Avid Bioservices, Inc. - Quarter Report: 2008 July (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
ý
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the quarterly period ended July 31, 2008
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OR
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the transition period from _______________ to
_______________
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Commission
file number: 0-17085
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
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95-3698422
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(State
or other jurisdiction of incorporation
or organization)
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(I.R.S.
Employer Identification
No.)
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14282
Franklin Avenue, Tustin, California
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92780-7017
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(Address
of principal executive offices)
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(Zip
Code)
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(714)
508-6000
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(Registrant's
telephone number, including area
code)
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Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one)
Large
Accelerated Filer
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o
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Accelerated
Filer
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ý
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Non-
Accelerated Filer
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o
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Smaller
reporting company
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o
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(Do
not check if a smaller reporting
company)
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Indicate
by checkmark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act).
Yes o No ý
As of
July 31, 2008, there were 226,210,617 shares of common stock, $0.001 par value,
outstanding.
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
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Page
No.
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Item
1.
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Consolidated
Financial Statements (unaudited):
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||
Condensed
Consolidated Balance Sheets
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1
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Condensed
Consolidated Statements of Operations
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3
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Condensed
Consolidated Statements of Cash Flows
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4
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Notes
to Condensed Consolidated Financial Statements
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5
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Item
2.
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Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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13
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Company
Overview
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13
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Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk
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23
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Item
4.
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Controls
and Procedures
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23
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PART
II - OTHER INFORMATION
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|||
Item
1.
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Legal
Proceedings
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23
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Item
1A.
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Risk
Factors
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24
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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37
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Item
3.
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Defaults
upon Senior Securities
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37
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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37
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Item
5.
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Other
Information
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37
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Item
6.
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Exhibits
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37
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SIGNATURES
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38
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The terms “we,” “us,” “our,” “the Company,” and “Peregrine,” as used in this Report on Form 10-Q refers to Peregrine
Pharmaceuticals, Inc. and its wholly owned subsidiary, Avid Bioservices,
Inc.
i
PART I - FINANCIAL
INFORMATION
ITEM 1.
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CONSOLIDATED FINANCIAL
STATEMENTS
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PEREGRINE PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
JULY
31,
2008
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APRIL
30,
2008
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|||||||
Unaudited
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||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
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||||||||
Cash
and cash equivalents
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$ | 9,963,000 | $ | 15,130,000 | ||||
Trade
and other receivables
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2,099,000 | 605,000 | ||||||
Government
contract receivables
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1,794,000 | - | ||||||
Inventories,
net
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4,628,000 | 2,900,000 | ||||||
Prepaid
expenses and other current assets
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1,198,000 | 1,208,000 | ||||||
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||||||||
Total current
assets
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19,682,000 | 19,843,000 | ||||||
PROPERTY:
|
||||||||
Leasehold
improvements
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669,000 | 669,000 | ||||||
Laboratory
equipment
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4,140,000 | 4,140,000 | ||||||
Furniture,
fixtures and office equipment
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919,000 | 919,000 | ||||||
5,728,000 | 5,728,000 | |||||||
Less
accumulated depreciation and amortization
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(3,803,000 | ) | (3,670,000 | ) | ||||
Property, net
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1,925,000 | 2,058,000 | ||||||
Other
assets
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1,201,000 | 1,156,000 | ||||||
TOTAL
ASSETS
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$ | 22,808,000 | $ | 23,057,000 |
-1-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
JULY
31,
2008
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APRIL
30, 2008
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|||||||
Unaudited
|
||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
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$ | 3,134,000 | $ | 2,060,000 | ||||
Accrued
clinical trial site fees
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305,000 | 237,000 | ||||||
Accrued
legal and accounting fees
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210,000 | 450,000 | ||||||
Accrued
royalties and license fees
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151,000 | 222,000 | ||||||
Accrued
payroll and related costs
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955,000 | 1,084,000 | ||||||
Capital
lease obligation, current portion
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22,000 | 22,000 | ||||||
Deferred
revenue
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4,021,000 | 2,196,000 | ||||||
Deferred
government contract revenue
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980,000 | - | ||||||
Customer
deposits
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1,898,000 | 838,000 | ||||||
Other
current liabilities
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336,000 | 331,000 | ||||||
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||||||||
Total current
liabilities
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12,012,000 | 7,440,000 | ||||||
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||||||||
Capital
lease obligation, less current portion
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16,000 | 22,000 | ||||||
Commitments
and contingencies
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||||||||
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||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
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- | - | ||||||
Common
stock-$.001 par value; authorized 325,000,000 shares;
outstanding – 226,210,617 and 226,210,617,
respectively
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226,000 | 226,000 | ||||||
Additional
paid-in capital
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246,476,000 | 246,205,000 | ||||||
Accumulated
deficit
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(235,922,000 | ) | (230,836,000 | ) | ||||
Total stockholders'
equity
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10,780,000 | 15,595,000 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
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$ | 22,808,000 | $ | 23,057,000 |
See
accompanying notes to condensed consolidated financial
statements.
-2-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE
MONTHS ENDED
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||||||||
July
31, 2008
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July
31, 2007
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|||||||
Unaudited
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Unaudited
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|||||||
REVENUES:
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||||||||
Contract
manufacturing revenue
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$ | 1,193,000 | $ | 1,621,000 | ||||
Government
contract revenue
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324,000 | - | ||||||
License
revenue
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- | 4,000 | ||||||
Total
revenues
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1,517,000 | 1,625,000 | ||||||
COSTS
AND EXPENSES:
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||||||||
Cost
of contract manufacturing
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903,000 | 1,181,000 | ||||||
Research
and development
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4,068,000 | 3,624,000 | ||||||
Selling,
general and administrative
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1,706,000 | 1,708,000 | ||||||
Total
costs and expenses
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6,677,000 | 6,513,000 | ||||||
LOSS
FROM OPERATIONS
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(5,160,000 | ) | (4,888,000 | ) | ||||
OTHER
INCOME (EXPENSE):
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||||||||
Interest
and other income
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75,000 | 239,000 | ||||||
Interest
and other expense
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(1,000 | ) | (7,000 | ) | ||||
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||||||||
NET
LOSS
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$ | (5,086,000 | ) | $ | (4,656,000 | ) | ||
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||||||||
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
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226,210,617 | 206,071,568 | ||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
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$ | (0.02 | ) | $ | (0.02 | ) |
See
accompanying notes to condensed consolidated financial statements.
-3-
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE
MONTHS ENDED JULY 31,
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||||||||
2008
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2007
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|||||||
Unaudited
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Unaudited
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
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||||||||
Net
loss
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$ | (5,086,000 | ) | $ | (4,656,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
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133,000 | 119,000 | ||||||
Share-based
compensation
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271,000 | 197,000 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Trade
and other receivables
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(1,494,000 | ) | (764,000 | ) | ||||
Government
contract receivables
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(1,794,000 | ) | - | |||||
Inventories,
net
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(1,728,000 | ) | (447,000 | ) | ||||
Prepaid
expenses and other current assets
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10,000 | 16,000 | ||||||
Accounts
payable
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1,074,000 | (317,000 | ) | |||||
Accrued
clinical trial site fees
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68,000 | (115,000 | ) | |||||
Accrued
payroll and related costs
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(129,000 | ) | (210,000 | ) | ||||
Deferred
revenue
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1,825,000 | 756,000 | ||||||
Deferred
government contract revenue
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980,000 | - | ||||||
Customer
deposits
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1,060,000 | (464,000 | ) | |||||
Other
accrued expenses and current liabilities
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(306,000 | ) | (335,000 | ) | ||||
Net
cash used in operating activities
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(5,116,000 | ) | (6,220,000 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
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||||||||
Property
acquisitions
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- | (75,000 | ) | |||||
(Increase)
decrease in other assets
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(45,000 | ) | 71,000 | |||||
Net
cash used in investing activities
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(45,000 | ) | (4,000 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of common stock, net of issuance costs
of $1,641,000 (2007)
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- | 20,931,000 | ||||||
Principal
payments on notes payable and capital lease
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(6,000 | ) | (116,000 | ) | ||||
Net
cash (used in) provided by financing activities
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(6,000 | ) | 20,815,000 | |||||
NET (DECREASE)
INCREASE IN CASH AND CASH EQUIVALENTS
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(5,167,000
|
) | 14,591,000 | |||||
CASH AND CASH
EQUIVALENTS, beginning of period
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15,130,000 | 16,044,000 | ||||||
CASH AND CASH
EQUIVALENTS, end of period
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$ | 9,963,000 | $ | 30,635,000 |
See
accompanying notes to condensed consolidated financial statements.
-4-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited)
1. BASIS OF PRESENTATION
The
accompanying interim condensed consolidated financial statements include the
accounts of Peregrine Pharmaceuticals, Inc. (“Peregrine”), a biopharmaceutical
company developing a portfolio of clinical stage and pre-clinical product
candidates using monoclonal antibodies (“MAb”) for the treatment of cancer
and viral diseases, and its wholly owned subsidiary, Avid Bioservices, Inc.
(“Avid”), a bio-manufacturing company engaged in providing contract
manufacturing services for Peregrine and outside customers on a fee-for-services
basis (collectively, the “Company”). All intercompany balances and
transactions have been eliminated.
In
addition, the accompanying interim condensed consolidated financial statements
are unaudited; however they contain all adjustments (consisting only of normal
recurring adjustments) which, in the opinion of management, are necessary to
present fairly the condensed consolidated financial position of the Company at
July 31, 2008, and the condensed consolidated results of our operations and our
condensed consolidated cash flows for the three-month periods ended July 31,
2008 and 2007. We prepared the condensed consolidated financial
statements following the requirements of the Securities and Exchange Commission
(or SEC) for interim reporting. As permitted under those rules,
certain footnotes or other financial information that are normally required by
U.S. generally accepted accounting principles (or GAAP) can be condensed or
omitted. Although we believe that the disclosures in the financial
statements are adequate to make the information presented herein not misleading,
the information included in this quarterly report on Form 10-Q should be read in
conjunction with the consolidated financial statements and accompanying notes
included in our Annual Report on Form 10-K for the year ended April 30,
2008. Results of operations for interim periods covered by this
quarterly report on Form 10-Q may not necessarily be indicative of results of
operations for the full fiscal year.
Going Concern – Our interim
condensed consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. The financial
statements do not include any adjustments relating to the recoverability of the
recorded assets or the classification of liabilities that may be necessary
should it be determined that we are unable to continue as a going
concern.
At July
31, 2008, we had $9,963,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of
Avid. As a result, we have historically experienced negative cash
flows from operations since our inception and we expect to continue to
experience negative cash flows from operations for the foreseeable
future. Our net losses incurred during the past three fiscal years
ended April 30, 2008, 2007 and 2006 amounted to $23,176,000, $20,796,000, and
$17,061,000, respectively. Unless and until we are able to generate
sufficient revenues from Avid’s contract manufacturing services and/or from the
sale and/or licensing of our products under development, we expect such losses
to continue for the foreseeable future.
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations.
We will
need to raise additional capital through one or more methods, including equity
or debt financings, in order to support the costs of our clinical and
pre-clinical programs. As of July 31, 2008, we had an aggregate of
5,030,634 shares available under our existing effective Form S-3 registration
statements for possible future registered transactions. In addition,
we filed a separate shelf registration statement on Form S-3, File Number
333-139975, under which we may issue, from time to time, in one or more
offerings, shares of our common stock for remaining gross proceeds of up to
$7,500,000.
-5-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
We may
also raise additional capital though negotiating licensing or collaboration
agreements for our technology platforms. In addition, Avid represents
an additional asset in our portfolio and we are actively pursuing strategic
initiatives for Avid as a means of raising additional capital.
Although
we will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid, to
complete the research, development, and clinical testing of our product
candidates. Based on our current projections, which include projected
revenues from existing customers of Avid, combined with the projected revenues
from our government contract, we believe we have sufficient cash on hand
combined with amounts expected to be received from Avid customers and from our
government contract to meet our obligations as they become due through at least
fiscal year 2009. There are a number of uncertainties associated with
our financial projections, including but not limited to, termination of
contracts and technical challenges, which would reduce or delay our future
projected cash-inflows. As a result, we would not have sufficient
capital to operate our business through fiscal year 2009 unless we raise
additional capital. The uncertainties surrounding our future cash
inflows have raised substantial doubt regarding our ability to continue as a
going concern.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition - We
currently derive revenues primarily from contract manufacturing services
provided by Avid and from services performed under a government contract awarded
to Peregrine through the Transformational Medical Technologies Initiative (TMTI)
of the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) that
was signed on June 30, 2008.
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition. In accordance with SAB No. 104, revenue is
generally realized or realizable and earned when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the seller's price to the buyer is fixed or determinable, and (iv)
collectibility is reasonably assured.
In
addition, we comply
with Emerging Issues Task Force (“EITF”) Issue No. 00-21, Revenue Arrangements with Multiple
Deliverables, EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent, and Accounting Research Bulletin No. 43
Chapter 11, Government
Contracts.
