SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-QSB
x |
Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the quarterly period ended September 30,
2005.
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or
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|
o |
Transition report pursuant
to
Section 13 or 15(d) of the Securities Exchange Act of 1934 for
the transition period from __________ to
__________. |
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Commission
File Number 0-8092
OXIS
INTERNATIONAL, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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94-1620407
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(State
or other jurisdiction of
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(I.R.S.
Employer
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incorporation
or organization)
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Identification
No.)
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6040
N. Cutter Circle, Suite 317, Portland, Oregon
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97217
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(Address
of principal executive offices)
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(Zip
Code)
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(503)
283-3911
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(Registrant’s
telephone number, including area code)
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Indicate
by check mark whether the issuer (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 x No
o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
As
of
October 31, 2005, there were 42,538,397 of the registrant’s common stock
outstanding.
Transitional
Small Business Disclosure Format YES o
NO x
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(In
thousands of dollars)
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September
30, 2005 (unaudited)
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December
31, 2004
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ASSETS
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Current
assets:
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Cash
and cash equivalents
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$
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3,845
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$
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4,687
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Accounts
receivable, net of allowance of $5 and $7, respectively
|
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297
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|
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229
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Private
placement proceeds receivable
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—
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2,250
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Inventories
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289
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246
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Prepaid
expenses and other current assets
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119
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128
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Total
current assets
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4,550
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7,540
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Property,
plant and equipment, net
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68
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61
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Patents
and patents pending, net
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995
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875
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Deferred
acquisition costs
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88
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Total
assets
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$
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5,701
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$
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8,476
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|
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|
|
|
|
|
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The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS (continued)
(In
thousands of dollars)
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|
September
30, 2005 (unaudited)
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December
31, 2004
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LIABILITIES
AND SHAREHOLDERS’ EQUITY
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Current
liabilities:
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Notes
payable to shareholders
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$
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—
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$
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1,360
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Accounts
payable
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334
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491
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Accrued
liabilities
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154
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774
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Accrued
payroll
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51
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55
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Total
current liabilities
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539
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2,680
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Commitments
and contingencies
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—
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—
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Shareholders’
equity:
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Convertible
preferred stock - $0.01 par value; 15,000,000 shares
authorized:
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Series
B - 0 and 428,389 shares issued and outstanding (aggregate liquidation
preference of $1,000,000) at September 30, 2005 and December 31,
2004,
respectively
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—
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4
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Series
C - 96,230 shares issued and outstanding
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1
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1
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Common
stock - $0.001 par value; 95,000,000 shares authorized;
42,538,397 and
28,807,040 shares issued and outstanding at September 30, 2005 and
December 31, 2004, respectively, and 12,264,158 issuable at December
31,
2004
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42
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41
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Stock
options
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170
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162
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Warrants
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4,161
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4,161
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Additional
paid-in capital
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64,342
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64,114
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Accumulated
deficit
|
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(63,137
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)
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(62,270
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)
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Accumulated
other comprehensive loss
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(417
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)
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(417
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)
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Total
shareholders’ equity
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5,162
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5,796
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Total
liabilities and shareholders’ equity
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$
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5,701
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$
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8,476
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|
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The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In
thousands of dollars, except earnings per share data)
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Three
Months Ended
September
30,
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Nine
Months Ended
September
30,
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2005
(unaudited)
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2004
(unaudited)
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2005
(unaudited)
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2004
(unaudited)
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Product
revenues
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$
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532
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$
|
504
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$
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1,718
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$
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1,504
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License
revenues
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—
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450
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—
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450
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Total
revenue
|
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532
|
|
|
954
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1,718
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|
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1,954
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Cost
of product revenues
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333
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|
|
282
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906
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835
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Gross
profit
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199
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672
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812
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1,119
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Operating
expenses:
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Research
and development
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69
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43
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191
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200
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Selling,
general and administrative
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470
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469
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1,551
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1,459
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Foreign
legal proceedings
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—
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16
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|
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—
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183
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Restructuring
charges
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—
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|
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—
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|
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—
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605
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Total
operating expenses
|
|
|
539
|
|
|
528
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|
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1,742
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|
|
2,447
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating
income (loss)
|
|
|
(340
|
)
|
|
144
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|
|
(930
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)
|
|
(1,328
|
)
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|
|
|
|
|
|
|
|
|
|
|
|
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Other
income and expenses:
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|
|
|
|
|
|
|
|
|
|
|
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Other
income
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|
|
—
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|
|
—
|
|
|
—
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|
|
—
|
|
Interest
income
|
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22
|
|
|
1
|
|
|
74
|
|
|
1
|
|
Financing
fees
|
|
|
—
|
|
|
(164
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)
|
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—
|
|
|
(464
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)
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Other
|
|
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—
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|
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—
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|
|
—
|
|
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19
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|
Interest
expense
|
|
|
—
|
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(34
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)
|
|
(11
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)
|
|
(67
|
)
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Total
other income and expenses
|
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|
22
|
|
|
(197
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)
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63
|
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|
(511
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
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Loss
before income taxes
|
|
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(318
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)
|
|
(53
|
)
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|
(867
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)
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|
(1,839
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
taxes
|
|
|
—
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|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net
loss
|
|
|
(318
|
)
|
|
(53
|
)
|
|
(867
|
)
|
|
(1,839
|
)
|
Other
comprehensive income (loss)
Foreign
currency translation adjustment
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
|
(318
|
)
|
$
|
(51
|
)
|
$
|
(867
|
)
|
$
|
(1,871
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share - basic and diluted
|
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
$
|
(0.02
|
)
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares
used
in computation - basic and diluted
|
|
|
42,438,261
|
|
|
26,739,887
|
|
|
42,104,110
|
|
|
26,654,218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands of dollars)
|
|
Nine
Months Ended
|
|
|
|
September
30, 2005 (unaudited)
|
|
September
30, 2004 (unaudited)
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
Net
loss
|
|
$
|
(867
|
)
|
$
|
(1,839
|
)
|
Adjustments
to reconcile net loss to cash
used
for operating activities:
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
58
|
|
|
129
|
|
Common
stock and stock options issued for services
|
|
|
8
|
|
|
47
|
|
Accrued
interest paid by issuance of stock
|
|
|
83
|
|
|
|
|
Amortization
of deferred financing costs
|
|
|
—
|
|
|
464
|
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(68
|
)
|
|
(119
|
)
|
Inventories
|
|
|
(43
|
)
|
|
(59
|
)
|
Other
current assets
|
|
|
9
|
|
|
19
|
|
Accounts
payable
|
|
|
(157
|
)
|
|
(73
|
)
|
Accrued
liabilities and other
|
|
|
(615
|
)
|
|
339
|
|
Net
cash used for operating activities
|
|
|
(1,592
|
)
|
|
(1,092
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
Purchases
of equipment
|
|
|
(22
|
)
|
|
(24
|
)
|
Additions
to other assets
|
|
|
(171
|
)
|
|
(240
|
)
|
Net
cash provided by (used for) investing activities
|
|
|
(193
|
)
|
|
(264
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
Short-term
borrowings with warrants attached, net of
deferred
financing charges
|
|
|
—
|
|
|
486
|
|
Increase
(repayment) of short-term borrowings
|
|
|
(1,200
|
)
|
|
1,200
|
|
Proceeds
from issuance of stock and warrants attached, net
of
financing charges
|
|
|
1,948
|
|
|
—
|
|
Expenses
relating to business acquisitions
|
|
|
(88
|
)
|
|
—
|
|
Proceeds
from employee stock purchase
|
|
|
239
|
|
|
—
|
|
Proceeds
from exercise of stock options
|
|
|
44
|
|
|
80
|
|
Net
cash provided by financing activities
|
|
|
943
|
|
|
1,766
|
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash
|
|
|
—
|
|
|
4
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
(842
|
)
|
|
414
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - beginning of period
|
|
|
4,687
|
|
|
372
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - end of period
|
|
$
|
3,845
|
|
$
|
786
|
|
|
|
|
|
|
|
|
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS (continued)
(In
thousands of dollars)
|
|
Nine
Months Ended
|
|
|
|
September
30, 2005 (unaudited)
|
|
September
30, 2004 (unaudited))
|
|
Supplemental
cash flow disclosures:
|
|
|
|
|
|
Interest
paid
|
|
$
|
22
|
|
$
|
—
|
|
Income
taxes paid
|
|
$
|
—
|
|
$
|
—
|
|
Non-cash
investing and financing:
|
|
|
|
|
|
|
|
Issuance
of common stock for services
|
|
$
|
—
|
|
$
|
47
|
|
Debt
discount on convertible bridge loans
|
|
$
|
—
|
|
$
|
570
|
|
Common
stock issued for debt
|
|
$
|
160
|
|
$
|
—
|
|
Conversion
of preferred stock into common stock
|
|
$
|
783
|
|
$
|
—
|
|
Accrued
interest paid by issuance of common stock
|
|
$
|
83
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
The
foregoing unaudited interim financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-QSB and Regulation S-B as
promulgated by the Securities and Exchange Commission (“SEC”). Accordingly,
these financial statements do not include all of the disclosures required by
generally accepted accounting principles in the United States of America for
complete financial statements. These unaudited interim financial statements
should be read in conjunction with the audited financial statements and the
notes thereto included in Form 10-KSB/A for the period ended December 31, 2004.
