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 March 31, 2010
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
o 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
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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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 May 1, 2010, 27,865,010 shares of common stock were outstanding.
NEUROLOGIX, INC.
(A Development Stage Company)
BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
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March 31, |
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December 31, |
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2010 |
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2009 |
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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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$ |
6,484 |
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$ |
9,637 |
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Prepaid expenses and other current assets |
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242 |
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395 |
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Total current assets |
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6,726 |
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10,032 |
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Equipment, less accumulated depreciation of $644 and $624 at March
31, 2010 and December 31, 2009, respectively |
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109 |
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129 |
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Intangible assets, less accumulated amortization of $283 and $262
at March 31, 2010 and December 31, 2009, respectively |
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947 |
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891 |
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Other assets |
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5 |
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5 |
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Total assets |
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$ |
7,787 |
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$ |
11,057 |
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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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$ |
1,515 |
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$ |
1,834 |
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Total current liabilities |
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1,515 |
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1,834 |
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Derivative financial instruments, at estimated fair value warrants |
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4,203 |
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3,847 |
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Total liabilities |
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5,718 |
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5,681 |
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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 March 31, 2010 and
December 31, 2009, with an aggregate liquidation preference of
$1 |
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Series C Convertible, $0.10 par value; 700,000 shares
designated, 281,263 shares issued and outstanding at March 31,
2010 and December 31, 2009, with an aggregate liquidation
preference of $7,241 and $7,008 at March 31, 2010 and December
31, 2009, respectively |
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28 |
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28 |
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Series D Convertible, $0.10 par value; 792,100 shares
designated, 734,898 shares issued and outstanding at March 31,
2010 and December 31, 2009, with an aggregate liquidation
preference of $29,967 and $29,420 at March 31, 2010 and
December 31, 2009, respectively |
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73 |
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73 |
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Common Stock: |
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$0.001 par value; 100,000,000 shares authorized, 27,865,010
shares issued and outstanding at each of March 31, 2010 and
December 31, 2009 |
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28 |
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28 |
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Additional paid-in capital |
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56,965 |
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56,775 |
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Deficit accumulated during the development stage |
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(55,025 |
) |
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(51,528 |
) |
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Total stockholders equity |
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2,069 |
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5,376 |
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Total liabilities and stockholders equity |
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$ |
7,787 |
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$ |
11,057 |
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See accompanying notes to financial statements.
3
NEUROLOGIX, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
(UNAUDITED)
(Amounts in thousands, except share and per share amounts)
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For the period |
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Three Months Ended |
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February 12, 1999 |
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March 31, |
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(inception) through |
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2010 |
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2009 |
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March 31, 2010 |
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Revenues |
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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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1,857 |
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1,409 |
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29,318 |
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General and administrative expenses |
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1,284 |
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749 |
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20,281 |
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Loss from operations |
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(3,141 |
) |
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(2,158 |
) |
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(49,599 |
) |
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Other income (expense): |
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Dividend, interest and other income |
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33 |
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1,883 |
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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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(356 |
) |
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(2,789 |
) |
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(3,133 |
) |
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Other expense, net |
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(356 |
) |
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(2,756 |
) |
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(1,661 |
) |
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Net loss |
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(3,497 |
) |
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(4,914 |
) |
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$ |
(51,260 |
) |
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Preferred stock dividends |
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(771 |
) |
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(717 |
) |
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Net loss applicable to common stock |
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$ |
(4,268 |
) |
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$ |
(5,631 |
) |
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Net loss applicable to common stock
per share, basic and diluted |
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$ |
(0.15 |
) |
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$ |
(0.20 |
) |
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Weighted average common shares
outstanding, basic and diluted |
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27,865,010 |
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27,764,058 |
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See accompanying notes to financial statements.
4
NEUROLOGIX, INC.
