as Vice President, Business Development for PhaseRx, an early stage biotechnology company with a novel drug delivery technology. From January 2006 to March 2011, Mr. Rieger served as Senior Engagement Manager, Life Sciences and Medical Technology for L.E.K. Consulting, where he was a consultant for numerous engagements. From 2004 through 2006, Mr. Rieger served as Vice President, Business Development for Dendreon Corporation. From 1996 through 2004, Mr. Rieger served in varying capacities for Abbott Laboratories, including as the company’s Director, Licensing and Business Development. Mr. Rieger holds a Bachelor of Science in Electrical Engineering from the University of Notre Dame and an MBA in Finance and Business Policy from the University of Chicago.
On November 14, 2011, the Company issued a press release announcing the appointment of Mr. Rieger to the newly created position of Vice President, Commercial Operations. A copy of the press release is attached as Exhibit 99.1 to this Current Report on
Form 8-K.
Announcement of Third Quarter 2011 Financial Results
On November 15, 2011, the Company issued a press release announcing its third quarter 2011 financial and operational results. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
| (c) | Exhibits |
| 99.1 | Press Release issued by the Company on November 14, 2011, announcing the appointment of Richard Rieger as Vice President, Commercial Operations. | |
| 99.2 | Press Release issued by the Company on November 15, 2011 announcing the Company’s financial and operational results for the three and nine month periods ended September 30, 2011. | |
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.
| Catalyst Pharmaceutical Partners, Inc. | ||
| By: | /s/ Jack Weinstein | |
| Jack Weinstein | ||
| Vice President, Treasurer and CFO | ||
Dated: November 16, 2011
Exhibit 99.1
| NEWS RELEASE | FOR IMMEDIATE RELEASE | |
| For Further Information Contact: | ||
| Patrick J. McEnany | Melody Carey | |
| Catalyst Pharmaceutical Partners | Rx Communications Group | |
| Chief Executive Officer | Co-President | |
| (305) 529-2522 | (917) 322-2571 | |
| pmcenany@catalystpharma.com | mcarey@rxir.com | |
CATALYST PHARMACEUTICAL PARTNERS APPOINTS RICHARD P. RIEGER
AS VICE PRESIDENT, COMMERCIAL OPERATIONS
CORAL GABLES, FL, November 14, 2011 — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) (“Company”) today announced that Richard P. Rieger has been appointed as Vice President, Commercial Operations, effective immediately. Rieger brings extensive corporate development and management consulting experience to Catalyst from the pharmaceutical, biotechnology and high-tech industries.
In this newly created position, Rieger will provide strategic leadership as the Company pursues business development and commercialization opportunities around its portfolio of drugs utilizing Catalyst’s proprietary GABA aminotransferase inhibition (GABA-AT) technology for addictions, epilepsy and other diseases of the central nervous system (CNS). Rieger will report to Patrick J. McEnany, Catalyst’s President and CEO.
“Rich is a proven leader with the vision and experience to maximize the value of our GABA-AT technology, as well as any broader set of CNS opportunities that we may decide to pursue,” said McEnany. “He brings to Catalyst a unique background in pharmaceutical and biotech strategy, business development, marketing and consulting, including franchise development and licensing/M&A in the CNS area. We believe that Rich will add great value to our management team as our addiction, epilepsy and other potential CNS programs unfold.”
“Catalyst’s CPP-109 and CPP-115 products have transformational potential for patients, and have advanced to the stage where strategic alliances can be considered to further advance them through development and commercialization,” said Rieger. Catalyst has an outstanding group of Officers, Directors and Scientific Advisors, as well as excellent clinical development relationships with the National Institute on Drug Abuse and the Veteran’s Administration. These relationships further support my belief in the potential of Catalyst’s current portfolio. I look forward to contributing my experience at this stage of the Company’s development.”
Mr. Rieger has over 15 years of experience in the pharmaceutical and biotech industries in a wide range of positions, and joins Catalyst from PhaseRx, Inc. where he served as Vice President, Business Development and the leader of their commercial initiatives. As a Senior Engagement Manager in L.E.K. Consulting’s Life Sciences & Medical Technology practice, Mr. Rieger led more than 50 strategic engagements involving licensing/M&A, commercial planning and portfolio development, including corporate strategy, industry-leading licensing/M&A transactions and commercial support for CNS clients. Mr. Rieger also served as Vice President, Business Development at Dendreon Corporation and held positions of increasing responsibility in business development and marketing at Abbott Laboratories, also including CNS transactions and franchises.