In the opinion of management, the unaudited interim financial statements
furnished herein include all adjustments, all of which are of a normal recurring
nature, necessary for a fair statement of the results for the interim period
presented.
The
preparation of financial statements in accordance with generally accepted
accounting principles in the United States of America requires the use of
estimates and assumptions that affect the reported amounts of assets and
liabilities, disclosure of contingent assets and liabilities known to exist
as
of the date the financial statements are published, and the reported amounts
of
revenues and expenses during the reporting period. Uncertainties with respect
to
such estimates and assumptions are inherent in the preparation of the financial
statements of OXIS International, Inc. (“the Company”); accordingly, it is
possible that the actual results could differ from these estimates and
assumptions and could have a material effect on the reported amounts of the
Company’s financial position and results of operations.
Operating
results for the nine-month period ended September 30, 2005 are not necessarily
indicative of the results that may be expected for the year ending December
31,
2005.
2. |
LIMITED
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
This
summary of significant accounting policies of the Company is presented to assist
in understanding the Company’s financial statements. The financial statements
and notes are prepared and presented by the Company’s management, which is
responsible for their integrity and objectivity. These accounting policies
conform to accounting principles generally accepted in the United States of
America, and have been consistently applied in the preparation of the financial
statements.
Use
of Estimates
- The
process of preparing financial statements in conformity with accounting
principles generally accepted in the United States of America requires the
use
of estimates and assumptions regarding certain types of assets, liabilities,
revenues and expenses. Such estimates primarily relate to unsettled transactions
and events as of the date of the financial statements. Accordingly, upon
settlement, actual results may differ from estimated amounts.
Inventory
- The
Company maintains an inventory of raw materials, work in process and finished
goods. The inventory is valued based upon actual cost under the first-in
first-out method. As of September 30, 2005, the Company’s raw materials, work in
process and finished goods inventories totaled approximately $80,000, $64,000
and $145,000, respectively.
Basic
earnings (loss) per share is computed by dividing the net income (loss) by
the
weighted average number of shares outstanding during the period. The weighted
average number of shares is calculated by taking the number of shares
outstanding and weighting them by the amount of time that they were
outstanding.
Diluted
loss per share is computed by dividing the net loss by the weighted average
number of basic shares outstanding increased by the number of shares that would
be outstanding assuming the exercise of stock options to purchase 1,992,118
shares and the conversion of warrants to purchase 15,927,833 shares.
Utilizing the treasury stock method as of September 30, 2005, these possible
dilutive issuances would have resulted in approximately 809,000 common stock
equivalents being considered for additional dilution. In this case,
diluted net loss per share is the same as basic net loss per share as the
inclusion of the common stock equivalents would be anti-dilutive.
4. |
DEFERRED
ACQUISITION COSTS
|
In
September 2005, the Company entered into a Stock Purchase Agreement with
BioCheck, Inc. (“BioCheck”), a privately held California corporation, and the
stockholders of BioCheck pursuant to which the Company has agreed to purchase
up
to all of the outstanding shares of common stock of BioCheck for an aggregate
purchase price of $6 million in cash. Fees related to the Stock Purchase
Agreement have been deferred until the acquisition has been completed at which
time all related fees will be offset against additional paid in capital; in
the
event that the acquisition is not consummated all related costs will be offset
against expense.
5. |
STOCK
RELATED
TRANSACTIONS
|
During
the nine months ended September 30, 2005, 12,264,158 shares were issued that
were identified as issuable at December 31, 2004. In addition, 322,166 shares
of
common stock were issued to current and former employees upon the exercise
of
stock options; 600,000 shares of common stock were purchased by an employee
at
$0.40 per share, pursuant to the terms of an employment agreement; 459,355
shares of common stock were issued for cancellation of a note payable and
accrued interest and 85,678 shares of common stock were issued for the
conversion and cancellation of all of the outstanding shares of Series B
Preferred Stock.
6. |
STOCK-BASED
COMPENSATION
|
The
Company accounts for stock issued for compensation in accordance with Accounting
Principles Board Opinion 25 (“APB 25”), “Accounting for Stock Issued to
Employees.” Under this standard, compensation cost is the difference between the
exercise price of the option and fair market value of the underlying stock
on
the grant date.
Statement
of Financial Accounting Standards No. 123 (“SFAS 123”), “Accounting for
Stock-Based Compensation” encourages the use of the fair value based method of
accounting for stock-based employee compensation. Alternatively, SFAS No. 123
allows entities to continue to apply the intrinsic value method prescribed
by
APB 25, and related interpretations and provide pro forma disclosures
of
net income (loss) and earnings (loss) per share, as if the fair value based
method of accounting had been applied to employee awards. The Company follows
the fair valued based method for non-employee awards and has elected to continue
to apply the provisions of APB 25 and provide the disclosures required by SFAS
No. 123 and SFAS No. 148, “Accounting for Stock-Based Compensation - Transition
and Disclosure.” The following table illustrates the effect on net loss and loss
per share if the fair value based method had been applied to all awards:
|
|
Three
months ended
September
30,
|
|
|
|
|
|
|
|
Net
loss:
|
|
|
|
|
|
As
reported
|
|
$
|
(318,000
|
)
|
$
|
(53,000
|
)
|
Stock
based compensation determined
|
|
|
|
|
|
|
|
under
the fair value based method
|
|
|
(34,000
|
)
|
|
(331,000
|
)
|
Pro
forma
|
|
$
|
(352,000
|
)
|
$
|
(384,000
|
)
|
Net
loss per share - basic and diluted:
|
|
|
|
|
|
|
|
As
reported
|
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
Pro
forma
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
|
|
Nine
months ended September 30,
|
|
|
|
2005
|
|
|
|
Net
loss:
|
|
|
|
|
|
As
reported
|
|
$
|
(867,000
|
)
|
$
|
(1,839,000
|
)
|
Stock
based compensation determined
|
|
|
|
|
|
|
|
under
the fair value based method
|
|
|
(124,000
|
)
|
|
(455,000
|
)
|
Pro
forma
|
|
$
|
(991,000
|
)
|
$
|
(2,294,000
|
)
|
Net
loss per share - basic and diluted:
|
|
|
|
|
|
|
|
As
reported
|
|
$
|
(0.02
|
)
|
$
|
(0.07
|
)
|
Pro
forma
|
|
$
|
(0.02
|
)
|
$
|
(0.09
|
)
|
On
June 1, 2004, the Company secured a $1,200,000 loan from its then majority
shareholder, Axonyx Inc. (the “Axonyx Loan”). To evidence the Axonyx Loan, the
Company issued to Axonyx a one-year secured promissory note. The Axonyx Loan
accrued interest at 7% per annum, payable quarterly.
The
Company’s indebtedness under the promissory note was due and payable on May 31,
2005. However, under the terms of the promissory note, if the Company completed
an equity or convertible debt financing approved by Axonyx, which resulted
in
net proceeds to the Company of at least $2,000,000, the Company’s indebtedness
under the Axonyx Loan would become immediately due and payable.
In
December 2004, the Company raised net proceeds of approximately $6,100,000
in a
private placement of its common stock. In January 2005, per the terms of the
Axonyx Loan, the Company repaid to Axonyx the full amount of the loan plus
accrued interest.
As
of
September 30, 2005, the Company had net deferred tax assets of approximately
$12,550,000. Because of the Company’s history of operating losses, management
has provided a valuation allowance equal to its net deferred tax assets. For
the
periods ended September 30, 2005 and 2004, there were no reductions in this
valuation allowance.
9. |
COMMITMENTS
AND
CONTINGENCIES
|
Acquisitions
- In
September 2005 the Company entered into a Stock Purchase Agreement with BioCheck
and the stockholders of BioCheck pursuant to which the Company has agreed to
purchase up to all of the outstanding shares of common stock of BioCheck for
an
aggregate purchase price of $6 million in cash. Pursuant to the Stock Purchase
Agreement and subject to certain conditions, in an initial closing the Company
will purchase not less than fifty one percent of the outstanding shares of
common stock of BioCheck from each of the stockholders of BioCheck on a pro
rata
basis. This initial closing will occur only after certain preconditions are
met,
including the consummation of a financing transaction by the Company raising
sufficient capital to execute the initial closing.
If
the
Company does not purchase all of the outstanding shares of BioCheck in the
initial closing, the Company has agreed to use its reasonable best efforts
to
consummate a follow-on financing transaction to raise additional capital with
which to purchase the remaining outstanding shares of BioCheck in one or more
additional closings. The purchase price for any BioCheck shares purchased after
the initial closing will be increased by an additional 8% per annum from the
date of the initial closing through the date of such purchase. If the Company
has not purchased all of the outstanding shares of BioCheck within twelve months
of the initial closing, the EBITDA (earnings before interest, taxes,
depreciation and amortization expenses), if any, of BioCheck, at that point
a
majority owned subsidiary of the Company, could be used to repurchase the
remaining outstanding BioCheck shares at one or more additional
closings.
As
of
September 30, 2005, the initial closing of the acquisition of BioCheck has
not
occurred and none of the shares of BioCheck have been acquired.
The
acquisition of the outstanding shares of BioCheck, if and when it occurs, will
require that the Company undertake to merge its operations with those of
BioCheck. We may not be able to successfully integrate the BioCheck business
into our existing business in a timely and non-disruptive manner, or at all.
