UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[Mark One]
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
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For the Quarterly Period Ended September 30, 2006
OR
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o
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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Commission File No. 001-33057
CATALYST PHARMACEUTICAL PARTNERS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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76-0837053
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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220 Miracle Mile
Suite 234
Coral Gables, Florida
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33134
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
(305) 529-2522
Indicate by checkmark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such report(s), and (2) has been
subject to such filing requirements for the past 90 days. Yes
o
No
þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act (Check one):
Large Accelerated Filer
o
Accelerated Filer
o
Non-Accelerated Filer
þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes
o
No
þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date: 12,516,667 shares of common stock, $0.001 par value per share, were
outstanding as of December 6, 2006.
CATALYST PHARMACEUTICAL PARTNERS, INC.
INDEX
2
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
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September 30, 2006
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December 31, 2005
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(unaudited)
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ASSETS
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Current Assets:
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Cash and cash equivalents
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$
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3,003,436
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$
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771,127
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Prepaid expenses
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3,225
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440
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Total current assets
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3,006,661
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771,567
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Property and equipment, net
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19,717
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4,031
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Deferred public offering costs
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472,074
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Other assets
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13,555
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13,852
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Total assets
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$
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3,512,007
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$
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789,450
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current Liabilities:
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Accounts payable
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$
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417,754
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$
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67,753
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Accrued expenses
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268,765
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275,235
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Total current liabilities
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686,519
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342,988
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Stockholders equity
Preferred Stock, $.01 par value, 5,000,000
shares authorized, par value $0.001 per share
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Series A Preferred Stock, 70,000 shares
outstanding at September 30, 2006 and
December 31, 2005
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70
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700
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Series B Preferred Stock, 7,644 shares
outstanding at September 30, 2006 and no
shares outstanding at December 31, 2005
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8
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Common Stock, par value $0.001 per share,
100,000,000 shares authorized, 7,029,787
shares issued and outstanding at September 30,
2006 and 6,887,513 shares issued and outstanding at
December 31, 2005
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7,029
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68,875
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Additional paid-in capital
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7,836,354
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3,406,647
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Accumulated deficit
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(5,017,973
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)
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(3,029,760
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)
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Total stockholders equity
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2,825,488
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446,462
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Total liabilities and stockholders equity
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$
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3,512,007
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$
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789,450
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The accompanying notes are an integral part of these financial statements.
3
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED
STATEMENTS OF OPERATIONS (unaudited)
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Cumulative Period
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from January 4,
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2002 (date of
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inception) to
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For the Three Months Ended September 30,
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For the Nine Months Ended September 30,
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September 30,
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2006
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2005
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2006
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2005
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2006
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Revenues
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$
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$
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$
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$
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$
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Operating costs and expenses:
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Research and development
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235,467
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127,378
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668,231
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1,105,772
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2,915,883
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General and administrative
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1,106,752
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106,577
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1,348,945
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455,763
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2,156,676
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Total operating costs and
expenses
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1,342,219
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233,955
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2,017,176
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1,561,535
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5,072,559
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Loss from operations
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(1,342,219
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)
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(233,955
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)
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(2,017,176
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)
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(1,561,535
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)
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(5,072,559
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)
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Interest income
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20,831
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6,184
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28,963
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12,092
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54,586
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Loss before income taxes
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(1,321,388
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)
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(227,771
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)
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(1,988,213
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)
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(1,549,443
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)
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(5,017,973
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)
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Provision for income taxes
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Net loss
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$
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(1,321,388
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)
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$
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(227,771
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)
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$
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(1,988,213
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)
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$
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(1,549,443
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)
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$
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(5,017,973
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)
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Loss per share basic and diluted
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$
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(0.19
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)
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$
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(0.03
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)
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$
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(0.29
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)
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$
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(0.26
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)
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Weighted average shares
outstanding basic and diluted
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7,020,508
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6,887,513
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6,932,332
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5,974,940
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The accompanying notes are an integral part of these financial statements
.
4
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED STATEMENT OF STOCKHOLDERS EQUITY (unaudited)
For the nine months ended September 30, 2006
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Deficit Accumulated
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Preferred Stock
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During the
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Series A
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Series B
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Common Stock
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Paid-in Capital
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Development Stage
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Total
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Balance at
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December 31, 2005
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$
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700
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$
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$
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68,875
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$
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3,406,647
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$
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(3,029,760
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)
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$
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446,462
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Issuance of stock
options
for services
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947,099
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947,099
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Issuance of common
stock for services
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142
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194,858
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195,000
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Change in par value
due to merger
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(630
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)
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(61,988
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)
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62,618
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Issuance of preferred
stock, net
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8
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3,225,132
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3,225,140
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Net loss
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(1,988,213
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)
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(1,988,213
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)
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Balance at
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September 30, 2006
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$
|
70
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$
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8
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$
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7,029
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$
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7,836,354
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$
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(5,017,973
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)
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$
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2,825,488
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The accompanying notes are an integral part of this financial statement.
5
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
CONDENSED
STATEMENTS OF CASH FLOWS (unaudited)
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Cumulative Period
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from January 4,
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2002 (date of
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For the Nine Months Ended
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inception) through
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September 30,
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September 30,
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2006
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2005
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2006
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(unaudited)
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Operating Activities:
|
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|
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|
|
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Net loss
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$
|
(1,988,213
|
)
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$
|
(1,549,443
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)
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|
$
|
(5,017,973
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)
|
Adjustments to reconcile net loss to net
cash used in operating activities:
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|
|
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Depreciation
|
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4,190
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1,031
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5,930
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Stock-based compensation
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1,069,943
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1,093,063
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2,729,192
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Change in assets and liabilities
(Increase) in other prepaid expenses and
deposits
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(2,487
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)
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(15,000
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)
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(16,779
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)
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(Decrease) increase in accounts payable
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350,001
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|
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(27,993
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)
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417,753
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Increase in accrued expenses
|
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|
65,685
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|
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97,356
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|
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235,921
|
|
|
|
|
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Net cash used in operating activities
|
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(500,881
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)
|
|
|
(400,986
|
)
|
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|
(1,645,956
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)
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|
|
|
|
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|
|
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Investing Activities:
|
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|
|
|
|
|
|
|
|
|
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Capital expenditures
|
|
|
(19,876
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)
|
|
|
(2,468
|
)
|
|
|
(25,647
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)
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(19,876
|
)
|
|
|
(2,468
|
)
|
|
|
(25,647
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
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Proceeds from issuance of common stock
|
|
|
|
|
|
|
1,046,515
|
|
|
|
1,151,516
|
|
Proceeds from issuance of preferred stock
|
|
|
3,225,140
|
|
|
|
|
|
|
|
3,895,597
|
|
Prepaid expenses for initial public offering
|
|
|
(472,074
|
)
|
|
|
|
|
|
|
(472,074
|
)
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
2,753,066
|
|
|
|
1,046,515
|
|
|
|
4,575,039
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash
|
|
|
2,232,309
|
|
|
|
643,061
|
|
|
|
2,903,436
|
|
Cash and cash equivalents at beginning of
period
|
|
|
771,127
|
|
|
|
183,911
|
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
3,003,436
|
|
|
$
|
826,972
|
|
|
|
3,003,436
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Supplemental disclosures of cash flow
information:
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Cash paid during the year for interest
|
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|
|
|
|
|
|
|
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Cash paid during the year for income taxes
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Non-cash financing activities:
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|
|
|
|
|
|
|
|
|
|
|
During the nine months ended September 30, 2006 and 2005, the Company recorded compensation
expense of $947,099 and $1,033,063, respectively, related to the issuance of stock options to
nonemployees.
The accompanying notes are an integral part of these financial statements.
6
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
1.
|
|
Organization and Description of Business.
|
Catalyst Pharmaceutical Partners, Inc. (the Company) is a development-stage specialty
pharmaceutical company focused on the acquisition, development and commercialization of
prescription drugs for the treatment of drug addiction.
The Company was incorporated in Delaware in July 2006. It is the successor by merger to
Catalyst Pharmaceutical Partners, Inc., a Florida corporation, which commenced operations in
January 2002.
On October 3, 2006, the Companys Board of Directors approved an approximate 1.4592-to-one
forward stock split (effected in the form of a stock dividend). All common stock share and per
share amounts set forth in these financial statements have been adjusted retroactively to reflect
the split.
The Company has incurred operating losses in each period from inception through September 30,
2006. The Company has been able to fund its cash needs to date through an initial funding from its
founders and four subsequent private placements. Further, on November 13, 2006 the Company
completed an initial public offering (IPO) of its common stock.
2.
|
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Basis of Presentation and Significant Accounting Policies.
|
|
a.
|
|
DEVELOPMENT STAGE COMPANY.
