Armata Pharmaceuticals, Inc. - Quarter Report: 2007 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY
PERIOD ENDED JUNE 30, 2007
|
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: 0-23930
TARGETED
GENETICS CORPORATION
(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
Washington
|
91-1549568
|
|
(State
of Incorporation)
|
(I.R.S.
Employer Identification No.)
|
1100
Olive Way, Suite 100 Seattle, WA 98101
(Address
of principal executive offices)(Zip Code)
(206)
623-7612
(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 the filing requirements
for
at least the past 90 days. Yes x 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 “accelerated
filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act.
(check one):
Large
accelerated filer ¨ Accelerated
filer ¨ Non-accelerated
filer ý
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). o
Yes x
No
Shares
of
Common Stock, par value $0.01 per share, outstanding as of August 3, 2007:
19,814,161
TARGETED
GENETICS CORPORATION
Quarterly
Report on Form 10-Q
For
the
quarter ended June 30, 2007
TABLE
OF
CONTENTS
|
|
Page No.
|
|
PART I
|
FINANCIAL
INFORMATION
|
|
|
|
|
|
|
Item 1.
|
Financial
Statements
|
|
|
|
|
|
|
a)
|
Condensed
Consolidated Balance Sheets at June 30, 2007 and December 31,
2006
|
1
|
|
b)
|
Condensed
Consolidated Statements of Operations for the three and six months
ended
June 30, 2007 and 2006
|
2
|
|
c)
|
Condensed
Consolidated Statements of Cash Flows for the six months ended
June 30,
2007 and 2006
|
3
|
|
d)
|
Notes
to Condensed Consolidated Financial Statements
|
4
|
|
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
9
|
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
15
|
|
Item
4T.
|
Controls
and Procedures
|
16
|
|
|
|
|
|
PART
II
|
OTHER
INFORMATION
|
|
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
17
|
|
Item
1A.
|
Risk
Factors
|
17
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
19
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
19
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
20
|
|
Item
5.
|
Other
Information
|
21
|
|
Item
6.
|
Exhibits
|
21
|
|
|
|
|
|
SIGNATURES
|
22
|
||
INDEX
TO EXHIBITS
|
23
|
i
PART
I FINANCIAL INFORMATION
Item
1. Financial
Statements
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June
30,
2007
|
December
31,
2006
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
26,045,000
|
$
|
6,206,000
|
|||
Accounts
receivable
|
1,874,000
|
1,498,000
|
|||||
Prepaid
expenses and other
|
375,000
|
531,000
|
|||||
Total
current assets
|
28,294,000
|
8,235,000
|
|||||
Property
and equipment, net
|
1,053,000
|
1,100,000
|
|||||
Goodwill
|
7,926,000
|
7,926,000
|
|||||
Other
assets
|
200,000
|
206,000
|
|||||
Total
assets
|
$
|
37,473,000
|
$
|
17,467,000
|
|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
4,005,000
|
$
|
1,901,000
|
|||
Accrued
employee expenses
|
624,000
|
861,000
|
|||||
Accrued
restructure charges
|
678,000
|
1,046,000
|
|||||
Deferred
revenue
|
67,000
|
251,000
|
|||||
Current
portion of long-term obligations
|
1,224,000
|
1,129,000
|
|||||
Total
current liabilities
|
6,598,000
|
5,188,000
|
|||||
Accrued
restructure charges
|
6,634,000
|
6,331,000
|
|||||
Long-term
obligations
|
454,000
|
570,000
|
|||||
Deferred
rent
|
10,000
|
11,000
|
|||||
Commitments
and Contingencies
|
|||||||
Shareholders’
equity:
Preferred
stock, $0.01 par value, 600,000 shares authorized:
|
|||||||
Series
A preferred stock, 180,000 shares designated, none issued and
outstanding
|
—
|
—
|
|||||
Common
stock, $0.01 par value, 30,000,000 shares authorized, 19,814,161
shares
issued and outstanding at June 30, 2007 and 10,921,736 shares issued
and
outstanding at December 31, 2006
|
198,000
|
109,000
|
|||||
Additional
paid-in capital
|
315,628,000
|
289,324,000
|
|||||
Accumulated
deficit
|
(292,049,000
|
)
|
(284,027,000
|
)
|
|||
Accumulated
other comprehensive loss
|
—
|
(39,000
|
)
|
||||
Total
shareholders’ equity
|
23,777,000
|
5,367,000
|
|||||
Total
liabilities and shareholders’ equity
|
$
|
37,473,000
|
$
|
17,467,000
|
1
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended
June 30,
|
Six months ended
June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Revenue
under collaborative agreements
|
$
|
3,008,000
|
$
|
1,414,000
|
$
|
4,669,000
|
$
|
3,844,000
|
|||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
5,270,000
|
3,683,000
|
8,966,000
|
7,360,000
|
|||||||||
General
and administrative
|
1,575,000
|
1,568,000
|
3,127,000
|
3,049,000
|
|||||||||
Restructure
charges
|
442,000
|
363,000
|
626,000
|
1,405,000
|
|||||||||
Goodwill
impairment charge
|
—
|
23,723,000
|
—
|
23,723,000
|
|||||||||
Total
operating expenses
|
7,287,000
|
29,337,000
|
12,719,000
|
35,537,000
|
|||||||||
Loss
from operations
|
(4,279,000
|
)
|
(27,923,000
|
)
|
(8,050,000
|
)
|
(31,693,000
|
)
|
|||||
Investment
income
|
93,000
|
170,000
|
28,000
|
321,000
|
|||||||||
Interest
expense
|
(1,000
|
)
|
(123,000
|
)
|
(1,000
|
)
|
(236,000
|
)
|
|||||
Net
loss
|
$
|
(4,187,000
|
)
|
$
|
(27,876,000
|
)
|
$
|
(8,023,000
|
)
|
$
|
(31,608,000
|
)
|
|
Net
loss per common share (basic and diluted)
|
$
|
(0.31
|
)
|
$
|
(2.83
|
)
|
$
|
(0.61
|
)
|
$
|
(3.37
|
)
|
|
Shares
used in computation of basic and diluted net loss per common
share
|
13,408,000
|
9,854,000
|
13,138,000
|
9,371,000
|
See
accompanying notes to condensed consolidated financial
statements
2
TARGETED
GENETICS CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six
months ended
|
|||||||
June
30,
|
|||||||
|
2007
|
2006
|
|||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(8,023,000
|
)
|
$
|
(31,608,000
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
290,000
|
364,000
|
|||||
Stock-based
compensation
|
395,000
|
464,000
|
|||||
Stock
issued to outside vendors
|
—
|
86,000
|
|||||
Goodwill
impairment charge
|
—
|
23,723,000
|
|||||
Loss
(gain) on investments
|
251,000
|
(8,000
|
)
|
||||
Changes
in assets and liabilities:
|
|||||||
Decrease
(increase) in accounts receivable
|
(376,000
|
)
|
90,000
|
||||
Increase
in prepaid expenses and other
|
(72,000
|
)
|
(243,000
|
)
|
|||
Decrease
in other assets
|
6,000
|
5,000
|
|||||
Increase
in current liabilities
|
1,868,000
|
385,000
|
|||||
Decrease
in deferred revenue
|
(184,000
|
)
|
(135,000
|
)
|
|||
Decrease
in deferred rent
|
(1,000
|
)
|
(99,000
|
)
|
|||
Increase
(decrease) in accrued restructure expenses
|
(65,000
|
)
|
336,000
|
||||
Net
cash used in operating activities
|
(5,911,000
|
)
|
(6,640,000
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of property and equipment
|
(243,000
|
)
|
(57,000
|
)
|
|||
Proceeds
from sale of investments
|
16,000
|
49,000
|
|||||
Net
cash used in investing activities
|
(227,000
|
)
|
(8,000
|
)
|
|||
Financing
activities:
|
|||||||
Net
proceeds from sales of capital stock and warrants
|
25,959,000
|
4,797,000
|
|||||
Proceeds
from the exercise of stock options
|
39,000
|
11,000
|
|||||
Payments
under leasehold improvements and equipment financing
arrangements
|
(21,000
|
)
|
(111,000
|
)
|
|||
Net
cash provided by financing activities
|
25,977,000
|
4,697,000
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
19,839,000
|
(1,951,000
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
6,206,000
|
14,122,000
|
|||||
Cash
and cash equivalents, end of period
|
$
|
26,045,000
|
$
|
12,171,000
|
See
accompanying notes to condensed consolidated financial
statements
3
TARGETED
GENETICS CORPORATION
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Summary
of Significant Accounting Policies
Basis
of Presentation
The
unaudited condensed consolidated financial statements included in this quarterly
report have been prepared by Targeted Genetics Corporation, or Targeted
Genetics, according to the rules and regulations of the Securities and Exchange
Commission, or SEC, and according to accounting principles generally accepted
in
the United States of America, or GAAP, for interim financial statements. The
accompanying balance sheet information as of December 31, 2006 is derived from
our audited financial statements. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with GAAP
have
been omitted in accordance with the SEC’s rules and regulations. Our condensed
consolidated financial statements include the accounts of Targeted Genetics
and
our inactive, wholly-owned subsidiaries, Genovo, Inc. and TGCF Manufacturing
Corporation.