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2010
(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 |
) |
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|
(328 |
) |
Balance, December 31, 1999 |
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|
$ |
0 |
|
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|
$ |
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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|
|
(1,055 |
) |
|
|
(1,055 |
) |
Balance, December 31, 2000 |
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|
|
|
|
$ |
0 |
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|
$ |
0 |
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|
6,004,146 |
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|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
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|
$ |
(1,383 |
) |
|
$ |
(1,379 |
) |
Stock options granted for services |
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9 |
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|
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|
9 |
|
Common stock issued for intangible
assets at $0.09 per share |
|
|
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|
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|
|
|
|
|
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|
|
259,491 |
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|
|
24 |
|
|
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|
|
|
|
|
|
|
|
24 |
|
Net loss |
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
(870 |
) |
|
|
(870 |
) |
Balance, December 31, 2001 |
|
|
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|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
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|
6,263,637 |
|
|
$ |
0 |
|
|
$ |
37 |
|
|
$ |
0 |
|
|
$ |
(2,253 |
) |
|
$ |
(2,216 |
) |
Retirement of founder shares |
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(33,126 |
) |
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Common Stock issued pursuant to license
agreement at $1.56 per share |
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|
368,761 |
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|
577 |
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|
|
(577 |
) |
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Private placement of Series B
convertible preferred stock |
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|
2,613 |
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|
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|
|
|
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|
2,613 |
|
Amortization of unearned compensation |
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|
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|
|
|
|
|
|
|
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|
24 |
|
|
|
|
|
|
|
24 |
|
Net loss |
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|
|
|
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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 |
|
|
|
|
|
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|
|
|
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|
|
276,054 |
|
|
|
|
|
|
|
90 |
|
|
|
(89 |
) |
|
|
|
|
|
|
1 |
|
Amortization of unearned compensation |
|
|
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2010
(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 ASC Topic 718 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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.
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2010
(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.
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2010
(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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448 |
|
|
|
|
|
|
|
|
|
|
|
448 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
185 |
|
|
|
|
|
|
|
|
|
|
|
185 |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,461 |
) |
|
|
(13,461 |
) |
Balance December 31, 2009 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
281,263 |
|
|
$ |
28 |
|
|
|
27,865,010 |
|
|
$ |
28 |
|
|
$ |
56,775 |
|
|
$ |
0 |
|
|
$ |
(51,528 |
) |
|
$ |
5,376 |
|
Employee share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171 |
|
|
|
|
|
|
|
|
|
|
|
171 |
|
Non-employee share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
19 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,497 |
) |
|
|
(3,497 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance March 31, 2010 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
281,263 |
|
|
$ |
28 |
|
|
|
27,865,010 |
|
|
$ |
28 |
|
|
$ |
56,965 |
|
|
$ |
0 |
|
|
$ |
(55,025 |
) |
|
$ |
2,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
8
NEUROLOGIX, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
|
|
|
|
|
|
|
|
(inception) |
|
|
|
Three Months Ended March 31, |
|
|
through |
|
|
|
2010 |
|
|
2009 |
|
|
March 31, 2010 |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,497 |
) |
|
$ |
(4,914 |
) |
|
$ |
(51,260 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
20 |
|
|
|
20 |
|
|
|
650 |
|
Amortization |
|
|
21 |
|
|
|
18 |
|
|
|
423 |
|
Gain on redemption of investment |
|
|
|
|
|
|
|
|
|
|
(62 |
) |
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
9 |
|
Impairment of intangible assets |
|
|
|
|
|
|
|
|
|
|
199 |
|
Amortization of non-employee share-based compensation |
|
|
29 |
|
|
|
67 |
|
|
|
1,736 |
|
Share-based employee compensation expense |
|
|
171 |
|
|
|
73 |
|
|
|
3,003 |
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
