Attached files
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EX-31.1 - GENVEC INC | v200731_ex31-1.htm |
EX-32.1 - GENVEC INC | v200731_ex32-1.htm |
EX-32.2 - GENVEC INC | v200731_ex32-2.htm |
EX-31.2 - GENVEC INC | v200731_ex31-2.htm |
EX-10.1 - GENVEC INC | v200731_ex10-1.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended September 30, 2010
or
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:
|
0-24469
|
GenVec,
Inc.
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
23-2705690
|
||
(State
or other jurisdiction of
|
(IRS
Employer Identification
|
||
incorporation
or organization)
|
Number)
|
65
West Watkins Mill Road, Gaithersburg, Maryland
|
20878
|
(Address
of principal executive offices)
|
(Zip
Code)
|
240-632-0740
|
(Registrant's
telephone number, including area
code)
|
(Former name, former address and
former fiscal year, if changed since last
report.)
|
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 x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes o No
o
Indicate
by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company.
See the definitions of “large accelerated filer”, “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer o
|
Accelerated
filer x
|
Non-accelerated
filer o
|
Smaller
reporting company o
|
(do
not check if a smaller reporting
company)
|
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o
No x
As of
October 31, 2010, the Registrant had 129,067,759 shares of common stock, $.001
par value, outstanding.
GENVEC,
INC.
FORM
10-Q
TABLE
OF CONTENTS
PART I.
|
FINANCIAL INFORMATION
|
3
|
Item
1.
|
Financial
Statements (unaudited)
|
3
|
Condensed
Balance Sheets
|
3
|
|
Condensed
Statements of Operations
|
4
|
|
Statements
of Comprehensive Loss
|
5
|
|
Condensed
Statement of Stockholders’ Equity and Comprehensive Loss
|
6
|
|
Condensed
Statements of Cash Flows
|
7
|
|
Notes
to Condensed Financial Statements
|
8
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
18
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
26
|
Item
4.
|
Controls
and Procedures
|
27
|
|
||
PART II.
|
OTHER INFORMATION
|
28
|
Item
1.
|
Legal
Proceedings
|
28
|
Item
1A.
|
Risk
Factors
|
28
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
28
|
Item
3.
|
Defaults
Upon Senior Securities
|
28
|
Item
4.
|
[Removed
and Reserved]
|
29
|
Item
5.
|
Other
Information
|
29
|
Item
6.
|
Exhibits
|
29
|
SIGNATURES |
30
|
2
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
GENVEC,
INC.
(in
thousands, except per share data)
September 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 35,899 | $ | 10,887 | ||||
Short-term
investments
|
48 | 74 | ||||||
Accounts
receivable
|
3,256 | 1,442 | ||||||
Prepaid
expenses and other
|
291 | 331 | ||||||
Total
current assets
|
39,494 | 12,734 | ||||||
Property
and equipment, net
|
773 | 687 | ||||||
Other
assets
|
22 | 22 | ||||||
Total
assets
|
$ | 40,289 | $ | 13,443 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 1,429 | $ | 1,096 | ||||
Accrued
clinical trial expenses
|
1,079 | 1,195 | ||||||
Accrued
other expenses
|
2,198 | 2,838 | ||||||
Unearned
revenue
|
2,100 | 603 | ||||||
Total
current liabilities
|
6,806 | 5,732 | ||||||
Unearned
revenue
|
544 | 75 | ||||||
Total
liabilities
|
7,350 | 5,807 | ||||||
Stockholders'
equity:
|
||||||||
Preferred stock, $0.001 par value, 5,000 shares
authorized;
|
||||||||
none issued and outstanding in 2010 and
2009
|
- | - | ||||||
Common
stock, $0.001 par value; 200,000 shares authorized; 129,068
and
|
||||||||
106,336
shares issued and outstanding at September 30, 2010 and December
31,
|
||||||||
2009,
respectively
|
129 | 106 | ||||||
Additional
paid-in capital
|
276,095 | 239,519 | ||||||
Accumulated
other comprehensive income (loss)
|
(24 | ) | 2 | |||||
Accumulated
deficit
|
(243,261 | ) | (231,991 | ) | ||||
Total
stockholders' equity
|
32,939 | 7,636 | ||||||
Total
liabilities and stockholders' equity
|
$ | 40,289 | $ | 13,443 |
See
accompanying notes to unaudited condensed financial statements.
3
GENVEC,
INC.
(in
thousands, except per share data)
(Unaudited)
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenues
|
$ | 5,156 | $ | 2,926 | $ | 11,276 | $ | 10,502 | ||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
5,137 | 4,774 | 16,016 | 19,159 | ||||||||||||
General
and administrative
|
2,397 | 1,719 | 6,626 | 5,102 | ||||||||||||
Total
operating expenses
|
7,534 | 6,493 | 22,642 | 24,261 | ||||||||||||
Loss
from operations
|
(2,378 | ) | (3,567 | ) | (11,366 | ) | (13,759 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
1 | 2 | 3 | 37 | ||||||||||||
Interest
(expense) income, net of change in fair value of warrants
|
(1 | ) | 3 | 124 | (62 | ) | ||||||||||
Other
|
- | - | (31 | ) | (268 | ) | ||||||||||
Total
other income (expense), net
|
- | 5 | 96 | (293 | ) | |||||||||||
Net
loss
|
$ | (2,378 | ) | $ | (3,562 | ) | $ | (11,270 | ) | $ | (14,052 | ) | ||||
Net
loss per share - basic and diluted
|
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.09 | ) | $ | (0.15 | ) | ||||
Weighted
average shares outstanding - basic and diluted
|
129,025 | 101,001 | 125,911 | 93,953 |
See
accompanying notes to unaudited condensed financial statements.
4
STATEMENTS
OF COMPREHENSIVE LOSS
(in
thousands)
(Unaudited)
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Net
loss
|
$ | (2,378 | ) | $ | (3,562 | ) | $ | (11,270 | ) | $ | (14,052 | ) | ||||
Unrealized
holding (loss) gain on securities available
|
||||||||||||||||
for
sale
|
(14 | ) | (95 | ) | (26 | ) | 70 | |||||||||
Comprehensive
loss
|
$ | (2,392 | ) | $ | (3,657 | ) | $ | (11,296 | ) | $ | (13,982 | ) |
See
accompanying notes to unaudited condensed financial statements.
5
GENVEC,
INC.
CONDENSED
STATEMENT OF STOCKHOLDERS’ EQUITY AND COMPREHENSIVE LOSS
(in
thousands)
(Unaudited)
Accumulated
|
||||||||||||||||||||||||
Additional
|
Other
|
|||||||||||||||||||||||
Common Stock
|
Paid-in
|
Comprehensive
|
Accumulated
|
|||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income (Loss)
|
Deficit
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2009
|
106,336 | $ | 106 | $ | 239,519 | $ | 2 | $ | (231,991 | ) | $ | 7,636 | ||||||||||||
Comprehensive
loss:
|
||||||||||||||||||||||||
Net
loss
|
- | - | - | - | (11,270 | ) | (11,270 | ) | ||||||||||||||||
Unrealized
change in
|
||||||||||||||||||||||||
investments, net
|
- | - | - | (26 | ) | - | (26 | ) | ||||||||||||||||
Total
comprehensive loss
|
(11,296 | ) | ||||||||||||||||||||||
Common
stock and warrants issued, net
|
22,417 | 22 | 34,951 | - | - | 34,973 | ||||||||||||||||||
Common
stock issued under
|
||||||||||||||||||||||||
stock
benefit plans
|
315 | 1 | 179 | - | - | 180 | ||||||||||||||||||
Stock-based
compensation
|
- | - | 1,446 | - | - | 1,446 | ||||||||||||||||||
Balance,
September 30, 2010
|
129,068 | $ | 129 | $ | 276,095 | $ | (24 | ) | $ | (243,261 | ) | $ | 32,939 |
See accompanying notes to
unaudited condensed financial statements.
6
GENVEC,
INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(in
thousands)
(Unaudited)
Nine Months Ended
|
||||||||
September 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (11,270 | ) | $ | (14,052 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
181 | 784 | ||||||
Non-cash
adjustments for premiums/discounts on investments
|
- | 11 | ||||||
Non-cash
charges for stock-based compensation
|
1,446 | 1,298 | ||||||
Change
in fair value of warrant
|
(124 | ) | 39 | |||||
Change
in accounts receivable
|
(1,814 | ) | 1,239 | |||||
Change
in accounts payable and accrued expenses
|
(298 | ) | (2,003 | ) | ||||
Change
in unearned revenue
|
1,966 | (1,983 | ) | |||||
Change
in other assets and liabilities, net
|
39 | 882 | ||||||
Net
cash used in operating activities
|
(9,874 | ) | (13,785 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases
of property and equipment
|
(267 | ) | (150 | ) | ||||
Purchases
of investment securities
|
- | (1,002 | ) | |||||
Proceeds
from sale and maturity of investment securities
|
- | 3,000 | ||||||
Net
cash (used in) provided by investing activities
|
(267 | ) | 1,848 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from issuance of common stock and warrants,
|
||||||||
net of issuance costs
|
35,153 | 11,201 | ||||||
Principal
payments of long-term debt and change in sinking fund
|
- | (452 | ) | |||||
Net
cash provided by financing activities
|
35,153 | 10,749 | ||||||
Increase
(decrease) in cash and cash equivalents
|
25,012 | (1,188 | ) | |||||
Beginning
balance of cash and cash equivalents
|
10,887 | 14,315 | ||||||
Ending
balance of cash and cash equivalents
|
$ | 35,899 | $ | 13,127 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Interest
paid
|
$ | - | $ | 37 |
See
accompanying notes to unaudited condensed financial statements.
