Form 10-Q
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 |
For the quarter ended September 30, 2009
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from _______ to _______
Commission File Number: 000-13347
NEUROLOGIX,
INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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06-1582875 |
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(State or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer Identification No.) |
One Bridge Plaza, Fort Lee, NJ 07024
(Address of principal executive offices)
(201) 592-6451
(Registrants telephone number, including area code)
Indicate by check mark 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 reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the Registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the Registrant was required to submit and post such files). Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See definition of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company 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
As of November 9, 2009, 27,865,010 shares of common stock were outstanding.
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
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September 30, |
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December 31, |
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2009 |
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2008 |
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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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$ |
11,771 |
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$ |
18,906 |
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Prepaid expenses and other current assets |
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346 |
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323 |
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Total current assets |
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12,117 |
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19,229 |
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Equipment, less accumulated depreciation of $602 and $542 at
September 30, 2009 and December 31, 2008, respectively |
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124 |
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141 |
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Intangible assets, less accumulated amortization of $243 and $182
at September 30, 2009 and December 31, 2008, respectively |
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848 |
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748 |
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Other assets |
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5 |
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5 |
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Total Assets |
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$ |
13,094 |
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$ |
20,123 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
1,201 |
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$ |
850 |
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Total current liabilities |
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1,201 |
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850 |
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Derivative financial instruments, at estimated fair value Warrants |
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3,773 |
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Total liabilities |
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4,974 |
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850 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock; 5,000,000 shares authorized |
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Series A Convertible, $0.10 par value; 650 shares
designated, 645 shares issued and outstanding at September
30, 2009 and December 31, 2008, with an aggregate liquidation
preference of $1 |
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Series C Convertible, $0.10 par value; 700,000 shares
designated, 281,263 and 285,878 shares issued and
outstanding at September 30, 2009 and December 31, 2008,
respectively, with an aggregate liquidation preference of
$7,301 and $5,863 at September 30, 2009 and December 31,
2008, respectively |
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28 |
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29 |
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Series D Convertible, $0.10 par value; 792,100 shares
designated, 734,898 shares issued and outstanding at
September 30, 2009 and December 31, 2008, with an aggregate
liquidation preference of $29,900 and $27,031 at September
30, 2009 and December 31, 2008, respectively |
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73 |
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73 |
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Common Stock: |
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$0.001 par value; 100,000,000 shares authorized, 27,865,010
and 27,764,058 issued and outstanding at September 30, 2009
and December 31, 2008, respectively |
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28 |
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28 |
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Additional paid-in capital |
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56,664 |
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62,393 |
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Deficit accumulated during the development stage |
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(48,673 |
) |
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(43,250 |
) |
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Total stockholders equity |
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8,120 |
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19,273 |
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Total Liabilities and Stockholders Equity |
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$ |
13,094 |
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$ |
20,123 |
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See accompanying notes to condensed financial statements.
3
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(Amounts in thousands, except share and per share amounts)
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For the period |
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Nine Months Ended |
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Three Months Ended |
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February 12, 1999 |
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September 30, |
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September 30, |
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(inception) through |
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2009 |
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2008 |
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2009 |
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2008 |
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September 30, 2009 |
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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 expenses: |
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Research and development |
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5,779 |
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2,911 |
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2,121 |
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1,082 |
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25,396 |
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General and administrative expenses |
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2,179 |
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2,495 |
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631 |
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734 |
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18,279 |
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Loss from operations |
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(7,958 |
) |
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(5,406 |
) |
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(2,752 |
) |
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(1,816 |
) |
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(43,675 |
) |
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Other income (expense): |
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Dividend, interest and other income |
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55 |
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478 |
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6 |
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167 |
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1,881 |
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Interest expense-related parties |
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(411 |
) |
Change in estimated fair value of derivative financial
instruments Warrants |
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(2,703 |
) |
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(723 |
) |
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(2,703 |
) |
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Other (expense) income, net |
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(2,648 |
) |
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478 |
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(717 |
) |
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167 |
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(1,233 |
) |
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Net loss |
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(10,606 |
) |
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(4,928 |
) |
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(3,469 |
) |
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(1,649 |
) |
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$ |
(44,908 |
) |
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Preferred stock dividends |
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(2,208 |
) |
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(1,937 |
) |
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(757 |
) |
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(707 |
) |
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Charge for accretion of beneficial conversion feature |
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(562 |
) |
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Charge for contingent beneficial conversion feature |
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(212 |
) |
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Net loss applicable to common stock |
|
$ |
(12,814 |
) |
|
$ |
(7,639 |
) |
|
$ |
(4,226 |
) |
|
$ |
(2,356 |
) |
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Net loss applicable to common stock per share, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.08 |
) |
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Weighted average common shares outstanding, basic and diluted |
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|
27,819,156 |
|
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|
27,668,255 |
|
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|
27,865,010 |
|
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|
27,738,379 |
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|
|
|
|
|
|
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|
|
|
|
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|
|
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|
|
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|
See accompanying notes to condensed financial statements.
4
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH SEPTEMBER 30, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
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Deficit |