Further,
upon completion of the acquisition, we will
likely
(i) relocate
all core
operations of the Company to a facility in Northern California where
BioCheck is located and
close
the
Portland facility and (ii) terminate
Company
employees in connection with the integration of the work force for the two
companies. The costs related to this consolidation of operations could equal
or
exceed $350,000.
On
October 28, 2005, the Company entered into a Tenth Amendment to Lease with
Rosan, Inc., the landlord of its corporate office premises at 6040 N. Cutter
Circle, Suite 317, Portland, Oregon, pursuant to which the lease of the office
premises is extended for an additional three months. The lease term is now
extended from November 14, 2005 to February 14, 2006.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
The
statements contained in this Report on Form 10-QSB that are not purely
historical are forward-looking statements within the meaning of Section 27A
of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934, including, without limitation, statements regarding our expectations,
objectives, anticipations, plans, hopes, beliefs, intentions or strategies
regarding the future. Forward-looking statements include, without limitation,
statements regarding: (i) our expectation that, subject to certain conditions,
the Company will purchase not less than fifty one percent of the outstanding
shares of common stock of BioCheck from each of the stockholders of BioCheck
on
a pro rata basis in an initial closing to occur only after certain preconditions
are met, including the consummation of a financing transaction by the Company
raising sufficient capital to execute the initial closing; (ii) our
plan
that, if the Company does not purchase all of the outstanding shares of BioCheck
in the initial closing, the Company will use its reasonable best efforts to
consummate a follow-on financing transaction to raise additional capital with
which to purchase the remaining outstanding shares of BioCheck in one or more
additional closings; (iii) our expectation that, if the Company has
not
purchased all of the outstanding shares of BioCheck within twelve months of
the
initial closing, the EBITDA (earnings before interest, taxes, depreciation
and
amortization expenses), if any, of BioCheck, at that point a majority owned
subsidiary of the Company, will be used to repurchase the remaining outstanding
BioCheck shares at one or more additional closings; (iv) our intent
that,
upon completion of the BioCheck acquisition, we will likely relocate all core
operations of the Company to a facility in Northern California, close the
Portland facility and terminate Company employees in connection with the
integration of the work force for the two companies; (v) our expectation
that, if we do not consummate the BioCheck acquisition, we may reduce our
employee workforce, outsource certain Company functions and take other steps
intended to reduce costs and improve efficiencies; (vi) our intention to provide
a more effective diagnostic predictor test for patients at risk of cardiac
events, to submit the OXIS cardiac predictor test(s) for FDA diagnostic approval
and to commercialize the OXIS cardiac predictor test(s) during 2006; (vii)
our
plans to conduct collaborative research to design an oxidative stress paradigm
to diagnose the early onset of potentially fatal human and animal diseases;
(viii) our intention to attempt to develop diagnostic biomarkers that can
identify at an early stage the presence of a disease state, distinguish which
patients are most suited for a particular drug, and provide feedback to the
physician on how well the drug is working; (ix) our intention to pursue the
development of Ergothioneine as a nutraceutical supplement that can be sold
over
the counter; (x) our belief that the $6,500,000 in additional capital received
in the form of private placement of equity will allow us to continue operating
in accordance with our current plans for twelve months, and sustain our
development plans with respect to our cardiac predictor product, diagnostic
biomarkers and Ergothioneine as a nutraceutical supplement; (xi) our expectation
that our research and development expenses will increase significantly as we
attempt to develop potential products; (xii) our expectation that restructuring
charges will not be recurring expenses; and (xiii) our belief that we are in
reasonable compliance with best practices.
All
forward-looking statements included in this document are based on information
available to us on the date hereof, and we assume no obligation to update any
such forward-looking statements. It is important to note that our actual results
could differ materially from those included in such forward-looking statements.
Factors that could cause actual results to differ materially from the forward
looking statements include, but are not limited to, the following: (1) we may
not be able to obtain sufficient financing to undertake our acquisition of
the
outstanding shares of BioCheck on terms favorable to us, or at all; (2) we
may not be able to successfully integrate the BioCheck business into our
existing business in a timely and non-disruptive manner, or at all; (3) if
we do not complete our acquisition of BioCheck, we may implement a cost
reduction plan that could adversely affect our operations; (4) the cost
of
complying with the regulatory requirements related to being listed on a stock
exchange in France may exceed expectations; (5) Axonyx holds the voting power
to
influence matters affecting us, and such concentration of voting power could
have the effect of delaying, deterring or preventing a change of control; (6)
uncertainties exist relating to issuance, validity and ability to enforce and
protect patents, other intellectual property and certain proprietary
information; (7) the potential for patent-related litigation expenses and other
costs resulting from claims asserted against us or our customers by third
parties; (8) our products may not meet product performance specifications;
(9)
new products may be unable to compete successfully in either existing or new
markets; (10) availability and future costs of materials and other
operating expenses; (11) weakness in the global economy and changing
market
conditions, together with general economic conditions affecting our target
industries, could cause the our operating results to fluctuate; (12) the risks
involved in international sales; and (13) disclosure controls cannot prevent
all
error and all fraud. For a more detailed explanation of such risks, please
see
“Factors That May Affect Future Operating Results” below. Such risks, as well as
such other risks and uncertainties as are detailed in our SEC reports and
filings for a discussion of the factors that could cause actual results to
differ materially from the forward- looking statements. Given these
uncertainties, readers are cautioned not to place undue reliance on the
forward-looking statements.
The
following discussion should be read in conjunction with the audited consolidated
financial statements and the notes thereto and Management’s Discussion and
Analysis of Financial Condition and Results of Operations included in our Report
on Form 10-KSB/A, filed with the SEC on June 16, 2005 (SEC File
No. 000-08092).
General
OXIS
International, Inc. (“OXIS”) is a biopharmaceutical/nutraceutical company
engaged in the development of research assays, diagnostics, nutraceutical and
therapeutic products, which include new technologies applicable to conditions
and/or diseases associated with oxidative stress.
We
market
diagnostic assays and fine chemicals to research laboratories and other
customers. Our biopharmaceutical and nutraceutical discovery and research
efforts are focused on new drugs and compounds to treat diseases associated
with
tissue damage from free radicals and reactive oxygen species. We derive revenues
primarily from sales of research assays, as well as fine chemicals such as
Ergothioneine to researchers and the cosmetics industry. Our diagnostic products
include twenty-five assays designed to measure markers of oxidative stress.
Our
current plans include a new focus on the areas of clinical cardiac-predictor
testing, biomarker research and the nutraceutical marketplace. We are pursuing
the development of a cardiovascular predictor product intended to provide a
more
effective diagnostic predictor test for patients at risk of cardiac events
before they occur. We are developing this product through the combination of
our
Myeloperoxidase assay with other assays currently in-house (as well as with
other assays under development). Our current plan is to submit for United States
Food and Drug Administration (“FDA”) diagnostic approval and to commercialize
the OXIS cardiac predictor test(s) during 2006.
In
early
2005, we announced our plans to conduct collaborative research with selective
scientists and university laboratories to design an oxidative stress paradigm
to
diagnose the early onset of potentially fatal human and animal diseases. We
intend to attempt to develop diagnostic biomarkers that can identify at an
early
stage the presence of a disease state, distinguish which patients are most
suited for a particular drug, and provide feedback to the physician on how
well
the drug is working.
We
also
believe that our Ergothioneine compound may be well suited for development
as a
nutraceutical supplement that can be sold over the counter and we intend to
pursue the development of Ergothioneine for use in such markets.
On
September 28, 2004, we entered into an exclusive license and supply agreement
with HaptoGuard Inc. relating to our proprietary compound BXT-51072 and related
compounds. Under the agreement, HaptoGuard has exclusive worldwide rights,
with
respect to certain cardiovascular indications only, to develop, manufacture
and
market BXT-51072 and related compounds from our library of such antioxidant
compounds. Further, HaptoGuard is responsible for worldwide product development
programs with respect to licensed compounds. HaptoGuard paid us upfront license
fees aggregating $450,000. The agreement provides that HaptoGuard must pay
us
royalties, as well as additional fees for the achievement of development
milestones in excess of $21 million if all specified milestones are met and
regulatory approvals are granted. However, there can be no assurances that
royalty payments will result or that milestone payments will be
realized.
Due
to
the lack of financial resources, we ceased further testing of BXT-51072 but
continue to review the possibility of further developing applications for
BXT-51072 and related compounds outside of the areas defined in the
license.
Our
actual research and development and related activities may vary significantly
from current plans depending on numerous factors, including changes in the
costs
of such activities from current estimates, currency fluctuations, the results
of
our research and development programs, the timing of regulatory submissions,
technological advances, determinations as to commercial viability and the status
of competitive products. The focus and direction of our operations will also
be
dependent on the establishment of collaborative arrangements with other
companies, the availability of financing and other factors.
Throughout
the first ten weeks of 2004, Axonyx Inc. acquired approximately 52.4% of our
outstanding voting stock. Axonyx’s holdings subsequently were diluted to
approximately 34% following a private placement of equity at December 30, 2004
(which closed on January 6, 2005).
Recent
Activities
During
the first quarter of 2005 we engaged Steven T. Guillen as our Chief Executive
Officer, and are currently seeking suitable candidates for the vacant position
of Chief Financial Officer and other key management positions.
