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ý
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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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20-8099512
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(State of incorporation)
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(I.R.S. Employer Identification No.)
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Large accelerated filer
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¨
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Accelerated filer
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ý
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Non-accelerated filer
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¨
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(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Part
No.
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Item
No.
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Description
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Page
No.
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I
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1
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Condensed Consolidated Balance Sheets as of September 30, 2015 (unaudited) and December 31, 2014
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Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2015 and 2014
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Condensed Consolidated Statement of Stockholders' Equity (unaudited) for the nine months ended September 30, 2015
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Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2015 and 2014
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2
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3
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4
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II
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1
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Legal Proceedings
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1A
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Risk Factors
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6
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EX-10.6
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EX-10.7
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EX-31.1
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EX-31.2
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EX-32.1
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September 30, 2015
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December 31, 2014
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||||
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(Unaudited)
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|||||
ASSETS
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||||
Current assets:
|
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||||
Cash and cash equivalents
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$
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34,812
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$
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23,650
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Restricted cash
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401
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200
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||
Prepaid expenses and other current assets
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1,174
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1,237
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||
Current assets held for sale, net
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17,801
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27,013
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Total current assets
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54,188
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|
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52,100
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Equipment and furnishings, net
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288
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|
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285
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In-process research and development
|
12,864
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12,864
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GALE-401 rights
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9,255
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9,255
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Goodwill
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5,898
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5,897
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Deposits and other assets
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176
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87
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Total assets
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$
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82,669
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$
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80,488
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||
Current liabilities:
|
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||||
Accounts payable
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$
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1,238
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$
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1,886
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Accrued expenses and other current liabilities
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7,329
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8,885
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Fair value of warrants potentially settleable in cash
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16,661
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5,383
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Current portion of long-term debt
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4,166
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3,910
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Current liabilities held for sale
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7,697
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7,169
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Total current liabilities
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37,091
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27,233
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Deferred tax liability
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5,053
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5,053
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Contingent purchase price consideration
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6,582
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6,651
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Long-term debt, net of current portion
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1,526
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4,492
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Total liabilities
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50,252
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43,429
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Commitments and contingencies
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Stockholders’ equity:
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||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding
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—
