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Armata Pharmaceuticals, Inc. - Quarter Report: 2007 September (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 SEPTEMBER 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 o   Accelerated filer o   Non-accelerated filer x

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 October 29, 2007: 19,814,161
 



 
TARGETED GENETICS CORPORATION
Quarterly Report on Form 10-Q
For the quarter ended September 30, 2007
 
TABLE OF CONTENTS

 
 
 
  
Page No.
PART I
 
FINANCIAL INFORMATION
  
 
 
 
 
  
 
Item 1.
 
Financial Statements
  
 
 
 
 
  
 
a)
 
Condensed Consolidated Balance Sheets at September 30, 2007 and December 31, 2006
  
1
b)
 
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2007 and 2006
  
2
c)
 
Condensed Consolidated Statements of Cash Flows for the nine months ended September 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
  
10
 
 
 
  
Item 3.
 
Quantitative and Qualitative Disclosures About Market Risk
  
16
       
Item 4T.
 
Controls and Procedures
  
17
 
 
 
  
 
PART II
 
OTHER INFORMATION
  
17
 
 
 
  
 
Item 1.
 
Legal Proceedings
  
17
Item 1A.
 
Risk Factors
 
17
Item 2.
 
Unregistered Sales of Equity Securities and Use of Proceeds
  
20
Item 3.
 
Defaults Upon Senior Securities
  
20
Item 4.
 
Submission of Matters to a Vote of Security Holders
  
20
Item 5.
 
Other Information
  
20
Item 6.
 
Exhibits
  
20
 
 
 
  
 
SIGNATURES
  
21
INDEX TO EXHIBITS
 
22

i


PART I    FINANCIAL INFORMATION
 
Item 1.    Financial Statements 
 
TARGETED GENETICS CORPORATION
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
 
   
September 30,
 
December 31,
 
   
2007
 
2006
 
ASSETS
         
Current assets:
         
Cash and cash equivalents
 
$
20,531,000
 
$
6,206,000
 
Accounts receivable
   
1,544,000
   
1,498,000
 
Prepaid expenses and other
   
321,000
   
531,000
 
Total current assets
   
22,396,000
   
8,235,000
 
Property and equipment, net
   
986,000
   
1,100,000
 
Goodwill
   
7,926,000
   
7,926,000
 
Other assets
   
200,000
   
206,000
 
Total assets
 
$
31,508,000
 
$
17,467,000
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
             
               
Current liabilities:
             
Accounts payable and accrued expenses
 
$
2,058,000
 
$
1,901,000
 
Accrued employee expenses
   
702,000
   
861,000
 
Accrued restructure charges
   
1,643,000
   
1,046,000
 
Deferred revenue
   
218,000
   
251,000
 
Current portion of long-term obligations
   
504,000
   
1,129,000
 
Total current liabilities
   
5,125,000
   
5,188,000
 
               
Accrued restructure charges
   
5,506,000
   
6,331,000
 
Long-term obligations
   
   
570,000
 
Deferred rent
   
9,000
   
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 September 30, 2007 and 10,921,736 shares issued and outstanding at December 31, 2006
   
198,000
   
109,000
 
Additional paid-in capital
   
315,744,000
   
289,324,000
 
Accumulated deficit
   
(295,080,000
)
 
(284,027,000
)
Accumulated other comprehensive gain (loss)
   
6,000
   
(39,000
)
Total shareholders’ equity 
   
20,868,000
   
5,367,000
 
Total liabilities and shareholders’ equity
 
$
31,508,000
 
$
17,467,000
 

See accompanying notes to condensed consolidated financial statements
 
1


TARGETED GENETICS CORPORATION
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

   
Three months ended
September 30,
 
Nine months ended
September 30,
 
   
2007
 
2006
 
2007
 
2006
 
Revenue:
                 
Collaborative revenue
 
$
1,943,000
 
$
2,012,000
 
$
6,612,000
 
$
5,856,000
 
Licensing revenue
   
500,000
   
   
500,000
   
 
Total revenue
   
2,443,000
   
2,012,000
   
7,112,000
   
5,856,000
 
                           
Operating expenses:
                         