All
significant intercompany transactions have been eliminated in consolidation.
The
financial statements reflect, in the opinion of management, all adjustments
which consist solely of normal recurring adjustments necessary to present fairly
our financial position and results of operations as of and for the periods
indicated. Certain reclassifications have been made to conform prior period
results to the current period presentation.
We
do not
believe that our results of operations for the three and six months ended June
30, 2007 are necessarily indicative of the results to be expected for the full
year.
The
unaudited condensed consolidated financial statements included in this quarterly
report should be read in conjunction with our audited consolidated financial
statements and related footnotes included in our annual report on Form 10-K
for
the year ended December 31, 2006.
Our
combined cash and cash equivalents totaled $26.0 million at June 30, 2007.
We
believe that our current resources, including the capital raised in January
2007
and June 2007 and the cash anticipated to be received from our collaborative
partners, are sufficient to fund our currently planned operations, including
our
clinical trials, for at least a year. This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned funding from our collaborators.
Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional commercial opportunities,
advancing our clinical development programs, and accessing the public and
private capital markets at appropriate times.
Depending on our ability to successfully access additional funding, we
may
be
forced to preserve our cash position through a combination of cost reduction
measures, sales of assets likely at values significantly below their potential
worth, or the pursuit of alternative financing transactions that would likely
be
on terms disadvantageous to us and dilutive to our shareholders. We
have
prepared the accompanying financial statements on a going concern basis, which
assumes that we will realize our assets and satisfy our liabilities in the
normal course of business. The
accompanying financial statements do not include any adjustments that may impact
the amount and classifications of assets or liabilities that may result from
these liquidity uncertainties.
Accounting
for Uncertainties in Income Taxes
Recently
Issued Accounting Standards
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair
Value Measurements,”
or SFAS
No. 157. SFAS No. 157 provides guidance for using fair value to
measure assets and liabilities and requires expanded information about the
extent to which companies measure assets and liabilities at fair value, the
information used to measure fair value, and the effect of fair value
measurements on earnings. The standard applies whenever other standards require
or permit assets or liabilities to be measured at fair value. The standard
does
not expand the use of fair value in any new circumstances. SFAS No. 157 is
effective for fiscal years beginning after November 15, 2007. We are in the
process of evaluating the adoption of SFAS No. 157 and have not yet
determined its impact, if any.
4
2. Long-Term
Obligations
Long-term
obligations consist of the following:
|
June 30,
2007
|
December 31,
2006
|
|||||
Loans
payable to Biogen Idec
|
$
|
1,672,000
|
$
|
1,672,000
|
|||
Equipment
financing obligations
|
6,000
|
27,000
|
|||||
Total
obligations
|
1,678,000
|
1,699,000
|
|||||
Less
current portion
|
(1,224,000
|
)
|
(1,129,000
|
)
|
|||
Total
long-term obligations
|
$
|
454,000
|
$
|
570,000
|
As
of
June 30, 2007, we owed $1.7 million to Biogen Idec, a beneficial owner of
approximately 11% of our outstanding common shares. This
debt
is the remaining balance of a $10.0 million loan from Biogen Idec initiated
in
2001. As
part
of our 2006 debt restructuring, we agreed to terms that resulted in a loan
payable balance of $1.7 million, which consisted of $1.5 million principal
and
$167,000 of estimated future interest payments, to be paid to Biogen Idec in
two
installments: $1.0 million plus accrued interest, which we paid on August 1,
2007, and the remaining balance on August 1, 2008. We must apply one-third
of
certain up-front payments received from potential future corporate
collaborations to the outstanding balance on this loan payable, first to
repayment of any accrued and unpaid interest on the principal being repaid,
and
second to the repayment of outstanding principal in reverse order of maturity.
Outstanding borrowings under this unsecured loan agreement bear interest at
the
one-year London Interbank Offered Rate, or LIBOR, plus 1%, which is reset
quarterly. Since the estimated future interest payments are included in the
balance of the obligation, we do not incur further interest charges attributable
to this debt. The loan contains financial covenants that limit our ability
to
declare or pay cash dividends.
As
of
June 30, 2007, future aggregate principal payments related to the $1.7 million
Biogen Idec debt are $1.1 million in 2007, which includes a $115,000 principal
payment made in July 2007 and the $1 million August 1, 2007 principal
installment, $410,000 in 2008 and zero there after. The long-term portion of
$454,000 includes principal of $410,000 and interest of $44,000.
3. Accrued
Restructure Charges
We
apply
the provisions of SFAS No. 146, “Accounting
for Costs Associated with Exit or Disposal Activities,” as
it
relates to our facility in Bothell, Washington and record restructure charges
on
the operating lease for the facility as a result of our 2003 decision to
discontinue use of the facility. Accrued restructure charges represent our
best
estimate of the fair value of the liability as determined under SFAS No. 146
and
are computed as the fair value of the difference between the remaining lease
payments, net of assumed sublease income and expense. We also record accretion
expense based upon changes in the accrued liability that results from the
passage of time at an assumed discount rate of 10%. Accretion expense is
recorded on an ongoing basis through the end of the lease term in September
2015
and is reflected as a restructuring charge in the accompanying condensed
consolidated statements of operations.
The
table
below presents a reconciliation of the accrued restructure liability for the
six
month period ended June 30, 2007:
Contract
Termination
Costs
|
||||
December
31, 2006 accrued liability
|
$
|
7,377,000
|
||
Charges
related to changes in lease assumptions
|
260,000
|
|||
Accretion
expense
|
366,000
|
|||
Amount
paid
|
(691,000
|
)
|
||
June
30, 2007 accrued liability
|
$
|
7,312,000
|
During
the second quarter of 2007, we recorded additional restructure charges of
$260,000 as a result of updating our estimates of costs and sublease income
associated with exiting the Bothell facility. As part of this assessment we
extended the anticipated lead time for subleasing the facility. In addition
to
this adjustment to the accrued restructure liability, we incurred $182,000
of
accretion expense for the three months ended June 30, 2007 and $366,000 of
accretion expense for the six months ended June 30, 2007. The total of these
charges and adjustments to the liability are reflected as restructure charges
in
the accompanying consolidated statement of operations.
5
Through
June 30, 2007, we have recorded contract termination costs totaling $10.6
million for our Bothell facility. We expect to incur an additional $2.8 million
in accretion expense through the expiration of the Bothell lease in September
2015.
We
periodically evaluate our restructuring estimates and assumptions and record
additional restructure charges as necessary. Because restructure charges are
estimates based upon assumptions regarding the timing and amounts of future
events, significant adjustments to the accrual may be necessary in the future
based on the actual outcome of events and as we become aware of new facts and
circumstances.
4.
Equity
Financing
On
June
27, 2007, we sold approximately 6.7 million shares of our common stock in a
private placement at a price of $2.905 per share and received net proceeds
of
approximately $17.8 million. In addition, in connection with the financing,
we
issued warrants to purchase up to approximately 6.7 million shares of our common
stock. These warrants expire in June 2012 and are exercisable at a price of
$3.25 per share beginning June 27, 2007. We also issued a warrant with the
same
terms as the ones issued pursuant to our private placement to purchase 334,989
shares of our common stock as compensation to the placement agent in this
transaction.
On
January 11, 2007, we sold approximately 2.2 million shares of our common stock
in a private placement at a price of $4.00 per share and received net proceeds
of approximately $8.1 million. In addition, in connection with the financing,
we
issued warrants to purchase up to 763,000 shares of our common stock. These
warrants expire in January 2012 and are exercisable at $5.41 per share beginning
July 19, 2007. We also issued a warrant with the same terms as the ones issued
pursuant to the private placement to purchase 16,119 shares of our common stock
as compensation to the placement agent in this transaction.
Stock
Based Compensation
In
May
2007, our shareholders approved our proposal to amend, restate and rename the
Targeted Genetics Corporation 1999 Stock Option Plan into the Targeted Genetics
Corporation Stock Incentive Plan (Stock Incentive Plan). The Stock Incentive
Plan provides for the issuance of long-term incentive awards (Awards) in the
form of nonqualified and incentive stock options (Options), stock appreciation
rights, stock grants and restricted stock units. The Awards may be granted
by
our Board of Directors to our employees, directors and officers and to
consultants, agents, advisors and independent contractors who provide services
to us. The exercise price for the Options must not be less than the fair market
value of the shares on the date of grant. Options expire no later than ten
years
from the date of grant and generally vest and become exercisable over a
four-year period following the date of grant. In 2006, as part of an employee
retention plan, we granted options to purchase an aggregate of 306,500 shares
of
our common stock with a twelve-month vesting period. Restricted stock units
expire no later than 10 years from the date of grant and generally vest over
a
three-year period following the date of grant. Every non-employee member of
our
Board of Directors receives an annual nonqualified stock option or restricted
stock unit grant and these awards vest over a twelve-month period provided
the
grantee continues service to us. Upon the exercise of stock options and the
vesting of restricted stock units, we issue new shares from shares reserved
for
issuance under our Stock Incentive Plan.