7
GENVEC,
INC.
(Unaudited)
(1)
General
Basis
of Presentation
The
condensed financial statements included herein have been prepared by GenVec,
Inc. (GenVec, we, our, or the Company) without audit pursuant to the rules and
regulations of the Securities and Exchange Commission (SEC). Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the
United States have been condensed or omitted pursuant to such rules and
regulations. We believe the disclosures are adequate to make the information
presented not misleading. The condensed financial statements included
herein should be read in conjunction with the financial statements and the notes
thereto included in our 2009 Annual Report on Form 10-K filed with the
SEC.
In the
opinion of management, the accompanying condensed, unaudited financial
statements contain all adjustments (consisting of only normal recurring
accruals) necessary to present fairly the financial position of the Company as
of September 30, 2010 and December 31, 2009 and the results of its operations
and cash flows for the three-month and nine-month periods ended September 30,
2010 and September 30, 2009. The results of operations for any interim
period are not necessarily indicative of the results of operations for any other
interim period or for a full fiscal year.
Business
In June
2010, GenVec announced that the Company had retained Wells Fargo Securities, LLC
to conduct a comprehensive review of strategic alternatives aimed at enhancing
shareholder value. As part of this process, we solicited proposals for
strategic transactions, including proposals for the disposition of some or all
of the Company’s assets, or for the sale or merger of the entire entity. In
November 2010, we announced that we had concluded our engagement of Wells
Fargo. During the course of the strategic review, we did not receive any
proposals to acquire the Company, or for the acquisition of all or part of its
assets. The Board of Directors has endorsed an independent operating plan
focused on the development and commercialization of our product opportunities in
the ordinary course of business. We will continue to explore value enhancing
strategic opportunities while focusing on our core business.
Key
components of our strategy moving forward include:
|
·
|
Working
with Novartis to facilitate the development of first-in-class products for
the treatment of hearing and balance
disorders;
|
|
·
|
Entering
into new collaborations to support the development of our pipeline of
products in oncology, vaccines, and animal
health.
|
|
·
|
Supporting
our funded contracts and collaborations for the development of new
vaccines.
|
|
·
|
Exploring
new applications of our technology to address the treatment and prevention
of major unmet medical needs.
|
|
·
|
Minimizing
our cash burn rate and avoiding the need for additional equity
financing.
|
On May
12, 2010, we received a notice from the Nasdaq Stock Market (NASDAQ) stating
that the minimum bid price of our common stock was below $1.00 per share for 30
consecutive business days and that we were therefore not in compliance with the
minimum bid price requirement for continued listing set forth in Marketplace
Rule 5450. The notification letter stated that we would be afforded 180 calendar
days, or until November 8, 2010, to regain compliance with the minimum bid price
requirement. To regain compliance, the closing bid price of our common stock
would have had to meet or exceed $1.00 per share for at least ten consecutive
business days during the 180 calendar day grace period. In order to obtain
additional time to seek to regain compliance with the minimum bid price
requirement, on November 1, 2010 we applied to transfer our common stock to the
NASDAQ Capital Market, and such transfer was declared effective as of November
8, 2010. On November 9, 2010, NASDAQ notified us that we
would have an additional 180 days, or until May 9, 2011, to regain
compliance with the minimum bid price rule while listed on the NASDAQ Capital
Market. NASDAQ may, in its discretion, require our common stock to maintain a
bid price of at least $1.00 per share for a period in excess of ten consecutive
business days, but generally no more than 20 consecutive business days, before
determining that we have demonstrated an ability to maintain long-term
compliance. If we do not regain compliance with the minimum bid price
requirement by May 9, 2011, NASDAQ will provide written notification to us that
our common stock will be delisted. At that time, we may appeal NASDAQ's
delisting determination to a NASDAQ Listing Qualifications
Panel.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the US, or GAAP, requires management to make judgments,
estimates, and assumptions that affect the amount reported in the Company’s
condensed financial statements and accompanying notes. Actual results
could differ materially from those estimates.
8
Revenue
Recognition
Revenue
is recognized when all four of the following criteria are met (1) a contract is
executed, (2) the contract price is fixed and determinable, (3) delivery of the
service or products have occurred, and (4) collectability of the contract
amounts is considered probable.
Our
collaborative research and development agreements can provide for upfront
license fees, research payments, and/or milestone payments. Upfront
nonrefundable fees associated with license and development agreements where we
have continuing involvement in the agreement are recorded as deferred revenue
and recognized over the estimated service period. If the estimated service
period is subsequently modified, the period over which the upfront fee is
recognized is modified accordingly on a prospective basis. Non-refundable
research and development fees for which no future performance obligations exist
are recognized when collection is assured. Our collaborative agreements
also contain substantive milestone payments. Substantive milestone payments are
considered performance payments and are recognized upon achievement of the
milestone if all of the following criteria are met: (i) achievement of the
milestone involves a degree of risk and was not reasonably assured at the
inception of the arrangement; (ii) substantive effort is involved in achieving
the milestone; and (iii) the amount of the milestone payment is reasonable in
relation to all of the deliverables and payment terms within the
arrangement. Determination of whether a milestone meets the aforementioned
conditions involves the judgment of management.
Research
and development revenue from cost-reimbursement and cost-plus fixed fee
agreements is recognized as earned based on the performance requirements of the
contract. Revisions in revenues, cost, and billing factors (e.g. indirect
rate estimates) are accounted for in the period of change. Reimbursable
costs under such contracts are subject to audit and retroactive
adjustment. Contract revenues and accounts receivable reported in the
financial statements are recorded at the amount expected to be received.
Contract revenues are adjusted to actual upon final audit and retroactive
adjustment. Estimated contractual allowances are provided based on
management’s evaluation of current contract terms and past experience with
disallowed costs and reimbursement levels. Payments received in advance of
work performed are recorded as deferred revenue.
New
Accounting Pronouncements
In
October 2009, the Financial Accounting Standards Board (the FASB) issued
Accounting Standards Update (ASU) No. 2009-13, “Multiple-Deliverable
Revenue Arrangements.” ASU 2009-13 amends existing revenue recognition
accounting pronouncements that are currently within the scope of FASB ASC Topic
605. This consensus provides accounting principles and application guidance on
how the arrangement should be separated, and the consideration allocated. This
guidance changes how to determine the fair value of undelivered products and
services for separate revenue recognition. Allocation of consideration is now
based on management’s estimate of the selling price for an undelivered item
where there is no other means to determine the fair value of that undelivered
item. This new approach is effective prospectively for revenue arrangements
entered into or materially modified in fiscal years beginning on or after
June 15, 2010, with early application permitted. We are currently
evaluating the impact, if any, on our financial condition and results of
operations.
In
January 2010, the FASB issued ASU No. 2010-06, “Fair Value Measurements and
Disclosures.” This ASU amends Topic 820 and related guidance within U.S.
GAAP to require disclosure of the transfers in and out of Levels 1 and 2 and a
schedule for Level 3 that separately identifies purchases, sales, issuances and
settlements and requires more detailed disclosures regarding valuation
techniques and inputs. The adoption of this standard did not have a
material impact on the presentation of our financial statements.
In March
2010, the Patient Protection and Affordable Care Act and the Health Care and
Education Reconciliation Act were signed into law. We are currently in the
process of determining the effects, if any, of these new laws on the
Company.
9
In April
2010, FASB issued ASU No. 2010-17, “Revenue Recognition—Milestone Method,” which
provides guidance on defining a milestone and determining when it may be
appropriate to apply the milestone method of revenue recognition for research or
development transactions. Research or development arrangements frequently
include payment provisions whereby a portion or all of the consideration is
contingent upon milestone events such as successful completion of phases in a
study or achieving a specific result from the research or development efforts.
The amendments in this ASU provide guidance on the criteria that should be met
for determining whether the milestone method of revenue recognition is
appropriate. The ASU is effective for fiscal years and interim periods within
those years beginning on or after June 15, 2010, with early adoption permitted.
We are currently evaluating the impact, if any on our financial condition and
results of operations.