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Accumulated |
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Additional |
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During the |
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Series D Preferred Stock |
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Series C Preferred Stock |
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Common Stock |
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Paid-in |
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Unearned |
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Development |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Compensation |
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Stage |
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Total |
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Sale of common stock to founders |
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|
$ |
0 |
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|
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|
$ |
0 |
|
|
|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
4 |
|
Net loss |
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|
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|
|
|
|
|
|
(328 |
) |
|
|
(328 |
) |
Balance, December 31, 1999 |
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|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
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|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
(328 |
) |
|
$ |
(324 |
) |
Net loss |
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|
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|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
(1,055 |
) |
|
|
(1,055 |
) |
Balance, December 31, 2000 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
(1,383 |
) |
|
$ |
(1,379 |
) |
Stock options granted for services |
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9 |
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|
9 |
|
Common stock issued for intangible assets at $0.09 per share |
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
259,491 |
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
24 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
(870 |
) |
|
|
(870 |
) |
Balance, December 31, 2001 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,263,637 |
|
|
$ |
0 |
|
|
$ |
37 |
|
|
$ |
0 |
|
|
$ |
(2,253 |
) |
|
$ |
(2,216 |
) |
Retirement of founder shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,126 |
) |
|
|
|
|
|
|
|
|
|
|
|
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|
Common Stock issued pursuant to license agreement at $1.56 per share |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
368,761 |
|
|
|
|
|
|
|
577 |
|
|
|
(577 |
) |
|
|
|
|
|
|
|
|
Private placement of Series B convertible preferred stock |
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
Amortization of unearned compensation |
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
24 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
(1,310 |
) |
|
|
(1,310 |
) |
Balance, December 31, 2002 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,599,272 |
|
|
$ |
0 |
|
|
$ |
3,227 |
|
|
$ |
(553 |
) |
|
$ |
(3,563 |
) |
|
$ |
(889 |
) |
Sale of Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
276,054 |
|
|
|
|
|
|
|
90 |
|
|
|
(89 |
) |
|
|
|
|
|
|
1 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
164 |
|
|
|
|
|
|
|
164 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,274 |
) |
|
|
(2,274 |
) |
Balance, December 31, 2003 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,875,326 |
|
|
$ |
0 |
|
|
$ |
3,317 |
|
|
$ |
(478 |
) |
|
$ |
(5,837 |
) |
|
$ |
(2,998 |
) |
Conversion of note payable to Common Stock at $2.17 per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,091,321 |
|
|
|
1 |
|
|
|
2,371 |
|
|
|
|
|
|
|
|
|
|
|
2,372 |
|
Conversion of mandatory redeemable preferred stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,086,991 |
|
|
|
6 |
|
|
|
494 |
|
|
|
|
|
|
|
|
|
|
|
500 |
|
Conversion of Series B convertible preferred stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,354,746 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Effects of reverse acquisition |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,103,020 |
|
|
|
14 |
|
|
|
5,886 |
|
|
|
|
|
|
|
|
|
|
|
5,900 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
202 |
|
|
|
|
|
|
|
202 |
|
5
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH SEPTEMBER 30, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
During the |
|
|
|
|
|
|
Series D Preferred Stock |
|
|
Series C Preferred Stock |
|
|
Common Stock |
|
|
Paid-in |
|
|
Unearned |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Compensation |
|
|
Stage |
|
|
Total |
|
|
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42 |
|
|
|
(42 |
) |
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
15 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,937 |
) |
|
|
(2,937 |
) |
Balance, December 31, 2004 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
22,521,404 |
|
|
$ |
22 |
|
|
$ |
12,124 |
|
|
$ |
(318 |
) |
|
$ |
(8,774 |
) |
|
$ |
3,054 |
|
Sale of Common Stock through private placement at an average price of $1.30 per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,473,914 |
|
|
|
4 |
|
|
|
3,062 |
|
|
|
|
|
|
|
|
|
|
|
3,066 |
|
Sale of Common Stock at an average price of $1.752 per share and warrants to Medtronic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,141,552 |
|
|
|
1 |
|
|
|
2,794 |
|
|
|
|
|
|
|
|
|
|
|
2,795 |
|
Amortization of unearned compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
825 |
|
|
|
|
|
|
|
825 |
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,305 |
|
|
|
(1,305 |
) |
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
406,054 |
|
|
|
|
|
|
|
127 |
|
|
|
|
|
|
|
|
|
|
|
127 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,345 |
) |
|
|
(5,345 |
) |
Balance, December 31, 2005 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
26,542,924 |
|
|
$ |
27 |
|
|
$ |
19,412 |
|
|
$ |
(798 |
) |
|
$ |
(14,119 |
) |
|
$ |
4,522 |
|
Sale of Preferred Stock through private placement at an average price of $35.00 per share |
|
|
|
|
|
|
|
|
|
|
342,857 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
11,578 |
|
|
|
|
|
|
|
|
|
|
|
11,612 |
|
Fair value of beneficial conversion rights issued in connection with issuance of Series C Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
Preferred Dividend and accretion of fair value of beneficial conversion charge |
|
|
|
|
|
|
|
|
|
|
25,298 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
(2,621 |
) |
|
|
(2,621 |
) |
Employee share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83 |
|
|
|
|
|
|
|
|
|
|
|
83 |
|
Reclassification of prior year non-employee compensation to prepaid expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
487 |
|
|
|
|
|
|
|
487 |
|
Effects of adoption of SFAS 123R |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(311 |
) |
|
|
311 |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,046 |
) |
|
|
(7,046 |
) |
Balance, December 31, 2006 |
|
|
|
|
|
$ |
0 |
|
|
|
368,155 |
|
|
$ |
37 |
|
|
|
26,542,924 |
|
|
$ |
27 |
|
|
$ |
34,573 |
|
|
$ |
0 |
|
|
$ |
(23,786 |
) |
|
$ |
10,851 |
|
Sale of Series D Preferred Stock through private placement at an average price of $35.00 per share |
|
|
428,571 |
|
|
|
43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,727 |
|
|
|
|
|
|
|
|
|
|
|
14,770 |
|
6
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH SEPTEMBER 30, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
During the |
|
|
|
|
|
|
Series D Preferred Stock |
|
|
Series C Preferred Stock |
|
|
Common Stock |
|
|
Paid-in |
|
|
Unearned |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Compensation |
|
|
Stage |
|
|
Total |
|
|
|
Fair value of beneficial conversion rights issued in connection with the issuance of Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,130 |
|
|
|
|
|
|
|
|
|
|
|
2,130 |
|
Preferred Dividend and accretion of fair value of beneficial conversion charge |
|
|
5,108 |
|
|
|
1 |
|
|
|
68,801 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
|
|
|
|
|
(2,130 |
) |
|
|
(2,130 |
) |
Contingent beneficial conversion feature related to Series C Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
627 |
|
|
|
|
|
|
|
(627 |
) |
|
|
|
|
Induced conversion of preferred stock in connection with the issuance of Series D Preferred Stock |
|
|
163,470 |
|
|
|
16 |
|
|
|
(230,184 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
(347 |
) |
|
|
|
|
|
|
354 |
|
|
|
|
|
Issuance of Series C Preferred Stock in connection with induced conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
93,940 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
2,949 |
|
|
|
|
|
|
|
(2,958 |
) |
|
|
|
|
Issuance of Common Stock in connection with issuance of Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
192,017 |
|
|
|
|
|
|
|
192 |
|
|
|
|
|
|
|
(192 |
) |
|
|
|
|
Employee share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
702 |
|
|
|
|
|
|
|
|
|
|
|
702 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72 |
|
|
|
|
|
|
|
|
|
|
|
72 |
|
Conversion of Series C Preferred Stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
(5,597 |
) |
|
|
|
|
|
|
110,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
787,815 |
|
|
|
1 |
|
|
|
590 |
|
|
|
|
|
|
|
|
|
|
|
591 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,817 |
) |
|
|
(6,817 |
) |
Balance, December 31, 2007 |
|
|
597,149 |
|
|
$ |
60 |
|
|
|
295,115 |
|
|
$ |
30 |
|
|
|
27,632,808 |
|
|
$ |
28 |
|
|
$ |
56,207 |
|
|
$ |
0 |
|
|
$ |
(36,156 |
) |
|
$ |
20,169 |
|
Sale of Series D Preferred Stock through private placement at an average price of $35.00 per share |
|
|
142,857 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,918 |
|
|
|
|
|
|
|
|
|
|
|
4,932 |
|
Fair value of beneficial conversion rights issued in connection with the issuance of Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
562 |
|
|
|
|
|
|
|
|
|
|
|
562 |
|
Accretion of fair value of beneficial conversion charge |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(562 |
) |
|
|
(562 |
) |
Contingent beneficial conversion feature related to Series C Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
212 |
|
|
|
|
|
|
|
(212 |
) |
|
|
|
|
Adjustment to preferred dividends accrued |
|
|
(5,108 |
) |
|
|
(1 |
) |
|
|
(3,237 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
7
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH SEPTEMBER 30, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
During the |
|
|
|
|
|
|
Series D Preferred Stock |
|
|
Series C Preferred Stock |
|
|
Common Stock |
|
|
Paid-in |
|
|
Unearned |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Compensation |
|
|
Stage |
|
|
Total |
|
|
|
Employee share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
489 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
Conversion of Series C Preferred Stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
(6,000 |
) |
|
|
|
|
|
|
131,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,320 |
) |
|
|
(6,320 |
) |
Balance December 31, 2008 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
285,878 |
|
|
$ |
29 |
|
|
|
27,764,058 |
|
|
$ |
28 |
|
|
$ |
62,393 |
|
|
$ |
0 |
|
|
$ |
(43,250 |
) |
|
$ |
19,273 |
|
Employee share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
376 |
|
|
|
|
|
|
|
|
|
|
|
376 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
146 |
|
|
|
|
|
|
|
|
|
|
|
146 |
|
Cumulative effect of adoption of ASC Topic 815-40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,252 |
) |
|
|
|
|
|
|
5,183 |
|
|
|
(1,069 |
) |
Conversion of Series C Preferred Stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
(4,615 |
) |
|
|
(1 |
) |
|
|
100,952 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,606 |
) |
|
|
(10,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance September 30, 2009 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
281,263 |
|
|
$ |
28 |
|
|
|
27,865,010 |
|
|
$ |
28 |
|
|
$ |
56,664 |
|
|
$ |
0 |
|
|
$ |
(48,673 |
) |
|
$ |
8,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed financial statements.