Effective
January 2006, we adopted SFAS No. 123R, “Share-Based
Payment”
which
requires us to expense the fair value of share-based payments granted over
the
vesting period. This compensation expense includes: (a) compensation cost for
all share-based stock options granted prior to, but not yet vested as of January
1, 2006, based on the grant-date fair value used for prior pro forma disclosures
and (b) compensation cost for all share-based payments granted subsequent to
January 1, 2006, based on the grant-date fair value estimate in accordance
with
the provisions of SFAS No. 123R. We value awards granted subsequent to January
1, 2006 at fair value in accordance with provisions of SFAS No. 123R and
recognize stock-based compensation expense on a straight line basis over the
service period of each award. Stock-based
compensation expense is reduced by an estimated forfeiture rate that we derived
from historical employee termination behavior. If the actual number of
forfeitures differs from our estimates, we may record adjustments to increase
or
decrease compensation expense in future periods.
6
Following
is a summary of our compensation expense for the three and six months ended
June
30, 2007:
Three months ended
June 30,
|
Six months ended
June 30,
|
||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Stock
options:
|
|||||||||||||
Research
and development expense
|
$
|
99,000
|
$
|
137,000
|
$
|
194,000
|
$
|
262,000
|
|||||
General
and administrative expense
|
61,000
|
106,000
|
150,000
|
202,000
|
|||||||||
Restricted
stock units:
|
|||||||||||||
Research
and development expense
|
17,000
|
—
|
17,000
|
—
|
|||||||||
General
and administrative expense
|
34,000
|
—
|
34,000
|
—
|
|||||||||
Total
compensation expense
|
$
|
211,000
|
$
|
243,000
|
$
|
395,000
|
$
|
464,000
|
Stock
Options
Following
is a summary of stock option activity and related prices for the first six
months of 2007:
|
Shares
|
Weighted
Average
Exercise
Price
|
Remaining
Average
Contractual
Term (Years)
|
Intrinsic
Value
|
|||||||||
Outstanding,
December 31, 2006
|
835,085
|
$
|
15.39
|
||||||||||
Granted
|
15,800
|
3.88
|
|||||||||||
Exercised
|
(12,632
|
)
|
3.10
|
||||||||||
Expired
|
(13,892
|
)
|
40.66
|
||||||||||
Forfeited
|
(41,439
|
)
|
9.19
|
||||||||||
Outstanding,
June 30, 2007
|
782,922
|
$
|
15.23
|
6.77
|
$
|
226,000
|
|||||||
Exercisable
at June 30, 2007
|
672,233
|
$
|
16.29
|
6.57
|
$
|
195,000
|
The
aggregate intrinsic value is determined using the closing price of our common
stock of $2.72 on June 30, 2007. The intrinsic value of stock options exercised
was $22,000 during the six months ended June 30, 2007 and $3,000 during the
six
months ended June 30, 2006. We received $39,000 from the exercise of stock
options for the six months ended June 30, 2007.
As
of
June 30, 2007, total unrecognized compensation cost related to unvested options
was approximately $219,000, net of estimated forfeitures, which we expect to
recognize over a weighted average period of approximately 1 year.
Stock
options outstanding and exercisable as of June 30, 2007 are summarized
below:
Outstanding
|
Exercisable
|
|||||||||||||||
Range of Exercise Prices
|
Number of
Option
Shares
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Life
(Years)
|
Number of
Option Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||
$1.80
- $3.24
|
95,483
|
$
|
2.50
|
8.57
|
83,001
|
$
|
2.54
|
|||||||||
3.80
- 3.80
|
187,000
|
3.80
|
8.95
|
187,000
|
3.80
|
|||||||||||
3.87
- 9.10
|
167,821
|
7.28
|
7.36
|
105,994
|
7.23
|
|||||||||||
10.80
- 14.90
|
157,445
|
13.10
|
6.53
|
122,860
|
13.10
|
|||||||||||
15.30
- 148.80
|
175,173
|
43.92
|
3.11
|
173,378
|
44.13
|
|||||||||||
Balance,
June 30, 2007
|
782,922
|
$
|
15.23
|
6.77
|
672,233
|
$
|
16.29
|
The
fair
value of each stock option award is estimated on the date of the grant using
the
Black-Scholes-Merton option pricing model. The
weighted average fair value of options granted during the six months ended
June
30, 2007 was $3.88 and was $1.85 for the six months ended June 30, 2006.
7
The
following are the weighted average assumptions for the periods
noted:
Six Months ended June 30,
|
||
2007
|
2006
|
|
Expected
dividend rate
|
Nil
|
Nil
|
Expected
stock price volatility
|
1.047
- 1.114
|
1.086-1.107
|
Risk-free
interest rate range
|
4.54
- 4.58%
|
4.25-4.85%
|
Expected
life of options
|
4
-
5 years
|
4-5
years
|
Expected
Dividend: We
do not
anticipate any dividends based on our current dividend restrictions related
to
our Biogen Idec note.
Expected
Life: Our
expected life represents the period that our stock-based awards are expected
to
be outstanding. We determine expected life based on historical experience and
vesting schedules of similar awards.
Expected
Volatility: Our
expected volatility represents the weighted average historical volatility of
the
shares of our common stock for the most recent four-year and five-year periods.
Risk-Free
Interest Rate: We
base the risk-free interest rate used on the implied yield currently available
on U.S. Treasury zero-coupon issues with an equivalent remaining term.
Where the expected term of our stock-based awards do not correspond with the
terms for which interest rates are quoted, we perform a straight-line
interpolation to determine the rate from the available term
maturities.
Restricted
Stock Units
|
Shares
|
Weighted
Average
Grant Date
Fair Value
|
|||||
Nonvested,
December 31, 2006
|
—
|
$
|
—
|
||||
Granted
|
517,000
|
3.13
|
|||||
Vested
|
—
|
—
|
|||||
Forfeited
|
—
|
—
|
|||||
Nonvested,
June 30, 2007
|
517,000
|
$
|
3.13
|
As
of
June 30, 2007, total unrecognized compensation cost related to unvested
restricted stock units was approximately $904,000, net of estimated forfeitures,
which we expect to recognize over a weighted average period of approximately
2.5
years.
Comprehensive
loss is the total of net loss and all other non-owner changes in equity.
Comprehensive loss includes net unrealized gains from investments and foreign
currency translations on our common stock investment in Chromos Molecular
Systems Inc., or Chromos, as presented in the following table:
Three months ended
June 30,
|
Six months ended
June 30,
|
||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Net
loss as reported
|
$
|
(4,187,000
|
)
|
$
|
(27,876,000
|
)
|
$
|
(8,023,000
|
)
|
$
|
(31,608,000
|
)
|
|
Other
comprehensive income:
|
|||||||||||||
Unrealized gain on available-for-sale securities
|
—
|
—
|
—
|
48,000
|
|||||||||
Foreign
currency translation adjustment
|
—
|
15,000
|
—
|
13,000
|
|||||||||
Other
comprehensive loss
|
$
|
(4,187,000
|
)
|
$
|
(27,861,000
|
)
|
$
|
(8,023,000
|
)
|
$
|
(31,547,000
|
)
|
6.
Investments
As
of
June 30, 2007, we
held
approximately 2.4 million shares of
Chromos,
a
publicly traded company whose common stock is listed on the Toronto Stock
Exchange. Periodically, we sell these shares on a specific identification method
based on when we received the shares. During the six months ended June 30,
2007,
we sold 100,000 shares resulting in a realized gain of $1,000.
8
We
record
our common stock investment in Chromos at fair market value and record changes
in the fair market value of this stock in accumulated other comprehensive
loss
in the accompanying condensed
consolidated balance sheet.
We
periodically evaluate our Chromos stock for signs of impairment that may
be
other-than-temporary, which would necessitate a reduction in the carrying
value
of the investment and charge to expense. During the first and second quarters
of
2007, due to the
declining market value of the Chromos securities and a decline in Chromos’
current financial position, we determined that our investment is
other-than-temporarily impaired. Accordingly, we wrote the asset down to
the
fair market value of the Chromos stock on both March 31, 2007 and June 30,
2007
and recognized a realized loss of $208,000 in the first quarter and an
additional realized loss of $44,000 in the second quarter.
Fair
Value |
Unrealized
Losses |
Proceeds
from the sale of securities |
Realized
Loss |
||||||||||
Marketable
equity securities
|
$
|
89,000
|
$
|
—
|
$
|
16,000
|
$
|
(251,000
|
)
|
7.
Goodwill
We
perform goodwill impairment tests in accordance with SFAS No. 142, “Goodwill
and Other Intangible Assets”
on an
annual basis or more frequently if events and changes in business conditions
indicate that the carrying amount of our goodwill may not be recoverable.