|
|
378 |
|
Change in estimated fair value of derivative financial
instruments warrants |
|
|
356 |
|
|
|
2,789 |
|
|
|
3,133 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in prepaid expenses and other current assets |
|
|
143 |
|
|
|
12 |
|
|
|
681 |
|
(Decrease) increase in accounts payable and accrued expenses |
|
|
(319 |
) |
|
|
(24 |
) |
|
|
1,455 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,076 |
) |
|
|
(1,959 |
) |
|
|
(39,655 |
) |
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Security deposits paid |
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Purchases of equipment |
|
|
|
|
|
|
|
|
|
|
(645 |
) |
Additions to intangible assets |
|
|
(77 |
) |
|
|
(62 |
) |
|
|
(1,539 |
) |
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 |
|
|
(77 |
) |
|
|
(62 |
) |
|
|
(2,126 |
) |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
34,427 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
|
|
48,265 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(3,153 |
) |
|
|
(2,021 |
) |
|
|
6,484 |
|
Cash and cash equivalents, beginning of period |
|
|
9,637 |
|
|
|
18,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
6,484 |
|
|
$ |
16,885 |
|
|
$ |
6,484 |
|
|
|
|
|
|
|
|
|
|
|
9
NEUROLOGIX, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
|
|
|
|
|
|
|
|
(inception) |
|
|
|
Three Months Ended March 31, |
|
|
through |
|
|
|
2010 |
|
|
2009 |
|
|
March 31, 2010 |
|
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 |
|
$ |
771 |
|
|
$ |
717 |
|
|
$ |
6,689 |
|
Accretion of fair value of beneficial conversion on preferred stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
5,313 |
|
Accretion of contingent beneficial conversion related on Series C
Preferred Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
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 financial statements.
10
NEUROLOGIX, INC.
(A Development Stage Company)
Notes to Unaudited 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 Accounting Standards
Codification (the Codification or ASC) Topic 915.
The Company incurred net losses of $3,497, $4,914 and $51,260 and negative cash flows from
operating activities of $3,076, $1,959 and $39,655 for the three months ended March 31, 2010 and
2009 and for the period from February 12, 1999 (inception) to March 31, 2010, 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 $6,484 and $9,637 as of March 31, 2010 and
December 31, 2009, respectively. Based on its cash flow projections, the Company will need
additional financing to carry out its planned business activities and complete its plan of
operations through December 31, 2010. At the Companys present level of activities, the Companys
cash and cash equivalents are believed, at this time, to be sufficient to fund its operations only
into the fourth quarter of this current fiscal year. Accordingly, there is substantial doubt as to
the Companys ability to continue as a going concern by the end of its current fiscal year. The
Company is currently seeking to raise funds, through public or private equity offerings, debt
financings or corporate collaboration and licensing arrangements, sufficient to finance its ongoing
operations. 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. The
financial statements do not include any adjustments that may result from the outcome of this
uncertainty.
(2) Basis of Presentation
The accompanying unaudited 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, 2009 (the 2009 10-K) filed with the Securities
and Exchange Commission (the SEC) on March 26, 2010. 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, 2009 balance sheet information was derived
from the audited financial statements as of that date.
11
(3) Summary of Significant Accounting Policies
(a) Stock-Based Compensation:
At March 31, 2010, 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, Compensation 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 employee stock option awards is expensed ratably over the service
period of the employees receiving the awards. As of March 31, 2010, total unrecognized compensation
cost related to stock option awards, to be recognized as expense subsequent to March 31, 2010, was
approximately $96, 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 months ended March 31, 2010 and
2009 was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2010 |
|
|
2009 |
|
Research and development |
|
$ |
22 |
|
|
$ |
18 |
|
General and administrative |
|
|
149 |
|
|
|
55 |
|
|
|
|
|
|
|
|
Employee share-based
compensation expense |
|
$ |
171 |
|
|
$ |
73 |
|
|
|
|
|
|
|
|
Net share-based compensation
expenses per basic and diluted
common share |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
12
A summary of option activity as of March 31, 2010 and changes during the three 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, 2009 |
|
|
4,174 |
|
|
$ |
1.19 |
|
|
|
6.30 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(140 |
) |
|
|
1.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2010 |
|
|
4,034 |
|
|
$ |
1.20 |
|
|
|
6.04 |
|
|
$ |
204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2010 |
|
|
3,370 |
|
|
$ |
1.30 |
|
|
|
5.63 |
|
|
$ |
131 |
|
The fair value of each stock option award is estimated on the date of the grant using the
Black-Scholes option pricing model. Expected volatility is based on historical volatility of the
Common Stock. The risk-free interest rate is based on the 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, as 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.