Revenues
associated with contract manufacturing services provided by Avid are generally
recognized once the service has been provided and/or upon shipment of the
product to the customer. We also record a provision for estimated
contract losses, if any, in the period during which they are
determined.
Our
contract with the DTRA is a “cost-plus-fixed-fee”
contract. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
-6-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
Allowance for Doubtful
Accounts - We continually monitor our allowance for doubtful accounts for
all receivables. A considerable amount of judgment is required in
assessing the ultimate realization of these receivables and we estimate an
allowance for doubtful accounts based on these factors at that point in
time. As of July 31, 2008, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers, we determined no allowance for doubtful accounts was
necessary.
Inventories – Inventories are
stated at the lower of cost or market and primarily include raw materials,
direct labor and overhead costs associated with our wholly owned
subsidiary, Avid. Inventories consist of the following at July 31,
2008 and April 30, 2008:
July
31,
2008
|
April
30,
2008
|
|||||||
Raw
materials
|
$ | 1,664,000 | $ | 1,115,000 | ||||
Work-in-process
|
2,964,000 | 1,785,000 | ||||||
Total inventories,
net
|
$ | 4,628,000 | $ | 2,900,000 |
Comprehensive Loss –
Comprehensive loss is equal to net loss for all periods presented.
Reclassification – Certain
amounts in the fiscal year 2008 condensed consolidated financial statements have
been reclassified to conform to the current year presentation.
Customer Deposits – Customer
deposits primarily represent advance billings and/or advance payments received
from customers prior to the initiation of contract manufacturing
services.
Basic and Dilutive Net Loss Per
Common Share – Basic and dilutive net loss per common share are
calculated in accordance with Statement of Financial Accounting Standards No.
128, Earnings per
Share. Basic net loss per common share is computed by dividing
our net loss by the weighted average number of common shares outstanding during
the period excluding the dilutive effects of options and warrants (fiscal year
2008 only). Diluted net loss per common share is computed by dividing
the net loss by the sum of the weighted average number of common shares
outstanding during the period plus the potential dilutive effects of options and
warrants (fiscal year 2008 only) outstanding during the period calculated in
accordance with the treasury stock method, but are excluded if their effect is
anti-dilutive. Because the impact of options and warrants are
anti-dilutive during periods of net loss, there was no difference between basic
and diluted loss per share amounts for the three months ended July 31,
2008 and 2007.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants (fiscal year 2008 only) to purchase up to 332,140
and 840,752 shares of common stock for the three months ended July 31, 2008
and 2007, respectively, since the impact of such options and warrants are
anti-dilutive during periods of net loss.
The
calculation of weighted average diluted shares outstanding also excludes
weighted average outstanding options and warrants (fiscal year 2008 only) to
purchase up to 10,466,421 and 10,228,390 shares of common stock for the three
months ended July 31, 2008 and 2007, respectively, as the exercise prices
of those options were greater than the average market price of our common stock
during the respective periods, resulting in an anti-dilutive
effect.
-7-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
Recent Accounting
Pronouncements - In September 2006, the Financial Accounting Standards
Board (“FASB”) issued Statement of Financial Accounting Standards No. 157
(“SFAS No. 157”), Fair Value
Measurements, which defines fair value, establishes a framework for
measuring fair value under GAAP, and expands disclosures about fair value
measurements. SFAS No. 157 establishes a three-level hierarchy that
prioritizes the inputs used to measure fair value. The hierarchy
defines the three levels of inputs to measure fair value, as
follows:
●
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities.
|
|
●
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as assets or liabilities whose value are based on quoted market prices in
markets where trading occurs infrequently or whose values are based on
quoted prices of instruments with similar attributes in active
markets.
|
|
●
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and significant to the overall fair value
measurement.
|
We
adopted SFAS No. 157 on May 1, 2008, which did not have a material impact
on our consolidated financial statements as we currently do not have any Level 2
or Level 3 financial assets or liabilities and cash and cash equivalents are
carried at fair value based on quoted market prices for identical securities
(Level 1 input).
In
February 2007, the FASB issued Statement of Financial Accounting Standards No.
159 (“SFAS No. 159”), The Fair
Value Option for Financial Assets and Financial Liabilities – Including an
amendment of FASB statement No. 115. SFAS No. 159 permits
entities to choose to measure many financial instruments and certain other items
at fair value. If the fair value method is selected, a business
entity shall report unrealized gains and losses on elected items in earnings at
each subsequent reporting date. The standard also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar types
of assets and liabilities. We adopted SFAS No. 159 on May 1, 2008,
which did not have a material impact on our consolidated financial statements as
the fair value option was not elected for any of our financial assets or
financial liabilities.
In June
2007, the FASB ratified EITF Issue No. 07-3 (“EITF No. 07-3”), Accounting for Non-Refundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities, which requires nonrefundable advance payments for
goods and services that will be used or rendered for future research and
development activities be deferred and capitalized. These amounts
will be recognized as expense in the period that the related goods are delivered
or the related services are performed. We adopted the provisions of
EITF No. 07-3 on May 1, 2008, which did not have a material impact on
our consolidated financial statements.
In
November 2007, the FASB ratified EITF Issue 07-01 (“EITF No. 07-01”), Accounting for Collaborative
Arrangements, which defines collaborative arrangements and requires that
revenues and costs incurred with third parties that do not participate in the
collaborative arrangements be reported in the statement of operations gross or
net pursuant to the guidance in EITF No. 99-19, Reporting Revenue Gross as a
Principal versus Net as an Agent. Classification of
payments made between participants of a collaborative arrangement are to be
based on other applicable authoritative accounting literature or, in the absence
of other applicable authoritative accounting literature, based on analogy to
authoritative accounting literature or a reasonable, rational, and consistently
applied accounting policy election. EITF No. 07-01 will be
effective for fiscal years beginning after December 15, 2008, which we
would be required to implement no later than May 1, 2009, and applied as a
change in accounting principal to all prior periods retrospectively for all
collaborative arrangements existing as of the effective date. We have
not yet evaluated the potential impact of adopting EITF No. 07-01 on our
consolidated financial statements.
-8-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
We
account for stock options granted under our equity compensation plans in
accordance with Statement of Financial Accounting Standards No. 123R (“SFAS No.
123R”), Share-Based Payment
(Revised 2004). SFAS No. 123R requires the recognition of
compensation expense, using a fair value based method, for costs related to all
share-based payments including grants of employee stock options. In
addition, SFAS No. 123R requires companies to estimate the fair value of
share-based payment awards on the date of grant using an option-pricing
model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense on a straight-line basis over the
requisite service periods (typically 2 to 4 years).
The fair
value of each option grant is estimated using the Black-Scholes option valuation
model. The use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs including
estimated stock price volatility, risk-free interest rate, expected dividends
and projected employee stock option exercise behaviors. In addition, SFAS
No. 123R requires forfeitures to be estimated at the time of grant and revised,
if necessary, in subsequent periods if actual forfeitures differ from those
estimates.
Total
share-based compensation expense related to employee stock option grants for the
three months ended July 31, 2008 and 2007 are included in the accompanying
condensed consolidated statements of operations as follows:
Three
Months Ended
July
31, 2008
|
Three
Months Ended
July
31, 2007
|
||||||
Research
and development
|
$ | 141,000 | $ | 129,000 | |||
Selling,
general and administrative
|
125,000 | 54,000 | |||||
Total
|
$ | 266,000 | $ | 183,000 |
As of
July 31, 2008, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,727,000. This cost is expected to be
recognized over a weighted average vesting period of 2.11 years based on current
assumptions.
Periodically,
we grant stock options to non-employee consultants. The fair value of
options granted to non-employees are measured utilizing the Black-Scholes option
valuation model and are amortized over the estimated period of service or
related vesting period in accordance with EITF 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. Share-based compensation expense
recorded during the three months ended July 31, 2008 and 2007 associated with
non-employees amounted to
$5,000 and $14,000,
respectively.
4. GOVERNMENT
CONTRACT
On June
30, 2008, we were awarded a five-year contract potentially worth up to $44.4
million to test and develop bavituximab and an equivalent fully human antibody
as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $5 million appropriated immediately for the current
federal fiscal year ending September 30, 2008. The remainder of the
$22.3 million in funding is expected to be appropriated over the remainder of
the two-year base period ending June 29, 2010. Subject to the
progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period through three one-year option
terms. Work under this contract commenced on June 30, 2008 and direct
costs associated with the contract are included in research and development
expense in the accompanying condensed consolidated statements of
operations.
-9-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
5.
STOCKHOLDERS’ EQUITY
On June
28, 2007, we entered into a Securities Purchase Agreement with several
institutional investors whereby we sold 30,000,000 shares of our common stock in
exchange for gross proceeds of $22,500,000. After deducting placement
agent fees, legal fees and other costs associated with the offering, we received
net proceeds of $20,859,000. The shares of common stock were issued
from our shelf registration statement on Form S-3, File Number 333-139975
(“January 2007 Shelf”), which allows us to issue, in one or more offerings,
shares of common stock for proceeds up to $30,000,000. As of July 31,
2008, we could raise up to $7,500,000 in remaining gross proceeds under the
January 2007 Shelf.
In
addition, as of July 31, 2008, an aggregate of 5,030,634 shares of common stock
were available for issuance under two separate effective shelf registration
statements.
As of
July 31, 2008, we have reserved 20,837,989 additional shares of our common stock
which may be issued under our shelf registration statements and stock option
plans, excluding shares of common stock that could potentially be issued under
the January 2007 Shelf, as further described in the following
table:
Number
of Shares
Reserved
|
||||
Shares
of common stock reserved for issuance under two registration
statements
|
5,030,634 | |||
Shares
of common stock reserved for issuance upon exercise of outstanding
options
|
14,437,436 | |||
Shares
of common stock reserved for future option grants under our Option
Plans
|
1,369,919 | |||
Total
shares of common stock reserved for issuance
|
20,837,989 |
6.
WARRANTS
During
the three months ended July 31, 2008, we had no outstanding
warrants. During the three months ended July 31, 2007, warrants to
purchase 53,416 shares of our common stock were exercised for net proceeds of
$45,000.
7.
SEGMENT REPORTING
Our
business is organized into two reportable operating
segments. Peregrine is engaged in the research and development of
monoclonal antibody-based therapies for the treatment of cancer and viral
infections. Avid is engaged in providing contract manufacturing
services for Peregrine and outside customers on a fee-for-services
basis.
The
accounting policies of the operating segments are the same as those described in
Note 2. We primarily evaluate the performance of our contract
manufacturing services segment based on gross profit or
loss. However, our products in research and development segment are
not evaluated based on gross profit or loss, but rather based on scientific
progress of the technologies. As such, gross profit is only provided
for our cointract manufacturing services segment in the below
table. All revenues shown below are derived from transactions with
external customers.
-10-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
Segment
information is summarized as follows:
Three
Months Ended July 31,
|
||||||||
2008
|
2007
|
|||||||
|
||||||||
Contract
manufacturing services revenue
|
$ | 1,193,000 | $ | 1,621,000 | ||||
Cost
of contract manufacturing services
|
903,000 | 1,181,000 | ||||||
Gross
profit
|
290,000 | 440,000 | ||||||
Revenues
from products in research and development
|
324,000 | 4,000 | ||||||
Research
and development expense
|
(4,068,000 | ) | (3,624,000 | ) | ||||
Selling,
general and administrative expense
|
(1,706,000 | ) | (1,708,000 | ) | ||||
Other
income, net
|
74,000 | 232,000 | ||||||
Net
loss
|
$ | (5,086,000 | ) | $ | (4,656,000 | ) |
Revenues
generated from our contract manufacturing services segment were from
the following customers:
Three
Months Ended July 31,
|
||||||||
|
2008
|
2007
|
||||||
Customer
revenues as a % of revenues:
|
||||||||
United
States (one customer)
|
84%
|
79%
|
||||||
Other
customers
|
|
16%
|
21%
|
|||||
Total
customer revenues as a % of revenues
|
100%
|
100%
|
Revenues
generated from our products in research and development segment during the three
months ended July 31, 2008 were from revenues earned under the government
contract with the DTRA (Note 4). Revenues generated from our products
in research and development segment during the three months ended July 31, 2007
were from the amortized portion of an up-front license fee received under a
license agreement.