On
September 19, 2005, we entered into a Common Stock Purchase with BioCheck,
a
leading producer of enzyme immunoassay research kits, pursuant to which we
agreed to acquire
up to
all of
the
outstanding capital stock of privately held BioCheck for
an
aggregate purchase price of up to $6 million in cash. Subject to the
satisfaction of certain conditions, at the initial closing of the transaction,
we agreed to purchase not less than 51% of the outstanding BioCheck shares
of
capital stock. The closing is subject to several contingencies, including our
consummation of a financing transaction that will provide us the capital needed
to purchase the BioCheck shares. The
acquisition could result in the use of significant amounts of cash, dilutive
issuances of equity securities, or the incurrence of debt or amortization
expenses related to goodwill and other intangible assets, any of which could
materially adversely affect our business, operating results and financial
condition.
If
we do
not purchase all of the outstanding shares of BioCheck in the initial closing,
we have agreed to use our reasonable best efforts to consummate a follow-on
financing transaction to raise additional capital with which to purchase the
remaining outstanding shares of BioCheck in one or more additional closings.
The
purchase price for any BioCheck shares purchased after the initial closing
will
be increased by an additional 8% per annum from the date of the initial closing
through the date of such purchase. If we have not purchased all of the
outstanding shares of BioCheck within twelve months of the initial closing,
the
EBITDA (earnings before interest, taxes, depreciation and amortization
expenses), if any, of BioCheck, at that point a majority owned subsidiary of
OXIS, will be used to repurchase the remaining outstanding BioCheck shares
at
one or more additional closings.
The
acquisition of the outstanding shares of BioCheck, if and when it occurs, will
require that we undertake to merge our operations with those of BioCheck. We
may
not be able to successfully integrate the BioCheck business into our existing
business in a timely and non-disruptive manner, or at all. Further, upon
completion of the acquisition, we will
likely
(i) relocate
all core
operations of the Company to a facility in Northern California and close
the
Portland facility and (ii) terminate
Company
employees in connection with the integration of the work force for the two
companies. The costs related to this consolidation of operations could equal
or
exceed $350,000.
Critical
Accounting Policies
Management’s
discussion and analysis of our financial condition and results of operations
are
based on our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States.
The preparation of these consolidated financial statements requires management
to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent assets
and liabilities. A limited summary of our critical accounting policies are
described in Note 2 of the OXIS consolidated financial statements. This summary
of our critical accounting policies is presented to assist in understanding
our
financial statements. All accounting estimates may change because of internal
and external factors and when adjustments are adopted. Most of our estimates
are
based upon historically known data and have remained stable over time. Certain
estimates are subject to market place conditions, and are discussed
below.
On
an
ongoing basis, management evaluates its estimates, including those related
to
impairment of long-lived assets, including finite lived intangible assets,
accrued liabilities and certain expenses. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. The results of such estimates and assumptions form
the
basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results may differ
materially from these estimates under different assumptions or conditions.
We
believe the following critical accounting estimates and policies, among others,
involve the more significant judgments and estimates used in the preparation
of
our financial statements.
Intellectual
Property License Fees - We
recognize license fee revenue for our licenses of intellectual property when
earned under the terms of the agreements. Generally, revenue is recognized
upon
transfer of the license unless we have continuing obligations for which fair
value cannot be established, in which case the revenue is recognized over the
period of the obligation.
Inventories
- Inventories
are stated at the lower of cost to purchase and/or manufacture the inventory
or
the current estimated market value of the inventory. We regularly review our
inventory quantities on hand and record a provision for excess and obsolete
inventory based primarily on our estimated forecast of product demand and/or
our
ability to sell the products and production requirements. Demand for our
products can fluctuate significantly. Factors which could affect demand for
our
products include unanticipated changes in consumer preferences, general market
conditions or other factors, which may result in cancellations of advance orders
or a reduction in the rate of reorders placed by customers and/or continued
weakening of economic conditions. Additionally, our estimates of future product
demand may be inaccurate, which could result in an understated or overstated
provision required for excess and obsolete inventory. Our estimates are based
upon our understanding of historical relationships which can change at
anytime.
Product
sales - We
manufacture, or have manufactured on a contract basis, products that are sold
to
customers. We recognize revenue from sales when there is persuasive evidence
that an arrangement exists, services have been rendered, the price is
determinable, and collectibility is reasonably assured. Our mix of product
sales
is substantially at risk to market conditions and demand, which may change
at
any time.
Patents
and trademarks -
Our
patents and trademarks are stated at cost. The recoverability of patents and
trademarks is reevaluated each year based upon management’s expectations
relating to the life of the technology and current competitive market
conditions. As of December 31, 2004 and 2003, we have recorded $77,000 and
$65,000 in amortization expense, respectively, related to our patents, patents
pending and trademarks. We are amortizing these costs over the life of the
respective patents or trademarks.
Inflation
- We
do not
believe that inflation had a significant impact on our results of operations
for
the periods presented.
RESULTS
OF OPERATIONS - THREE MONTHS ENDED SEPTEMBER 30, 2005
COMPARED
WITH THREE MONTHS ENDED SEPTEMBER 30, 2004
Revenues
Our
revenues for the quarters ended September 30, 2005 and 2004 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
assays and fine chemicals
|
|
$
|
532,000
|
|
$
|
504,000
|
|
License
revenue
|
|
|
—
|
|
|
450,000
|
|
|
|
$
|
532,000
|
|
$
|
954,000
|
|
|
|
|
|
|
|
|
|
Total
revenues for the three-month period ended September 30, 2005 were $532,000,
compared to $954,000 for the same period in 2004, a decrease of $422,000 or
approximately 44%. This decrease was due to the $450,000 in license revenue
we
received pursuant to an exclusive license agreement we entered into in the
third
quarter of 2004 that did not recur during the third quarter of 2005. There
can
be no assurances that future milestone events and payments will be realized
under the exclusive license agreement or that we will be able to enter into
additional future license agreements.
Revenues
from sales of research assays and fine chemicals for the three-month period
ended September 30, 2005 were $532,000, compared to $504,000 for the same period
in 2004, an increased of $28,000, or approximately 6%. This increase was
primarily comprised of an increase in sales volumes to U.S. and foreign
distributors.
Costs
and Expenses
Cost
of
revenue as a percentage of product revenue for the third quarter of 2004 was
56%, and increased to 63% for the third quarter of 2005. This increase in costs
of 7% is due primarily to increased labor costs along with a higher percentage
of product sales being from products with lower margins from a year
ago.
Gross
profit related to product revenues for the third quarter of 2004 was $222,000,
or 44% of product revenue, compared to the second quarter of 2005 of $199,000,
or 37% of revenue. The decrease in gross profit is primarily due to increased
sales of low margin products resulting in higher direct material and labor
costs.
Research
and development expenses increased from $43,000 in 2004, to $69,000 in 2005.
Research and development expense is expected to increase significantly over
the
next twelve months
due to the cost of developing the cardiac predictor program.
Selling,
general and administrative expenses increased by $1,000 from $469,000 in the
second quarter of 2004 to $470,000 during the second quarter of 2005. There
can
be no assurance that future expenses will remain at this consistent
level.
Foreign
legal proceedings during the third quarter of 2004 were related to French
securities laws and the securities regulations of the Autorité des Marchés
Financiers (the “AMF”), the French regulatory agency overseeing the Nouveau
Marché, an exchange on which our shares are listed. Costs
associated with the AMF proceedings included legal expenses of $40,000 and
fines
imposed by the AMF of $62,000. As
of
December 31, 2004, OXIS recorded approximately $183,000 related to the
defense and settlement of the investigation, including foreign legal expenses
of
$121,000 and fines imposed by the AMF of $62,000. In a related legal proceeding
before French judicial authorities, we incurred additional legal expenses and
paid an additional approximately $11,600 in settlement of any obligation to
pay
fines. Although we are not, as of the date of this Report, aware of any pending
AMF allegations, in the event the AMF makes additional allegations against
us or
in the event that we are required to answer additional charges in French legal
proceedings, we may incur further substantial costs and fines.
Financing
Fees
In
connection with the closing of a $570,000 convertible bridge loan financing
in
January 2004, $164,000 was charged for the amortization of the debt discount
on
the convertible bridge loan during the third quarter of 2004.
Net
Loss
We
continued to experience losses in the third quarter of 2005. The third quarter
2005 net loss of $318,000 ($0.01 per share-basic and diluted) was $265,000
more
than the $53,000 ($0.00 per share-basic and diluted) net loss for the third
quarter of 2004. The increase in the net loss is primarily due to the $450,000
licensing revenue during 2004 that did not reoccur during 2005. Without this
licensing revenue, the third quarter 2004 loss would have been $503,000. The
decrease in net loss based on the adjusted 2004 loss would have been $185,000,
primarily due to decreased foreign legal proceedings and financing activities
in
2005.
Our
losses
and expenses may increase and fluctuate from quarter to quarter as we expand
our
development activities. There can be no assurance that we will achieve
profitable operations.