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—
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Common stock, $0.0001 par value; 275,000,000 shares authorized, 162,575,446 shares issued and 161,900,446 shares outstanding at September 30, 2015; 200,000,000 shares authorized, 130,146,341 shares issued and 129,471,341 shares outstanding at December 31, 2014
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15
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12
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Additional paid-in capital
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295,956
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256,377
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Accumulated deficit
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(259,705
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)
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(215,481
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)
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Less treasury shares at cost, 675,000 shares
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(3,849
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)
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(3,849
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)
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Total stockholders’ equity
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32,417
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37,059
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Total liabilities and stockholders’ equity
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$
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82,669
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$
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80,488
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Three Months Ended September 30,
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Nine Months Ended September 30,
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||||||||||||
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2015
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2014
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2015
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2014
|
||||||||
Operating expenses:
|
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|
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||||||||
Research and development
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$
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5,740
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$
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7,025
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$
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18,762
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|
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$
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21,463
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General and administrative
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2,895
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3,542
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7,869
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|
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12,744
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|
||||
Total operating expenses
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8,635
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10,567
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26,631
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34,207
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||||
Operating loss
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(8,635
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)
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(10,567
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)
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(26,631
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)
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(34,207
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)
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||||
Non-operating income (expense):
|
|
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|
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||||||||
Change in fair value of warrants potentially settleable in cash
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2,134
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|
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6,735
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|
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(981
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)
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13,174
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|
||||
Interest income (expense), net
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(158
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)
|
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(297
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)
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(607
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)
|
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(925
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)
|
||||
Other income (expense)
|
307
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|
|
597
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69
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(59
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)
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||||
Total non-operating income (expense), net
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2,283
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7,035
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(1,519
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)
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12,190
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||||
Loss from continuing operations
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(6,352
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)
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(3,532
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)
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(28,150
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)
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(22,017
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)
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||||
Discontinued operations
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Loss from discontinued operations, including $8,071 impairment charge from classification as held for sale for three and nine months ended September 30, 2015
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(11,674
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)
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(2,641
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)
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(16,074
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)
|
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(6,633
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)
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||||
Net loss
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$
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(18,026
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)
|
|
$
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(6,173
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)
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$
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(44,224
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)
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$