Normally, we perform our annual impairment test as of October 1. However,
as a
result of a decline in market price of our common stock in June 2006, to
a level
that reduced our market capitalization to an amount less than the fair value
of
our net assets, we concluded that this was an indicator of impairment of
our
goodwill and therefore we were required to perform an interim goodwill
impairment test. In the first step of this testing, since we are comprised
of
only one reporting unit, we compared our fair value, as measured by market
capitalization and discounted cash flow analysis, to the net carrying value
of
our assets. Since our indicated fair value was less than the net carrying
value
of our assets, we were then required to perform the second step of the
evaluation and measure the amount of the impairment loss. This analysis required
us to determine the implied value of goodwill by allocating our estimated
fair
value to its assets and liabilities including intangible assets such as
in-process research and development, completed technology, and trademarks
and
trade names using a hypothetical purchase price allocation as if we had been
acquired in a business combination as of the date of the impairment test.
This
evaluation resulted in an implied goodwill balance of $7.9 million and a
second
quarter 2006 non-cash goodwill impairment charge of $23.7 million.
8.
Income Taxes
We adopted the provisions of FASB Interpretation No. 48, “Accounting
for Uncertainty in Income Taxes”,
or FIN
48, on January 1, 2007. We have been in a net operating loss position since
inception and have not recognized any tax benefits for any of our income
tax
positions as a result of a full valuation allowance. There were no changes
to
the amount of recognized tax benefits as a result of adopting FIN 48, and
there
were no changes to the recognized tax benefits during the three and six months
ended June 30, 2007.
Historically,
we have not incurred any interest or penalties associated with tax matters
and
no interest or penalties were recognized during the three and six months
ended
June 30, 2007. We have adopted a policy whereby amounts related to interest
and
penalties associated with tax matters are classified as additional income
tax
expense when incurred.
Tax
years
that remain open for examination include 2003, 2004, 2005, and 2006. In
addition, tax years from 1992 to 2002 may be subject to examination in the
event
that we utilize the net operating losses from those years in our current
or
future year tax returns.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements within
the
meaning of the private Securities Litigation Reform Act of 1995. All statements
other than statements of historical fact are forward-looking and involve
risks
and uncertainties. Forward-looking statements include statements about our
product development and commercialization goals and expectations, potential
market opportunities, our plans for and anticipated results of our clinical
development activities and the potential advantage of our product candidates,
our future cash requirements and the sufficiency of our cash and cash
equivalents to meet these requirements, our ability to raise capital when
needed
and other statements that are not historical facts. Words such as “may,” “will,”
“believes,” “estimates,” “expects,” “anticipates,” “plans” and “intends,” or
statements concerning “potential” or “opportunity” and other words of similar
meaning or the negative thereof, may identify forward-looking statements,
but
the absence of these words does not mean that a statement is not
forward-looking. In making these statements, we rely on a number of assumptions
and make predictions about the future. Our actual results could differ
materially from those stated in, or implied by, forward-looking statements
for a
number of reasons, including the risks described in greater detail in the
section entitled “Risk Factors” in Part I, Item IA of our annual report on Form
10-K for the year ended December 31, 2006, as supplemented by the section
entitled “Risk Factors” in Part II, Item 1A of this quarterly
report.
9
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 after the date of this quarterly report
to
reflect circumstances or events occurring after the date of this quarterly
report or to conform the statement to actual results or changes in our
expectations. You should, however, review the risk factors and other information
we provide in the reports we file from time to time with the SEC.
BUSINESS
OVERVIEW
We
are a
clinical-stage therapeutic biotechnology company. We are at the forefront
of
developing, with the goal of commercializing, a new class of therapeutic
products called gene therapeutics. We believe that a wide range of diseases
may
potentially be treated or prevented with gene therapeutics. In addition to
treating diseases that have not had treatments in the past, we believe that
there is also a significant opportunity to use gene therapeutics to more
effectively treat diseases that are currently treated using other therapeutic
classes of drugs such as protein-based drugs, monoclonal antibodies or small
molecule drugs.
Gene
therapeutics consist of a delivery vehicle, called a vector, and genetic
material. The role of the vector is to carry the genetic material into a
target
cell. Once delivered into the cell, the gene can express or direct production
of
the specific proteins encoded by the gene. Gene therapeutics may be used
to
treat disease facilitating the normal protein production or gene regulation
capabilities of cells. Gene therapeutics may be used to enable cells to produce
more of a certain protein or different proteins than they normally produce
thereby treating a disease state. Gene therapeutics may also be used for
RNAi
interference, or RNAi, to deliver small RNA molecules that once delivered
into
the cell may shut down or interfere with cellular functions.
We
are
primarily focused on the following adeno-associated
viral vectors, or AAV, based product
development programs:
Description
|
Indication
|
Partners
|
Development
Status |
|||
AAV
delivery of TNF-alpha antagonist
|
Inflammatory
Arthritis
|
None
|
Phase
I/II
|
|||
AAV
delivery of HIV antigens
|
HIV/AIDS
|
IAVI
|
Phase
II
|
|||
AAV
delivery of SERCA2a
|
Congestive
Heart Failure
|
Celladon
|
Phase
I
|
|||
AAV
delivery of HIV antigens
|
HIV/AIDS
|
CHOP,
CCRI and NIAID
|
Preclinical
|
|||
AAV
expression of htt shRNA (RNAi)
|
Huntington’s
disease
|
Sirna
Therapeutics as a
subsidiary of Merck |
Preclinical
|
In
the
first half of 2007, we made progress in our development collaborations and
our
product development programs and expanded and leveraged our patent portfolio.
More specifically:
· |
In
February and May 2007, we reported additional data on the results
of our
ongoing Phase I/II clinical trial of our inflammatory arthritis
candidate
that demonstrated the results continue to show evidence for sustained
improvement in signs and symptoms of the
disease.
|
· |
In
February 2007, we reported results from IAVI’s Phase I clinical trial of
our investigational HIV/AIDS vaccine candidate. The
results reported indicated favorable safety and tolerability profiles
consistent with the results observed in clinical trials to date,
and
provide the rationale for evaluating the vaccine at higher doses
and at
different dosing intervals.
|
· |
In
May 2007, in collaboration with the University
College London's Institute of Ophthalmology and Moorfields Eye
Hospital, a
Phase I/II clinical trial was initiated to test the use of an
AAV
vector to deliver RPE65 to treat
a
form of childhood blindness. We produced
the vector used in this trial. The trial is funded by the UK Department
of
Health.
|
· |
In
May 2007, the first patient was dosed in the Phase I clinical trial
of
MYDICAR, the congestive heart failure product candidate under development
through our collaboration with
Celladon.
|
10
· |
In
May 2007, we completed enrollment and initial dosing in the Phase
I/II
clinical trial of our inflammatory arthritis candidate though this
clinical trial has more recently been placed on clinical hold.
Please see
"Risk Factors" in Item 1A for more information on this development.
|
· |
Issuance
of patents strengthening our AAV vector patent
portfolio.
|
Most
of
our expenses are related to advancing our research and development programs,
conducting preclinical studies and clinical trials and for general and
administrative support of these activities. We have financed the company
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
for
product development and manufacturing activities, through proceeds from the
issuance of debt and to a lesser extent through loan funding under equipment
financing arrangements. During 2007, we completed two private placements
of our
common stock generating approximately $25.9 million to fund our programs.
On
June 27, 2007, we sold approximately 6.7 million shares of our common stock
in a
private placement at a price of $2.905 per share and received net proceeds
of
approximately $17.8 million. In connection with the financing we issued
five-year warrants to purchase up to approximately 6.7 million shares of
our
common stock. We also issued a warrant to purchase 334,989 shares of our
common
stock as compensation to the placement agent in this transaction. On January
11,
2007, we sold approximately 2.2 million shares of our common stock in a private
placement at a price of $4.00 per share and received net proceeds of
approximately $8.1 million. In connection with this financing we issued
five-year warrants to purchase up to 763,000 shares of our common stock.
We also
issued a warrant to purchase 16,119 shares of our common stock as compensation
to the placement agent in this transaction.
As
of
June 30, 2007, our accumulated deficit totaled $292.0 million. We expect
to
generate substantial additional losses for the foreseeable future, primarily
due
to the costs associated with funding our inflammatory arthritis clinical
development program, developing and maintaining our manufacturing capabilities
and developing our intellectual property assets.
We
will
require access to significantly higher amounts of capital than we currently
have
in order to successfully develop our lead inflammatory arthritis product
candidate and other product candidates. We may be unable to obtain required
funding when needed or on acceptable terms, obtain or maintain corporate
partnerships, or complete acquisition transactions necessary or desirable
to
complete the development of our product candidates.
CRITICAL
ACCOUNTING POLICIES, ESTIMATES AND ASSUMPTIONS
Other
than with respect to those items described below, there have been no material
changes from the critical accounting policies, estimates and assumptions
as
disclosed in Item 7 “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” of the Company’s annual report on Form 10-K for the
year ended December 31, 2006. The critical accounting policies, estimates
and
assumptions described below have been updated to provide more recent financial
and factual information as of June 30, 2007.