8
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
Nine Months Ended September 30, |
|
|
(inception) through |
|
|
|
2009 |
|
|
2008 |
|
|
September 30, 2009 |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,606 |
) |
|
$ |
(4,928 |
) |
|
$ |
(44,908 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
61 |
|
|
|
83 |
|
|
|
609 |
|
Amortization |
|
|
61 |
|
|
|
38 |
|
|
|
383 |
|
Gain on redemption of investment |
|
|
|
|
|
|
|
|
|
|
(62 |
) |
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
9 |
|
Impairment of intangible assets |
|
|
5 |
|
|
|
29 |
|
|
|
199 |
|
Amortization of non-employee share-based compensation |
|
|
179 |
|
|
|
46 |
|
|
|
1,658 |
|
Share-based employee compensation expense |
|
|
376 |
|
|
|
408 |
|
|
|
2,760 |
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
|
|
378 |
|
Change in estimated fair value of derivative financial instruments |
|
|
2,703 |
|
|
|
|
|
|
|
2,703 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in prepaid expenses and other current assets |
|
|
(55 |
) |
|
|
58 |
|
|
|
598 |
|
Increase (decrease) in accounts payable and accrued expenses |
|
|
351 |
|
|
|
(577 |
) |
|
|
1,140 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,925 |
) |
|
|
(4,843 |
) |
|
|
(34,533 |
) |
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Security deposits paid |
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Purchases of equipment |
|
|
(44 |
) |
|
|
(15 |
) |
|
|
(619 |
) |
Additions to intangible assets |
|
|
(166 |
) |
|
|
(171 |
) |
|
|
(1,400 |
) |
Proceeds from redemption of investment |
|
|
|
|
|
|
|
|
|
|
65 |
|
Purchases of marketable securities |
|
|
|
|
|
|
|
|
|
|
(12,673 |
) |
Proceeds from maturities of marketable securities |
|
|
|
|
|
|
|
|
|
|
12,673 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(210 |
) |
|
|
(186 |
) |
|
|
(1,961 |
) |
|
|
|
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from note payable |
|
|
|
|
|
|
|
|
|
|
1,100 |
|
Borrowings from related party |
|
|
|
|
|
|
|
|
|
|
2,000 |
|
Cash acquired in Merger |
|
|
|
|
|
|
|
|
|
|
5,413 |
|
Merger-related costs |
|
|
|
|
|
|
|
|
|
|
(375 |
) |
Payments of capital lease obligations |
|
|
|
|
|
|
|
|
|
|
(99 |
) |
Proceeds from exercise of stock options |
|
|
|
|
|
|
|
|
|
|
733 |
|
Proceeds from issuance of common stock and warrants |
|
|
|
|
|
|
|
|
|
|
5,066 |
|
Proceeds from issuance of preferred stock |
|
|
|
|
|
|
4,932 |
|
|
|
34,427 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
4,932 |
|
|
|
48,265 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(7,135 |
) |
|
|
(97 |
) |
|
|
11,771 |
|
Cash and cash equivalents, beginning of period |
|
|
18,906 |
|
|
|
20,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
Nine Months Ended September 30, |
|
|
(inception) through |
|
|
|
2009 |
|
|
2008 |
|
|
September 30, 2009 |
|
Cash and cash equivalents, end of period |
|
$ |
11,771 |
|
|
$ |
20,060 |
|
|
$ |
11,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on Series C Preferred Stock paid in preferred shares |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,811 |
|
Accrued dividends on Preferred Stock |
|
$ |
2,208 |
|
|
$ |
1,937 |
|
|
$ |
5,152 |
|
Accretion of fair value of beneficial conversion on preferred stock |
|
$ |
|
|
|
$ |
562 |
|
|
$ |
5,313 |
|
Accretion of contingent beneficial conversion related on Series C Preferred Stock |
|
$ |
|
|
|
$ |
212 |
|
|
$ |
839 |
|
Induced conversion of preferred stock in connection with issuance of Series D
Preferred Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,796 |
|
Issuance of Common Stock to pay debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,372 |
|
Reverse acquisition net liabilities assumed, excluding cash |
|
$ |
|
|
|
$ |
|
|
|
$ |
(214 |
) |
Mandatory redeemable convertible preferred stock converted to Common Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
500 |
|
Common Stock issued to acquire intangible assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
24 |
|
Stock options granted for services |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,424 |
|
Deferred research and development cost resulting from Medtronic Stock Purchase |
|
$ |
|
|
|
$ |
|
|
|
$ |
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of equipment through capital leases |
|
$ |
|
|
|
$ |
|
|
|
$ |
106 |
|
See accompanying notes to condensed financial statements.
10
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to Unaudited Condensed Financial Statements
(In thousands, except for share and per share amounts)
(1) Description of Business
Neurologix, Inc. (Neurologix or the Company) is engaged in the research
and development of proprietary treatments for disorders of the brain and central nervous system,
primarily utilizing gene therapies. These treatments are designed as alternatives to conventional
surgical and pharmacological treatments. The Company has not generated any operating revenues and,
accordingly, it is considered to be a development stage company as defined by ASC Topic 915,
Development Stage Entities.
The Company incurred net losses of $10,606, $4,928 and $44,908 and negative cash flows from
operating activities of $6,925, $4,843 and $34,533 for the nine months ended September 30, 2009 and
2008 and for the period from February 12, 1999 (inception) to September 30, 2009, respectively.
The Company expects that it will continue to incur net losses and cash flow deficiencies from
operating activities for the foreseeable future.
The Company had cash and cash equivalents of $11,771 and $18,906 as of September 30, 2009 and
December 31, 2008, respectively. Management believes that the Companys current resources will
enable it to continue as a going concern through at least September 30, 2010. Accordingly, it
will, from time to time, continue to seek additional funds through public or private equity
offerings, debt financings or corporate collaboration and licensing arrangements. The Company does
not know whether additional financing will be available when needed, or, if available, will be on
acceptable or favorable terms to it or its stockholders. If the Company is unable to secure
additional funding by December 31, 2009 or shortly thereafter, its ability to continue as a going
concern may be in doubt.