Our
long-lived assets consist of leasehold improvements, laboratory equipment, and
furniture, fixtures and computer equipment and are net of accumulated
depreciation. Long-lived assets by segment consist of the
following:
July
31,
2008
|
April
30,
2008
|
|||||||
Long-lived
Assets, net:
|
||||||||
Contract
manufacturing services
|
$ | 1,716,000 | $ | 1,825,000 | ||||
Products
in research and development
|
209,000 | 233,000 | ||||||
Total
long-lived assets, net
|
$ | 1,925,000 | $ | 2,058,000 |
-11-
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2008 (unaudited) (continued)
8. LITIGATION
In the ordinary
course of business, we are at times subject to various legal proceedings and
disputes. Although we currently are not aware of any such legal
proceedings or claims that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or cash
flows, however, we did file or are involved with the following
lawsuits:
On January 12,
2007, we filed a complaint in the Superior Court of the State of California for
the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, MD. The lawsuit alleges claims
for breach of contract, interference with contractual relations, declaratory
relief, and injunctive relief against the defendants. Peregrine's
claims stem from a 1995 license agreement with CTL, and two amendments thereto
(collectively referred to as the "License Agreement"). Peregrine
claims that CTL breached the License Agreement by, among other things, (i) not
sharing with Peregrine all inventions, technology, know-how, patents and other
information, derived and/or developed in the People’s Republic of China and/or
at the CTL laboratory, as was required under the License Agreement; (ii) not
splitting revenue appropriately with Peregrine as required under the License
Agreement; (iii) utilizing Peregrine's licensed technologies outside of the
People’s Republic of China; and (iv) failing to enter a sublicense agreement
with a Chinese sponsor obligating the Chinese sponsor to comply with the terms
and obligations in the License Agreement. Peregrine further alleges
that Medibiotech and Shanghai Medipharm Biotech Co., Ltd. ("Medipharm Entities")
interfered with the License Agreement, leading to CTL's
breaches. This interference by the Medipharm Entities includes: 1)
posturing Shanghai Medipharm as the designated sublicensee under the License
Agreement, without binding any of the Medipharm Entities to the terms
and obligations of an appropriate sublicense agreement called for under the
License Agreement; 2) entering into a license agreement with defendant Epstein
("Epstein License Agreement") instead of CTL; 3) restricting the information CTL
was allowed to provide to Peregrine, thereby prohibiting CTL from providing to
Peregrine all information required under the License Agreement; and 4) providing
compensation to CTL, and its principals, so that CTL would enter agreements that
prohibited CTL from performing under the License Agreement. These
same monetary inducements also interfered with the 1999 Material Transfer
Agreement between Peregrine and Dr. Epstein ("MTA"), and caused Dr. Epstein to
breach the MTA. Dr. Epstein has attempted to have our claims against
him referred to binding arbitration. The Superior Court has declined
his request.
On
March 28, 2007, CTL filed a cross-complaint, which it amended on May 30, 2007,
alleging that the Company breached the Agreement, improperly terminated the
Agreement, is interfering with CTL’s agreements with various MediPharm entities
and is double-licensing the technology licensed to CTL to another
party. CTL’s cross-complaint, which seeks $20 million in damages, is
in part predicated on the existence of a sublicense agreement between CTL and
MediPharm. We are challenging the cross-complaint on the basis that
not only did CTL fail to allege an agreement with which the Company interfered,
they have been unable to produce the alleged sublicense agreement with MediPharm
despite our repeated demands.
On February
22, 2008, the MediPharm entities filed a cross-complaint alleging, as a third
party beneficiary, that that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichment. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. We intend to bring pre-trial motions to dispose of the
MediPharm Cross-Complaint.
The discovery
phase on the aforementioned cases is still ongoing. Until we complete
the discovery phase and our objections are considered, we cannot estimate the
magnitude of the claims of the parties against each other or probable outcome of
the litigation.
-12-
ITEM
2.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
This
Quarterly Report on Form 10-Q contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, which
represent our projections, estimates, expectations or beliefs concerning among
other things, financial items that relate to management’s future plans or
objectives or to our future economic and financial performance. In
some cases, you can identify these statements by terminology such as “may”,
“should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect”
“project”, or “intend”, including their opposites or similar phrases or
expressions. You should be aware that these statements are
projections or estimates as to future events and are subject to a number of
factors that may tend to influence the accuracy of the
statements. These forward-looking statements should not be regarded
as a representation by the Company or any other person that the events or plans
of the Company will be achieved. You should not unduly rely on these
forward-looking statements, which speak only as of the date of this Quarterly
Report. We undertake no obligation to publicly revise any
forward-looking statement to reflect circumstances or events after the date of
this Quarterly Report or to reflect the occurrence of unanticipated events. You
should, however, review the factors and risks we describe in the reports we file
from time to time with the Securities and Exchange Commission (“SEC”)
after the date of this Quarterly Report. Actual results may differ
materially from any forward looking statement.
Company
Overview
We are a
clinical stage biopharmaceutical company developing monoclonal antibodies
for the treatment of cancer and hepatitis C virus (“HCV”)
infection. We are advancing three separate clinical programs with our
first-in-class compounds bavituximab and Cotara® that employ our two platform
technologies: Anti-Phosphatidylserine (“Anti-PS”) therapeutics and
Tumor Necrosis Therapy (“TNT”). Our lead Anti-PS product,
bavituximab, is being evaluated under two separate clinical programs for the
treatment of solid cancers and hepatitis C virus (“HCV”)
infection. Under our TNT technology platform, our lead candidate
Cotara®, is advancing through two clinical studies for the treatment of patients
with brain cancer.
We are
organized into two reportable operating segments: (i) Peregrine, the parent
company, is engaged in the research and development of monoclonal antibody
products for the treatment of cancer and viral infections and (ii) Avid
Bioservices, Inc., (“Avid”) a wholly owned subsidiary, is engaged in providing
contract manufacturing services for Peregrine and outside customers on a
fee-for-services basis.
Going
Concern
The
Company’s consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. The financial
statements do not include any adjustments relating to the recoverability of the
recorded assets or the classification of liabilities that may be necessary
should it be determined that we are unable to continue as a going
concern.
At July
31, 2008, we had $9,963,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of our wholly owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. Unless and until we are
able to generate sufficient revenues from Avid’s contract manufacturing services
and/or from the sale and/or licensing of our products under development, we
expect such losses to continue for the foreseeable future.
-13-
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations. As discussed in Note 1 to the condensed consolidated
financial statements, there exists substantial doubt regarding our ability to
continue as a going concern.
We will
need to raise additional capital through one or more methods, including equity
or debt financings, in order to support the costs of our clinical and
pre-clinical programs through one or more methods including either equity or
debt financing. As of July 31, 2008, we had an aggregate of 5,030,634
shares available under our existing effective Form S-3 registration statements
for possible future registered transactions. In addition, we filed a
separate shelf registration statement on Form S-3, File Number 333-139975, under
which we may issue, from time to time, in one or more offerings, shares of our
common stock for remaining gross proceeds of up to $7,500,000.
We may
also raise additional capital though negotiating licensing or collaboration
agreements for our technology platforms. In addition, our wholly
owned subsidiary Avid Bioservices, Inc., represents an additional asset in our
portfolio and we are actively pursuing strategic initiatives for Avid as a means
of raising additional capital.
Although we will continue
to explore these potential opportunities, there can be no assurances that we
will be successful in raising sufficient capital on terms acceptable to us, or
at all, or that sufficient additional revenues will be generated from Avid or
under potential licensing or partnering agreements or from a potential strategic
transaction related to our subsidiary, Avid Bioservices, Inc. to complete the
research, development, and clinical testing of our product
candidates. Based on our current projections, which include
projected revenues from existing customers of Avid Bioservices, Inc., combined
with the projected revenues from our government contract, we believe we have
sufficient cash on hand combined with amounts expected to be received from Avid
customers and from our government contract to meet our obligations as they
become due through at least fiscal year 2009. There are a number of
uncertainties associated with our financial projections, including but not
limited to, termination of contracts and technical challenges, which would
reduce or delay our future projected cash-inflows. As a result, we would not
have sufficient capital to operate our business through fiscal year 2009 unless
we raise additional capital. The uncertainties surrounding our
future cash inflows have raised substantial doubt regarding our ability to
continue as a going concern.
-14-
Clinical
Trial Programs
The following represents a summary of
our ongoing clinical trial programs:
Product
|
Indication
|
Trial
Design
|
Trial
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I monotherapy repeat dose safety study designed to treat up to 28
patients.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
plus docetaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients if six or more
objective tumor responses are observed in the initial 15
patients.
|
Patient
enrollment for the first 15 patients is complete and the pre-defined
primary endpoint of six or more objective tumor responses was achieved
with seven of fourteen evaluable patients achieving objective tumor
response at the first eight week evaluation point. The design
of the clinical trial now allows for an additional 31 study patients to be
enrolled. Patients are continuing to be monitored for secondary
endpoints.
|
Bavituximab
plus carboplatin and paclitaxel
|
Advanced
breast cancer
|
Phase
II study designed to treat up to 15 patients initially. Study
may be expanded to treat up to a total of 46 patients if promising results
are observed in the initial 15 patients.
|
Patient
dosing was initiated in August 2008 and enrollment is
continuing.
|
Bavituximab
plus carboplatin and paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II study designed to treat 21 patients initially. Study may be expanded to
treat up to a total of 49 patients if promising results are observed in
the initial 21 patients.
|
Patient
dosing was initiated in June 2008 and enrollment is
continuing.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Patient
enrollment is continuing in this study.
|
Cotara
|
Glioblastoma
multiforme (GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at first
relapse.
|
Patient
enrollment is continuing in this study.
|
Bavituximab
|
Chronic
hepatitis C virus (“HCV”) infection co-infected with HIV
|
Phase
Ib repeat dose safety study designed to treat up to 24
patients.
|
Patient
enrollment is continuing in this
study.
|
-15-
Results
of Operations
The
following table compares the unaudited condensed consolidated statements of
operations for the three-month periods ended July 31, 2008 and
2007. This table provides you with an overview of the changes in the
condensed consolidated statements of operations for the comparative periods,
which are further discussed below.
Three
Months Ended July 31,
|
||||||||||||
2008
|
2007
|
$
Change
|
||||||||||
REVENUES:
|
||||||||||||
Contract
manufacturing revenue
|
$ | 1,193,000 | $ | 1,621,000 | $ | (428,000 | ) | |||||
Government
contract revenue
|
324,000 | - | 324,000 | |||||||||
License
revenue
|
- | 4,000 | (4,000 | ) | ||||||||
Total
revenues
|
1,517,000 | 1,625,000 | (108,000 | ) | ||||||||
COSTS
AND EXPENSES:
|
||||||||||||
Cost
of contract manufacturing
|
903,000 | 1,181,000 | (278,000 | ) | ||||||||
Research
and development
|
4,068,000 | 3,624,000 | 444,000 | |||||||||
Selling,
general & administrative
|
1,706,000 | 1,708,000 | (2,000 | ) | ||||||||
Total
costs and expenses
|
6,677,000 | 6,513,000 | 164,000 | |||||||||
LOSS
FROM OPERATIONS
|
(5,160,000 | ) | (4,888,000 | ) | (272,000 | ) | ||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||
Interest
and other income
|
75,000 | 239,000 | (164,000 | ) | ||||||||
Interest
and other expense
|
(1,000 | ) | (7,000 | ) | 6,000 | |||||||
NET
LOSS
|
$ | (5,086,000 | ) | $ | (4,656,000 | ) | $ | (430,000 | ) |
Results
of operations for interim periods covered by this quarterly report on Form 10-Q
may not necessarily be indicative of results of operations for the full fiscal
year.
Total
Revenues.
The
decrease in total revenues of $108,000 during the three months ended July 31,
2008 compared to the same period in the prior year was due to decreases in
contract manufacturing revenue of $428,000 and license revenue of $4,000, which
amounts were offset by a $324,000 increase in government contract
revenue. The decrease in contract manufacturing revenue was primarily
due to a decrease in services provided to unrelated entities on a
fee-for-service basis including a decrease in the number of completed
manufacturing runs compared to the same quarter in the prior
year. This decrease was offset by an increase in government
contract revenue associated with research and development services performed
under our federal contract with the U.S. Department of Defense’s Defense Threat
Reduction Agency (DTRA).
We expect
to continue to generate contract manufacturing revenue during the remainder of
the current fiscal year based on the anticipated completion of in-process
customer related projects and the anticipated demand for Avid’s services under
signed and outstanding proposals.
-16-
In
addition, we expect to continue to generate government contract revenue
associated with our federal contract with the DTRA, which was awarded to us on
June 30, 2008 and is a five-year contract potentially worth up to $44.4 million
to test and develop bavituximab and an equivalent fully human antibody as
potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $5 million appropriated immediately for the current
federal fiscal year ending September 30, 2008. The remainder of the
$22.3 million in funding is expected to be appropriated over the remainder of
the two-year base period ending June 29, 2010. Subject to the
progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period through three one-year option
terms.
Cost of Contract
Manufacturing.
The
decrease in cost of contract manufacturing of $278,000 during the three months
ended July 31, 2008 compared to the same period in the prior year was directly
related to the current quarter decrease in contract manufacturing
revenue. We expect contract manufacturing costs to increase during
the remainder of the current fiscal year based on the anticipated completion of
customer projects under our current contract manufacturing
agreements.
Research and
Development Expenses.
