e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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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 November 30, 2006
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 0-24050
NORTHFIELD LABORATORIES INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction
of incorporation or organization)
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36-3378733
(I.R.S. Employer
Identification Number) |
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1560 SHERMAN AVENUE, SUITE 1000, EVANSTON,
ILLINOIS
(Address of principal executive offices)
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60201-4800
(Zip Code) |
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (847) 864-3500
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 is a large accelerated filer, an accelerated
filer or a non-accelerated filer.
Large
accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2
under the Exchange Act) Yes o No þ
As
of November 30, 2006, Registrant had 26,814,475 shares of common stock outstanding
TABLE OF CONTENTS
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This Quarterly Report contains forward-looking statements concerning, among other things, our
prospects, clinical and regulatory developments affecting our potential product and our business
strategies. These forward-looking statements are identified by the use of such terms as intends,
expects, plans, estimates, anticipates, forecasts, should, believes and similar
terms.
These forward-looking statements involve risks and uncertainties. Actual results may differ
materially from those predicted by the forward-looking statements because of various factors and
possible events, including those discussed under Risk Factors in our Annual Report on Form 10-K
filed with the Securities and Exchange Commission and those matters discussed under Legal
Proceedings in this Quarterly Report. Because these forward-looking statements involve risks and
uncertainties, actual results may differ significantly from those predicted in these
forward-looking statements. You should not place undue weight on these statements. These statements
speak only as of the date of this document or, in the case of any document incorporated by
reference, the date of that document.
All subsequent written and oral forward-looking statements attributable to Northfield or any person
acting on our behalf are qualified by the cautionary statements in this section and in our Annual
Report. We will have no obligation to revise these forward-looking statements.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders
Northfield Laboratories Inc.:
We have reviewed the balance sheet of Northfield Laboratories Inc. (a company in the development
stage) as of November 30, 2006, and the related statements of
operations for the three-month periods ended November 30, 2006
and November 30, 2005, and the statements of operations and cash flows for the
six-month periods ended November 30, 2006 and November 30,
2005 and for the period from June 19, 1985 (inception) through
November 30, 2006. We have also reviewed the
statements of shareholders equity (deficit) for the
six-month period ended November 30, 2006 and for the period from June 19, 1985 (inception) through
November 30, 2006.
These financial statements are the responsibility of the Companys management.
We conducted our review in accordance with the standards of the Public Company Accounting Oversight
Board (United States). A review of interim financial information consists principally of applying
analytical procedures and making inquiries of persons responsible for financial and accounting
matters. It is substantially less in scope than an audit conducted in accordance with the
standards of the Public Company Accounting Oversight Board (United States), the objective of which
is the expression of an opinion regarding the financial statements taken as a whole. Accordingly,
we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should be made to the
financial statements referred to above for them to be in conformity U.S. generally accepted
accounting principles.
We have
previously audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the balance sheet of Northfield Laboratories Inc. as of May 31, 2006, and
the related statements of operations, shareholders equity (deficit), and cash flows for the year
then ended and for the period from June 19, 1985 (inception) through May 31, 2006 (not presented
herein); and in our report dated August 11, 2006, we expressed an unqualified opinion on those
financial statements. In our opinion, the information set forth in the accompanying balance sheet
as of May 31, 2006 and in the accompanying statements of operations, cash flows and shareholders
equity (deficit) for the period from June 19, 1985
(inception) through May 31, 2006 is fairly stated, in all material respects, in relation to the statements from
which it has been derived.
Chicago, IL
January 9, 2007
Part
I
FINANCIAL INFORMATION
Item
1. Financial Statements.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
November 30, 2006 and May 31, 2006
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November 30, |
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May 31, |
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2006 |
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2006 |
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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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$ |
30,839,591 |
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39,304,602 |
|
Restricted cash |
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|
227,458 |
|
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|
926,492 |
|
Marketable securities |
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|
20,792,724 |
|
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|
33,679,022 |
|
Prepaid expenses |
|
|
782,334 |
|
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|
813,104 |
|
Other assets |
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|
38,129 |
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|
|
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Total current assets |
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52,680,236 |
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74,723,220 |
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Property, plant, and equipment |
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21,562,127 |
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|
15,654,049 |
|
Accumulated depreciation |
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|
(13,090,764 |
) |
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|
(14,575,118 |
) |
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Net property, plant, and equipment |
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8,471,363 |
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1,078,931 |
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Other assets |
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19,550 |
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|
68,941 |
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|
|
|
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|
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|
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|
|
|
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$ |
61,171,149 |
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|
75,871,092 |
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Liabilities and Shareholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,641,577 |
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|
4,481,804 |
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Accrued expenses |
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|
93,870 |
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|
134,006 |
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Accrued compensation and benefits |
|
|
986,412 |
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|
742,038 |
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Government grant liability |
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|
227,458 |
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|
926,492 |
|
Other |
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6,021 |
|
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|
249,580 |
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|
|
|
|
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Total liabilities |
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4,955,338 |
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|
6,533,920 |
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Shareholders equity: |
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Preferred stock, $.01 par value. Authorized 5,000,000 shares;
none issued and outstanding |
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Common stock, $.01 par value. Authorized 60,000,000 shares;
issued 26,816,192 at November 30, 2006 and 26,777,655 at
May 31, 2006 |
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268,162 |
|
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|
267,777 |
|
Additional paid-in capital |
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243,275,100 |
|
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|
241,240,276 |
|
Deficit accumulated during the development stage |
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|
(187,302,058 |
) |
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|
(172,136,429 |
) |
Deferred compensation |
|
|
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(9,059 |
) |
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56,241,204 |
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69,362,565 |
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Less cost of common shares in treasury; 1,717 shares and
1,717 shares, respectively |
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|
(25,393 |
) |
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|
(25,393 |
) |
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Total shareholders equity |
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56,215,811 |
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69,337,172 |
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$ |
61,171,149 |
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|
75,871,092 |
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|
|
|
|
|
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|
See accompanying notes to financial statements and accountants review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statement of Operations
Three
and six months ended November 30, 2006 and November 30,
2005 and for the cumulative period
from June 19, 1985 (inception) through November 30, 2006
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Cumulative |
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from |
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June 19, 1985 |
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Three months ended November 30, |
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Six months ended November 30, |
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through |
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2006 |
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2005 |
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2006 |
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2005 |
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November 30, 2006 |
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(unaudited) |
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|
(unaudited) |
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|
(unaudited) |
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|
(unaudited) |
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|
