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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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22-2816046
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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9920 Belward Campus Drive, Rockville, MD
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20850
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(Address of principal executive offices)
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(Zip code)
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Large accelerated filer
¨
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Accelerated filer
x
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Non-accelerated filer
¨
(Do not check if a smaller reporting company)
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Smaller reporting company
¨
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Page No.
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PART I. FINANCIAL INFORMATION
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||
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Item 1.
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Financial Statements
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Balance Sheets as of March 31, 2011 (unaudited)
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and December 31, 2010
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1
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Statements of Operations for the three months ended
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||
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March 31, 2011 and 2010 (unaudited)
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2
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Statements of Cash Flows for the three months ended
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March 31, 2011 and 2010 (unaudited)
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3
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Notes to the Financial Statements (unaudited)
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4
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Item 2.
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Management’s Discussion and Analysis of Financial
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Condition and Results of Operations
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11
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Item 3.
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Quantitative and Qualitative Disclosures about Market Risk
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19
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Item 4.
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Controls and Procedures
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20
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PART II. OTHER INFORMATION
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||
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Item 1.
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Legal Proceedings
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20
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Item 1A.
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Risk Factors
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20
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Item 5.
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Other Information
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20
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Item 6.
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Exhibits
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21
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SIGNATURES
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22
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|
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March 31,
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December 31,
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|||||||
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2011
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2010
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|||||||
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(unaudited)
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||||||||
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ASSETS
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||||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$ | 8,358 | $ | 8,061 | ||||
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Short-term investments available-for-sale
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15,565 | 23,615 | ||||||
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Accounts receivables
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2,517 | 54 | ||||||
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Unbilled receivables
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834 | — | ||||||
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Prepaid expenses and other current assets
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1,702 | 1,607 | ||||||
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Total current assets
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28,976 | 33,337 | ||||||
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Property and equipment, net
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7,859 | 8,206 | ||||||
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Goodwill
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33,141 | 33,141 | ||||||
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Other non-current assets
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160 | 160 | ||||||
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Total assets
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$ | 70,136 | $ | 74,844 | ||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
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Current liabilities:
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||||||||
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Accounts payable
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$ | 3,362 | $ | 3,572 | ||||
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Accrued expenses and other current liabilities
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4,832 | 6,273 | ||||||
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Current portion of notes payable
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80 | 80 | ||||||
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Deferred revenue
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2,500 | — | ||||||
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Deferred rent
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352 | 341 | ||||||
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Total current liabilities
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11,126 | 10,266 | ||||||
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Warrant liability
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2,909 | 2,842 | ||||||
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Non-current portion of notes payable
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300 | 320 | ||||||
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Deferred rent
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2,272 | 2,366 | ||||||
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Total liabilities
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16,607 | 15,794 | ||||||
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Commitments and contingences
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— | — | ||||||
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Stockholders’ equity:
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||||||||
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Preferred stock, $0.01 par value, 2,000,000 shares authorized; no shares issued and outstanding
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— | — | ||||||
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Common stock, $0.01 par value, 200,000,000 shares authorized; and 112,025,714 shares issued and 111,570,284 shares outstanding at March 31, 2011 and 111,492,014 shares issued and 111,036,584 shares outstanding at December 31, 2010
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1,120 | 1,115 | ||||||
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Additional paid-in capital
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373,277 | 371,477 | ||||||
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Notes receivable from former directors
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(1,572 | ) | (1,572 | ) | ||||
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Accumulated deficit
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(317,745 | ) | (310,292 | ) | ||||
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Treasury stock, 455,430 shares, cost basis
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(2,450 | ) | (2,450 | ) | ||||
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Accumulated other comprehensive income
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899 | 772 | ||||||
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Total stockholders’ equity
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53,529 | 59,050 | ||||||
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Total liabilities and stockholders’ equity
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$ | 70,136 | $ | 74,844 | ||||
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For the Three Months
Ended March 31,
|
||||||||
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2011
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2010
|
|||||||
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Revenue
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$ | 834 | $ | 110 | ||||
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Operating expenses:
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||||||||
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Research and development
