Avid Bioservices, Inc. - Quarter Report: 2007 July (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
quarterly period ended July 31, 2007
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the
transition period from _______________ to _______________
Commission
file number: 0-17085
PEREGRINE
PHARMACEUTICALS, INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3698422
|
(State
or other jurisdiction
of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
14282
Franklin Avenue, Tustin,
California
|
92780-7017
|
(Address
of principal executive
offices)
|
(Zip
Code)
|
(714)
508-6000
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports); and (2) has been subject to such filing requirements
for
the past 90 days.
Yes ý No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “an accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one)
Large
Accelerated Filer o
|
Accelerated
Filer ý
|
Non-
Accelerated Filer o
|
Indicate
by checkmark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act).
Yes o No ý
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date.
Class
|
Shares
Outstanding at September 7, 2007
|
|
Common
Stock, $0.001 par value per share
|
226,210,617
shares
|
PEREGRINE
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
Page
No.
|
||
Item
1.
|
Consolidated
Financial Statements (unaudited):
|
||
Condensed
Consolidated Balance Sheets
|
1
|
||
Condensed
Consolidated Statements of Operations
|
3
|
||
Condensed
Consolidated Statements of Cash Flows
|
4
|
||
Notes
to Condensed Consolidated Financial Statements
|
5
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
|
Company
Overview
|
14
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
22
|
|
Item
4.
|
Controls
and Procedures
|
22
|
|
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
22
|
|
Item
1A.
|
Risk
Factors
|
23
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
35
|
|
Item
3.
|
Defaults
upon Senior Securities
|
35
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
35
|
|
Item
5.
|
Other
Information
|
35
|
|
Item
6.
|
Exhibits
|
35
|
|
SIGNATURES
|
36
|
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. CONSOLIDATED
FINANCIAL STATEMENTS
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
JULY
31,
2007
|
APRIL
30,
2007
|
||||||
Unaudited
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
30,635,000
|
$
|
16,044,000
|
|||
Trade
and other receivables
|
1,514,000
|
750,000
|
|||||
Inventories,
net
|
2,363,000
|
1,916,000
|
|||||
Prepaid
expenses and other current assets
|
1,172,000
|
1,188,000
|
|||||
Total
current assets
|
35,684,000
|
19,898,000
|
|||||
PROPERTY:
|
|||||||
Leasehold
improvements
|
655,000
|
646,000
|
|||||
Laboratory
equipment
|
3,587,000
|
3,533,000
|
|||||
Furniture,
fixtures and office equipment
|
886,000
|
873,000
|
|||||
5,128,000
|
5,052,000
|
||||||
Less
accumulated depreciation and amortization
|
(3,332,000
|
)
|
(3,212,000
|
)
|
|||
Property,
net
|
1,796,000
|
1,840,000
|
|||||
Other
assets
|
1,188,000
|
1,259,000
|
|||||
TOTAL
ASSETS
|
$
|
38,668,000
|
$
|
22,997,000
|
1
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued) | |||||||
JULY
31,
2007
|
APRIL
30,
2007
|
||||||
Unaudited
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
1,366,000
|
$
|
1,683,000
|
|||
Accrued
clinical trial site fees
|
113,000
|
228,000
|
|||||
Accrued
legal and accounting fees
|
281,000
|
392,000
|
|||||
Accrued
royalties and license fees
|
107,000
|
337,000
|
|||||
Accrued
payroll and related costs
|
664,000
|
874,000
|
|||||
Notes
payable, current portion
|
317,000
|
379,000
|
|||||
Capital
lease obligation, current portion
|
17,000
|
17,000
|
|||||
Deferred
revenue
|
1,820,000
|
1,060,000
|
|||||
Other
current liabilities
|
427,000
|
885,000
|
|||||
Total
current liabilities
|
5,112,000
|
5,855,000
|
|||||
Notes
payable, less current portion
|
69,000
|
119,000
|
|||||
Capital
lease obligation, less current portion
|
26,000
|
30,000
|
|||||
Deferred
license revenue
|
-
|
4,000
|
|||||
Commitments
and contingencies
|
|||||||
STOCKHOLDERS'
EQUITY:
|
|||||||
Preferred
stock-$.001 par value; authorized 5,000,000 shares;
non-voting; nil
shares outstanding
|
-
|
-
|
|||||
Common
stock-$.001 par value; authorized 250,000,000 shares; outstanding
-
226,210,617 and 196,112,201, respectively
|
226,000
|
196,000
|
|||||
Additional
paid-in capital
|
245,551,000
|
224,453,000
|
|||||
Accumulated
deficit
|
(212,316,000
|
)
|
(207,660,000
|
)
|
|||
Total
stockholders' equity
|
33,461,000
|
16,989,000
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
38,668,000
|
$
|
22,997,000
|
See
accompanying notes to condensed consolidated
financial statements
2
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
THREE
MONTHS ENDED
|
|||||||
July
31, 2007
|
July
31, 2006
|
||||||
Unaudited
|
Unaudited
|
||||||
REVENUES:
|
|||||||
Contract
manufacturing revenue
|
$
|
1,621,000
|
$
|
398,000
|
|||
License
revenue
|
4,000
|
23,000
|
|||||
Total
revenues
|
1,625,000
|
421,000
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of contract manufacturing
|
1,181,000
|
530,000
|
|||||
Research
and development
|
3,624,000
|
4,041,000
|
|||||
Selling,
general and administrative
|
1,708,000
|
1,641,000
|
|||||
Total
costs and expenses
|
6,513,000
|
6,212,000
|
|||||
LOSS
FROM OPERATIONS
|
(4,888,000
|
)
|
(5,791,000
|
)
|
|||
OTHER
INCOME (EXPENSE):
|
|||||||
Interest
and other income
|
239,000
|
349,000
|
|||||
Interest
and other expense
|
(7,000
|
)
|
(15,000
|
)
|
|||
NET
LOSS
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING
|
206,071,568
|
184,108,083
|
|||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
See accompanying notes to condensed consolidated financial statements
3
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
THREE
MONTHS ENDED JULY 31,
|
|||||||
2007
|
2006
|
||||||
Unaudited
|
Unaudited
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
119,000
|
115,000
|
|||||
Stock-based
compensation and issuance of common stock under stock bonus
plan
|
197,000
|
373,000
|
|||||
Amortization
of expenses paid in shares of common stock
|
-
|
209,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Trade
and other receivables
|
(764,000
|
)
|
317,000
|
||||
Inventories
|
(447,000
|
)
|
(86,000
|
)
|
|||
Prepaid
expenses and other current assets
|
16,000
|
130,000
|
|||||
Accounts
payable
|
(317,000
|
)
|
(85,000
|
)
|
|||
Accrued
clinical trial site fees
|
(115,000
|
)
|
(19,000
|
)
|
|||
Deferred
revenue
|
756,000
|
(250,000
|
)
|
||||
Accrued
payroll and related costs
|
(210,000
|
)
|
(226,000
|
)
|
|||
Other
accrued expenses and current liabilities