(unaudited) |
|
Revenues
license income |
|
$ |
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
3,000,000 |
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|
Costs and
expenses: |
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Research and development |
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5,625,231 |
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|
5,573,302 |
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|
11,451,344 |
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|
10,667,176 |
|
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|
159,232,541 |
|
General and administrative |
|
|
2,700,999 |
|
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|
1,459,825 |
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|
5,264,648 |
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|
2,848,819 |
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|
60,540,548 |
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|
|
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|
8,326,230 |
|
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|
7,033,127 |
|
|
|
16,715,992 |
|
|
|
13,515,995 |
|
|
|
219,773,089 |
|
|
Other income
and expenses: |
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|
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|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
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Interest income |
|
|
723,175 |
|
|
|
764,016 |
|
|
|
1,550,363 |
|
|
|
1,466,158 |
|
|
|
29,629,186 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83,234 |
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|
|
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|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
723,175 |
|
|
|
764,016 |
|
|
|
1,550,363 |
|
|
|
1,466,158 |
|
|
|
29,545,952 |
|
|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
Net loss
before cumulative effect of change in accounting principle |
|
|
(7,603,055 |
) |
|
|
(6,269,111 |
) |
|
|
(15,165,629 |
) |
|
|
(12,049,837 |
) |
|
|
(187,227,137 |
) |
|
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Cumulative
effect of change in accounting principle |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
74,921 |
|
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|
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|
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Net loss |
|
$ |
(7,603,055 |
) |
|
|
(6,269,111 |
) |
|
|
(15,165,629 |
) |
|
|
(12,049,837 |
) |
|
|
(187,302,058 |
) |
|
|
|
|
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Net loss per
share basic and diluted |
|
$ |
(0.28 |
) |
|
|
(0.23 |
) |
|
|
(0.57 |
) |
|
|
(0.45 |
) |
|
|
(16.60 |
) |
|
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|
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|
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Shares used
in calculation of per share data basic and diluted |
|
|
26,800,028 |
|
|
|
26,758,538 |
|
|
|
26,790,669 |
|
|
|
26,754,947 |
|
|
|
11,281,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements and accountants review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders Equity (Deficit)
Six months ended November 30, 2006 and the cumulative period
from June 19, 1985 (inception) through November 30, 2006
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Deficit |
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|
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|
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|
|
Total |
|
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Series A convertible |
|
|
Series B convertible |
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|
accumulated |
|
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|
|
|
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|
|
|
|
share- |
|
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|
Preferred stock |
|
|
Common stock |
|
|
preferred stock |
|
|
preferred stock |
|
|
Additional |
|
|
during the |
|
|
Deferred |
|
|
|
|
|
|
holders |
|
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
paid-in |
|
|
development |
|
|
compen- |
|
|
Treasury |
|
|
equity |
|
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
capital |
|
|
stage |
|
|
sation |
|
|
shares |
|
|
(deficit) |
|
Issuance of common stock on August 27, 1985 |
|
|
|
|
|
$ |
|
|
|
|
3,500,000 |
|
|
$ |
35,000 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
(28,000 |
) |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
$ |
7,000 |
|
Issuance of Series A convertible preferred stock at $4.00 per share on
August 27, 1985 (net of costs of issuance of $79,150) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
670,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
920,850 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(607,688 |
) |
|
|
|
|
|
|
|
|
|
|
(607,688 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
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|
Balance at May 31, 1986 |
|
|
|
|
|
|
|
|
|
|
3,500,000 |
|
|
|
35,000 |
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
642,850 |
|
|
|
(607,688 |
) |
|
|
|
|
|
|
|
|
|
|
320,162 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,429,953 |
) |
|
|
|
|
|
|
|
|
|
|
(2,429,953 |
) |
Deferred compensation relating to grant of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,340,000 |
|
|
|
|
|
|
|
(2,340,000 |
) |
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
720,000 |
|
|
|
|
|
|
|
720,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1987 |
|
|
|
|
|
|
|
|
|
|
3,500,000 |
|
|
|
35,000 |
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
2,982,850 |
|
|
|
(3,037,641 |
) |
|
|
(1,620,000 |
) |
|
|
|
|
|
|
(1,389,791 |
) |
Issuance of Series B convertible preferred stock at $35.68 per share on
August 14, 1987 (net of costs of issuance of $75,450) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,633 |
|
|
|
200,633 |
|
|
|
6,882,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,083,135 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,057,254 |
) |
|
|
|
|
|
|
|
|
|
|
(3,057,254 |
) |
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
566,136 |
|
|
|
|
|
|
|
566,136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1988 |
|
|
|
|
|
|
|
|
|
|
3,500,000 |
|
|
|
35,000 |
|
|
|
250,000 |
|
|
|
250,000 |
|
|
|
200,633 |
|
|
|
200,633 |
|
|
|
9,865,352 |
|
|
|
(6,094,895 |
) |
|
|
(1,053,864 |
) |
|
|
|
|
|
|
3,202,226 |
|
Issuance of common stock at $24.21 per share on June 7, 1988 (net of costs of issuance of $246,000) |
|
|
|
|
|
|
|
|
|
|
413,020 |
|
|
|
4,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,749,870 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,754,000 |
|
Conversion of Series A convertible preferred stock to common stock on June 7, 1988 |
|
|
|
|
|
|
|
|
|
|
1,250,000 |
|
|
|
12,500 |
|
|
|
(250,000 |
) |
|
|
(250,000 |
) |
|
|
|
|
|
|
|
|
|
|
237,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Series B convertible preferred stock to common stock on June 7, 1988 |
|
|
|
|
|
|
|
|
|
|
1,003,165 |
|
|
|
10,032 |
|
|
|
|
|
|
|
|
|
|
|
(200,633 |
) |
|
|
(200,633 |
) |
|
|
190,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options at $2.00 per share |
|
|
|
|
|
|
|
|
|
|
47,115 |
|
|
|
471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
93,759 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
94,230 |
|
Issuance of common stock at $28.49 per share on March 6, 1989 (net of costs of issuance of $21,395) |
|
|
|
|
|
|
|
|
|
|
175,525 |
|
|
|
1,755 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,976,855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,978,610 |
|
Issuance of common stock at $28.49 per share on March 30, 1989 (net of costs of issuance of $10,697) |
|
|
|
|
|
|
|
|
|
|
87,760 |
|
|
|
878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,488,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,489,234 |
|
Sale of options at $28.29 per share to purchase common stock at $.20 per share on
March 30, 1989 (net of costs of issuance of $4,162) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,443,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,443,118 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(791,206 |
) |
|
|
|
|
|
|
|
|
|
|
(791,206 |
) |
Deferred compensation relating to grant of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
683,040 |
|
|
|
|
|
|
|
(683,040 |
) |
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
800,729 |
|
|
|
|
|
|
|
800,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1989 |
|
|
|
|
|
|
|
|
|
|
6,476,585 |
|
|
|
64,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,728,451 |
|
|
|
(6,886,101 |
) |
|
|
(936,175 |
) |
|
|
|
|
|
|
27,970,941 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,490,394 |
) |
|
|
|
|
|
|
|
|
|
|
(3,490,394 |
) |
Deferred compensation relating to grant of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
699,163 |
|
|
|
|
|
|
|
(699,163 |
) |
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
546,278 |
|
|
|
|
|
|
|
546,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1990 |
|
|
|
|
|
|
|
|
|
|
6,476,585 |
|
|
|
64,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,427,614 |
|
|
|
(10,376,495 |
) |
|
|
(1,089,060 |
) |
|
|
|
|
|
|
25,026,825 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,579,872 |
) |
|
|
|
|
|
|
|
|
|
|
(5,579,872 |
) |
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
435,296 |
|
|
|
|
|
|
|
435,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1991 |
|
|
|
|
|
|
|
|
|
|
6,476,585 |
|
|
|
64,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,427,614 |
|
|
|
(15,956,367 |
) |
|
|
(653,764 |
) |
|
|
|
|
|
|
19,882,249 |
|
Exercise of stock warrants at $5.60 per share |
|
|
|
|
|
|
|
|
|
|
90,000 |
|
|
|
900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
503,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
504,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,006,495 |
) |
|
|
|
|
|
|
|
|
|
|
(7,006,495 |
) |
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254,025 |
|
|
|
|
|
|
|
254,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1992 |
|
|
|
|
|
|
|
|
|
|
6,566,585 |
|
|
|
65,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,930,714 |
|
|
|
(22,962,862 |
) |
|
|
(399,739 |
) |
|
|
|
|
|
|
13,633,779 |
|
Exercise of stock warrants at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
106,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107,040 |
|
Issuance of common stock at $15.19 per share on April 19, 1993 (net of costs of issuance of $20,724) |
|
|
|
|
|
|
|
|
|
|
374,370 |
|
|
|
3,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,663,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,667,454 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,066,609 |
) |
|
|
|
|
|
|
|
|
|
|
(8,066,609 |
) |
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254,025 |
|
|
|
|
|
|
|
254,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1993 |
|
|
|
|
|
|
|
|
|
|
6,955,955 |
|
|
|
69,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,701,314 |
|
|
|
(31,029,471 |
) |
|
|
(145,714 |
) |
|
|
|
|
|
|
11,595,689 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,363,810 |
) |
|
|
|
|
|
|
|
|
|
|
(7,363,810 |
) |
Issuance of common stock at $6.50 per share on May 26, 1994 (net of costs of issuance of $2,061,149) |
|
|
|
|
|
|
|
|
|
|
2,500,000 |
|
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,163,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,188,851 |
|
Cancellation of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(85,400 |
) |
|
|
|
|
|
|
85,400 |
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
267 |
|
|
|
|
|
|
|
267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1994 |
|
|
|
|
|
|
|
|
|
|
9,455,955 |
|
|
|
94,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,779,765 |
|
|
|
(38,393,281 |
) |
|
|
(60,047 |
) |
|
|
|
|
|
|
18,420,997 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,439,013 |