Since inception, the Company has devoted
substantially all of its efforts to business planning, research and development,
recruiting management and technical staff, acquiring operating assets and raising
capital. Accordingly, the Company is considered to be in the development stage and the
Companys financial statements are presented in accordance with Statement of Financial
Accounting Standards No. 7, Accounting and Reporting by Development Stage
Enterprises.
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|
|
b.
|
|
INTERIM FINANCIAL STATEMENTS.
The accompanying unaudited interim condensed
financial statements have been prepared pursuant to the rules and regulations of the
Securities and Exchange Commission for reporting of interim financial information.
Pursuant to such rules and regulations, certain information and footnote disclosures
normally included in financial statements prepared in accordance with accounting
principles generally accepted in the United States have been condensed or omitted. The
accompanying unaudited condensed financial statements should be read in conjunction
with the Companys audited financial statements and the notes thereto included in the
Prospectus, dated November 7, 2006 (the Prospectus), that is a part of the Companys
Registration Statement on Form S-1 (file no. 333-136039).
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|
|
|
|
In the opinion of management, the accompanying unaudited interim condensed financial
statements of the Company contain all adjustments (consisting of only normal
recurring adjustments) necessary to present fairly the financial position of the
Company as of September 30, 2006, the results of its operations for the three and
nine month periods ended September 30, 2006 and 2005 and its cash flows for the nine
month periods ended September 30, 2006 and 2005. The results of operations and cash
flows for the nine month period ended September 30, 2006 are not necessarily
indicative of the results of operations or cash flows which may be reported for the
year ending December 31, 2006.
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c.
|
|
USE OF ESTIMATES.
The preparation of financial statements in conformity with
U.S. generally accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
|
7
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d.
|
|
EARNINGS (LOSS) PER SHARE.
Basic earnings (loss) per share is computed by
dividing net earnings (loss) for the period by the weighted average number of common shares
outstanding during the period. Diluted earnings (loss) per share is computed by
dividing net earnings (loss) for the period by the weighted average number of common shares
outstanding during the period, plus the dilutive effect of common stock
equivalents, such as convertible preferred stock and stock options. For all periods
presented, all common stock equivalents were excluded because their inclusion would
have been anti-dilutive. Potentially dilutive common stock equivalents as of September
30, 2006 include 70,000 shares of Series A Preferred Stock convertible into 1,021,453
shares of common stock, 7,644 shares of Series B Preferred Stock convertible into
1,115,427 Shares of common stock and stock options to purchase up to 2,361,016 shares
of common stock at exercise prices ranging from $0.69 to $6.00. Subsequent to
September 30, 2006, all of the outstanding shares of Series A Preferred Stock and
Series B Preferred Stock automatically converted into common stock at the closing of
the IPO. See Note 9.
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|
|
e.
|
|
STOCK COMPENSATION PLANS.
Through July 2006, the Company did not have a formal
stock option plan, although stock options were granted pursuant to written agreements.
In July 2006, the Company adopted the 2006 Stock Incentive Plan (the Plan). See Note
8.
|
|
|
|
|
As of September 30, 2006, there were outstanding stock options to purchase 2,361,016
shares of common stock (including options to purchase 21,888 shares granted under
the Plan), of which stock options to purchase 2,193,206 shares of common stock were
exercisable as of September 30, 2006.
|
|
|
|
|
For the nine month periods ended September 30, 2006 and 2005, the Company recognized
stock compensation expense of $1,069,943 and $1,093,063, respectively, $302,368 and
$836,000 of which is included in research and development expenses and $767,575 and
$257,063 of which is included in general and administrative expenses.
|
|
|
|
|
For the three month periods ended September 30, 2006 and 2005, the Company
recognized stock compensation expense of $828,818 and $79,688, respectively, $88,993
and $45,000 of which is included in research and development expenses and $739,825
and $34,688 of which is included in general and administrative expenses.
|
|
|
|
|
The Company has elected to use the modified prospective transition method for
adopting SFAS No. 123R, which requires the recognition of stock-based compensation
cost on a prospective basis; therefore, prior period financial statements have not
been restated. Under this method, the provisions of SFAS No. 123R are applied to all
awards granted after the adoption date and to awards not yet vested with
unrecognized expense at the adoption date based on the estimated fair value at grant
date as determined under the original provisions of SFAS No. 123. The impact of
forfeitures that may occur prior to vesting is also estimated and considered in the
amount recognized. In addition, the realization of tax benefits in excess of
amounts recognized for financial reporting purposes will be recognized as a
financing activity rather than an operating activity as in the past. Pursuant to the
requirements of SFAS No. 123R, the Company will continue to present the pro forma
information for periods prior to the adoption date.
|
|
|
|
|
No tax benefits were attributed to the stock-based compensation expense because a
valuation allowance was maintained for substantially all net deferred tax assets.
The Company elected to adopt the alternative method of calculating the historical
pool of windfall tax benefits as permitted by FASB Staff Position (FSP) No. SFAS
123R-c, Transition Election Related to Accounting for the Tax Effects of
Share-Based Payment Awards. This is a simplified method to determine the pool of
windfall tax benefits that is used in determining the tax effects of stock
compensation in the results of operations and cash flow reporting for awards that
were outstanding as of the adoption of SFAS No. 123R. As of September 30, 2006, the
Company has no unrecognized compensation costs related to non-vested employee stock
option awards.
|
8
|
|
|
The following information applies to options outstanding and exercisable at
September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Remaining
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Contractual Term
|
|
|
Aggregate
|
|
|
|
Options
|
|
|
Exercise Price
|
|
|
(in years)
|
|
|
Intrinsic Value
|
|
Options outstanding at January 1, 2006
|
|
|
2,188,828
|
|
|
$
|
1.02
|
|
|
|
8.3
|
|
|
$
|
10,900,363
|
|
Granted
|
|
|
172,188
|
|
|
|
3.32
|
|
|
|
4.5
|
|
|
|
461,464
|
|
Exercised
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2006
|
|
|
2,361,016
|
|
|
$
|
1.19
|
|
|
|
7.3
|
|
|
$
|
11,356,486
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2006
|
|
|
2,193,206
|
|
|
$
|
1.02
|
|
|
|
7.5
|
|
|
$
|
10,922,165
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
|
|
|
Options Exercisable
|
|
|
|
|
|
|
Weighted-Average
|
|
Weighted
|
|
|
|
|
|
Weighted
|
Range of Exercise Shares
|
|
|
|
|
|
Remaining
|
|
Average
|
|
|
|
|
|
Average
|
Prices
|
|
Shares
|
|
Contractual Life
|
|
Exercise Price
|
|
Shares
|
|
Exercise Price
|
$.69 - $1.37
|
|
|
2,047,284
|
|
|
8.57 years
|
|
$
|
.88
|
|
|
|
2,047,284
|
|
|
$
|
.88
|
|
$2.98
|
|
|
291,844
|
|
|
5.0 years
|
|
$
|
2.98
|
|
|
|
145,922
|
|
|
|
2.98
|
|
$6.00
|
|
|
21,888
|
|
|
5.0 years
|
|
$
|
6.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,361,016
|
|
|
|
|
|
|
|
|
|
|
|
2,193,206
|
|
|
|
|
|
|
|
|
The Company utilizes the Black-Scholes option-pricing model to determine the fair
value of stock options on the date of grant. This model derives the fair value of
stock options based on certain assumptions related to expected stock price
volatility, expected option life, risk-free interest rate and dividend yield. The
Companys expected volatility is based on the historical volatility of other
publicly traded development stage companies in the same industry. The estimated
expected option life is based upon estimated employee exercise patterns and
considers whether and the extent to which the options are in-the-money. The
risk-free interest rate assumption is based upon the U.S. Treasury yield curve
appropriate for the term of the Companys stock options awards. For the three and
nine month periods ended September 30, 2006 the assumptions used were an estimated
annual volatility of 100%, expected holding periods of five to ten years, and a
risk-free interest rate of 5.5%. The expected dividend rate is zero and no
forfeiture rate was applied. Stock options to purchase 172,188 shares were granted
during the nine month period ended September 30, 2006 at an average fair value of
price of $5.02 per share. For the nine month period ended September 30, 2005, the
weighted average fair value of stock options granted was $1.66 per share.