The
increase in research and development (“R&D”) expenses of $444,000 during the
three-month period ended July 31, 2008 compared to the same period in the prior
year was primarily due to a net increase in expenses associated with each of our
following platform technologies under development:
Technology
Platform
|
R&D
Expenses-
Quarter Ended July 31,
2008
|
R&D
Expenses-
Quarter Ended July 31,
2007
|
$
Change
|
|||||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$ | 2,809,000 | $ | 2,294,000 | $ | 515,000 | ||||||
TNT
(Cotara®)
|
1,155,000 | 709,000 | 446,000 | |||||||||
VTA
and Anti-Angiogenesis Agents
|
92,000 | 464,000 | (372,000 | ) | ||||||||
VEA
|
12,000 | 157,000 | (145,000 | ) | ||||||||
Total
R&D Expenses
|
$ | 4,068,000 | $ | 3,624,000 | $ | 444,000 |
o
|
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) – The increase in
Anti-PS Immunotherapeutics program expenses of $515,000 during the three
months ended July 31, 2008 compared to the same period in the prior year
is primarily due to an increase in clinical trial and manufacturing
expenses to support the advancement of four clinical trials using
bavituximab for the treatment of solid tumors and one clinical trial for
the treatment of HCV patients co-infected with HIV.
|
|
o
|
Tumor Necrosis Therapy (“TNT”)
(Cotara®) – The increase in TNT program expenses of $446,000 during
the three months ended July 31, 2008 compared to the same period in the
prior year is primarily due to increases in clinical trial and
manufacturing expenses to support the continued advancement of our two
ongoing Cotara® clinical trials for the treatment of brain
cancer.
|
|
o
|
Vascular Targeting Agents
(“VTAs”) and Anti-Angiogenesis Agents – The decrease in
VTA and Anti-Angiogenesis Agents program expenses of $372,000 during the
three months ended July 31, 2008 compared to the same period in the prior
year is primarily due to our efforts to significantly curtail our
development expenses associated with this program while focusing our
efforts on seeking partners to further advance these
technologies.
|
-17-
o
|
Vasopermeation Enhancement
Agents (“VEAs”) – The decrease in VEA program expenses of $145,000
during the three months ended July 31, 2008 compared to the same period in
the prior year is primarily due to our efforts to significantly curtail
our development expenses associated with this program while focusing our
efforts on seeking partners to further advance this
technology.
|
Looking
beyond the current fiscal year, it is extremely difficult for us to reasonably
estimate all future research and development costs associated with each of our
technologies due to the number of unknowns and uncertainties associated with
pre-clinical and clinical trial development. These unknown variables
and uncertainties include, but are not limited to:
●
|
the
uncertainty of future clinical trial results;
|
|
●
|
the
uncertainty of the ultimate number of patients to be treated in any
current or future clinical trial;
|
|
●
|
the
uncertainty of the U.S. Food and Drug Administration allowing our studies
to move forward from Phase I clinical studies to Phase II and Phase III
clinical studies;
|
|
●
|
the
uncertainty of the rate at which patients are enrolled into any current or
future study. Any delays in clinical trials could significantly
increase the cost of the study and would extend the estimated completion
dates;
|
|
●
|
the
uncertainty of future costs associated with our pre-clinical candidates,
including Vascular Targeting Agents, Anti-Angiogenesis Agents, and
Vasopermeation Enhancement Agents, which costs are dependent on the
success of pre-clinical development. We are not certain whether
these product candidates will be successful or whether we will incur any
additional costs beyond pre-clinical development given our above stated
intent to find partners to move these programs forward;
|
|
●
|
the
uncertainty of terms related to potential future partnering or licensing
arrangements; and
|
|
●
|
the
uncertainty of protocol changes and modifications in the design of our
clinical trial studies, which may increase or decrease our future
costs.
|
We or our
potential partners will need to do additional development and clinical testing
prior to seeking any regulatory approval for commercialization of our product
candidates as all of our products are in discovery, pre-clinical or clinical
development. Testing, manufacturing, commercialization, advertising,
promotion, exporting, and marketing, among other things, of our proposed
products are subject to extensive regulation by governmental authorities in the
United States and other countries. The testing and approval process
requires substantial time, effort, and financial resources, and we cannot
guarantee that any approval will be granted on a timely basis, if at
all. Companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in conducting advanced human clinical trials,
even after obtaining promising results in earlier
trials. Furthermore, the United States Food and Drug Administration
may suspend clinical trials at any time on various grounds, including a finding
that the subjects or patients are being exposed to an unacceptable health
risk. Even if regulatory approval of a product is granted, such
approval may entail limitations on the indicated uses for which it may be
marketed. Accordingly, we or our potential partners may experience
difficulties and delays in obtaining necessary governmental clearances and
approvals to market our products.
Selling,
General and Administrative Expenses.
Selling,
general and administrative expenses consist primarily of payroll and related
expenses, director fees, legal and accounting fees, share-based compensation
expense, investor and public relation fees, insurance, and other expenses
relating to the general management, administration, and business development
activities of the Company.
Selling,
general and administrative expenses during the three months ended July 31, 2008
remained in line with the same period in the prior year decreasing slightly by
$2,000. The net decrease in selling, general and administrative
expenses of $2,000 was primarily due to a decrease in corporate legal fees
offset by an increase in payroll and related expenses. Corporate
legal fees decreased $95,000 from $210,000 in the prior year three-month period
to $115,000 in the current year three-month period primarily due to a decrease
in legal fees associated with the lawsuit described in this Quarterly Report on
Form 10-Q under Part II, Item 1, “Legal Proceedings”, combined with a decrease
in legal fees associated with general corporate matters. Payroll and
related expenses increased $90,000 from $768,000 in the prior year three-month
period to $858,000 in the current year three-month period primarily due to an
increase in consulting fees associated with business development activities and
other general corporate activities.
-18-
Interest and
Other Income.
The
decrease in interest and other income of $164,000 during the three months ended
July 31, 2008 compared to the same period in the prior year was due to a
$165,000 decrease in interest income as a result of a lower average cash balance
on hand during the current year period compared to the prior year
period.
Critical
Accounting Policies
The
methods, estimates, and judgments we use in applying our most critical
accounting policies have a significant impact on the results we report in our
condensed consolidated financial statements. We evaluate our estimates and
judgments on an ongoing basis. We base our estimates on historical
experience and on assumptions that we believe to be reasonable under the
circumstances. Our experience and assumptions form the basis for our
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may vary from
what we anticipate and different assumptions or estimates about the future could
change our reported results. We believe the following accounting policies are
the most critical to us, in that they are important to the portrayal of our
financial statements and they require our most difficult, subjective or complex
judgments in the preparation of our condensed consolidated financial
statements:
Revenue
Recognition
We
recognize revenues pursuant to the SEC’s Staff Accounting Bulletin No. 104 (“SAB
No. 104”), Revenue
Recognition. In accordance with SAB No. 104, revenue is
generally realized or realizable and earned when (i) persuasive evidence of an
arrangement exists, (ii) delivery has occurred or services have been rendered,
(iii) the seller's price to the buyer is fixed or determinable, and (iv)
collectibility is reasonably assured.
We also comply with Financial
Accounting Standards Board’s Emerging Issues Task Force No. 00-21 (“EITF
00-21”), Revenue Arrangements
with Multiple Deliverables. In accordance with EITF 00-21, we
recognize revenue for delivered elements only when the delivered element has
stand-alone value and we have objective and reliable evidence of fair value for
each undelivered element. If the fair value of any undelivered
element included in a multiple element arrangement cannot be objectively
determined, revenue is deferred until all elements are delivered and services
have been performed, or until fair value can objectively be determined for any
remaining undelivered elements.
In July
2000, the Emerging Issues Task Force (“EITF”) released Issue 99-19 (“EITF
99-19”), Reporting Revenue
Gross as a Principal versus Net as an Agent. EITF 99-19
summarized the EITF’s views on when revenue should be recorded at the gross
amount billed to a customer because it has earned revenue from the sale of goods
or services, or the net amount retained (the amount billed to the customer less
the amount paid to a supplier) because it has earned a fee or
commission. In addition, the EITF released Issue 00-10 (“EITF
00-10”), Accounting for
Shipping and Handling Fees and Costs, and Issue 01-14 (“EITF 01-14”),
Income Statement
Characterization of Reimbursements Received for “Out-of-Pocket” Expenses
Incurred. EITF 00-10 summarized the EITF’s views on how the
seller of goods should classify in the income statement amounts billed to a
customer for shipping and handling and the costs associated with shipping and
handling. EITF 01-14 summarized the EITF’s views on when the
reimbursement of out-of-pocket expenses should be characterized as revenue or as
a reduction of expenses incurred. Our revenue recognition policies
are in compliance with EITF 99-19, EITF 00-10 and EITF 01-14 whereby we record
revenue for the gross amount billed to customers (the cost of raw materials,
supplies, and shipping, plus the related handling mark-up fee) and we record the
cost of the amounts billed as cost of sales as we act as a principal in these
transactions.
-19-
Revenues
associated with contract manufacturing services provided by Avid are generally
recognized once the service has been provided and/or upon shipment of the
product to the customer. We also record a provision for estimated
contract losses, if any, in the period in which they are
determined.
Revenues
associated with licensing agreements primarily consist of nonrefundable up-front
license fees and milestone payments. Revenues under licensing
agreements are recognized based on the performance requirements of the
agreement. Nonrefundable up-front license fees received under license
agreements, whereby continued performance or future obligations are considered
inconsequential to the relevant licensed technology, are generally recognized as
revenue upon delivery of the technology. Nonrefundable up-front
license fees, whereby we have an ongoing involvement or performance obligations,
are recorded as deferred revenue and recognized as revenue over the term of the
performance obligation or relevant agreement. Milestone payments are
generally recognized as revenue upon completion of the milestone assuming there
are no other continuing obligations. Under some license agreements,
the obligation period may not be contractually defined. Under these
circumstances, we must exercise judgment in estimating the period of time over
which certain deliverables will be provided to enable the licensee to practice
the license.
Revenues
associated with our government contract are recognized in accordance with
Accounting Research Bulletin No. 43 Chapter 11, Government
Contracts. Our government contract with the U.S. Department of
Defense’s Defense Threat Reduction Agency (DTRA) is a “cost-plus-fixed-fee”
contract. Reimbursable costs under the contract primarily
include direct labor, subcontract costs, materials, equipment, travel, indirect
costs, and a fixed fee for our efforts. Revenue under this
“cost-plus-fixed-fee” contract is recognized as we perform the underlying
research and development activities. However, progress payments
associated with contract manufacturing services performed under the DTRA
contract are classified as Deferred Government Contract Revenue and are
recognized as revenue upon delivery or transfer of legal title of the product to
the DTRA.
Share-based
Compensation Expense
We
currently maintain four equity compensation plans which provide for the granting
of options to our employees to purchase shares of our common stock at exercise
prices not less than the fair market value of our common stock at the date of
grant. The granting of options are share-based payments and are
subject to the fair value recognition provisions of Statement of Financial
Accounting Standards No. 123R (“SFAS No. 123R”), Share-Based Payment (Revised
2004), which requires the recognition of compensation expense, using a
fair value based method, for costs related to all share-based payments including
grants of employee stock options.
The fair
value of each option grant is estimated using the Black-Scholes option valuation
model and are amortized as compensation expense on a straight-line basis over
the requisite service periods of the awards, which is generally the vesting
period (typically 2 to 4 years). Use of a valuation model requires us
to make certain estimates and assumptions with respect to selected model
inputs. Expected volatility is based on daily historical volatility
of our stock covering the estimated expected term. The expected term
of options granted prior to November 1, 2007 was based on the expected time to
exercise using the “simplified” method allowable under the Security and Exchange
Commission’s Staff Accounting Bulletin No. 107 (“SAB No.
107”). Effective November 1, 2007, the expected term reflects actual
historical exercise activity and assumptions regarding future exercise activity
of unexercised, outstanding options and is applied to all option grants
subsequent to October 31, 2007. The risk-free interest rate is based
on U.S. Treasury notes with terms within the contractual life of the option at
the time of grant. In addition, SFAS No. 123R requires
forfeitures to be estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those
estimates.
Our loss
from operations for the three-month periods ended July 31, 2008 and 2007
included share-based compensation expense of $266,000 and $183,000,
respectively. We believe that non-cash share-based compensation
expense for the remaining nine months of fiscal year 2009 may be up to
approximately $609,000 based on actual shares granted and unvested as of July
31, 2008. However, the actual expense may differ materially from this
estimate as a result of changes in a number of factors that affect the amount of
non-cash compensation expense, including the number of options granted by our
Board of Directors during the remainder of the fiscal year, the price of our
common stock on the date of grant, the volatility of our stock price, the
estimate of the expected life of options granted and the risk-free interest
rates.
-20-
As of
July 31, 2008, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,727,000. This cost is expected to be
recognized over a weighted average period of 2.11 years.
Allowance
for Doubtful Accounts
We
continually monitor our allowance for doubtful accounts for all
receivables. A considerable amount of judgment is required in
assessing the ultimate realization of these receivables and we estimate an
allowance for doubtful accounts based on these factors at that point in
time. As of July 31, 2008, based on our analysis of our accounts
receivable balances and based on historical collectibility of receivables from
our current customers, we determined no allowance for doubtful accounts was
necessary.