(2) Basis of Presentation
The accompanying unaudited condensed financial statements of the Company should be read in
conjunction with the audited financial statements and notes thereto included in the Companys
Annual Report on Form 10-K for the year ended December 31, 2008 (the 2008 10-K) filed
with the Securities and Exchange Commission (the SEC) on March 25, 2009. The accompanying
financial statements have been prepared in accordance with accounting principles generally accepted
in the United States (GAAP) for interim financial information, the instructions to Form
10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the
accompanying financial statements do not include all of the information and notes required by GAAP
for annual financial statements, but reflect all adjustments consisting of normal, recurring
adjustments, that are necessary for a fair presentation of the financial position, results of
operations and cash flows for the interim periods presented. Interim results are not necessarily
indicative of results for a full year. The December 31, 2008 balance sheet information was derived
from the audited financial statements as of that date.
11
In June 2009, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update No. 2009-01, Generally Accepted Accounting Principles (ASC Topic 105), which
establishes the FASB Accounting Standards Codification (the Codification or
ASC) as the single source of authoritative GAAP. All existing accounting standards in effect prior
to the Codification were superseded by the Codification. All other accounting guidance not included
in the Codification will be considered non-authoritative. The Codification also includes all
relevant SEC guidance organized using the same topical structure in separate sections within the
Codification. The Codification does not change GAAP and does not impact the Companys financial
statements. Beginning with the financial statements and the notes thereto included in this
quarterly report, all references to authoritative accounting literature (including references
related to periods prior to the establishment of the Codification) will be referenced in accordance
with the Codification.
(3) Summary of Significant Accounting Policies
(a) Stock-Based Compensation:
At September 30, 2009, the Company had one active share-based employee compensation plan
available for grants to employees, non-employee directors and consultants. Stock option awards
granted from this plan are granted at the fair market value on the date of grant, vest over a
period determined at the time the options are granted, ranging from zero to three years, and
generally have a maximum term of ten years. Certain options provide for accelerated vesting if
there is a change in control (as defined in the plan) or if there is a termination of employment
event for specified reasons set forth in certain employment agreements. When options are exercised,
new shares of the Companys common stock, par value $0.001 per share (the Common Stock),
are issued.
The Company follows the provisions of ASC Topic 718, Stock Compensation (ASC Topic
718) for employee stock options and other share-based compensation using the modified
prospective method. The Company continues to reflect share-based employee compensation cost in net
loss.
The total value of the stock option awards is expensed ratably over the service period of the
employees receiving the awards. As of September 30, 2009, total unrecognized compensation cost
related to stock option awards, to be recognized as expense subsequent to September 30, 2009, was
approximately $265, and the related weighted-average period over which it is expected to be
recognized was approximately 1 year.
The amount of compensation expense recognized during the three and nine months ended September
30, 2009 and 2008 was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Three Months Ended September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Research and development |
|
$ |
113 |
|
|
$ |
112 |
|
|
$ |
23 |
|
|
$ |
22 |
|
General and administrative |
|
|
263 |
|
|
|
296 |
|
|
|
48 |
|
|
|
61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee share-based
compensation expense |
|
$ |
376 |
|
|
$ |
408 |
|
|
$ |
71 |
|
|
$ |
83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net share-based
compensation expenses per
basic and diluted common share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12
A summary of option activity as of September 30, 2009 and changes during the nine months then
ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Shares |
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
Subject to |
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Option |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
Options |
|
(000) |
|
|
Price |
|
|
Term (years) |
|
|
Value |
|
Outstanding at December 31, 2008 |
|
|
3,623 |
|
|
$ |
1.38 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,088 |
|
|
|
0.65 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(537 |
) |
|
|
1.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009 |
|
|
4,174 |
|
|
$ |
1.19 |
|
|
|
6.39 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2009 |
|
|
3,186 |
|
|
$ |
1.36 |
|
|
|
5.91 |
|
|
$ |
0 |
|
The weighted-average grant-date fair value of options granted during the nine months ended
September 30, 2009 and 2008 was $0.52 and $0.46, respectively and was estimated using the
Black-Scholes option pricing model.
The fair value of each stock option award is estimated on the date of the grant using the
Black-Scholes option pricing model based on the assumptions noted in the following table:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2009 |
|
|
2008 |
|
Expected option term |
|
|
5-6 |
|
|
|
5-6 |
|
Risk-free interest rate |
|
|
2.06 |
% |
|
|
3.79 |
% |
Expected volatility |
|
|
116 |
% |
|
|
91 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility is based on historical volatility of the Common Stock. The risk-free rate
is based on the five-year U.S. Treasury security rate.
The expected option term represents the period that stock-based awards are expected to be
outstanding based on the simplified method provided in Staff Accounting Bulletin No. 107 (SAB
107), which averages an awards weighted-average vesting period and expected term for plain
vanilla share options. Under SAB 107, options are considered to be plain vanilla if they have
the following basic characteristics: granted at-the-money; exercisability is conditioned upon
service through the vesting date; termination of service prior to vesting results in forfeiture;
limited exercise period following termination of service; and options are non-transferable and
non-hedgeable.
In December 2007, the SEC issued Staff Accounting Bulletin No. 110 (SAB 110). SAB
110 was effective January 1, 2008 and expresses the views of the staff of the SEC with respect to
extending the use of the simplified method, provided in SAB 107, in developing an estimate of the
expected term of plain vanilla share options in accordance with ASC Topic 718. The Company will
continue to use the simplified method until it has the historical data necessary to provide a
reasonable estimate of expected life in accordance with SAB 107, as amended by SAB 110. For the
expected option term, the Company has plain-vanilla stock options and, therefore, used a simple average of the vesting period and the contractual term for options granted
subsequent to January 1, 2006 as permitted by SAB 107.
13
For equity awards to non-employees, the Company also applies the Black-Scholes option pricing
model to determine the fair value of such instruments in accordance with ASC Topic 718 and the
provisions of ASC Topic 505-50, Equity-Based Payments to Non-Employees. The options granted to
non-employees are re-measured as they vest and the resulting value is recognized as an adjustment
against the Companys net loss over the period during which the services are received.
(b) Basic and Diluted Net Loss Per Common Share:
Basic net loss per common share excludes the effects of potentially dilutive securities and is
computed by dividing net loss applicable to common stock by the weighted average number of common
shares outstanding for the period. Diluted net income or loss per common share is adjusted for the
effects of convertible securities, options, warrants and other potentially dilutive financial
instruments only in the periods in which such effects would have been dilutive.
The following securities were not included in the computation of diluted net loss per share
because to do so would have had an anti-dilutive effect for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
Stock options |
|
|
4,173,833 |
|
|
|
3,623,333 |
|
Warrants |
|
|
7,441,920 |
|
|
|
7,441,920 |
|
Common Stock issuable upon conversion of Series
A Convertible Preferred Stock |
|
|
645 |
|
|
|
645 |
|
Common Stock issuable upon conversion of Series
C Convertible Preferred Stock |
|
|
7,275,494 |
|
|
|
6,757,647 |
|
Common Stock issuable upon conversion of Series
D Convertible Preferred Stock |
|
|
25,066,747 |
|
|
|
23,400,144 |
|
(c) Derivative Instruments:
Effective December 28, 2008, the Company adopted provisions of ASC Topic 815-10, Derivatives
and Hedging Overall (ASC Topic 815-10) relating to the Companys derivative and
hedging activities. ASC Topic 815-10 requires enhanced disclosure of the Companys derivatives and
hedging activities, including certain derivative instruments embedded in other contracts. All
derivatives are recorded on the Companys balance sheet at fair value in accordance with current
accounting guidelines for such complex financial instruments. (See Note 4 and Note 5).