|
|
|
|
|
Had compensation cost for the stock-based compensation plans been determined based
on the fair value method at the grant dates for awards of employee stock options
consistent with the method of SFAS No. 123, pro forma net loss and loss per share
would be as follows:
|
9
|
|
|
|
|
|
|
|
|
|
|
For the Three
|
|
|
For the Nine Months
|
|
|
|
Months Ended
|
|
|
Ended September 30,
|
|
|
|
September 30, 2005
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
Net loss, as reported
|
|
$
|
(227,771
|
)
|
|
$
|
(1,309,694
|
)
|
Total stock-based employee compensation
expense determined under fair value-based
method
|
|
|
|
|
|
|
(488,959
|
)
|
|
|
|
|
|
|
|
Net loss, pro forma
|
|
$
|
(227,771
|
)
|
|
$
|
(1,798,653
|
)
|
|
|
|
|
|
|
|
Loss per share basic and diluted, as reported
|
|
$
|
(0.03
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
|
Loss per share basic and diluted, pro forma
|
|
$
|
(0.03
|
)
|
|
$
|
(0.30
|
)
|
|
|
|
The above pro forma disclosures may not be representative of the effects on reported
net (loss) earnings for future years as options vest over several years and the
Company may continue to grant options to employees.
|
|
f.
|
|
Recent Accounting Pronouncements
|
|
|
|
In September 2006, the SEC Office of the Chief Accountant and Divisions of
Corporation Finance and Investment Management released SAB No. 108, Considering the
Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year
Financial Statements (SAB No. 108), that provides interpretive guidance on how
the effects of the carryover or reversal of prior year misstatements should be
considered in quantifying a current year misstatement. The SEC staff believes that
registrants should quantify errors using both a balance sheet and an income
statement approach and evaluate whether either approach results in quantifying a
misstatement that, when all relevant quantitative and qualitative factors are
considered, is material. This guidance is effective for fiscal years ending after
November 15, 2006. The Company does not expect the adoption of SAB No. 108 to have
a material impact on its financial position, results of operations, or cash flows.
|
|
|
|
|
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS
No. 157). This statement provides a single definition of fair value, a framework
for measuring fair value, and expanded disclosures concerning fair value.
Previously, different definitions of fair value were contained in various accounting
pronouncements creating inconsistencies in measurement and disclosures. SFAS No. 157
applies under those previously issued pronouncements that prescribe fair value as
the relevant measure of value, except SFAS No. 123(R) and related interpretations
and pronouncements that require or permit measurement similar to fair value but are
not intended to measure fair value. This pronouncement is effective for fiscal years
beginning after November 15, 2007. The Company does not expect the adoption of SFAS
No. 157 to have a material impact on its financial position, results of operations,
or cash flows.
|
|
|
|
|
In June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an interpretation of FASB Statement No. 109 (FIN No. 48). This
interpretation clarifies the accounting for uncertainty in income taxes recognized
in a companys financial statements in accordance with SFAS No. 109, Accounting for
Income Taxes. This interpretation seeks to reduce the diversity in practice
associated with certain aspects of measurement and recognition in accounting for
income taxes. In addition, it requires expanded disclosure with respect to the
uncertainty in income taxes. FIN No. 48 is effective January 1, 2007 and is not
expected to have a material impact on the Companys financial statements.
|
10
|
|
|
Other accounting standards that have been issued or proposed by the FASB or other
standards-setting bodies that do not require adoption until a future date are not
expected to have a material impact on the Companys financial statements upon
adoption.
|
On September 7, 2006, the Company completed a merger with Catalyst Pharmaceutical Partners,
Inc., a Florida corporation (CPP-Florida) in which CPP-Florida was merged with and into the
Company and all of CPP-Floridas assets, liabilities and attributes were transferred to the Company
by operation of law. Prior to the merger, the Company was a wholly-owned subsidiary of
CPP-Florida. The merger was effected to reincorporate the Company in Delaware.
After the merger, holders of CPP-Florida common stock held an equal number of shares of the
Companys common stock, holders of CPP-Florida Series A preferred stock held an equal number of
shares of the Companys Series A Preferred Stock and holders of CPP-Florida Series B Preferred
Stock held an equal number of shares of the Companys Series B Preferred Stock.
Shares of CPP-Florida common and preferred stock had a par value of $0.01 per share. Shares of
the Companys common and preferred stock have a par value of $0.001 per share. An adjustment has
been made to capital stock and additional paid in capital on the Companys condensed balance sheet
at September 30, 2006 to reflect this change.
4.
|
|
Property and Equipment.
|
|
|
Property and equipment, net consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006
|
|
|
December 31, 2005
|
|
Computer equipment
|
|
$
|
17,192
|
|
|
$
|
3,303
|
|
Furniture and equipment
|
|
|
8,456
|
|
|
|
2,468
|
|
Accumulated depreciation
|
|
|
(5,931
|
)
|
|
|
(1,741
|
)
|
|
|
|
|
|
|
|
Total property and equipment
|
|
$
|
19,717
|
|
|
$
|
4,031
|
|
|
|
|
|
|
|
|
|
a.
|
|
COMMON STOCK.
The Company has 100,000,000 shares of authorized common stock
with a par value of $0.001 per share. At September 30, 2006 and December 31, 2005,
respectively, there were 7,029,787 and 6,887,513 shares of common stock issued and
outstanding. Each holder of common stock is entitled to one vote of each share of
common stock held of record on all matters on which stockholders generally are entitled
to vote.
|
|
|
b.
|
|
PREFERRED STOCK.
The Company has 5,000,000 shares of authorized preferred
stock outstanding, $0.001 par value per share.
|
|
i.
|
|
Series A Preferred Stock.
At September 30, 2006 and December
31, 2005, the Company had 70,000 shares of Series A Preferred Stock
outstanding. Each share of outstanding Series A Preferred Stock has a
liquidation preference of $10.00 per share and votes with the common stock on
the basis of approximately 15 votes for each share of Series A Preferred Stock
outstanding. Each share of Series A Preferred Stock is convertible, at the
option of the holder, into approximately 15 shares of common stock; provided,
however, that all of the outstanding shares of Series A Preferred Stock will
automatically convert into shares of the Companys Common Stock under certain
circumstance. See Note 9.
|
11
|
ii.
|
|
Series B Preferred Stock.
At September 30, 2006, the Company
had 7,644 shares of Series B Preferred Stock outstanding. Each share of
outstanding Series B Preferred Stock has a liquidation preference of $435 per
share and votes with the Common Stock on the basis of approximately 145 votes
for each share of Series B Preferred Stock outstanding. Each share of Series B
Preferred Stock is convertible, at the option of the holder, into approximately
145 shares of common stock; provided, however, that all of the
outstanding shares of Series B Preferred Stock will automatically convert
into shares of common stock under certain circumstances. See Note 9.
|
6.
|
|
Related Party Transactions.
|
Since its inception in 2002, the Company has entered into various consulting agreements with
non-employee officers and with members of the Companys Scientific Advisory Board. Several of these
agreements are with related parties under common ownership and control. During the three and nine
months ended September 30, 2006 and 2005, the Company paid approximately $37,500 and $102,500 and
$34,750 and $105,250, respectively, in consulting fees to related parties. In addition, as of
September 30, 2006 the Company has accrued $32,844 related to common stock payable under one of
these consulting agreements. A fair value of $6.00 per share was used to determine the related
expense.
The Companys consulting agreement with its Chief Financial Officer required a bonus payment
upon the completion of a U.S. initial public offering of at least $10 million. The Company paid
the required bonus in the amount of $140,575 upon the successful completion of the Companys IPO in
November 2006. Three and nine month 2006 results of operations include an accrual for this bonus
payment in general and administrative expenses. See Note 9.
On July 24, 2006, the Company completed a private placement in which it raised net proceeds of
$3,225,140 through the sale of 7,644 shares of the Companys Series B Preferred Stock.
8.
|
|
2006 Stock Incentive Plan.
|
In July 2006, the Company adopted the 2006 Stock Incentive Plan (the Plan). The Plan
provides for the Company to issue options, restricted stock, stock appreciation rights and
restricted stock units (collectively, the Awards) to employees, directors and consultants of the
Company. Under the Plan, 2,188,828 shares of the Companys common stock have been reserved for
issuance. Options to purchase 21,888 shares have been granted to date under the Plan.
|
a.
|
|
Stock Split.