There were no options granted during the three months ended March 31, 2010 or March 31, 2009.
For equity awards to non-employees, the Company also applies the Black-Scholes option pricing
model to determine the fair value of such awards 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.
13
(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:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
|
2010 |
|
|
2009 |
|
Stock options |
|
|
4,033,833 |
|
|
|
3,615,833 |
|
Warrants |
|
|
6,839,680 |
|
|
|
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 |
|
|
6,152,628 |
|
|
|
6,253,581 |
1 |
Common Stock issuable upon
conversion of Series D Convertible
Preferred Stock |
|
|
22,173,636 |
|
|
|
22,173,636 |
1 |
|
|
|
(1) |
|
These amounts are different from those reported in the
Companys Quarterly Report on Form 10-Q for the period ended March 31, 2009
because the prior number assumed that the Company would pay dividends owed to
the holders of Series C Convertible Preferred Stock and Series D Convertible
Preferred Stock with shares of Common Stock. The current number assumes that
such payment will be made with cash. |
(c) Derivative Instruments:
The Companys derivative liabilities are related to warrants issued in connection with
financing transactions and are therefore not designated as hedging instruments. 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).
(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. |
14
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.
(e) Recent Accounting Pronouncements:
In January 2010, the Financial Accounting Standards Board issued Accounting Standards Update
(ASU) 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about
Fair Value Measurements (ASU 2010-06). ASU 2010-06 includes new disclosure requirements
related to fair value measurements, including transfers in and out of Levels 1 and 2 and
information about purchases, sales, issuances and settlements for Level 3 fair value measurements.
This update also clarifies existing disclosure requirements relating to levels of disaggregation
and disclosures of inputs and valuation techniques. The provisions of ASU 2010-06 are effective
for periods beginning after December 15, 2009. The disclosures relating to Level 3 activity are
effective for fiscal years beginning after December 15, 2010 and for interim periods within those
fiscal years. The adoption of ASU 2010-06 did not have a material impact on the Companys
financial statements.
(4) Derivative Financial Instruments
Effective January 1, 2009, the Company adopted the provisions of ASC Topic 815-40,
Derivatives and Hedging: Contracts in Entitys Own Equity (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.
Based upon the Companys analysis of the criteria contained in ASC Topic 815-40, all 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 on 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 on 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 was initially recorded as additional paid-in capital upon issuance, was
reclassified to long-term liabilities upon the 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. The Company recorded other expense
relating to the change in fair value of the Warrants of $356 and $2,789 for the three months ended
March 31, 2010 and 2009, respectively.
15
The Company estimates the fair value of the Warrants using the probability-weighted
Black-Scholes option pricing model. The assumptions used for the three months ended March 31, 2010
and 2009 are noted in the following table:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2010 |
|
|
2009 |
|
Expected option term |
|
|
5 to 7 years |
|
|
|
5 to 7 years |
|
Risk-free interest rate |
|
|
2.55% 3.28 |
% |
|
|
1.87% 2.28 |
% |
Expected volatility |
|
|
129 |
% |
|
|
117 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility is based on historical volatility of the 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 interest rate is based on the five-year and seven-year U.S. Treasury security rates.