Mr. Rieger earned an MBA in Finance and Business Policy with honors from the University of Chicago's Booth School of Business and a Bachelor of Science Degree in Electrical Engineering from the University of Notre Dame.
About Catalyst Pharmaceutical Partners, Inc.
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of addiction and epilepsy. Catalyst has two products in development, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109 (vigabatrin), 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. 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 (initially infantile spasms) and for other selected central nervous disease indications. 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 the inhibition of GABA aminotransferase. For more information about Catalyst, 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 those described in the Company’s filings with the 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.
# # #
Page 2
Exhibit 99.2
| NEWS RELEASE | FOR IMMEDIATE RELEASE | |
| For Further Information Contact: | ||
| Jack Weinstein | Melody Carey | |
| Chief Financial Officer | Co-President | |
| Catalyst Pharmaceutical Partners | Rx Communications | |
| (201) 934-4201 | (917) 322-2571 | |
| jweinstein@catalystpharma.com | mcarey@rxir.com | |
CATALYST PHARMACEUTICAL PARTNERS
ANNOUNCES THIRD QUARTER 2011 FINANCIAL RESULTS
CORAL GABLES, FL, November 15, 2011 — Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) today announced its financial results for the third quarter and nine months ended September 30, 2011. For the three months ended September 30, 2011, the Company reported a net loss of $1,127,841, or $0.05 per basic and diluted share, compared to a net loss of $903,985, or $0.05 per basic and diluted share, for the same period in 2010. For the nine months ended September 30, 2011, the Company reported a net loss of $4,039,128, or $0.19 per basic and diluted share, compared to a net loss of $3,277,569, or $0.18 per basic and diluted share, for the same period in 2010.
Research and development expenses for the third quarter of 2011 were $614,137, compared to $500,091 in the third quarter of 2010. Research and development expenses for the nine months ended September 30, 2011 were $2,423,725, compared to $1,737,613 for the same period in 2010. The increase is the result of increased clinical trial activity in the first nine months of 2011 as compared to the prior year. The Company expects that research and development expenses will increase during the balance of 2011 as, among other activities, the Company moves forward with its Phase I(a) human safety study of CPP-115. General and administrative expenses for the third quarter of 2011 totaled $516,873, compared to $408,374 in the third quarter of 2010. General and administrative expenses for the first nine months of 2011 totaled $1,623,998 compared to $1,554,396 in the first nine months of 2010.
As a development stage pharmaceutical company, Catalyst had no revenues in either the first nine months of 2011 or first nine months of 2010.
At September 30, 2011, the Company had cash, cash equivalents and CDs totaling $4.2 million and no debt. Subsequent to quarter-end, on November 2, 2011, the company completed a public offering of common stock together with warrants with net proceeds totaling approximately $3,150,000. The Company believes that it now has the resources necessary to fund all of its currently ongoing projects and has sufficient working capital to support its operations through the second quarter of 2013, during which time the Company expects to receive the top-line data from its Phase II(b) trial evaluating CPP-109 for the treatment of cocaine addiction.
“During the third quarter, we continued to actively enroll patients in our CPP-109 Phase II(b) trial. We are pleased with our progress and currently expect to complete this trial’s enrollment during the first half of 2012 and to report top-line results during the fourth quarter of 2012,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “In addition, we expect to commence a Phase I(a) safety study for CPP-115 in this quarter. Our goal is to complete this study by the
end of the first quarter or the beginning of the second quarter of 2012. We are also hoping to do additional CPP-115 non-clinical and clinical studies for a variety of central nervous system diseases and addiction disorders.”