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5,414 | 9,029 | ||||||
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General and administrative
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2,850 | 2,535 | ||||||
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Total operating expenses
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8,264 | 11,564 | ||||||
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Loss from operations
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(7,430 | ) | (11,454 | ) | ||||
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Other income (expense):
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Interest income
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46 | 44 | ||||||
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Interest expense
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(2 | ) | (2 | ) | ||||
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Change in fair value of warrant liability
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(67 | ) | 1,069 | |||||
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Net loss
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$ | (7,453 | ) | $ | (10,343 | ) | ||
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Basic and diluted net loss per share
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$ | (0.07 | ) | $ | (0.10 | ) | ||
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Basic and diluted weighted average number of common shares outstanding
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111,188 | 100,188 | ||||||
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For the Three Months
Ended March 31,
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||||||||
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2011
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2010
|
|||||||
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Operating Activities:
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||||||||
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Net loss:
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$ | (7,453 | ) | $ | (10,343 | ) | ||
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Reconciliation of net loss to net cash used in operating activities:
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||||||||
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Change in fair value of warrant liability
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67 | (1,069 | ) | |||||
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Depreciation and amortization
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389 | 296 | ||||||
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Amortization of short-term investments premium (discount)
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150 | — | ||||||
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Deferred rent
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(83 | ) | (72 | ) | ||||
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Non-cash stock-based compensation
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432 | 84 | ||||||
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Changes in operating assets and liabilities:
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Accounts receivables
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37 | 27 | ||||||
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Unbilled receivables
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(834 | ) | — | |||||
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Prepaid expenses and other current assets
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(95 | ) | 597 | |||||
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Accounts payable and accrued expenses
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(1,651 | ) | 1,189 | |||||
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Deferred revenue
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— | (89 | ) | |||||
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Net cash used in operating activities
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(9,041 | ) | (9,380 | ) | ||||
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Investing Activities:
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||||||||
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Capital expenditures
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(41 | ) | (658 | ) | ||||
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Proceeds from maturities of short-term investments
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8,525 | — | ||||||
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Purchases of short-term investments
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(499 | ) | (14,182 | ) | ||||
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Net cash provided by (used in) by investing activities
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7,985 | (14,840 | ) | |||||
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Financing Activities:
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||||||||
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Principal payments of notes payable
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(20 | ) | (26 | ) | ||||
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Net proceeds from sales of common stock
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1,317 | — | ||||||
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Proceeds from the exercise of stock options
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56 | 64 | ||||||
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Net cash provided by financing activities
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1,353 | 38 | ||||||
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Net increase (decrease) in cash and cash equivalents
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297 | (24,182 | ) | |||||
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Cash and cash equivalents at beginning of period
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8,061 | 38,757 | ||||||
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Cash and cash equivalents at end of period
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$ | 8,358 | $ | 14,575 | ||||
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Supplemental disclosure of non-cash activities:
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||||||||
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Equipment purchases included in accounts payable
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$ | — | $ | 96 | ||||
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·
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Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
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·
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Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
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·
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Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
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Fair Value at March 31, 2011
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Fair Value at December 31, 2010
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|||||||||||||||||||||||
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Level 1
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Level 2
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Level 3
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Level 1
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Level 2
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Level 3
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|||||||||||||||||||
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Assets
|
||||||||||||||||||||||||
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Corporate debt securities
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$ | — | $ | 15,565 | $ | — | $ | — | $ | 23,615 | $ | — | ||||||||||||
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Total Short-term investments
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$ | — | $ | 15,565 | $ | — | $ | — | $ | 23,615 | $ | — | ||||||||||||
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Liabilities
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||||||||||||||||||||||||
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Warrant liability
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$ | — | $ | — | $ | 2,909 | $ | — | $ | — | $ | 2,842 | ||||||||||||
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Fair Value Measurements of
Warrants Using Significant
Unobservable Inputs
(Level 3)
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Balance at December 31, 2010
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$ | 2,842 | ||
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Change in fair value of Warrant liability
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67 | |||
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Balance at March 31, 2011
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$ | 2,909 | ||
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March 31, 2011
|
December 31, 2010
|
|||||||||||||||||||||||||||||||
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Amortized
Cost
|
Gross
Unrealized
Gains
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Gross
Unrealized
Losses
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Fair Value
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Amortized
Cost
|
Gross
Unrealized
Gains
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Gross
Unrealized
Losses
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Fair Value
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|||||||||||||||||||||||||
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Auction rate securities
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$ | 3,373 | $ | 900 | $ | — | $ | 4,273 | $ | 3,373 | $ | 773 | $ | — | $ | 4,146 | ||||||||||||||||
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Corporate debt securities
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11,293 | — | (1 | ) | 11,292 | 19,470 | — | (1 | ) — | 19,469 | ||||||||||||||||||||||