|
(799,000
|
)
|
4,000
|
||||
Net
cash used in operating activities
|
(6,220,000
|
)
|
(4,975,000
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Property
acquisitions
|
(75,000
|
)
|
(46,000
|
)
|
|||
Decrease
in other assets
|
71,000
|
-
|
|||||
Net
cash used in investing activities
|
(4,000
|
)
|
(46,000
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of common stock, net of issuance costs of $1,641,000
and
$46,000, respectively
|
20,931,000
|
16,448,000
|
|||||
Principal
payments on notes payable and capital lease
|
(116,000
|
)
|
(109,000
|
)
|
|||
Net
cash provided by financing activities
|
20,815,000
|
16,339,000
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
14,591,000
|
11,318,000 | |||||
CASH
AND CASH EQUIVALENTS, beginning
of period
|
16,044,000
|
17,182,000
|
|||||
CASH
AND CASH EQUIVALENTS,
end of period
|
$ | 30,635,000 | $ | 28,500,000 |
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, 2007 (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 biomanufacturing 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, 2007, and the condensed consolidated results of our operations and
our
condensed consolidated cash flows for the three-month periods ended July 31,
2007 and 2006. 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, 2007. 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.
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of years
since our inception. Since inception, we have financed our operations primarily
through the sale of our common stock and issuance of convertible debt, which
has
been supplemented with payments received from various licensing collaborations
and through the revenues generated by Avid. We expect negative cash flows from
operations to continue until we are able to generate sufficient revenue from
the
contract manufacturing services provided by Avid and/or from the sale and/or
licensing of our products under development.
Revenues
earned by Avid during the three months ended July 31, 2007 and 2006 amounted
to
$1,621,000 and $398,000, respectively. We expect that Avid will continue to
generate revenues which should partially offset our consolidated cash flows
used
in operations, although we expect those near term revenues will be insufficient
to fully cover our anticipated consolidated cash flows used in operations.
In
addition, revenues that may be generated from the sale and/or licensing of
our
products under development are always uncertain. 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 beyond fiscal year 2008.
At
July 31, 2007, we had $30,635,000 in cash and cash equivalents, which we
currently believe is sufficient capital to maintain our operations through
at
least fiscal year 2008 based on our current projections.
5
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
We
may
raise additional capital through the sale of shares of our common stock to
continue our research, development, and clinical testing of our product
candidates beyond fiscal year 2008. We have approximately 5,031,000 shares
available for possible future registered transactions under two separate
registration statements. In addition, during January 2007, we filed a separate
registration statement on Form S-3, File Number 333-139975, which allows us
to
issue, from time to time, in one or more offerings, shares of our common stock
for remaining proceeds of up to $7,500,000. However, given uncertain market
conditions and the volatility of our stock price and trading volume, we may
not
be able to sell our securities at prices or on terms that are favorable to
us,
if at all.
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 agreements to complete
the
research, development, and clinical testing of our product candidates beyond
fiscal year 2008.
2.
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
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, 2007 and
April 30, 2007:
July
31,
2007
|
April
30,
2007
|
||||||
Raw
materials
|
$
|
892,000
|
$
|
810,000
|
|||
Work-in-process
|
1,471,000
|
1,106,000
|
|||||
Total
inventories, net
|
$
|
2,363,000
|
$
|
1,916,000
|
Comprehensive
Loss
-
Comprehensive loss is equal to net loss for all periods presented.
Income
taxes
- In
June 2006,
the
Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48
(“FIN No. 48”), Accounting
for Uncertainty in Income Taxes—An Interpretation of FASB Statement No. 109,
which
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. Under
FIN
No. 48, tax positions are recognized in the financial statements when it is
more
likely than not the position will be sustained upon examination by the tax
authorities. An uncertain income tax position will not be recognized if it
has
less than a 50% likelihood of being sustained upon examination by the tax
authorities. FIN No. 48 also provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosures and
transition.
We
adopted FIN No. 48 on May 1, 2007 and determined that the adoption of FIN No.
48
did not have a material impact on our consolidated financial statements. In
addition, there are no unrecognized tax benefits included in our consolidated
balance sheet that would, if recognized, affect our effective tax rate.
It
is our
policy to recognize interest and penalties related to income tax matters in
interest and other expense in our consolidated statement of operations. We
did
not recognize interest or penalties related to income taxes during the three
months ended July 31, 2007 and 2006, and we did not accrue for interest or
penalties as of July 31, 2007 or April 30, 2007.
6
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
We
are
primarily subject to U.S. federal and California state jurisdictions. To our
knowledge, all tax years remain open to examination by U.S. federal and state
authorities.
At
May 1,
2007, we had total deferred tax assets of $59.4 million. The deferred tax
assets are primarily comprised of federal and state tax net operating loss
(“NOL”) carryforwards. Due to uncertainties surrounding our ability to generate
future taxable income to realize these tax assets, a full valuation has been
established to offset our total deferred tax assets. Additionally, the future
utilization of our NOL carryforwards to offset future taxable income may be
subject to an annual limitation as a result of ownership changes that may have
occurred previously or that could occur in the future. We have not yet
determined whether such an ownership change has occurred, however we plan to
complete an analysis regarding the limitation of the NOL carryforwards.
