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 quarterly period ended September 30, 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 the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
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 10, 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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September 30, |
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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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|
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Current assets: |
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|
|
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|
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|
Cash and cash equivalents |
|
$ |
3,004 |
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|
$ |
9,637 |
|
Prepaid expenses and other current assets |
|
|
158 |
|
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|
395 |
|
|
|
|
|
|
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|
Total current assets |
|
|
3,162 |
|
|
|
10,032 |
|
Equipment,
less accumulated depreciation of $671 and $624 at September 30, 2010 and December 31, 2009, respectively |
|
|
82 |
|
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|
129 |
|
Intangible
assets, less accumulated amortization of $335 and $262 at September 30, 2010 and December 31, 2009, respectively |
|
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1,004 |
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|
891 |
|
Other assets |
|
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5 |
|
|
|
5 |
|
|
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|
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Total assets |
|
$ |
4,253 |
|
|
$ |
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 |
|
$ |
1,838 |
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$ |
1,834 |
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Total current liabilities |
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1,838 |
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1,834 |
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Derivative financial instruments, at estimated fair value warrants |
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6,735 |
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|
3,847 |
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Total liabilities |
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|
8,573 |
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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 September
30, 2010 and December 31, 2009, with an aggregate liquidation
preference of $1 |
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|
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Series C Convertible, $0.10 par value; 700,000 shares
designated, 281,263 shares issued and outstanding at
September 30, 2010 and December 31, 2009, with an aggregate
liquidation preference of $9,119 and $7,008 at September 30,
2010 and December 31, 2009, respectively |
|
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28 |
|
|
|
28 |
|
Series D Convertible, $0.10 par value; 792,100 shares
designated, 734,898 shares issued and outstanding at September
30, 2010 and December 31, 2009, with an aggregate liquidation
preference of $34,078 and $29,420 at September 30, 2010 and
December 31, 2009, respectively |
|
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73 |
|
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|
73 |
|
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 September 30, 2010
and December 31, 2009 |
|
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28 |
|
|
|
28 |
|
Additional paid-in capital |
|
|
57,352 |
|
|
|
56,775 |
|
Deficit accumulated during the development stage |
|
|
(61,801 |
) |
|
|
(51,528 |
) |
|
|
|
|
|
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|
Total stockholders equity |
|
|
(4,320 |
) |
|
|
5,376 |
|
|
|
|
|
|
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Total liabilities and stockholders equity |
|
$ |
4,253 |
|
|
$ |
11,057 |
|
|
|
|
|
|
|
|
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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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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2010 |
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2009 |
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2010 |
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2009 |
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September 30, 2010 |
|
Revenues |
|
$ |
|
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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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4,503 |
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|
5,779 |
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|
1,104 |
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|
2,121 |
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|
31,964 |
|
General and administrative
expenses |
|
|
2,884 |
|
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|
2,179 |
|
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|
901 |
|
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|
631 |
|
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|
21,881 |
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|
|
|
|
|
|
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|
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Loss from operations |
|
|
(7,387 |
) |
|
|
(7,958 |
) |
|
|
(2,005 |
) |
|
|
(2,752 |
) |
|
|
(53,845 |
) |
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Other income (expense): |
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Dividend, interest and other income |
|
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2 |