Accounting
for Uncertainties in Income Taxes
Effective
the beginning of 2007, we adopted FASB Interpretation No. 48, “Accounting
for Uncertainty in Income Taxes,” or
FIN
48. FIN 48 provides guidance to address uncertainty in tax positions and
clarifies the accounting for income taxes by specifying a minimum recognition
threshold which income tax positions must achieve before being recognized
in the
financial statements. The adoption of FIN 48 had no impact on our net loss,
earnings per share or financial position for the three and six months ended
June
30, 2007.
The
application of income tax law is inherently complex. Laws and regulations
in
this area are voluminous and are often ambiguous. As such, we are required
to
make many subjective assumptions and judgments regarding our income tax
exposures. Interpretations of and guidance surrounding income tax laws and
regulations change over time. Changes in our subjective assumptions and
judgments can materially affect amounts recognized in the consolidated balance
sheets and statements of income.
RESULTS
OF OPERATIONS
Revenue
Revenue
increased to $3.0 million for the three months ended June 30, 2007 as compared
to $1.4 million for the same period in 2006. Revenue increased to $4.7 million
for the six months ended June 30, 2006 as compared to $3.8 million for the
same
period in 2006. The increase in revenue reflects an increase in research
and
development activities under the National Institute of Allergy and Infectious
Diseases, or NIAID, funded HIV/AIDS vaccine project in collaboration with
the
Children’s Hospital of Philadelphia, or CHOP, and the Columbus Children’s
Research Institute, or CCRI, and under our collaboration with Celladon
Corporation, or Celladon. This increase is partially offset by lower research
and development activities under our collaboration with the
International AIDS Vaccine Initiative, or IAVI. We
expect
that our revenue for the remainder of 2007 will continue to consist primarily
of
research and development revenue earned from the NIAID-funded HIV/AIDS vaccine
project in collaboration with CHOP and CCRI and work under our collaboration
with Celladon. For the next several years, our revenue will depend on the
continuation of the current collaborations and our success in entering into
and
performing under new collaborations.
11
Operating
Expenses
Research
and Development Expenses. Research
and development expenses increased to $5.3 million for the three months ended
June 30, 2007 compared to $3.7 million for the same period in 2006.
Research and development expenses increased to $9.0 million for the six months
ended June 30, 2007 compared to $7.4 million for the same period in 2006.
Costs
for both the three and six month periods are higher due to increased research
and development costs for our preclinical programs, specifically the
NIAID-funded HIV/AIDS vaccine program in collaboration with CHOP and CCRI
and
costs incurred to support the initiation of clinical trials for the congestive
heart failure product; which began in May 2007. Costs related to our
inflammatory arthritis program increased due to a higher number of enrolled
subjects and higher clinical trial activity to support the increased enrollment.
This cost increase was partially offset by lower costs related to our HIV/AIDS
vaccine collaboration with IAVI as a result of less development activity
as the
project has progressed into clinical testing. We expect that our research
and
development expenses for the remainder of 2007 will vary depending on the
amount
and timing of development efforts and outside services necessary to advance
our
clinical programs, our congestive heart failure collaboration with Celladon
and
the NIAID-funded HIV/AIDS vaccine project in collaboration with CHOP and
CCRI.
The
following is an allocation of our total research and development costs between
our programs in clinical development and those that are in research or
preclinical stages of development:
Three
months ended
June
30,
|
Six
months ended
June
30,
|
||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Programs
in clinical development:
|
|||||||||||||
Inflammatory
arthritis
|
$
|
1,095,000
|
$
|
875,000
|
$
|
1,857,000
|
$
|
1,433,000
|
|||||
IAVI
HIV/AIDS vaccine
|
60,000
|
794,000
|
169,000
|
1,111,000
|
|||||||||
Congestive
heart failure (1)
|
203,000
|
—
|
203,000
|
—
|
|||||||||
Indirect
costs and other
|
1,008,000
|
1,280,000
|
1,530,000
|
1,627,000
|
|||||||||
Total
clinical development program expense
|
2,366,000
|
2,949,000
|
3,759,000
|
4,171,000
|
|||||||||
Research
and preclinical development program expense
|
2,904,000
|
734,000
|
5,207,000
|
3,189,000
|
|||||||||
Total
research and development expense
|
$
|
5,270,000
|
$
|
3,683,000
|
$
|
8,966,000
|
$
|
7,360,000
|
(1)
Includes costs incurred after the clinical trial was initiated in May 2007.
Costs incurred prior to that are included as research and preclinical
development program expense.
Research
and development costs attributable to programs in clinical development include
salaries and benefits, clinical trial costs, outside services, and materials
and
supplies incurred to support the clinical programs. Indirect costs allocated
to
clinical programs include facility and occupancy costs, research and development
administrative costs, and license and royalty payments. These costs are further
allocated between clinical and preclinical programs based on relative levels
of
program activity. IAVI separately manages and funds the clinical trial costs
of
our HIV/AIDS vaccine program for the developing world and Celladon separately
manages and funds the clinical trial costs of our congestive heart failure
program. As a result, we do not include those costs in our research and
development expenses.
Costs
attributed to research and preclinical programs represent our earlier-stage
development activities and include costs incurred for development activities
for
the NIAID-funded HIV/AIDS vaccine in collaboration with CHOP and CCRI as
well as
other programs prior to their transition into clinical trials. Research and
preclinical program expense also includes costs that are not allocable to
a
clinical development program, such as unallocated manufacturing infrastructure
costs. Because we conduct multiple research projects and utilize resources
across several programs, our research and preclinical development costs are
not
directly assigned to individual programs.
For
purposes of reimbursement from our collaboration partners, we capture the
level
of effort expended on a program through our project management system, which
is
based primarily on human resource time allocated to each program, supplemented
by an allocation of indirect costs and other specifically identifiable costs,
if
any. As a result, the costs allocated to programs identified in the table
above
do not necessarily reflect the actual costs of the program.
12
General
and Administrative Expenses. General
and administrative expenses remained consistent at $1.6 million for the three
months ended June 30, 2007 and June 30, 2006. General and administrative
expense
increased to $3.1 million for the six months ended June 30, 2007 compared
to
$3.0 million for the same period in 2006. General
and administrative expenses consist primarily of salaries, patent costs,
legal
and audit fees and shareholder costs.
Restructure
Charges. Restructure
charges increased to $442,000 for the three months ended June 30, 2007 compared
to $363,000 million for the same period in 2006. Restructure charges decreased
to $626,000 for the six months ending June 30, 2007 compared to $1.4 million
for
the same period in the prior year. Restructuring charges in 2007 include
$260,000 related to changes in our estimates of the anticipated lead time
to
sublease the facility. Restructuring charges for the first six months of
2006
include charges of $639,000 related to changes in our expectations regarding
market conditions for the Bothell facility subleasing market, $219,000 related
to employee termination benefits of our restructuring efforts to realign
our
cost structure and $174,000 in relation to the early termination of a portion
of
our Seattle facility lease resulting from the head count reductions.
Restructuring charges also include accretion expense of $366,000 for the
six
months ended June 30, 2007 and $375,000 for the six months ended June 30,
2006.
Goodwill
Impairment Charge. We
periodically and annually on October 1st
evaluate
the carrying value of our goodwill in accordance with SFAS No. 142, “Goodwill
and Other Intangible Assets”
and if
there
is evidence of an impairment in value, we reduce the carrying value of the
asset. As discussed in Note 7 of the notes to our condensed consolidated
financial statements, we recognized a non-cash loss on impairment of goodwill
during second quarter of 2006. As a result of a decline in our share price
during June 2006, to a level which reduced market capitalization to an amount
less than the fair value of our net assets, we were required to perform an
interim goodwill impairment test. As a result of this evaluation, during
the
second quarter of 2006, we recognized a non-cash impairment charge of $23.7
million, which was equal to the recorded value of goodwill in excess of its
implied value.
Other
Income and Expense
Investment
Income(Loss).
Investment income reflects interest income earned on our short term investments
and realized gains or losses on our investment in Chromos Molecular Systems
Inc,
or Chromos. Investment income decreased to $93,000 for the three months ended
June 30, 2007 compared to income of $170,000 for the same period in 2006.
Investment income decreased to $28,000 for the six months ended June 30,
2007
compared to $321,000 for the same period in 2006. Investment income reflects
a
net realized loss of $44,000 in the three months ended June 30, 2007 and
$251,000 in the six months ended June 30, 2007 related to an
other-than-temporary impairment loss on our investment in Chromos due to
the
declining market value of the Chromos securities combined with decline in
Chromos’ current financial position.
Interest
Expense.
Interest expense decreased to $1,000 for the three months ended June 30,
2007,
compared to $123,000 for the same period in 2006. Interest expense decreased
to
$1,000 for the six months ended June 30, 2007, compared to $236,000 for the
same
period in the prior year. In November 2006, we restructured a $8.15 million
outstanding loan from Biogen Idec by exchanging $5.65 million of the balance
for
common shares of our stock, making a $500,000 payment and establishing a
new
repayment schedule for the remaining balance. As a result of restructuring
the
Biogen Idec debt, the $1.7 million carrying value of the remaining debt as
of
June 30, 2007 includes the related estimated future interest payments and
accordingly, we did not record interest expense on the Biogen Idec loan in
the three six month periods ended June 30, 2007. We do not expect to record
future interest expense on this restructured debt.