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(28,650
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)
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|
|
|
|
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|
||||||||
Net loss per common share:
|
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share, continuing operations
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$
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(0.04
|
)
|
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$
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(0.03
|
)
|
|
$
|
(0.18
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)
|
|
$
|
(0.19
|
)
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Basic and diluted net loss per share, discontinued operations
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$
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(0.07
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.06
|
)
|
Basic net loss per share
|
$
|
(0.11
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)
|
|
$
|
(0.05
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)
|
|
$
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(0.29
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)
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$
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(0.25
|
)
|
Weighted-average common shares outstanding: basic and diluted
|
161,857,522
|
|
|
119,038,656
|
|
|
153,000,857
|
|
|
117,767,791
|
|
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Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Treasury Stock
|
|
Total
|
|||||||||||||
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Shares Issued
|
|
Amount
|
|
|
|
|
|
|
|
|
|||||||||||
Balance at December 31, 2014
|
130,146,341
|
|
|
$
|
12
|
|
|
$
|
256,377
|
|
|
$
|
(215,481
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
37,059
|
|
Issuance of common stock
|
32,158,685
|
|
|
3
|
|
|
47,413
|
|
|
—
|
|
|
—
|
|
|
47,416
|
|
|||||
Common stock warrants issued in connection with March 2015 common stock offering
|
—
|
|
|
—
|
|
|
(10,296
|
)
|
|
—
|
|
|
—
|
|
|
(10,296
|
)
|
|||||
Issuance of common stock in connection with employee stock purchase plan
|
231,312
|
|
|
—
|
|
|
309
|
|
|
—
|
|
|
—
|
|
|
309
|
|
|||||
Stock-based compensation for directors and employees
|
—
|
|
|
—
|
|
|
2,122
|
|
|
—
|
|
|
—
|
|
|
2,122
|
|
|||||
Exercise of stock options
|
39,108
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
—
|
|
|
31
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(44,224
|
)
|
|
—
|
|
|
(44,224
|
)
|
|||||
Balance at September 30, 2015
|
162,575,446
|
|
|
$
|
15
|
|
|
$
|
295,956
|
|
|
$
|
(259,705
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
32,417
|
|
|
For the Nine Months Ended September 30,
|
||||||
|
2015
|
|
2014
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Cash flows from continuing operating activities:
|
|
|
|
||||
Net loss from continuing operations
|
$
|
(28,150
|
)
|
|
$
|
(22,017
|
)
|
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization expense
|
304
|
|
|
340
|
|
||
Non-cash stock-based compensation
|
1,334
|
|
|
3,878
|
|
||
Change in fair value of common stock warrants
|
982
|
|
|
(13,174
|
)
|
||
Change in fair value of contingent consideration
|
(69
|
)
|
|
59
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(26
|
)
|
|
(348
|
)
|
||
Accounts payable
|
(648
|
)
|
|
54
|
|
||
Accrued expenses and other current liabilities
|
(1,556
|
)
|
|
2,465
|
|
||
Net cash used in continuing operating activities
|
(27,829
|
)
|
|
(28,743
|
)
|
||
Cash flows from discontinued operating activities:
|
|
|
|
||||
Net loss from discontinued operations
|
(16,074
|
)
|
|
(6,633
|
)
|
||
Impairment charge from classification of assets held for sale
|
8,071
|
|
|
—
|
|
||
Changes in operating assets and liabilities attributable to discontinued operations
|
2,956
|
|
|
3,241
|
|
||
Net cash used in discontinued operating activities
|
(5,047
|
)
|
|
(3,392
|
)
|
||
Net cash used in operating activities
|
(32,876
|
)
|
|
(32,135
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Change in restricted cash
|
(201
|
)
|
|
—
|
|
||
Cash paid for acquisition of GALE-401 rights
|
—
|
|
|
(2,315
|
)
|
||
Cash paid for purchase of equipment and furnishings
|
(81
|
)
|
|
(48
|
)
|
||
Net cash used in continuing investing activities
|
(282
|
)
|
|
(2,363
|
)
|
||
Net cash used in discontinued investing activities
|
(534
|
)
|
|
(3,056
|
)
|
||
Net cash used in investing activities
|
(816
|
)
|
|
(5,419
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Net proceeds from issuance of common stock
|
47,416
|
|
|
—
|
|
||
Net proceeds from exercise of stock options
|
31
|
|
|
4,342
|
|
||
Proceeds from exercise of warrants
|
—
|
|
|
10,717
|
|
||
Proceeds from common stock issued in connection with ESPP
|
309
|
|
|
263
|
|
||
Principle payments on long-term debt
|
(2,902
|
)
|
|
(908
|
)
|
||
Net cash provided by financing activities
|
44,854
|
|
|
14,414
|
|
||
Net increase (decrease) in cash and cash equivalents
|
11,162
|
|
|
(23,140
|
)
|
||
Cash and cash equivalents at the beginning of period
|
23,650
|
|
|
47,787
|
|
||
Cash and cash equivalents at end of period
|
$
|
34,812
|
|
|
$
|
24,647
|
|
|
|
|
|
||||
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash received during the periods for interest
|
$
|
12
|
|
|
$
|
13
|
|
Cash paid during the periods for interest
|
$
|
437
|
|
|
$
|
632
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
||||
Fair value of warrants issued in connection with common stock recorded as cost of equity
|
$
|
10,296
|
|
|
$
|
27,026
|
|
Reclassification of warrant liabilities upon exercise
|
$
|
—
|
|
|
$
|
27,020
|
|
•
|
Phase 3 Ongoing: Our Phase 3 PRESENT (
P
revention of
R
ecurrence in
E
arly-
S
tage, Node-Positive Breast Cancer with Low to Intermediate HER2
E
xpression with
NeuVax
T
reatment) study targeted enrollment of
700
HER2 1+/2+ patients under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The multinational, multicenter, randomized, double-blinded PRESENT trial is ongoing in North America, Western and Eastern Europe, and Israel. The trial is fully enrolled with
758
patients.
|
•
|
Phase 2b Ongoing: A randomized, multicenter, investigator-sponsored,
300
patient Phase 2b clinical trial is enrolling HER2 1+/2+ node-positive and high-risk node-negative breast cancer patients who are HLA A2+, A3+, A24+ or A26+ to study NeuVax in combination with trastuzumab in the adjuvant setting. This trial is co-funded by Genentech/Roche (providing both trastuzumab and monetary support) and Galena (providing NeuVax and monetary support).
|
•
|
Phase 2 Ongoing: An investigator-sponsored trial is ongoing to study NeuVax in combination with trastuzumab. The study will enroll
100
node positive and negative HER2 IHC 3+ patients or HER2 gene-amplified breast cancer patients who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence. Partial funding for this trial comes from the Department of Defense (DoD) through the Congressionally Directed Medical Research Program via legislation known as the Defense Appropriations Act. The grant was awarded under a Breast Cancer Research Program with the Breakthrough Award given to the lead investigator for the trial.
|
•
|
Phase 2 Planned: A clinical trial, entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide
VA
ccine in Women with
D
C
IS
of the Breast is planned to initiate by the end of 2015/early 2016. The Phase 2 trial will be a single-blind, double arm, randomized, controlled trial in pre- or post-menopausal patients with DCIS and are HLA-A2 positive. VADIS will be co-funded and run in collaboration with the National Cancer Institute (NCI).
|
•
|
Phase 2 Planned: A Phase 2 clinical trial in patients with gastric cancer is expected to initiate in 2016. The trial will be run in India by our partner, Dr. Reddy’s Laboratories, Ltd., as part of our NeuVax commercialization agreement in that region with Dr. Reddy’s.