|
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|
55 |
|
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|
1 |
|
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|
6 |
|
|
|
1,885 |
|
Interest expense-related parties |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
(411 |
) |
Change in estimated fair value of
derivative financial instruments
warrants |
|
|
(2,888 |
) |
|
|
(2,703 |
) |
|
|
(300 |
) |
|
|
(723 |
) |
|
|
(5,665 |
) |
|
|
|
|
|
|
|
|
|
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|
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|
Other (expense) income, net |
|
|
(2,886 |
) |
|
|
(2,648 |
) |
|
|
(299 |
) |
|
|
(717 |
) |
|
|
(4,191 |
) |
|
|
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|
|
|
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|
|
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|
|
|
|
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|
Net loss |
|
|
(10,273 |
) |
|
|
(10,606 |
) |
|
|
(2,304 |
) |
|
|
(3,469 |
) |
|
$ |
(58,036 |
) |
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|
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|
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|
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|
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|
Preferred stock dividends |
|
|
(2,375 |
) |
|
|
(2,208 |
) |
|
|
(817 |
) |
|
|
(757 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss applicable to common stock |
|
$ |
(12,648 |
) |
|
$ |
(12,814 |
) |
|
$ |
(3,121 |
) |
|
$ |
(4,226 |
) |
|
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss applicable to common stock
per share, basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.15 |
) |
|
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|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
27,865,010 |
|
|
|
27,819,156 |
|
|
|
27,865,010 |
|
|
|
27,865,010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 SEPTEMBER 30, 2010
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
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|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
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|
|
|
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|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock to founders |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
4 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(328 |
) |
|
|
(328 |
) |
Balance, December 31, 1999 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,004,146 |
|
|
$ |
0 |
|
|
$ |
4 |
|
|
$ |
0 |
|
|
$ |
(328 |
) |
|
$ |
(324 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
9 |
|
Common stock issued for
intangible assets at $0.09 per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
259,491 |
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
24 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(870 |
) |
|
|
(870 |
) |
Balance, December 31, 2001 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
6,263,637 |
|
|
$ |
0 |
|
|
$ |
37 |
|
|
$ |
0 |
|
|
$ |
(2,253 |
) |
|
$ |
(2,216 |
) |
Retirement of founder shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,126 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock issued pursuant to
license agreement at $1.56 per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
368,761 |
|
|
|
|
|
|
|
577 |
|
|
|
(577 |
) |
|
|
|
|
|
|
|
|
Private placement of Series B
convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
|
|
|
|
|
|
|
|
|
|
2,613 |
|
Amortization of unearned
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
|
24 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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.
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH SEPTEMBER 30, 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 SEPTEMBER 30, 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 SEPTEMBER 30, 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
434 |
|
|
|
|
|
|
|
|
|
|
|
434 |
|
Non-employee share-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143 |
|
|
|
|
|
|
|
|
|
|
|
143 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,273 |
) |
|
|
(10,273 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance September 30, 2010 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
281,263 |
|
|
$ |
28 |
|
|
|
27,865,010 |
|
|
$ |
28 |
|
|
$ |
57,352 |
|
|
$ |
0 |
|
|
$ |
(61,801 |
) |
|
$ |
(4,320 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
Nine Months Ended September 30, |
|
|
(inception) through |
|
|
|
2010 |
|
|
2009 |
|
|
September 30, 2010 |
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,273 |
) |
|
$ |
(10,606 |
) |
|
$ |
(58,036 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
47 |
|
|
|
61 |
|
|
|
677 |
|
Amortization |
|
|
73 |
|
|
|
61 |
|
|
|
475 |
|
Gain on redemption of investment |
|
|
|
|
|
|
|
|
|
|
(62 |
) |
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
9 |
|
Impairment of intangible assets |
|
|
|
|
|
|
5 |
|
|
|
199 |
|
Amortization of non-employee share-based compensation |
|
|
157 |
|
|
|
179 |
|
|
|
1,864 |
|
Share-based employee compensation expense |
|
|
434 |
|
|
|
376 |
|
|
|
3,266 |
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
|
|
378 |
|
Change in estimated fair value of derivative financial instruments
warrants |
|
|
2,888 |
|
|
|
2,703 |
|
|
|
5,665 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and other current assets |
|
|
223 |
|
|
|
(55 |
) |
|
|
761 |
|
(Decrease) increase in accounts payable and accrued expenses |
|
|
4 |
|
|
|
351 |
|
|
|
1,778 |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,447 |
) |
|
|
(6,925 |
) |
|
|
(43,026 |
) |
|
|
|
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Security deposits paid |
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Purchases of equipment |