Therefore, it is possible that a portion of these deferred tax assets may be
limited in their use after this study is completed. If necessary, the deferred
tax assets will be reduced by any carryforwards that expire prior to utilization
as a result of such limitations, with a corresponding reduction of the valuation
allowance. Due to the existence of the valuation allowance, future changes
in
our unrecognized tax benefits will not impact our effective tax rate.
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. 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 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, 2007 and 2006.
The
calculation of weighted average diluted shares outstanding excludes the dilutive
effect of options and warrants to purchase up to 840,752
and 4,815,222 shares
of
common stock for the three months ended July 31, 2007 and 2006,
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 to purchase up to 10,228,390
and 5,292,369 shares of common stock for the three months ended July 31,
2007 and 2006, 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.
Recent
Accounting Pronouncements
- In
September 2006, the 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 will be
effective for fiscal years beginning after November 15, 2007, which we
would be required to implement no later than May 1, 2008. Our adoption of SFAS
No. 157 is not expected to have a material impact on our consolidated financial
statements.
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. SFAS No.
159
is effective for fiscal years beginning after November 15, 2007, which we would
be required to implement no later than May 1, 2008. Our adoption of SFAS No.
159
is not expected to have a material impact on our consolidated financial
statements.
7
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
3.
STOCK-BASED
COMPENSATION
We
currently maintain four equity compensation plans referred to as the 1996 Plan,
the 2002 Plan, the 2003 Plan, and the 2005 Plan (collectively referred to as
the
“Option Plans”). The Option Plans provide for the granting of options 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 options generally
vest over a four year period and no options are exercisable after ten years
from
the date of grant.
On
May 1,
2006, we adopted 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. 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 (vesting period). We adopted SFAS No. 123R
using the modified-prospective method and, accordingly, stock-based compensation
cost recognized beginning May 1, 2006 includes: (i) compensation cost for all
share-based payments granted prior to, but not yet vested as of May 1, 2006,
based on the grant date fair value estimated in accordance with the original
provisions of SFAS No. 123, and (ii) compensation cost for all share-based
payments granted on or subsequent to May 1, 2006, based on the grant date fair
value estimated in accordance with the provisions of SFAS No. 123R.
Our
net
loss for the three months ended July 31, 2007 and 2006, increased by $183,000
and $299,000, respectively, as a result of the application of SFAS No. 123R,
which costs are included in the accompanying condensed consolidated statements
of operations as follows:
Three
Months Ended
July
31, 2007
|
Three
Months Ended
July
31, 2006
|
||||||
Research
and development
|
$
|
129,000
|
$
|
166,000
|
|||
Selling,
general and administrative
|
54,000
|
133,000
|
|||||
Total
|
$
|
183,000
|
$
|
299,000
|
8
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
The
fair
value of each option grant is estimated using the Black-Scholes option valuation
model and is amortized as compensation expense on a straight-line basis over
the
requisite service period of the award, which is generally the vesting period
(typically 4 years). The use of a valuation model requires us to make certain
estimates and assumptions with respect to selected model inputs. The expected
volatility is based on the daily historical volatility of our stock covering
the
estimated expected term. The expected term of options granted is 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”). 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. The expected
dividend yield assumption is based on our expectation of future dividend
payouts. We have never declared or paid cash dividends on our common stock
and
currently do not anticipate paying such cash dividends. 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. The fair value of
stock options on the date of grant and the weighted-average assumptions used
to
estimate the fair value of the stock options using the Black-Scholes option
valuation model during the periods presented, were as follows:
Three
Months Ended
July
31,
|
|||||||||
2007
|
2006
|
||||||||
Risk-free
interest rate
|
4.56
|
%
|
|
5.00
|
%
|
|
|||
Expected
life (in years)
|
5.98
|
6.25
|
|||||||
Expected
volatility
|
87
|
%
|
|
101
|
%
|
|
|||
Expected
dividend yield
|
-
|
-
|
As
of
July 31, 2007, options to purchase up to 11,716,945 shares of our common stock
were issued and outstanding under the Option Plans with a weighted average
exercise price of $1.51 per share and expire at various dates through July
30,
2017. Options to purchase up to 4,405,235 shares of common stock were available
for future grant under the Option Plans as of July 31, 2007.
The
following summarizes all stock option transaction activity for the three months
ended July 31, 2007:
Stock
Options
|
Shares
|
Weighted
Average
Exercisable
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
May 1, 2007
|
11,537,946
|
$
|
1.54
|
||||||||||
Granted
|
485,920
|
$
|
0.86
|
||||||||||
Exercised
|
(45,000
|
)
|
$
|
0.60
|
|||||||||
Canceled
or expired
|
(261,921
|
)
|
$
|
1.39
|
|||||||||
Outstanding,
July 31, 2007
|
11,716,945
|
$
|
1.51
|
5.68
|
$
|
512,000
|
|||||||
Exercisable
and expected to vest
|
11,498,740
|
$
|
1.52
|
5.63
|
$
|
511,000
|
|||||||
Exercisable,
July 31, 2007
|
9,338,556
|
$
|
1.60
|
4.98
|
$
|
507,000
|
The
weighted-average grant date fair value of options granted during the three-month
periods ended July 31, 2007 and 2006 was $0.64 per share and $1.23 per share,
respectively. The aggregate intrinsic value of options exercised during the
three-month periods ended July 31, 2007 and 2006 was $19,000 and $13,000,
respectively.
9
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
Cash
proceeds from stock options exercised during the three-month periods ended
July
31, 2007 and 2006 totaled $27,000 and $44,000, respectively.
We
issue
shares of common stock that are reserved for issuance under the Option Plans
upon the exercise of stock options, and we do not expect to repurchase shares
of
common stock from any source to satisfy our obligations under our compensation
plans.
As
of
July 31, 2007, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,846,000. This cost is expected to be recognized
over a weighted average vesting period of 2.85 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.
Stock-based compensation expense recorded during the three months ended July
31,
2007 and 2006 associated with non-employees amounted to $14,000 and $26,000,
respectively.
4.
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, 2007, we could raise up
to
$7,500,000 in remaining gross proceeds under the January 2007 Shelf.