RESULTS
OF OPERATIONS - NINE MONTHS ENDED SEPTEMBER 30, 2005
COMPARED
WITH NINE MONTHS ENDED SEPTEMBER 30, 2004
Revenues
Our
revenues for the nine-month periods ended September 30, 2005 and 2004 were
as
follows:
|
|
2005
|
|
2004
|
|
|
|
|
|
|
|
|
|
Research
assays and fine chemicals
|
|
$
|
1,718,000
|
|
$
|
1,504,000
|
|
License
revenues
|
|
|
—
|
|
|
450,000
|
|
|
|
$
|
1,718,000
|
|
$
|
1,954,000
|
|
|
|
|
|
|
|
|
|
Total
revenues for the nine-month period ended September 30, 2005 were $1,718,000,
compared to $1,954,000 for the same period in 2004, a decrease of $236,000
or
12%. This overall decrease was due to the $450,000 in license revenue that
we
received in the third quarter of 2004 pursuant to an exclusive license
agreement. There can be no assurances that future milestone events and payments
will be realized under the exclusive license agreement or that we will be able
to enter into additional future license agreements.
Revenues
from product sales for the first nine months of 2005 were $1,718,000, an
increase of $214,000 (or approximately 14%) compared to our $1,504,000 in
revenue for the first nine months of 2004. This increase was comprised of a
$138,000 increase in sales to U.S. distributors, and a $76,000 increase in
sales
to other customers. Further, the $214,000
increase in sales included approximately $19,000 (or 9%) attributed to price
increases over the previous year’s first nine months and $195,000 (or 91%)
attributed to increased sales volumes.
Costs
and Expenses
Cost
of
product revenue as a percentage of revenue for the first nine months of 2004
was
56%, and decreased to 53% for the first nine months of 2005. This decrease
in
costs of 3% is due primarily to the increase in sales during the first nine
months of 2005 over the same period of 2004 without a corresponding increase
in
costs. Our manufacturing capacity was not fully utilized during the first nine
months of 2004. During the same period of 2005, we more fully utilized our
manufacturing capacity (generating additional revenue in doing so) without
incurring significant additional costs, except for the direct cost of materials.
Gross
profit for the first nine months of 2005 was $812,000, or 47% of product
revenue, as compared to $669,000, or 44% of product revenue, in the first nine
months of 2004. The increase in gross profit is primarily due to the increase
in
sales between the first nine months of 2004 and the first nine months of 2005
without a corresponding increase in costs. We had available manufacturing
capacity that we utilized in 2005 without significantly increasing costs, except
for direct material costs.
Research
and development expenses decreased slightly from $200,000 during the first
nine
months of 2004, to $191,000 during the first nine months of 2005. Research
and
development expenses are expected to increase significantly over the next twelve
months due to the cost of developing the cardiac predictor program.
Selling,
general and administrative expenses were $1,551,000 during the first nine months
of 2005, compared to $1,459,000 in the first half of 2004, an increase of
$92,000. This increase is primarily due to increased legal ($100,000),
consulting ($144,000) and marketing expenses ($46,000), partially offset by
a
reduction of expenditures for the cardiac program ($68,000) and the cancellation
of the animal health profiling program ($141,000).
Foreign
legal proceedings during the first nine months of 2004 of $183,000 are related
to the AMF proceedings including legal expenses of $121,000 and fines
imposed by the AMF of $62,000. In a related legal proceeding before French
judicial authorities, we incurred additional legal expenses and paid an
additional approximately $11,600 in settlement of any obligation to pay fines.
Although we are not, as of the date of this Report, aware of any pending AMF
allegations, in the event the AMF would make additional allegations against
us
or in the event that we would be required to answer additional charges in French
legal proceedings, we may incur further substantial costs and
fines.
Restructuring
charges during the first nine months of 2004 of $605,000 were related to the
Axonyx change of control, including legal ($196,000), management consulting
($34,000), travel ($8,000), executive search ($22,000) and severance ($345,000)
expenses which are not expected to be recurring expenses.
Financing
Fees
We
paid
finders’ fees and professional fees of approximately $85,000 in connection with
the closing of a $570,000 convertible bridge loan financing on January 14,
2004.
These fees were amortized over the life of the loan. Total amortization of
the
debt discount on the convertible bridge loans and the related fees were
approximately $464,000 for the nine months ended September 30, 2004 and were
amortized through the end of 2004.
Net
Loss
We
experienced a loss in the first nine months of 2005 of $867,000 ($0.02 per
share-basic and diluted) which was $972,000 less than the $1,839,000 ($0.07
per
share-basic and diluted) net loss for the first nine months of 2004. The
decrease in the net loss is primarily due to reduced costs relating to foreign
legal proceedings and restructuring costs of $788,000 and reduced financing
fees
of $464,000, partially offset by a decrease in gross profit of $307,000 and
increased selling, general and administrative costs.
Our
losses and expenses may increase and fluctuate from quarter to quarter as we
expand our development activities. There can be no assurance that we will
achieve profitable operations.
FINANCIAL
CONDITION, LIQUIDITY AND CAPITAL RESOURCES
Our
working capital decreased during the first nine months of 2005 by $849,000,
from
$4,860,000 at December 31, 2004, to $4,011,000 at September 30, 2005. The
decrease in working capital resulted primarily from the net loss of $549,000
adjusted for depreciation and amortization of $38,000, and an investment in
equipment and patent expenses in an aggregate amount of $137,000.
Cash
and
cash equivalents decreased from $4,687,000 at December 31, 2004, to $3,845,000
at September 30, 2005. This decrease of $842,000 is primarily the result of
the
repayment of short-term notes and interest payable ($1,222,000), cash used
for
operations ($1,592,000) and investments in equipment and patents expenses in
an
aggregate amount of $193,000, partially offset by the receipt of $2,250,000
in
receipt of proceeds in January 2005 from the closing of the 2004 year-end
private placement.
On
January 6, 2005 we closed a private placement in which we received aggregate
gross proceeds of $6,500,000. These funds have been allocated to fund our
operations, including our research and development plans. We believe that these
funds will allow us to continue operating in accordance with our current plans
for at least the next twelve months. However, we will need up to $6 million
through debt or equity financing in order to complete our acquisition of
BioCheck pursuant to our Stock Purchase Agreement dated September 19, 2005.
The
acquisition of the outstanding shares of BioCheck, if and when it occurs, will
require that we undertake to merge our operations with those of BioCheck. This
is likely to include consolidation of our respective staffs, our manufacturing
facilities, marketing and sales, as well as our research and development
activities. At this point the overall net costs of undertaking the merger of
operations with BioCheck is uncertain and consequently the impact on the capital
resources of the combined company is difficult to determine. Further, if we
determine to engage in further development and commercialization programs with
respect to our antioxidant therapeutic technologies, oxidative stress assays,
or
other currently unidentified opportunities, or acquire additional technologies
or businesses, additional capital may be required.
We
have
incurred losses in each of the last six years. As of September 30, 2005, OXIS
has an accumulated deficit of $63,137,000. We expect to incur operating losses
for the foreseeable future. Although we have sufficient cash to fulfill our
2005
operating plans, we will need to raise additional capital to complete our
contemplated product development programs and the acquisition of BioCheck.
No
assurances can be given that we will be able to raise such capital on terms
favorable to us or at all. The unavailability of additional capital could cause
us to abandon the acquisition of BioCheck, cease or curtail our operations
and/or delay or prevent the development and marketing of our existing and
potential products.
FACTORS
THAT MAY AFFECT FUTURE OPERATING RESULTS
OXIS
operates in a rapidly changing environment that involves a number of risks,
some
of which are beyond its control. The following discussion highlights some of
these risks and others are discussed elsewhere in this report or in our Annual
Report on Form 10-KSB/A for the period ended December 31,
2004.
Risks
Related to Our Business
We
operate in a rapidly changing environment that involves a number of risks,
some
of which are beyond our control. The following discussion highlights some of
these risks and others are discussed elsewhere in this Report.
We
will need to raise additional capital in order to complete our acquisition
of
the outstanding shares of BioCheck, Inc.
On
September 19, 2005 we entered into a Stock Purchase Agreement with BioCheck,
Inc. (“BioCheck”) and the stockholders of BioCheck pursuant to which OXIS
undertakes to purchase up to all of the outstanding shares of common stock
of
BioCheck for an aggregate purchase price of $6 million in cash.
The
acquisition of BioCheck will occur only after certain preconditions are met,
including our consummation of a financing transaction. The successful
acquisition of BioCheck is dependent upon obtaining financing on acceptable
terms. No assurances can be given that we will be able to complete such a
financing sufficient to undertake our acquisition of the outstanding shares
of
BioCheck on terms favorable to us, or at all. Any financing that we do undertake
to finance the acquisition of BioCheck will likely involve dilution of our
common stock if it is an equity financing or will involve the assumption of
significant debt by OXIS.
We
will need additional financing in order to complete our development and
commercialization programs.
As
of
September 30, 2005, we had an accumulated deficit of approximately $63,137,000.
We currently do not have sufficient capital resources to complete the
development and commercialization of our antioxidant therapeutic technologies
and oxidative stress assays, and no assurances can be given that we will be
able
to raise such capital in the future on terms favorable to us, or at all. The
unavailability of additional capital could cause us to cease or curtail our
operations and/or delay or prevent the development and marketing of our
potential products. In addition, we may choose to abandon certain issued United
States and international patents that we deem to be of lesser importance to
our
strategic direction, in an effort to preserve our financial resources.