LIQUIDITY
AND CAPITAL RESOURCES
We
had
cash and cash equivalents of $26.0 million at June 30, 2007 compared to
$6.2 million at December 31, 2006. Our cash and cash equivalents increased
in the six months ended June 30, 2007 primarily reflecting the net proceeds
of
$25.9 million from our January and June 2007 sales of our common stock and
warrants, partially offset by our net loss and the resulting cash used in
operations of $5.9 million.
On
June
27, 2007, we sold approximately 6.7 million shares of our common stock in
a
private placement at a price of $2.905 per share and received net proceeds
of
approximately $17.8 million. In addition, in connection with the financing,
we
issued five-year warrants to purchase up to approximately 6.7 million shares
of
our common stock. We also issued a warrant to purchase 334,989 shares of
our
common stock as compensation to the placement agent in this transaction.
On
January 11, 2007, we sold approximately 2.2 million shares of our common
stock
in a private placement at a price of $4.00 per share and received net proceeds
of approximately $8.1 million. In addition, in connection with the financing
we
issued five-year warrants to purchase up to 763,000 shares of our common
stock. We also issued a warrant to purchase 16,119 shares
of our common stock as compensation to the placement agent in this transaction.
We intend to continue to seek appropriate opportunities to access the public
and
private capital markets, however, our ability to issue equity securities
at the
current market price will likely be adversely affected by the fact that we
are
presently ineligible under SEC rules to utilize Form S-3 for primary offerings
of our securities because the aggregate market value of our outstanding common
stock held by non-affiliates is less than $75
million.
13
Our
primary expenses are related to the development of our research and development
programs, the conduct of preclinical studies and clinical trials and general
and
administrative support for these activities. Our HIV/AIDS vaccine candidate
for
the developing world, our inflammatory arthritis product candidate and our
congestive heart failure product candidate are all in clinical trials. We
expect
to continue incurring significant expense in advancing our product candidates
toward commercialization. As a result, we do not expect to generate sustained
positive cash flow from our operations for at least the next several years
and
only then if we can successfully develop and commercialize our product
candidates. We currently have 84,453 of unreserved authorized shares and
will
require substantial additional financial resources to fund the development
and
commercialization of our lead product candidate in inflammatory
arthritis.
We
are
currently focusing our development funding on our inflammatory arthritis
product
candidate, which is in Phase I/II clinical trials. We currently fund all
costs
of this program from our working capital and expect to do so for the foreseeable
future, although our strategy is to ultimately seek a partner to fund
later-stage development of this program.
In
addition to the funding necessary to advance our product development candidates
and fund our ongoing operations, we also have significant lease commitments,
long-term obligations and outstanding debt that draw on our cash resources.
Our
most significant obligations are approximately $12.6 million of remaining
Bothell facility lease payments, which we are obligated to pay at $1.4 million
to $1.6 million per year until the year 2015 and $1.7 million of aggregate
principal and interest payments to Biogen Idec under an outstanding loan
payable. Under our 2006 modified loan agreements with Biogen Idec, the
loan
bears interest at the rate of LIBOR plus 1.0% and we repaid a total of $1.1
million of the loan in July and August 2007 and agreed to repay the remaining
balance on August 1, 2008. The Biogen Idec loan agreement includes a provision
that requires us to apply one-third of certain up-front payments received
from
potential future corporate collaborations to the outstanding balance on this
loan payable.
We
expect
the level of our future operating expenses to be driven by the needs of our
product development programs, our debt obligations and our lease obligations,
offset by the availability of funds through equity offerings, partner-funded
collaborations or other financing or business development activities. The
size,
scope and pace of our product development activities depend on the availability
of these resources. Our future cash requirements will depend on many factors,
including:
• |
the
rate and extent of scientific progress in our research and development
programs;
|
• |
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
• |
competing
technological and market developments;
|
• |
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
• |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
We
have
financed our product development activities and general corporate functions
primarily through proceeds from public and private sales of our equity
securities, through cash payments received from our collaborative partners
and
proceeds from the issuance of debt. To a lesser degree, we have also financed
our operations through interest earned on cash and cash equivalents, loan
funding under equipment financing agreements and research grants. These
financing sources have historically allowed us to maintain adequate levels
of
cash and cash equivalents.
Our
development collaborations have typically provided us with funding in several
forms, including purchases of our equity securities, loans, payments for
reimbursement of research and development costs and milestone fees and payments.
We and our partners typically agree on a target disease and create a development
plan for the product candidate, which generally extends for multiple one-year
terms and is subject to termination or extension. For example, when the IAVI
collaboration was initiated in 2000, it originally had a three-year term
yet the
work plan was established and funded on an annual basis. In 2004, we and
IAVI
agreed to extend the underlying program through the end of 2006 and in 2006
we
agreed to further extend the program until the expiration of the term of
the
last patent within the patent rights controlled by us and utilized in the
IAVI
vaccine. In 2005, we extended the scope of our HIV/AIDS vaccine program
activities to the developed world, via a NIAID-funded collaboration with
CHOP
and CCRI. To date we have received $2.6 million under this subcontract and
our
portion of the remaining project funding could be up to an additional $15.6
million over the remaining three years of the contract. The funding is awarded
to us in annual installments based on an approved work plan and achievement
of
milestones.
14
The
funding from each of our collaborative partners fully offsets our incremental
program costs related to each collaboration and our overhead and fixed costs.
Our revenue from collaborative agreements and licenses totaled $9.9 million
in
2006 and, assuming that we complete all of the planned development activities
for each of these funded projects, we expect revenue from our collaborative
partners of up to $10 million in 2007.
Each
of
our collaborations has provisions that allow our partners the right to terminate
both the underlying collaboration and the obligation to provide research
funding
at any time with as little as 90 days notice. If we were to lose the expected
funding from the NIAID-funded collaboration with CHOP and CCRI, Celladon
or IAVI
collaborations and were unable to obtain alternative sources of funding,
we
would be unable to continue our research and development program for that
product candidate and our cash horizon would be shortened.
Our
near-term financing strategy includes leveraging our development capabilities
and intellectual property assets into additional capital raising opportunities,
advancing our clinical development programs and accessing the public and
private
capital markets at appropriate times. Our financing strategy is focused
around the advancement of our two programs in clinical development, advancement
of our newer development collaborations and generating value from our
intellectual assets and capabilities. In the biotechnology industry, there
is a
low level of success in clinical trials and our ability to raise capital
depends
in part on clinical trial success.
Additional
sources of financing could involve one or more of the following:
· |
entering
into additional product development
collaborations;
|
· |
mergers
and acquisitions;
|
· |
issuing
equity in the public or private markets;
|
· |
extending
or expanding our current
collaborations;
|
· |
selling
or licensing our technology or product candidates;
|
· |
borrowing
under loan or equipment financing arrangements;
and/or
|
· |
issuing
debt.
|
Additional
funding may not be available to us on reasonable terms, if at all.
We
expect
that our total cash requirements for 2007 will range from $13
million to $16 million and that our cash and cash equivalents at June 30,
2007,
plus the anticipated funding from our product development collaborations
and
contracts will be sufficient to fund our operations for at least a year.
This
estimate is based on our ability to perform planned research and development
activities and the receipt of planned funding from our
collaborators.
Depending
on our ability to successfully access additional funding, we may be forced
to
implement additional cost reduction measures. Further adjustments may include
scaling back or delaying our inflammatory arthritis development program,
staff
reductions, scaling back our intellectual property prosecution, subleasing
portions of our lab facilities, curtailing capital expenditures or reducing
other operating activities. We may also be required to relinquish some rights
to
our technology or product candidates or grant licenses on unfavorable terms,
either of which would reduce the ultimate value to us of the technology or
product candidates.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
We are exposed to market risk for the effect of interest rate changes, foreign
currency fluctuations and changes in the market values of our
investments.
Items
with interest rate risk:
· Short
term investments:
Because
of the short-term nature of our investments, we believe that our exposure
to
market rate fluctuations on our investments is minimal. Currently, we do
not use
any derivative or other financial instruments or derivative commodity
instruments to hedge any market risks and do not plan to employ these
instruments in the future. At June 30, 2007, we held $26.0 million in cash,
which is primarily invested in money market funds and denominated in U.S.
dollars. An analysis of the impact on these securities of a hypothetical
10.0%
change in short-term interest rates from those in effect at June 30, 2007,
indicates that such a change in interest rates would not have a significant
impact on our financial position or on our expected results of operations
in
2007.
15
· Notes
payable: Our
results of operations are affected by changes in short-term interest rates
as a
result of a loan from Biogen Idec that contains a variable interest rate.