Recent Accomplishments and Upcoming Events
| • | On August 31, 2011, Dr. Richard B. Silverman, the inventor of CPP-115, presented data regarding CPP-115 at the American Chemical Society Annual Fall Meeting. The presentation discussed the medical relevance of GABA aminotransferase inactivators in the treatment of epilepsy and drug addiction, the history of the discovery of CPP-115, a detailed mechanistic analysis of GABA-AT inactivators, and a summary of CPP-115’s pharmacological properties, including its superior visual safety profile and potency compared to vigabatrin. |
| • | On September 21, 2011, the Company adopted a Stockholder Rights Plan designed to provide adequate time for the Board of Directors and the stockholders to assess an unsolicited takeover bid for the Company, to provide the Board of Directors with sufficient time to explore and develop alternatives for maximizing shareholder value if a takeover bid is made, and to provide stockholders with an equal opportunity to participate in a takeover bid and receive full and fair value for their common shares. |
| • | On October 25, 2011, the Company presented at the BIO Investor Forum in San Francisco. |
| • | October 28, 2011, the Company sold 3,046,740 shares of the its common stock together with warrants to purchase 1,523,370 shares of its common stock at a price of $1.15 per share and corresponding warrant and received gross proceeds of approximately $3.5 million. |
| • | On November 14, 2011, the Company announced that Richard P. Rieger has joined Catalyst as Vice President of Commercial Operations. Rieger will provide strategic leadership as Catalyst pursues business development and commercialization opportunities around its portfolio of drugs utilizing the Company’s proprietary GABA aminotransferase inhibition technology. |
| • | The Company has submitted for review an Investigational New Drug Application (IND) for CPP-115 and, following the acceptance of such IND, the Company expects to commence a Phase I(a) human safety study evaluating CPP-115 in healthy volunteers. Based on current information, the Company expects to commence this study during this quarter, and to report results from this study during the first quarter or the beginning of the second quarter of 2012. |
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of addiction and epilepsy. Catalyst has two products in development, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109 (vigabatrin), 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. 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 (initially
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infantile spasms) and for other selected central nervous disease indications. 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 the inhibition of GABA aminotransferase. For more information about Catalyst, 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 forward looking statements contained in this press release, including the anticipated timing of the receipt of results from the Company’s Phase II(b) trial evaluating CPP-109 for the treatment of cocaine addiction, the anticipated timing of the receipt of results from the Company’s upcoming Phase I(a) study evaluating CPP-115 in healthy volunteers, and those forward looking statements contained in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), may prove to be incorrect, which 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, |
|||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Revenues |
$ | — | $ | — | $ | — | $ | — | ||||||||
| Operating costs and expenses: |
||||||||||||||||
| Research and development |
614,137 | 500,091 | 2,423,725 | 1,737,613 | ||||||||||||
| General and administrative |
516,873 | 408,374 | 1,623,998 | 1,554,396 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating costs and expenses |
1,131,010 | 908,465 | 4,047,723 | 3,292,009 | ||||||||||||
|
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|
|
|
|
|
|
|
|||||||||
| Loss from operations |
(1,131,010 | ) | (908,465 | ) | (4,047,723 | ) | (3,292,009 | ) | ||||||||
| Interest income |
3,169 | 4,480 | 8,595 | 14,440 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Loss before income taxes |
(1,127,841 | ) | (903,985 | ) | (4,039,128 | ) | (3,277,569 | ) | ||||||||
| Provision for income taxes |
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net loss |
$ | (1,127,841 | ) | $ | (903,985 | ) | $ | (4,039,128 | ) | $ | (3,277,569 | ) | ||||
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|
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|
|||||||||
| Loss per share – basic and diluted |
$ | (0.05 | ) | $ | (0.05 | ) | $ | (0.19 | ) | $ | (0.18 | ) | ||||
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|
|
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|
|||||||||
| Weighted average shares outstanding – basic and diluted |
21,654,680 | 18,821,881 | 21,083,485 | 18,305,735 | ||||||||||||
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CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
| September 30, 2011 |
December 31, 2010 |
|||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: |
||||||||
| Cash and cash equivalents |
$ | 2,151,432 | $ | 5,475,158 | ||||
| Certificate of deposit |
2,003,707 | — | ||||||
| Government grant receivable |
— | 134,025 | ||||||
| Prepaid expenses |
113,820 | 166,221 | ||||||
|
|
|
|
|
|||||
| Total current assets |
4,268,959 | 5,775,404 | ||||||
| Property and equipment, net |
18,281 | 45,573 | ||||||
| Deposits |
10,511 | 10,511 | ||||||
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| Total assets |
$ | 4,297,751 | $ | 5,831,488 | ||||
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| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: |
||||||||
| Accounts payable |
$ | 174,038 | $ | 105,933 | ||||
| Accrued expenses and other liabilities |
248,616 | 193,028 | ||||||
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|
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| Total current liabilities |
422,654 | 298,961 | ||||||
| Accrued expenses and other liabilities, non-current |
— | 14,748 | ||||||
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|
|
|||||
| Total liabilities |
422,654 | 313,709 | ||||||
| Total stockholders’ equity |
3,875,097 | 5,517,779 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 4,297,751 | $ | 5,831,488 | ||||
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