In
addition, as of July 31, 2007, 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, 2007, we have reserved 21,512,814 additional shares of our common
stock
which may be issued under our shelf registration statements, stock option plans
and outstanding warrants, 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
|
11,716,945
|
|||
Shares
of common stock reserved for future option grants under our Option
Plans
|
4,405,235
|
|||
Shares
of common stock reserved for issuance under outstanding warrant
arrangements
|
360,000
|
|||
Total
shares of common stock reserved for issuance
|
21,512,814
|
10
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
5. 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. As of July 31, 2007,
warrants to purchase up to 360,000 shares of our common stock were issued and
outstanding at a weighted average exercise price of $1.50 per share and expire
in March 2008.
6.
SEGMENT
REPORTING
Our
business is organized into two reportable operating segments. Peregrine is
engaged in the research and development of targeted products for the treatment
of cancer and viral infections using monoclonal antibodies. 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
Notes 1 and 2. We primarily evaluate the performance of our segments based
on
net revenues, gross profit or loss (exclusive of research and development
expenses, selling, general and administrative expenses, and interest and other
income/expense) and long-lived assets. Our segment net revenues shown below
are
derived from transactions with external customers. Our segment gross profit
or
loss represents net revenues less the cost of sales. Our long-lived assets
consist of leasehold improvements, laboratory equipment, and furniture, fixtures
and computer equipment and are net of accumulated depreciation.
Segment
information for the three-month periods is summarized as follows:
Three
Months Ended July 31,
|
|||||||
2007
|
2006
|
||||||
Net
Revenues:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,621,000
|
$
|
398,000
|
|||
Products
in research and development
|
4,000
|
23,000
|
|||||
Total
revenues, net
|
$
|
1,625,000
|
$
|
421,000
|
|||
Gross
Profit (Loss):
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
440,000
|
$
|
(132,000
|
)
|
||
Products
in research and development
|
4,000
|
23,000
|
|||||
Total
gross profit (loss)
|
444,000
|
(109,000
|
)
|
||||
Research
and development expense
|
(3,624,000
|
)
|
(4,041,000
|
)
|
|||
Selling,
general and administrative expense
|
(1,708,000
|
)
|
(1,641,000
|
)
|
|||
Other
income, net
|
232,000
|
334,000
|
|||||
Net
loss
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
11
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
Net
revenues generated from Avid for the three-month periods were from the following
customers:
Three
Months Ended July 31,
|
|||||||||
2007
|
2006
|
||||||||
Customer
revenues as a % of net revenues:
|
|||||||||
United
States (one customer)
|
79
|
%
|
|
1
|
%
|
|
|||
Australia
(one customer)
|
0
|
%
|
|
93
|
%
|
|
|||
Other
customers
|
21
|
%
|
|
6
|
%
|
|
|||
Total
customer revenues as a % of net revenues
|
100
|
%
|
|
100
|
%
|
|
Net
revenues generated from products in research and development during the three
months ended July 31, 2007 were from the amortized portion of the up-front
license fee received under the August 2005 license agreement with Medarex,
Inc.
Net revenues generated from products in research and development during the
three months ended July 31, 2006 were from the amortized portion of the up-front
license fees received under the December 2002 license agreement with Schering
A.G and the August 2005 license agreement with Medarex, Inc.
Long-lived
assets by segment consist of the following:
July
31,
2007
|
April
30,
2007
|
||||||
Long-lived
Assets, net:
|
|||||||
Contract
manufacturing and development of biologics
|
$
|
1,490,000
|
$
|
1,527,000
|
|||
Products
in research and development
|
306,000
|
313,000
|
|||||
Total
long-lived assets, net
|
$
|
1,796,000
|
$
|
1,840,000
|
7.
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 claim that we believe will have, individually or in the
aggregate, a material adverse effect on our business, operating results or
cash
flows, we did file or are involved with a lawsuit against Cancer Therapeutics
Laboratories (“CTL”). The lawsuit alleges that CTL has breached various
agreements with the Company by (i) failing to pay to the Company its contractual
share of the proceeds received by CTL when it formed a joint venture with a
company in China involving the Company’s technology that had been licensed to
CTL pursuant to an earlier agreement (the “Agreement”), (ii) failing to procure
a sublicense with the company in China prior to transferring the Company’s
technology to such company in China, and (iii) failing to provide the Company
with access to CTL’s books and records, as required by the Agreement. Based on
early discovery, we amended the complaint on May 4, 2007 to include claims
against Shanghai MediPharm and its related entities, and Alan Epstein, M.D
alleging that these defendants collaborated to interfere with the Agreement
by
entering in to a secret economic relationship between themselves and designed
not to share profits and know-how with Company in violation of the Agreement,
including proprietary technologies that they developed and are required to
share
with Company. The Company is seeking unspecified damages and declaratory relief
with respect to the termination of the Agreement with CTL, the exclusion of
certain technology from the Agreement, and an accounting of all monies, data
and
other items that should have been paid or given to the Company under the
Agreement.
12
PEREGRINE
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR
THE THREE MONTHS ENDED JULY 31, 2007 (unaudited)
(continued)
On
March
28, 2007, CTL filed a cross-complaint, which they 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. While we
are
objecting to the cross-complaint on several grounds, we are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which Company interfered, they have been unable to produce the alleged
sublicense agreement with MediPharm despite our repeated demands.
The
discovery phase on the aforementioned cases has only recently commenced. Until
we complete the initial 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.
13
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
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.
We are
advancing three separate clinical programs encompassing two platform
technologies: Anti-PhosphatidylSerine (“Anti-PS”) Immunotherapeutics and Tumor
Necrosis Therapy (“TNT”). Our lead Anti-PS product, bavituximab, is in separate
clinical trials 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 brain
cancer.
We
are
organized into two reportable operating segments: (i) Peregrine Pharmaceuticals,
Inc. (“Peregrine”), the parent company, is engaged in the research and
development of monoclonal antibody-based therapeutics 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-service
basis.