Research and development
   
3,874,000
   
3,123,000
   
12,840,000
   
10,483,000
 
General and administrative
   
1,694,000
   
1,687,000
   
4,821,000
   
4,736,000
 
Restructure charges
   
183,000
   
413,000
   
809,000
   
1,818,000
 
Goodwill impairment charge
   
   
   
   
23,723,000
 
Total operating expenses
   
5,751,000
   
5,223,000
   
18,470,000
   
40,760,000
 
                           
Loss from operations
   
(3,308,000
)
 
(3,211,000
)
 
(11,358,000
)
 
(34,904,000
)
Investment income
   
277,000
   
147,000
   
305,000
   
468,000
 
Interest expense
   
   
(126,000
)
 
(1,000
)
 
(362,000
)
Net loss
 
$
(3,031,000
)
$
(3,190,000
)
$
(11,054,000
)
$
(34,798,000
)
                           
Net loss per common share (basic and diluted)
 
$
(0.15
)
$
(0.32
)
$
(0.72
)
$
(3.64
)
Shares used in computation of basic and diluted net loss per common share
   
19,814,000
   
9,894,000
   
15,388,000
   
9,548,000
 
 
See accompanying notes to condensed consolidated financial statements
 
2


TARGETED GENETICS CORPORATION
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 
   
Nine months ended
 
   
September 30,
 
 
 
2007
 
2006
 
Operating activities:
         
Net loss
 
$
(11,054,000
)
$
(34,798,000
)
Adjustments to reconcile net loss to net cash used in operating activities:
             
Depreciation
   
447,000
   
537,000
 
Stock-based compensation
   
514,000
   
691,000
 
Stock issued to outside service providers
   
   
141,000
 
Goodwill impairment charge
   
   
23,723,000
 
Gain on the sale of property and equipment
   
(22,000
)
 
 
Loss (gain) on investments
   
251,000
   
(8,000
)
Changes in assets and liabilities:
             
Increase in accounts receivable
   
(46,000
)
 
(233,000
)
Decrease (increase) in prepaid expenses and other
   
(12,000
)
 
48,000
 
Decrease in other assets
   
6,000
   
8,000
 
Increase (decrease) in current liabilities
   
(1,000
)
 
38,000
 
Increase (decrease) in deferred revenue
   
(33,000
)
 
45,000
 
Decrease in deferred rent
   
(2,000
)
 
(99,000
)
Increase (decrease) in accrued restructure expenses
   
(228,000
)
 
385,000
 
Net cash used in operating activities
   
(10,180,000
)
 
(9,522,000
)
               
Investing activities:
             
Purchases of property and equipment
   
(333,000
)
 
(72,000
)
Proceeds from the sale of property and equipment
   
22,000
   
 
Proceeds from sale of investments
   
16,000
   
49,000
 
Net cash used in investing activities
   
(295,000
)
 
(23,000
)
               
Financing activities:
             
Net proceeds from sales of common stock
   
25,956,000
   
4,826,000
 
Proceeds from the exercise of stock options
   
39,000
   
12,000
 
Payments under debt and equipment financing arrangements
   
(1,195,000
)
 
(135,000
)
Net cash provided by financing activities
   
24,800,000
   
4,703,000
 
               
Net increase (decrease) in cash and cash equivalents
   
14,325,000
   
(4,842,000
)
Cash and cash equivalents, beginning of period
   
6,206,000
   
14,122,000
 
Cash and cash equivalents, end of period
 
$
20,531,000
 
$
9,280,000
 
 
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 nine months ended September 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 $20.5 million at September 30, 2007. We believe that our current resources, including the capital raised in January 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, but not yet approved, 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

Effective the beginning of 2007, we adopted Financial Accounting Standards Board, or 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 nine months ended September 30, 2007.