|
|
|
|
|
|
(44 |
) |
|
|
(645 |
) |
Additions to intangible assets |
|
|
(186 |
) |
|
|
(166 |
) |
|
|
(1,648 |
) |
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 |
|
|
(186 |
) |
|
|
(210 |
) |
|
|
(2,235 |
) |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
(6,633 |
) |
|
|
(7,135 |
) |
|
|
3,004 |
|
Cash and cash equivalents, beginning of period |
|
|
9,637 |
|
|
|
18,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
NEUROLOGIX, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period |
|
|
|
|
|
|
|
|
|
|
|
February 12, 1999 |
|
|
|
Nine Months Ended September 30, |
|
|
(inception) through |
|
|
|
2010 |
|
|
2009 |
|
|
September 30, 2010 |
|
Cash and cash equivalents, end of period |
|
$ |
3,004 |
|
|
$ |
11,771 |
|
|
$ |
3,004 |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
2,375 |
|
|
$ |
2,208 |
|
|
$ |
8,293 |
|
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 $10,273, $10,606 and $58,036 and negative cash flows from
operating activities of $6,447, $6,925 and $43,026 for the nine months ended September 30, 2010 and
2009 and for the period from February 12, 1999 (inception) to September 30, 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 $3,004 and $9,637 as of September 30, 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 to 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
through the end of this month. In an effort to obtain additional financing, the Company has entered
into non-binding letter agreements with certain of its existing stockholders to raise a minimum of
$7.0 million through the issuance of senior secured notes and common stock warrants (the
Financing). The notes would carry an annual interest rate of 10%, have an outside maturity date
of October 31, 2011, and would be secured by substantially all of the Companys assets, subject to
obtaining necessary consents. The Company believes that the proceeds from the Financing will
provide it with sufficient time to consummate a strategic transaction or, in the alternative, to
raise additional funds to finance the continuing operations and business of the Company. However,
the Company does not know if or when the Financing will be consummated and the financial statements
do not include any adjustments that may result from the outcome of this uncertainty. If the
Financing is not consummated by the end of November 2010, and the Company is unable to obtain
alternative funding by the end of November 2010, it is likely that the Company will not be able to
continue as a going concern and will have to explore its liquidation options, which may include
voluntarily filing for protection under the federal bankruptcy laws.
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 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.
11
(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 2009 10-K. 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.
(3) Summary of Significant Accounting Policies
(a) Stock-Based Compensation:
At September 30, 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 reflects share-based employee compensation expense 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 September 30, 2010, total unrecognized
compensation cost related to stock option awards, to be recognized as expense subsequent to
September 30, 2010, was approximately $237, 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, 2010 and 2009 was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Research and development |
|
$ |
126 |
|
|
$ |
113 |
|
|
$ |
26 |
|
|
$ |
23 |
|
General and administrative |
|
|
308 |
|
|
|
263 |
|
|
|
41 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense |
|
$ |
434 |
|
|
$ |
376 |
|
|
$ |
67 |
|
|
$ |
71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net share-based
compensation expenses per
basic and diluted common share |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12
A summary of option activity as of September 30, 2010 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, 2009 |
|
|
4,174 |
|
|
$ |
1.19 |
|
|
|
6.30 |
|
|
|
|
|
Granted |
|
|
1,015 |
|
|
$ |
0.65 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(582 |
) |
|
|
2.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2010 |
|
|
4,607 |
|
|
$ |
0.93 |
|
|
|
4.99 |
|
|
$ |
1,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2010 |
|
|
3,711 |
|
|
$ |
1.00 |
|
|
|
4.66 |
|
|
$ |
1,451 |
|
The weighted-average grant-date fair value of options granted during the nine months ended
September 30, 2010 and 2009 was $0.57 and $0.52, respectively, and was estimated using the
Black-Scholes option pricing model.
The following table sets forth the assumptions used with the Black-Scholes option pricing
model in determining stock-based compensation under ASC Topic 718 in 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
Expected option term |
|
5-6 years |
|
5-6 years |
Risk-free interest rate |
|
|
2.26% |
|
|
|
2.06% |
|
Expected volatility |
|
|
129% |
|
|
|
116% |
|
Dividend yield |
|
|
0% |
|
|
|
0% |
|
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.
13
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.
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.
(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, |
|
|
|
2010 |
|
|
2009 |
|
Stock options |
|
|
4,606,833 |
|
|
|
4,173,833 |
|
Warrants |
|
|
6,535,062 |
|
|
|
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 |
|
|
|
6,152,628 |
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 September 30, 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 on conversion of such shares with shares of Common Stock. The
current number assumes that such payment will be made with cash. |
14
(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.
In estimating the fair value of the Companys derivative liabilities, the Company used a
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.