|
Description
|
September 30, 2015
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
32,618
|
|
|
$
|
32,618
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Assets held for sale
|
17,801
|
|
|
—
|
|
|
—
|
|
|
17,801
|
|
||||
Total assets measured and recorded at fair value
|
$
|
50,419
|
|
|
$
|
32,618
|
|
|
$
|
—
|
|
|
$
|
17,801
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
16,661
|
|
|
$
|
—
|
|
|
$
|
16,661
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
6,582
|
|
|
—
|
|
|
—
|
|
|
6,582
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
23,243
|
|
|
$
|
—
|
|
|
$
|
16,661
|
|
|
$
|
6,582
|
|
Description
|
December 31, 2014
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
19,477
|
|
|
$
|
19,477
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured and recorded at fair value
|
$
|
19,477
|
|
|
$
|
19,477
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
5,383
|
|
|
$
|
—
|
|
|
$
|
5,383
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
6,651
|
|
|
—
|
|
|
—
|
|
|
6,651
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
12,034
|
|
|
$
|
—
|
|
|
$
|
5,383
|
|
|
$
|
6,651
|
|
|
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
|
||
Balance, January 1, 2015
|
$
|
6,651
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
(69
|
)
|
|
Balance at September 30, 2015
|
$
|
6,582
|
|
|
September 30, 2015
|
|
December 31, 2014
|
||||
Clinical trial costs
|
$
|
5,179
|
|
|
$
|
6,967
|
|
Compensation and related benefits
|
992
|
|
|
1,040
|
|
||
Professional fees
|
1,121
|
|
|
821
|
|
||
Interest expense
|
37
|
|
|
57
|
|
||
Accrued expenses and other current liabilities
|
$
|
7,329
|
|
|
$
|
8,885
|
|
|
As of September 30, 2015
|
|
Warrants outstanding
|
22,308
|
|
Stock options outstanding
|
11,188
|
|
Options reserved for future issuance under the Company’s 2007 Incentive Plan
|
10,251
|
|
Shares reserved for future issuance under the Employee Stock Purchase Plan
|
528
|
|
Total reserved for future issuance
|
44,275
|
|
|
March 2015 Warrants
|
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
|
Consultant
and Oxford Warrants
|
|
Total
|
||||||||
Outstanding, January 1, 2015
|
—
|
|
|
3,973
|
|
|
3,031
|
|
|
615
|
|
|
176
|
|
|
25
|
|
|
720
|
|
|
8,540
|
|
Issued
|
14,006
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,006
|
|
Expired
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(238
|
)
|
|
(238
|
)
|
Outstanding, September 30, 2015
|
14,006
|
|
|
3,973
|
|
|
3,031
|
|
|
615
|
|
|
176
|
|
|
25
|
|
|
482
|
|
|
22,308
|
|
Expiration
|
March 2020
|
|
September 2018
|
|
December 2017
|
|
April 2017
|
|
March 2016
|
|
March 2016
|
|
Varies 2014-2020
|
|
|
|
As of September 30, 2015
|
||||||||||||||||||||||
|
March 2015 Warrants
|
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
||||||||||||
Strike price
|
$
|
2.08
|
|
|
$
|
2.50
|
|
|
$
|
1.83
|
|
|
$
|
0.65
|
|
|
$
|
0.65
|
|
|
$
|
2.02
|
|
Expected term (years)
|
4.47
|
|
|
2.97
|
|
|
2.23
|
|
|
1.56
|
|
|
0.43
|
|
|
0.49
|
|
||||||
Volatility %
|
74.99
|
%
|
|
76.85
|
%
|
|
75.45
|
%
|
|
69.48
|
%
|
|
72.42
|
%
|
|
68.33
|
%
|
||||||
Risk-free rate %
|
1.25
|
%
|
|
0.91
|
%
|
|
0.70
|
%
|
|
0.50
|
%
|
|
0.06
|
%
|
|
0.08
|
%
|
|
As of December 31, 2014
|
||||||||||||||||||
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
||||||||||
Strike price
|
$
|
2.50
|
|
|
$
|
1.90
|
|
|
$
|
0.65
|
|
|
$
|
0.65
|
|
|
$
|
2.15
|
|
Expected term (years)