(2)
|
Fair
Value Measurements
|
We apply
the provisions of the FASB Accounting Standards Codification (ASC) Section 820
(formerly SFAS No. 157) “Fair Value Measurements and Disclosures” (ASC 820). ASC
820 establishes a three-level hierarchy for fair value measurements. The
hierarchy is based upon the transparency of inputs to the valuation of an asset
or liability as of the measurement date. The three levels of inputs used to
measure fair value are as follows:
·
|
Level
1 – Quoted prices in active markets for identical assets or
liabilities;
|
·
|
Level
2 – Observable inputs other than quoted prices included in Level 1, such
as quoted prices for similar assets and liabilities in active markets;
quoted prices for identical or similar assets and liabilities in markets
that are not active; or other inputs that are observable or can be
corroborated by observable market data;
and
|
·
|
Level
3 – Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value of the assets or
liabilities. This includes certain pricing models, discounted cash
flow methodologies, and similar techniques that use significant
unobservable inputs.
|
The
following table presents information about assets and liabilities recorded at
fair value on a recurring basis at September 30, 2010 on the Condensed Balance
Sheet:
Quoted Prices in
|
||||||||||||||||
Active Markets for
|
Significant
|
Significant
|
||||||||||||||
Total Carrying
|
Identical
|
Other Observable
|
Unobservable
|
|||||||||||||
Value on the
|
Assets/Liabilities
|
Inputs
|
Inputs
|
|||||||||||||
(In thousands)
|
Balance Sheet
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 35,899 | $ | 35,899 | $ | - | $ | - | ||||||||
Marketable
securities
|
48 | 48 | - | - | ||||||||||||
Total
assets at fair value
|
$ | 35,947 | $ | 35,947 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Warrant
liability
|
$ | 8 | $ | - | $ | 8 | $ | - | ||||||||
Total
liabilities at fair value
|
$ | 8 | $ | - | $ | 8 | $ | - |
10
The
following table presents information about assets and liabilities recorded at
fair value on a recurring basis at December 31, 2009 on the Condensed Balance
Sheet:
Quoted Prices in
|
||||||||||||||||
Active Markets for
|
Significant
|
Significant
|
||||||||||||||
Total Carrying
|
Identical
|
Other Observable
|
Unobservable
|
|||||||||||||
Value on the
|
Assets/Liabilities
|
Inputs
|
Inputs
|
|||||||||||||
(In thousands)
|
Balance Sheet
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 10,887 | $ | 10,887 | $ | - | $ | - | ||||||||
Marketable
securities
|
74 | 74 | - | - | ||||||||||||
Total
assets at fair value
|
$ | 10,961 | $ | 10,961 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Warrant
liability
|
$ | 133 | $ | - | $ | 133 | $ | - | ||||||||
Total
liabilities at fair value
|
$ | 133 | $ | - | $ | 133 | $ | - |
We
determine fair value for marketable securities with Level 1 inputs through
quoted market prices and have classified them as available-for-sale. Our
marketable securities consist of an investment in equity securities of a
publically traded company.
The
warrant liability has been valued using the Black-Scholes pricing model, the
inputs of which are described more fully in Note 4 to the condensed financial
statements. The warrant liability, related to the Kingsbridge warrants, has been
classified within Level 2.
There
were no transfers of assets or liabilities between Level 1 and Level 2 during
the nine months ended September 30, 2010.
All
unrealized holding gains or losses related to our investments in marketable
securities are reflected in accumulated other comprehensive income (loss) in
stockholders’ equity. Included in accumulated other comprehensive loss was a net
unrealized loss of $26,000 for the nine months ended September 30,
2010.
(3)
Stock Benefit Plans
Stock
Option Plans
Our
stockholders approved the 2002 Incentive Stock Plan (2002 Plan) as the
replacement for the 1993 Stock Incentive Plan (1993 Plan) and 2000 Director Plan
(2000 Plan) in June 2002. Amendments to the 2002 Plan have increased the
number of shares of common stock available to be issued under the 2002 Plan to
16,700,000. At September 30, 2010 there are 7,599,969 shares available for
future issuance under the 2002 Plan. Outstanding options under the 2002 Plan at
September 30, 2010 expire through 2020. Outstanding options under the 1993
Plan and 2000 Plan at September 30, 2010 expire through 2012 and 2011,
respectively.
In August
2003, GenVec, Inc. and Diacrin Inc. consummated a business combination under
which we acquired Diacrin through an exchange of stock. Under the terms of
the agreement, we agreed to assume each option, vested or unvested, granted by
Diacrin pursuant to the Diacrin 1997 Stock Option Plan (1997 Plan). As of
September 30, 2010, awards outstanding under the 1997 Plan were 48,934 shares,
which expire through 2012.
11
Stock-Based
Compensation Expense
We
measure the cost of all share-based payment awards made to our employees and
directors including awards of employee stock options, restricted stock units and
employee stock purchases based on the fair value method of measurement and
recognize compensation expense on a straight-line basis over the service period
of each award.
The
following table summarizes stock-based compensation expense related to employee
stock options for the three and nine month periods ended September 30, 2010 and
September 30, 2009, which was allocated as follows:
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
(in thousands)
|
(in thousands)
|
|||||||||||||||
Research
and development
|
$ | 337 | $ | 325 | $ | 1,041 | $ | 952 | ||||||||
General
and administrative
|
140 | 124 | 405 | 346 | ||||||||||||
$ | 477 | $ | 449 | $ | 1,446 | $ | 1,298 |
The
weighted-average estimated fair value of employee stock options granted during
the nine months ended September 30, 2010 and 2009 were $1.52 and $0.34,
respectively. The weighted-average estimated fair value of employee stock
options granted during the nine months ended September 30, 2010 and 2009 was
calculated using the Black-Scholes model with the following weighted-average
assumptions:
For the Nine
|
For the Nine
|
|||||||
Months Ended
|
Months Ended
|
|||||||
September 30, 2010
|
September 30, 2009
|
|||||||
Risk-free
interest rate
|
2.40 | % | 1.69 | % | ||||
Expected
dividend yield
|
0.00 | % | 0.00 | % | ||||
Expected
volatility
|
90.08 | % | 94.59 | % | ||||
Expected
life (years)
|
5.85 | 5.87 |
The
volatility assumption for 2010 and 2009 is based on the weighted average
volatility for the most recent one-year period as well as the volatility over
the expected life of 5.85 years and 5.87 years, respectively.
The
risk-free interest rate assumption is equal to the five year U.S. Treasury note
at various rates as of the date of the grants ranging from 1.39% to 2.65% for
the nine months ended September 30, 2010 and 1.61% to 2.69% for the nine months
ended September 30, 2009. The five year U.S. Treasury note is used based
on the expected life of the grant at the grant date.
The
dividend yield is based on the assumption that we do not expect to declare a
dividend over the life of the options.
The
expected life of employee stock options represents the weighted average of the
actual life of options that have already been exercised or cancelled with the
expected life of all outstanding options. The expected life of outstanding
options is calculated assuming the options will be exercised at the midpoint of
the vesting date (four years) and the full contractual term (ten years).
Forfeitures are estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates.
Forfeitures are estimated based on our historical forfeiture rates and standard
probabilities of employee turnover based on the demographics of current option
holders. We do not record tax related effects on stock-based compensation
given our historical and anticipated operating experience and offsetting changes
in our valuation allowance which fully reserves against potential deferred tax
assets.
12
Stock
Options
The
following table summarizes the stock option activity for the nine months ended
September 30, 2010:
Weighted
|
Weighted
|
|||||||||||||||
average
|
average
|
Aggregate
|
||||||||||||||
Number
|
exercise
|
contractual
|
intrinsic
|
|||||||||||||
(in thousands, except exercise price and contractual term
data)
|
of shares
|
price
|
life (years)
|
value
|
||||||||||||
Stock
options outstanding, December 31, 2009
|
7,854 | $ | 1.72 | |||||||||||||
Granted
|
2,062 | 2.04 | ||||||||||||||
Exercised
|
(163 | ) | 0.63 | |||||||||||||
Forfeited
|
(722 | ) | 1.40 | |||||||||||||
Expired
|
(568 | ) | 2.18 | |||||||||||||
Stock
options outstanding at September 30, 2010
|
8,463 | $ | 1.82 | 6.74 | $ | 304 | ||||||||||
Vested
or expected to vest at September 30, 2010
|
7,359 | $ | 1.87 | 6.45 | $ | 255 | ||||||||||
Exercisable
at September 30, 2010
|
5,418 | $ | 2.00 | 5.66 | $ | 121 |
Unrecognized
stock-based compensation related to stock options was approximately $2.7 million
as of September 30, 2010. This amount is expected to be expensed over a weighted
average period of 2.7 years. We realized $106,000 in proceeds from options
exercised during the nine months ended September 30, 2010 and no proceeds during
the nine months ended September 30, 2009.
The
following table summarizes information about our stock options outstanding at
September 30, 2010:
Outstanding
|
Exercisable
|
|||||||||||||||||||
Weighted
|
||||||||||||||||||||
average
|
Weighted
|
Weighted
|
||||||||||||||||||
remaining
|
average
|
average
|
||||||||||||||||||
Range of exercise
|
Number
|
contractual
|
exercise
|
Number
|
exercise
|
|||||||||||||||
prices
|
of shares
|
life (in years)
|
price
|
of shares
|
price
|
|||||||||||||||
(number of shares in thousands)
|
||||||||||||||||||||
$0.00
- $1.00
|
1,882 | 8.43 | $ | 0.46 | 758 | $ | 0.47 | |||||||||||||
$1.01
- $3.00
|
5,691 | 6.80 | 1.99 | 3,785 | 1.95 | |||||||||||||||
$3.01
- $4.00
|
714 | 2.74 | 3.23 | 710 | 3.23 | |||||||||||||||
$4.01
- $5.00
|
120 | 3.84 | 4.12 | 109 | 4.12 | |||||||||||||||
$5.01
- $10.00
|
56 | 0.42 | 6.37 | 56 | 6.37 | |||||||||||||||
8,463 | 6.74 | $ | 1.82 | 5,418 | $ | 2.00 |
13
In
October 2009, the Company issued 500,000 restricted shares of common stock under
the 2002 Plan. The following table summarizes the status of the Company’s
unvested restricted stock as of September 30, 2010:
Weighted
|
||||||||||||
Average
|
Aggregate
|
|||||||||||
Number
|
Grant Date
|
Intrinsic
|
||||||||||
(in thousands, except per share data)
|
of Units
|
Fair Value
|
Value
|
|||||||||
Non-vested
RSU's at December 31, 2009
|
500 | $ | 0.79 | |||||||||
Granted
|
- | - | ||||||||||
Exercised
|
- | - | ||||||||||
Cancelled
|
(70 | ) | 0.79 | |||||||||
Non-vested
restricted stock units at September 30, 2010
|
430 | $ | 0.79 | $ | 340 | |||||||
Expected
to vest at September 30, 2010
|
274 | $ | 0.79 | $ | 216 |
Restricted
stock units granted are scheduled to vest 50 percent two years after the date of
grant and 50 percent three years after the date of grant. The cost of the
grant is charged to operations over the vesting period. At September 30,
2010, the weighted average remaining term of non-vested restricted stock was 2.0
years.