On October 3, 2006, the Companys board of directors approved an
approximate 1.4592-to-one forward stock split (effected in the form of a stock
dividend). All stock value, common shares outstanding and per share amounts set forth
in these financial statements have been adjusted retroactively to reflect this split.
|
|
|
b.
|
|
Initial Public Offering
. On November 13, 2006, the Company closed its IPO. In
the IPO, the Company sold 3,350,000 shares of its authorized but unissued common stock
at an initial public offering price of $6.00 per share. The Company received net
proceeds from the offering of $17,693,000 (gross proceeds of $20,100,000 less a 7%
underwriting discount aggregating $1,407,000 and estimated offering expenses of
$1,000,000). The net proceeds of the offering will be used for product development and
general corporate purposes. At the closing of the IPO, all of the Companys
outstanding Series A Preferred Stock and Series B Preferred Stock automatically
converted into an aggregate of 2,136,860 shares of the Companys common stock.
|
|
|
|
|
Costs related to the IPO were deferred when incurred and amounted to $472,074 at
September 30, 2006. Such costs are included as an asset on the accompanying
unaudited condensed balance sheet
|
12
|
|
|
at September 30, 2006. All such costs were charged to paid-in-capital at the successful
completion of the IPO. Such costs are a portion of the estimated IPO expenses referred to above.
|
|
|
c.
|
|
Employment Agreements
. At the closing of the IPO, the Company entered into
employment agreements with Patrick J. McEnany, its Chairman, President and Chief
Executive Officer, and Jack Weinstein, its Vice President, Treasurer and Chief
Financial Officer. Under these agreements, Messrs. McEnany and Weinstein will receive
base salaries of $315,000 and $200,000, respectively, and bonus compensation based on performance.
|
13
ITEM 2: MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with our financial
statements and the related notes and schedule thereto appearing elsewhere in this
Form 10-Q
and in
the Prospectus, dated November 7, 2006 (the Prospectus), that is a part of our Registration
Statement on
Form S-1
(file no. 333-136039). This discussion and analysis may contain
forward-looking statements based upon current expectations that involve risks and uncertainties.
Our actual results may differ materially as a result of various factors, including those set forth
herein and in the Risk Factors section of the Prospectus.
Overview
We are a specialty pharmaceutical company focused on the development and commercialization of
prescription drugs for the treatment of drug addiction. Our initial product candidate is CPP-109,
which is based on the chemical compound
gamma-vinyl-GABA,
commonly referred to as vigabatrin. We
intend in the first quarter of 2007 to commence a U.S. Phase II clinical trial evaluating CPP-109
as a treatment for cocaine addiction.
We recently completed an initial public offering in which we raised net proceeds of
approximately $17.7 million. We intend to use these proceeds to complete the clinical and
non-clinical studies that we believe, based on currently available information, will be required
for us to file a new drug application, or NDA, for the use of CPP-109 to treat cocaine addiction.
Subject to the availability of funding, we also hope to develop CPP-109 for the treatment of
methamphetamine addiction and other addictions. There can be no assurance that we will receive
approval of an NDA for CPP-109.
The successful development of CPP-109 or any other product we may develop, acquire, or license
is highly uncertain. We cannot reasonably estimate or know the nature, timing, or estimated
expenses of the efforts necessary to complete the development of, or the period in which material
net cash inflows are expected to commence due to the numerous risks and uncertainties associated
with developing, such products, including the uncertainty of:
|
|
|
the scope, rate of progress and expense of our clinical trials and our other product
development activities;
|
|
|
|
|
the results of future clinical trials, and the number of clinical trials (and the
scope of such trials) that will be required to seek and obtain approval of an NDA for
CPP-109; and
|
|
|
|
|
the expense of filing, prosecuting, defending and enforcing any patent claims and
other intellectual property rights.
|
Research and development expenses, in the aggregate, represented approximately 33% of our
total operating expenses for the nine months ended September 30, 2006. Research and development
expenses consist primarily of costs incurred for clinical trials and development costs related to
CPP-109, personnel and related costs related to our product development activities, and outside
professional fees related to clinical development and regulatory matters.
We expect that our research and development expenses will substantially increase as a
percentage of our total expenses due to the estimated expense of our planned U.S. Phase II clinical
trial, our anticipated costs related to the clinical trial to be conducted in Mexico, and any
required Phase I studies that we undertake. We estimate, based on the information available to us
at this date, that we will incur approximately $15.7 million in expenses, in addition to costs
previously incurred, for our further clinical trials and development costs for CPP-109 to treat
cocaine addiction. These estimates assume that a U.S. Phase III clinical trial will be required by
the FDA before we are able to obtain approval of an NDA for CPP-109.
The above costs include assumptions about facts and events that are outside of our control.
For example, most of the expenses for completing the development of CPP-109 to treat cocaine
addiction will be in the form of fees and expenses we will be
required to pay a clinical research
organization to conduct this work for us. We have
14
not yet selected or contracted with any third party for this purpose, and our estimate of the
fees and expenses we will have to pay is based on our experience with these organizations rather
than firm quotes. The actual cost to us could be significantly greater than we expect. In
addition, the FDA could require us to alter or delay our clinical trials at any stage, which may
significantly increase the costs of that trial, as well as delay our commercialization of CPP-109
and our future revenue.
Basis of Presentation
Revenues
We are a development stage company and have had no revenues to date. We will not have
revenues until such time as we receive approval of CPP-109 and successfully commercialize our
product, of which there can be no assurance.
Research and development expenses
Our research and development expenses consist of costs incurred for company-sponsored research
and development activities. These expenses consist primarily of direct and research-related
allocated overhead expenses such as facilities costs, material supply costs, and medical costs for
visual field defect testing. It also includes both cash and non-cash compensation paid to our
scientific advisors and consultants related to our product development efforts. To date, all of
our research and development resources have been devoted to the development of CPP-109. We expect
this to continue for the foreseeable future. Costs incurred in connection with research and
development activities are expensed as incurred.
Clinical trial activities require significant expenditures up front. We anticipate paying
significant portions of a trials cost before it begins, as well
as additional expenditures as
the trial progresses and reaches certain milestones.
Selling and marketing expenses
We do not currently have any selling or marketing expenses, as we have not yet received
approval for the commercialization of CPP-109. We expect we will begin to incur such costs upon
our filing of an NDA, so that we can have a sales force in place to commence our selling efforts
immediately upon receiving approval of such NDA, of which there can be no assurance.
General and administrative expenses
Our general and administrative expenses consist primarily of salaries, consulting fees for
members of our Scientific Advisory Board, information technology, and corporate administration
functions. Other costs include administrative facility costs, regulatory fees, and professional
fees for legal and accounting services.
Stock-based compensation
Commencing on January 1, 2006, we recognize costs related to the issuance of common stock to
employees and consultants by using the estimated fair value of the stock at the date of grant, in
accordance with Statement of Financial Accounting Standards (SFAS) No. 123(R), Accounting for
Share-Based Payments (SFAS 123(R)).
Income taxes
We have incurred operating losses since inception. The related deferred tax asset resulting
primarily from the net operating loss carryforwards has a 100% valuation allowance as of December
31, 2005 and 2004, as we believe it is more likely than not that the deferred tax asset will not be
realized. Further, as a result of our recent IPO, our use of our net
operating losses against net income, if any, generated in future periods could be limited under Section 382 of the
Internal Revenue Code.
15
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the U.S. The preparation of these financial statements requires us to make
judgments, estimates, and assumptions that affect the reported amounts of assets and liabilities
and the disclosure of contingent assets and liabilities at the date of the financial statements as
well as the reported revenue and expenses during the reporting periods. We continually evaluate
our judgments, estimates and assumptions. We base our estimates on the terms of underlying
agreements, our expected course of development, historical experience and other factors we believe
are reasonable based on the circumstances, the results of which form our managements basis for
making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates.
The list below is not intended to be a comprehensive list of all of our accounting policies.
In many cases, the accounting treatment of a particular transaction is specifically dictated by
generally accepted accounting principles, or GAAP. There are also areas in which our managements
judgment in selecting any available alternative would not produce a materially different result.
Our financial statements and the notes thereto included elsewhere in this report contain accounting
policies and other disclosures required by GAAP.
Non-clinical study and clinical trial expenses
Research and development expenditures are charged to operations as incurred. Our expenses
related to clinical trials are expected to be based on actual and estimated costs of the services
received and efforts expended pursuant to contracts with multiple research institutions and
clinical research organizations that conduct and manage clinical trials on our behalf. The
financial terms of these agreements are subject to negotiation and vary from contract to contract
and may result in uneven payment flows. Generally, these agreements set forth the scope of the
work to be performed at a fixed fee or unit price. Payments under the contracts will depend on
factors such as the successful enrollment of patients or the completion of clinical trial
milestones. Expenses related to clinical trials generally are expected to be accrued based on
contracted amounts applied to the level of patient enrollment and activity according to the
protocol. If timelines or contracts are modified based upon changes in the clinical trial protocol
or scope of work to be performed, we would be required to modify our estimates accordingly on a
prospective basis.
Stock-based compensation
In December 2004, the FASB issued Statement 123(R), Accounting for Share-Based Payment,
which addresses the accounting for share-based payment transactions (for example, stock options and
awards of restricted stock) in which an employer receives employee-services in exchange for equity
securities of the company or liabilities. Statement 123(R) requires that compensation cost be
measured based on the fair value of the companys equity securities. This proposal eliminates use
of APB Opinion No. 25, Accounting for Stock Issued to Employees, and requires such transactions
to be accounted for using a fair value-based method and recording compensation expense rather than
optional pro forma disclosure. The new standard substantially amends SFAS 123. Statement 123(R)
requires us to recognize an expense for the fair value of our unvested outstanding stock options
beginning with our financial statements for the year ended December 31, 2006.