15
(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 $2,888 and $2,703 for the nine months ended September 30, 2010 and
2009, respectively. The Company recorded other expense relating to the change in fair value of the
Warrants of $300 and $723 for the three months ended September 30, 2010 and 2009, respectively.
The Company estimates the fair value of the Warrants using a probability-weighted
Black-Scholes option pricing model. The assumptions used for the three and nine months ended
September 30, 2010 and 2009 are noted in the following table:
|
|
|
|
|
|
|
|
|
|
|
Three and Nine Months Ended |
|
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
Expected option term |
|
|
2.6 to 4.1 years |
|
|
|
5 to 7 years |
|
Risk-free interest rate |
|
|
0.64% - 1.27% |
|
|
|
2.31% - 2.93% |
|
Expected volatility |
|
|
128% |
|
|
|
123% |
|
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 three-year, five-year and seven-year U.S. Treasury security
rates.
16
(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 September 30, 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 |
|
|
September |
|
Description |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
30, 2010 |
|
Derivative
liabilities related
to Warrants |
|
$ |
|
|
|
$ |
|
|
|
$ |
6,735 |
|
|
$ |
6,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended September 30, 2010 and for the year ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
|
|
|
Balance as of |
|
|
|
December 31, |
|
|
|
|
|
|
September |
|
Description |
|
2009 |
|
|
Losses |
|
|
30, 2010 |
|
Derivative
liabilities related
to Warrants |
|
$ |
3,847 |
|
|
$ |
2,888 |
|
|
$ |
6,735 |
|
|
|
|
|
|
|
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
(6) Commitments and Contingencies
Threatened Litigation:
A participant in the Phase 2 clinical trial for Parkinsons disease, through his counsel, is
claiming that he was injured during the trials surgical procedure by receiving a double dose of
the drug used in the trial on one side of his brain rather than a bilateral dose of such drug as
called for by the trials protocol. The participants counsel, by letter dated June 18, 2010,
notified certain parties involved in the trial, including the Company, of his clients assertion of
injury and other claims regarding the conduct of the clinical trial, and requested a settlement of
the matter prior to any litigation. The participants claimed injury does not represent a serious
adverse event, as determined by the monitoring entities that make such determinations, reportable
as such to the U.S. Food and Drug Administration (the FDA). The Company has reviewed the
matter with its counsel and certain of the parties participating in the trial and has discussed the
matter with the participants counsel. The Company does not believe that the participants claimed
injury is related to the drug used in the trial or to the trials protocol. The Company believes
that the participants claim against the Company is without merit and, if filed, the Company
intends to vigorously defend against such claim.
(7) Subsequent Events
Consulting and Employment Agreements:
On November 9, 2010 the Company entered into a letter agreement (the Letter
Agreement) with Dr. Matthew During. The Letter Agreement amends, effective as of September
30, 2010, a Consulting Agreement dated October 1, 1999, as amended (the Consulting
Agreement), by and between the Company and Dr. During. The Letter Agreement extends the term
of the Consulting Agreement from September 30, 2010 to September 30, 2011 at the current annual
rate of $175. A copy of the Letter Agreement is attached hereto as Exhibit 10.1.
18
On November 9, 2010 the Company approved an extension of its employment agreement with Marc L.
Panoff, the Companys Chief Financial Officer, Treasurer and Secretary, from December 4, 2010 until
December 4, 2011 at the current annual rate of $203.
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.
To date, the Company has not generated any operating revenues and has incurred annual net
losses. From inception through September 30, 2010, the Company had an accumulated deficit of
$61,801, and it expects to incur additional losses for the foreseeable future. The Company
recognized net losses of $10,273 for the nine months ended September 30, 2010, and $10,606 for the
nine months ended September 30, 2009.
Since its inception, the Company has financed its operations primarily through sales of its
equity and debt securities. From inception through September 30, 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. The Company continues to seek additional funds
through the sale of its securities to fund its operations. 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.