The
following represents a summary of our ongoing and anticipated clinical trial
programs:
Product
|
Indication
|
Trial
Design
|
Status
|
Bavituximab
|
Solid
tumor cancers
|
Phase
I repeat dose monotherapy safety study to treat up to 28 patients.
|
Study
is open for enrollment in the U.S.
|
Bavituximab
plus chemotherapy agents carboplatin/paclitaxel
|
Non-small
cell lung cancer (NSCLC)
|
Phase
II combination therapy study to treat up to 49 patients.
|
Submitted
clinical protocol with the regulatory authorities in India. Patient
enrollment is expected to initiate later this year.
|
Bavituximab
plus chemotherapy and/or radiation therapy
|
Solid
tumor cancers
|
Phase
I/II and Phase II studies.
|
Additional
clinical studies are currently being planned are expected to initiate
later this year.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme or GBM)
|
Dosimetry
and dose confirmation study designed to treat up to 12 patients with
recurrent GBM.
|
Study
is open for enrollment in the U.S.
|
Cotara®
|
Brain
cancer (glioblastoma multiforme or GBM)
|
Phase
II safety and efficacy study to treat up to 40 patients at 1st
relapse.
|
Study
is open for enrollment in India.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection (co-infected with HIV)
|
Phase
Ib repeat dose safety study in 24 patients.
|
Study
is open for enrollment in the U.S.
|
Bavituximab
|
Chronic
Hepatitis C Virus (“HCV”) infection
|
Phase
Ib safety and dosing study.
|
Study
is being planned.
|
14
Results
of Operations
The
following table compares the unaudited condensed consolidated statements of
operations for the three-month periods ended July 31, 2007 and 2006. 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,
|
||||||||||
2007
|
2006
|
$
Change
|
||||||||
REVENUES:
|
||||||||||
Contract
manufacturing revenue
|
$
|
1,621,000
|
$
|
398,000
|
$
|
1,223,000
|
||||
License
revenue
|
4,000
|
23,000
|
(19,000
|
)
|
||||||
Total
revenues
|
1,625,000
|
421,000
|
1,204,000
|
|||||||
COSTS
AND EXPENSES:
|
||||||||||
Cost
of contract manufacturing
|
1,181,000
|
530,000
|
651,000
|
|||||||
Research
and development
|
3,624,000
|
4,041,000
|
(417,000
|
)
|
||||||
Selling,
general & administrative
|
1,708,000
|
1,641,000
|
67,000
|
|||||||
Total
costs and expenses
|
6,513,000
|
6,212,000
|
301,000
|
|||||||
LOSS
FROM OPERATIONS
|
(4,888,000
|
)
|
(5,791,000
|
)
|
903,000
|
|||||
OTHER
INCOME (EXPENSE):
|
||||||||||
Interest
and other income
|
239,000
|
349,000
|
(110,000
|
)
|
||||||
Interest
and other expense
|
(7,000
|
)
|
(15,000
|
)
|
8,000
|
|||||
NET
LOSS
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
$
|
801,000
|
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
increase in total revenues of $1,204,000 during the three months ended July
31,
2007 compared to the same period in the prior year was due to an increase in
contract manufacturing revenue of $1,223,000 offset with a $19,000 decrease
in
license revenue. This increase in contract manufacturing revenue was due to
an
increase in services provided to unrelated entities on a fee-for-service basis
associated with an increase in active projects including an increase in the
number of completed manufacturing runs compared to the same three-month period
in the prior year.
We
expect
an increase in 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
outstanding proposals. Avid is presently working on several active projects
for
existing clients and has submitted project proposals to various potential
clients. Since the timing to initiate and complete projects from existing
clients and our ability to convert outstanding proposals into new contracts
and
new business is at the discretion of our clients or potential clients, we cannot
reasonably estimate with a high degree of likelihood our revenues for the
remainder of fiscal year 2008.
15
Cost
of Contract Manufacturing.
The
increase in cost of contract manufacturing of $651,000 during the three
months
ended July 31, 2007 compared to the same period in the prior year was primarily
related to the current quarter increase in contract manufacturing revenue.
This
increase was offset by the prior year write-off of unusable work-in-process
inventory generated for an unrelated entity during the quarter ended July
31,
2006, combined with an estimated contract loss provision for the same unrelated
entity, which amount in the aggregate totaled $208,000. 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
decrease in research and development (“R&D”) expenses of $417,000
during the three-month period ended July 31, 2007 compared to the same
period in
the prior year was primarily due to a net decrease in expenses associated
with
each of our following platform technologies under
development:
Technology
Platform
|
R&D
Expenses-Quarter Ended
July
31, 2007
|
R&D
Expenses-Quarter Ended
July
31, 2006
|
$
Change
|
|||||||
Anti-PS
Immunotherapeutics (bavituximab)
|
$
|
2,294,000
|
$
|
2,558,000
|
$
|
(264,000
|
)
|
|||
TNT
(Cotara®)
|
709,000
|
832,000
|
(123,000
|
)
|
||||||
VTA
and Anti-Angiogenesis Agents
|
464,000
|
532,000
|
(68,000
|
)
|
||||||
VEA
|
157,000
|
119,000
|
38,000
|
|||||||
Total
R&D Expenses
|
$
|
3,624,000
|
$
|
4,041,000
|
$
|
(417,000
|
)
|
o |
Anti-Phosphatidylserine
(“Anti-PS”) Immunotherapeutics (bavituximab) -
The decrease in Anti-PS Immunotherapeutics program expenses of $264,000
during the three months ended July 31, 2007 compared to the same
period in
the prior year is primarily due to a decrease in clinical trial patient
fees and related expenses combined with a decrease in manufacturing
expenses. During the current quarter, we were primarily involved
in
designing and preparing the necessary protocols to study bavituximab
in
two additional clinical trials. In July 2007, we initiated a Phase
Ib
study using bavituximab for the treatment of hepatitis C virus infection
in patients co-infected with HIV. In addition, during the same month,
we
submitted a Phase II clinical protocol in India to treat patients
with
non-small cell lung cancer (“NSCLC”) using bavituximab in combination with
chemotherapy. During the prior year fiscal quarter ended July 31,
2006,
clinical trial patient fees and related expenses were greater than
the
current quarter as we were enrolling patents in three separate Phase
I
clinical trials, two of which completed enrollment in fiscal year
2007.