Results of Operations
Revenues
. We had no revenues for the three and nine-month periods ended September 30, 2006
and 2005.
Research and Development Expenses
. Research and development expenses for the three months
ended September 30, 2006 and 2005 were $235,467 and $127,378, respectively. Research and
development expenses for the nine months ended September 30, 2006 and 2005 were $668,231 and
$1,105,772, respectively. Expenses include payments with respect to clinical studies that we have
supported in the past and payments made to consultants and members of our Scientific Advisory Board
and to other service providers who have assisted us with respect to our product development
efforts.
16
We recorded non-cash compensation in each of the three and nine-month periods in 2006 and 2005
($56,149 and $163,235, respectively, for the comparative three month periods and $297,274 and
$90,000, respectively, for the comparative nine month periods) relating to our research and
development. Such non-cash compensation related to shares of common stock issued to several of our
consultants and scientific advisors for services rendered and the value of stock options granted to
non-employees.
We expect that research and development activities will increase substantially as we receive
the vigabatrin that will be used in our upcoming clinical trials, as we pay the costs associated
with our ongoing clinical studies and trials, and as we expand our product development activities
generally.
Selling and Marketing Expenses
. We had no selling and marketing expenses during the three and
nine months ended September 30, 2006 and 2005. We anticipate that we will begin to incur sales and
marketing expenses when we file an NDA for CPP-109, in order to develop a sales organization to
market CPP-109 and other products we may develop upon the receipt of required approvals.
General and Administrative Expenses
. General and administrative expenses were $1,106,752 and
$106,577, respectively, for the three months ended September 30, 2006 and 2005, and $1,348,945 and
$455,763, respectively, for the nine months ended September 30, 2006 and 2005. Three and nine
month 2006 general and administrative expenses includes $739,825 and $767,575 in non-cash
compensation expense relating to the vesting of previously issued non-employee stock options.
General and administrative expenses include office expenses, legal and accounting fees and
travel expenses for our employees, consultants and members of our Scientific Advisory Board. We
expect general and administrative expenses to increase in future periods as we incur general
non-research expenses relating to the monitoring and oversight of our clinical trials, add staff,
expand our infrastructure to support the requirements of being a public company and otherwise
expend funds to continue to develop our business as set forth in our Prospectus and this Quarterly
Report on Form 10-Q.
Stock-Based Compensation
. We issued (i) stock options to non-employees in early 2005, (ii)
stock options to our Chief Executive Officer in early 2005, and (iii) shares of our common stock to
several of our scientific advisors and consultants in 2005 and in the first nine months of 2006.
See
Research and Development
above. The measurement date for all these equity instruments, other
than options granted to our Chief Executive Officer, is based on the guidance of EITF 96-18, and
accordingly the options are marked to their fair value at the end of each period until the
non-employee guarantee has fully vested in the award. The options granted to our Chief Executive
Officer were accounted for using the intrinsic value method in accordance with APB No. 25,
Accounting for Stock Issued to Employees, and accordingly have no compensation expense related to
them because the fair value of our common stock at the grant date was equal to the exercise price
of the options. For accounting purposes, we calculated stock-based compensation based on a fair
value of $6.00 per share as of September 30, 2006. As of September 30, 2006, we had outstanding
stock options to purchase 2,361,016 shares of our common stock, of which options to purchase
2,193,206 were vested and 167,810 were unvested. We also had 5,474 shares of common stock payable
at September 30, 2006. Finally, we had 142,272 shares of common stock payable at June 30, 2006
which we issued in July 2006.
Interest Income
. We reported interest income in all periods relating to our investment of
funds received from our private placements in 2005 and 2006. All such funds were invested in short
and medium-term interest bearing obligations, certificates of deposit and direct or guaranteed
obligations of the United States government.
Income taxes
. We have incurred net operating losses since inception. Consequently, we have
applied a 100% valuation allowance against our deferred tax asset as we believe that it is more
likely than not that the deferred tax asset will not be realized.
17
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily through the net proceeds of
private placements of our equity securities. As of September 30, 2006, we had received total net
proceeds of approximately $5.0 million from private placements of our securities. Subsequent to
September 30, 2006, we completed our IPO in which we raised gross proceeds of $20.1 million.
At September 30, 2006, we had cash and cash equivalents of $3,003,436 and had working capital
of $2,320,142. Additionally, subsequent to September 30, 2006, we closed our IPO in which we
received net proceeds of $17,693,000. See Note 9 of Notes to Unaudited Condensed Financial
Statements.
Operating Capital and Capital Expenditure Requirements
We have to date incurred operating losses, and we expect these losses to increase
substantially in the future as we expand our product development programs and prepare for the
commercialization of CPP-109. We anticipate using the net proceeds from our IPO to finance these
activities. It may take several years to obtain the necessary regulatory approvals to
commercialize CPP-109 in the United States.
We believe that our available resources will be sufficient to meet our projected operating
requirements for the next 24 months, including our requirements relating to obtaining necessary
regulatory approvals of CPP-109 for use in treating cocaine addiction.
Our future funding requirements will depend on many factors, including:
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the scope, rate of progress and cost of our clinical trials and other product
development activities;
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future clinical trial results;
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the terms and timing of any collaborative, licensing and other arrangements that we
may establish;
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the cost and timing of regulatory approvals;
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the cost and delays in product development as a result of any changes in regulatory
oversight applicable to our products;
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the cost and timing of establishing sales, marketing and distribution capabilities;
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the effect of competition and market developments;
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the cost of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights; and
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the extent to which we acquire or invest in other products.
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If we are unable to generate a sufficient amount of revenue to finance our future operations,
product development and regulatory plans, we may seek to raise additional funds through public or
private equity offerings, debt financings, capital lease transactions, corporate collaborations or
other means. We may seek to raise additional capital due to favorable market conditions or
strategic considerations even if we have sufficient funds for planned operations. Any sale by us
of additional equity or convertible debt securities could result in dilution to our stockholders.
To the extent that we raise additional funds through collaborative arrangements, it may be
necessary to relinquish some rights to our technologies or grant sublicenses on terms that are not
favorable to us. We do not know whether additional funding will be available on acceptable terms,
or at all. If we are not able to secure
18
additional funding when needed, we may have to delay, reduce the scope of or eliminate one or
more research and development programs or sales and marketing initiatives.
Cash Flows
Net cash used in operations was $500,881 and $400,986, respectively, for the nine months ended
September 30, 2006 and 2005. Net cash used in each of these periods primarily reflects that
portion of the net loss for these periods not attributed to non-cash compensation.
Net cash used in investing activities was $19,876 and $2,468 for the nine months ended
September 30, 2006 and 2005, respectively. Such funds were used primarily to purchase computer
equipment.
Net cash provided by financing activities was $2,753,066 and $1,046,515 for the nine months
ended September 30, 2006 and 2005, respectively. Net cash from financing activities is comprised
of the net proceeds of the private placements that we completed in July 2006 and March 2005 net of
deferred public offering costs relating to our IPO. Such funds were used to fund our research and
development costs and our general and administrative costs in the first nine months of 2005 and
2006.
Off-Balance Sheet Arrangement
We currently have no debt and no capital leases. We have an operating lease for our office
facility. We do not have any off-balance sheet arrangements as such term is defined in rules
promulgated by the SEC.
Recent Accounting Pronouncements
In September 2006, the SEC Office of the Chief Accountant and Divisions of Corporation Finance
and Investment Management released SAB No. 108, Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial Statements (SAB No. 108),
that provides interpretive guidance on how the effects of the carryover or reversal of prior year
misstatements should be considered in quantifying a current year misstatement. The SEC staff
believes that registrants should quantify errors using both a balance sheet and an income statement
approach and evaluate whether either approach results in quantifying a misstatement that, when all
relevant quantitative and qualitative factors are considered, is material. This guidance is
effective for fiscal years ending after November 15, 2006. We do not expect the adoption of SAB
No. 108 to have a material impact on our financial position, results of operations, or cash flows.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
This statement provides a single definition of fair value, a framework for measuring fair value,
and expanded disclosures concerning fair value. Previously, different definitions of fair value
were contained in various accounting pronouncements creating inconsistencies in measurement and
disclosures. SFAS No. 157 applies under those previously issued pronouncements that prescribe fair
value as the relevant measure of value, except SFAS No. 123(R) and related interpretations and
pronouncements that require or permit measurement similar to fair value but are not intended to
measure fair value. This pronouncement is effective for fiscal years beginning after November 15,
2007. We do not expect the adoption of SFAS No. 157 to have a material impact on our financial
position, results of operations, or cash flows.