19
Plan of Operation
Parkinsons Disease
In June 2010, the Company announced positive results in its Phase 2 clinical trial of its
investigational gene therapy for advanced Parkinsons disease, NLX-P101. This trial was designed to
evaluate the safety and efficacy of NLX-P101 in subjects with moderate to advanced Parkinsons
disease who were not well-controlled on available medical therapy. Approximately 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 who received NLX-P101 experienced statistically significant and clinically
meaningful improvements in off-medication motor scores compared to Control Participants who
received sham surgery, measured on the Unified Parkinsons Disease Rating Scale Part 3 (Motor
section). The results also demonstrated a positive safety profile for NLX-P101, with no serious
adverse events related to the gene therapy or surgical procedure reported. All treated subjects
will continue to be monitored for safety for a 12-month period following their surgical procedure.
Subject to the availability of adequate funds and the availability of a catheter infusion device,
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.
A participant in the Phase 2 clinical trial for Parkinsons disease, through his counsel, is
claiming that he was injured during the trials surgical procedure by receiving a double dose of
the drug used in the trial on one side of his brain rather than a bilateral dose of such drug as
called for by the trials protocol. The participants counsel, by letter dated June 18, 2010,
notified certain parties involved in the trial, including the Company, of his clients assertion of
injury and other claims regarding the conduct of the clinical trial, and requested a settlement of
the matter prior to any litigation. The participants claimed injury does not represent a serious
adverse event, as determined by the monitoring entities that make such determinations, reportable
as such to the U.S. Food and Drug Administration (the FDA). The Company has reviewed the
matter with its counsel and certain of the parties participating in the trial and has discussed the
matter with the participants counsel. The Company does not believe that the participants claimed
injury is related to the drug used in the trial or to the trials protocol. The Company believes
that the participants claim against the Company is without merit and, if filed, the Company
intends to vigorously defend against such claim.
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 FDA in 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. 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.
20
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
Subject to the receipt of adequate funding, the Company expects to spend, over the next 12
months, in addition to its normal recurring expenditures, approximately $5,000 in Phase 2 clinical
trial expenses with regard to its Parkinsons treatment; $1,400 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.
See Liquidity and Capital Resources.
Results of Operations
Three Months Ended September 30, 2010 Compared to the Three Months Ended September 30, 2009
Revenues. The Company did not generate any operating revenues in the three months ended
September 30, 2010 or in the three months ended September 30, 2009.
21
Costs and Expenses.
Research and Development. Research and development expenses decreased by $1,017 during the
three months ended September 30, 2010 to $1,104 as compared to $2,121 during the
comparable period in 2009. The decrease was mainly due to a $920 decrease in expenses related
to the Companys Phase 2 clinical trial for Parkinsons disease, as well as a $125 decrease in
process development expenses for large scale manufacturing of the Companys products and infusion
devices. These decreases were offset, in part, by increases in miscellaneous research and
development expenses.
General and Administrative. General and administrative expenses increased by $270 to $901
during the three months ended September 30, 2010, as compared to $631 during the comparable period
in 2009. This increase was due mainly to a $341 increase in professional fees, including strategic
advisory fees, legal fees, accounting fees, investor relations fees and public relations fees,
offset by an $87 decrease in cash and non-cash employee compensation expense.
Other Expense, Net. The Company had net other expense of $299 during the three months ended
September 30, 2010, as compared to net other expense of $717 during the comparable period in 2009.
The change is mainly due to a $423 decrease in other expense recognized for the increase in
estimated fair value of its derivative liabilities during the three months ended September 30,
2010.
Nine Months Ended September 30, 2010 Compared to the Nine Months Ended September 30, 2009
Revenues. The Company did not generate any operating revenues in the nine months ended
September 30, 2010 or in the nine months ended September 30, 2009.
Costs and Expenses.
Research and Development. Research and development expenses decreased by $1,276 during the
nine months ended September 30, 2010 to $4,503 as compared to $5,779 during the comparable period
in 2009. The decrease was primarily due to a $929 decrease in expenses related to the Companys
Phase 2 clinical trial for Parkinsons disease, as well as a $223 decrease in process development
expenses for large scale manufacturing of the Companys products and infusion devices and a $194
decrease in fees related to license agreements and sponsored research agreements. These decreases
were offset by a $108 increase in cash and non-cash compensation to the Companys researchers and
scientific consultants.