) |
|
|
|
|
|
|
|
|
|
|
(7,439,013 |
) |
Issuance of common stock at $6.50 per share on June 20, 1994 (net of issuance costs of $172,500) |
|
|
|
|
|
|
|
|
|
|
375,000 |
|
|
|
3,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,261,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,265,000 |
|
Exercise of stock options at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,400 |
|
Exercise of stock options at $2.00 per share |
|
|
|
|
|
|
|
|
|
|
187,570 |
|
|
|
1,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
373,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
375,139 |
|
Cancellation of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(106,750 |
) |
|
|
|
|
|
|
106,750 |
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(67,892 |
) |
|
|
|
|
|
|
(67,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1995 |
|
|
|
|
|
$ |
|
|
|
|
10,028,525 |
|
|
$ |
100,285 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
59,378,829 |
|
|
$ |
(45,832,294 |
) |
|
$ |
(21,189 |
) |
|
|
|
|
|
$ |
13,625,631 |
|
See accompanying notes to financial statements and accountants review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders Equity (Deficit)
Six months ended November 30, 2006 and the cumulative period
from June 19, 1985 (inception) through November 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A convertible |
|
|
Series B convertible |
|
|
|
|
|
|
accumulated |
|
|
|
|
|
|
|
|
|
|
share- |
|
|
|
Preferred stock |
|
|
Common stock |
|
|
preferred stock |
|
|
preferred stock |
|
|
Additional |
|
|
during the |
|
|
Deferred |
|
|
|
|
|
|
holders |
|
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
Number |
|
|
Aggregate |
|
|
paid-in |
|
|
development |
|
|
compen- |
|
|
Treasury |
|
|
equity |
|
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
of shares |
|
|
amount |
|
|
capital |
|
|
stage |
|
|
sation |
|
|
shares |
|
|
(deficit) |
|
Net loss |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(4,778,875 |
) |
|
$ |
|
|
|
|
|
|
|
$ |
(4,778,875 |
) |
Issuance of common stock at $17.75 per share on August 9, 1995 (net of issuance costs of $3,565,125) |
|
|
|
|
|
|
|
|
|
|
2,925,000 |
|
|
|
29,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,324,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,353,624 |
|
Issuance of common stock at $17.75 per share on September 11, 1995
(net of issuance costs of $423,238) |
|
|
|
|
|
|
|
|
|
|
438,750 |
|
|
|
4,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,360,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,364,575 |
|
Exercise of stock options at $2.00 per share |
|
|
|
|
|
|
|
|
|
|
182,380 |
|
|
|
1,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
362,937 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
364,761 |
|
Exercise of stock options at $6.38 per share |
|
|
|
|
|
|
|
|
|
|
1,500 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,570 |
|
Exercise of stock options at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,400 |
|
Cancellation of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(80,062 |
) |
|
|
|
|
|
|
80,062 |
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,726 |
) |
|
|
|
|
|
|
(62,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1996 |
|
|
|
|
|
|
|
|
|
|
13,586,155 |
|
|
|
135,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,427,120 |
|
|
|
(50,611,169 |
) |
|
|
(3,853 |
) |
|
|
|
|
|
|
64,947,960 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,245,693 |
) |
|
|
|
|
|
|
|
|
|
|
(4,245,693 |
) |
Exercise of stock options at $0.20 per share |
|
|
|
|
|
|
|
|
|
|
263,285 |
|
|
|
2,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,658 |
|
Exercise of stock options at $2.00 per share |
|
|
|
|
|
|
|
|
|
|
232,935 |
|
|
|
2,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
463,540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
465,869 |
|
Exercise of stock options at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,400 |
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,569 |
|
|
|
|
|
|
|
2,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1997 |
|
|
|
|
|
|
|
|
|
|
14,092,375 |
|
|
|
140,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,011,985 |
|
|
|
(54,856,862 |
) |
|
|
(1,284 |
) |
|
|
|
|
|
|
61,294,763 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,883,378 |
) |
|
|
|
|
|
|
|
|
|
|
(5,883,378 |
) |
Exercise of stock options at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,700 |
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,284 |
|
|
|
|
|
|
|
1,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1998 |
|
|
|
|
|
|
|
|
|
|
14,097,375 |
|
|
|
140,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,047,635 |
|
|
|
(60,740,240 |
) |
|
|
|
|
|
|
|
|
|
|
55,448,369 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,416,333 |
) |
|
|
|
|
|
|
|
|
|
|
(7,416,333 |
) |
Non-cash compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,354 |
|
Exercise of stock options at $7.14 per share |
|
|
|
|
|
|
|
|
|
|
17,500 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,950 |
|
Exercise of stock warrants at $8.00 per share |
|
|
|
|
|
|
|
|
|
|
125,000 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
998,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 1999 |
|
|
|
|
|
|
|
|
|
|
14,239,875 |
|
|
|
142,399 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,185,514 |
|
|
|
(68,156,573 |
) |
|
|
|
|
|
|
|
|
|
|
49,171,340 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,167,070 |
) |
|
|
|
|
|
|
|
|
|
|
(9,167,070 |
) |
Non-cash compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,112 |
|
Exercise of stock options at $13.38 per share |
|
|
|
|
|
|
|
|
|
|
2,500 |
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,450 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2000 |
|
|
|
|
|
|
|
|
|
|
14,242,375 |
|
|
|
142,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,276,051 |
|
|
|
(77,323,643 |
) |
|
|
|
|
|
|
|
|
|
|
40,094,832 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,174,609 |
) |
|
|
|
|
|
|
|
|
|
|
(10,174,609 |
) |
Non-cash compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options at $6.38 per share |
|
|
|
|
|
|
|
|
|
|
6,000 |
|
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,280 |
|
Exercise of stock options at $10.81 per share |
|
|
|
|
|
|
|
|
|
|
17,500 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
189,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
189,175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2001 |
|
|
|
|
|
|
|
|
|
|
14,265,875 |
|
|
|
142,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,503,271 |
|
|
|
(87,498,252 |
) |
|
|
|
|
|
|
|
|
|
|
30,147,678 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,717,360 |
) |
|
|
|
|
|
|
|
|
|
|
(10,717,360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2002 |
|
|
|
|
|
|
|
|
|
|
14,265,875 |
|
|
|
142,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,503,271 |
|
|
|
(98,215,612 |
) |
|
|
|
|
|
|
|
|
|
|
19,430,318 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,250,145 |
) |
|
|
|
|
|
|
|
|
|
|
(12,250,145 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2003 |
|
|
|
|
|
|
|
|
|
|
14,265,875 |
|
|
|
142,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,503,271 |
|
|
|
(110,465,757 |
) |
|
|
|
|
|
|
|
|
|
|
7,180,173 |
|
Issuance of common stock at $5.60 per share on July 28, 2003 (net of costs of issuance of $909,229) |
|
|
|
|
|
|
|
|
|
|
1,892,857 |
|
|
|
18,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,671,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,690,771 |
|
Issuance of common stock to directors at $6.08 per share on October 30, 2003 |
|
|
|
|
|
|
|
|
|
|
12,335 |
|
|
|
123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000 |
|
Deferred compensation related to stock grants |
|
|
|
|
|
|
|
|
|
|
25,500 |
|
|
|
255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
190,995 |
|
|
|
|
|
|
|
(191,250 |
) |
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,630 |
|
|
|
|
|
|
|
35,630 |
|
Issuance of common stock at $5.80 per share on January 29, 2004
(net of costs of issuance of $1,126,104) |
|
|
|
|
|
|
|
|
|
|
2,585,965 |
|
|
|
25,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,846,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,872,493 |
|
Issuance of common stock at $5.80 per share on February 18, 2004
(net of costs of issuance of $116,423) |
|
|
|
|
|
|
|
|
|
|
237,008 |
|
|
|
2,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,255,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,258,223 |
|
Issuance of common stock at $5.80 per share on April 15, 2004 (net of costs of issuance of $192,242) |
|
|
|
|
|
|
|
|
|
|
409,483 |
|
|
|
4,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,178,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,182,759 |
|
Issuance of common stock at $12.00 per share on May 18, 2004 (net of costs of issuance of $1,716,831.36) |
|
|
|
|
|
|
|
|
|
|
1,954,416 |
|
|
|
19,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,716,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,736,160 |
|
Exercise of stock options at $6.38 per share |
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,700 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,573,798 |
) |
|
|
|
|
|
|
|
|
|
|
(14,573,798 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2004 |
|
|
|
|
|
|
|
|
|
|
21,398,439 |
|
|
|
213,984 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,534,302 |
|
|
|
(125,039,555 |
) |
|
|
(155,620 |
) |
|
|
|
|
|
|
41,553,111 |
|
Deferred compensation related to stock grants |
|
|
|
|
|
|
|
|
|
|
5,500 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,055 |
|
|
|
|
|
|
|
(71,110 |
) |
|
|
|
|
|
|
|
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122,121 |
|
|
|
|
|
|
|
122,121 |
|
Exercise of stock options between $5.08 and $14.17 per share |
|
|
|
|
|
|
|
|
|
|
167,875 |
|
|
|
1,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,739,585 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,741,264 |
|
Cost of shares in treasury, 1,717 shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,393 |
) |
|
|
(25,393 |
) |
Issuance of common stock to directors at $12.66 per share on
September 21, 2004 |
|
|
|
|
|
|
|
|
|
|
5,925 |
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74,941 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000 |
|
Issuance of common stock at $15.00 per share on February 9, 2005
(net of costs of issuance of $4,995,689) |
|
|
|
|
|
|
|
|
|
|
5,175,000 |
|
|
|
51,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,577,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,629,311 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,321,456 |
) |
|
|
|
|
|
|
|
|
|
|
(20,321,456 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2005 |
|
|
|
|
|
|
|
|
|
|
26,752,739 |
|
|
|
267,527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
240,997,444 |
|
|
|
(145,361,011 |
) |
|
|
(104,609 |
) |
|
|
(25,393 |
) |
|
|
95,773,958 |
|
Amortization of deferred compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,550 |
|
|
|
|
|
|
|
95,550 |
|
Exercise of stock options at $7.13 and $10.66 per share |
|
|
|
|
|
|
|
|
|
|
2,875 |
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,324 |
|
Issuance of common stock to directors at $13.05 per share on September 29, 2005 |
|
|
|
|
|
|
|
|
|
|
5,750 |
|
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000 |
|
Issuance of common stock to director at $13.21 per share on October 3, 2005 |
|
|
|
|
|
|
|
|
|
|
1,135 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
Issuance of common stock to director at $10.67 per share on February 24, 2006 |
|
|
|
|
|
|
|
|
|
|
1,406 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,986 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
Exercise of stock options at $10.66, $5.15 and $11.09 per share |
|
|
|
|
|
|
|
|
|
|
8,000 |
|
|
|
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,155 |
|