In June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes an interpretation of FASB Statement No. 109 (FIN No. 48). This interpretation clarifies
the accounting for uncertainty in income taxes recognized in a companys financial statements in
accordance with SFAS No. 109, Accounting for Income Taxes. This interpretation seeks to reduce
the diversity in practice associated with certain aspects of measurement and recognition in
accounting for income taxes. In addition, it requires expanded disclosure with respect to the
uncertainty in income taxes. FIN No. 48 is effective January 1, 2007 and is not expected to have a
material impact on our financial statements.
19
Other accounting standards that have been issued or proposed by the FASB or other
standards-setting bodies that do not require adoption until a future date are not expected to have
a material impact on our financial statements upon adoption.
ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Market risk represents the risk of changes in the value of market risk-sensitive instruments
caused by fluctuations in interest rates, foreign exchange rates and commodity prices. Changes in
these factors could cause fluctuations in our results of operations and cash flows.
Our exposure to interest rate risk is currently confined to our cash that is invested in
highly liquid money market funds. The primary objective of our investment activities is to
preserve our capital to fund operations. We also seek to maximize income from our investments
without assuming significant risk. We do not use derivative financial instruments in our
investment portfolio. Our cash and investments policy emphasizes liquidity and preservation of
principal over other portfolio considerations.
ITEM 4. CONTROLS AND PROCEDURES
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a.
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We have carried out an evaluation, under the supervision
and with the participation of our management, including our principal executive
officer and principal financial officer, of the effectiveness of the design and
operation of our disclosure controls and procedures. Based on such evaluation, our
principal executive officer and principal financial officer have
concluded that as of September 30, 2006, except as set forth in
the next paragraph, our
Companys disclosure controls and procedures were effective to
ensure that the information required to be disclosed by us in the
reports filed or submitted by us under the Securities Exchange Act of
1934, as amended, was recorded, processed, summarized or reported
with the time periods specified in the rules and regulations of the
SEC, and include controls and procedures designed to ensure that
information required to be disclosed by us in such reports was
accumulated and communicated to management, including our principal
executive officer and principal financial officer, as appropriate to
allow timely decisions regarding required disclosures.
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As stated in our Prospectus, following completion of their audits of our financial
statements for 2005, 2004 and 2003, our independent auditors, Grant Thornton, LLP,
advised our Board of Directors and management that during the course of their audit,
they noted an internal control deficiency constituting a significant deficiency and
a material weakness as defined in professional standards. The deficiency noted
related to our knowledge of accounting for equity instruments. Our auditors
identified that we had not recorded compensation expense related to the issuance of
non-employee stock options and had not reported sufficient compensation expense
relating to stock that we issued to our consultants and scientific advisors for
services. Management intends to correct this weakness by hiring a Controller/Chief
Accounting Officer with experience in preparing financial statements in accordance
with generally accepted accounting principles. Management expects to retain a
Controller/Chief Accounting Officer with the requisite experience in the near
future.
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b.
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There have been no changes in our internal controls or in other factors that
could have a material affect, or are reasonably likely to have a material affect to the
internal controls subsequent to the date of their evaluation in connection with the
preparation of this Quarterly Report on Form 10-Q.
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20
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is not a party to any legal proceedings.
ITEM 1A. RISK FACTORS
The Companys Registration Statement on Form S-1 (File No. 333-136039) became effective on November
7, 2006, Risk Factors relating to the Companys business were contained in the Prospectus which
forms a part of the Registration Statement. There are no changes in the risk factors from those
contained within the Prospectus. The Company has not yet filed an Annual Report on Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On July 24, 2006, the Company completed a private placement of 7,644 shares of its Series B
Preferred Stock at a price of $435 per share to 51 investors, all of whom are accredited investors.
The offering resulted in net proceeds to the Company of $3,225,140. The offering was made pursuant
to an exemption from registration under Rule 506 of Regulation D.
The proceeds from the offering are being used for the following purposes:
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approximately $100,000 to purchase the active pharmaceutical ingredient required to
manufacture batches of CPP-109 for use in the Companys Phase II clinical trial;
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approximately $600,000 to pay a contract manufacturer for services in connection
with the development and manufacture of the Companys formulation of vigabatrin and to
pay for required bioequivalency studies with respect to the chemical composition of
CPP-109; and
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the remainder to fund the Companys support of an upcoming clinical study in Mexico,
to pay $125,000 in deferred compensation to the Companys Chief Executive Officer, and
for general corporate purposes.
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITIES HOLDERS
On September 7, 2006, the merger between the Company and Catalyst Pharmaceutical Partners,
Inc., a Florida corporation (CPP-Florida), became effective. The merger was approved in
August 2006 by the stockholders of both CPP-Florida and the Company. See Note 3 of Notes to
Financial Statements.
ITEM 5. OTHER INFORMATION
On November 13, 2006, the Company closed its IPO and sold 3,350,000 shares of its common
stock at a price to public of $6.00 per share. All shares were offered by the Company. The
Company intends to use the net proceeds of the offering, aggregating approximately $17.6
million, to pay costs associated with the clinical and non-clinical trials required to seek
approval to commercialize CPP-109, the Companys product candidate based on vigabatrin, to
treat cocaine addiction, and for general corporate purposes.
In connection with the IPO, the Company granted the underwriters a 30-day option to purchase
up to an additional 502,500 shares of the Companys authorized but unissued common stock for
the IPO price to cover overallotments, if any. The option expired unexercised on December 7,
2006.
21
At the closing of the IPO, the Company entered into employment agreements with Patrick J.
McEnany, its Chairman and Chief Executive Officer, and Jack Weinstein, its Vice President,
Treasurer and Chief Financial Officer. Under these agreements, Messrs. McEnany and
Weinstein will receive base salaries of $315,000 and $200,000, respectively, and bonus
compensation based on performance.
ITEM 6. EXHIBITS
(a) Exhibits
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10.1
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Employment Agreement between the Company and Patrick J. McEnany, dated November 8, 2006
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10.2
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Employment Agreement between the Company and Jack Weinstein, dated November 8, 2006
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10.3
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Stock Option Agreement between the Company and M. Douglas Winship
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31.1
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Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification of Principal Financial Officer under
Section 302 of the Sarbanes-Oxley Act of 2002
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32.1
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Certification of Principal Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002
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32.2
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Certification of Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002
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22
SIGNATURES
Pursuant to the Securities Exchange Act of 1934, the Registrant has caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
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Catalyst Pharmaceutical Partners, Inc.
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By:
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/s/ Jack Weinstein
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Jack Weinstein
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Chief Financial Officer
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Date: December 15, 2006
23
Exhibit Index
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Exhibit
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Number
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Description
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10.1
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Employment Agreement between the Company and Patrick J. McEnany, dated November 8, 2006
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10.2
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Employment Agreement between the Company and Jack Weinstein, dated November 8, 2006
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10.3
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Stock Option Agreement between the Company and M. Douglas Winship
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31.1
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Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification
of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002
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32.1
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Certification of Principal Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002
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32.2
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Certification
of Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002
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EXHIBIT 10.3
STOCK OPTION AGREEMENT
THIS STOCK OPTION AGREEMENT
(this Agreement), is made and effective as of the
10
th
day of July, 2006 (the Grant Date), by and between Catalyst Pharmaceutical
Partners, Inc., a Florida corporation (Catalyst), and M. Douglas Winship (the Optionee).
WITNESSETH:
NOW, THEREFORE,
in consideration of the foregoing, and for other good and valuable
consideration, Catalyst hereby grants the Optionee options to purchase shares of Common Stock of
Catalyst, upon the following terms and conditions:
Subject to the terms and conditions of this Agreement, Catalyst hereby grants to the Optionee
an option (the Option) to purchase an aggregate of one hundred thousand (100,000) shares (the
Option Shares) of Catalysts common stock, with $0.01 par value per share (Common Stock). This
Option is a non-qualified stock option which is not intended to meet the requirements of an
incentive stock option within the meaning of Section 422 of the Internal Revenue Code of 1986, as
amended (the Code).
The exercise price (Option Price) of this Option shall be $4.35 per Option Share. The
Option Price of this Option shall be subject to adjustment in the event of changes in the
capitalization of Catalyst, as set forth in Section 9 hereto.
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3.
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TERM AND VESTING OF OPTION
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(a)
Option Period
. Subject to the provisions of this Section 3 and Section 6 hereof,
this Option shall terminate and all rights to purchase shares hereunder shall cease five years
after the date they become exercisable and are granted pursuant to section 3(b) hereof.