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:
 
 
 
September 30,
 
December 31,
 
   
2007
 
2006
 
           
Loans payable to Biogen Idec
 
$
501,000
 
$
1,672,000
 
Equipment financing obligations
   
3,000
   
27,000
 
Total obligations
   
504,000
   
1,699,000
 
Less current portion
   
(504,000
)
 
(1,129,000
)
Total long-term obligations
 
$
 
$
570,000
 

As of September 30, 2007, we owed $501,000 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. In the fourth quarter of 2006, as part of a debt restructuring, we agreed to terms that resulted in a loan payable balance of $2.2 million, which consisted of $2.0 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 which is due on August 1, 2008.  We must apply one-third of certain up-front payments received from potential future corporate collaborations and one-third of certain milestone payments 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. Since December 2006, as a result of the receipt of upfront payments in the fourth quarter of 2006 and the first three quarters of 2007, we have made principal and interest payments totaling $917,000. The note balance of $501,000 as of September 30, 2007 includes principal of $410,000 and interest of $91,000. As of September 30, 2007, future aggregate principal payments related to the Biogen Idec debt are $410,000 in 2008 and zero there after. Subsequent to quarter end, we made a $161,000 principal payment in October 2007.

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 nine month period ended September 30, 2007:

   
Contract
Termination
Costs
 
December 31, 2006 accrued liability
 
$
7,377,000
 
Charges related to changes in lease assumptions
   
260,000
 
Accretion expense
   
549,000
 
Amount paid
   
(1,037,000
)
September 30, 2007 accrued liability
 
$
7,149,000
 

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 $183,000 of accretion expense for the three months ended September 30, 2007 and $549,000 of accretion expense for the nine months ended September 30, 2007. The total of these charges and adjustments to the liability are reflected as restructure charges in the accompanying consolidated statements of operations.

Through September 30, 2007, we have recorded contract termination costs totaling $10.8 million for our Bothell facility. As of September 30, 2007, we expect to incur an additional $2.6 million in accretion expense through the expiration of the Bothell lease in September 2015. If we were to determine that we were unable to sublease the facility, we would record additional restructure charges of $1.2 million.

5

 
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 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 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. We also issued a warrant with the same terms as those 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 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 ou r common stock. These warrants expire in January 2012 and are exercisable at $5.41 per share. We also issued a warrant with the same terms as those 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 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 nine months ended September 30, 2007:

   
Three months ended
September 30,
 
Nine months ended
September 30,
 
 
 
2007
 
2006
 
2007
 
2006
 
                   
Stock options:
                 
Research and development expense
 
$
1,000
 
$
117,000
 
$
195,000
 
$
379,000
 
General and administrative expense
   
7,000
   
110,000
   
157,000
   
312,000
 
Restricted stock units:
                         
Research and development expense
   
38,000
   
   
55,000
   
 
General and administrative expense
   
73,000
   
   
107,000
   
 
Total compensation expense
 
$
119,000
 
$
227,000
 
$
514,000
 
$
691,000
 
 
Stock Options

Following is a summary of stock option activity and related prices for the first nine 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
   
(43,353
)
 
8.95
             
Outstanding, September 30, 2007
   
781,008
 
$
15.26
   
6.51
 
$
3,000
 
                           
Exercisable at September 30, 2007
   
688,694
 
$
16.17
   
6.34
 
$
1,000
 
 
 
The aggregate intrinsic value is determined using the closing price of our common stock of $1.87 on September 28, 2007. The intrinsic value of stock options exercised was $22,000 during the nine months ended September 30, 2007 and $3,000 during the nine months ended September 30, 2006. We received $39,000 from the exercise of stock options for the nine months ended September 30, 2007 and $2,000 for the nine months ended September 30, 2006.
 
As of September 30, 2007, total unrecognized compensation cost related to unvested options was approximately $171,000, net of estimated forfeitures, which we expect to recognize over a weighted average period of approximately one year.
 