Exercise of stock options at $10.66 and $7.13 per share |
|
|
|
|
|
|
|
|
|
|
2,750 |
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,668 |
|
Exercise of stock options at $5.15 and $7.13 per share |
|
|
|
|
|
|
|
|
|
|
3,000 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,935 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,775,418 |
) |
|
|
|
|
|
|
|
|
|
|
(26,775,418 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at May 31, 2006 |
|
|
|
|
|
|
|
|
|
|
26,777,655 |
|
|
|
267,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
241,240,276 |
|
|
|
(172,136,429 |
) |
|
|
(9,059 |
) |
|
|
(25,393 |
) |
|
|
69,337,172 |
|
Eliminate remaining deferred compensation (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,059 |
|
|
|
|
|
|
|
9,059 |
|
Exercise of stock options at $5.15 and $7.13 per share (unaudited) |
|
|
|
|
|
|
|
|
|
|
2,750 |
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,133 |
|
Exercise of stock options at $7.13 per share (unaudited) |
|
|
|
|
|
|
|
|
|
|
750 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,355 |
|
Issuance of common stock to directors at $13.03 per share on September 20, 2006 (unaudited) |
|
|
|
|
|
|
|
|
|
|
6,912 |
|
|
|
69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
90,000 |
|
Exercise of stock options at $11.44 per share (unaudited) |
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,400 |
|
Exercise of stock options at $5.15, $11.92 and $13.21 per share (unaudited) |
|
|
|
|
|
|
|
|
|
|
3,125 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,677 |
|
Exercise of stock options at $5.08 and $6.08 per share (unaudited) |
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81,200 |
|
Share-based
compensation (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,702,444 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,702,444 |
|
Net loss (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,165,629 |
) |
|
|
|
|
|
|
|
|
|
|
(15,165,629 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 30, 2006 (unaudited) |
|
|
|
|
|
$ |
|
|
|
|
26,816,192 |
|
|
$ |
268,162 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
243,275,100 |
|
|
$ |
(187,302,058 |
) |
|
$ |
|
|
|
|
(25,393 |
) |
|
$ |
56,215,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements and accountants review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Cash Flows
Six months ended November 30, 2006 and November 30, 2005
and the cumulative period from June 19, 1985
(inception) through November 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
from |
|
|
|
|
|
|
|
|
|
|
|
June 19, 1985 |
|
|
|
Six months ended November 30, |
|
|
through |
|
|
|
2006 |
|
|
2005 |
|
|
November 30, 2006 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,165,629 |
) |
|
|
(12,049,837 |
) |
|
|
(187,302,058 |
) |
Adjustments to reconcile net loss to net
cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Marketable security amortization |
|
|
(696,573 |
) |
|
|
(971,514 |
) |
|
|
(2,994,776 |
) |
Depreciation and amortization |
|
|
245,815 |
|
|
|
123,043 |
|
|
|
19,190,586 |
|
Stock based compensation |
|
|
1,801,503 |
|
|
|
155,768 |
|
|
|
5,862,527 |
|
Loss of sale of equipment |
|
|
|
|
|
|
|
|
|
|
66,359 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
30,770 |
|
|
|
290,882 |
|
|
|
(991,545 |
) |
Other assets |
|
|
11,262 |
|
|
|
34,588 |
|
|
|
(1,878,589 |
) |
Accounts payable |
|
|
(840,227 |
) |
|
|
(899,519 |
) |
|
|
3,641,577 |
|
Accrued expenses |
|
|
(40,136 |
) |
|
|
(3,164 |
) |
|
|
93,870 |
|
Government grant liability |
|
|
(699,034 |
) |
|
|
|
|
|
|
227,458 |
|
Accrued compensation and benefits |
|
|
244,374 |
|
|
|
557,936 |
|
|
|
986,412 |
|
Other liabilities |
|
|
(243,559 |
) |
|
|
(14,806 |
) |
|
|
6,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(15,351,434 |
) |
|
|
(12,776,623 |
) |
|
|
(163,092,158 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property, plant, equipment, and
capitalized engineering costs |
|
|
(7,638,247 |
) |
|
|
(235,644 |
) |
|
|
(27,586,560 |
) |
Proceeds from sale of land and equipment |
|
|
|
|
|
|
|
|
|
|
1,863,023 |
|
Proceeds from matured marketable securities |
|
|
58,000,000 |
|
|
|
99,170,000 |
|
|
|
675,646,352 |
|
Proceeds from sale of marketable securities |
|
|
|
|
|
|
|
|
|
|
7,141,656 |
|
Purchase of marketable securities |
|
|
(44,417,129 |
) |
|
|
(49,357,247 |
) |
|
|
(700,591,736 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
5,944,624 |
|
|
|
49,577,109 |
|
|
|
(43,527,265 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
242,765 |
|
|
|
29,324 |
|
|
|
236,367,900 |
|
Payment of common stock issuance costs |
|
|
|
|
|
|
|
|
|
|
(14,128,531 |
) |
Proceeds from issuance of preferred stock |
|
|
|
|
|
|
|
|
|
|
6,644,953 |
|
Proceeds
from sale of stock options to purchase common shares |
|
|
|
|
|
|
|
|
|
|
7,443,118 |
|
Proceeds from issuance of notes payable |
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
Repayment of notes payable |
|
|
|
|
|
|
|
|
|
|
(140,968 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
242,765 |
|
|
|
29,324 |
|
|
|
237,686,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash |
|
|
(9,164,045 |
) |
|
|
36,829,810 |
|
|
|
31,067,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at beginning of period |
|
|
39,304,602 |
|
|
|
6,800,405 |
|
|
|
|
|
Restricted cash |
|
|
699,034 |
|
|
|
|
|
|
|
(227,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at end of period |
|
$ |
30,839,591 |
|
|
|
43,630,215 |
|
|
|
30,839,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Schedule of Noncash Financing Activities : |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock option, 5,000 shares in exchange for
1,717 treasury shares |
|
$ |
|
|
|
|
|
|
|
|
25,393 |
|
See accompanying notes to financial statements and accountants review report.
NORTHFIELD
LABORATORIES INC.
(a company in the development stage)
Notes to
Financial Statements
November 30, 2006
(unaudited)
(1) BASIS OF PRESENTATION
The interim financial statements presented are unaudited but, in the opinion of management,
have been prepared in conformity with accounting principles generally accepted in the United States
of America applied on a basis consistent with those of the annual financial statements. Such
interim financial statements reflect all adjustments (consisting of normal recurring accruals)
necessary for a fair presentation of the financial position, results of operations and cash flows
for the interim periods presented. The results of operations for the interim periods presented are
not necessarily indicative of the results to be expected for the full fiscal years. The interim
financial statements should be read in connection with the audited financial statements for the
year ended May 31, 2006.
(2) USE OF ESTIMATES
Our management has made a number of estimates and assumptions relating to the reporting of
assets and liabilities and the disclosure of contingent assets and liabilities to prepare these
financial statements in conformity with accounting principles generally accepted in the United
States of America. Actual results could differ from those estimates.
(3) COMPUTATION OF NET LOSS PER SHARE
Basic
earnings per share is based on the weighted average number of shares outstanding and
excludes the dilutive effect of unexercised common stock equivalents.
Diluted earnings per share is
based on the weighted average number of shares outstanding and
includes the dilutive effect of
unexercised common stock equivalents. Because we reported net losses for all periods presented,
basic and diluted per share amounts are the same. As of November 30, 2006, we have 1,599,483
options and 212,392 warrants that were excluded from the diluted net loss per share calculation because
their inclusion would have been anti-dilutive.
(4) SHARE-BASED COMPENSATION
The Companys Nonqualified Stock Option Plan for Outside Directors (Directors Plan) lapsed on
May 31, 2004. Following the termination of the plan, all options outstanding prior to plan
termination may be exercised in accordance with their terms. As of November 30, 2006 options to purchase a
total of 60,000 shares of the Companys common stock at prices between $4.09 and $13.38 per share
were outstanding under this plan. These options expire between 2008 and 2012, ten years after the date of grant.
With an effective date of October 1, 1996, the Company established the Northfield Laboratories
Inc. 1996 Stock Option Plan (the 1996 Option Plan). Following the
termination of the plan, all options outstanding prior to plan
termination may be exercised in accordance with their terms. This plan provides for the granting of stock
options to the Companys directors, officers, key employees, and consultants. Stock options to
purchase a total of 500,000 shares of common stock are available under the 1996 Option Plan. During
the quarters ended November 30, 2006 and 2005, the Company did not grant any options from this plan.
As of November 30, 2006, options to purchase a total of 274,500 shares of the Companys common
stock at prices between $9.56 and $15.41 were outstanding under this plan. These options expire between 2007 and
2008, ten years after the date of grant.
With an effective date of June 1, 1999, the Company established the Northfield Laboratories
Inc. 1999 Stock Option Plan (the 1999 Option Plan). This plan provides for the granting of stock
options to the Companys directors, officers, key employees, and consultants. Stock options to
purchase a total of 500,000 shares of common stock are available under the 1999 Option Plan. During
the quarters ended November 30, 2006 and November 30, 2005,
the Company did not grant any options from this plan to
purchase shares of common stock. As of November 30, 2006, options to purchase a total of 286,375
shares of the Companys common stock at prices between $3.62 and $14.17 per share were outstanding under this plan.
These options expire in 2013, ten years after the date of grant.
With an effective date of January 1, 2003, the Company established the New Employee Stock
Option
Plan (the New Employee Plan). This plan provides for the granting of stock options to the
Companys new employees. Stock options to purchase a total of 350,000 shares are available under
the New Employee Plan. During the quarter ended November 30,
2006, the Company granted no options
to purchase shares of common stock under this plan. During the quarter ended November 30, 2005, the
Company granted 5,000 options to purchase shares of common stock at a price of $12.70 per share. As
of November 30, 2006, options to purchase a total of 105,000 shares of the Companys common stock
at prices between $3.62 and $18.55 per share were outstanding under this plan. These options expire between 2014
and 2016, ten years after the date of grant.
With an effective date of September 17, 2003, the Company established and shareholders
approved the 2003 Equity Compensation Plan with 750,000 available share awards. This plan provides
for the granting of stock, stock options and various other types of equity compensation to the
Companys employees, non-employee directors and consultants. On September 29, 2005, the number of
available share awards was increased to 2,250,000 by shareholder approval. During the quarter ended
November 30, 2006, the Company granted 62,500 options to purchase shares of common stock at prices
between $13.03 and $14.68. During the quarter ended November 30, 2005, the Company granted 145,000
options to purchase shares of common stock at prices between $12.70 and $13.22. At November 30,
2006, options to purchase a total of 1,086,000 shares of the Companys common stock at prices
between $5.94 and $18.55 were outstanding under this plan. These options expire between 2014 and 2016, ten years
after the date of grant.
The service period for option plans is generally four years, with shares vesting at a rate of
25% each year.
Restricted stock awards are granted to key members of the Companys management team.