Forfeitures
are estimated based on our historical forfeiture rates and standard
probabilities of employee turnover based on the demographics of current
restricted stockholders.
Unrecognized
stock-based compensation related to restricted stock units was approximately
$0.2 million as of September 30, 2010. This amount is expected to be expensed
over a weighted average period of 2.0 years.
Employee
Stock Purchase Plan
In
December 2000, we adopted the 2000 Employee Stock Purchase Plan (Purchase
Plan). Under the Purchase Plan, employees may purchase our common stock
through payroll deductions at a purchase price equal to 85 percent of the fair
market value of our common stock on either the first business day or last
business day of the applicable six month offering period, whichever is
lower. Substantially all employees are eligible to participate.
Participants may purchase common stock through payroll deductions of up to 15
percent of the participant’s compensation. As of September 30, 2010, there
were 1,430,952 shares available for issuance under the Purchase Plan. In
July 2010, subsequent to the offering period ended June 30, 2010; we issued
84,642 shares of common stock pursuant to the Purchase Plan for net proceeds of
approximately $33,000. The maximum number of shares a participant may
purchase during a six-month offering period is 6,250 shares. The Purchase Plan
terminated on October 18, 2010.
(4)
Committed Equity Financing Facility (CEFF)
On March
15, 2006, we entered into a Committed Equity Financing Facility (CEFF) with
Kingsbridge Capital Ltd. (Kingsbridge), under which Kingsbridge committed to
purchase up to $30.0 million of our common stock within a 3-year period, subject
to certain conditions and limitations. The CEFF expired on March 15,
2009. Due to the pricing formula under the CEFF the actual amount of
financing available to us under the CEFF was substantially less than the
committed amount. Net proceeds from the sale of common stock under the
CEFF were used to help defray costs associated with expanded clinical testing of
TNFerade™ in locally advanced pancreatic cancer and/or other indications and
used for general corporate purposes. As part of the arrangement, we issued a
warrant to Kingsbridge to purchase 520,000 shares of our common stock at an
exercise price equal to $2.67 per share. The warrant became exercisable on
September 15, 2006 and will remain exercisable until September 15, 2011.
We classified the warrant as a current liability, which is recorded at its fair
value of $8,000 as of September 30, 2010 as determined under a Black-Scholes
pricing model. Changes in fair value are recorded against operations in
the reporting period in which they occur; increases and decreases in fair value
are recorded to interest expense.
14
Prior to
the expiration of the CEFF, we had sold 3,284,830 shares of common stock to
Kingsbridge in the aggregate for gross proceeds of $6.5 million.
Kingsbridge holds no shares of common stock purchased pursuant to the CEFF;
therefore all shares sold are recorded in permanent equity. When the CEFF
expired we expensed the remaining $273,000 of deferred financing charges
associated with the CEFF.
(5)
Net Loss per Share
We
calculate net loss per share in accordance with ASC 260 (formerly SFAS No. 128)
“Earnings per Share.” Basic earnings per share is computed based upon the
net loss available to common stock stockholders divided by the weighted average
number of common stock shares outstanding during the period. The dilutive effect
of common stock equivalents is included in the calculation of diluted earnings
per share only when the effect of the inclusion would be dilutive. For the nine
months ended September 30, 2010 and 2009 approximately 5.4 million and 4.6
million common stock equivalent shares associated with our stock option plans
and unvested restricted shares and approximately 14.0 million and 16.4 million
common stock equivalent shares associated with our warrants, respectively, were
excluded from the denominator in the diluted loss per share calculation as their
inclusion would have been antidilutive.
(6)
Stockholders’ Equity
On
February 1, 2010, pursuant to the 2007 shelf registration statement, we
completed a registered direct offering to various investors of 14,000,000 shares
of common stock and warrants to purchase 4,200,000 shares of common stock.
The shares of common stock and warrants were offered in units consisting of one
share of common stock and 0.3 warrants to purchase one share of common stock at
a per unit price of $2.00. The warrants, which have a term of five years
and an exercise price of $2.75 per share, have been valued using the
Black-Scholes pricing model as of the closing date and have been accounted for
in permanent equity. The estimated fair market value of the warrants at the date
of issuance was $5.0 million. Proceeds of this offering, net of offering
costs, totaled $26.2 million.
During
the nine months ended September 30, 2010, 6,547,820 warrants to purchase shares
of common stock were exercised for gross proceeds of $5.6 million.
The table
below sets forth the outstanding warrants as of September 30, 2010:
Offering Date
|
Outstanding Warrants
|
Exercise Price
|
Expiration Date
|
Status
|
|||||||
March
2006
|
520,000 | $ | 2.670 |
9/15/2011
|
Exercisable
|
||||||
June
2008
|
2,203,833 | $ | 2.016 |
6/11/2013
|
Exercisable
|
||||||
May
2009
|
7,115,385 | $ | 0.858 |
5/29/2014
|
Exercisable
|
||||||
February
2010
|
4,200,000 | $ | 2.750 |
2/1/2015
|
Exercisable
|
||||||
14,039,218 |
On
February 11, 2010, we filed with the Securities and Exchange Commission a $150.0
million shelf registration statement on Form S-3 that allows us to issue any
combination of common stock, preferred stock, or warrants to purchase common
stock or preferred stock. This shelf registration was declared effective
on May 20, 2010.
15
(7)
Collaborative Agreement
In
January 2010, we signed a research collaboration and license agreement (the
Agreement) with Novartis Institutes for BioMedical Research, Inc.
(Novartis) to discover and develop novel treatments for hearing loss and balance
disorders. Under terms of the Agreement, we licensed the world-wide rights to
our preclinical hearing loss and balance disorders program to Novartis. We
received a $5 million non-refundable upfront license fee and Novartis purchased
$2.0 million of our common stock. The common stock was recorded at fair value of
$3.3 million on the date of issuance. The upfront non-refundable fee will
be recognized ratably over the term of the two year research and collaboration
term of the Agreement. Revenue to be recognized from the non-refundable
upfront license fee will be $3.7 million by the end of the Agreement due to the
pricing agreement associated with the sale of our common stock. In
addition, we will receive funding from Novartis for a research program focused
on developing additional adenovectors for hearing loss. If certain clinical,
regulatory, and sales milestones are met, we are eligible to receive up to an
additional $206.3 million in milestone payments in addition to royalties on
future sales, if any. During the three months and nine months ended
September 30, 2010 we recognized $466,000 and $1,321,000 of the upfront payment
and $386,000 and $973,000 for research performed under this
Agreement.
In
September 2010, we achieved the first milestone in our collaboration with
Novartis. The milestone was triggered by the successful completion of
certain preclinical development activities. If certain additional
clinical, regulatory, and sales milestones are met, we are eligible to receive
up to an additional $206.3 million in milestone payments.
In August
2010, we signed a new agreement for the supply of services relating to
development materials with Novartis Pharma AG (Novartis Pharma), related to the
collaboration in hearing loss and balance disorders. Under this new
agreement, GenVec could receive approximately $13 million over four years to
manufacture clinical trial material for up to two lead candidates. During
the three months and nine months ended September 30, 2010 we recognized
$2,033,000 for services performed under this new agreement.
16
GENVEC,
INC.
FORM
10-Q
FORWARD-LOOKING
STATEMENTS
This
report includes 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.
Forward-looking
statements also may be included in other statements that we make. All statements
that are not descriptions of historical facts are forward-looking statements and
are based on management’s estimates, assumptions, and projections that are
subject to risks and uncertainties. These statements can generally be identified
by the use of forward-looking words like “believe,” “expect,” “intend,” “may,”
“will,” “should,” “anticipate,” “estimate,” or similar
terminology.