14
ASC Topic 815-10 requires entities that utilize derivative instruments to provide qualitative
disclosures about their objectives and strategies for using such instruments, as well as any
details of credit-risk-related contingent features contained within derivatives. ASC Topic 815-10
also requires entities to disclose additional information about the amounts and location of
derivatives located within the financial statements, how the provisions of ASC Topic 815-10 have
been applied and the impact that hedges have on an entitys financial position, financial
performance and cash flows. The Companys derivative liabilities are related to warrants issued
in connection with financing transactions and are therefore not designated as hedging instruments.
(d) Financial Instruments and Fair Value:
Effective January 1, 2008, the Company adopted provisions of ASC Topic 820, Fair Value
Measurements and Disclosures, as they relate to financial assets and financial liabilities
(ASC Topic 820). ASC Topic 820 establishes a fair value hierarchy that prioritizes the
inputs to valuation techniques used to measure fair value. The hierarchy gives the highest
priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1
measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three
levels of the fair value hierarchy under ASC Topic 820 are described below:
Level 1 Unadjusted quoted prices in active markets that are accessible at the
measurement date for identical, unrestricted assets or liabilities;
Level 2 Quoted prices in markets that are not active or financial instruments for
which all significant inputs are observable, either directly or indirectly; and
Level 3 Prices or valuations that require inputs that are both significant to the
fair value measurement and unobservable.
In estimating the fair value of the Companys derivative liabilities, the Company used the
probability-weighted Black-Scholes option pricing model. (See Note 4 and Note 5).
Financial assets with carrying values approximating fair value include cash and cash
equivalents. Financial liabilities with carrying values approximating fair value include accounts
payable and other accrued liabilities. The carrying value of these financial instruments
approximates fair value due to their short maturities or variable interest rates that approximate
current market rates.
(e) Recent Accounting Pronouncements:
In August 2009, the FASB issued Accounting Standards Update No. 2009-05, Measuring
Liabilities at Fair Value (ASU 2009-05). ASU 2009-05 amends ASC Topic 820 and clarifies
that, where a quoted price in an active market for the identical liability is not available, a
reporting entity is required to measure fair value using one or more of the following methods: 1) a
valuation technique that uses a) the quoted price of the identical liability when traded as an
asset or b) quoted prices for similar liabilities or similar liabilities when traded as assets
and/or 2) a valuation technique that is consistent with the principles of ASC Topic 820. ASU
2009-05 also clarifies that, when estimating the fair value of a liability, a reporting entity is
not required to adjust to include inputs relating to the existence of transfer restrictions on that liability.
The adoption of ASU 2009-05 did not have a material impact on the Companys financial statements.
15
In April 2009, the FASB issued guidance within ASC Topic 825-10, Financial Instruments
Overall, concerning interim disclosures about fair value instruments. This guidance requires that
disclosures about the fair value of a companys financial instruments be made whenever summarized
financial information for interim reporting periods is made. The provisions of this guidance are
effective for interim periods ending after June 15, 2009. The adoption of this guidance did not
have a material impact on the Companys financial statements.
In May 2009, the FASB issued guidance within ASC Topic 855-10, Subsequent Events, relating
to subsequent events. This guidance establishes principles and requirements for subsequent
events. This guidance defines the period after the balance sheet date during which events or
transactions that may occur would be required to be disclosed in a companys financial statements.
Public entities are required to evaluate subsequent events through the date that financial
statements are issued. This guidance also provides guidelines for evaluating whether or not events
or transactions occurring after the balance sheet date should be recognized in the financial
statements. This guidance requires disclosure of the date through which subsequent events have
been evaluated. The Company has evaluated subsequent events immediately prior to the date of
issuance of this report.
(4) Derivative Financial Instruments
Effective January 1, 2009, the Company adopted provisions of ASC Topic 815-40, Derivatives
and Hedging: Contracts in Entitys Own Entity (ASC Topic 815-40). ASC Topic 815-40
clarifies the determination of whether an instrument issued by an entity (or an embedded feature in
the instrument) is indexed to an entitys own stock, which would qualify as a scope exception under
ASC Topic 815-10.
Based upon the Companys analysis of the criteria contained in ASC Topic 815-40, certain
warrants (the Warrants) issued in connection with the issuance of the Series C
Convertible Preferred Stock, par value $0.10 per share, and the Series D Convertible Preferred
Stock, par value $0.10 per share, must now be treated as derivative liabilities in the Companys
balance sheet.
Consistent with ASC Topic 815-40 requirements, the Company recognized the cumulative effect of
the change in accounting principle to reduce the opening balance of the deficit accumulated during
the development stage for fiscal year 2009. The cumulative effect adjustment of $5,183 represents
the difference between the amounts recognized in the balance sheet before initial application of
ASC Topic 815-40 on January 1, 2009. Additionally, the initial fair value of the Warrants,
aggregating $6,252, which were initially recorded as additional paid-in capital upon issuance, was
reclassified to long-term liabilities upon adoption of ASC Topic 815-40. The amounts recognized at
initial issuance were determined based on the estimated fair value of the Warrants using a
probability-weighted Black-Scholes option pricing model. Prospectively, the Warrants will be
re-measured at each balance sheet date based on estimated fair value, and any resultant changes in
fair value will be recorded as non-cash valuation adjustments within other income (expense) in the
Companys statement of operations. During the nine months ended September 30, 2009, the Company
recorded other expense of $2,703 relating to the change in fair value of the Warrants during this period. During the three months ended September 30, 2009,
the Company recorded other expense of $723 relating to the change in fair value of the Warrants
during this period.
16
The Company estimates the fair value of the Warrants using the probability-weighted
Black-Scholes option pricing model. The assumptions used for the three and nine months ended
September 30, 2009 are noted in the following table:
|
|
|
|
|
Three and Nine Months |
|
|
Ended September 30, 2009 |
|
|
|
Expected option term |
|
5 to 7 years |
Risk-free interest rate |
|
2.31% 2.93% |
Expected volatility |
|
123% |
Dividend yield |
|
0% |
Expected volatility is based on historical volatility of the Companys common stock. The
Warrants have a transferability provision and based on guidance provided in SAB 107 for options
issued with such a provision, the Company used the full contractual term as the expected term of
the Warrants. The risk free rate is based on the five-year and seven-year U.S. Treasury security
rates.