(5) Fair Value Measurements
The following tables present 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 March 31, 2010 and December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
|
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Identical |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
Assets and |
|
|
Observable |
|
|
Unobservable |
|
|
Balance as of |
|
|
|
Liabilities |
|
|
Inputs |
|
|
Inputs |
|
|
March 31, |
|
Description |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2010 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
|
|
|
$ |
4,203 |
|
|
$ |
4,203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
|
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Identical |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
Assets and |
|
|
Observable |
|
|
Unobservable |
|
|
Balance as of |
|
|
|
Liabilities |
|
|
Inputs |
|
|
Inputs |
|
|
December |
|
Description |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
31, 2009 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
|
|
|
$ |
3,847 |
|
|
$ |
3,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following tables set forth a summary of changes in the fair value of the Companys Level 3
liabilities for the three months ended March 31, 2010 and for the year ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
|
|
|
Balance as of |
|
|
|
December 31, |
|
|
|
|
|
|
March 31, |
|
Description |
|
2009 |
|
|
Losses |
|
|
2010 |
|
Derivative liabilities
related to Warrants |
|
$ |
3,847 |
|
|
$ |
356 |
|
|
$ |
4,203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of the |
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Adoption of ASC |
|
|
|
|
|
|
Balance at |
|
|
|
December 31, |
|
|
Topic 815-40 |
|
|
|
|
|
|
December |
|
Description |
|
2008 |
|
|
(See Note 4) |
|
|
Losses |
|
|
31, 2009 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
1,070 |
|
|
$ |
2,777 |
|
|
$ |
3,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The 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.
17
(6) Commitments and Contingencies
(a) Consulting and Employment Agreements:
Effective March 10, 2010, John E. Mordock resigned as a director and as President and Chief
Executive Officer of the Company, and, in connection therewith, entered into a separation
agreement, dated March 1, 2010, with the Company, pursuant to which his employment agreement,
dated August 20, 2009, was terminated, except for the provisions thereunder relating to
non-competition, non-solicitation, indemnification and confidentiality. Under the separation
agreement, the Company agreed to pay or provide to Mr. Mordock the severance benefits contained in
his employment agreement. Accordingly, Mr. Mordock has been paid one year of base salary of $275
and one year of health, disability and life insurance premiums of approximately $16. The Company
recognized and paid these amounts as compensation expense on the effective date of Mr. Mordocks
resignation. Also, all 800,000 stock options held by him have vested and are exercisable until
March 10, 2011. The Company recognized a net non-cash compensation charge of $98 on the effective
date of Mr. Mordocks resignation as a result of the accelerated vesting of and the extension of
the exercise period for Mr. Mordocks stock options.
On March 23, 2010, the Company extended the term of its consulting agreement with Dr. Martin
Kaplitt from January 1, 2010, until December 31, 2010, at the annual rate of $125.
On March 23, 2010, the Company approved an extension of its consulting agreement with Dr.
Michael Kaplitt from April 30, 2010 until April 30, 2011 at the annual rate of $175. (See Note 7).
(b) Operating Lease Agreement:
On March 31, 2010, the Company amended its lease (the BPRA Lease) with Bridge Plaza
Realty Associates, LLC to extend the term through April 30, 2011 at an annual rate of $58. The
Company uses the office space covered under the BPRA Lease as its corporate offices.
(7) Subsequent Event
On April 26, 2010, the Company and Dr. Michael Kaplitt executed a letter agreement that
extended the Companys consulting agreement with Dr. Michael Kaplitt from April 30, 2010 until
April 30, 2011. (See Note 6).
|
|
|
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 as of and for the year ended December 31, 2009 included in the 2009 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.
18
To date, the Company has not generated any operating revenues and has incurred annual net
losses. From inception through March 31, 2010, the Company had an accumulated deficit of
$55,025, and it expects to incur additional losses for the foreseeable future. The Company
recognized net losses of $3,497 for the three months ended March 31, 2010, and $4,914 for the three
months ended March 31, 2009.
Since its inception, the Company has financed its operations primarily through sales of its
equity and debt securities. From inception through March 31, 2010, 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. While the Company will continue to seek additional funds
through the sale of its securities to fund its operations, the Company will also seek to obtain
strategic collaborations to finance the further development of its Parkinsons product, including
the ultimate marketing and sale of such product. (See Liquidity and Capital Resources).