|
o |
Tumor Necrosis Therapy (“TNT”)
(Cotara®) - The
decrease in TNT program expenses of $123,000 during the three months
ended
July 31, 2007 compared to the same period in the prior year is primarily
due to a decrease in manufacturing and related expenses as more
manufacturing capacity was utilized by third-party customers. This
decrease was offset by a slight increase in clinical trial expenses
associated with the two 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
$68,000 during the three months ended July 31, 2007 compared to the
same
period in the prior year is primarily due to decreases in technology
license fees, sponsored research fees and payroll and related expenses
offset by an increase in manufacturing
expenses.
|
o |
Vasopermeation
Enhancement Agents (“VEAs”) -
The increase in VEA program expenses of $38,000 during the three
months
ended July 31, 2007 compared to the same period in the prior year
is
primarily due to increases in payroll and related expenses and laboratory
materials associated with increased efforts to advance the pre-clinical
development of our VEA program.
|
16
Looking
beyond the current fiscal year, it is 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 our capital resources to fund research, development
and
clinical studies beyond fiscal year
2008;
|
· |
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 uncertain whether or
not these
product candidates will be successful and we are uncertain whether
or not
we will incur any additional costs beyond pre-clinical
development;
|
· |
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, stock-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 slightly increased by $67,000 during the
three months ended July 31, 2007 compared to the same period in the prior year.
This increase was primarily due to increases in corporate legal fees and payroll
and related expenses. Corporate legal fees increased $43,000 from $167,000
in
the prior year three-month period to $210,000 in the current year three-month
period. This increase was primarily related to legal fees associated with the
lawsuit described in this Quarterly Report on Form 10-Q under Part II, Item
1,
“Legal Proceedings”, combined with legal fees associated with licensing and
other corporate matters. Payroll and related expenses remained fairly consistent
with the prior year slightly, increasing $36,000 from $732,000 in the prior
year
three-month period to $768,000 in the current year three-month period. In
addition, these current year three-month period increases were supplemented
by
incremental increases in investor and public relation fees and business
development related travel expenses. These increases in selling, general and
administrative expenses were offset with a decrease in non-cash stock-based
compensation expense of $86,000 from $140,000 in the prior year three-month
period to $54,000 in the current year three-month period primarily due to a
$79,000 decrease in stock-based compensation expense associated with the
amortization of the fair value of options granted to employees in accordance
with SFAS No. 123R.
17
Interest
and Other Income.
The
decrease in interest and other income of $110,000 during the three months ended
July 31, 2007 compared to the same period in the prior year was due to a
$131,000 decrease in other income primarily associated with the sale of a
trademark name in the prior year quarter ended July 31, 2006 offset with a
$21,000 increase in interest income as a result of higher prevailing interest
rates 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.
In
addition, we 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.
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.
18
Contract
manufacturing revenues 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.
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.
Stock-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. On May 1, 2006, we adopted SFAS No. 123R using the
modified-prospective method and, accordingly, stock-based compensation cost
recognized beginning May 1, 2006 includes: (a) compensation cost for all
share-based payments granted prior to, but not yet vested as of May 1, 2006,
based on the grant date fair value estimated in accordance with the original
provisions of SFAS No. 123, and (b) compensation cost for all share-based
payments granted on or subsequent to May 1, 2006, based on the grant date fair
value estimated in accordance with the provisions of SFAS No. 123R. Under the
modified-prospective method results for prior periods are not
restated.
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 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 is 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”). 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.
19
Our
loss
from operations for the three-month periods ended July 31, 2007 and 2006
included stock-based compensation expense of $183,000 and $299,000,
respectively. We believe that non-cash stock-based compensation expense for
the
remaining nine months of fiscal year 2008 may be up to approximately $523,000
based on actual shares granted and unvested as of July 31, 2007. 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.
As
of
July 31, 2007, the total estimated unrecognized compensation cost related to
non-vested stock options was $1,846,000. This cost is expected to be recognized
over a weighted average period of 2.85 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.
Liquidity
and Capital Resources
As
of
July 31, 2007, we had $30,635,000 in cash and cash equivalents on hand compared
to $16,044,000 at April 30, 2007. Although we have sufficient cash on hand
to
meet our planned obligations through at least fiscal year 2008 based on our
current projections, our development efforts are highly dependent on our ability
to raise additional capital to support our future operations.
We
have
expended substantial funds on the development of our product candidates and
we
have incurred negative cash flows from operations for the majority of years
since our inception. Since inception, we have financed our operations primarily
through the sale of our common stock and issuance of convertible debt, which
has
been supplemented with payments received from various licensing collaborations
and through the revenues generated by Avid. We expect negative cash flows from
operations to continue until we are able to generate sufficient revenue from
contract manufacturing services provided by Avid and/or from the sale and/or
licensing of our products under development.
Revenues
earned by Avid during the three months ended July 31, 2007 and 2006 amounted
to
$1,621,000 and $398,000, respectively. We expect that Avid will continue to
generate revenues which should partially offset our consolidated cash flows
used
in operations, although we expect those near-term revenues will be insufficient
to cover total anticipated cash flows used in operations. In addition, revenues
from the sale and/or licensing of our products under development are always
uncertain. 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 beyond fiscal year 2008.
We
may
raise additional capital through the sale of shares of our common stock, and
as
of July 31, 2007, we had approximately 5,031,000 shares available for possible
future registered transactions under two separate registration statements.
In
addition, during January 2007, we filed a separate registration statement on
Form S-3, File Number 333-139975, which allows us to issue, from time to time,
in one or more offerings, shares of our common stock for remaining proceeds
of
up to $7,500,000. However, given uncertain market conditions and the volatility
of our stock price and trading volume, we may not be able to sell our securities
at prices or on terms that are favorable to us, if at all.
In
addition to equity financing, we actively explore various other sources of
funding, including possible debt financing and leveraging our many assets,
including our intellectual property portfolio. Our broad intellectual property
portfolio allows us to develop products internally while at the same time we
are
able to out-license certain areas of the technology which would not interfere
with our internal product development efforts.
20
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 agreements to complete
the
research, development, and clinical testing of our product candidates.