(5) Fair Value Measurements
The following table presents the Companys liabilities that are measured and recognized at
fair value on a recurring basis classified under the appropriate level of the fair value hierarchy
as of September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted |
|
|
|
|
|
|
|
|
|
|
|
|
Prices in |
|
|
|
|
|
|
|
|
|
|
|
|
Active |
|
|
|
|
|
|
|
|
|
|
|
|
Markets |
|
|
|
|
|
|
|
|
|
|
|
|
for |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Identical |
|
|
Other |
|
|
Significant |
|
|
Balance as |
|
|
|
Assets and |
|
|
Observable |
|
|
Unobservable |
|
|
of |
|
|
|
Liabilities |
|
|
Inputs |
|
|
Inputs |
|
|
September 30, |
|
Description |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2009 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
|
|
|
$ |
3,773 |
|
|
$ |
3,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth a summary of changes in the fair value of the Companys Level 3
liabilities for the nine months ended September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of the |
|
|
|
|
|
|
Balance as |
|
|
|
Balance at |
|
|
Adoption of |
|
|
|
|
|
|
of |
|
|
|
December 31, |
|
|
ASC Topic 815-40 |
|
|
Unrealized |
|
|
September 30, |
|
Description |
|
2008 |
|
|
(See Note 4) |
|
|
Losses |
|
|
2009 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
1,070 |
|
|
$ |
2,703 |
|
|
$ |
3,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
The unrealized losses on the derivative liabilities are classified in other expenses as a
change in derivative liabilities in the Companys statement of operations. Fair value is
determined based on a probability-weighted Black-Scholes option pricing model calculation. (See
Note 4).
A financial instruments level within the fair value hierarchy is based on the lowest level of
any input that is significant to the fair value measurement. At each reporting period, the Company
performs a detailed analysis of the assets and liabilities that are subject to ASC Topic 820. At
each reporting period, all assets and liabilities for which the fair value measurement is based on
significant unobservable inputs or instruments which trade infrequently and therefore have little
or no price transparency are classified as Level 3.
(6) Commitments and Contingencies
Research Agreements:
On July 23, 2009, the Company entered into Amendment No. 3 (the Amendment) to its
Clinical Study Agreement (the Agreement), dated as of July 2, 2003, as amended, with
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College
(Cornell). The Amendment extends the performance period of the Sponsored Research Program
referenced in Section 3 of the Agreement and eliminates certain activities from the Scope of Work
referenced in Section 1 of the Agreement. As a result of the Amendment, the Company will continue
to pay Cornell $135 per year through the performance period of the Sponsored Research Program, as
that term is defined in the Agreement.
On September 24, 2009, the Company entered into a Third Amendment (the Third
Amendment) to its Master Sponsored Research agreement (the Research Agreement),
dated as of May 10, 2006, as amended, with The Ohio State University Research Foundation, on behalf
of The Ohio State University. The Third Amendment, among other things, extends the term of the
Research Agreement to November 10, 2010 at the current annual rate of $167.
Consulting and Employment Agreements:
On August 31, 2009, the Company extended, for a period of one year, the term of its consulting
agreement, dated as of October 1, 1999, as amended, with Dr. Matthew J. During (the Consulting
Agreement), one of the Companys scientific co-founders. Pursuant to the Consulting
Agreement, Dr. During provides advice and consulting services to the Company on an exclusive basis
for scientific research on human gene therapy in the central nervous system. The Consulting
Agreement also provides for Dr. During to assist the Company in its fund raising efforts and to
serve as a member of the Companys Scientific Advisory Board. The Consulting Agreement, as
amended, provides for payments of $175 per annum.
18
On August 20, 2009, the Company and John E. Mordock, the Companys President and Chief
Executive Officer, entered into a new employment agreement (the Mordock Employment
Agreement). The Mordock Employment Agreement replaced an earlier employment agreement between
John Mordock and the Company, dated December 4, 2007. The Mordock Employment Agreement provides
that Mr. Mordock shall be employed by the Company through December 4, 2010, shall initially receive
an annual base salary of at least $275 and shall be eligible to receive an annual bonus at the
discretion of the Board.
During the period of his employment, Mr. Mordock will be reimbursed for temporary housing and
automobile expenses related to his employment. If Mr. Mordocks employment is terminated by the
Company without Cause or by Mr. Mordock for Good Reason (including a Change in Control), as
those terms are defined in the Mordock Employment Agreement, or if the Company chooses not to renew
the Mordock Employment Agreement for at least one additional year at the end of the employment
period, Mr. Mordock shall be entitled to a cash payment equal to one year of base salary. In
addition, all of Mr. Mordocks options shall immediately vest and be exercisable for up to one year
following the date of any such termination.
On August 20, 2009, the Company and Marc L. Panoff, the Companys Chief Financial Officer,
Treasurer and Secretary, entered into a new employment agreement (the Panoff Employment
Agreement). The Panoff Employment Agreement replaced an earlier employment agreement between
Marc Panoff and the Company, dated December 4, 2007. The Panoff Employment Agreement provides that
Mr. Panoff shall be employed by the Company through December 4, 2010, shall initially receive an
annual base salary of at least $203 and shall be eligible to receive an annual bonus at the
discretion of the Board.
During the period of his employment, if Mr. Panoffs employment is terminated by the Company
without Cause or by Mr. Panoff for Good Reason (including a Change in Control), as those
terms are defined in the Panoff Employment Agreement, or if the Company chooses not to renew the
Panoff Employment Agreement for at least one additional year at the end of the employment period,
Mr. Panoff shall be entitled to a cash payment equal to one year of base salary. In addition, all
of Mr. Panoffs options shall immediately vest and be exercisable for up to one year following the
date of any such termination.
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
The following discussion should be read in conjunction with the unaudited financial statements
and accompanying notes in this quarterly report on Form 10-Q and the audited financial statements
and notes thereto included in the Companys Annual Report on Form 10-K for the year ended December
31, 2008 (the 2008 10-K). Operating results are not necessarily indicative of results
that may occur in future periods. All amounts in this Item 2 are in thousands.
Business Overview
The Company is a development stage company that is engaged in the research and development of
proprietary treatments for disorders of the brain and central nervous system using gene transfer and other innovative therapies. These treatments are designed as
alternatives to conventional surgical and pharmacological treatments.
19
To date, the Company has not generated any operating revenues and has incurred annual net
losses. From inception through September 30, 2009, the Company had an accumulated deficit of
$48,673, and it expects to incur additional losses in the foreseeable future. The Company
recognized net losses of $10,606 for the nine months ended September 30, 2009, and $4,928 for the
nine months ended September 30, 2008.
Since its inception, the Company has financed its operations primarily through sales of its
equity and debt securities. From inception through September 30, 2009, the Company received
proceeds primarily from private sales of equity and debt securities and from its merger in February
2004 of approximately $44,531 in the aggregate.
The Company has devoted a significant portion of its capital resources to the research and
development of its products. The Companys primary efforts are directed to the development of a
therapeutic product to meet the needs of patients suffering from Parkinsons disease.
In addition to its product for Parkinsons disease, the Company is currently undertaking
efforts to develop a product for the treatment of Huntingtons disease and is engaged in
pre-clinical activities relating to such product. The Company also has undertaken efforts to
develop a product for temporal lobe epilepsy (TLE) but does not anticipate using its
current funds for the further development of its TLE product at this time. See Plan of Operation
Huntingtons Disease and Plan of Operation Epilepsy below.
Plan of Operation
Parkinsons Disease
In October 2006, the Company announced that it had completed its Phase 1 clinical trial for
Parkinsons disease. The results of this trial indicate that the treatment appears to be safe and
well-tolerated in trial participants with advanced Parkinsons disease, with no evidence of adverse
effects or immunologic reaction related to the study treatment. The trial, in which treatment was
confined to only one side of the brain, also yielded statistically significant clinical efficacy
and neuroimaging results. The results were peer-reviewed and published in the June 23, 2007 issue
of the journal The Lancet and the online edition of the Proceedings of the National Academy of
Sciences in November 2007.