Restricted stock awards granted to employees, beginning with shares granted in 2003, vest 50% on
their first anniversary and in their entirety on the second anniversary of the award. At November
30, 2006, there were no shares of unvested restricted stock. All restricted stock vested in the
2nd quarter of 2007. No restricted shares were granted in the six months ended November
30, 2006, and 2,750 shares vested during the six months ended November 30, 2006. We measure the fair
value of restricted stock based upon the market price of the underlying common stock at the date of
grant. At November 30, 2006 and
November 30, 2005, the amount of related deferred compensation reflected in shareholders equity was
$0 and $38,839, respectively. The amortization of deferred
compensation for the three-month period ended
November 30, 2006 and November 30, 2005 was $94 and
$32,705, respectively. The
amortization of deferred compensation for the six-month period ended
November 30, 2006, and November 30, 2005, was $9,059 and
$155,700, respectively.
The Company issued shares from authorized but unissued common shares upon share option
exercises and restricted stock grants.
Effective June 1, 2006, we adopted Financial Accounting Standards Board (FASB) Statement No.
123 (revised), Share-Based Payment (SFAS 123R). Among its provisions, SFAS 123R requires us to
recognize compensation expense for equity awards over the vesting period based on their grant-date
fair value. Prior to the adoption of SFAS 123R, we utilized the intrinsic-value based method of
accounting under APB Opinion No. 25, Accounting for Stock Issued to Employees and related
interpretations, and adopted the disclosure requirements of SFAS No. 123, Accounting for
Stock-Based Compensation (SFAS 123). Under the intrinsic-value based method of accounting,
compensation expense for stock options granted to our employees was measured as the excess of the
fair value of the Companys common stock at the grant date over the amount the employee must pay
for the stock.
We adopted SFAS 123R in the first quarter of fiscal 2007 using the modified prospective
approach. Under this transition method, the measurement and our method of amortization of costs for
share-based payments granted prior to, but not vested as of
June 1, 2006, is based on the
same estimate of the grant-date fair value and the same amortization method that was previously
used in our SFAS 123 pro forma disclosure. Results for prior periods have not been restated as
provided for under the modified prospective approach. For equity awards granted after the date of
adoption, we will amortize share-based compensation expense on a straight-line basis over the
vesting term.
Compensation expense is recognized only for share-based payments expected to vest. We estimate
forfeitures at the date of grant based on our historical experience and future expectations. Prior
to the adoption of SFAS 123R, the effect of forfeitures on the pro forma expense amounts was
recognized based on actual forfeitures.
The Company does not recognize a tax benefit related to share based compensation due to the
historical net operating losses and related valuation allowance.
The effect of adopting SFAS 123R and the impact of the expense on basic earnings per share for
the three and six months ended November 30, 2006 was $.04 and
$.06, respectively, and the related charge
recognized in Statement of Operations in the three
and six months ended November 30, 2006 was $1.1 million
and $1.7 million, respectively.
The following table shows the effect on net income for three and six months ended November 30,
2005 had compensation expense been recognized based upon the estimated fair value on the grant date
of awards, in accordance with SFAS 123, as amended by SFAS
No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure.
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Six months |
|
|
|
Ended |
|
|
Ended |
|
|
|
November 30, 2005 |
|
|
November 30, 2005 |
|
Net loss as reported |
|
|
(6,269,111 |
) |
|
$ |
(12,049,837 |
) |
Add: Stock based compensation expense
included in statements of
operations |
|
|
122,705 |
|
|
|
155,770 |
|
|
|
|
|
|
|
|
|
|
Deduct: Total stock based compensation
expense determined under the fair
value method for all awards |
|
|
(1,144,955 |
) |
|
|
(1,642,070 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(7,291,361 |
) |
|
$ |
(13,536,137 |
) |
|
|
|
|
|
|
|
Basic and diluted earnings per share: |
|
|
|
|
|
|
|
|
As reported |
|
|
(.23 |
) |
|
|
(.45 |
) |
Pro forma |
|
|
(.27 |
) |
|
|
(.51 |
) |
|
|
|
|
|
|
|
As of November 30, 2006, there was approximately $5,047,556 of total unrecognized compensation
cost related to non-vested share-based compensation arrangements granted under the incentive plans.
That cost is expected to be recognized over a weighted-average period of 1.97 years.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes
option-pricing model. The table below outlines the weighted average assumptions for options granted
during the three and six months ended November 30, 2006 and November 30, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
November 30, |
|
November 30, |
|
November 30, |
|
November 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Fair value |
|
$ |
580,000 |
|
|
$ |
1,144,955 |
|
|
$ |
1,090,890 |
|
|
$ |
1,642,070 |
|
Expected volatility |
|
|
72.6 |
% |
|
|
73.5 |
% |
|
|
73.1 |
% |
|
|
71.6 |
% |
Risk-free interest rate |
|
|
5.0 |
% |
|
|
4.2 |
% |
|
|
5.0 |
% |
|
|
4.2 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected lives |
|
6.7 years |
|
7.0 years |
|
6.8 years |
|
7.2 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The expected term of the options represents the estimated period of time until exercise and is
based on historical experience of similar awards, giving consideration to the contractual terms,
vesting schedules and expectations of future employee behavior. Expected stock price volatility is
based on historical volatility of the Companys stock. The risk free interest rate is based on the
implied yield available on U.S. Treasury zero-coupon issues with equivalent remaining term.
On June 30, 2006, the Company issued 5,000 options to purchase shares of common stock to
one individual at a price of $9.65 per share. On July 6, 2006, the Company issued 33,000 options to
purchase shares of common stock to 22 individuals at a price of $10.94 per share. On July 21, 2006,
the Company issued 2,000 options to purchase share of common stock to one individual at a price of
$11.59 per share. On August 14, 2006, the Company issued 25,000 options to purchase shares of
common stock to one individual at a price of $10.87 per share. On September 20, 2006, the company
issued 60,000 options to purchase shares of common stock to six individuals at a price of $13.03
per share. On October 11, 2006, the Company issued 2,500 options to one individual at a price of
$14.68 per share. For all options other than the September 20, 2006 option grant, the Company will
expense the share-based compensation over the vesting period of the options, which is four years.
The options granted on September 20, 2006, vested immediately.
The weighted average grant-date fair value of options granted during the six months ended
November 30, 2006 and November 30, 2005 was $1,090,890 and
$1,642,070, respectively. The weighted
average grant date fair value of options granted during the three months ended November 30, 2006
and November 30, 2005 was $580,000 and $1,144,955, respectively.
The following table summarizes the Companys option activity during the six months ended
November 30, 2006:
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Range of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Exercise Prices |
|
|
Price |
|
|
Terms (years) |
|
|
Value |
|
Outstanding at May 31, 2006 |
|
|
1,747,375 |
|
|
$ |
3.62 $19.00 |
|
|
$ |
11.11 |
|
|
|
|
|
|
|
|
|
Granted at Fair Value |
|
|
65,000 |
|
|
$ |
9.65 $11.59 |
|
|
$ |
10.83 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
3,500 |
|
|
$ |
5.15 $ 7.13 |
|
|
$ |
6.43 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
16,000 |
|
|
$ |
5.15 $15.15 |
|
|
$ |
12.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at August 31, 2006 |
|
|
1,791,875 |
|
|
$ |
3.62 $19.00 |
|
|
$ |
11.10 |
|
|
|
6.06 |
|
|
$ |
2,797,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at August 31, 2006 |
|
|
533,500 |
|
|
$ |
3.62 $15.90 |
|
|
$ |
11.24 |
|
|
|
6.06 |
|
|
$ |
353,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted at Fair Value |
|
|
62,500 |
|
|
$ |
13.03 $14.68 |
|
|
$ |
13.10 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
28,125 |
|
|
$ |
5.08 $13.21 |
|
|
$ |
7.83 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
5,000 |
|
|
$ |
11.44 |
|
|
$ |
11.44 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
9,375 |
|
|
$ |
10.66 $22.02 |
|
|
$ |
17.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at November 30, 2006 |
|
|
1,811,875 |
|
|
$ |
3.62 $19.00 |
|
|
$ |
11.18 |
|
|
|
6.23 |
|
|
$ |
8,312,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at November 30, 2006 |
|
|
983,625 |
|
|
$ |
3.62 $15.90 |
|
|
$ |
9.54 |
|
|
|
6.23 |
|
|
$ |
5,663,189 |
|
The aggregate intrinsic value in the table above is before taxes and based on a weighted average
exercise price of $11.18 and $9.54, respectively. The total intrinsic value of options exercised
during the three months ended November 30, 2006 and November 30, 2005 was $195,541 and $0,
respectively. The total intrinsic value of options exercised during the six months ended November 30, 2006
and November 30, 2005 was $201,911 and $10,058, respectively. The total fair value of
options vested during the three months ended November 30, 2006 and November 30, 2005 was $1,108,658
and $1,022,250, respectively. The total fair value of options vested during the six months ended
November 30, 2006 and November 30, 2005 was $1,702,442 and $1,486,300, respectively.
(5) RECENTLY ISSUED ACCOUNTING STANDARD
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation
(FIN) 48, Accounting for Uncertainty in Income Taxes. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
FASB Statement of Financial Accounting Standards (SFAS) 109, Accounting for Income Taxes. This Interpretation
defines the minimum recognition threshold a tax position is required to meet before being
recognized in the financial statements. FIN 48 is effective for fiscal years beginning after
December 15, 2006. The Company is currently evaluating the effect that the adoption of FIN 48 will
have on its financial position and results of operations.