Significant
components of the changes in cash flows from operating, investing, and financing
activities for the three months ended July 31, 2007 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, 2007, cash used
in operating activities increased $1,245,000 to $6,220,000 compared to
$4,975,000 for the three months ended July 31, 2006. This increase 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
$1,665,000. This amount was offset by lower net loss reported in current quarter
after taking into consideration non-cash operating expenses in the amount of
$420,000. The decrease in our current quarter net loss was primarily due to
a
current quarter increase in contract manufacturing revenue combined with a
decrease 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,
2007
|
July
31,
2006
|
||||||
Net
loss, as reported
|
$
|
(4,656,000
|
)
|
$
|
(5,457,000
|
)
|
|
Less
non-cash expenses
and adjustments to net loss:
Depreciation
and amortization
Stock-based
compensation and common stock issued under stock bonus plan
Amortization
of expenses paid in shares of common stock
|
119,000
197,000
-
|
115,000
373,000
209,000
|
|||||
Net
cash used in operating activities before changes in operating assets
and
liabilities
|
$
|
(4,340,000
|
)
|
$
|
(4,760,000
|
)
|
|
Net
change in operating assets and liabilities
|
$
|
(1,880,000
|
)
|
$
|
(215,000
|
)
|
|
Net
cash used in operating activities
|
$
|
(6,220,000
|
)
|
$
|
(4,975,000
|
)
|
Cash
Used In Investing Activities.
Net cash
used in investing activities decreased $42,000 to $4,000 for the three months
ended July 31, 2007 compared to net cash used of $46,000 for the three months
ended July 31, 2006. This decrease was primarily due to the reclassification
of
a $67,000 security deposit from other long-term assets to other current assets
during the quarter ended July 31, 2007 as such deposit becomes due and payable
to us within the next twelve months. The decrease in net cash used in investing
activities was offset by a $29,000 increase in property
acquisitions.
Cash
Provided By Financing Activities.
Net
cash provided by financing activities increased $4,476,000 to $20,815,000 for
the three months ended July 31, 2007 compared to net cash provided of
$16,339,000 for the three months ended July 31, 2006. Cash provided by financing
activities during the three months ended July 31, 2007 was due to proceeds
received under 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, which was supplemented with net proceeds of $72,000 from the
exercise of stock options and warrants. Cash provided by financing activities
during the three months ended July 31, 2006 was due to net proceeds received
from the sale of our common stock under a security purchase agreement in the
amount of $12,970,000 supplemented with net proceeds of $3,478,000 from the
exercise of stock options and warrants.
Commitments
At
July
31, 2007, we had no material capital commitments.
21
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, 2007,
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 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, 2007, 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, 2007.
There
were no significant changes in the Company’s internal controls over financial
reporting, during the quarter ended July 31, 2007, that have materially
affected, or are reasonably likely to materially affect, the Company’s internal
controls over financial reporting.
PART
II OTHER INFORMATION
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:
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 lawsuit alleges that CTL has breached various agreements with the
Company by (i) failing to pay to the Company its contractual share of the
proceeds received by CTL when it formed a joint venture with a company in China
involving the Company’s technology that had been licensed to CTL pursuant to an
earlier agreement (the “Agreement”), (ii) failing to procure a sublicense with
the company in China prior to transferring the Company’s technology to such
company in China, and (iii) failing to provide the Company with access to CTL’s
books and records, as required by the Agreement. Based on early discovery,
we
amended the complaint on May 4, 2007 to include claims against Shanghai
MediPharm and its related entities, and Alan Epstein, M.D alleging that these
defendants collaborated to interfere with the Agreement by entering in to a
secret economic relationship between themselves and designed not to share
profits and know-how with Company in violation of the Agreement, including
proprietary technologies that they developed and are required to share with
Company. The Company is seeking unspecified damages and declaratory relief
with
respect to the termination of the Agreement with CTL, the exclusion of certain
technology from the Agreement, and an accounting of all monies, data and other
items that should have been paid or given to the Company under the
Agreement.
22
On
March
28, 2007, CTL filed a cross-complaint, which they 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. While we
are
objecting to the cross-complaint on several grounds, we are challenging the
cross-complaint on the basis that not only did CTL fail to allege an agreement
with which Company interfered, they have been unable to produce the alleged
sublicense agreement with MediPharm despite our repeated demands.
The
discovery phase on the aforementioned cases has only recently commenced. Until
we complete the initial 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 on Form 10-K for the fiscal year ended April 30, 2007.
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, 2007, we had approximately $30.6 million 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, 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.
Revenues
earned by Avid during the three months ended July 31, 2007 and 2006 amounted
to
$1,621,000 and $398,000, respectively. We expect that Avid will continue to
generate revenues which should partially offset our consolidated cash flows
used
in operations, although we expect those near term revenues will be insufficient
to cover total anticipated cash flows used in operations. In addition, revenues
from the sale and/or licensing of our products under development are always
uncertain. 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 beyond fiscal year 2008.
We
currently expect our monthly negative cash flow to continue for the foreseeable
future
due to
the anticipated increase in clinical trials, including trials associated with
bavituximab for the treatment of both solid tumors and hepatitis C virus (“HCV”)
infection and trials associated with Cotara® for the treatment of brain cancer.
In addition, we plan to expend additional resources on our continued research
and development directed towards our other technologies in pre-clinical
development, and our possible expansion of our manufacturing capabilities.
We
plan
to obtain any necessary funding to support the costs of our clinical and
pre-clinical programs through one or more methods including either equity or
debt financing and/or negotiating additional licensing or collaboration
agreements for our technology platforms. As of July 31, 2007, we had
an
aggregate of approximately 5,031,000 shares available under our existing Form
S-3 registration statements for possible future registered transactions. In
addition, during January 2007, we filed a separate shelf registration statement
on Form S-3, File Number 333-139975, which allows us to issue, from time to
time, in one or more offerings, shares of our common stock for remaining
proceeds of up to $7,500,000. 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. However, there
can
be no assurances that we will be successful in raising such funds on terms
acceptable to us, or at all, or that sufficient additional capital will be
raised to complete the research, development, and clinical testing of our
product candidates.