Although
we believe that the expectations reflected in our forward-looking statements are
reasonable as of the date we make them, actual results could differ materially
from those currently anticipated due to a number of factors, including risks
relating to:
•
|
our
financial condition and the sufficiency of our existing cash, cash
equivalents, marketable securities, and cash generated from
operations;
|
•
|
our
access to additional cash and working capital and our ability to raise
capital to fund clinical programs and future operations, including through
sales of common or preferred stock , the issuance of debt, or through
strategic alternatives;
|
•
|
our
product candidates being in the early stages of
development;
|
•
|
uncertainties
with, and unexpected results and related analyses relating to, clinical
trials of our product candidates (including the length of time required to
enroll suitable patient subjects and our ability to secure clinical trial
sites);
|
•
|
the
timing, amount, and availability of revenues from our government-funded
vaccine programs;
|
•
|
the
timing and content of future FDA regulatory actions related to us, our
product candidates, or our
collaborators;
|
•
|
our
ability to find collaborators or commercialize our product candidates;
and
|
•
|
the
scope and validity of patent protection for our product candidates and our
ability to commercialize products without infringing the patent rights of
others.
|
Further
information on the factors and risks that could affect our business, financial
condition, and results of operations is set forth under Item 1A of Part II in
this Quarterly Report on Form 10-Q, in Item 1A in our Annual Report on Form 10-K
for the year ended December 31, 2009, and Item 1A of Part II of our Quarterly
Reports on Form 10-Q for the quarters ended March 31 and June 30, 2010, and is
contained in our other filings with the SEC. The filings are available on our
website at www.genvec.com or at the SEC’s website, www.sec.gov.
These
forward-looking statements speak only as of the date of this Quarterly Report on
Form 10-Q, and we assume no duty to update our forward-looking
statements.
17
ITEM 2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
STRATEGIC
AND CLINICAL OVERVIEW
GenVec,
Inc. (GenVec, we, our, or the Company) is a clinical stage biopharmaceutical
company developing novel, gene-based therapeutic drugs and vaccines. We have
used our proprietary drug discovery and development technologies to create a
portfolio of product programs that address the prevention and treatment of a
number of major diseases and in partnership with our collaborators, we have
development programs utilizing our proprietary technology.
For
therapeutic applications, our core technology has the important advantage of
localizing protein delivery in the body. This is accomplished by using our
adenovector platform to locally deliver genes to cells, which then direct
production of the desired protein. We believe that localized production of
proteins can enable the proteins to produce a potential benefit while minimizing
the overall toxicity that can occur when proteins are introduced directly into
the body by systemic administration. We believe that this approach allows us to
take advantage of the established biology of known, important
proteins.
For
vaccines, the goal is to induce a broad immune response against a target protein
or antigen. This is accomplished by using the adenovector to deliver a gene that
causes production of an antigen, which then stimulates the desired immune
reaction by the body.
We are
developing applications of our technology for hearing and balance disorders. In
January 2010, we entered into a research collaboration and license agreement
with Novartis Institutes for BioMedical Research, Inc. (Novartis), which focuses
on the discovery and development of novel treatments for hearing loss and
balance disorders. Preclinical research in hearing loss and balance disorders
suggests delivery of the atonal gene using GenVec’s adenovector technology may
have the potential to restore hearing and balance function. There are currently
no effective treatments available for patients who have lost all balance
function, and hearing loss remains a major unmet medical problem. In September
2010, we announced that we had achieved the first milestone under a
collaboration with Novartis.
On August
4, 2010, we entered into an Agreement for the Supply of Services Relating to
Development Materials (the Clinical Supply Agreement) with Novartis Pharma AG
(Novartis Pharma). Pursuant to the terms of the Clinical Supply Agreement, and
in support of our obligations under the Agreement, we will provide to Novartis
Pharma certain services relating to development material, in connection with our
previously announced collaboration in hearing loss and balance disorders. Under
the Clinical Supply Agreement, we could receive approximately $13 million over
four years to manufacture clinical trial material for up to two lead
candidates.
The
Clinical Supply Agreement may be terminated by either party in the event of an
unremedied material breach after providing notice required under the Clinical
Supply Agreement. Novartis Pharma may terminate the Clinical Supply Agreement
immediately in the event that we are in material breach of our obligations under
the Agreement.
We are
evaluating our TNFeradeä biologic (TNFerade) for
use in the treatment of cancer. Using our core adenovector
technology, TNFerade stimulates the production of tumor necrosis factor alpha
(TNFα), a known anti-tumor protein in cells of the tumor. In March 2010,
GenVec discontinued a Phase 3 pivotal trial for first-line treatment of
inoperable, locally advanced pancreatic cancer (known as PACT) based on results
of an interim analysis. The interim data strongly suggested that the trial would
not achieve the statistical significance required to form the basis for approval
of a biological license application in the population chosen for study, thereby
warranting discontinuing the trial. We believe that identifying an appropriate
partner for TNFerade represents the best path forward in the development of the
product.
TNFerade
is also being evaluated for possible use in the treatment of other types of
cancer. Clinical trials have been conducted and encouraging results have
previously been reported in studies for esophageal cancer, head and neck cancer,
rectal cancer, and soft tissue sarcomas. We expect a Phase 1 clinical trial in
prostate cancer to be initiated at the University of Chicago in late 2010 or in
2011.
18
In
partnership with our collaborators, we also have multiple vaccines in
development. All of these programs are funded by third-parties and utilize our
core adenovector technology. One vaccine candidate targets the prevention of a
major animal health problem, foot-and-mouth disease (FMD). Development efforts
for this program are supported by the U.S. Department of Homeland Security (DHS)
and in collaboration with the U.S. Department of Agriculture. We anticipate a
conditional license application for a FMD vaccine will be filed in 2011. In
addition, we have a collaboration with the National Institute of Allergy and
Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to
develop a human immunodeficiency virus (HIV) vaccine and an influenza virus
vaccine. We also have a program with the U.S. Naval Medical Research Center to
develop vaccines for malaria. GenVec also has grant-supported preclinical
programs to develop vaccine candidates for the prevention of respiratory
syncytial virus (RSV) and herpes simplex virus type 2 (HSV-2).
In June
2010, GenVec announced that the Company had retained Wells Fargo Securities, LLC
to conduct a comprehensive review of strategic alternatives aimed at enhancing
shareholder value. As part of this process, we solicited proposals for strategic
transactions, including proposals for the disposition of some or all of the
Company’s assets, or for the sale or merger of the entire entity. In November
2010, we announced that we had concluded our engagement of Wells Fargo. During
the course of the strategic review, we did not receive any proposals to acquire
the Company, or for the acquisition of all or part of its assets. The Board of
Directors has endorsed an independent operating plan focused on the development
and commercialization of our product opportunities in the ordinary course of
business. We will continue to explore value enhancing strategic opportunities
while focusing on our core business.
Key
components of our strategy moving forward include:
|
·
|
Working
with Novartis to facilitate the development of first-in-class products for
the treatment of hearing and balance
disorders;
|
|
·
|
Entering
into new collaborations to support the development of our pipeline of
products in oncology, vaccines, and animal
health.
|
|
·
|
Supporting
our funded contracts and collaborations for the development of new
vaccines.
|
|
·
|
Exploring
new applications of our technology to address the treatment and prevention
of major unmet medical needs.
|
|
·
|
Minimizing
our cash burn rate and avoiding the need for additional equity
financing.
|
An
element of our current business strategy is to pursue, as resources permit, the
research and development of a range of product candidates for a variety of
indications. This is intended to allow us to diversify the risks associated with
our research and development expenditures. To the extent we are unable to
maintain a broad range of product candidates, our dependence on the success of
one or a few product candidates would increase.
Furthermore,
our current business strategy includes the option of entering into collaborative
arrangements with third parties to complete the development and
commercialization of our product candidates. In the event that third parties
take over the development of one or more of our product candidates (i.e. the
clinical trial process), the estimated completion date would largely be under
the control of that third party rather than us. We cannot forecast with any
degree of certainty which proprietary products or indications, if any, will be
subject to future collaborative arrangements, in whole or in part, and how such
arrangements would affect our development plan or capital requirements. Our
programs may also benefit from subsidies, grants, or government or
agency-sponsored studies that could reduce our development costs.
As a
result of the uncertainties discussed above, among others, we are unable to
estimate the duration and completion costs of our research and development
projects or when, if ever, and to what extent we will receive cash inflows from
the commercialization and sale of a product. Our inability to complete our
research and development projects in a timely manner or our failure to enter
into collaborative agreements when appropriate could significantly increase our
capital requirements and could adversely impact our liquidity. These
uncertainties could force us to seek additional, external sources of financing
from time to time in order to continue with our business strategy. Our inability
to raise additional capital, or to do so on terms reasonably acceptable to us,
would jeopardize the future success of our business.
19
While our
estimated future capital requirements are uncertain and will depend on, and
could increase or decrease as a result of, many factors, including the extent to
which we choose to advance our research, development and clinical activities, it
is clear we will need significant additional capital to develop our product
candidates through clinical development, manufacturing, and commercialization.
We do not know whether we will be able to access additional capital when needed
or on terms favorable to us or our stockholders.
As a
clinical stage biopharmaceutical company, our business and our ability to
execute our strategy to achieve our corporate goals are subject to numerous
risks and uncertainties. Material risks and uncertainties relating to our
business and our industry are described in Item 1A of Part II of this Quarterly
Report on Form 10-Q, in Item 1A of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2009, in Item 1A of Part II of our Quarterly Reports on
Form 10-Q for the quarters ended March 31 and June 30, 2010, and in our other
filings with the SEC. The description of our business in this Form 10-Q should
be read in conjunction with the information described in Item 1A of the
10-K.