Liquidity
and Capital Resources
At July
31, 2008, we had $9,963,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of our wholly owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect the negative cash flows from operations to continue for the foreseeable
future. Our net losses incurred during the past three fiscal years
ended April 30, 2008, 2007 and 2006 amounted to $23,176,000, $20,796,000, and
$17,061,000, respectively. Unless and until we are able to generate
sufficient revenues from Avid’s contract manufacturing services and/or from the
sale and/or licensing of our products under development, we expect such losses
to continue for the foreseeable future.
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations. As discussed in Note 1 to the condensed consolidated
financial statements, there exists substantial doubt regarding our ability to
continue as a going concern.
We will
need additional capital to support the costs of our clinical and pre-clinical
programs through one or more methods including either equity or debt
financing. As of July 31, 2008, we had an aggregate of approximately
5,030,634 shares available under our existing effective Form S-3 registration
statements for possible future registered transactions. In addition,
we filed a separate shelf registration statement on Form S-3, File Number
333-139975, under which we may issue, from time to time, in one or more
offerings, shares of our common stock for remaining gross proceeds of up to
$7,500,000.
We may
also raise additional capital though negotiating licensing or collaboration
agreements for our technology platforms. In addition, our wholly
owned subsidiary Avid Bioservices, Inc., represents an additional asset in our
portfolio and we are actively pursuing strategic initiatives for Avid as a means
of raising additional capital.
Although
we will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. to complete the research, development, and clinical testing of
our product candidates. Based on our current projections, which
includes projected revenues from existing
customers of Avid Bioservices, Inc., combined with the projected revenues from
our government contract, we believe we have sufficient cash on hand combined
with amounts expected to be received from Avid customers and from our government
contract to meet our obligations as they become due through at least fiscal year
2009. There are a number of uncertainties associated with our
financial projections, including but not limited to, termination of contracts
and technical challenges, which could significantly reduce or delay our future
projected cash-inflows. As a result, we would not have sufficient
capital to operate our business through fiscal year 2009 unless we raised
additional capital. The uncertainties surrounding our future cash
inflows have raised substantial doubt regarding our ability to continue as a
going concern.
-21-
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the three months ended July 31, 2008 compared to the same prior
year period are as follows:
Cash Used In Operating
Activities. Cash used in operating activities is primarily
driven by changes in our net loss. However, cash used in operating
activities generally differs from our reported net loss as a result of non-cash
operating expenses or differences in the timing of cash flows as reflected in
the changes in operating assets and liabilities. During the three
months ended July 31, 2008, cash used in operating activities decreased
$1,104,000 to $5,116,000 compared to $6,220,000 for the three months ended July
31, 2007. This decrease in net cash used in operating activities was
primarily due to a net change in operating assets and payment or reduction of
liabilities in the aggregate amount of $1,446,000. This amount was
offset by an increase of $342,000 in our net loss reported in
the current quarter after taking into consideration non-cash operating
expenses. The increase in our current quarter net loss was primarily
due to a current quarter increase in research and development
expenses.
The
changes in operating activities as a result of non-cash operating expenses or
differences in the timing of cash flows as reflected by the changes in operating
assets and liabilities are as follows:
THREE
MONTHS ENDED
|
||||||||
July
31,
2008
|
July
31,
2007
|
|||||||
Net
loss, as reported
|
$ | (5,086,000 | ) | $ | (4,656,000 | ) | ||
Less
non-cash expenses and adjustments to net loss:
|
|
|||||||
Depreciation
and amortization
|
133,000 | 119,000 | ||||||
Share-based
compensation
|
271,000 | 197,000 | ||||||
Net
cash used in operating activities before changes in operating assets and
liabilities
|
$ | (4,682,000 | ) | $ | (4,340,000 | ) | ||
Net
change in operating assets and liabilities
|
$ | (434,000 | ) | $ | (1,880,000 | ) | ||
Net
cash used in operating activities
|
$ | (5,116,000 | ) | $ | (6,220,000 | ) |
Cash Used In Investing
Activities. Net cash used in investing activities increased
$41,000 to $45,000 for the three months ended July 31, 2008 compared to net cash
used of $4,000 for the three months ended July 31, 2007. This
increase was due to a net increase in other assets of $116,000 primarily due to
the reclassification of a $67,000 security deposit from other long-term assets
to other current assets during the prior year three-month period ended July 31,
2007 combined with a $45,000 current year period increase in long-term deposits,
which amounts were offset by a decrease in property acquisitions of
$75,000.
Cash (Used In) Provided By Financing
Activities. Net cash provided by financing activities
decreased $20,821,000 for the three months ended July 31, 2008 compared to the
same prior year period. During the three months ended July 31, 2008,
we incurred $6,000 in principal payments on notes payable compared to $116,000
paid in the same prior year period, or a decrease of $110,000. This
amount was offset by cash provided from financing activities in the three months
ended July 31, 2007 in the amount of $20,931,000. In the prior year
period, we entered into a security purchase agreement whereby we sold and issued
a total of 30,000,000 shares of our common stock in exchange for net proceeds of
$20,859,000. This amount was supplemented with net proceeds of
$72,000 from the exercise of stock options and warrants.
-22-
Commitments
At July 31, 2008, we had no material
capital commitments.
ITEM
3.
|
QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Changes in United States interest rates
would affect the interest earned on our cash and cash
equivalents. Based on our overall interest rate exposure at July 31,
2008, a near-term change in interest rates, based on historical movements, would
not materially affect the fair value of interest rate sensitive
instruments. Our debt instruments, which consist of capital leases,
have fixed interest rates and terms and, therefore, a significant change in
interest rates would not have a material adverse effect on our financial
position or results of operations.
ITEM
4.
|
CONTROLS AND
PROCEDURES
|
The
Company maintains disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), that are designed to ensure that information
required to be disclosed in its reports filed under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and
communicated to our management, including its Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and
procedures, management recognized that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily was
required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
The
Company carried out an evaluation, under the supervision and with the
participation of management, including its Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its
disclosure controls and procedures as of July 31, 2008, the end of the period
covered by this Quarterly Report. Based on that evaluation, the
Company’s Chief Executive Officer and Chief Financial Officer concluded that its
disclosure controls and procedures were effective at the reasonable assurance
level as of July 31, 2008.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended July 31, 2008, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
ITEM
1.
|
LEGAL
PROCEEDINGS.
|
In the
ordinary course of business, we are at times subject to various legal
proceedings and disputes. Although we currently are not aware of any
such legal proceedings or claim that we believe will have, individually or in
the aggregate, a material adverse effect on our business, operating results or
cash flows, however, we did file or are involved with the following
lawsuits:
-23-
On
January 12, 2007, we filed a complaint in the Superior Court of the State of
California for the County of Orange against Cancer Therapeutics Laboratories
(“CTL”). The original complaint has been amended three times based on
the ongoing discovery to include claims against Shanghai MediPharm and its
related entities, and Alan Epstein, MD. The lawsuit alleges claims
for breach of contract, interference with contractual relations, declaratory
relief, and injunctive relief against the defendants. Peregrine's
claims stem from a 1995 license agreement with CTL, and two amendments thereto
(collectively referred to as the "License Agreement"). Peregrine
claims that CTL breached the License Agreement by, among other things, (i) not
sharing with Peregrine all inventions, technology, know-how, patents and other
information, derived and/or developed in the People’s Republic of China and/or
at the CTL laboratory, as was required under the License Agreement; (ii) not
splitting revenue appropriately with Peregrine as required under the License
Agreement; (iii) utilizing Peregrine's licensed technologies outside of the
People’s Republic of China; and (iv) failing to enter a sublicense agreement
with a Chinese sponsor obligating the Chinese sponsor to comply with the terms
and obligations in the License Agreement. Peregrine further alleges
that Medibiotech and Shanghai Medipharm Biotech Co., Ltd. ("Medipharm Entities")
interfered with the License Agreement, leading to CTL's
breaches. This interference by the Medipharm Entities includes: 1)
posturing Shanghai Medipharm as the designated sublicensee under the License
Agreement, without binding any of the Medipharm Entities to the terms
and obligations of an appropriate sublicense agreement called for under the
License Agreement; 2) entering into a license agreement with defendant Epstein
("Epstein License Agreement") instead of CTL; 3) restricting the information CTL
was allowed to provide to Peregrine, thereby prohibiting CTL from providing to
Peregrine all information required under the License Agreement; and 4) providing
compensation to CTL, and its principals, so that CTL would enter agreements that
prohibited CTL from performing under the License Agreement. These
same monetary inducements also interfered with the 1999 Material Transfer
Agreement between Peregrine and Dr. Epstein ("MTA"), and caused Dr. Epstein to
breach the MTA. Dr. Epstein has attempted to have our claims against
him referred to binding arbitration. The Superior Court has declined
his request.
On March
28, 2007, CTL filed a cross-complaint, which it amended on May 30, 2007,
alleging that the Company breached the Agreement, improperly terminated the
Agreement, is interfering with CTL’s agreements with various MediPharm entities
and is double-licensing the technology licensed to CTL to another
party. CTL’s cross-complaint, which seeks $20 million in damages, is
in part predicated on the existence of a sublicense agreement between CTL and
MediPharm. We are challenging the cross-complaint on the basis that
not only did CTL fail to allege an agreement with which the Company interfered,
they have been unable to produce the alleged sublicense agreement with MediPharm
despite our repeated demands.
On
February 22, 2008, the MediPharm entities filed a cross-complaint alleging, as a
third party beneficiary, that the Company breached the Agreement by
double-licensing the technology licensed to CTL to another party, intentionally
interfered with a prospective economic advantage, and unjust
enrichment. MediPharm’s cross-complaint, which seeks $30 million in
damages, is in part predicated on MediPharm being the “Chinese Sponsor” under
the Agreement. We intend to bring pre-trial motions to dispose of the
MediPharm Cross-Complaint.
The
discovery phase on the aforementioned cases is still ongoing. Until
we complete the discovery phase and our objections are considered, we cannot
estimate the magnitude of the claims of the parties against each other or
probable outcome of the litigation.
ITEM
1A.
|
RISK
FACTORS
|
The following risk factors below
update, and should be considered in addition to, the risk factors previously
disclosed by us in Part 1, Item 1A of our Annual Report for the fiscal year
ended April 30, 2008.
If
We Cannot Obtain Additional Funding, Our Product Development And
Commercialization Efforts May Be Reduced Or Discontinued And We May Not Be Able
To Continue Operations.
At July
31, 2008, we had $9,963,000 in cash and cash equivalents. We have
expended substantial funds on (i) the research, development and clinical trials
of our product candidates, and (ii) funding the operations of our wholly owned
subsidiary, Avid Bioservices, Inc. As a result, we have historically
experienced negative cash flows from operations since our inception and we
expect to continue to experience negative cash flows from operations for the
foreseeable future. Our net losses incurred during the past three
fiscal years ended April 30, 2008, 2007 and 2006 amounted to $23,176,000,
$20,796,000, and $17,061,000, respectively. Unless and until we are
able to generate sufficient revenues from Avid’s contract manufacturing services
and/or from the sale and/or licensing of our products under development, we
expect such losses to continue for the foreseeable future.
-24-
Therefore,
our ability to continue our clinical trials and development efforts is highly
dependent on the amount of cash and cash equivalents on hand combined with our
ability to raise additional capital to support our future
operations. As discussed in Note 1 to the condensed consolidated
financial statements, there exists substantial doubt regarding our ability to
continue as a going concern.
We will
need to raise additional capital through one or more methods, including equity
or debt financings, in order to support the costs of our clinical and
pre-clinical programs. If we raise additional capital through the issuance
of debt securities, the debt securities may be secured and any interest and
principal payments would reduce the amount of cash available to operate and grow
our business. If we raise additional capital through the issuance of
equity securities, such issuances will likely cause dilution to our
stockholders, particularly if we are required to do so during periods when our
common stock is trading at historically low price levels. As of July
31, 2008, we had an aggregate of approximately 5,030,634 shares available under
our existing effective Form S-3 registration statements for possible future
registered transactions. In addition, we filed a separate shelf
registration statement on Form S-3, File Number 333-139975, under which we may
issue, from time to time, in one or more offerings, shares of our common stock
for remaining gross proceeds of up to $7,500,000.
We may
also raise additional capital though negotiating licensing or collaboration
agreements for our technology platforms. In addition, our wholly
owned subsidiary Avid Bioservices, Inc., represents an additional asset in our
portfolio and we are actively pursuing strategic initiatives for Avid as a means
of raising additional capital.
Although
we will continue to explore these potential opportunities, there can be no
assurances that we will be successful in raising sufficient capital on terms
acceptable to us, or at all, or that sufficient additional revenues will be
generated from Avid or under potential licensing or partnering agreements or
from a potential strategic transaction related to our subsidiary, Avid
Bioservices, Inc. to complete the research, development, and clinical testing of
our product candidates. Based on our current projections, which
includes projected revenues from existing customers of Avid Bioservices, Inc.,
combined with the projected revenues from our government contract, we believe we
have sufficient cash on hand combined with amounts expected to be received from
Avid customers and from our government contract to meet our obligations as they
become due through at least fiscal year 2009. There are a number of
uncertainties associated with our financial projections, including but not
limited to, termination of contracts and technical challenges, which would
reduce or delay our future projected cash-inflows. As a result,
we would not have sufficient capital to operate our business through fiscal year
2009 unless we raise additional capital.