23
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 during the past three fiscal
years and during the three months ended July 31, 2007:
Net
Loss
|
||||
Three months ended July 31, 2007 (unaudited) | $ | 4,656,000 | ||
Fiscal Year 2007 | $ | 20,796,000 | ||
Fiscal Year 2006 | $ | 17,061,000 | ||
Fiscal Year 2005 | $ | 15,452,000 |
As
of
July 31, 2007, we had an accumulated deficit of $212,316,000. 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 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, 2007, we had 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 approximately 21,513,000 additional shares of our common stock
that are reserved for future issuance under our shelf registration statements,
stock option plans and for outstanding warrants, 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
|
16,122,180
|
|||
Common
shares issuable upon exercise of outstanding warrants
|
360,000
|
|||
Total
|
21,512,814
|
24
In
addition, the above table does not include shares of common stock that we could
issue under the registration statement we filed during January 2007 on Form
S-3,
File Number 333-139975, which allows us to issue, from time to time, in one
or
more offerings, shares of our common stock for remaining proceeds of up to
$7,500,000.
Of
the
total warrants and options outstanding as of July 31, 2007, approximately
1,512,000 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, 2007.
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.
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, 2007,
and our fiscal quarter ended July 31, 2007:
Common
Stock
Sales
Price
|
Common
Stock Daily
Trading
Volume
(000’s
omitted)
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
Fiscal
Year 2008
|
|||||||||||||
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
|
|||||||
Fiscal
Year 2005
|
|||||||||||||
Quarter
Ended April 30, 2005
|
$
|
1.64
|
$
|
1.11
|
5,945
|
223
|
|||||||
Quarter
Ended January 31, 2005
|
$
|
1.45
|
$
|
0.99
|
6,128
|
160
|
|||||||
Quarter
Ended October 31, 2004
|
$
|
1.96
|
$
|
0.95
|
2,141
|
148
|
|||||||
Quarter
Ended July 31, 2004
|
$
|
1.92
|
$
|
0.88
|
1,749
|
131
|
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;
|
· |
the
offering and sale of shares of our common stock at a discount under
an
equity transaction;
|
· |
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.
|
25
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.
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 set forth above. According to the Nasdaq
notice, we are automatically afforded an initial “compliance period” of 180
calendar days, or until January 22, 2008, to regain compliance with this
requirement. To regain compliance, the closing bid price of our common stock
must meet or exceed $1.00 per share for 10 consecutive business days. If we
are
still not in compliance with the minimum closing bid price requirement after
the
initial 180 calendar day period but we are in compliance with all initial
listing requirements other than the bid requirement, we will be afforded an
additional "compliance period" of 180 calendar days within which to regain
compliance. 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.
Although
we currently meet all other Nasdaq listing requirements, we cannot guarantee
that we will be able to regain compliance with the minimum closing bid price
requirement within the required compliance period. The market price of our
common stock has generally been highly volatile.
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.
26
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 commercial sales 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 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, 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.
27
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:
· |
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 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.
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.
28
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:
· |
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 assure you that we
will be able to find a suitable licensing partner for this technology.
Furthermore, we cannot assure you that if we do find a suitable licensing
partner, the financial terms that they propose will be acceptable to the
Company.
29
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 companies in India
that
could 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.
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. 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.
30
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.
|
31
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 brain cancer. We also recently opened enrollment in
a
Phase II study in India using Cotara® to treat up to 40 patients for the
treatment of recurrent brain cancer. Existing 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 CDX-110, a peptide vaccine under
development by Celldex. Merck KGaA is evaluating cilengitide in newly diagnosed
GBM patients. AstraZeneca is developing cediranib for patients with recurrent
GBM. 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
for the treatment of advanced solid cancers is currently in a Phase I clinical
trial in the U.S. In addition, in July 2007, we filed a Phase II protocol in
India to treat patients with non-small cell lung cancer in combination with
chemotherapy. 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 Biogen Idec Inc. and 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.
32
In
addition, we have completed Phase Ia single-dose and Phase Ib multiple dose
clinical trials evaluating bavituximab for the treatment of HCV. In addition,
we
recently initiated a Phase I study in HCV patients co-infected with HIV over
a
longer dosing period. 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 Valeant Pharmaceuticals International. 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 SCH7 from Schering-Plough Corporation.
New
And Potential New Accounting Pronouncements May Impact Our Future Financial
Position And Results Of Operations
There
may
be potential new accounting pronouncements or regulatory rulings, which may
have
an impact on our future financial position and results of operations. For
example, in December 2004, the FASB issued an amendment to SFAS No. 123,
Accounting
For Stock-Based Compensation
(“SFAS
No. 123R”), which we adopted May 1, 2006, as discussed in Note 3, “Stock-Based
Compensation,” in the notes to the condensed consolidated financial statements.
SFAS No. 123R eliminates the ability to account for share-based
compensation transactions using Accounting Principles Board Opinion No. 25
(“APB No. 25”), and instead requires companies to recognize compensation expense
using a fair-value based method for costs related to share-based payments
including stock options. Our adoption of SFAS No. 123R is expected to
materially impact our financial position and results of operations for future
periods. During the quarter ended July 31, 2007, our loss from operations
included non-cash stock-based compensation expense of $183,000 related to the
adoption of SFAS No. 123R. In addition, we believe that non-cash stock-based
compensation expense for the remainder of fiscal year 2007 may be up to
approximately $523,000 based on actual shares granted and unvested as of July
31, 2007. However, the actual share-based compensation expense recorded during
the remainder of fiscal year 2008 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 fiscal year 2008, 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. Also,
a
change in accounting pronouncements or taxation rules or practices can have
a
significant effect on our reported results and may even affect our reporting
of
transactions completed before the change is effective. Other new accounting
pronouncements or taxation rules and varying interpretations of accounting
pronouncements or taxation practice have occurred and may occur in the future.
Changes to existing rules, future changes, if any, or the questioning of current
practices may adversely affect our reported financial results or the way we
conduct our business, which may also adversely affect our stock
price.
33
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
and
Chief Executive Officer, 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,
· |
no
stockholder action may be taken without a meeting, without prior
notice
and without a vote; solicitations by consent are thus
prohibited;
|
· |
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.
34
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:
|
|
31.1 |
Certification
of the Chief Executive Officer
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
|
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.
|
35
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 7, 2007 | By: | /s/ STEVEN W. KING |
Steven
W. King
President
and Chief Executive Officer,
Director
|
Date: September 7, 2007 | 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)
|
36