|
3.72
|
|
|
2.98
|
|
|
2.31
|
|
|
1.18
|
|
|
1.24
|
|
|||||
Volatility %
|
75.60
|
%
|
|
76.85
|
%
|
|
78.24
|
%
|
|
77.38
|
%
|
|
77.12
|
%
|
|||||
Risk-free rate %
|
1.30
|
%
|
|
1.09
|
%
|
|
0.80
|
%
|
|
0.32
|
%
|
|
0.35
|
%
|
|
March 2015 Warrants
|
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
|
Total
|
||||||||||||||
Warrant liability, January 1, 2015
|
$
|
—
|
|
|
$
|
2,560
|
|
|
$
|
2,027
|
|
|
$
|
625
|
|
|
$
|
163
|
|
|
$
|
8
|
|
|
$
|
5,383
|
|
Fair value of warrants issued
|
10,296
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,296
|
|
|||||||
Change in fair value of warrants
|
1,313
|
|
|
(157
|
)
|
|
(162
|
)
|
|
(10
|
)
|
|
2
|
|
|
(4
|
)
|
|
982
|
|
|||||||
Warrant liability, September 30, 2015
|
$
|
11,609
|
|
|
$
|
2,403
|
|
|
$
|
1,865
|
|
|
$
|
615
|
|
|
$
|
165
|
|
|
$
|
4
|
|
|
$
|
16,661
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Research and development
|
$
|
83
|
|
|
$
|
92
|
|
|
$
|
253
|
|
|
$
|
438
|
|
General and administrative
|
492
|
|
|
990
|
|
|
1,081
|
|
|
3,440
|
|
||||
Total stock-based compensation from continuing operations
|
$
|
575
|
|
|
$
|
1,082
|
|
|
$
|
1,334
|
|
|
$
|
3,878
|
|
Stock based compensation from discontinued operations
|
$
|
275
|
|
|
$
|
217
|
|
|
$
|
788
|
|
|
$
|
557
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
Risk free interest rate
|
—
|
%
|
|
2.02
|
%
|
|
1.50
|
%
|
|
2.02
|
%
|
Volatility
|
—
|
%
|
|
79.10
|
%
|
|
74.20
|
%
|
|
79.47
|
%
|
Expected lives (years)
|
0.00
|
|
|
6.12
|
|
|
6.09
|
|
|
6.15
|
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Total
Number of
Shares
(In Thousands)
|
|
Weighted
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
(In Thousands)
|
|||||
Outstanding at January 1, 2015
|
8,590
|
|
|
$
|
3.25
|
|
|
|
|
|
Granted
|
3,682
|
|
|
1.73
|
|
|
|
|
||
Exercised
|
(39
|
)
|
|
0.79
|
|
|
$
|
37
|
|
|
Cancelled
|
(1,045
|
)
|
|
2.44
|
|
|
$
|
21
|
|
|
Outstanding at September 30, 2015
|
11,188
|
|
|
$
|
2.83
|
|
|
$
|
690
|
|
Options exercisable at September 30, 2015
|
6,622
|
|
|
$
|
3.32
|
|
|
$
|
618
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Change in fair value of the contingent purchase price liability
|
$
|
307
|
|
|
$
|
597
|
|
|
$
|
69
|
|
|
$
|
(59
|
)
|
Total other income (expense)
|
$
|
307
|
|
|
$
|
597
|
|
|
$
|
69
|
|
|
$
|
(59
|
)
|
|
Three and Nine Months Ended September 30,
|
||||
|
2015
|
|
2014
|
||
Warrants to purchase common stock
|
22,308
|
|
|
8,540
|
|
Options to purchase common stock
|
11,188
|
|
|
8,994
|
|
Total
|
33,496
|
|
|
17,534
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Net revenue
|
$
|
2,166
|
|
|
$
|
1,620
|
|
|
$
|
8,298
|
|
|
$
|
6,124
|
|
Cost of revenue
|
(712
|
)
|
|
(247
|
)
|
|
(1,573
|
)
|
|
(925
|
)
|
||||
Amortization of certain acquired intangible assets
|
(208
|
)
|
|
(70
|
)
|
|
(795
|
)
|
|
(259
|
)
|
||||
Research and development
|
(160
|
)
|
|
(219
|
)
|
|
(339
|
)
|
|
(619
|
)
|
||||
Selling, general, and administrative
|
(4,672
|
)
|
|
(3,725
|
)
|
|
(13,577
|
)
|
|
(10,954
|
)
|
||||
Non-operating income (expense)
|
(17
|
)
|
|
—
|
|
|
(17
|
)
|
|
—
|
|
||||
Impairment charge from classification as assets held for sale
|
(8,071
|
)
|
|
—
|
|
|
(8,071
|
)
|
|
—
|
|
||||
Loss from discontinued operations
|
$
|
(11,674
|
)
|
|
$
|
(2,641
|
)
|
|
$
|
(16,074
|
)
|
|
$
|
(6,633
|
)
|
|
September 30, 2015
|
|
September 30, 2014
|
||||