We
Have Had Significant Losses And We Anticipate Future Losses.
We have incurred net losses in most
fiscal years since we began operations in 1981. The following table
represents net losses incurred for the three months ended July 31, 2008 and
for each of the past three fiscal years:
Net Loss
|
||||
Three
months ended July 31, 2008 (unaudited)
|
$ | 5,086,000 | ||
Fiscal
Year 2008
|
$ | 23,176,000 | ||
Fiscal
Year 2007
|
$ | 20,796,000 | ||
Fiscal
Year 2006
|
$ | 17,061,000 |
-25-
As of
July 31, 2008, we had an accumulated deficit of $235,922,000. While
we expect to continue to generate revenues from Avid’s contract manufacturing
services, in order to achieve and sustain profitable operations, we must
successfully develop and obtain regulatory approval for our products, either
alone or with others, and must also manufacture, introduce, market and sell our
products. The costs associated with clinical trials and product
manufacturing is very expensive and the time frame necessary to achieve market
success for our products is long and uncertain. We do not expect to
generate product or royalty revenues for at least the next two years, and we may
never generate product and/or royalty revenues sufficient to become profitable
or to sustain profitability.
The Sale Of
Substantial Shares Of Our Common Stock May Depress Our Stock Price.
As of
July 31, 2008, there were approximately 226,211,000
shares of our common stock outstanding. Substantially all of these
shares are eligible for trading in the public market, subject in some cases to
volume and other limitations. The market price of our common stock
may decline if our common stockholders sell a large number of shares of our
common stock in the public market, or the market perceives that such sales may
occur.
We could
also issue up to 20,837,989 additional shares of our common stock that are
reserved for future issuance under our shelf registration statements and stock
option plans, as further described in the following table:
Number
of Shares
of Common Stock Reserved
For Issuance
|
|||||
Shares
reserved for issuance under two effective shelf registration
statements
|
5,030,634
|
||||
Common
shares reserved for issuance upon exercise of outstanding options
or reserved for future option grants under our stock incentive
plans
|
15,807,355
|
||||
Total
|
20,837,989
|
In
addition, the above table does not include shares of common stock that we have
available to issue from the registration statement we filed during January 2007
on Form S-3, File Number 333-139975, under which we may issue, from time to
time, in one or more offerings, shares of our common stock for remaining gross
proceeds of up to $7,500,000.
Of the
total options outstanding as of July 31, 2008, approximately 1,080,000 options
would be considered dilutive to stockholders because we would receive an amount
per share which is less than the market price of our common stock at July 31,
2008.
In
addition, we will need to raise substantial additional capital in the future to
fund our operations. If we raise additional funds by issuing equity
securities, the market price of our securities may decline and our existing
stockholders may experience significant dilution.
Our
Highly Volatile Stock Price And Trading Volume May Adversely Affect The
Liquidity Of Our Common Stock.
The
market price of our common stock and the market prices of securities of
companies in the biotechnology sector have generally been highly volatile and
are likely to continue to be highly volatile.
-26-
The
following table shows the high and low sales price and trading volume of our
common stock for each quarter in the three fiscal years ended April 30, 2008,
and our fiscal quarter ended July 31, 2008:
Common
Stock
Sales
Price
|
Common
Stock Daily Trading Volume
(000’s
omitted)
|
|||||||
High
|
Low
|
High
|
Low
|
|||||
Fiscal
Year 2009
|
||||||||
Quarter
Ended July 31, 2008
|
$0.53
|
$0.31
|
2,997
|
103
|
||||
Fiscal
Year 2008
|
||||||||
Quarter
Ended April 30, 2008
|
$0.73
|
$0.35
|
3,846
|
130
|
||||
Quarter
Ended January 31, 2008
|
$0.65
|
$0.35
|
3,111
|
140
|
||||
Quarter
Ended October 31, 2007
|
$0.79
|
$0.54
|
2,631
|
169
|
||||
Quarter
Ended July 31, 2007
|
$1.40
|
$0.72
|
21,653
|
237
|
||||
Fiscal
Year 2007
|
||||||||
Quarter
Ended April 30, 2007
|
$1.26
|
$0.86
|
6,214
|
408
|
||||
Quarter
Ended January 31, 2007
|
$1.39
|
$1.09
|
4,299
|
203
|
||||
Quarter
Ended October 31, 2006
|
$1.48
|
$1.12
|
3,761
|
277
|
||||
Quarter
Ended July 31, 2006
|
$1.99
|
$1.30
|
23,790
|
429
|
||||
Fiscal
Year 2006
|
|
|||||||
Quarter
Ended April 30, 2006
|
$1.76
|
$1.20
|
9,922
|
391
|
||||
Quarter
Ended January 31, 2006
|
$1.40
|
$0.88
|
12,152
|
251
|
||||
Quarter
Ended October 31, 2005
|
$1.28
|
$0.91
|
4,619
|
156
|
||||
Quarter
Ended July 31, 2005
|
$1.31
|
$0.92
|
7,715
|
178
|
The market price of our common stock
may be significantly impacted by many factors, including, but not limited
to:
·
|
announcements
of technological innovations or new commercial products by us or our
competitors;
|
|
·
|
publicity
regarding actual or potential clinical trial results relating to products
under development by us or our competitors;
|
|
·
|
our
financial results or that of our competitors, including our abilities to
continue as a going concern;
|
|
·
|
the
offering and sale of shares of our common stock at a discount under an
equity transaction;
|
|
·
|
changes
in our capital structure, including but not limited to any potential
reverse stock split;
|
|
·
|
published
reports by securities analysts;
|
|
·
|
announcements
of licensing agreements, joint ventures, strategic alliances, and any
other transaction that involves the sale or use of our technologies or
competitive technologies;
|
|
·
|
developments
and/or disputes concerning our patent or proprietary
rights;
|
|
·
|
regulatory
developments and product safety concerns;
|
|
·
|
general
stock trends in the biotechnology and pharmaceutical industry
sectors;
|
|
·
|
public
concerns as to the safety and effectiveness of our
products;
|
|
·
|
economic
trends and other external factors, including but not limited to, interest
rate fluctuations, economic recession, inflation, foreign market trends,
national crisis, and disasters; and
|
|
·
|
healthcare
reimbursement reform and cost-containment measures implemented by
government agencies.
|
These and
other external factors have caused and may continue to cause the market price
and demand for our common stock to fluctuate substantially, which may limit or
prevent investors from readily selling their shares of common stock, and may
otherwise negatively affect the liquidity of our common stock.
-27-
The
Liquidity Of Our Common Stock Will Be Adversely Affected If Our Common Stock Is
Delisted From The Nasdaq Capital Market.
Our
common stock is presently traded on The Nasdaq Capital Market. To
maintain inclusion on The Nasdaq Capital Market, we must continue to meet the
following six listing requirements:
1.
|
Net
tangible assets of at least $2,500,000 or market capitalization of at
least $35,000,000 or net income of at least $500,000 in either our latest
fiscal year or in two of our last three fiscal years;
|
|
2.
|
Public
float of at least 500,000 shares;
|
|
3.
|
Market
value of our public float of at least $1,000,000;
|
|
4.
|
A
minimum closing bid price of $1.00 per share of common stock, without
falling below this minimum bid price for a period of thirty consecutive
trading days;
|
|
5.
|
At
least two market makers; and
|
|
6.
|
At
least 300 stockholders, each holding at least 100 shares of common
stock.
|
On July
25, 2007, we received a deficiency notice from The NASDAQ Stock Market notifying
us that we had not met the $1.00 minimum closing bid price requirement for
thirty consecutive trading days as required under NASDAQ listing
rules. According to the NASDAQ notice, we were automatically afforded
an initial “compliance period” of 180 calendar days, or until January 22, 2008,
to regain compliance with this requirement. After the initial 180
calendar day period, we remained noncompliant with the minimum closing bid price
requirement but because we were in compliance with all other initial listing
requirements, we were afforded an additional “compliance period” of 180 calendar
days, or until July 21, 2008. Because we did not regain compliance,
i.e., the closing bid price of the Company’s common stock did not meet or exceed
$1.00 per share for a minimum of ten (10) consecutive business day prior to July
21, 2008, on July 22, 2008 we received a notice from The NASDAQ Stock Market
indicating that we were not in compliance with the minimum bid price requirement
for continued listing, and as a result our common stock is subject to
delisting. On July 28, 2008, we requested a hearing with the NASDAQ
Listing Qualifications Panel (“Panel”) to review the delisting
determination. Our request for a hearing will stay the delisting
pending a decision by the Panel. The oral hearing took place
September 4, 2008 in which we presented to the Panel our definitive plan to
achieve and sustain long-term compliance with the listing requirements of the
NASDAQ Capital Market. If the Panel agrees, it has discretion to
grant us a conditional listing (exemption) for an additional period of time not
to exceed the earlier of 90 days from the date of its decision or 180 days from
the date of the delisting notification. Such conditional listing
(exemption) will allow us time to conduct our 2008 annual meeting of
stockholders and to seek stockholder approval an amendment to our certificate of
incorporation to effect a reverse stock split. If such amendment to
our certificate of incorporation is approved by the stockholders, we will then
have time to file the amendment to effect the reverse split and thereafter have
a closing bid price of at least $1.00 for a minimum of ten (10) consecutive
business days, provided we have not otherwise regained compliance. We
expect a written final response from the Panel within 30 days from September 4,
2008.
We intend
to pursue all available options to ensure our continued listing on the Nasdaq
Stock Market. Although we currently meet all other Nasdaq listing
requirements, the market price of our common stock has generally been highly
volatile and we cannot guarantee that we will be able to regain compliance with
the minimum closing bid price requirement within the required compliance
period. If we fail to regain compliance with the minimum closing bid
price requirement or fail to comply with any other The Nasdaq Capital Market
listing requirements, the market value of our common stock could fall and
holders of common stock would likely find it more difficult to dispose of the
common stock.
If our
common stock is delisted, we would apply to have our common stock quoted on the
over-the-counter electronic bulletin board. Upon any such delisting,
our common stock would become subject to the regulations of the Securities and
Exchange Commission relating to the market for penny stocks. A penny
stock, as defined by the Penny Stock Reform Act, is any equity security not
traded on a national securities exchange that has a market price of less than
$5.00 per share. The penny stock regulations generally require that a
disclosure schedule explaining the penny stock market and the risks associated
therewith be delivered to purchasers of penny stocks and impose various sales
practice requirements on broker-dealers who sell penny stocks to persons other
than established customers and accredited investors. The
broker-dealer must make a suitability determination for each purchaser and
receive the purchaser’s written agreement prior to the sale. In
addition, the broker-dealer must make certain mandated disclosures, including
the actual sale or purchase price and actual bid offer quotations, as well as
the compensation to be received by the broker-dealer and certain associated
persons. The regulations applicable to penny stocks may severely
affect the market liquidity for our common stock and could limit your ability to
sell your securities in the secondary market.
-28-
If
We Effect A Reverse Stock Split The Liquidity of Our Common Stock And Market
Capitalization Could Be Adversely Affected.
A reverse
stock split is often viewed negatively by the market and, consequently, can lead
to a decrease in our overall market capitalization. If the per share
market price does not increase proportionately as a result of the reverse split,
then the value of our company as measured by our market capitalization will be
reduced, perhaps significantly. In addition, because the reverse
split will significantly reduce the number of shares of our common stock that
are outstanding, the liquidity of our common stock could be adversely affected
and you may find it more difficult to purchase or sell shares of our common
stock.
Successful
Development Of Our Products Is Uncertain. To Date, No Revenues Have
Been Generated From The Commercial Sale Of Our Products And Our Products May Not
Generate Revenues In The Future.
Our
development of current and future product candidates is subject to the risks of
failure inherent in the development of new pharmaceutical products and products
based on new technologies. These risks include:
·
|
delays
in product development, clinical testing or
manufacturing;
|
|
·
|
unplanned
expenditures in product development, clinical testing or
manufacturing;
|
|
·
|
failure
in clinical trials or failure to receive regulatory
approvals;
|
|
·
|
emergence
of superior or equivalent products;
|
|
·
|
inability
to manufacture on our own, or through others, product candidates on a
commercial scale;
|
|
·
|
inability
to market products due to third party proprietary rights;
and
|
|
·
|
failure
to achieve market acceptance.
|
Because
of these risks, our research and development efforts or those of our partners
may not result in any commercially viable products. If significant
portions of these development efforts are not successfully completed, required
regulatory approvals are not obtained, or any approved products are not
commercially successful, our business, financial condition and results of
operations may be materially harmed.
Because
we have not begun the commercial sale of any of our products, our revenue and
profit potential is unproven and our limited operating history makes it
difficult for an investor to evaluate our business and prospects. Our
technology may not result in any meaningful benefits to our current or potential
partners. No revenues have been generated from the commercial sale of
our products, and our products may not generate revenues in the
future. Our business and prospects should be considered in light of
the heightened risks and unexpected expenses and problems we may face as a
company in an early stage of development in a new and rapidly evolving
industry.