In November 2006, the U.S. Securities and Exchange Commission (SEC) issued SEC Staff
Accounting Bulletin (SAB) 108, Considering the Effects of Prior Year Misstatements in Current
Year Financial Statements. SAB 108 requires registrants to quantify misstatements using both the
balance sheet and income statement approaches and to evaluate whether either approach results in
quantifying an error that is material in light of the relevant quantitative and qualitative
factors. SAB 108 is effective for annual financial statements covering the first fiscal year ending
after November 15, 2006. The Company does not anticipate that the adoption of SAB
108 will have a material impact on its financial position and results of operations.
(6) RESTRICTED CASH
As of November 30, 2006, the Company had $227,458 in restricted cash from a government grant.
The funds are being used in accordance with the terms of the grant and all funds will be used
during the current fiscal year. The Company accounts for the lapse in cashs restriction when grant
expenditures are incurred. The Company recognizes the funds as a contra-expense or a reduction in
the asset carrying value based on the type of grant expenditure incurred.
(7) MARKETABLE SECURITIES
The Company, at November 30, 2006, is invested in high grade commercial paper. The Company has
the intent and ability to hold these securities until maturity and all securities have a maturity
of less than one year.
The fair market value of the Companys marketable securities was $20,788,486 at November 30,
2006, which included gross unrealized holding losses of $4,238. The fair market value of the
Companys marketable securities was $33,677,649 at May 31, 2006, which included gross unrealized
holding losses of $1,373. All of these marketable securities are scheduled to mature in less than
one year.
(8) PROPERTY, PLANT & EQUIPMENT
Property, plant and equipment are recorded at cost and are depreciated using the straight-line
method over the estimated useful lives of the respective assets. Leasehold improvements are
amortized using the straight-line method over the lesser of the life of the asset or the term of
the lease, generally five years.
On June 23, 2006, the Company purchased its previously leased manufacturing facility for
$6,731,000. With the purchase, the lease for the facility has been canceled, the asset retirement
obligation was terminated, and the lease deposit of $49,200 was refunded to the Company.
(9) LEGAL PROCEEDINGS
Between March 17, 2006 and May 15, 2006, ten separate complaints were filed, each purporting to be
on behalf of a class of the Companys shareholders, against the Company and Dr. Steven A. Gould,
the Companys Chief Executive Officer. Those putative class actions have been consolidated in a
case pending in the United States District Court for the Northern District of Illinois Eastern
Division. The Consolidated Amended Class Action Complaint was filed on September 8, 2006, and added
Richard DeWoskin, the Companys former Chief Executive Officer, as a defendant. That complaint
alleges, among other things, that during the period from March 19, 2001 through March 20, 2006, the
named defendants made or caused to be made a series of materially false or misleading statements
and omissions about the Companys elective surgery clinical trial and business prospects in
violation of Section 10(b) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5
promulgated thereunder and Section 20(a) of the Exchange Act. Plaintiffs allege that those
allegedly false and misleading statements and omissions caused the purported class to purchase the
Companys common stock at artificially inflated prices. As relief, the complaint seeks, among other
things, a declaration that the action be certified as a proper class action, unspecified
compensatory damages (including interest) and payment of costs and expenses (including fees for
legal counsel and experts). On November 20, 2006, Northfield, Dr. Steven A. Gould, and Richard
DeWoskin filed motions to dismiss the complaint, and on December 22, 2006, the plaintiffs filed a
response in opposition to those motions to dismiss. The briefing on the motions to dismiss
continues. The putative class action is at an early stage and it is not possible at this time to
predict the outcome of any of the matters or their potential effect, if any, on the Company or the
clinical development or future commercialization of PolyHeme. Given
the early stage of these proceedings, no amounts have been accrued
for the resolution of this matter. The Company intends to defend
vigorously against the allegations stated in the Consolidated Amended Class Action Complaint.
On March 13, 2006, the SEC notified the Company that it is conducting an informal inquiry, and
requested that the Company voluntarily provide the Securities and Exchange Commission, or SEC, with
certain categories of documents from 1998 to the present primarily relating to the Companys public
disclosures concerning the clinical development of PolyHeme. Since that time, the SEC has sent the
Company additional requests for documents and information, and has modified its initial requests.
The Company is cooperating with the SEC and has been providing the SEC with the requested documents
and information on a rolling basis.
On
March 17, 2006, the Company also received a letter from Senator Charles E. Grassley, Chairman of
the Senate Committee on Finance, requesting that the Company provide
certain categories of documents relating to the Phase III clinical
trauma trial as well as documents relating to correspondence with FDA. Since that time, the Company has produced
documents to the Committee, and the Committee has sought additional documents from the Company.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
RECENT DEVELOPMENTS
On
December 19, 2006 we reported preliminary top-line data from our pivotal Phase III trauma
trial assessing the efficacy and safety of PolyHeme. However, because of discrepancies in the
initial data, the database will be unlocked and corrected by the
Companys Contract Research Organization, or CRO, prior to finalizing the statistical
analyses.
The
study was conducted to seek an indication for the use of PolyHeme
that addresses a critical unmet medical need. This was an active
control dual superiority/non-inferiority trial, comparing the
survival of PolyHeme patients to those who receive standard
treatment, namely saltwater plus blood. The non-inferiority boundary
was based on the potential to provide a benefit in situations where a
transfusion of blood was indicated but not available.
The primary efficacy endpoint of the study is a dual superiority and non-inferiority test of
Day 30 mortality in the modified intent to treat, or MITT, population (those
who were randomized and received some treatment). In order to achieve the
superiority endpoint, the upper limit of the confidence interval, or
CI, surrounding the observed difference in mortality between the treatment and control groups needed to be less than zero; for
the non-inferiority endpoint, the upper limit of the CI needed to be
7% or less. Once again, the
non-inferiority boundary is based on the potential to provide a benefit in situations where
transfusion of blood is indicated but not available.
The preliminary results indicate that in the MITT population the upper limit of the CI exceeded the 7% threshold by
0.3%. However, in the pre-specified per protocol, or PP, population (those who both received the
correct treatment and did not otherwise violate the protocol), the upper limit of the CI was below
the threshold, at 5.8%.
The primary safety endpoints in the study were Day 1 mortality, Day 30 mortality, and durable
serious adverse events (SAEs). Durable serious adverse events were pre-defined as SAEs occurring
in any subject which results in a permanently disabling outcome. The statistical test for these
endpoints is inferiority to control.
With respect to Day 1 and Day 30 mortality in the MITT population, the preliminary analysis
reveals there was no statistically significant difference between the treatment and control groups.
There were 33 deaths (9.5%) in the PolyHeme group and 27 deaths (7.4%) in the control group on Day
1. The PP population was characterized by fewer deaths in the PolyHeme group (19 versus 21) and
identical mortality rates (6.8%). There were two durable SAEs in each group.
Once the preliminary study data have been verified and any discrepancies corrected, we will
issue a press release describing the final study data. It is possible that the final results may
differ from the preliminary results that we provided. In addition, we
expect that additional safety
data will be provided by our CRO with the final results. This
information will also be announced through a press release.
Based on the preliminary results, we will continue to move forward towards submission of a
Biologics License Application, or BLA, to FDA. We will review the
final data from our trial and submit those data to
FDA once we receive the complete analysis.
Since Northfields incorporation in 1985, we have devoted substantially all of our efforts and
resources to the research, development and clinical testing of PolyHeme. We have incurred operating
losses during each year of our operations since inception and expect to incur substantial
additional operating losses for the next several years. From Northfields inception through
November 30, 2006, we have incurred operating losses totaling $187,302,000.
We will be required to prepare and submit a BLA to FDA and obtain regulatory approval from FDA
before PolyHeme can be sold commercially. The FDA regulatory process is subject to significant
risks and uncertainties. We therefore cannot at this time reasonably estimate the timing of any
future revenues from the commercial sale of PolyHeme. The costs incurred by Northfield to date and
during each period presented below in connection with our development of PolyHeme are described in
the Statements of Operations in our financial statements.
Our success will depend on several factors, including our ability to obtain FDA regulatory
approval of PolyHeme and our manufacturing facilities, obtain sufficient quantities of blood to
manufacture PolyHeme in commercial quantities, manufacture and distribute PolyHeme in a
cost-effective manner, enforce our patent positions and raise sufficient capital to fund these
activities. We have experienced significant delays in the development and clinical testing of
PolyHeme. We cannot ensure that we will be able to achieve these goals or that we will be able to
realize product revenues or profitability on a sustained basis or at all.
We urge you to review the Risk Factors section in our most recent Annual Report on Form 10-K
filed with the Securities and Exchange Commission for a discussion of certain of these risks and
uncertainties.
RESULTS OF OPERATIONS
We reported no revenues for either of the three and six-month periods ended November 30, 2006
or 2005. From Northfields inception through November 30, 2006, we have reported total revenues of
$3,000,000, all of which were derived from licensing fees.
OPERATING EXPENSES
Operating expenses for our second fiscal quarter ended November 30, 2006 totaled $8,326,000,
an increase of $1,293,000 from the $7,033,000 reported in the second quarter of fiscal 2006.
Measured on a percentage basis, second quarter fiscal 2007 operating expenses exceeded second
quarter fiscal 2006 expenses by 18.4%. The increase is primarily driven by share based compensation
expense as we adopted SFAS 123R in the current fiscal year. See Share Based Compensation within
the notes to our unaudited financial statements included in this report. Also included in the
current quarter operating expenses was an increase in professional fees and incurred expenses
relating to our legal proceedings. See Legal Proceedings
within Part II, Item 1, included in
this report.