Impairment of assets held for sale
|
$
|
8,071
|
|
|
$
|
—
|
|
Depreciation and amortization
|
$
|
858
|
|
|
$
|
319
|
|
Stock-based compensation
|
$
|
788
|
|
|
$
|
557
|
|
Purchases of property and equipment
|
$
|
(34
|
)
|
|
$
|
—
|
|
Cash paid for acquisition of Zuplenz rights
|
$
|
(500
|
)
|
|
$
|
(3,056
|
)
|
•
|
Develop novel cancer immunotherapies to address unmet medical needs through the use of peptide-based vaccines targeting well-established tumor antigens. One of our key strategies is to target the adjuvant, minimum residual disease setting, in high risk patients who are more likely to benefit from treatment via immunotherapy. Our immunotherapy programs are currently targeting two key areas: secondary prevention to seek to significantly decrease the risk of disease recurrence in breast cancer, gastric cancer, endometrial and ovarian cancers; and moving towards primary prevention in breast cancer.
|
•
|
Expand our development pipeline by enhancing the clinical and geographic footprint of our technologies. We can accomplish this through the initiation of new clinical trials as well as through acquisition of additional development stage products in oncology indications.
|
•
|
Leverage valuable partnerships and collaborations, as well as investigator-sponsored trial arrangements, to maximize the scope of potential clinical opportunities in a cost effective and efficient manner.
|
•
|
Maximize the value of our commercial assets through divestiture. During the quarter ended September 30, 2015, we completed a strategic review of our commercial business and operations, and as a result of that review have decided to sell or otherwise divest our commercial business. We believe this disposition will allow us to focus our resources on our valuable and expanding clinical development programs and maximize the value of these assets to our shareholders
.
|
•
|
Phase 3 Ongoing: Our Phase 3 PRESENT (
P
revention of
R
ecurrence in
E
arly-
S
tage, Node-Positive Breast Cancer with Low to Intermediate HER2
E
xpression with
NeuVax
T
reatment) study targeted enrollment of 700 HER2 1+/2+ patients under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The multinational, multicenter, randomized, double-blinded PRESENT trial is ongoing in North America, Western and Eastern Europe, and Israel. The trial is fully enrolled with 758 patients.
|
•
|
Phase 2b Ongoing: A randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial is enrolling HER2 1+/2+ node-positive and high-risk node-negative breast cancer patients who are HLA A2+, A3+, A24+ or A26+ to study NeuVax in combination with trastuzumab in the adjuvant setting. This trial is co-funded by Genentech/Roche (providing both trastuzumab and monetary support) and Galena (providing NeuVax and monetary support).
|
•
|
Phase 2 Ongoing: An investigator-sponsored trial is ongoing to study NeuVax in combination with trastuzumab. The study will enroll 100 node positive and negative HER2 IHC 3+ patients or HER2 gene-amplified breast cancer patients who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence. Partial funding for this trial comes from the Department of Defense (DoD) through the Congressionally Directed Medical Research Program via legislation known as the Defense Appropriations Act. The grant was awarded under a Breast Cancer Research Program with the Breakthrough Award given to the lead investigator for the trial.