Stock options outstanding and exercisable as of September 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
   
94,233
 
$
2.50
   
8.31
   
82,725
 
$
2.54
 
  3.80 - 3.80 
   
187,000
   
3.80
   
8.69
   
187,000
   
3.80
 
  3.87 - 9.10
   
167,245
   
7.28
   
7.11
   
113,561
   
7.27
 
  10.80 - 14.90
   
157,370
   
13.10
   
6.28
   
131,435
   
13.10
 
  15.30 - 148.80
   
175,160
   
43.92
   
2.85
   
173,973
   
44.07
 
Balance, September 30, 2007
   
781,008
 
$
15.26
   
6.51
   
688,694
 
$
16.17
 

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 nine months ended September 30, 2007 was $3.88 and was $1.84 for the nine months ended September 30, 2006.  

7


The following are the weighted average assumptions for the periods noted:

   
Nine Months ended September 30,
 
   
2007
 
2006
 
Expected dividend rate
 
Nil
 
Nil
 
Expected stock price volatility
   
1.047 - 1.114
   
1.067-1.107
 
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. The terms of our Biogen Idec loan restricts our ability to declare or pay dividends.

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
   
528,000
   
3.10
 
Vested
   
   
 
Forfeited
   
(2,500
)
 
3.14
 
Nonvested, September 30, 2007
   
525,500
 
$
3.10
 

As of September 30, 2007, total unrecognized compensation cost related to unvested restricted stock units was approximately $802,000, net of estimated forfeitures, which we expect to recognize over a weighted average period of approximately 2.4 years.

5.   Other Comprehensive Loss
 
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
September 30,
 
Nine months ended
September 30,
 
 
 
2007
 
2006
 
2007
 
2006
 
                   
Net loss as reported
 
$
(3,031,000
)
$
(3,190,000
)
$
(11,054,000
)
$
(34,798,000
)
Other comprehensive income or loss:
                         
Unrealized gain (loss) on available-for-sale securities
   
   
(22,000
)
 
   
26,000
 
Foreign currency translation adjustment
   
6,000
   
2,000
   
6,000
   
15,000
 
Comprehensive loss
 
$
(3,025,000
)
$
(3,210,000
)
$
(11,048,000
)
$
(34,757,000
)

6.   Investments 

As of September 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 nine months ended September 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 sheets. 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. We evaluated the investment again on September 30, 2007 and based on additional facts about Chromos, we determined that our investment was not further impaired at that date. We recognized an unrealized gain due to a change in the exchange rate for the Canadian dollar during the third quarter of 2007. We continue to monitor the status of Chromos.

Following is a summary of our Investment activity for the nine months ended September 30, 2007:

   
Fair
Value
 
Unrealized
Gain
 
Proceeds
from the
sale of
securities
 
 
Net
Realized
Loss
 
Marketable equity securities
 
$
95,000
 
$
6,000
 
$
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, in the second quarter of 2006, 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 in this June 2006 test 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. Since the second quarter of 2006, we have had no further indications of impairment on our goodwill balance.

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 nine months ended September 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 nine months ended September 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 our inception in 1992 to 2002 may be subject to examination in the event we utilize the net operating losses from those years in our current or future year tax returns.

9


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.

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 and our partners, Celladon Corporation, or Celladon, the National Institute of Allergy and Infectious Diseases, or NIAID, the International AIDS Vaccine Initiative, or IAVI, the Children’s Hospital of Philadelphia, or CHOP, and The Research Institute at Nationwide Children’s Hospital (formerly known as the Columbus Children’s Research Institute), or NCH, 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, CHOP and NCH
 
Phase II
AAV delivery of SERCA2a
 
Congestive Heart Failure
 
Celladon
 
Phase I
AAV delivery of HIV antigens
 
HIV/AIDS
 
CHOP, NCH and NIAID
 
Preclinical
AAV expression of htt shRNA (RNAi)
 
Huntington’s disease
 
Sirna Therapeutics as a subsidiary of Merck
 
Preclinical

10

 
In the first nine months of 2007, we made progress in our development collaborations and our product development programs and expanded and leveraged our patent portfolio. More specifically:

 
·
In June 2007, we reported additional data from our ongoing Phase I/II clinical trial of our inflammatory arthritis candidate that demonstrated safety and a trend in two-point reduction in swelling in treated joints compared to placebo. We completed enrollment and initial dosing in this trial in May 2007. However, the trial was placed on clinical hold in July 2007 after a patient participating in the clinical trial experienced a serious adverse event, or SAE, and subsequently died. In September 2007, the National Institutes of Health Recombinant DNA Advisory Committee held a public hearing which reviewed the SAE. Evidence presented at the hearing suggested that the subject died of an invasive fungal infection. The medications the subject was on are known to be a risk factor for histoplasma infection, which is a fungal infection. Biochemical evidence that the subject already had fungal infection prior to the second dose was also reported at the meeting. Additionally, initial molecular tests showed there was no amplification of vector and only trace amounts of vector DNA in tissues outside the joint. Consequently, we believe these data suggest it is unlikely that our experimental inflammatory arthritis candidate contributed to the conditions that caused the death.

 
·
In February 2007, we reported results from a Phase I clinical trial of our investigational HIV/AIDS vaccine candidate which we have partnered with IAVI. The results of this study, which was funded and run by IAVI, indicated favorable safety and tolerability profiles consistent with the results observed in clinical trials to date, and provided the rationale for evaluating the vaccine at higher doses and at different dosing intervals. The Phase I clinical trial was a dose escalation safety trial and was conducted in Germany, Belgium and India. In addition, in August 2007, we presented interim results from a separate Phase II clinical trial of our partnered investigational HIV/AIDS vaccine candidate that demonstrated that the vaccine was safe and well tolerated and that modest immune responses were shown in some recipients who received higher doses. The Phase II clinical trial is also being funded and run by IAVI and is being conducted in South Africa, Uganda and Zambia to evaluate a higher dose and to systematically evaluate the utility and optimal timing of boost vaccination.

 
·
In May 2007, the first patient was dosed in the Phase I clinical trial of MYDICAR, which is our partnered congestive heart failure product candidate under development through our collaboration with Celladon.

 
·
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 September 2007, we received a milestone payment from Amsterdam Molecular Therapeutics upon initiation of a clinical trial for AMT-011, an AAV1-based therapy for LPL deficiency.

 
·
We have received issuances of additional patents, strengthening our AAV vector patent portfolio and expanding the potential applications of AAV-based gene delivery.

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, cash payments received from our collaborative partners for product development and manufacturing activities, 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 $26.0 million to fund our programs and operations. On June 27, 2007, we sold 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 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 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 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 September 30, 2007, our accumulated deficit totaled $295.1 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.

To enable us to successfully develop our lead inflammatory arthritis product candidate and other product candidates we will require access to significantly higher amounts of capital than we currently have. 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.

11

 
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 September 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 nine months ended September 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 $2.4 million for the three months ended September 30, 2007 as compared to $2.0 million for the same period in 2006. Revenue increased to $7.1 million for the nine months ended September 30, 2007 compared to $5.9 million for the same period in 2006. The increase in revenue for both the three and nine month periods primarily reflects an increase in research and development activities under the NIAID-funded HIV/AIDS vaccine project in collaboration with CHOP and NCH and licensing revenue from a milestone payment received in the third quarter. These increases were partially offset by lower research and development activities under our collaboration with IAVI as a result of less development activity as the project is largely focused on clinical testing. 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 NCH and to a lesser extent, 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.

Operating Expenses

Research and Development Expenses.    Research and development expenses increased to $3.9 million for the three months ended September 30, 2007 compared to $3.1 million for the same period in 2006 and increased to $12.8 million for the nine months ended September 30, 2007 compared to $10.5 million for the same period in 2006. Costs for both the three and nine 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 NCH 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 in our Phase I/II clinical trial. 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. 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 both our self-funded and partnered clinical programs, the NIAID-funded HIV/AIDS vaccine project in collaboration with CHOP and NCH and other programs in preclinical development.