FINANCIAL
OVERVIEW FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2010 AND
2009
Results
of Operations
GenVec’s
net loss was $2.4 million (or $0.02 per share) on revenues of $5.2 million for
the three months ended September 30, 2010. This compares to a net loss of $3.6
million (or $0.04 per share) on revenues of $2.9 million in the same period in
the prior year. GenVec’s net loss was $11.3 million (or $0.09 per share) on
revenues of $11.3 million for the nine months ended September 30, 2010. This
compares to a net loss of $14.1 million (or $0.15 per share) on revenues of
$10.5 million for the nine months ended September 30, 2009. Included in our net
loss for the first nine months of 2010 was stock-based compensation expense of
$1.4 million as compared to $1.3 million for the same period in the prior year.
GenVec ended the third quarter of 2010 with $35.9 million in cash, cash
equivalents, and short-term investments.
Revenue
Revenues
for the three-month and nine-month periods ended September 30, 2010 were $5.2
million and $11.3 million, respectively, which represent increases of 76 percent
and 7 percent, respectively as compared to $2.9 million and $10.5 million in the
comparable prior year periods.
Revenues
for the three and nine month periods ended September 30, 2010 were primarily
derived from the collaboration we entered with Novartis Institutes for
Biomedical Research Inc. (Novartis) to discover and develop novel treatments for
hearing loss and balance disorders. Revenue has also been derived from the
Company’s funded research and development programs with the Department of
Homeland Security (DHS), the National Institute of Allergy and Infectious
Diseases (NIAID), and the National Institutes of Health (NIH), all of which use
GenVec’s proprietary adenovector technology for the development of either
vaccine candidates against foot-and-mouth disease for livestock or vaccines
against malaria, HIV, RSV, and HSV-2.
In
January 2010, we signed a research collaboration and license agreement (the
Agreement) with Novartis to discover and develop novel treatments for hearing
loss and balance disorders. Under terms of the Agreement, we licensed the
world-wide rights to our preclinical hearing loss and balance disorders program
to Novartis. We received a $5 million non-refundable upfront license fee and
Novartis purchased $2.0 million of our common stock. The common stock was valued
at fair value on the date of issuance. The upfront non-refundable fee will be
recognized ratably over the term of the two year Agreement. Revenue to be
recognized from the non-refundable upfront license fee will be $3.7 million by
the end of the Agreement due to the pricing agreement associated with the sale
of our common stock. During the three and nine month periods ended September 30,
2010, we recognized $466,000 and $1,321,000, respectively of the upfront
payment. In September 2010, we achieved the first milestone in our collaboration
with Novartis. The milestone was triggered by the successful completion of
certain preclinical development activities. If certain additional clinical,
regulatory, and sales milestones are met, we are eligible to receive up to an
additional $206.3 million in milestone payments, out of the original $206.6
million in possible milestone payments in addition to royalties on future sales,
if any. During the three and nine month periods ended September 30, 2010, we
recognized $386,000 and $973,000 respectively for research performed under the
Agreement.
20
In August
2010, we signed a new agreement for the supply of services relating to
development materials with Novartis, related to companies’ collaboration in
hearing loss and balance disorders. Under this new agreement, GenVec could
receive approximately $13 million over four years to manufacture clinical trial
material for up to two lead candidates. During the three and nine months ended
September 30, 2010 we recognized $2.0 million for services performed under this
new agreement.
In
February 2010, we signed a new contract with the DHS to continue the development
of adenovector-based vaccines against FMD. Under this new contract, GenVec will
receive $3.8 million in program funding the first year and an additional $0.7
million if DHS exercises its renewal option under the contract. Under this
contract, we will use our adenovector technology to develop additional
FMD-serotype candidate vaccines and also explore methods to increase the potency
and simplify the production process of adenovector-based FMD vaccines. In June
2010 the DHS exercised the 2011 funding under this agreement for $0.7 million.
There was $292,000 and $327,000, respectively of revenue recognized under this
contract during the three month and nine month periods ended September 30,
2010.
In
November 2009, we entered into a new contract with SAIC-Frederick, Inc., a
subsidiary of Science Applications International Corporation (SAIC), for the
development of influenza and HIV vaccines pursuant to their prime grant from the
National Cancer Institute. Work under this contract includes generation of HIV
vaccine candidates, generation of a universal flu vaccine, process and assay
development for manufacture of vaccine candidates for clinical testing, and
continued support of the HIV vaccine candidates currently in clinical testing.
This four-year contract has a total value of over $22 million if all options are
exercised. Program funding for the first year of this contract was approximately
$2.6 million. There were $391,000 and $1.5 million, respectively, of revenues
recognized under this contract during the three and nine month periods ended
September 30, 2010.
In June
2010, we entered into a new agreement with SAIC to continue the development of a
universal influenza vaccine. Under this new agreement, GenVec will receive
$634,000 in program a funding. There were $207,000 of revenues recognized under
this contract during the three and nine month periods ended September 30,
2010.
In
September 2010, SAIC executed its first option period (year two) under the
previously disclosed four-year contract for the development of influenza and HIV
vaccines in support of the Vaccine Research Center of the NIAID, part of the
NIH. We will receive up to approximately $3.5 million for the second year of
activities under the SAIC contract. This funding increases the total value of
the contract, originally valued at $22 million, to up to approximately $24
million. There were no revenues recognized under this contract during the three
and nine month periods ended September 30, 2010.
21
Revenues
recognized under our various funded research projects for the three and nine
month periods ended September 30, 2010 and 2009 are as follows:
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
Program
|
2010
|
2009
|
2010
|
2009
|
||||||||||||
Hearing
loss and balance disorders
|
$ | 3,183 | $ | 48 | $ | 4,636 | $ | 160 | ||||||||
HIV
|
855 | 1,559 | 3,340 | 4,900 | ||||||||||||
FMD
|
591 | 858 | 1,655 | 4,081 | ||||||||||||
Malaria
|
38 | 213 | 373 | 422 | ||||||||||||
Other
|
489 | 248 | 1,272 | 939 | ||||||||||||
Total
|
$ | 5,156 | $ | 2,926 | $ | 11,276 | $ | 10,502 |
The
increase for the three and nine month periods ended September 30, 2010 is
primarily due to increased revenue associated with our hearing loss and balance
disorder program and collaboration with Novartis that began in January 2010.
During the three and nine month periods ended September 30, 2010, our revenues
for this program increased $3.1 million and $4.5 million, respectively.
Partially offsetting the increase in revenue associated with our hearing loss
and balance disorder program is lower revenue under both the FMD and HIV
programs, as a result of the decreased work scope and effort in 2010 as compared
to the 2009 periods. During the three and nine month periods ended September 30,
2010, revenue associated with our FMD program decreased $267,000 and $2.4
million, respectively as compared to the prior year periods. Revenue associated
with our HIV program decreased $704,000 and $1.6 million, respectively as
compared to the prior year periods.
Expenses
Operating
expenses were $7.5 million and $22.6 million for the three-month and nine-month
periods ended September 30, 2010, which represent an increase of 16 percent and
a decrease of 7 percent as compared to $6.5 million and $24.3 million in the
comparable prior year periods.
Research
and development expenses for the three-month and nine-month periods ended
September 30, 2010 increased 8 percent and decreased 16 percent to $5.1 million
and $16.0 million, respectively, as compared to $4.8 million and $19.2 million
for the comparable prior year periods. The increase for the three-month period
ended September 30, 2010 as compared to the same period in 2009 is primarily due
to manufacturing activities associated with our hearing program and general
laboratory and funded program supply costs. Partially offsetting these increases
are decreased manufacturing activities related to our FMD and TNFerade programs
and clinical costs related to the termination of the PACT trial which includes
both personnel and outside costs. The decrease for the nine-month period ended
September 30, 2010 as compared to the same period in 2009 is due mainly to lower
manufacturing costs during the period and to a lesser extent, clinical costs
related to the termination of the PACT trial. Manufacturing costs related to the
TNFerade program decreased by $2.9 million, due to the expense in 2009
associated with the termination of the Cobra Biomanufacturing Plc (Cobra)
agreement with no corresponding costs in the comparable period in 2010. Also
contributing to the decrease but to a lesser extent are lower personnel costs.
These decreases are partially offset by increased laboratory supply costs.
Included in the personnel costs are $0 and $193,000 in severance costs for the
three and nine month periods, respectively, ended September 30, 2009 as a result
of our reduction in force in January 2009. There were no severance costs in the
comparable periods in 2010. Additionally, stock-based compensation expense
allocated to research and development increased $12,000 and $89,000 for
the three and nine-month periods ended September 30, 2010, as
compared to the comparable prior year periods.
22
General
and administrative expense for the three-month and nine-month periods ended
September 30, 2010 increased 39 percent and 30 percent to $2.4 million and $6.6
million as compared to $1.7 million and $5.1 million for the comparable prior
year periods. During the three and nine month periods ended September 30, 2010
we experienced higher professional, personnel, and facility costs, offset by
lower depreciation and amortization costs. Stock-based compensation expense
allocated to general and administrative expenses, which is included in the
personnel costs, increased $16,000 and $59,000, respectively for the three and
nine month periods ended September 30, 2010 as compared to the same periods in
2009. Included in the personnel costs for the three and nine month periods ended
September 30, 2009 is $27,000 and $103,000 in severance costs. There is $377,000
in severance costs incurred in the three and nine-month period ended September
30, 2010.
Other
Income (Expense)
Total
other income decreased by $5,000 and increased by $389,000, respectively for the
three and nine month periods ended September 30, 2010 as compared to the prior
year periods. Total other income is composed of interest income, interest
expense, net of the change in fair value of the Kingsbridge warrants, and other
income.