In December 2008, the Company initiated a Phase 2 clinical trial for Parkinsons disease.
This trial is a randomized, controlled study designed to further establish the effectiveness and
the safety of the treatment. The trial is being conducted in multiple medical centers throughout
the U.S. with an expected 40 trial participants, 20 of which will be randomly selected to receive
the treatment and 20 of which will be randomly selected to receive a sterile saline solution.
In October 2009, the Data Monitoring Committee (the DMC), a group of independent
medical experts, selected by the Company, who are responsible for reviewing and evaluating the
safety data generated from the Companys Phase 2 clinical trial, recommended the continuation of
the clinical trial unmodified. This recommendation was based on the DMCs review of all safety data
from the first 7 patients enrolled in the clinical trial with at least three months of data. The Company expects to conclude the surgeries for its Phase 2 clinical trial in the second
half of 2009 and announce initial efficacy data in the first half of 2010.
20
The Company will take steps to move toward a pivotal trial for treatment of Parkinsons
disease, and hopes to be in a position to file its protocol with the U.S. Food and Drug
Administration (FDA) in 2010 or 2011. The Companys conduct of such trial will require,
among other things, approval by the FDA. Currently, the Company estimates that the pivotal trial
could be completed in 2013 and the estimated total costs to reach that milestone are expected to be
in excess of $20,000.
Huntingtons Disease
In November 2005, the Company announced findings from pre-clinical studies which showed that a
form of the gene XIAP (X-linked Inhibitor of Apoptosis Protein or dXIAP) may prevent the
progression of Huntingtons disease. The Company further investigated the neuroprotective effects
of dXIAP by injecting presymptomatic rodents with adeno-associated virus (AAV) vectors
encoding dXIAP into the striatum, an area of the brain normally affected in Huntingtons patients.
In the study, rodents injected with this vector experienced significant reversal of motor
dysfunction to the level of normal rodents, while there was no improvement in rodents treated with
a control vector. dXIAP also improved the function of the diseased neurons in culture.
Furthermore, no adverse effects due to dXIAP overproduction were observed.
In August 2008, the Company entered into a license agreement with respect to an exclusive
license for the worldwide rights, excluding China, for the use of dXIAP for therapeutic or
prophylactic purposes in the treatment of Huntingtons disease.
In September 2009, the Company received orphan drug designation from the FDA for its
Huntingtons disease product.
The Companys development of this therapy for Huntingtons disease is currently in the
pre-clinical phase. The Company is presently conducting a further review and analysis of its
pre-clinical results in order to determine how to best proceed to obtain regulatory clearance to
commence a Phase 1 clinical trial for this therapy. The timing of such trial is subject to the
completion of such review and analysis, the availability of funding, the availability of the AAV
vector and an infusion system and to receipt of applicable regulatory approvals.
Epilepsy
In December 2006, the Company submitted an investigational new drug application to the FDA for
permission to begin a Phase 1 clinical trial in TLE. The proposed clinical protocol for this study
was presented to the National Institute of Healths Office of Biotechnology Activities Recombinant
DNA Advisory Committee on September 23, 2004 and reviewed favorably.
During the second quarter of 2008, the Company learned that further action was required to
adequately protect the Companys intellectual property rights in its technology relating to its TLE
product. The Company discovered that certain individuals, not affiliated with the Company, may also have rights to use certain technology currently used by the Company with respect to
the TLE product. If the Company elects to proceed with its Phase 1 clinical trial for its TLE
product, the Company will need to conduct an additional pre-clinical study in non-human primates,
which would be conducted in accordance with guidance received from the FDA.
21
Based on the foregoing, the commencement of a Phase 1 clinical trial for the Companys TLE
product will be subject, among other things, to the successful resolution of the above mentioned
intellectual property issues, to the successful completion of an additional pre-clinical study, the
availability of funding, concurrence by the FDA and procurement of related intellectual property
licenses. The Company does not anticipate using its current funds for the further development of
its TLE product at this time.
Other Therapies
The Company will also continue its efforts in developing therapies to treat other
neurodegenerative and metabolic disorders, including depression and genetically-based obesity under
its research agreements with Cornell University for and on behalf of its Joan & Sanford I. Weill
Medical College and Ohio State University.
Future Operating Expenditures
Over the next 12 months, in addition to its normal recurring expenditures, the Company expects
to spend approximately $4,200 in Phase 2 clinical trial expenses with regard to its Parkinsons
treatment; $1,000 in costs associated with operating as a publicly traded company, such as legal
fees, accounting fees, insurance fees, insurance premiums, investor and public relations fees; $600
in research and licensing fees; and $600 in costs associated with scaling up its manufacturing
capabilities for the supply of product for a Parkinsons pivotal trial.
Results of Operations
Three Months Ended September 30, 2009 Compared to the Three Months Ended September 30, 2008
Revenues. The Company did not generate any operating revenues in the three months ended
September 30, 2009 or in the three months ended September 30, 2008.
Costs and Expenses.
Research and Development. Research and development expenses increased by $1,039 during the
three months ended September 30, 2009 to $2,121 as compared to $1,082 during the comparable period
in 2008. The increase was mainly due to a $1,128 increase in expenses related to the Companys
Phase 2 clinical trial for Parkinsons disease, as well as a $195 increase in process development
expenses for large scale manufacturing of the Companys products and infusion devices, offset by a
$216 decrease in fees related to license agreements and sponsored research agreements.
General and Administrative. General and administrative expenses decreased by $103 to $631
during the three months ended September 30, 2009, as compared to $734 during the comparable period
in 2008. This decrease was due mainly to an $81 decrease in professional fees, including a $38 decrease in legal fees, a $28 decrease in accounting fees and a $15
decrease in investor and public relations fees. The decrease was also due to a $22 decrease in
other administrative expenses during the three months ended September 30, 2009.
22
Other (Expense) Income, Net. The Company had net other expense of $717 during the three
months ended September 30, 2009, as compared to net other income of $167 during the comparable
period in 2008. The change is mainly due to charges of $723 recognized for the increase in
estimated fair value of its derivative liabilities during the three months ended September 30,
2009. Additionally, the Company earned $161 less in interest income during the three months ended
September 30, 2009 as compared to the comparable period in 2008.
Nine Months Ended September 30, 2009 Compared to the Nine Months Ended September 30, 2008
Revenues. The Company did not generate any operating revenues in the nine months ended
September 30, 2009 or in the nine months ended September 30, 2008.
Costs and Expenses.
Research and Development. Research and development expenses increased by $2,868 during the
nine months ended September 30, 2009 to $5,779 as compared to $2,911 during the comparable period
in 2008. The increase was mainly due to a $2,246 increase in expenses related to the Companys
Phase 2 clinical trial for Parkinsons disease, as well as a $448 increase in process development
expenses for large scale manufacturing of the Companys products and infusion devices and a $72
increase in pre-clinical costs associated with its Huntingtons disease product.
General and Administrative. General and administrative expenses decreased by $316 to $2,179
during the nine months ended September 30, 2009, as compared to $2,495 during the comparable period
in 2008. This decrease was due, in part, to a $190 decrease in professional fees, including legal
fees, accounting fees, investor and public relations fees, as well as a $68 decrease in employee
compensation expense, a $24 reduction in patent impairment charges and a $34 decrease in other
administrative expenses.