Our
future capital requirements will depend on many factors including the following:
• continued
scientific progress in our research and development programs and the
commercialization of additional products;
• the
cost
of our research and development and commercialization activities and
arrangements, including sales and marketing;
• the
costs
associated with the scale-up of manufacturing;
• the
success of pre-clinical and clinical trials;
• the
establishment of and changes in collaborative relationships;
• the
time
and costs involved in filing, prosecuting, enforcing and defending patent
claims;
• the
time
and costs required for regulatory approvals;
• the
acquisition of additional technologies or businesses;
• technological
competition and market developments; and
• the
cost
of complying with the requirements of the AMF in France.
We
have
not determined whether we will attempt to raise additional capital within the
next twelve to eighteen months to fund certain development and commercialization
programs. We believe that our current capital resources are sufficient to
sustain operations and our development programs with respect to our
cardiovascular predictor product, diagnostic biomarkers and Ergothioneine as
a
nutraceutical supplement. We have granted a licensee exclusive worldwide rights,
in certain defined areas of cardiovascular indications, to develop, manufacture
and market BXT-51072 and related compounds from our library of such antioxidant
compounds. The licensee is responsible for worldwide product development
programs with respect to the licensed compounds. Due to the lack of
financial resources, we ceased further testing of BXT-51072 but continue to
review the possibility of further developing applications for BXT-51072 and
related compounds outside of the areas defined in the license. However, further
development and commercialization of antioxidant therapeutic technologies,
oxidative stress assays or currently unidentified opportunities, or the
acquisition of additional technologies or businesses, may require additional
capital. The fact that further development and commercialization of a product
or
technology would require us to raise additional capital, would be an important
factor in our decision to engage in such further development or
commercialization. No assurances can be given that we will be able to raise
such
funds in the future on terms favorable to us, or at all.
If
we
complete our acquisition of BioCheck, our business could be materially and
adversely affected if we fail to adequately integrate the operations of the
two
companies.
If
we
consummate the acquisition of BioCheck as planned (“the Acquisition”) and we do
not successfully integrate the operations of the two companies, or if the
benefits of the transaction do not meet the expectations of financial or
industry analysts, the market price of our common stock may decline. The
Acquisition could result in the use of significant amounts of cash, dilutive
issuances of equity securities, or the incurrence of debt or amortization
expenses related to goodwill and other intangible assets, any of which could
materially adversely affect our business, operating results and financial
condition. Further, upon completion of the Acquisition, we will
likely
(i) relocate
all core
operations of the Company to a facility in Northern California where
BioCheck is located and
close
the
Portland facility and (ii) terminate
Company
employees in connection with the integration of the work force for the two
companies. Significant costs and expense would be incurred in connection with
relocation of our operations and the reduction in our work force.
We
may
not be able to successfully integrate the BioCheck business into our existing
business in a timely and non-disruptive manner, or at all. In addition, the
Acquisition may could
result in, among other things, substantial
charges
associated with acquired in-process research and development, future write-offs
of goodwill that is deemed to be impaired, restructuring charges related to
consolidation of operations, charges associated with unknown or unforeseen
liabilities of acquired businesses and increased general and administrative
expenses. Furthermore, the Acquisition may not produce revenues, earnings or
business synergies that we anticipate.
In
addition, acquisitions in general involve numerous risks, including:
• difficulties
in assimilating the operations, technologies, products and personnel of an
acquired company;
• risks
of
entering markets in which we have either no or limited prior
experiences;
• the
diversion of management’s attention from other business concerns; and
• the
potential loss of key employees of an acquired company.
The
time,
capital management and other resources spent on the Acquisition, if it fails
to
meet our expectations, could cause our business and financial condition to
be
materially and adversely affected.
If
we
do not complete our acquisition of BioCheck, we may implement a cost reduction
plan that could adversely affect our operations.
If
we do
not consummate the Acquisition, we may implement a strategy to reduce our cost
structure. In doing so, we may reduce our employee workforce, outsource certain
Company functions and take other steps intended to reduce costs and improve
efficiencies. Employee terminations and other cost reduction steps may cause
us
to incur upfront costs and expenses that may be significant. There are no
assurances that we will be able to improve efficiencies and function properly
following such reductions.
We
may experience disruption or may fail to achieve any benefits in connection
with
the recent changes in executive management and in Board membership.
During
the second quarter of 2004, our former chief executive officer retired, and
during the third quarter of 2004 our chief operating and financial officer
left
the employment of our company. As a result, others who had limited experience
with OXIS were appointed to serve as acting chief executive officer, acting
chief operating officer and acting chief financial officer. The acting chief
financial officer is also the chairman of the board of directors and is serving
in such capacities without cash compensation and without an employment
agreement. On February 28, 2005, the Board appointed Mr. Steven
T.
Guillen to the positions of president and chief executive officer of OXIS,
and
as a member of our board. In addition, during 2004 and early 2005, following
the
acquisition of a then-majority interest in OXIS by Axonyx, eight directors
resigned from the board resulting in a four person board. Four out of the five
directors currently serving on the board commenced their service on the board
during 2004 or 2005.
One
impact of such changes has been to delay our sales promotions in the research
assay market and in the development of Ergothioneine market opportunities.
Further, we narrowed our strategic focus to concentrate resources, including
discontinuing the Animal Health Profiling program. There can be no assurances
that these changes will not cause further disruptions in, or otherwise adversely
affect, our business and results of operations.
If
we
fail to attract and retain key personnel, our business could
suffer.
Our
future depends, in part, on our ability to attract and retain key personnel.
We
may not be able to hire and retain such personnel at compensation levels
consistent with our existing compensation and salary structure. While we had
interim chief executive officers in place, we deferred the hiring of other
senior management personnel in order to allow a newly-engaged full time chief
executive officer to assist in the selection and training of such key personnel.
While we have succeeded in engaging Mr. Steven T. Guillen as our president
and
chief executive officer, we cannot predict whether we will be successful in
finding suitable new candidates for the position chief financial officer and
other key management positions within OXIS. We have engaged an executive search
firm to assist us in the search for, and hiring of, a chief financial officer
and chief operating officer. While we have entered into a letter agreement
of
employment with Mr. Guillen, he is free to terminate his employment “at will.”
Further, we cannot predict whether Mr.
Guillen will
be
successful in his new role as our president and chief executive officer, or
whether senior management personnel hires will be effective. The loss of
services of executive officers or key personnel, any transitional difficulties
with our new chief executive officer or the inability to attract qualified
personnel could have a material adverse effect on our financial condition and
business. We
do not
have any key employee life insurance policies with respect to any of our
officers.
The
success of our business depends upon our ability to successfully develop and
commercialize products.
We
cannot
assure you that our efforts to develop and commercialize a cardiac predictor
product, diagnostic biomarkers, an Ergothioneine
nutraceutical product or any other products will be successful. The cost of
such
development and commercialization efforts can be significant and the likelihood
of success of any such programs is difficult to predict. The failure to develop
or commercialize such new products could be materially harmful to us and our
financial condition.
Our
future profitability is uncertain.
We
cannot
predict our ability to reduce our costs or achieve profitability. Our research
and development expenses are expected to increase as we attempt to develop
potential products. As evidenced by the substantial net losses during 2004
and
during the first nine months of 2005, losses and expenses may increase and
fluctuate from quarter to quarter. There can be no assurance that we will ever
achieve profitable operations.
We
have no biopharmaceutical or clinical diagnostic products available for sale
and
we may never be successful in developing products suitable for
commercialization.
All
of
our biopharmaceutical and clinical diagnostic candidates are at an early stage
of development and all of such therapeutic and clinical diagnostic candidates
will require expensive and lengthy testing and regulatory clearances. None
of
our therapeutic or clinical diagnostic candidates have been approved by
regulatory authorities. We have no therapeutic or clinical diagnostic products
available for sale and we may not have any products commercially available
for
several years, if at all. There are many reasons we may fail in our efforts
to
develop our therapeutic and clinical diagnostic candidates,
including:
• our
therapeutic and clinical diagnostic candidates may be ineffective, toxic or
may
not receive regulatory clearances,
• our
therapeutic and clinical diagnostic candidates may be too expensive to
manufacture or market or may not achieve broad market acceptance,
• third
parties may hold proprietary rights that may preclude us from developing or
marketing our therapeutic and clinical diagnostic candidates, or
• third
parties may market equivalent or superior products.
Clinical
development is inherently uncertain and expense levels may fluctuate
unexpectedly because we cannot accurately predict the timing and level of such
expenses.
Our
future success may depend in part upon the results of clinical trials designed
to assess the safety and efficacy of our potential products. We do not have
substantial experience in developing and running clinical trials. The completion
of clinical trials often depends significantly upon the rate of patient
enrollment, and our expense levels will vary depending upon the rate of
enrollment. In addition, the length of time necessary to complete clinical
trials and submit an application for marketing and manufacturing approvals
varies significantly and is difficult to predict. The expenses associated with
each phase of development depend upon the design of the trial. The design of
each phase of trials depends in part upon results of prior phases, and
additional trials may be needed at each phase. As a result, the expense
associated with future phases cannot be predicted in advance. Further, if we
undertake clinical trials, we may decide to terminate or suspend ongoing trials.
Failure to comply with extensive FDA regulations may result in unanticipated
delay, suspension or cancellation of a trial or the FDA's refusal to accept
test
results. The FDA may also suspend our clinical trials at any time if it
concludes that the participants are being exposed to unacceptable risks. As
a
result of these factors, we cannot predict the actual expenses that we will
incur with respect to clinical trials for any of our potential products, and
we
expect that our expense levels will fluctuate unexpectedly in the future.