Interest
income for the three and nine month periods ended September 30, 2010 was $1,000
and $3,000, respectively, as compared to $2,000 and $37,000, respectively in the
comparable prior year periods. The decrease in interest income was due mainly to
lower yields earned in 2010.
Interest
expense, net of the change in the fair market value of the Kingsbridge warrants,
for the three and nine month periods ended September 30, 2010 was a net interest
expense of $1,000 and a net interest income of $124,000, respectively, compared
to net interest income of $3,000 and a net interest expense of $62,000 in the
comparable prior year periods. The changes in interest expense, net of the
change in the fair market value of the Kingsbridge warrants, was primarily due
to an increase in the fair value of the Kingsbridge warrants in each period.
Additionally, during the three and nine month periods ended September 30, 2010,
there was no interest expense as we no longer have debt
obligations.
Other
income (expense) for the three and nine month periods ended September 30, 2010
was a net expense for the period of $0 and $31,000, respectively as compared to
net expense of $0 and $268,000, respectively in the comparable prior year
periods. The decrease resulted primarily from expensing the remaining $31,000 of
deferred financing charges associated with our shelf registration that expired
in February 2010 as compared to the expensing of $273,000 of deferred financing
charges associated with our Committed Equity Financing Facility (CEFF) with
Kingsbridge Capital Ltd. (Kingsbridge) when the agreement expired on March 15,
2009. In 2009 this expense was partially offset by miscellaneous discounts and
interest payments received from the government associated with late
payments.
Liquidity
and Capital Resources
We have
experienced significant losses since our inception. As of September 30, 2010 we
have an accumulated deficit of $243.3 million. The process of developing and
commercializing our product candidates requires significant research and
development work and clinical trial work, as well as significant manufacturing
and process development efforts. These activities, together with our general and
administrative expenses, are expected to continue to result in significant
operating losses for the foreseeable future.
As of
September 30, 2010, cash, cash equivalents, and short-term investments totaled
$35.9 million as compared to $11.0 million at December 31, 2009.
For the
nine months ended September 30, 2010, we used $9.9 million of cash for operating
activities. This consisted of a net loss for the period of $11.3 million, which
included approximately $181,000 of non-cash depreciation and amortization and
$1.4 million of non-cash stock option expense. In addition, cash was used for
the payment of accrued compensation and other obligations of $298,000 and
increased accounts receivable balances of $1.8 million due to the timing of
collections, offset by a net increase in unearned revenue, due mainly to the
Novartis agreement, of $2.0 million. Net cash was used primarily for the
advancement and subsequent wind down of our TNFerade pancreatic clinical trial,
and to a lesser extent general and administrative activities.
23
Net cash
used in investing activities during the nine months ended September 30, 2010 was
$267,000. The cash used during the period was for the purchase of laboratory
equipment.
Net cash
provided by financing activities during the nine months ended September 30, 2010
was $35.2 million, which included $26.2 million from the issuance of common
stock and warrants associated with our February 2010 equity financing, $3.3
million from our sale of common stock under our collaboration agreement with
Novartis, $5.6 million from the exercise of previously issued warrants, $180,000
from the issuance of common stock related to stock benefit plans.
On
February 11, 2010, we filed with the Securities and Exchange Commission a $150
million shelf registration statement on Form S-3, which we later amended on May
13, 2010 (the 2010 shelf registration statement). The 2010 shelf registration
statement was declared effective May 20, 2010 and allows us to issue any
combination of common stock, preferred stock, or warrants to purchase common
stock or preferred stock.
On June
11, 2008, pursuant to a shelf registration statement on Form S-3 filed on
February 1, 2007 that expired on February 12, 2010 (the 2007 shelf registration
statement), we completed a registered direct offering to various investors of
11,258,279 shares of common stock and warrants to purchase 2,251,653 shares of
common stock. Proceeds of this offering, net of offering costs, totaled $15.7
million. During the three months ended March 31, 2010, individual investors
exercised a portion of these warrants and purchased 47,820 shares of common
stock for gross proceeds to the Company of $96,000. The shares of common stock
issuable upon exercise of the remaining warrants have been registered on the
2010 shelf registration statement. There were no warrants exercised during the
three months ended June 30, 2010 nor the three months ended September 30,
2010.
On May
29, 2009, pursuant to the 2007 shelf registration statement, we completed a
registered direct offering to an institutional investor for the sale of
9,615,385 shares of common stock and warrants to purchase 9,615,385 shares of
common stock. Proceeds of this offering, net of offering costs, totaled $5.5
million. During the three months ended March 31, 2010, the institutional
investor exercised a portion of these warrants and purchased 2,500,000 shares of
common stock for gross proceeds to the Company of $2.1 million. The shares of
common stock issuable upon exercise of the remaining warrants have been
registered on the 2010 shelf registration statement. There were no warrants
exercised during the three months ended June 30, 2010 nor the three months ended
September 30, 2010.
On August
31, 2009, pursuant to the 2007 shelf registration statement, we completed a
registered direct offering to an institutional investor of 8,000,000 shares of
common stock and warrants to purchase 4,000,000 shares of common stock. Proceeds
of this offering, net of offering costs, totaled $5.5 million. During the three
months ended March 31, 2010, the institutional investor exercised all of these
warrants for gross proceeds to the Company of $3.3 million.
On
January 13, 2010 we entered into a research collaboration and license agreement
with Novartis to discover and develop novel treatments for hearing loss and
balance disorders. Under the terms of the Agreement, we licensed the world-wide
rights to our preclinical hearing loss and balance disorders program to
Novartis. Concurrent with entry into the agreement with Novartis, we sold
1,869,158 shares of our common stock to Novartis Pharma AG in a private
placement for $1.07 per share of common stock, which represents an aggregate
purchase price of approximately $2.0 million and was calculated based on the
average of the closing price for the common stock on the NASDAQ Global Market
for the 30 consecutive trading days ending on the fifth trading day prior to the
sale of the shares. The purchase of the shares of common stock by Novartis
Pharma AG was undertaken in partial consideration for the rights granted under
the research collaboration and license agreement. Due to the pricing formula
used in the sale of the common stock, a discount of approximately $1.3 million
has been recorded against the upfront license payment and the value of stock
associated with this sale is recorded in equity at $3.3 million.
On
February 1, 2010, pursuant to the 2007 shelf registration statement, we
completed a registered direct offering to various investors of 14,000,000 shares
of common stock and warrants to purchase 4,200,000 shares of common stock. The
shares of common stock and warrants were offered in units consisting of one
share of common stock and 0.3 warrants to purchase one share of common stock at
a per unit price of $2.00. The warrants, which have a term of five years and an
exercise price of $2.75 per share, have been valued using the Black-Scholes
pricing model as of the closing date and have been accounted for in permanent
equity. The estimated fair market value of the warrants at the date of issuance
was $5.0 million. Proceeds of this offering, net of offering costs, totaled
$26.2 million. The shares of common stock issuable upon exercise of the
remaining warrants have been registered on the 2010 shelf registration
statement. There were no warrants exercised during the nine months ended
September 30, 2010.
24
Our
estimated future capital requirements are uncertain and could change materially
as a result of many factors, including the progress of our research,
development, clinical, manufacturing, and commercialization
activities.
We
currently estimate we will use approximately $5.0 to $7.0 million of cash in the
12 months ending September 30, 2011. Our estimated cash to be used includes
approximately $0.9 million in contractual obligations and $0.2 million for
capital expenditures. Based on this estimate and our current expectations
regarding our operating plan we anticipate that we have sufficient resources to
fund our operations for at least 36 months.
On May
12, 2010, we received a notice from the Nasdaq Stock Market (NASDAQ) stating
that the minimum bid price of our common stock was below $1.00 per share for 30
consecutive business days and that we were therefore not in compliance with the
minimum bid price requirement for continued listing set forth in Marketplace
Rule 5450. The notification letter stated that we would be afforded 180 calendar
days, or until November 8, 2010, to regain compliance with the minimum bid price
requirement. To regain compliance, the closing bid price of our common stock
would have had to meet or exceed $1.00 per share for at least ten consecutive
business days during the 180 calendar day grace period. In order to obtain
additional time to seek to regain compliance with the minimum bid price
requirement, on November 1, 2010 we applied to transfer our common stock to the
NASDAQ Capital Market, and such transfer was declared effective as of November
8, 2010. On November 9, 2010, NASDAQ notified us that we
would have an additional 180 days, or until May 9, 2011, to regain
compliance with the minimum bid price rule while listed on the NASDAQ Capital
Market. NASDAQ may, in its discretion, require our common stock to maintain a
bid price of at least $1.00 per share for a period in excess of ten consecutive
business days, but generally no more than 20 consecutive business days, before
determining that we have demonstrated an ability to maintain long-term
compliance. If we do not regain compliance with the minimum bid price
requirement by May 9, 2011, NASDAQ will provide written notification to us that
our common stock will be delisted. At that time, we may appeal NASDAQ's
delisting determination to a NASDAQ Listing Qualifications
Panel.
Significant
additional capital will be required to develop our product candidates through
clinical development, manufacturing, and commercialization. Subject to our
review of strategic alternatives, we may seek additional capital through further
public or private equity offerings, debt financing, additional strategic
alliance and licensing arrangements, collaborative arrangements, or some
combination of these financing alternatives. If we are successful in raising
additional funds through the issuance of equity securities, investors will
likely experience dilution, or the equity securities may have rights,
preferences, or privileges senior to those of the holders of our common stock.