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Total
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$ | 14,666 | $ | 900 | $ | (1 | ) | $ | 15,565 | $ | 22,843 | $ | 773 | $ | (1 | ) | $ | 23,615 | ||||||||||||||
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Three Months Ended
March 31,
|
||||||||
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2011
|
2010
|
|||||||
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Research and development
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$ | 123 | $ | (69 | ) | |||
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General and administrative
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309 | 153 | ||||||
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Total stock-based compensation expenses
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$ | 432 | $ | 84 | ||||
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2005 Stock Incentive
Plan
|
1995 Stock Option
Plan
|
|||||||||||||||
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Stock
Options
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Weighted-
Average
Exercise
Price
|
Stock
Options
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Weighted-
Average
Exercise
Price
|
|||||||||||||
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Outstanding at January 1, 2011
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5,214,794 | $ | 2.34 | 579,850 | $ | 4.97 | ||||||||||
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Granted
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1,254,400 | $ | 2.50 | — | $ | — | ||||||||||
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Exercised
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(33,700 | ) | $ | 1.67 | — | $ | — | |||||||||
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Canceled
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(77,170 | ) | $ | 2.30 | (7,700 | ) | $ | 9.30 | ||||||||
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Outstanding at March 31, 2011
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6,358,324 | $ | 2.38 | 572,150 | $ | 4.92 | ||||||||||
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Shares exercisable at March 31, 2011
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3,234,148 | $ | 2.30 | 572,150 | $ | 4.92 | ||||||||||
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Shares available for grant at March 31, 2011
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1,483,125 | |||||||||||||||
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Three Months Ended
March 31,
|
||||||
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2011
|
2010
|
|||||
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Weighted average fair value of options granted
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$1.40 | $1.62 | ||||
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Risk-free interest rate
|
1.33%-1.86% | 1.46%-2.89% | ||||
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Dividend yield
|
0% | 0% | ||||
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Volatility
|
73.82%-80.48% | 99.53%-107.83% | ||||
|
Expected life (in years)
|
3.34-4.47 | 3.11-6.26 | ||||
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Expected forfeiture rate
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0%-23.15% | 21.07% | ||||
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Number of
Shares
|
Per Share
Weighted-
Average
Grant-Date
Fair Value
|
|||||||
|
Outstanding at January 1, 2011
|
56,666 | $ | 2.47 | |||||
|
Restricted stock granted
|
— | $ | — | |||||
|
Restricted stock vested
|
(50,000 | ) | $ | 2.11 | ||||
|
Restricted stock forfeited
|
— | $ | — | |||||
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Outstanding at March 31, 2011
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6,666 | $ | 5.21 | |||||
|
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·
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potential commercialization of our product candidates;
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·
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our expectation that we will have adequate capital resources available to operate at planned levels for at least the next twelve months;
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·
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the expected increase in our capital expenditures;
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·
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our expectations for future revenue under the contract with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) and funding requirements and capital raising activity, including anticipated proceeds from our At Market Issuance Sales Agreement with MLV;
|
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·
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our expectations on financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding operating expenses, use of cash, and the fluctuations in expenses and capital requirements associated with pre-clinical studies, clinical trials and other research and development activities;
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·
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our expectations on clinical development and anticipated milestones, including under the contract with HHS BARDA and our RSV clinical trial;
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·
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our expectations that our trivalent seasonal influenza VLP vaccine could potentially address an unmet medical need in older adults;
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·
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our expectations regarding payments to Wyeth and UMMS;
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·
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our expectations for the use of results from our Pandemic H1N1 clinical trial in Mexico to support the development of our influenza vaccines in other countries, including the United States;
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·
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the impact of new accounting pronouncements; and
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·
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our expectations concerning payments under existing license agreements.
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·
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our ability to progress any vaccine candidates into pre-clinical studies or clinical trials;
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·
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the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities;
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·
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clinical trial results;
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·
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even with positive data from pre-clinical studies or clinical trials, the vaccine candidate may not prove to be safe and efficacious;
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·
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decisions by regulatory agencies may delay or prevent our development programs or increase the costs of such programs;
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·
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regulatory approval is needed before any vaccines can be sold in or outside the United States and, to date, no governmental authority has approved any of our vaccine candidates for sale;
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·
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influenza is seasonal in nature, and if approval or commercial launch after approval is not timely in relation to the influenza season, we may not be able to manufacture or sell our influenza vaccines on terms favorable to us until the next influenza season, if at all;
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·
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RSV is a difficult disease to prevent and there is significant activity by many companies toward the development of a suitable vaccine;
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·
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we have not manufactured any of our vaccine candidates at a commercial level;
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·
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we utilize a unique manufacturing process and the scale-up of that process may prove difficult and/or costly;
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·
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our dependence on third parties to manufacture and distribute our vaccines;
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·
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risks associated with conducting business outside of the United States;
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·
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the cost and our ability of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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·
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competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility;
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·
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our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration;
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·
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our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financings or otherwise;
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·
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our ability to meet the significant requirements of a federal government contractor, which includes having appropriate accounting, project tracking and earned-value management systems implemented and operational, under our contract with HHS BARDA; and
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·
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other factors referenced herein.