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 has undertaken efforts to
develop a product for the treatment of temporal lobe epilepsy (TLE) but does not
anticipate using its current funds for the further development of its TLE product at this time.
The Company also has undertaken efforts to develop a product for Huntingtons disease and is
engaged in pre-clinical activities relating to such product. See Plan of Operation Epilepsy
and Plan of Operation Huntingtons Disease 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 indicated that the treatment, which was confined to
only one side of the brain, appeared 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 also yielded statistically significant clinical efficacy and
neuro-imaging results. The results were published in two leading peer-reviewed medical and
scientific journals: 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 November 2009, the Company completed all 44 of the planned surgeries associated with its
Phase 2 clinical trial for the treatment of advanced Parkinsons disease. Half of the trial
participants were randomly selected to receive an infusion of the gene-based treatment bilaterally
and the other half, the Control Participants, were randomly selected to receive a sterile saline
solution. Trial participants are being assessed for safety and for treatment effects by
standardized Parkinsons disease ratings at multiple time points both pre and post-procedure. The
primary endpoint for the trial will be a clinical assessment of motor function at 6 months using
the Unified Parkinsons Disease Rating Scale (UPDRS). All participants in the trial will continue
to be monitored for safety for 12 months following their respective surgical procedures. If such
initial efficacy results are significantly positive and if the 12-month safety data is acceptable,
then those Control Participants who continue to meet all entry, medical and surgical criteria for
the trial will be offered the opportunity to participate in the open label arm of the trial to
receive a bilateral infusion of the gene-based treatment.
19
The Company is currently taking 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 (the FDA) in 2010 or 2011. The ability of the Company to conduct such a
trial will require, among other things, the approval of the FDA and the availability of adequate
funds, which, in turn, will be largely dependent upon the safety and efficacy results obtained from
its Phase 2 clinical trial. Currently, the Company estimates that the pivotal trial could be
completed in 2013 and the estimated total direct costs to reach that milestone are expected to be
between $20 million and $40 million.
Epilepsy
In December 2006, the Company submitted an investigational new drug application to the FDA for
permission to begin a Phase 1 clinical trial of gene transfer therapy for 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 was reviewed
favorably.
The Company does not, at this time, intend to commit its current funds to continue work on its
gene transfer therapy for TLE. As previously stated, the Company intends to focus its efforts and
resources on its Parkinsons product.
Huntingtons Disease
In November 2005, the Company announced findings from pre-clinical studies that showed that a
form of the gene dXIAP may prevent the progression of Huntingtons disease.
The Companys development of this therapy for Huntingtons disease is currently in the
pre-clinical phase. The Company reviewed and analyzed its initial pre-clinical results and
determined that additional pre-clinical testing is required prior to seeking regulatory clearance
to commence a Phase 1 clinical trial for this therapy.
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 $4,100 in Phase 2 clinical trial expenses with regard to its Parkinsons
treatment; $1,000 in expenses in order to scale up its manufacturing capabilities for the supply of
product for a Parkinsons pivotal trial; $1,000 in costs associated with operating as a publicly
traded company, such as legal fees, accounting fees, insurance premiums, investor and public
relations fees; and $600 in research and licensing fees.
20
Results of Operations
Three Months Ended March 31, 2010 Compared to the Three Months Ended March 31, 2009
Revenues. The Company did not generate any operating revenues in the three months ended March
31, 2010 or in the three months ended March 31, 2009.
Costs and Expenses.
Research and Development. Research and development expenses increased by $448 during the three
months ended March 31, 2010 to $1,857 as compared to $1,409 during the comparable period in 2009.
The increase was mainly due to a $670 increase in expenses related to the Companys Phase 2
clinical trial for Parkinsons disease, including a (i) $579 increase in fees due to the
investigator, surgical sites and brain imaging sites participating in the clinical trial, and (ii)
$91 increase in other expenses related to the administration of the clinical trial, including fees
to the clinical research organization assisting the Company in overseeing the conduct of the trial.