If we raise funds through the issuance of debt securities, those securities
would have rights, preferences, and privileges senior to those of our common
stock. If we seek strategic alliances, licenses, or other alternative
arrangements, such as arrangements with collaborative partners or others, we may
need to relinquish rights to certain of our existing or future technologies,
product candidates, or products we would otherwise seek to develop or
commercialize on our own, or to license the rights to our technologies, product
candidates, or products on terms that are not favorable to us. We also will
continue to look for government sponsored research collaborations and grants to
help offset future anticipated losses from operations, as we expect to continue
to rely on government funding for a significant portion of our revenues for the
next few years, to a lesser extent, interest income.
If
adequate funds are not available through either the capital markets, strategic
alliances, or collaborators, we may be required to delay, reduce the scope of
efforts, effect additional changes to our facilities or personnel, or obtain
funds through other arrangements that may require us to relinquish some of our
assets or rights to certain of our existing or future technologies, product
candidates, or products on terms not favorable to us.
Off-Balance
Sheet Arrangements and Contractual Obligations
We have
no off-balance sheet financing arrangements other than in connection with our
operating leases, which are disclosed in the contractual commitments table in
our Form 10-K for the year ended December 31, 2009.
25
Significant
Accounting Policies and Estimates
We
describe our significant accounting policies in Note 2, Summary of Significant Accounting
Policies, of the Notes to Financial Statements included in our Annual
Report on Form 10-K for the year ended December 31, 2009. We discuss our
critical accounting estimates in Item 7, Management’s Discussion and Analysis
of Financial Condition and Results of Operations, in our Annual Report on
Form 10-K for the year ended December 31, 2009. There has been no significant
change in our significant accounting policies or critical accounting estimates
since the end of 2009.
Recently
Issued Accounting Pronouncements
In
October 2009, the Financial Accounting Standards Board (the FASB) issued
Accounting Standards Update (ASU) No. 2009-13, “Multiple-Deliverable Revenue
Arrangements.” ASU 2009-13 amends existing revenue recognition accounting
pronouncements that are currently within the scope of FASB ASC Topic 605. This
consensus provides accounting principles and application guidance on how the
arrangement should be separated, and the consideration allocated. This guidance
changes how to determine the fair value of undelivered products and services for
separate revenue recognition. Allocation of consideration is now based on
management’s estimate of the selling price for an undelivered item where there
is no other means to determine the fair value of that undelivered item. This new
approach is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, with
early application permitted. We are currently
evaluating the impact, if any, on our financial condition and results of
operations.
In
January 2010, the FASB issued ASU No. 2010-06, “Fair Value Measurements and
Disclosures.” This ASU amends Topic 820 and related guidance within U.S. GAAP to
require disclosure of the transfers in and out of Levels 1 and 2 and a schedule
for Level 3 that separately identifies purchases, sales, issuances and
settlements and requires more detailed disclosures regarding valuation
techniques and inputs. The adoption of this standard did not have a material
impact on the presentation of our financial statements.
In March
2010, the Patient Protection and Affordable Care Act and the Health Care and
Education Reconciliation Act were signed into law. We are currently in the
process of determining the effects, if any, of these new laws on the
Company.
In April
2010, FASB issued ASU No. 2010-17, “Revenue Recognition—Milestone Method,” which
provides guidance on defining a milestone and determining when it may be
appropriate to apply the milestone method of revenue recognition for research or
development transactions. Research or development arrangements frequently
include payment provisions whereby a portion or all of the consideration is
contingent upon milestone events such as successful completion of phases in a
study or achieving a specific result from the research or development efforts.
The amendments in this ASU provide guidance on the criteria that should be met
for determining whether the milestone method of revenue recognition is
appropriate. The ASU is effective for fiscal years and interim periods within
those years beginning on or after June 15, 2010, with early adoption permitted.
We are currently evaluating the impact, if any on our financial condition and
results of operations.
ITEM
3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
The
primary objective of our investment activities is to preserve our capital until
it is required to fund operations while at the same time maximizing the income
we receive from our investments without significantly increasing risk. Our cash
flow and earnings are subject to fluctuations due to changes in interest rates
in our investment portfolio. We maintain a portfolio of various issuers, types,
and maturities. These securities are classified as available-for-sale and,
consequently, are recorded on the balance sheet at fair value with unrealized
gains or losses reported as a component of accumulated other comprehensive loss
included in stockholders’ equity.
26
ITEM
4. CONTROLS AND
PROCEDURES
As of
September 30, 2010, under the supervision and with the participation of our
President and Chief Executive Officer and our Senior Vice President, Chief
Financial Officer, Treasurer, and Corporate Secretary (our principal executive
officer and principal financial officer, respectively), we have reviewed and
evaluated the effectiveness of the design and operation of our disclosure
controls and procedures. Based on that evaluation, the President and Chief
Executive Officer and the Senior Vice President, Chief Financial Officer,
Treasurer, and Corporate Secretary have concluded that, as of September 30,
2010, these disclosure controls and procedures are effective at the reasonable
assurance level in alerting them in a timely manner to material information
required to be included in our periodic SEC reports.
There
were no changes in our internal controls over financial reporting during the
quarter ended September 30, 2010 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
27
PART
II. OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
We are not currently a party to any
material legal proceedings.
ITEM
1A. RISK FACTORS
An
investment in our securities involves a high degree of risk. Before making an
investment decision you should carefully consider the risk factors discussion
provided under Risk Factors in Item 1A of our Annual Report on Form 10-K for the
fiscal year ended December 31, 2009, in Item 1A of Part II of our Quarterly
Reports on Form 10-Q for the quarters ended March 31 and June 30, 2010, and all
of the other information we include in this report and the additional
information in the other reports we file with the Securities and Exchange
Commission. If any of the risks contained in those reports, or described below,
actually occur, our business, results of operations, financial condition and
liquidity could be harmed and the value of our securities could decline and you
could lose all or part of your investment. In addition, you should
also consider the following risk factors, which amend and supplements the
foregoing risk factors.
Our
common stock is at risk for delisting from the NASDAQ Stock Market. If it
is delisted, our stock price and the liquidity of our common stock would be
impacted.
On May
12, 2010, we received a notice from the Nasdaq Stock Market (NASDAQ) stating
that the minimum bid price of our common stock was below $1.00 per share for 30
consecutive business days and that we were therefore not in compliance with the
minimum bid price requirement for continued listing set forth in Marketplace
Rule 5450. The notification letter stated that we would be afforded 180 calendar
days, or until November 8, 2010, to regain compliance with the minimum bid price
requirement. To regain compliance, the closing bid price of our common stock
would have had to meet or exceed $1.00 per share for at least ten consecutive
business days during the 180 calendar day grace period. In order to obtain
additional time to seek to regain compliance with the minimum bid price
requirement, on November 1, 2010 we applied to transfer our common stock to the
NASDAQ Capital Market, and such transfer was declared effective as of November
8, 2010. On November 9, 2010, NASDAQ notified us that we
would have an additional 180 days, or until May 9, 2011, to regain
compliance with the minimum bid price rule while listed on the NASDAQ Capital
Market. NASDAQ may, in its discretion, require our common stock to maintain a
bid price of at least $1.00 per share for a period in excess of ten consecutive
business days, but generally no more than 20 consecutive business days, before
determining that we have demonstrated an ability to maintain long-term
compliance. If we do not regain compliance with the minimum bid price
requirement by May 9, 2011, NASDAQ will provide written notification to us that
our common stock will be delisted. At that time, we may appeal NASDAQ's
delisting determination to a NASDAQ Listing Qualifications
Panel.
Delisting
from NASDAQ would adversely affect our ability to raise additional financing
through the public or private sale of equity securities, would significantly
affect the ability of investors to trade our securities and would negatively
affect the value and liquidity of our common stock. Delisting could also have
other negative results, including the potential loss of confidence by employees,
the loss of institutional investor interest, and fewer business development
opportunities.
ITEM
2. UNREGISTERED SALES OF
EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM
3. DEFAULTS UPON SENIOR
SECURITIES
None
28
ITEM
4. {REMOVED AND
RESERVED}
None
ITEM
5. OTHER
INFORMATION
None
ITEM
6. EXHIBITS
10.1
|
Agreement,
dated November 3, 2009, between GenVec, Inc. and SAIC-Frederick, Inc.
+
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
Certification
of Chief Executive Officer, pursuant to Rule 13a-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
of Chief Financial Officer, pursuant to Rule 13a-14(a) of the Securities
Exchange Act of 1934, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
+
|
Certain
portions of this exhibit have been omitted based upon a request for
confidential treatment. The omitted portions have been filed with the
Commission pursuant to an application for confidential
treatment.
|
29
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
GENVEC,
INC.
|
||
(Registrant)
|
||
Date:
November 9, 2010
|
By:
|
/s/
Paul H. Fischer, Ph.D.
|
Paul
H. Fischer, Ph.D.
|
||
President
and Chief Executive Officer
|
Date:
November 9, 2010
|
By:
|
/s/
Douglas J. Swirsky
|
Douglas
J. Swirsky
|
||
Chief
Financial Officer,
Treasurer,
and Corporate Secretary
|
30