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Program
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Development Phase
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Pandemic Influenza (H1N1)
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Phase II (
ended
)
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Pandemic Influenza (H5N1)
|
Phase II
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Seasonal Influenza
|
Phase II
|
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Respiratory Syncytial Virus (RSV)
|
|
Phase I
|
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Three Months Ended
March 31,
|
||||||||||||
|
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
|
Revenue:
|
||||||||||||
|
Total revenue
|
$ | 834 | $ | 110 | $ | 724 | ||||||
|
Three Months Ended
March 31,
|
||||||||||||
|
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
$ | 5,414 | $ | 9,029 | $ | (3,615 | ) | |||||
|
General and administrative
|
2,850 | 2,535 | 315 | |||||||||
|
Total operating expenses
|
$ | 8,264 | $ | 11,564 | $ | (3,300 | ) | |||||
|
Manufacturing
|
$ | 3.1 | ||
|
Vaccine Discovery
|
0.9 | |||
|
Clinical & Regulatory Affairs
|
1.4 | |||
|
Total research & development expenses
|
$ | 5.4 |
|
|
·
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the number of patients who participate in the trials;
|
|
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·
|
the number of sites included in the trials;
|
|
|
·
|
if trial locations are domestic, international or both;
|
|
|
·
|
the time to enroll patients;
|
|
|
·
|
the duration of treatment and follow-up;
|
|
|
·
|
the safety and efficacy profile of the vaccine candidate; and
|
|
|
·
|
the cost and timing of, and the ability to secure, regulatory approvals.
|
|
Three Months Ended
March 31,
|
||||||||||||
|
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
|
Other Income (Expense):
|
||||||||||||
|
Interest income
|
$ | 46 | $ | 44 | $ | 2 | ||||||
|
Interest expense
|
(2 | ) | (2 | ) | — | |||||||
|
Change in fair value of warrant liability
|
(67 | ) | 1,069 | (1,136 | ) | |||||||
|
Total other income (expense)
|
$ | (23 | ) | $ | 1,111 | $ | (1,134 | ) | ||||
|
Three Months Ended
March 31,
|
||||||||||||
|
2011
|
2010
|
Change
2010 to
2011
|
||||||||||
|
Net Loss:
|
||||||||||||
|
Net loss
|
$ | (7,453 | ) | $ | (10,343 | ) | $ | 2,890 | ||||
|
Net loss per share
|
$ | (0.07 | ) | $ | (0.10 | ) | $ | 0.03 | ||||
|
Weighted shares outstanding
|
111,188 | 100,188 | 11,000 | |||||||||
|
Three Months Ended
March 31,
|
||||||||||||
|
2011
|
2010
|
Change 2010
to 2011
|
||||||||||
|
Summary of Cash Flows:
|
||||||||||||
|
Net cash (used in) provided by:
|
||||||||||||
|
Operating activities
|
$ | (9,041 | ) | $ | (9,380 | ) | $ | 339 | ||||
|
Investing activities
|
7,985 | (14,840 | ) | 22,825 | ||||||||
|
Financing activities.
|
1,353 | 38 | 1,315 | |||||||||
|
Net increase (decrease) in cash and cash equivalents.
|
297 | (24,182 | ) | 24,479 | ||||||||
|
Cash and cash equivalents at beginning of period
|
8,061 | 38,757 | (30,696 | ) | ||||||||
|
Cash and cash equivalents at end of period
|
$ | 8,358 | $ | 14,575 | $ | (6,217 | ) | |||||
|
10.1* **
|
Contract, effective as of February 24, 2011, between the Company and HHS/OS/ASPR/BARDA
|
|
|
10.2* **
|
License Agreement, entered in February 25, 2011, effective as of December 9, 2010, between the Company and LG Life Sciences, Ltd.
|
|
|
10.3*
|
Guidelines on Significant Corporate Governance Issues effective as of January 1, 2011
|
|
|
31.1*
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
|
|
31.2*
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
|
|
|
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
|
|
|
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
|
|
NOVAVAX, INC.
|
||
|
Date: May 10, 2011
|
By:
|
/s/ Stanley C. Erck
|
|
President and Chief Executive Officer
|
||
|
and Director
|
||
|
(Principal Executive Officer)
|
||
|
Date: May 10, 2011
|
By:
|
/s/ Frederick W. Driscoll
|
|
Vice President, Chief Financial Officer
|
||
|
and Treasurer
|
||
|
(Principal Financial and Accounting Officer)
|
||
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|