Research and development expenses during the second quarter of fiscal 2007 totaled $5,625,000,
and remained essentially level with the $5,573,000 reported in the second quarter of fiscal 2006. Included in
the current quarter research and development expenses was an increase in salaries and benefits
expense related to headcount increasing to 78 as of November 30, 2006 from 62 as of November 30,
2005. The increase in headcount is directly related to the reporting
of data from our trial to FDA, as well as our preparation for FDA
review of our planned manufacturing
facility. This increase was offset by a decrease in spending for outside clinical expenses
related to our Phase III trial as enrollment was completed in the first fiscal quarter of 2007.
We anticipate a continued high level of research and development spending for the remainder of
fiscal 2007. We reported preliminary top-line data of our pivotal
Phase III trial in December 2006 and continue the significant task of data assembly, analysis and reporting to
FDA. Preparing the Biologics License Application for PolyHeme will continue
through fiscal 2007. At the same time, we will continue to prepare for
FDAs review of our planned manufacturing facility. We expect to expand the use of external resources to
complete these tasks in a timely manner.
General and administrative expenses in the second quarter of fiscal 2007 totaled $2,701,000,
which is an increase of $1,241,000, or 85.0%, from the $1,460,000 of general and administrative
expenses reported in the second quarter of fiscal 2006. The increased expenses in the second
quarter of fiscal 2007
compared to the second quarter of fiscal year 2006 were primarily due to increased share based
compensation expense with the adoption of SFAS 123R in the first quarter of fiscal 2007. Also
included in the current fiscal quarter is an increase for professional service fees and expenses
related to our ongoing legal proceedings.
We anticipate significant general and administrative expense increases for the remainder of
fiscal 2007. Additional share based compensation expense, legal expenses as well as other
professional service costs, such as market research and corporate
communications, are expected.
For the six-month period ended November 30, 2006, operating expenses of $16,716,000 exceeded
the operating expenses of $13,516,000 incurred in the six-month period ended November 30, 2005. The
dollar increase was $3,200,000 and the percentage increase equaled 23.6%. The increases were
primarily driven by shared based compensation and legal expenses. In addition, we experienced
increases in salaries and benefits as we expanded our internal capabilities through increased
headcount.
Research and development expenses for the six-month period ended November 30, 2006 totaled
$11,451,000, which represents a $784,000, or 7.3%, increase from the
comparable expenses of $10,667,000 incurred
in the six-month period ended November 30, 2005. The increased expenses this fiscal year are share
based compensation and salaries and benefits.
General and administrative expenses for the six-month period ended November 30, 2006 totaled
$5,265,000, which is an increase of $2,776,000, or 97.4%, from the $2,849,000 of general and
administrative expenses reported for the six-month period ended November 30, 2005. The increased
expenses this fiscal year are share based compensation and professional fees related to legal
expenses.
INTEREST INCOME
Interest income for the three-month period ended November 30, 2006 totaled $723,000, a
decrease of $41,000 from the $764,000 in interest income reported in the three-month period ended
November 30, 2005. Although we had a significantly lower level of cash and marketable securities
available to invest during the current fiscal quarter, higher short-term interest rates offset most
of the negative impact.
Interest income for the six-month period ended November 30, 2006 totaled $1,550,000, an
increase of $84,000 from $1,466,000 in interest income reported in the six-month period ended
November 30, 2005. The decrease in cash balances was more than offset by the increase in
short-term interest rates. We continue to invest our funds only in high grade, short-term
instruments.
NET LOSS
Our net loss for the three-month period ended November 30, 2006 totaled $7,603,000, or $0.28
per share, compared to a net loss of $6,269,000, or $0.23 per share, for the three-month period
ended November 30, 2005. In dollar terms, the loss increased by
$1,334,000, or 21.2%, primarily as a
result of share based compensation expense as we adopted SFAS 123R in the current fiscal year.
Also included in the current fiscal quarter is an increase for professional service fees and
expenses related to our ongoing legal proceedings.
On a fiscal year to date basis, we reported a loss of $15,166,000, or $0.57 per share,
compared to a prior year six-month loss of $12,050,000, or $0.45 per share. The increased net loss
of $3,116,000, or 25.8%, was primarily the result of share based compensation, legal expenses and
salaries and benefits expense.
LIQUIDITY AND CAPITAL RESOURCES
From Northfields inception through November 30, 2006, we have used cash in operating
activities and for the purchase of property, plant, equipment and engineering services in the
amount of $190,679,000.
For the six months ended November 30, 2006 and 2005, these cash expenditures totaled
$22,990,000 and $13,012,000, respectively. The current fiscal year six-month increase in cash
utilization is due primarily to the Companys purchase of its previously leased manufacturing
facility for $6,731,000. Other contributing factors are our increased salaries and benefit expense
related to our expanded infrastructure, as well as professional fees and expense related to our
legal proceedings.
We have financed our research and development and other activities to date through the public
and private sale of equity securities and, to a more limited extent, through the license of product
rights. As of November 30, 2006, we had cash and marketable
securities totaling $51,633,000. As
previously reported, we have been successful in securing a $1.4 million federal appropriation as
part of the Defense Appropriation Bill in 2005 and a $3.5 million federal appropriation as part of
the Fiscal 2006 Defense Appropriation Bill. As of November 30, 2006, we have received $1,235,000 of
these funds.
We are currently utilizing our cash resources at a rate of approximately $28 million per year.
Based on our current estimates, we believe our existing capital resources would be sufficient
to permit us to conduct our operations, including the preparation and submission of a BLA to FDA,
for approximately 21 to 24 months. As of the date of this report, a decision to launch our planned
manufacturing facility construction project and expansion of our manufacturing, sales, marketing
and distribution capabilities, has been deferred until we have final data from our pivotal Phase
III trial and have submitted that data to FDA.
We may in the future issue additional equity or debt securities or enter into collaborative
arrangements with strategic partners, which could provide us with additional funds or absorb
expenses we would otherwise be required to pay. We are also pursuing potential sources of
additional government funding. Any one or a combination of these sources may be utilized to raise
additional capital. We believe our ability to raise additional capital or enter into a
collaborative arrangement with a strategic partner will depend primarily on the results of our
clinical trial, as well as general conditions in the business and financial markets.
Our capital requirements may vary materially from those now anticipated because of the timing
of final results of our clinical testing of PolyHeme, the establishment of relationships with
strategic partners, changes in the scale, timing or cost of our planned commercial manufacturing
facility, competitive and technological advances, the FDA regulatory process, changes in our
marketing and distribution strategy and other factors.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements requires management to make estimates and assumptions
that affect amounts reported therein. We believe the following critical accounting policy reflects
our more significant judgments and estimates used in the preparation of our financial statements.
NET DEFERRED TAX ASSETS VALUATION
We record our net deferred tax assets in the amount that we expect to realize based on
projected future taxable income. In assessing the appropriateness of our valuation, assumptions and
estimates are required, such as our ability to generate future taxable income. In the event we were
to determine that it was more likely than not we would be able to realize our deferred tax assets
in the future in excess of their carrying value, an adjustment to recognize the deferred tax assets
would increase income in the period such determination was made. As of November 30, 2006, we have
recorded a 100% valuation allowance against our net deferred tax assets.
CONTRACTUAL OBLIGATIONS
The following table reflects a summary of our contractual cash obligations as of November 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LESS THAN |
|
|
|
|
Contractual Obligations |
|
TOTAL |
|
|
ONE YEAR |
|
|
1-3 YEARS |
|
Lease Obligations (1) |
|
$ |
905,152 |
|
|
$ |
356,819 |
|
|
|
548,333 |
|
Other Obligations (2) |
|
$ |
1,230,000 |
|
|
$ |
1,230,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contractual Cash Obligation |
|
$ |
2,135,152 |
|
|
$ |
1,586,819 |
|
|
$ |
548,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The lease for our Evanston headquarters is cancelable with six months notice combined with
a termination payment equal to three months base rent at any time after February 14, 2009. If the
lease is cancelled as of February 15, 2009, unamortized broker commissions of $17,470 would also be
due. |
|
(2) |
|
Represents payments required to be made upon termination of employment agreements with two
of our executive officers. The employment contracts renew automatically unless terminated. Figures
shown represent compensation payable upon the termination of the employment agreements for reasons
other than death, disability, cause or voluntary termination of employment by the executive officer
other than for good reason. Additional payments may be required under the employment agreements in
connection with a termination of employment of the executive officers following a change in control
of Northfield. |
RECENT ACCOUNTING PRONOUNCEMENTS
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation
(FIN) 48, Accounting for Uncertainty in Income Taxes. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
FASB Statement of Financial Accounting Standards (SFAS) 109, Accounting for Income Taxes. This
Interpretation defines the minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. FIN 48 is effective for fiscal years beginning after
December 15, 2006. The Company is currently evaluating the effect that the adoption of FIN 48 will
have on its financial position and results of operations.
In November 2006, the U.S. Securities and Exchange Commission (SEC) issued SEC Staff
Accounting Bulletin (SAB) 108, Considering the Effects of Prior Year Misstatements in Current
Year Financial Statements. SAB 108 requires registrants to quantify misstatements using both the
balance sheet and income statement approaches and to evaluate whether either approach results in
quantifying an error that is material in light of the relevant quantitative and qualitative
factors. SAB 108 is effective for annual financial statements covering the first fiscal year ending
after November 15, 2006. The Company does not anticipate that the adoption of SAB
108 will have a material impact on its financial position and results of operations.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We currently do not have any foreign currency exchange risk. We invest our cash and cash
equivalents in government securities, certificates of deposit and money market funds. These
investments are subject to interest rate risk. However, due to the nature of our short-term
investments, we believe that
the financial market risk exposure is not material. A one percentage point decrease in the
interest rate received on our cash and marketable securities of
$51,633,000 at November 30, 2006
would decrease interest income by $516,330 on an annual basis.