12


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
September 30,
 
Nine months ended
September 30,
 
 
 
2007
 
2006
 
2007
 
2006
 
Programs in clinical development:
                         
Inflammatory arthritis
 
$
1,091,000
 
$
771,000
 
$
2,948,000
 
$
2,204,000
 
Congestive heart failure (1)
   
170,000
   
   
373,000
   
 
IAVI HIV/AIDS vaccine
   
33,000
   
383,000
   
202,000
   
1,494,000
 
Indirect costs and other
   
631,000
   
556,000
   
2,161,000
   
2,187,000
 
Total clinical development program expense
   
1,925,000
   
1,710,000
   
5,684,000
   
5,885,000
 
Research and preclinical development program expense
   
1,949,000
   
1,413,000
   
7,156,000
   
4,598,000
 
Total research and development expense
 
$
3,874,000
 
$
3,123,000
 
$
12,840,000
 
$
10,483,000
 

(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. Celladon separately manages and funds the clinical trial costs of our congestive heart failure program and IAVI separately manages and funds the clinical trial costs of our HIV/AIDS vaccine program for the developing world. 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 project in collaboration with CHOP and NCH as well as other programs prior to their transition into clinical trials. Research and preclinical development 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.
  
General and Administrative Expenses.    General and administrative expenses remained consistent at $1.7 million for the three months ended September 30, 2007 and September 30, 2006. General and administrative expense increased to $4.8 million for the nine months ended September 30, 2007 from $4.7 million for the nine months ended September 30, 2006. General and administrative expenses consist primarily of salaries, patent costs, legal and audit fees and shareholder costs.

Restructure Charges.    Restructure charges decreased to $183,000 for the three months ended September 30, 2007 compared to $413,000 for the same period in 2006. Restructure charges decreased to $809,000 for the nine months ended September 30, 2007 compared to $1.8 million for the same period in the prior year. Restructuring charges for the nine months ended September 30, 2007 include $260,000 related to changes in our estimates of the anticipated lead time to sublease the Bothell facility. Restructuring charges for the first nine months of 2006 include charges of $860,000 related to changes in our expectations regarding market conditions for the Bothell facility subleasing market, charges of $219,000 related to employee termination benefits of our restructuring efforts to realign our cost structure and charges of $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 $549,000 for the nine months ended September 30, 2007 and $564,000 for the nine months ended September 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.

13


Other Income and Expense

Investment Income.     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 increased to $277,000 for the three months ended September 30, 2007 compared to income of $147,000 for the same period in 2006. The increase is due to income earned on higher average cash balances during the third quarter of 2007. Investment income decreased to $305,000 for the nine months ended September 30, 2007 compared to $468,000 for the same period in 2006. Investment income for the nine month period reflects a net realized loss of $251,000 recognized in the first and second quarters of 2007 related to an other-than-temporary impairment loss on our investment in Chromos due to the declining market value of Chromos’ securities combined with a decline in Chromos’ current financial position.  

Interest Expense.     Interest expense decreased to zero for the three months ended September 30, 2007, compared to $126,000 for the same period in 2006. Interest expense decreased to $1,000 for the nine months ended September 30, 2007, compared to $362,000 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 $501,000 carrying value of the remaining debt as of September 30, 2007 includes the related estimated future interest payments and accordingly, we did not record interest expense on the Biogen Idec debt in the three month and nine month periods ended September 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 $20.5 million at September 30, 2007 compared to $6.2 million at December 31, 2006. Our cash and cash equivalents increased in the nine months ended September 30, 2007 primarily reflecting the net proceeds of $25.9 million from our January and June 2007 sales of our common stock, partially offset by our net loss and the resulting cash used in operations of $10.2 million and debt payments of $1.2 million made to Biogen related to our outstanding loan.

On June 27, 2007, we sold 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 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 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. 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.

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 partnered HIV/AIDS vaccine candidate for the developing world, our inflammatory arthritis product candidate and our partnered congestive heart failure product candidate are all in the clinical phase of development. We expect to continue incurring significant expense in developing and advancing our technology and 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 at September 30, 2007 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 long-term lease commitments that draw on our cash resources. Our most significant obligation is approximately $12.3 million of lease payments remaining on our Bothell facility, which we are obligated to pay at $1.4 million to $1.6 million per year until the year 2015.