Our
Product Development Efforts May Not Be Successful.
Our
product candidates have not received regulatory approval and are generally in
research, pre-clinical and various clinical stages of development. If
the results from any of the clinical trials are poor, those results may
adversely affect our ability to raise additional capital or obtain regulatory
approval to conduct additional clinical trials, which will affect our ability to
continue full-scale research and development for our antibody
technologies. In addition, our product candidates may take longer
than anticipated to progress through clinical trials, or patient enrollment in
the clinical trials may be delayed or prolonged significantly, thus delaying the
clinical trials. Patient enrollment is a function of many factors,
including the size of the patient population, the nature of the protocol, the
proximity of patients to the clinical sites, and the eligibility criteria for
the study. In addition, because our Cotara® product currently in
clinical trials represents a departure from more commonly used methods for
cancer treatment, potential patients and their doctors may be inclined to use
conventional therapies, such as chemotherapy, rather than enroll patients in our
clinical study.
-29-
Clinical
Trials Required For Our Product Candidates Are Expensive And Time Consuming, And
Their Outcome Is Uncertain.
In order
to obtain FDA approval to market a new drug product, we or our potential
partners must demonstrate proof of safety and efficacy in humans. To
meet these requirements, we or our potential partners will have to conduct
extensive pre-clinical testing and “adequate and well-controlled” clinical
trials. Conducting clinical trials is a lengthy, time-consuming and
expensive process. The length of time may vary substantially
according to the type, complexity, novelty and intended use of the product
candidate, and often can be several years or more per trial. Delays
associated with products for which we are directly conducting pre-clinical or
clinical trials may cause us to incur additional operating
expenses. Moreover, we may continue to be affected by delays
associated with the pre-clinical testing and clinical trials of certain product
candidates conducted by our partners over which we have no
control. The commencement and rate of completion of clinical trials
may be delayed by many factors, including, for example:
·
|
obtaining
regulatory approval to commence a clinical trial;
|
|
·
|
reaching
agreement on acceptable terms with prospective contract research
organizations, or CROs, and trial sites, the terms of which can be subject
to extensive negotiation and may vary significantly among different CROs
and trial sites;
|
|
·
|
slower
than expected rates of patient recruitment due to narrow screening
requirements;
|
|
·
|
the
inability of patients to meet FDA or other regulatory authorities imposed
protocol requirements;
|
|
·
|
the
inability to retain patients who have initiated a clinical trial but may
be prone to withdraw due to various clinical or personal reasons, or who
are lost to further follow-up;
|
|
·
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices, or cGMPs, for use in clinical
trials;
|
|
·
|
the
need or desire to modify our manufacturing processes;
|
|
·
|
the
inability to adequately observe patients after
treatment;
|
|
·
|
changes
in regulatory requirements for clinical trials;
|
|
·
|
the
lack of effectiveness during the clinical trials;
|
|
·
|
unforeseen
safety issues;
|
|
·
|
delays,
suspension, or termination of the clinical trials due to the institutional
review board responsible for overseeing the study at a particular study
site; and
|
|
·
|
government
or regulatory delays or “clinical holds” requiring suspension or
termination of the trials.
|
Even if
we obtain positive results from pre-clinical or initial clinical trials, we may
not achieve the same success in future trials. Clinical trials may
not demonstrate statistically sufficient safety and effectiveness to obtain the
requisite regulatory approvals for product candidates employing our
technology.
Clinical
trials that we conduct or that third-parties conduct on our behalf may not
demonstrate sufficient safety and efficacy to obtain the requisite regulatory
approvals for any of our product candidates. We expect to commence
new clinical trials from time to time in the course of our business as our
product development work continues. The failure of clinical trials to
demonstrate safety and effectiveness for our desired indications could harm the
development of that product candidate as well as other product
candidates. Any change in, or termination of, our clinical trials
could materially harm our business, financial condition and results of
operations.
-30-
Our
International Clinical Trials May Be Delayed Or Otherwise Adversely Impacted By
Social, Political And Economic Factors Affecting The Particular Foreign
Country.
We are
presently conducting clinical trials in India and the Republic of
Georgia. Our ability to successfully initiate, enroll and complete a
clinical trial in either country, or in any future foreign country in which we
may initiate a clinical trial, are subject to numerous risks unique to
conducting business in foreign countries, including:
·
|
difficulty
in establishing or managing relationships with clinical research
organizations and physicians;
|
|
·
|
different
standards for the conduct of clinical trials and/or health care
reimbursement;
|
|
·
|
our
inability to locate qualified local consultants, physicians, and
partners;
|
|
·
|
the
potential burden of complying with a variety of foreign laws, medical
standards and regulatory requirements, including the regulation of
pharmaceutical products and treatment; and
|
|
·
|
general
geopolitical risks, such as political and economic instability, and
changes in diplomatic and trade
relations.
|
Because
we will be conducting a number of our Phase II clinical trials in India and the
Republic of Georgia and potentially other foreign countries, any disruption to
our international clinical trial program could significantly delay our product
development efforts. In addition, doing business in the Republic of
Georgia, which is in Eastern Europe, involves other significant risks which
could materially and adversely affect our business as there remains a high
degree of political instability in many parts of Eastern Europe.
Success
In Early Clinical Trials May Not Be Indicative Of Results Obtained In Later
Trials.
A number
of new drugs and biologics have shown promising results in initial clinical
trials, but subsequently failed to establish sufficient safety and effectiveness
data to obtain necessary regulatory approvals. Data obtained from
pre-clinical and clinical activities are subject to varying interpretations,
which may delay, limit or prevent regulatory approval.
Positive
results from pre-clinical studies and our Phase I clinical trials should not be
relied upon as evidence that later or larger-scale clinical trials will
succeed. The Phase I studies we have completed to date have been
designed to primarily assess safety in a small number of
patients. The limited results we have obtained may not predict
results for any future studies and also may not predict future therapeutic
benefit. We will be required to demonstrate through larger-scale
clinical trials that bavituximab and Cotara® are safe and effective for use in a
diverse population before we can seek regulatory approval for their commercial
sale. There is typically an extremely high rate of attrition from the
failure of drug candidates proceeding through clinical trials.
In
addition, regulatory delays or rejections may be encountered as a result of many
factors, including changes in regulatory policy during the period of product
development.
If
We Successfully Develop Products But Those Products Do Not Achieve And Maintain
Market Acceptance, Our Business Will Not Be Profitable.
Even if
bavituximab, Cotara®, or any future product candidate is approved for commercial
sale by the FDA or other regulatory authorities, the degree of market acceptance
of any approved product candidate by physicians, healthcare professionals and
third-party payors and our profitability and growth will depend on a number of
factors, including:
-31-
·
|
our
ability to provide acceptable evidence of safety and
efficacy;
|
|
·
|
relative
convenience and ease of administration;
|
|
·
|
the
prevalence and severity of any adverse side effects;
|
|
·
|
availability
of alternative treatments;
|
|
·
|
pricing
and cost effectiveness;
|
|
·
|
effectiveness
of our or our collaborators’ sales and marketing strategy;
and
|
|
·
|
our
ability to obtain sufficient third-party insurance coverage or
reimbursement.
|
In
addition, if bavituximab, Cotara®, or any future product candidate that we
discover and develop does not provide a treatment regimen that is more
beneficial than the current standard of care or otherwise provide patient
benefit, that product likely will not be accepted favorably by the
market. If any products we may develop do not achieve market
acceptance, then we may not generate sufficient revenue to achieve or maintain
profitability.
In
addition, even if our products achieve market acceptance, we may not be able to
maintain that market acceptance over time if new products or technologies are
introduced that are more favorably received than our products, are more cost
effective or render our products obsolete.
If
We Cannot License Or Sell Cotara®, It May Be Delayed Or Never Be Further
Developed.
We have
completed Phase I and Phase I/II studies with Cotara® for the treatment of brain
cancer. In addition, we are currently conducting a dose confirmation
and dosimetry clinical trial in patients with recurrent glioblastoma multiforme
(“GBM”) in the U.S. In June 2007, we opened enrollment in a Phase II
safety and efficacy study in India using a single administration of the drug
through an optimized delivery method. Taken together, the
current U.S. study along with data collected from the Phase II safety and
efficacy study in India should provide the safety, dosimetry and efficacy data
that will support the final design of the larger Phase III
study. Once we complete these two Cotara® studies for the treatment
of GBM, substantial financial resources will be needed to complete the final
part of the trial and any additional supportive clinical studies necessary for
potential product approval. We do not presently have the financial
resources internally to complete the larger Phase III study. We
therefore intend to continue to seek a licensing or funding partner for Cotara®,
and hope that the data from the U.S. and the Phase II study in India will
enhance our opportunities of finding such partner. If a partner is
not found for this technology, we may not be able to advance the project past
its current state of development. Because there are a limited number
of companies which have the financial resources, the internal infrastructure,
the technical capability and the marketing infrastructure to develop and market
a radiopharmaceutical based oncology drug, we may not find a suitable partnering
candidate for Cotara®. We also cannot ensure that we will be able to
find a suitable licensing partner for this technology. Furthermore,
we cannot ensure that if we do find a suitable licensing partner, the financial
terms that they propose will be acceptable to the Company.
Our
Dependency On Our Radiolabeling Suppliers May Negatively Impact Our Ability To
Complete Clinical Trials And Market Our Products.
We have
procured our antibody radioactive isotope combination services (“radiolabeling”)
for Cotara® with Iso-tex Diagnostics, Inc. for all U.S. clinical trials and with
the Board of Radiation & Isotope Technology (“BRIT”) for our Phase II study
in India. If either of these suppliers is unable to continue to
qualify its respective facility or radiolabel and supply our antibody in a
timely manner, our current clinical trials using radiolabeling technology could
be adversely affected and significantly delayed. While there are
other suppliers for radioactive isotope combination services in the U.S., our
clinical trial would be delayed for up to twelve to eighteen months because it
may take that amount of time to certify a new facility under current Good
Manufacturing Practices and qualify the product, plus we would incur significant
costs to transfer our technology to another vendor. In addition, the
number of facilities that can perform these radiolabeling services is very
limited. Prior to commercial distribution of any of our products, if
approved, we will be required to identify and contract with a company for
commercial antibody manufacturing and radioactive isotope combination
services. An antibody that has been combined with a radioactive
isotope, such as Iodine-131, cannot be stored for long periods of time, as it
must be used within one week of being radiolabeled to be
effective. Accordingly, any change in our existing or future
contractual relationships with, or an interruption in supply from, any such
third-party service provider or antibody supplier could negatively impact our
ability to complete ongoing clinical trials conducted by us or a potential
licensing partner.
-32-
Our
Manufacturing Facilities May Not Continue To Meet Regulatory Requirements And
Have Limited Capacity.
Before
approving a new drug or biologic product, the FDA requires that the facilities
at which the product will be manufactured be in compliance with current Good
Manufacturing Practices, or cGMP requirements. To be successful, our
therapeutic products must be manufactured for development and, following
approval, in commercial quantities, in compliance with regulatory requirements
and at acceptable costs. Currently, we manufacture all pre-clinical
and clinical material through Avid Bioservices, our wholly owned
subsidiary. While we believe our current facilities are adequate for
the manufacturing of product candidates for clinical trials, our facilities may
not be adequate to produce sufficient quantities of any products for commercial
sale.
If we are
unable to establish and maintain a manufacturing facility or secure third-party
manufacturing capacity within our planned time frame and cost parameters, the
development and sales of our products, if approved, may be materially
harmed.
We may
also encounter problems with the following:
·
|
production
yields;
|
|
·
|
quality
control and quality assurance;
|
|
·
|
shortages
of qualified personnel;
|
|
·
|
compliance
with FDA or other regulatory authorities regulations, including the
demonstration of purity and potency;
|
|
·
|
changes
in FDA or other regulatory authorities requirements;
|
|
·
|
production
costs; and/or
|
|
·
|
development
of advanced manufacturing techniques and process
controls.
|
In
addition, we or any third-party manufacturer will be required to register the
manufacturing facilities with the FDA and other regulatory authorities, provided
it had not already registered. The facilities will be subject to
inspections confirming compliance with cGMP or other regulations. If
any of our third-party manufacturers or we fail to maintain regulatory
compliance, the FDA can impose regulatory sanctions including, among other
things, refusal to approve a pending application for a new drug product or
biologic product, or revocation of a pre-existing approval. As a
result, our business, financial condition and results of operations may be
materially harmed.
We
Currently Depend On a Government Contract To Partially Fund Our Research And
Development Efforts. If Our Current Government Funding Is Reduced Or
Delayed, Our Drug Development Efforts May Be Negatively Affected.