General and Administrative. General and administrative expenses increased by $705 to $2,884
during the nine months ended September 30, 2010, as compared to $2,179 during the comparable period
in 2009. This increase was primarily due to a $505 increase in professional fees, including
strategic advisory fees, legal fees, accounting fees, investor relations fees and public relations
fees, as well as a $229 increase in cash and non-cash compensation to the Companys employees in
2010. These increases were offset, in part, by decreases in miscellaneous general and
administrative expenses.
Other Expense, Net. The Company had net other expense of $2,886 during the nine months ended
September 30, 2010, as compared to net other expense of $2,648 during the comparable period in
2009. The change is mainly due to other expense of $185 recognized for the increase in estimated
fair value of its derivative liabilities during the nine months ended September 30, 2010.
Additionally, the Company earned $53 less in interest income during the nine months ended September
30, 2010 as compared to the comparable period in 2009.
22
Liquidity and Capital Resources
Cash and cash equivalents were $3,004 at September 30, 2010.
The Company is a development stage company and has not generated any operating revenues as of
September 30, 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 to 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 through the end of this month. In an
effort to obtain additional financing, the Company has entered into non-binding letter agreements
with certain of its existing stockholders to raise a minimum of $7.0 million through the issuance
of senior secured notes and common stock warrants (theFinancing). The notes would carry an
annual interest rate of 10%, have an outside maturity date of October 31, 2011, and would be
secured by substantially all of the Companys assets, subject to obtaining necessary consents. The
Company believes that the proceeds from the Financing will provide it with sufficient time to
consummate a strategic transaction or, in the alternative, to raise additional funds to finance the
continuing operations and business of the Company. However, the Company does not know if or when
the Financing will be consummated. If the Financing is not consummated by the end of November 2010,
and the Company is unable to obtain alternative funding by the end of November 2010, it is likely
that the Company will not be able to continue as a going concern and will have to explore its
liquidation options, which may include voluntarily filing for protection under the federal
bankruptcy laws.
In June 2010, the Company announced positive results in its Phase 2 clinical trial of its
investigational gene therapy for advanced Parkinsons disease, NLX-P101. Given these results, the
Company is seeking to raise additional funds to develop further its Parkinsons product as well as
to develop its other technologies for the treatment of certain neurological and psychiatric
diseases. In this regard, the Company may seek to raise funds through corporate collaborations or
licensing arrangements for its Parkinsons product or other technologies. In addition, the Company
is pursuing other strategic transactions which are intended to maximize value for the Company and
its stockholders. 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 or
whether a strategic transaction can be consummated in furtherance of its objectives.
The Companys ability to continue pursuing such corporate collaborations, licensing
arrangements and other strategic transactions is contingent upon the consummation of the Financing
or the procurement of alternative funds as described above.
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.
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Net cash used in operating activities was $6,447 for the nine months ended September 30, 2010
as compared to $6,925 during the comparable period in 2009. The $478 decrease in net
cash used in operations was primarily due to a $333 decrease in net loss for the nine months
ended September 30, 2010, as well as a $214 increase in non-cash expenses in 2010, offset by a $69
increase in cash used as a result of changes to working capital in the first nine months of 2010.
The Company had net cash used in investing activities of $186 during the nine months ended
September 30, 2010 as compared to $210 during the nine months ended September 30, 2009. Cash used
in investing activities relates to additions to intangible assets and purchases of equipment made
by the Company during the first nine months of each of 2010 and 2009.
The Company had no net cash used in or provided by financing activities during the nine months
ended September 30, 2010 and 2009.
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. |
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.
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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 September 30, 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 September 30, 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
Item 5. Other Information
On November 9, 2010 the Company entered into a letter agreement (the Letter
Agreement) with Dr. Matthew During. The Letter Agreement amends, effective as of September
30, 2010, a Consulting Agreement dated October 1, 1999, as amended (the Consulting
Agreement), by and between the Company and Dr. During. The Letter Agreement extends the term
of the Consulting Agreement from September 30, 2010 to September 30, 2011 at the current annual
rate of $175,000. The Company is including this disclosure in this Quarterly Report on Form 10-Q in
lieu of reporting it on Form 8-K under Item 1.01. A copy of the Letter Agreement is attached
hereto as Exhibit 10.1.
Item 6. Exhibits
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 12, 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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November 12, 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 November 9, 2010 between Neurologix,
Inc. and Dr. Matthew During.** |
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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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