Interest payments on this loan are established quarterly based upon LIBOR
plus
1%. Changes in market interest rates and the timing of these remaining interest
payments may ultimately result in adjustments to the gain on debt restructuring
we recognized in 2006. The carrying amount of the note payable approximates
fair
value because the interest rate on this instrument changes with, or
approximates, market rates. The following table provides information as of
June
30, 2007, about our obligations that are sensitive to changes in interest
rate
fluctuations:
Expected
Maturity Date
|
|||||||||||||||||||
|
2007
|
2008
|
2009
|
2010
|
2011
|
Total
|
|||||||||||||
Variable
rate note
|
$
|
1,115,000
|
$
|
410,000
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
1,525,000
|
Items
with market and foreign currency exchange risk:
· Investment
in Chromos Molecular Systems, Inc.:
At June
30, 2007, we held 2.4 million shares of Chromos common shares with a market
value of $0.04 per common share as quoted by the Toronto Stock Exchange and
denominated in Canadian dollars. As of June 30, 2007 the Canadian dollar
to US
dollar exchange rate was US $0.9443 per CA $1.00. As of June 30, 2007, this
investment is recorded at $89,000 and is classified within prepaid expenses
and
other in
the
accompanying condensed
consolidated balance sheet.
We
recorded a net realized loss of $44,000 in the three months ended June 30,
2007
and $251,000 in the six months ended June 30, 2007 due to an
other-than-temporary impairment resulting from a decline in market value
of the
Chromos securities combined with decline in Chromos’ current financial position.
We hold these shares of common stock as available-for-sale securities as
we
periodically sell them on the Toronto Stock Exchange. As a result of selling
100,000 shares of Chromos stock in the six months ended June 30, 2007, we
recorded $1,000 of realized gains and received $16,000 in cash. The amount
of
potential realizable value in this investment will be determined by the market,
the exchange rate between the Canadian and US dollar and our ability to sell
the
shares in the open market.
Evaluation
of disclosure controls and procedures. Based
on
our management’s evaluation, with the participation of our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of our disclosure
controls and procedures as of the end of the period covered by this quarterly
report, our Chief Executive Officer and Chief Financial Officer have concluded
that our disclosure controls and procedures are effective in ensuring that
information we are required to disclose in reports that we file or submit
under
the Securities Exchange Act of 1934, as amended, is recorded, processed,
summarized and reported within the time periods specified in the SEC rules
and
forms.
Changes
in internal control over financial reporting. There
was
no change in our internal control over financial reporting, that occurred
during
the period covered by this quarterly report that materially affected, or
is
reasonably likely to materially affect, our internal control over financial
reporting.
16
We
are
currently not a party to any legal proceedings.
Item
1A. Risk Factors
Other
than with respect to the risk factors below, there have been no material
changes
from the risk factors disclosed in “Section 1A. Risk Factors” of our annual
report on Form 10-K for the year ended December 31, 2006 but please
carefully consider both the risk factors of our annual report on Form 10-K
and
the risk factors below. The risk factors described below were previously
disclosed on the Form 10-K but have been updated to provide more recent
financial and factual information as of June 30, 2007.
Risks
Related to Our Business
We
expect to continue to operate at a loss and may never become
profitable.
Substantially all of our revenue to date has been derived under collaborative
research and development agreements relating to the development of our potential
product candidates. We have incurred, and will continue to incur for the
foreseeable future, significant expense to develop our research and development
programs, conduct preclinical studies and clinical trials, seek regulatory
approval for our product candidates and provide general and administrative
support for these activities. As a result, we have incurred significant net
losses since inception, and we expect to continue to incur substantial
additional losses in the future. As of June 30, 2007, we had an
accumulated deficit of $292.0 million. We may never be able to
commercialize our products or generate profits and, if we do become profitable,
we may be unable to sustain or increase profitability.
Our
lead product candidate has been placed on clinical hold and we do not currently
know when or if the clinical trial of the product candidate will
resume.
On
July
24, 2007, the FDA placed a clinical hold on our Phase I/II clinical trial
of
tgAAC94, our inflammatory arthritis product candidate, after a patient
participating in the clinical trial experienced a serious adverse event,
or SAE.
This patient subsequently died and the cause of death is currently under
investigation.
Based
on
the results of such investigation, we or the FDA may identify concerns
that
could cause a delay in or termination of the Phase I/II tgAAC94 clinical
trial.
We can make no assurance as to when or if the FDA will remove the hold
or will
allow us to continue the administration of tgAAC94 in this study or any
other
future clinical studies. Any significant delay in removing the clinical
hold
from this study, or termination of this study, or any significant delay
or
termination of any other of our clinical trials, may negatively impact
our
future operating results, may damage our reputation in the industry and
may
result in a decrease in the trading price of our common shares.
All
of our product candidates are in early-stage clinical trials or preclinical
development, and if we and our partners are unable to successfully develop
and
commercialize our product candidates we will be unable to generate sufficient
capital to maintain our business.
As
of July 2007, our congestive heart failure product candidate in collaboration
with Celladon is in a Phase I clinical trial, our inflammatory arthritis
candidate is in a Phase I/II trial, our HIV/AIDS product candidate in
collaboration with IAVI is in a Phase II trial and no product candidates
are in
Phase III or Phase IV trials. Of the trials that are currently being conducted,
we will not generate any product revenue or revenue sharing for at least
several
years and then only if we can and/or our partners successfully develop and
commercialize our product candidates. Commercializing our potential products
depends on successful completion of additional research and development and
testing, in both preclinical development and clinical trials. Clinical trials
may take several years or more to complete. The commencement, cost and rate
of
completion of our clinical trials may vary or be delayed for many reasons.
If we
are unable to successfully complete preclinical and clinical development
of some
or all of our product candidates in a timely manner, we may be unable to
generate sufficient product revenue to maintain our business.
Even if our potential products succeed in clinical trials and are approved
for
marketing, these products may never achieve market acceptance. If we are
unsuccessful in commercializing our product candidates for any reason, including
greater effectiveness or economic feasibility of competing products or
treatments, the failure of the medical community or the public to accept
or use
any products based on gene delivery, inadequate marketing and distribution
capabilities or other reasons discussed elsewhere in this section, we will
be
unable to generate sufficient product revenue to maintain our
business.
17
Any
success of our clinical trials and preclinical studies may not be indicative
of
results in a large number of subjects of either safety or
efficacy.
The successful results of our technology in preclinical studies using animal
models may not be predictive of the results that we will see in our clinical
trials. In addition, results in early-stage clinical trials generally test
for
drug safety rather than efficacy and are based on limited numbers of subjects.
Drug development involves a high degree of risk and our reported progress
and
results from our early phases of clinical testing of our product candidates
may
not be indicative of progress or results that will be achieved from larger
populations, which could be less favorable. Moreover, we do not know if any
favorable results we achieve in clinical trials will have a lasting or
repeatable effect. If a larger group of subjects does not experience positive
results or if any favorable results do not demonstrate a beneficial effect,
our
product candidates that we advance to clinical trials may not receive approval
from the FDA for further clinical trials or commercialization. For example,
in
March 2005, we discontinued the development of tgAAVCF, our product candidate
for the treatment of cystic fibrosis, following the analysis of Phase II
clinical trial data in which tgAAVCF failed to achieve the efficacy endpoints
of
the trial.
If
we are unable to raise additional capital when needed, we will be unable
to
conduct our operations and develop our potential
products.
Because
internally generated cash flow will not fund development and commercialization
of our product candidates, we will require substantial additional financial
resources. Our future capital requirements will depend on many factors,
including:
• |
the
rate and extent of scientific progress in our research and development
programs;
|
•
|
the
timing, costs and scope of, and our success in, conducting clinical
trials, obtaining regulatory approvals and pursuing patent
prosecutions;
|
• |
competing
technological and market developments;
|
•
|
the
timing and costs of, and our success in, any product commercialization
activities and facility expansions, if and as required;
and
|
• |
the
existence and outcome of any litigation or administrative proceedings
involving intellectual property.
|
Additional
sources of financing could involve one or more of the following:
• |
entering
into additional product development
collaborations;
|
• |
mergers
and acquisitions;
|
• |
issuing
equity in the public or private markets;
|
• |
extending
or expanding our current
collaborations;
|
• |
selling
or licensing our technology or product candidates;
|
• |
borrowing
under loan or equipment financing arrangements; and
|
• |
issuing
debt.
|
Additional
funding may not be available to us on reasonable terms, if at all. Our ability
to issue equity, and our ability to issue it at the current market price,
may be
adversely affected by the fact that we are presently ineligible under SEC
rules
to utilize Form S-3 for primary offerings of our securities because the
aggregate market value of our outstanding common stock held by non-affiliates
is
less than $75.0 million.
The
perceived risk associated with the possible sale of a large number of shares
of
our common stock could cause some of our shareholders to sell their stock,
thus
causing the price of our stock to decline. In addition, actual or anticipated
downward pressure on our stock price due to actual or anticipated sales of
stock
could cause some institutions or individuals to engage in short sales of
our
common stock, which may itself cause the price of our stock to decline.