|
•
|
Phase 2 Planned: A clinical trial, entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide
VA
ccine in Women with
D
C
IS
of the Breast is planned to initiate by the end of 2015/early 2016. The Phase 2 trial will be a single-blind, double arm, randomized, controlled trial in pre- or post-menopausal patients with DCIS and are HLA-A2 positive. VADIS will be co-funded and run in collaboration with the National Cancer Institute (NCI).
|
•
|
Phase 2 Planned: A Phase 2 clinical trial in patients with gastric cancer is expected to initiate in 2016. The trial will be run in India by our partner, Dr. Reddy’s Laboratories, Ltd., as part of our NeuVax commercialization agreement in that region with Dr. Reddy’s.
|
(dollars in thousands)
|
Three Months Ended September 30,
|
|||||||||
|
2015
|
|
2014
|
|
% Change
|
|||||
Operating loss
|
$
|
(8,635
|
)
|
|
$
|
(10,567
|
)
|
|
18
|
%
|
Non-operating income (expense)
|
2,283
|
|
|
7,035
|
|
|
(68
|
)%
|
||
Loss from discontinued operations
|
(11,674
|
)
|
|
(2,641
|
)
|
|
(342
|
)%
|
||
Net loss
|
$
|
(18,026
|
)
|
|
$
|
(6,173
|
)
|
|
(192
|
)%
|
|
|
|
|
|
|
|||||
Net loss per common share:
|
|
|
|
|
|
|||||
Basic and diluted net loss per share, continuing operations
|
$
|
(0.04
|
)
|
|
$
|
(0.03
|
)
|
|
(33
|
)%
|
Basic and diluted net loss per share, discontinued operations
|
$
|
(0.07
|
)
|
|
$
|
(0.02
|
)
|
|
(250
|
)%
|
Basic net loss per share
|
$
|
(0.11
|
)
|
|
$
|
(0.05
|
)
|
|
(120
|
)%
|
(dollars in thousands)
|
Nine Months Ended September 30,
|
|||||||||
|
2015
|
|
2014
|
|
% Change
|
|||||
Operating loss
|
$
|
(26,631
|
)
|
|
$
|
(34,207
|
)
|
|
22
|
%
|
Non-operating income (expense)
|
(1,519
|
)
|
|
12,190
|
|
|
(112
|
)%
|
||
Loss from discontinued operations
|
(16,074
|
)
|
|
(6,633
|
)
|
|
(142
|
)%
|
||
Net loss
|
$
|
(44,224
|
)
|
|
$
|
(28,650
|
)
|
|
(54
|
)%
|
|
|
|
|
|
|
|||||
Net loss per common share:
|
|
|
|
|
|
|||||
Basic and diluted net loss per share, continuing operations
|
$
|
(0.18
|
)
|
|
$
|
(0.19
|
)
|
|
5
|
%
|
Basic and diluted net loss per share, discontinued operations
|
$
|
(0.11
|
)
|
|
$
|
(0.06
|
)
|
|
(83
|
)%
|
Basic net loss per share
|
$
|
(0.29
|
)
|
|
$
|
(0.25
|
)
|
|
(16
|
)%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
% Change
|
|
2015
|
|
2014
|
|
% Change
|
||||||||||
Research and development expense
|
$
|
5,740
|
|
|
$
|
7,025
|
|
|
(18
|
)%
|
|
$
|
18,762
|
|
|
$
|
21,463
|
|
|
(13
|
)%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
% Change
|
|
2015
|
|
2014
|
|
% Change
|
||||||||||
General and administrative expense
|
$
|
2,895
|
|
|
$
|
3,542
|
|
|
(18
|
)%
|
|
$
|
7,869
|
|
|
$
|
12,744
|
|
|
(38
|
)%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
% Change
|
|
2015
|
|
2014
|
|
% Change
|
||||||||||
Change in fair value of warrants potentially settleable in cash
|
$
|
2,134
|
|
|
$
|
6,735
|
|
|
(68
|
)%
|
|
$
|
(981
|
)
|
|
$
|
13,174
|
|
|
(107
|
)%
|
Interest income (expense), net
|
(158
|
)
|
|
(297
|
)
|
|
(47
|
)%
|
|
(607
|
)
|
|
(925
|
)
|
|
(34
|
)%
|
||||
Other income (expense)
|
307
|
|
|
597
|
|
|
(49
|
)%
|
|
69
|
|
|
(59
|
)
|
|
(217
|
)%
|
||||
Total non-operating income (expense), net
|
$
|
2,283
|
|
|
$
|
7,035
|
|
|
(68
|
)%
|
|
$
|
(1,519
|
)
|
|
$
|
12,190
|
|
|
(112
|