Competition
in most of our primary current and potential market areas is intense and
expected to increase.
The
diagnostic, pharmaceutical and nutraceutical industries are highly competitive.
The main commercial competition at present in our research assay business is
represented by, but not limited to, the following companies: Cayman Chemical,
Assay Designs and Randox. In addition, our competitors and potential competitors
include large pharmaceutical/nutraceutical companies, universities and research
institutions. Relative to OXIS, these competitors may have substantially greater
capital resources, research and development staffs, facilities, as well as
greater expertise manufacturing and making products. In addition, these
companies, as well as others, may have or may develop new technologies or use
existing technologies that are, or may in the future be, the basis for
competitive products. There can be no assurance that we can compete
successfully.
In
addition, current and potential competitors may make strategic acquisitions
or
establish cooperative relationships among themselves or with third parties,
thereby increasing the ability of their products to address the needs of our
current and prospective customers. Accordingly, it is possible that new
competitors or alliances among current and new competitors may emerge and
rapidly gain significant market share. Such competition could materially
adversely affect our ability to commercialize existing technologies or new
technologies on terms favorable to us. Further, competitive pressures could
require us to reduce the price of our products and technologies, which could
materially adversely affect our business, operating results and financial
condition. We may not be able to compete successfully against current and future
competitors and any failure to do so would have a material adverse effect upon
our business, operating results and financial condition.
Axonyx
holds the voting power to influence matters affecting us.
Axonyx
currently owns approximately 34.0% of our issued and outstanding stock. In
addition, Dr. Marvin Hausman is a member of the board of directors of Axonyx
and
is the chairman of our board and the acting chief financial officer of OXIS,
and
Mr. S. Colin Neill, the chief financial officer of Axonyx, is a member of our
board of directors and secretary of OXIS. Given these circumstances, Axonyx
may
influence our business direction and policies, and, thus, may have the ability
to control certain material decisions affecting us. In addition, such
concentration of voting power could have the effect of delaying, deterring
or
preventing a change of control or other business combination that might
otherwise be beneficial to our shareholders. Section 203 of the Delaware General
Corporation Law prohibits a Delaware corporation from engaging in any business
combination with any interested shareholder for a period of three years unless
the transaction meets certain conditions. Section 203 also limits the
extent to which an interested shareholder can receive benefits from our assets.
These provisions could complicate or prohibit certain transactions (including
a
financing transaction between OXIS and Axonyx), or limit the price that other
investors might be willing to pay in the future for shares of our common
stock.
If
we
are unable to develop and maintain alliances with collaborative partners, we
may
have difficulty developing and selling our products and services.
Our
ability to realize significant revenues from new products and technologies
is
dependent upon, among other things, our success in developing business alliances
and licensing arrangements with nutraceutical/biopharmaceutical and/or health
related companies to develop and market these products. To date, we have had
limited success in establishing foundations for such business alliances and
licensing arrangements and there can be no assurance that our efforts to develop
such business relationships will progress to mature relationships or that any
such relationships will be successful. Further, relying on these or other
alliances is risky to our future success because:
• our
partners may develop products or technologies competitive with our products
and
technologies;
• our
partners may not devote sufficient resources to the development and sale of
our
products and technologies;
• our
collaborations may be unsuccessful; or
• we
may
not be able to negotiate future alliances on acceptable terms.
Our
revenues and quarterly results have fluctuated historically and may continue
to
fluctuate, which could cause our stock price to decrease.
Our
revenues and operating results may fluctuate due in part to factors that are
beyond our control and which we cannot predict. Material shortfalls in revenues
will materially adversely affect our results and may cause us to experience
losses. In particular, our revenue growth and profitability depend on sales
of
our research assays and fine chemicals. Factors that could cause sales for
these
products and other products to fluctuate include:
• an
inability to produce products in sufficient quantities and with appropriate
quality;
• an
inability to obtain sufficient raw materials;
• the
loss
of or reduction in orders from key customers;
• variable
or decreased demand from our customers;
• the
receipt of relatively large orders with short lead times;
• our
customers' expectations as to how long it takes us to fill future orders;
• customers'
budgetary constraints and internal acceptance review procedures;
• there
may
be only a limited number of customers that are willing to purchase our research
assays and fine chemicals;
• a
long
sales cycle that involves substantial human and capital resources;
and
• potential
downturns in general or in industry specific economic conditions.
Each
of
these factors has impacted, and may in the future impact, the demand for and
availability of our products and our quarterly operating results. For example,
due to the unavailability of beef liver as a source for bSOD we were unable
to
sell any bSOD during 2004, as compared to sales of $562,000 in 2003.
We
do not
anticipate this source becoming available again within the foreseeable future
and do not anticipate any revenues from sales of this product in the foreseeable
future. In addition, a decrease in the demand for our Ergothioneine product
resulted in a reduction of sales of Ergothioneine
to
$87,000 in 2004, compared to $333,000 in 2003. For the first nine months of
2005
our revenues from Ergothioneine were $18,000. We cannot predict with any
certainty our future sales of Ergothioneine.
If
the
sales or development cycles for research assays and fine chemicals lengthen
unexpectedly, our revenues may decline or not grow as anticipated and our
results from operations may be harmed.
Changes
in accounting standards regarding stock option plans could increase our reported
losses, cause our stock price to decline and limit the desirability of granting
stock options.
The
Financial Accounting Standards Board has issued regulations that eliminate
the
ability to account for share-based compensation transactions using the intrinsic
method that we currently use and generally would require that such transactions
be accounted for using a fair-value-based method and recognized as an expense
in
our consolidated statement of operations. As currently contemplated, we will
be
required to expense stock options after January 1, 2006. Currently,
we
generally only disclose such expenses on a pro forma basis in the notes to
our
consolidated financial statements in accordance with accounting principles
generally accepted in the United States. Expensing such stock options will
add
to our losses or reduce our profits, if any. In addition, stock options are
an
important employee recruitment and retention tool, and we may not be able to
attract and retain key personnel if we reduce the scope of our employee stock
option program.
Our
income may suffer if we receive relatively large orders with short lead times,
or our manufacturing capacity does not otherwise match our demand.
Because
we cannot immediately adapt our production capacity and related cost structures
to rapidly changing market conditions, when demand does not meet our
expectations, our manufacturing capacity will likely exceed our production
requirements. Fixed costs associated with excess manufacturing capacity could
adversely affect our income. Similarly, if we receive relatively large orders
with short lead times, we may not be able to increase our manufacturing capacity
to meet product demand, and, accordingly, we will not be able to fulfill orders
in a timely manner. During a market upturn, we may not be able to purchase
sufficient supplies to meet increasing product demand. In addition, suppliers
may extend lead times, limit supplies or increase prices due to capacity
constraints or other factors. These factors could materially and adversely
affect our results.
Securities
regulation compliance in France and legal proceedings involving the AMF in
France have resulted in, and may in the future result in, unexpected financial
consequences to the Company.
In
1997,
we completed an offering of our common stock to European investors, and listed
the resulting shares on the Nouveau Marché in France. As a result of such
listing, we have been subject to French securities laws and the securities
regulations of the Autorité des Marchés Financiers (the “AMF”), the French
regulatory agency overseeing the Nouveau Marché. The cost of complying with such
securities laws and regulations can be substantial. The AMF engaged in an
investigation alleging that we failed to file financial and other disclosure
information as required under French law from 1999 through 2002. As a result
of
the investigation, we incurred substantial defense costs and paid a fine of
approximately $62,000. As of December 31, 2004, we recorded approximately
$183,000 related to the defense and settlement of the investigation, including
foreign legal expenses of $121,000 and fines imposed by the AMF of $62,000.
In a
related legal proceeding before French judicial authorities, we incurred
additional legal expenses and paid an additional approximately $11,600 in
settlement of any obligation to pay fines. Although we are not as of the date
of
this Report aware of any pending AMF allegations, in the event the AMF would
make additional allegations against us or in the event that we would be required
to answer additional charges in French legal proceedings, we may incur further
substantial costs and fines. No assurances can be given that we would be able
to
settle any such matters with the AMF, or if we do settle these matters with
the
AMF, that we would be able to do so on terms favorable to us.
Our
success will require that we establish a strong intellectual property position
and that we can defend ourselves against intellectual property claims from
others.
Maintaining
a strong patent position is important to our competitive advantage. We currently
have approximately 85 patents either granted or applied for in 15 countries
with
expiration dates ranging from 2006 to 2024. Litigation on patent-related matters
has been prevalent in our industry and we expect that this will continue. Patent
law relating to the scope of claims in the technology fields in which we operate
is still evolving and the extent of future protection is highly uncertain,
so
there can be no assurance that the patent rights we have or may obtain will
be
valuable. Others may have filed, or may in the future file, patent applications
that are similar or identical to ours. To determine the priority of inventions,
we may have to participate in interference proceedings declared by the United
States Patent and Trademark Office that could result in substantial costs in
legal fees and could substantially affect the scope of our patent protection.
We
cannot assure investors that any such patent applications will not have priority
over our patent applications. Further, we may choose to abandon certain issued
United States and international patents that we deem to be of lesser importance
to our strategic direction, in an effort to preserve our financial resources.
Abandonment of patents could substantially affect the scope of our patent
protection. In addition, we may in future periods incur substantial costs in
litigation to defend against patent suits brought by third parties or if we
initiate such suits.