This increase was offset by decreases, from the prior comparable period, including $138 in fees
related to license agreements and sponsored research agreements and $77 in other basic research
expenses, including laboratory supplies and preclinical research.
General and Administrative. General and administrative expenses increased by $535 to $1,284
during the three months ended March 31, 2010, as compared to $749 during the comparable period in
2009. This increase was primarily due to a $420 increase in employee compensation expense mainly
related to a (i) $98 charge for the accelerated vesting of and the extension of the exercise period
for John Mordocks stock options in connection with his resignation and (ii) $291 charge for
severance paid to Mr. Mordock in connection with his resignation. The increase was also due to a
$162 increase in professional fees, including legal fees, strategic advisory fees, accounting fees
and investor and public relations fees. These increases were offset by minor decreases in
miscellaneous items.
Other Expense, Net. The Company had net other expenses of $356 during the three months ended
March 31, 2010, as compared to net other expense of $2,756 during the comparable period in 2009.
The decrease is mainly due to a $2,433 decrease in charges incurred for the change in estimated
fair value of its derivative liabilities.
Liquidity and Capital Resources
Cash and cash equivalents were $6,484 at March 31, 2010.
The Company is a development stage company and has not generated any operating revenues as of
March 31, 2010. In addition, the Company will continue to incur net losses and cash flow
deficiencies from operating activities for the foreseeable future.
Based on its cash flow projections, the Company will need additional financing to carry out
its planned business activities and complete its plan of operations through December 31, 2010. At
the Companys present level of activities, the Companys cash and cash equivalents are believed, at
this time, to be sufficient to fund its operations only into the fourth quarter of this
current fiscal year. Accordingly, there is substantial doubt as to the Companys ability to
continue as a going concern by the end of its current fiscal year.
21
Much of the Companys ability to raise additional capital or secure a strategic collaboration
for the financing of its continued operations and product development will depend substantially on
the successful outcome of its Phase 2 clinical trial for its Parkinsons product. The initial
6-month safety and efficacy results from that trial will not be available until June or July of
2010. Since the Company is unable to fund its operations through December 31, 2010, it is making
every effort to secure capital commitments for funds at this time. The Company is also currently
seeking to raise funds through corporate collaboration and licensing arrangements in connection
with its ongoing and long-term operations. 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.
The Companys independent registered public accounting firm expressed substantial doubt about
the Companys ability to continue as a going concern in the audit report on the Companys audited
financial statements for the fiscal year ended December 31, 2009 included in the 2009 10-K.
Net cash used in operating activities was $3,076 for the three months ended March 31, 2010 as
compared to $1,959 during the comparable period in 2009. The $1,117 increase in net cash used in
operations was primarily due to a $2,370 decrease in non-cash expenses, as well as a $164 increase
in cash used as a result of changes to working capital in 2010, offset by a $1,417 increase in net
loss for the three months ended March 31, 2010.
The Company had net cash used in investing activities of $77 during the three months ended
March 31, 2010 as compared to $62 during the three months ended March 31, 2009. Cash used in
investing activities relates to additions to intangible assets made by the Company during 2010 and
2009.
The Company had no net cash used in or provided by financing activities during the three
months ended March 31, 2010 and 2009.
22
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:
|
|
|
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 |
|
|
|
the inability of the Company to successfully commence and complete all necessary
clinical trials for the commercialization of its product to treat Parkinsons
disease. |
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 2009 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.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures About Market Risk |
Not applicable.
|
|
|
Item 4. |
|
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 March 31, 2010, 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 March 31, 2010.
(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.
PART II. OTHER INFORMATION
See Exhibit Index.
23
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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May 13, 2010 |
/s/ Clark A. Johnson
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Clark A. Johnson |
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President and Chief Executive Officer
(as Principal Executive Officer) |
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May 13, 2010 |
/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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Letter Agreement dated March 1, 2010 between Neurologix, Inc.
and John E. Mordock (filed as Exhibit 10.49 to the
Registrants Annual Report on Form 10-K, dated March 26, 2010,
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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