ITEM 4. CONTROLS AND PROCEDURES.
Based on their evaluation as of the end of the period covered by this report, our Chief
Executive Officer and Vice President Finance have concluded that Northfields disclosure controls
and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934, are effective to ensure that information required to be disclosed by us in the reports that
we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the Securities and Exchange Commissions rules and forms.
There were no changes in our internal control over financial reporting that occurred during our
most recent fiscal quarter that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Part II
OTHER INFORMATION
Item 1. Legal Proceedings.
Between March 17, 2006 and May 15, 2006, ten separate complaints were filed, each purporting to be
on behalf of a class of the Companys shareholders, against the Company and Dr. Steven A. Gould,
the Companys Chief Executive Officer. Those putative class actions have been consolidated in a
case pending in the United States District Court for the Northern District of Illinois Eastern
Division. The Consolidated Amended Class Action Complaint was filed on September 8, 2006, and added
Richard DeWoskin, the Companys former Chief Executive Officer, as a defendant. That complaint
alleges, among other things, that during the period from March 19, 2001 through March 20, 2006, the
named defendants made or caused to be made a series of materially false or misleading statements
and omissions about the Companys elective surgery clinical trial and business prospects in
violation of Section 10(b) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5
promulgated thereunder and Section 20(a) of the Exchange Act. Plaintiffs allege that those
allegedly false and misleading statements and omissions caused the purported class to purchase the
Companys common stock at artificially inflated prices. As relief, the complaint seeks, among other
things, a declaration that the action be certified as a proper class action, unspecified
compensatory damages (including interest) and payment of costs and expenses (including fees for
legal counsel and experts). On November 20, 2006, Northfield, Dr. Steven A. Gould, and Richard
DeWoskin filed motions to dismiss the complaint, and on December 22, 2006, the plaintiffs filed a
response in opposition to those motions to dismiss. The briefing on the motions to dismiss
continues. The putative class action is at an early stage and it is not possible at this time to
predict the outcome of any of the matters or their potential effect, if any, on the Company or the
clinical development or future commercialization of PolyHeme. Given
the early stage of these proceedings, no amounts have been accrued
for the resolution of this matter. The Company intends to defend
vigorously against the allegations stated in the Consolidated Amended Class Action Complaint.
On March 13, 2006, the SEC notified the Company that it is conducting an informal inquiry, and
requested that the Company voluntarily provide the SEC with certain categories of documents from
1998 to the present primarily relating to the Companys public disclosures concerning the clinical
development of PolyHeme. Since that time, the SEC has sent the Company additional requests for
documents and information, and has modified its initial requests. The Company is cooperating with
the SEC and has been providing the SEC with the requested documents and information on a rolling
basis.
On
March 17, 2006, the Company also received a letter from Senator Charles E. Grassley, Chairman of
the Senate Committee on Finance, requesting that the Company provide
certain categories of documents relating to the Phase III clinical trauma trial as well as documents relating to correspondence with FDA. Since that time, the Company has produced
documents to the Committee, and the Committee has sought additional documents from the Company.
Item 1A. Risk Factors.
The following indicates changes to the risk factors previously disclosed in Northfields
Annual Report on Form 10-K for the fiscal year ended May 31, 2006:
We are required to receive FDA approval before we may sell PolyHeme commercially, data from our
clinical trials to date may not be adequate to obtain FDA approval, and we may be required to
conduct additional clinical trials in the future.
On December 19, 2006, we reported preliminary top-line data from our pivotal Phase III trauma
trial assessing the safety and efficacy of PolyHeme. The primary efficacy endpoint in the study is
a dual superiority and non-inferiority test of Day 30 mortality in the modified intent to treat, or
MITT, population. In order to achieve the superiority endpoint, the upper limit of the confidence
interval, or CI, surrounding the observed difference in mortality between the treatment and control
groups needed to be less than zero. For the noninferiority endpoint, the upper limit of the CI
needed to be 7% or less. The noninferiority boundary is based on the potential to provide a benefit
in situations where transfusion of blood is indicated but not available.
The preliminary results we received from our Contract Research Organization indicated that in
the primary MITT population (those who were randomized and received some treatment) the upper limit
of the CI exceeded the 7% threshold by 0.3%. In the pre-specified per protocol population (those
who both received the correct treatment and did not otherwise violate the protocol), the upper
limit of the CI was below the threshold, at 5.8%.
Because of discrepancies in the preliminary trial data we received, the database has been
unlocked and will be corrected by the Companys Contract Research Organization prior to finalizing
the statistical analyses. Once the preliminary study data have been verified and any discrepancies
corrected, we will issue a press release describing the final study data. It is possible that the
final results may differ from the preliminary results announced by Northfield. In addition, we
expect that additional safety data from our trial will be reported once it is provided to us by our
Contract Research Organization.
Based on our preliminary results, we will continue to move forward towards submission of a
Biologics License Application, or BLA, to FDA. The preparation of a BLA is a complex and
time-consuming process and there can be no assurance that we will be
able to submit our BLA in a timely manner. If the completion of our BLA takes longer than expected, FDA approval for the
commercial sale of PolyHeme may be substantially delayed.
Once we submit our BLA, there can be no assurance that the submission will be accepted for
filing or that FDA may not issue a refusal to file, or RTF, if it believes the filing is inadequate
or incomplete. FDA previously issued an RTF to us in 2001 when we submitted a BLA based on data
from our prior Phase II trauma trials. Northfield submitted an application for Fast Track for
PolyHeme in August. Fast Track does not apply to a product alone, but to a combination of the
product and a specific indication for use. Northfields pivotal Phase III trial is atypical in
that it has dual primary endpoints of superiority and non-inferiority. The breadth of the label
indication that Northfield intends to seek for PolyHeme will thus be dependent upon the outcome of
the pivotal trial. Therefore, Northfield and FDA agreed that the
decision would be deferred until
the endpoint, which will be the basis of the Fast Track designation, has been determined. We also plan to
seek priority review of our BLA filing. Even if FDA accepts our BLA filing, there can be no
assurance that FDA will grant PolyHeme Fast Track designation or will grant the BLA priority
review. There can also be no assurance that FDA will determine that the trial data included in our
BLA are sufficient to demonstrate that PolyHeme is safe or that we have achieved the clinical
endpoints for effectiveness that are part of the trial protocol for our pivotal Phase III trial.
FDA may accordingly refuse to approve PolyHeme for commercial sale or may require us to conduct
additional clinical trials of PolyHeme in order to obtain approval. Even if FDA approval for the
commercial sale of PolyHeme is obtained, it may include significant limitations on the indicated
uses for which PolyHeme may be marketed. FDA requires a separate approval for each proposed
indication for the use of PolyHeme in the United States. If we want to expand PolyHemes
indications, we will have to design additional clinical trials, submit the trial designs to FDA for
review and complete those trials successfully.
Our business, financial condition and results of operations are critically dependent on
receiving FDA approval of PolyHeme. A significant delay in achieving or failure to achieve FDA
approval for commercial sales of PolyHeme would have a material adverse effect on us and could
result in the cessation of our business.
Item 4. Submission of Matters to a Vote of Security Holders
Our annual meeting of stockholders was held on September 20, 2006 for the purpose of electing
directors and ratifying the appointment of KPMG LLP as our independent registered public accounting
firm. Proxies for the meeting were solicited pursuant to Section 14(a) of the Securities Exchange
Act of 1934 and there was not solicitation in opposition to managements solicitation. Each of the
nominees for director, as listed in the Companys proxy statement, was elected with the number
of votes set forth below.
|
|
|
|
|
|
|
|
|
Nominee |
|
For |
|
Withheld |
Steven A. Gould, M.D. |
|
|
23,994,437 |
|
|
|
1,029,596 |
|
John F. Bierbaum |
|
|
24,756,760 |
|
|
|
267,273 |
|
Bruce S. Chelberg |
|
|
23,543,084 |
|
|
|
1,480,949 |
|
Alan L. Heller |
|
|
24,771,074 |
|
|
|
252,959 |
|
Paul M. Ness, M.D. |
|
|
23,484,952 |
|
|
|
1,539,081 |
|
David A. Savner |
|
|
24,714,607 |
|
|
|
309,426 |
|
Edward C. Wood, Jr. |
|
|
24,756,986 |
|
|
|
258,047 |
|
The aforesaid nominees have been elected as Directors.
The results of other matters voted upon at the annual meeting are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proposal |
|
For |
|
Against |
|
Abstain |
The proposal to ratify the
appointment of KPMG LLP
as independent registered public accounting firm for the
Company to serve for the Companys
2007 fiscal year was approved. |
|
|
24,785,317 |
|
|
|
144,904 |
|
|
|
93,812 |
|
|
|
|
Exhibit 15
|
|
Letter regarding unaudited interim financial information |
|
|
|
Exhibit 31.1
|
|
Certification of Steven A. Gould, M.D., pursuant to Rule
13a-14(a) under the Securities Exchange Act of 1934 |
|
|
|
Exhibit 31.2
|
|
Certification of John J. Hinds, pursuant to Rule 13a-14(a)
under the Securities Exchange Act of 1934 |
|
|
|
Exhibit 32.1
|
|
Certification of Steven A. Gould, M.D., pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|
|
|
Exhibit 32.2
|
|
Certification of John J. Hinds, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Company in the capacities indicated on
January 9, 2007.
|
|
|
Signature |
|
Title |
/s/ Steven A. Gould, M.D.
Steven A. Gould, M.D. |
|
Chairman of the Board and Chief
Executive Officer |
/s/ John J. Hinds
John J. Hinds |
|
Vice President of Finance |