(b)
Vesting and Exercisability
. Subject to the provisions of Section 6 hereof, this
Option shall become vested upon the dates (the Vesting Date) described in the following schedule:
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Incremental Number of
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Cumulative Number of
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Date
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Vested Option Shares
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Vested Option Shares
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July 10, 2007
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25
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%
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25
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%
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July 10, 2008
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25
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%
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50
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%
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July 10, 2009
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25
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%
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75
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%
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July 10, 2010
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25
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%
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100
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%
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Notwithstanding the foregoing, the Board of Directors of Catalyst (the Board) may in its
discretion provide that any vesting requirement or other such limitation on the exercise of this
Option may be rescinded, modified or waived by the Board, in its sole discretion, at any time and
from time to time after the Grant Date, so as to accelerate the time at which this Option may be
exercised.
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4.
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MANNER OF EXERCISE AND PAYMENT
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(a)
Exercise
. This Option may be exercised to the extent vested as provided in
Section 3 by delivery to Catalyst on any business day, at its principal office, addressed to the
attention of the President, of written notice of exercise, which notice shall specify the number of
shares with respect to which this Option is being exercised, and shall be accompanied by payment in
full of the Option Price of the shares for which this Option is being exercised, in accordance with
Section 4(b) below. The minimum number of shares of Common Stock with respect to which this Option
may be exercised, in whole or in part, at any time shall be the lesser of one hundred (100) shares
or the maximum number of shares available for purchase under this Option at the time of exercise.
(b)
Payment
. Payment of the Option Price for the shares of Common Stock purchased
pursuant to the exercise of this Option shall be made in cash or in cash equivalents. An attempt
to exercise any Option granted hereunder other than as set forth above shall be invalid and of no
force and effect.
(c)
Issuance of Certificates
. Promptly after the exercise of this Option, Optionee
shall be entitled to the issuance of a certificate or certificates evidencing his ownership of such
shares of Common Stock. An individual holding or exercising an Option shall have none of the
rights of a stockholder until the shares of Common Stock covered thereby are fully paid and issued
to him and, except as provided in Section 9 below, no adjustment shall be made for dividends or
other rights for which the record date is prior to the date of such issuance.
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5.
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TRANSFERABILITY OF OPTION
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Unless otherwise permitted by the Board in its sole and absolute discretion, this Option shall
not be assignable or transferable by the Optionee, other than by will or the laws of descent and
distribution.
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6.
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TERMINATION OF EMPLOYMENT, DEATH OR DISABILITY
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(a)
General
. Upon the termination of the employment or other service of the Optionee
with Catalyst, other than by reason of Cause (as defined below), death or permanent and total
disability (within the meaning of Section 22(e)(3) of the Code) of the Optionee, this Option shall
expire thirty (30) days following the last day of the Optionees employment with Catalyst, or, if
earlier, the date specified in this Agreement. Options will be exercisable only to the extent they
are exercisable on the date the Optionees employment or service terminates. Notwithstanding the
foregoing provisions of this Section 6, the Board may provide, in its discretion, that following
the termination of employment or service of Optionee with Catalyst, Optionee may exercise this
Option, in whole or in part, at any time subsequent to such termination of employment or service
and prior to termination of this Option pursuant to Section 3(a) above, either subject to or
without regard to any vesting or other limitation on exercise imposed pursuant to Section 3(b)
above. Unless otherwise determined by the Board, temporary absence from employment or service
because of illness, vacation, approved leaves of absence, military service and transfer of
employment shall not constitute a termination of employment or service with Catalyst.
(b)
Cause
. If Catalyst terminates the Optionees employment for Cause (as defined
below), all Options granted to Optionee shall terminate upon the date of such termination of
employment or service and Optionee shall have no further right to purchase Common Stock pursuant to
such Options. For purposes of this Agreement, Cause means (i) failure or refusal of the Optionee
to perform the duties and responsibilities that Catalyst requires to be performed by him, (ii)
gross negligence or willful misconduct by the Optionee in the performance of his duties, (iii)
commission by the Optionee of an act of dishonesty affecting Catalyst , or the commission of an act
constituting common law fraud or a felony, or (iv) the Optionees commission of an act (other than
the good faith exercise of his business judgment in the exercise of his responsibilities) resulting
in material damages to Catalyst. Notwithstanding the above, if Optionee and Catalyst have entered
into an employment or other agreement which defines the term Cause for purposes of such agreement,
Cause shall be defined pursuant to the definition in such agreement with respect to such
Optionees Options. The Board shall determine whether Cause exists for purposes of this Agreement
and such determination shall be final, conclusive and binding on the Optionee.
(c)
Death or Disability
. If Optionees employment with Catalyst terminates by reason
of death or permanent and total disability (within the meaning of Section 22(e)(3) of the Code),
Optionee, Optionees estate or the devisee named in Optionees valid last will and testament or
Optionees heir at law who inherits the Option (whichever is applicable) has the right, at any time
within a period not to exceed three (3) months after the date of such termination and prior to the
termination of this Option pursuant to Section 3(a) above, to exercise, in whole or in part, any
vested portion of this Option (in accordance with Section 3(b) above) held by Optionee upon such
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termination. Any unvested portion of this Option shall terminate upon Optionees termination of
employment or service with Catalyst by reason of death or permanent and total disability.
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7.
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FORFEITURE OF GAIN IF TERMINATED FOR CAUSE OR FOR BREACH OF NON-COMPETE AGREEMENT OR
CONFIDENTIALITY AGREEMENT
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If Optionees employment or service with Catalyst is terminated for Cause, or if Optionee
violates the terms of any non-compete agreement or any confidentiality agreement entered into by
the Optionee and Catalyst, then the Optionee shall pay to Catalyst any gains related to any
Common Stock issued pursuant to the exercise of this Option (Option Stock). For purposes of this
Agreement, gains shall mean the amount realized on the sale of any Option Stock that was sold
during the one-year period immediately preceding Optionees termination of employment or service,
minus the Option Price paid for the Option Stock.
(a)
Violations of Law
. Catalyst shall not be required to sell or issue any shares of
Common Stock under this Option if the sale or issuance of such shares would constitute a violation
by the individual exercising this Option or Catalyst of any provisions of any law or regulation of
any governmental authority, including without limitation, any federal or state securities laws or
regulations. Any determination in this connection by the Board shall be final, binding, and
conclusive. Catalyst shall not be obligated to take any affirmative action in order to cause the
exercise of this Option or the issuance of shares pursuant thereto to comply with any law or
regulation of any governmental authority.
(b)
Registration
. At the time of any exercise of this Option, Catalyst may, if it
shall determine it necessary or desirable for any reason, require the Optionee (or his or her
heirs, legatees or legal representative, as the case may be), as a condition to the exercise
thereof, to deliver to Catalyst a written representation of present intention to purchase the
shares for their own account as an investment and not with a view to, or for sale in connection
with, the distribution of such shares, except in compliance with applicable federal and state
securities laws with respect thereto. In the event such representation is required to be
delivered, an appropriate legend may be placed upon each certificate delivered to the Optionee (or
his or her heirs, legatees or legal representative, as the case may be) upon his or her exercise of
part or all of this Option and a stop transfer order may be placed with the transfer agent. This
Option shall also be subject to the requirement that, if at any time Catalyst determines, in its
discretion, that the listing, registration or qualification of the shares subject to this Option
upon any securities exchange or under any state or federal law, or the consent or approval of any
governmental regulatory body is necessary or desirable as a condition of or in connection with, the
issuance or purchase of the shares thereunder, this Option may not be exercised in whole or in part
unless such listing, registration, qualification, consent or approval shall have been effected or
obtained free of any conditions not acceptable to Catalyst in its sole discretion. Optionee agrees
to execute any lock-up or similar agreement required by Catalysts underwriters in connection
with Catalysts initial public offering. Catalyst shall not be obligated to take any
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affirmative action in order to cause the exercisability or vesting of this Option or to cause the exercise of
this Option or the issuance of shares pursuant thereto to comply with any law or regulation of any
governmental authority.
(c)
Withholding
. The Board may make such provisions and take such steps as it may
deem necessary or appropriate for the withholding of any taxes that Catalyst is required by any law
or regulation of any governmental authority, whether federal, state or local, domestic or foreign,
to withhold in connection with the exercise of this Option, including, but not limited to, (i)
the withholding of delivery of shares of Common Stock upon exercise of this Option until the holder
reimburses Catalyst for the amount Catalyst is required to withhold with respect to such taxes,
(ii) the canceling of any number of shares of Common Stock issuable upon exercise of this Option in
an amount sufficient to reimburse Catalyst for the amount it is required to so withhold, (iii)
withholding the amount due from Optionees wages or compensation due such person, or (iv) requiring
the Optionee to pay Catalyst cash in the amount Catalyst is required to withhold with respect to
such taxes.