In
addition to patent protection, we also rely upon trade secret protection for
our
confidential and proprietary information. There can be no assurance, however,
that such measures will provide adequate protection for our trade secrets or
other proprietary information. In addition, there can be no assurance that
trade
secrets and other proprietary information will not be disclosed, that others
will not independently develop substantially equivalent proprietary information
and techniques or otherwise gain access to or disclose our trade secrets and
other proprietary information. If we cannot obtain, maintain or enforce
intellectual property rights, competitors can design and commercialize competing
technologies.
We
may
face challenges from third parties regarding the validity of our patents and
proprietary rights, or from third parties asserting that we are infringing
their
patents or proprietary rights, which could result in litigation that would
be
costly to defend and could deprive us of valuable rights.
Extensive
litigation regarding patents and other intellectual property rights has been
common in the biotechnology and pharmaceutical industries. The defense and
prosecution of intellectual property suits, United States Patent and Trademark
Office interference proceedings, and related legal and administrative
proceedings in the United States and internationally involve complex legal
and
factual questions. As a result, such proceedings are costly and time-consuming
to pursue and their outcome is uncertain. Litigation may be necessary to:
• enforce
patents that we own or license;
• protect
trade secrets or know-how that we own or license; or
• determine
the enforceability, scope and validity of the proprietary rights of others.
Our
involvement in any litigation, interference or other administrative proceedings
could cause us to incur substantial expense and could significantly divert
the
efforts of our technical and management personnel. An adverse determination
may
subject us to loss of our proprietary position or to significant liabilities,
or
require us to seek licenses that may not be available from third parties. An
adverse determination in a judicial or administrative proceeding, or a failure
to obtain necessary licenses, may restrict or prevent us from manufacturing
and
selling our products. Costs associated with these arrangements may be
substantial and may include ongoing royalties. Furthermore, we may not be able
to obtain the necessary licenses on satisfactory terms, if at all. These
outcomes could materially harm our business, financial condition and results
of
operations.
We
may be exposed to liability due to product defects.
The
risk
of product liability claims is inherent in the testing, manufacturing, marketing
and sale of our products. We may seek to acquire additional insurance for
liability risks. We may not be able to obtain such insurance or general product
liability insurance on acceptable terms or in sufficient amounts. A product
liability claim or recall could have a serious adverse effect on our business,
financial condition and results of operations.
Disclosure
controls are no assurance that the objectives of the control system are
met.
Although
we have an extensive operating history, resources are limited for the
development and maintenance of our control environment. We have a limited number
of personnel and therefore segregation of duties can be somewhat limited as
to
their scope and effectiveness. We believe, however, that we are in reasonable
compliance with the best practices given the environment in which we operate.
Although existing controls in place are deemed appropriate for the prevention,
detection and minimization of fraud, theft, and errors, they may result in
only
limited assurances, at best, that the total objectives of the control system
are
met. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, can be detected and/or prevented and as such this is a risk
area for investors to consider.
Risks
Related to Our Common Stock
Our
common stock is traded on the OTCBB, our stock price is highly volatile, and
you
may not be able to sell your shares of our common stock at a price greater
than
or equal to the price you paid for such shares.
Our
shares of common stock are currently traded on the Over the Counter Bulletin
Board (“OTCBB”). Stocks traded on the OTCBB generally have limited trading
volume and exhibit a wide spread between the bid/ask quotation. The market
price
of our common stock is extremely volatile. To demonstrate the volatility of
our
stock price, during the twelve-month period ending on December 31, 2004, the
volume of our common stock traded on any given day ranged from 0 to 542,342
shares. Moreover, during that period, our common stock traded as low as
$0.32 per
share
and as high as $0.90 per share, a 281.25% difference. This may impact an
investor’s decision to buy or sell our common stock. As of September 30, 2005
there were approximately 5,500 holders of our common stock. Factors affecting
our stock price include:
• our
financial results;
• fluctuations
in our operating results;
• announcements
of technological innovations or new commercial health care products or
therapeutic products by us or our competitors;
• government
regulation;
• developments
in patents or other intellectual property rights;
• developments
in our relationships with customers and potential customers; and
• general
market conditions.
Furthermore,
volatility in the stock price of other companies has often led to securities
class action litigation against those companies. Any such securities litigation
against us could result in substantial costs and divert management's attention
and resources, which could seriously harm our business and financial
condition.
In
addition, the 12,264,158 outstanding shares of our common stock, and the
12,877,366 shares of our common stock that are issuable upon exercise of
warrants we issued in the private placement of equity that closed on January
6,
2005 have been registered with the United States Securities & Exchange
Commission (“SEC”) and may be sold into the market. We cannot control when and
in what quantities the selling shareholders will choose to sell shares of our
common stock and such sales may cause the price of our common stock to
decline.
Our
common stock may be subject to “penny stock” rules which may be detrimental to
investors.
Our
common stock may be, or may become, subject to the regulations promulgated
by
the SEC for “penny stock”. SEC regulation relating to penny stock is presently
evolving, and the OTCBB may react to such evolving regulation in a way that
adversely affects the market liquidity of our common stock. Penny stock
currently includes any non-NASDAQ equity security that has a market price of
less than $5.00 per share, subject to certain exceptions. The regulations
require that prior to any non-exempt buy/sell transaction in a penny stock,
a
disclosure schedule set forth by the SEC relating to the penny stock market
must
be delivered to the purchaser of such penny stock. This disclosure must include
the amount of commissions payable to both the broker-dealer and the registered
representative and current price quotations for the common stock. The
regulations also require that monthly statements be sent to holders of penny
stock that disclose recent price information for the penny stock and information
of the limited market for penny stocks. These requirements may adversely affect
the market liquidity of our common stock.
Sales
of our common stock may require broker-dealers to make special suitability
determinations regarding prospective purchasers.
Our
common stock may be, or may become, subject to Rule 15g-1 through 15g-9 under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which
imposes certain sales practice requirements on broker-dealers which sell our
common stock to persons other than established customers and “accredited
investors” (generally, individuals with a net worth in excess of $1,000,000 or
an annual income exceeding $200,000 (or $300,000 together with their spouses)).
For transactions covered by this rule, a broker-dealer must make a special
suitability determination for the purchaser and have received the purchaser’s
written consent to the transaction prior to the sale. Applicability of this
rule
would adversely affect the ability of broker-dealers to sell our common stock
and purchasers of our common stock to sell their shares of such common stock.
Accordingly, the market for our common stock may be limited and the value
negatively impacted.
We
will incur expenses in connection with registration of our shares which may
be
significant in relation to our revenues.
We
are
required to pay fees and expenses incident to the registration with the SEC
of
the shares issued in the private placement of equity which closed on January
6,
2005 and maintain adequate disclosure in connection with such registration,
including updating prospectuses. These expenses may be significant in relation
to our revenues. We have also agreed to indemnify such selling shareholders
against losses, claims, damages and liabilities arising out of relating to
any
misstatements or omissions in our registration statement and related
prospectuses, including liabilities under the Securities Act. In the event
such
a claim is made in the future, such losses, claims, damages and liabilities
arising therefrom could be significant in relation to our revenues.
Item
3. Controls
and Procedures.
The
Company's Chief Executive Officer (principal executive officer) and Chief
Financial Officer (principal financial officer) have evaluated the effectiveness
of the Company's disclosure controls and procedures (as such term is defined
in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended (the "Exchange Act")) as of September 30, 2005 (the "Evaluation Date").
Based on such evaluation, such officers have concluded that, as of the
Evaluation Date, the Company's disclosure controls and procedures are effective
in alerting them on a timely basis to material information relating to the
Company required to be included in the Company's periodic filings under the
Exchange Act. In addition, there have been no significant changes in the
Company’s internal control over financial reporting or in other factors that
could significantly affect this control subsequent to the date of the previously
mentioned evaluation.
Disclosure
controls and procedures are our controls and other procedures that are designed
to ensure that information required to be disclosed by us in the reports that
we
file or submit under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by
us in
the reports that we file under the Exchange Act is accumulated and communicated
to our management, including our principal executive officer and principal
financial officer, as appropriate to allow timely decisions regarding required
disclosures.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
None.
Item
2. Unregistered Sales of Equity Securities and Use Of Proceeds.
None.
Item
3. Defaults upon Senior Securities.
None.
Item
4. Submission of Matters to a Vote of Securities Holders.
None.
Item
5. Other Information.
None.
Item
6. Exhibits.
See
Exhibit Index on page 36.
In
accordance with the requirements of the Exchange Act, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
|
|
|
|
|
|
|
OXIS
International, Inc. |
|
|
|
November
14, 2005 |
By: |
/s/ Steven
T. Guillen |
|
Steven
T. Guillen |
|
President
and Chief Executive Officer |
|
|
|
November
14, 2005
|
By: |
/s/ Marvin
S. Hausman, M.D. |
|
Marvin
S. Hausman, M.D. |
|
Principal
Financial Officer |
EXHIBIT
INDEX
Exhibit
Number
|
Description
of
Document |
10.r
|
Stock
Purchase Agreement between OXIS International, Inc. and BioCheck
Inc.
dated September 19, 2005*
|
|
31.a
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.b
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.a
|
Certification
pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
|
32.b
|
Certification
pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
|
* Incorporated
by reference to the Company’s Form 8-K Current Report filed on September
22, 2005