On June
30, 2008, we were awarded up to a five-year contract potentially worth up to
$44.4 million to test and develop bavituximab and an equivalent fully human
antibody as potential broad-spectrum treatments for viral hemorrhagic fever
infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA). This federal
contract is expected to provide us with up to $22.3 million in funding over
a 24-month base period, with $5 million appropriated immediately for the current
federal fiscal year ending September 30, 2008. The remainder of the
$22.3 million in funding is expected to be appropriated over the remainder of
the two-year base period ending June 29, 2010. Subject to the
progress of the program and budgetary considerations in future years, the
contract can be extended beyond the base period to cover up to $44.4 million in
funding over the five-year contract period. Work under this contract
commenced on June 30, 2008. If we do not receive the expected funding
under this contract, we may not be able to develop therapeutics to treat
hemorrhagic fever virus infection nor otherwise receive the other indirect
benefits that may be derived from receipt of the full funding under this
contract.
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We
May Have Significant Product Liability Exposure Because We Maintain Only Limited
Product Liability Insurance.
We face an inherent business risk of
exposure to product liability claims in the event that the administration of one
of our drugs during a clinical trial adversely affects or causes the death of a
patient. Although we maintain product liability insurance for
clinical studies in the amount of $3,000,000 per occurrence or $3,000,000 in the
aggregate on a claims-made basis, this coverage may not be
adequate. Product liability insurance is expensive, difficult to
obtain and may not be available in the future on acceptable terms, if at
all. Our inability to obtain sufficient insurance coverage on
reasonable terms or to otherwise protect against potential product liability
claims in excess of our insurance coverage, if any, or a product recall, could
negatively impact our financial position and results of operations.
In addition, the contract manufacturing
services that we offer through Avid expose us to an inherent risk of liability
as the antibodies or other substances manufactured by Avid, at the request and
to the specifications of our customers, could possibly cause adverse effects or
have product defects. We obtain agreements from our customers
indemnifying and defending us from any potential liability arising from such
risk. There can be no assurance that such indemnification agreements
will adequately protect us against potential claims relating to such contract
manufacturing services or protect us from being named in a possible
lawsuit. Although Avid has procured insurance coverage, there is no
guarantee that we will be able to maintain our existing coverage or obtain
additional coverage on commercially reasonable terms, or at all, or that such
insurance will provide adequate coverage against all potential claims to which
we might be exposed. A partially successful or completely uninsured
claim against Avid would have a material adverse effect on our consolidated
operations.
If
We Are Unable To Obtain, Protect And Enforce Our Patent Rights, We May Be Unable
To Effectively Protect Or Exploit Our Proprietary Technology, Inventions And
Improvements.
Our
success depends in part on our ability to obtain, protect and enforce
commercially valuable patents. We try to protect our proprietary
positions by filing United States and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to
developing our business. However, if we fail to obtain and maintain
patent protection for our proprietary technology, inventions and improvements,
our competitors could develop and commercialize products that would otherwise
infringe upon our patents.
Our
patent position is generally uncertain and involves complex legal and factual
questions. Legal standards relating to the validity and scope of
claims in the biotechnology and biopharmaceutical fields are still
evolving. Accordingly, the degree of future protection for our patent
rights is uncertain. The risks and uncertainties that we face with
respect to our patents include the following:
·
|
the
pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we expect
to result in issued patents;
|
|
·
|
the
claims of any patents that issue may not provide meaningful
protection;
|
|
·
|
we
may be unable to develop additional proprietary technologies that are
patentable;
|
|
·
|
the
patents licensed or issued to us may not provide a competitive
advantage;
|
|
·
|
other
parties may challenge patents licensed or issued to us;
|
|
·
|
disputes
may arise regarding the invention and corresponding ownership rights in
inventions and know-how resulting from the joint creation or use of
intellectual property by us, our licensors, corporate partners and other
scientific collaborators; and
|
|
·
|
other
parties may design around our patented
technologies.
|
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We
May Become Involved In Lawsuits To Protect Or Enforce Our Patents That Would Be
Expensive And Time Consuming.
In order
to protect or enforce our patent rights, we may initiate patent litigation
against third parties. In addition, we may become subject to
interference or opposition proceedings conducted in patent and trademark offices
to determine the priority and patentability of inventions. The
defense of intellectual property rights, including patent rights through
lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings, would be costly and divert our technical and
management personnel from their normal responsibilities. An adverse
determination of any litigation or defense proceedings could put our pending
patent applications at risk of not being issued.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of
litigation. For example, during the course of this kind of
litigation, confidential information may be inadvertently disclosed in the form
of documents or testimony in connection with discovery requests, depositions or
trial testimony. This disclosure could have a material adverse effect
on our business and our financial results.
We
May Not Be Able To Compete With Our Competitors In The Biotechnology Industry
Because Many Of Them Have Greater Resources Than We Do And They Are Further
Along In Their Development Efforts.
The
pharmaceutical and biotechnology industry is intensely competitive and subject
to rapid and significant technological change. Many of the drugs that
we are attempting to discover or develop will be competing with existing
therapies. In addition, we are aware of several pharmaceutical and
biotechnology companies actively engaged in research and development of
antibody-based products that have commenced clinical trials with, or have
successfully commercialized, antibody products. Some or all of these
companies may have greater financial resources, larger technical staffs, and
larger research budgets than we have, as well as greater experience in
developing products and running clinical trials. We expect to
continue to experience significant and increasing levels of competition in the
future. In addition, there may be other companies which are currently
developing competitive technologies and products or which may in the future
develop technologies and products that are comparable or superior to our
technologies and products.
We are
conducting the Cotara® dose confirmation and dosimetry clinical trial for the
treatment of recurrent glioblastoma multiforme (“GBM”), the most aggressive form
of brain cancer. Approved treatments for brain cancer include the
Gliadel® Wafer (polifeprosan 20 with carmustine implant) from MGI Pharma, Inc.
and Temodar® (temozolomide) from Schering-Plough
Corporation. Gliadel® is inserted in the tumor cavity following
surgery and releases a chemotherapeutic agent over time. Temodar® is
administered orally to patients with brain cancer.
Because
Cotara® targets brain tumors from the inside out, it is a novel treatment
dissimilar from other drugs in development for this disease. Some
products in development may compete with Cotara® should they become approved for
marketing. These products include, but are not limited
to: Neuradiab, a radiolabeled anti-tenascin monoclonal antibody
sponsored by Bradmer Pharmaceuticals, CDX-110, a peptide vaccine under
development by Celldex, cilengitide in newly diagnosed GBM patients being
evaluated by Merk KGaA, and cediranib for patients with recurrent GBM being
developed by AstraZeneca. In addition, oncology products marketed for
other indications such as Gleevec® (Novartis), Tarceva® (Genentech/OSI),
Avastin® (Genentech) and Nexavar® (Bayer), are being tested in clinical trials
for the treatment of brain cancer.
Bavituximab
is currently in clinical trials for the treatment of advanced solid
cancers. There are a number of possible competitors with approved or
developmental targeted agents used in combination with standard chemotherapy for
the treatment of cancer, including but not limited to, Avastin® by
Genentech, Inc., Gleevec® by Novartis, Tarceva® by OSI Pharmaceuticals, Inc. and
Genentech, Inc., Erbitux® by ImClone Systems Incorporated and Bristol-Myers
Squibb Company, Rituxan® and Herceptin® by Genentech, Inc., and Vectibix™ by
Amgen. There are a significant number of companies developing cancer
therapeutics using a variety of targeted and non-targeted
approaches. A direct comparison of these potential competitors will
not be possible until bavituximab advances to later-stage clinical
trials.
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In
addition, we are evaluating bavituximab for the treatment of
HCV. Bavituximab is a first-in-class approach for the treatment of
HCV. We are aware of no other products in development targeting
phosphatidylserine as a potential therapy for HCV. There are a number
of companies that have products approved and on the market for the treatment of
HCV, including but not limited to: Peg-Intron® (pegylated
interferon-alpha-2b), Rebetol® (ribavirin), and Intron-A (interferon-alpha-2a),
which are marketed by Schering-Plough Corporation, and Pegasys® (pegylated
interferon-alpha-2a), Copegus® (ribavirin USP) and Roferon-A®
(interferon-alpha-2a), which are marketed by Roche Pharmaceuticals, and
Infergen® (interferon alfacon-1) now marketed by Three Rivers Pharmaceuticals,
LLC. First line treatment for HCV has changed little since alpha
interferon was first introduced in 1991. The current standard of care
for HCV includes a combination of an alpha interferon (pegylated or
non-pegylated) with ribavirin. This combination therapy is generally
associated with considerable toxicity including flu-like symptoms, hematologic
changes and central nervous system side effects including
depression. It is not uncommon for patients to discontinue alpha
interferon therapy because they are unable to tolerate the side effects of the
treatment.
Future
treatments for HCV are likely to include a combination of these existing
products used as adjuncts with products now in
development. Later-stage developmental treatments include
improvements to existing therapies, such as Albuferon™ (albumin interferon) from
Human Genome Sciences, Inc. and Viramidine™ (taribavirin), a prodrug analog of
ribavirin being developed by Valeant Pharmaceuticals
International. Other developmental approaches include, but are not
limited to, protease inhibitors such as telaprevir from Vertex Pharmaceuticals
Incorporated and boceprevir from Schering-Plough Corporation.
If
We Lose Qualified Management And Scientific Personnel Or Are Unable To Attract
And Retain Such Personnel, We May Be Unable To Successfully Develop Our Products
Or We May Be Significantly Delayed In Developing Our Products.
Our
success is dependent, in part, upon a limited number of key executive officers,
each of whom is an at-will employee, and also upon our scientific
researchers. For example, because of his extensive understanding of
our technologies and product development programs, the loss of Mr. Steven W.
King, our President & Chief Executive Officer and Director, would adversely
affect our development efforts and clinical trial programs during the six to
twelve month period that we estimate it would take to find and train a qualified
replacement.
We also
believe that our future success will depend largely upon our ability to attract
and retain highly-skilled research and development and technical
personnel. We face intense competition in our recruiting activities,
including competition from larger companies with greater
resources. We do not know if we will be successful in attracting or
retaining skilled personnel. The loss of certain key employees or our
inability to attract and retain other qualified employees could negatively
affect our operations and financial performance.
Our
Governance Documents And State Law Provide Certain Anti-Takeover Measures Which
Will Discourage A Third Party From Seeking To Acquire Us Unless Approved By the
Board of Directors.
We
adopted a shareholder rights plan, commonly referred to as a “poison pill,” on
March 16, 2006. The purpose of the shareholder rights plan is to
protect stockholders against unsolicited attempts to acquire control of us that
do not offer a fair price to our stockholders as determined by our Board of
Directors. Under the plan, the acquisition of 15% or more of our
outstanding common stock by any person or group, unless approved by our board of
directors, will trigger the right of our stockholders (other than the acquiror
of 15% or more of our common stock) to acquire additional shares of our common
stock, and, in certain cases, the stock of the potential acquiror, at a 50%
discount to market price, thus significantly increasing the acquisition cost to
a potential acquiror. In addition, our certificate of incorporation
and by-laws contain certain additional anti-takeover protective
devices. For example,
-36-
·
|
no
stockholder action may be taken without a meeting, without prior notice
and without a vote; solicitations by consent are thus
prohibited;
|
|
·
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special
meetings of stockholders may be called only by our Board of Directors;
and
|
|
·
|
our
Board of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences, and issue shares, of
preferred stock. An issuance of preferred stock with dividend and
liquidation rights senior to the common stock and convertible into a large
number of shares of common stock could prevent a potential acquiror from
gaining effective economic or voting
control.
|
Further,
we are subject to Section 203 of the Delaware General Corporation Law which,
subject to certain exceptions, restricts certain transactions and business
combinations between a corporation and a stockholder owning 15% or more of the
corporation’s outstanding voting stock for a period of three years from the date
the stockholder becomes a 15% stockholder.
Although we believe these provisions
and our rights plan collectively provide for an opportunity to receive higher
bids by requiring potential acquirers to negotiate with our Board of Directors,
they would apply even if the offer may be considered beneficial by some
stockholders. In addition, these provisions may frustrate or prevent
any attempts by our stockholders to replace or remove our current management by
making it more difficult for stockholders to replace members of our Board of
Directors, which is responsible for appointing the members of our
management.
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 SECURITY HOLDERS. None
ITEM
5. OTHER
INFORMATION. None.
ITEM 6. EXHIBITS.
(a)
|
Exhibits:
|
10.110 | Government contract by and between Peregrine Pharmaceuticals, Inc. and the Defense Threat Reduction Agency dated June 30, 2008. | |
31.1
|
||
31.2
|
Certification
of the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
-37-
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned thereunto duly
authorized.
PEREGRINE
PHARMACEUTICALS, INC.
Date: September 8,
2008
|
By: /s/ STEVEN W.
KING
|
|
Steven
W. King
|
||
President,
Chief Executive Officer, and
Director
|
Date: September 8,
2008
|
By: /s/ PAUL J.
LYTLE
|
|
Paul
J. Lytle
|
||
Chief
Financial Officer
|
||
(signed
both as an officer duly authorized to sign on behalf of the
Registrant and principal financial officer and chief accounting
officer)
|
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