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9.
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EFFECT OF CHANGES IN CAPITALIZATION
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(a)
Recapitalization
. If the outstanding shares of Common Stock of Catalyst are
increased or decreased or changed into or exchanged for a different number or kind of shares or
other securities of Catalyst by reason of any recapitalization, reclassification, reorganization
(other than as described in 9(b) below), stock split, reverse split, combination of shares,
exchange of shares, stock dividend or other distribution payable in capital stock of Catalyst, or
other increase or decrease in such shares effected without receipt of consideration by Catalyst, an
appropriate and proportionate adjustment shall be made by the Board in the number and kind of
shares of Common Stock issuable upon exercise of this Option, and in the Option Price per share of
this Option.
(b)
Reorganization or Change in Control
. In the event of a Reorganization (as defined
below) of Catalyst or a Change in Control (as defined below) of Catalyst, the Board may in its sole
and absolute discretion, provide that (i) this Option is immediately exercisable or vested, without
regard to any limitation imposed pursuant to this Agreement and/or (ii) that this Option
terminates, provided however, that Optionee shall have the right, immediately prior to the
occurrence of such Reorganization or Change in Control and during such reasonable period as the
Board in its sole discretion shall determine and designate, to exercise any vested portion of this
Option in whole or in part. In the event that the Board does not terminate this Option upon a
Reorganization of Catalyst then this Option shall upon exercise thereafter entitle the Optionee to
such number of shares of Common Stock or other securities or property to which a holder of shares
of Common Stock would have been entitled to upon such Reorganization. For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however
, that the transaction shall not be a Reorganization if Catalyst, any Parent or
any Subsidiary is the surviving entity. For purposes of
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this Agreement, a Change in Control shall be deemed to occur if any person or group of persons shall acquire direct or indirect
beneficial ownership (whether as a result of stock ownership, revocable or irrevocable proxies or
otherwise) of securities of an entity, pursuant to one or more transactions, such that after
consummation and as a result of such transaction, such person has direct or indirect beneficial
ownership of 50% or more of the total combined voting power of the Common Stock. For purposes of
this Agreement, a person shall mean any person, corporation, partnership, joint venture or other
entity or any group (as such term is defined for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act)), other than a Parent or Subsidiary, and beneficial ownership shall be determined in accordance with Rule 13d-3 under
the Exchange Act.
(c)
Dissolution or Liquidation
. Upon the dissolution or liquidation of Catalyst, this
Option shall terminate. In the event of any termination of this Option under this Section 9(c),
Optionee shall have the right, immediately prior to the occurrence of such termination and during
such reasonable period as the Board in its sole discretion shall determine and designate, to
exercise this Option in whole or in part, whether or not this Option was otherwise exercisable at
the time such termination occurs and without regard to any vesting or other limitation on exercise
imposed pursuant to Section 3 above.
(d)
Adjustments
. Adjustments under this Section 9 related to stock or securities of
Catalyst shall be made by the Board, whose determination in that respect shall be final, binding,
and conclusive. No fractional shares of Common Stock or units of other securities shall be issued
pursuant to any such adjustment, and any fractions resulting from any such adjustment shall be
eliminated in each case by rounding downward to the nearest whole share or unit.
(e)
No Limitations
. The grant of this Option hereunder shall not affect or limit in
any way the right or power of Catalyst to make adjustments, reclassifications, reorganizations or
changes of its capital or business structure or to merge, consolidate, dissolve or liquidate, or to
sell or transfer all or any part of its business or assets.
No provision of this Agreement shall be construed to confer upon any individual, including
Optionee, the right to remain in the employ of or to continue in any other contractual relationship
with Catalyst or to interfere in any way with the right and authority of Catalyst either to
increase or decrease the compensation of any individual, including Optionee, at any time, or to
terminate any employment or other relationship between any individual, including Optionee, and
Catalyst.
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11.
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NONEXCLUSIVITY OF THIS AGREEMENT
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This Agreement shall not be construed as creating any limitations upon the right and authority
of the Board to adopt such other incentive compensation arrangements (which arrangements may be
applicable either generally to a class or classes of individuals or specifically to
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a particular individual or individuals) as the Board in its discretion determines desirable, including, without
limitation, the granting of stock options or stock appreciation rights.
(a)
Indulgences, Etc.
Neither the failure nor any delay on the part of either party
to exercise any right, remedy, power or privilege under this Agreement shall operate as a waiver
thereof, nor shall any single or partial exercise of any right, remedy, power or privilege preclude
any other or further exercise of the same or of any other right, remedy, power or privilege, nor
shall any waiver of any right, remedy, power or privilege with respect to any occurrence be
construed as a waiver of such right, remedy, power or privilege with respect to any other occurrence. No
waiver shall be effective unless it is in writing and is signed by the party asserted to have
granted such waiver.
(b)
Controlling Law
. This Agreement and all questions relating to its validity,
interpretation, performance and enforcement (including, without limitation, provisions concerning
limitations of actions), shall be governed by and construed in accordance with the laws of the
State of Florida, without application to the principles of conflict of laws.
(c)
Notices
. All notices, requests, demands and other communications required or
permitted under this Agreement shall be in writing and shall be deemed to have been duly given,
made and received only when personally delivered, one day following the day when deposited with an
overnight courier service for overnight priority service, such as Federal Express, for delivery to
the intended addressee or three days following the day when deposited in the United States mails,
first class postage prepaid, certified or registered mail, and addressed, in the case of Catalyst,
its principal place of business, and, in the case of Optionee, as set forth below Optionees
signature on the last page hereof. Any person may alter the address to which communications or
copies are to be sent by giving notice of such change of address in conformity with the provisions
of this Section for the giving of notice.
(d)
Binding Nature of Agreement; Transferability
. This Agreement shall be binding
upon and inure to the benefit of the parties hereto and their respective heirs, personal
representatives, successors and assigns. This Agreement shall not be assignable or transferable by
the Optionee other than by will or the laws of descent and distribution.
(e)
Severability
. The provisions of this Agreement are independent of and separable
from each other, and no provision shall be affected or rendered invalid or unenforceable by virtue
of the fact that for any reason any other or others of them may be invalid or unenforceable in
whole or in part.
(f)
Section Headings
. The section headings in this Agreement are for convenience
only; they form no part of this Agreement and shall not affect its interpretation.
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(g)
Number of Days
. In computing the number of days for purposes of this Agreement,
all days shall be counted, including Saturdays, Sundays and holidays;
provided, however,
that if
the final day of any time period falls on a Saturday, Sunday or holiday on which federal banks are
or may elect to be closed, then the final day shall be deemed to be the next day which is not a
Saturday, Sunday or such holiday.
(h)
No Third-Party Beneficiaries
. This Agreement shall not confer any rights or
remedies upon any person other than the parties and their respective successors and permitted
assigns.
(i)
Entire Agreement; Amendments
. This Agreement (including the documents referred to
herein) constitutes the entire agreement among the parties and supersedes any prior understandings,
agreements, or representations by or among the parties, written or oral, that may have related in any way to the subject matter hereof. This Agreement may not be amended,
supplemented or modified in whole or in part except by an instrument in writing signed by the party
or parties against whom enforcement of any such amendment, supplement or modification is sought.
(j)
Construction
. The language used in this Agreement will be deemed to be the
language chosen by the parties to express their mutual intent, and therefore strict construction
shall be applied against any party. Any reference to any federal, state, local or foreign statute
or law shall be deemed also to refer to the rules and regulations promulgated thereunder, unless
the context requires otherwise. The parties intend that each representation, warranty, and
covenant contained herein shall have independent significance. If any party has breached any
representation, warranty, or covenant contained herein in any respect, the fact that there exists
another representation, warranty or covenant relating to the same subject matter (regardless of the
relative levels of specificity) which the party has not breached shall not detract from or mitigate
the fact that the party is in breach of the first representation, warranty or covenant.
(k)
Counterparts
. This Agreement may be executed in one or more counterparts, each of
which will be deemed an original and all of which together will constitute one and the same
instrument.
(l)
Pronouns
. The use of any gender in this Agreement shall be deemed to include all
genders, and the use of the singular shall be deemed to include the plural and vice versa, wherever
it appears appropriate from the context.
[SIGNATURES ON FOLLOWING PAGE]
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IN WITNESS WHEREOF
, the parties have executed this Agreement as of the day and year first
above written.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By:
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/s/ Patrick J. McEnany
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Patrick J. McEnany
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President
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OPTIONEE:
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/s/ M. Douglas Winship
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Name: M. Douglas Winship
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Address:
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