18
If
our
stock price declines, we may be unable to raise additional capital. A sustained
inability to raise capital could force us to go out of business. Significant
declines in the price of our common stock could also impair our ability
to
attract and retain qualified employees, reduce the liquidity of our common
stock
and result in the delisting of our common stock from the NASDAQ Capital
Market.
The
funding that we expect to receive from our collaborations depends on continued
scientific progress under the collaborations and our collaborators’ ability and
willingness to continue or extend the collaboration. If we are unable to
successfully access additional capital, we may need to scale back, delay
or
terminate one or more of our development programs, curtail capital expenditures
or reduce other operating activities. We may also be required to relinquish
some
rights to our technology or product candidates or grant or take licenses
on
unfavorable terms, either of which would reduce the ultimate value to us
of our
technology or product candidates.
Risks
Related to Our Common Stock
Concentration
of ownership of our common stock may give certain shareholders significant
influence over our business.
A
small
number of investors own a significant number of shares of our common stock.
As
of June 30, 2007, Special Situations held approximately 2.6 million shares,
Biogen Idec held approximately 2.2 million shares, Orbimed Advisors LLC
held
approximately 1.4 million shares and Elan held approximately 1.2 million
shares,
of our common stock. Together these holdings represent approximately 37%
of our
common shares outstanding as of June 30, 2007. This concentration of stock
ownership may allow these shareholders to exercise significant control
over our
strategic decisions and block, delay or substantially influence all matters
requiring shareholder approval, such as:
• election
of directors;
• amendment
of our charter documents; or
• approval
of significant corporate transactions, such as a change of control of
us.
The
interests of these shareholders may conflict with the interests of other
holders
of our common stock with regard to such matters. Furthermore, this concentration
of ownership of our common stock could allow these shareholders to delay,
deter
or prevent a third party from acquiring control of us at a premium over
the
then-current market price of our common stock, which could result in a
decrease
in our stock price.
Special
Situations, Biogen Idec and Elan have all sold shares of our common stock
and
may continue to do so. Sales of significant value of stock by these investors
may introduce increased volatility to the market price of our common stock.
In
accordance with the termination agreement that we entered into with Elan
in
March 2004, Elan is only permitted to sell quantities of our stock equal
to 175%
of the volume limitation set forth in Rule 144(e)(1) promulgated under the
Securities Act of 1933, as amended, subject to certain exceptions.
On
June
22, 2007, we entered into a securities purchase agreement with certain
institutional and other accredited purchasers to sell an aggregate of 6,699,793
shares of the Company's common stock at a price of $2.905 per share, together
with five-year warrants to purchase, upon exercise, an aggregate of 6,699,793
shares of the company's common stock, or the Offering. The warrants issued
in
the transaction are exercisable at $3.25 per share. The Offering closed
on June
27, 2007.
In
connection with the Offering, Targeted Genetics issued an additional five-year
warrant, on the same terms as those received by the purchasers to the securities
purchase agreement, to the placement agent of the Offering to purchase,
upon
exercise, up to 334,989 shares of the Company's common stock.
The
Company received net proceeds of approximately $17.8 million in connection
with
the Offering.
Item
3. Defaults Upon Senior Securities
Not
applicable.
19
Item
4. Submission of Matters to a Vote of Security Holders
We
held
our Annual Meeting of Shareholders in Seattle, Washington on May 17, 2007.
Of
the 13,108,735 shares issued and outstanding as of the record date for
the
Annual Meeting, there were present at the meeting, in person or by proxy,
shareholders of the Company who were holders of 9,804,216, or 74.79%, of
the
total shares eligible to vote. At the Annual Meeting, our shareholders
approved
the following matters by the votes indicated below:
(i) Election
of Directors;
At
the
Annual Meeting, our shareholders approved the election of the persons named
below to our Board of Directors as Class 1 Directors for a two-year term
expiring in 2009, or until the successor of each is elected and qualified,
by
the votes set forth below:
Nominee
|
Votes
For
|
Votes
Withheld
|
||
Jack
L. Bowman
|
9,681,481
|
122,734
|
||
Jeremy
L. Curnock Cook (chairman)
|
9,679,397
|
124,818
|
The
Board
members whose terms in office continued after the Annual Meeting were Joseph
M.
Davie, Roger L. Hawley, Nelson L. Levy, H. Stewart Parker and Michael S.
Perry.
(ii) Approval
of amendment to amended and restated articles of
incorporation;
Our
shareholders approved an amendment to the amended and restated articles
of
incorporation to increase the authorized number of shares of our common
stock
from 18,000,000 to 30,000,000 by the votes set forth below:
Voted
|
|
Votes
For
|
9,399,591
|
Votes
Against
|
396,427
|
Abstain
|
8,197
|
Broker
Non-Votes
|
3,304,519
|
(iii) Approval
of amendment to the Company's 1999 Stock Option Plan, or the Plan;
and
Our
shareholders approved an amendment and restatement of the Plan to (a) increase
the maximum number of shares of our common stock available for issuance
under
the Plan from 1,297,944 shares to 2,547,944, an increase of 1,250,000 shares,
(b) provide for the issuance of stock appreciation rights, stock grants
and
stock units, in addition to stock options, and (c) to rename the Plan the
"Targeted Genetics Corporation Stock Incentive Plan," by the votes set
forth
below:
Voted
|
|
Votes
For
|
4,829,468
|
Votes
Against
|
261,438
|
Abstain
|
22,979
|
Broker
Non-Votes
|
7,994,850
|
(iv) Ratification
of auditor.
Our
shareholders ratified the appointment of Ernst & Young LLP as the Company's
independent registered public accounting firm for the fiscal year ending
December 31, 2007 by the votes set forth below:
Voted
|
|
Votes
For
|
9,741,388
|
Votes
Against
|
51,361
|
Abstain
|
11,468
|
Broker
Non-Votes
|
3,304,518
|
20
Item
5. Other Information
Not
applicable.
Item
6. Exhibits
See
accompanying
Exhibit
Index
included
after
the
signature page of
this
quarterly
report
for a list of the exhibits filed or furnished with the
report.
21
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.
|
Targeted
Genetics Corporation
|
||||
Date:
|
|
August
7, 2007
|
By:
|
|
/s/ H.
Stewart
Parker
H.
Stewart Parker,
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
|
Date:
|
|
August
7, 2007
|
By:
|
|
/s/ David
J. Poston
David
J. Poston,
Chief
Financial Officer
(Principal
Financial and Accounting
Officer)
|
22
INDEX
TO EXHIBITS
Exhibit
Number
|
Exhibit
Description
|
Form
|
Date
of
First
Filing
|
Exhibit
Number
|
Filed
Herewith
|
|||||
3.1.1
|
Amended
and Restated Articles of Incorporation, dated May 9, 2006.
|
X
|
||||||||
3.1.2
|
Articles
of Amendment to the Restated Articles of Incorporation, dated
May 17,
2007.
|
X
|
||||||||
3.2
|
Amended
and Restated Bylaws.
|
10-K
|
3/17/97
|
3.2
|
||||||
4.1
|
Registration
Rights Agreement among Targeted Genetics Corporation and certain
investors
dated as of January 8, 2007.
|
8-K
|
1/8/07
|
10.2
|
||||||
4.2
|
Registration
Rights Agreement among Targeted Genetics Corporation and certain
purchasers dated as of June 22, 2007.
|
8-K
|
6/22/07
|
10.2
|
||||||
10.1
|
Amendment
No. 3 to Exclusive Sublicense Agreement, dated as of March 9,
2007,
between Targeted Genetics and Alkermes, Inc. *
|
10-K
|
3/29/07
|
10.5(c)
|
||||||
10.2
|
Securities
Purchase Agreement among Targeted Genetics Corporation and certain
investors dated January 8, 2007.
|
8-K
|
1/8/07
|
10.1
|
||||||
10.3
|
Form
of Warrant to Purchase Shares of Common Stock of Targeted Genetics
Corporation dated January 11, 2007.
|
8-K
|
1/8/07
|
10.3
|
||||||
10.4
|
Securities
Purchase Agreement among Targeted Genetics Corporation and certain
purchasers dated as of June 22, 2007.
|
8-K
|
6/22/07
|
10.1
|
||||||
10.5
|
Form
of Common Stock Purchase Warrant of Targeted Genetics Corporation
dated as
of June 27, 2007.
|
8-K
|
6/22/07
|
10.3
|
||||||
10.6
|
Targeted
Genetics Corporation Stock Plan.
|
8-K
|
5/22/07
|
10.1
|
||||||
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934.
|
X
|
||||||||
31.2
|
Certification
of Chief Financial Officer pursuant to Rules 13a-15(e) and 15d-15(e)
under
the Securities Exchange Act of 1934.
|
X
|
||||||||
32.1
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
X
|
||||||||
32.2
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
X
|
* |
Portions
of this exhibit have been omitted based on a grant of or application
for
confidential treatment from the SEC. The omitted portions of
these
exhibits have been filed separately with the
SEC.
|
23