Other (Expense) Income, Net. The Company had net other expenses of $2,648 during the nine
months ended September 30, 2009, as compared to net other income of $478 during the comparable
period in 2008. The change is mainly due to charges of $2,703 recognized for the increase in
estimated fair value of its derivative liabilities during the nine months ended September 30, 2009.
Additionally, the Company earned $423 less in interest income during the nine months ended
September 30, 2009 as compared to the comparable period in 2008.
Liquidity and Capital Resources
Cash and cash equivalents were $11,771 at September 30, 2009.
The Company is a development stage company and has not generated any operating revenues as of
September 30, 2009. In addition, the Company will continue to incur net losses and cash flow
deficiencies from operating activities for the foreseeable future.
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Based on its cash flow projections, the Company believes that its current resources will
enable it to continue as a going concern through at least September 30, 2010, thereby allowing it
to fund operations through its receipt of primary efficacy data from its Phase 2 clinical trial for
Parkinsons disease and to fund its pre-clinical expenses for Huntingtons disease. Accordingly,
the Company will continue to seek additional funds through public or private equity offerings, debt
financings or corporate collaboration and licensing arrangements. The Company does not know
whether additional financing will be available when needed or, if available, will be on acceptable
or favorable terms to it or its stockholders. If the Company is unable to secure additional funding
by December 31, 2009, or shortly thereafter, its ability to continue as a going concern may be in
doubt.
Net cash used in operating activities was $6,925 for the nine months ended September 30, 2009
as compared to $4,843 during the comparable period in 2008. The $2,082 increase in net cash used
in operations was primarily due to a $5,678 increase in net loss, offset by $2,781 in adjustments
to net loss for increased non-cash expenses, as well as a $815 decrease in cash used as a result of
changes to working capital in 2009.
The Company had net cash used in investing activities of $210 during the nine months ended
September 30, 2009 as compared to $186 during the nine months ended September 30, 2008. Cash used
in investing activities relates to purchases of equipment and additions to intangible assets made
by the Company during 2009 and 2008.
The Company had no net cash used in or provided by financing activities during the nine months
ended September 30, 2009. Net cash provided by financing activities during the nine months ended
September 30, 2008 was $4,932, which represented net proceeds received by the Company in a private
placement of its Series D Stock in April 2008.
FORWARD-LOOKING STATEMENTS
This document includes certain statements of the Company that may constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act) and
which are made pursuant to the Private Securities Litigation Reform Act of 1995. These
forward-looking statements and other information relating to the Company are based upon the beliefs
of management and assumptions made by and information currently available to the Company.
Forward-looking statements include statements concerning plans, objectives, goals, strategies,
future events, or performance, as well as underlying assumptions and statements that are other than
statements of historical fact. When used in this document, the words expects, anticipates,
estimates, plans, intends, projects, predicts, believes, may, should, potential,
continue and similar expressions, are intended to identify forward-looking statements. These
statements reflect the current view of the Companys management with respect to future events and
are subject to numerous risks, uncertainties, and assumptions. Many factors could cause the actual
results, performance or achievements of the Company to be materially different from any future
results, performance, or achievements that may be expressed or implied by such forward-looking
statements, including, among other things:
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the inability of the Company to raise additional funds, when needed, through
public or private equity offerings, debt financings or additional corporate
collaboration and licensing arrangements; and |
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the inability of the Company to successfully commence and complete all necessary
clinical trials for the commercialization of its product to treat Parkinsons
disease. |
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Other factors and assumptions not identified above could also cause the actual results to
differ materially from those set forth in the forward-looking statements. Additional information
regarding factors which could cause results to differ materially from managements expectations is
found in the section entitled Risk Factors contained in the 2008 10-K. Although the Company
believes these assumptions are reasonable, no assurance can be given that they will prove correct.
Accordingly, you should not rely upon forward-looking statements as a prediction of actual results.
Further, the Company undertakes no obligation to update forward-looking statements after the date
they are made or to conform the statements to actual results or changes in the Companys
expectations.
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
Not applicable.
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Item 4. |
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Controls and Procedures |
(a) Disclosure Controls and Procedures. The Company maintains disclosure controls and
procedures as required under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act,
that are designed to ensure that information required to be disclosed in the Companys Exchange Act
reports is recorded, processed, summarized and reported within the time periods specified in the
SECs rules and forms, and that such information is accumulated and communicated to the Companys
management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to
allow timely decisions regarding required disclosure.
As of September 30, 2009, the Companys management carried out an evaluation, under the
supervision and with the participation of the Companys Chief Executive Officer and Chief Financial
Officer, of the effectiveness of its disclosure controls and procedures. Based on the foregoing,
its Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure
controls and procedures were effective as of September 30, 2009.
(b) Changes in Internal Control Over Financial Reporting. There were no changes in the
Companys internal control over financial reporting that occurred during the period covered by this
report that have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
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PART II. OTHER INFORMATION
See Exhibit Index.
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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NEUROLOGIX, INC.
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November 10, 2009 |
/s/ John E. Mordock
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John E. Mordock |
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President and Chief Executive Officer
(as Principal Executive Officer) |
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November 10, 2009 |
/s/ Marc L. Panoff
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Marc L. Panoff |
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Chief Financial Officer, Secretary and Treasurer
(as Principal Accounting Officer/Principal Financial Officer) |
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EXHIBIT INDEX
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Exhibit No. |
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Exhibit |
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10.1 |
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Amendment No. 3 to the Clinical Study Agreement between
Neurologix, Inc. and Cornell University for and on behalf
of its Joan & Sanford I. Weill Medical College, dated as of
July 23, 2009 (filed as exhibit 10.1 to the Registrants
Current Report on Form 8-K, dated July 24, 2009, and
incorporated herein by reference). |
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10.2 |
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Employment Agreement dated August 20, 2009 by and between
John E. Mordock and Neurologix, Inc. (filed as exhibit 10.1
to the Registrants Current Report on Form 8-K, dated
August 20, 2009, and incorporated herein by reference). |
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10.3 |
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Employment Agreement dated August 20, 2009 by and between
Marc Panoff and Neurologix, Inc. (filed as exhibit 10.2 to
the Registrants Current Report on Form 8-K, dated August
20, 2009, and incorporated herein by reference). |
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10.4 |
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Letter Agreement dated August 31, 2009 by and between
Neurologix, Inc. and Dr. Matthew During (filed as exhibit
10.1 to the Registrants Current Report on Form 8-K dated
August 31, 2009, and incorporated herein by reference). |
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10.5 |
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Third Amendment to Master Sponsored Research Agreement
between Neurologix, Inc. and The Ohio State University
Research Foundation, on behalf of Ohio State University,
dated as of September 24, 2009 (filed as exhibit 10.1 to
the Registrants Current Report on Form 8-K dated September
24, 2009, and incorporated herein by reference). |
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31.1 |
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Rule 13a-14(a)/15d-14(a) Certification of President and
Chief Executive Officer (as Principal Executive Officer).** |
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31.2 |
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Rule 13a-14(a)/15d-14(a) Certification of Chief Financial
Officer, Secretary and Treasurer (as Principal Accounting
Officer/Principal Financial Officer).** |
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32.1 |
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Section 1350 Certification of Chief Executive Officer and
Chief Financial Officer, Secretary and Treasurer.** |
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