14


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 and loan funding under equipment financing agreements. 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 HIV/AIDS vaccine project in collaboration with CHOP and NCH. To date we have received $4.2 million under this subcontract and our portion of the remaining project funding could be up to an additional $14.0 million over the remaining three years of the contract. Funding for this subcontract is awarded to us in annual installments based on an approved work plan and achievement of milestones.

The funding we receive 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 collaborative agreement and license revenue 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 any of our collaborators 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. 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;

15


·
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 $14 million to $16 million and that our cash and cash equivalents at September 30, 2007, plus the anticipated funding from our product development collaborations and contracts, will be sufficient to fund our currently forecast 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 September 30, 2007, we held $20.5 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 September 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.

· 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 September 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
 
$
 
$
410,000
 
$
 
$
 
$
 
$
410,000
 

Items with market and foreign currency exchange risk:
 
· Investment in Chromos Molecular Systems, Inc.: At September 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 September 30, 2007 the Canadian dollar to US dollar exchange rate was US $1.00712 per CA $1.00. As of September 30, 2007, this investment is recorded at $95,000 and is classified within prepaid expenses and other in the accompanying condensed consolidated balance sheet. We recorded a net realized loss of $251,000 in the nine months ended September 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 nine months ended September 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.

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Item 4T. Controls and Procedures 
 
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.

PART II    OTHER INFORMATION
 
Item 1. Legal Proceedings
 
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 September 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 since 2005 has been derived from collaborative research and development agreements in connection with the development of our potential product candidates including our collaborations with IAVI and Celladon and our NIAID-funded subcontract with CHOP and NCH. 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 September 30, 2007, we had an accumulated deficit of $295.1 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 was placed on clinical hold and we do not currently know when or if the clinical trial of the product candidate will resume.

On July 20, 2007, we and 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.

In September 2007, the National Institutes of Health Recombinant DNA Advisory Committee held a public hearing which presented the preliminary evidence of the investigation.  Preliminary experimental evidence and autopsy findings presented at the hearing suggested that the subject died of an invasive fungal infection.  While we believe these data suggest it is unlikely that our experimental inflammatory arthritis candidate contributed to the conditions that caused the death, we, the FDA or others may identify concerns that could cause further delay or termination of the Phase I/II tgAAC94 clinical trial.   The investigation is ongoing and no assurance can be made that the FDA will remove the hold or will allow us to continue the administration of tgAAC94 in this study or in other future clinical studies. Any significant delay in removing the clinical hold from this study, or an ultimate termination of this study related to the clinical hold, would negatively impact our future operating results and would likely result in a decrease in the trading price of our common shares.

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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 we have no product candidates in Phase III trials. Of the trials that are currently being conducted, we will not generate any product revenue, manufacturing revenue, revenue sharing or royalties 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 marketing or 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.

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 with human subjects. 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 our 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;

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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.

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 and may result in certain decisions that are contrary to your interests.

A small number of investors own a significant number of shares of our common stock. As of September 30, 2007, Special Situations held approximately 2.6 million shares, Biogen Idec held approximately 2.2 million shares, Orbimed Advisors LLC held approximately 1.3 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 September 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 your interests or 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 and a reduction in the value of your investment.

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.

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Item 2. Unregistered Sales of Securities and Use of Proceeds
  
Not applicable.

Item 3. Defaults Upon Senior Securities
 
Not applicable.

Item 4. Submission of Matters to a Vote of Security Holders

Not applicable.

 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.
 


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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: October 31, 2007  
By: 
  /s/    H. Stewart Parker
     
 
H. Stewart Parker,
 President, Chief Executive Officer and Director
 (Principal Executive Officer)
 
Date:  October 31, 2007 
By: 
/s/    David J. Poston 
 
 
 David J. Poston,  
Chief Financial Officer
(Principal Financial and Accounting Officer)

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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.
 
10-Q
 
8/7/07
 
3.1
   
                     
3.1.2
 
Articles of Amendment to the Restated Articles of Incorporation, dated May 17, 2007.
 
10-Q
 
8/7/07
 
3.1.2
   
                     
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.

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