)%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Net revenue
|
$
|
2,166
|
|
|
$
|
1,620
|
|
|
$
|
8,298
|
|
|
$
|
6,124
|
|
Cost of revenue
|
(712
|
)
|
|
(247
|
)
|
|
(1,573
|
)
|
|
(925
|
)
|
||||
Amortization of certain acquired intangible assets
|
(208
|
)
|
|
(70
|
)
|
|
(795
|
)
|
|
(259
|
)
|
||||
Research and development
|
(160
|
)
|
|
(219
|
)
|
|
(339
|
)
|
|
(619
|
)
|
||||
Selling, general, and administrative
|
(4,672
|
)
|
|
(3,725
|
)
|
|
(13,577
|
)
|
|
(10,954
|
)
|
||||
Non-operating income (loss)
|
(17
|
)
|
|
—
|
|
|
(17
|
)
|
|
—
|
|
||||
Impairment charge from classification of assets held for sale
|
(8,071
|
)
|
|
—
|
|
|
(8,071
|
)
|
|
—
|
|
||||
Loss from discontinued operations
|
$
|
(11,674
|
)
|
|
$
|
(2,641
|
)
|
|
$
|
(16,074
|
)
|
|
$
|
(6,633
|
)
|
|
For the Nine Months Ended September 30,
|
||||||
|
2015
|
|
2014
|
||||
Cash flows from continuing operations:
|
|
|
|
||||
Cash flows used in continuing operating activities
|
$
|
(27,829
|
)
|
|
$
|
(28,743
|
)
|
Cash flows used in continuing investing activities
|
(282
|
)
|
|
(2,363
|
)
|
||
Cash flows provided by continuing financing activities
|
44,854
|
|
|
14,414
|
|
||
Total cash flows provided by (used in) continuing operating activities
|
16,743
|
|
|
(16,692
|
)
|
||
|
|
|
|
||||
Cash flows from discontinued operations:
|
|
|
|
||||
Cash flows used in discontinued operating activities
|
(5,047
|
)
|
|
(3,392
|
)
|
||
Cash flows used in discontinued investing activities
|
(534
|
)
|
|
(3,056
|
)
|
||
Total cash flows provided by (used in) discontinued operating activities
|
(5,581
|
)
|
|
(6,448
|
)
|
||
|
|
|
|
||||
Total cash flows:
|
|
|
|
||||
Cash flows used in operating activities
|
(32,876
|
)
|
|
(32,135
|
)
|
||
Cash flows used in investing activities
|
(816
|
)
|
|
(5,419
|
)
|
||
Cash flows provided by financing activities
|
44,854
|
|
|
14,414
|
|
||
Total increase (decrease) in cash and cash equivalents
|
$
|
11,162
|
|
|
$
|
(23,140
|
)
|
(a)
|
our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and
|
(b)
|
our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure.
|
•
|
diversion of resources and management’s attention from the operation of our business;
|
•
|
loss of key employees in anticipation of or following such a sale;
|
•
|
insufficient sale proceeds to offset transaction-related expenses;
|
•
|
negative effects on our reported results of operations from discontinued operations, disposition-related charges, amortization of expenses related to intangibles and charges for impairment of long-term assets; and
|
•
|
damage to our existing investor, customer and supplier relationships.
|
•
|
differing regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;
|
•
|
unexpected changes in tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance
|
•
|
foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating in another country;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the U.S.;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism.
|
Exhibit
Number
|
|
Description
|
|
|
|
|
|
|
|
|
|
10.6
|
|
Settlement and License agreement dated October 23, 2015 between Galena Biopharma, Inc., Actavis Laboratories FL, Inc., and Orexo AB. (3) **
|
|
|
|
|
|
10.7
|
|
Employment Offer Letter effective October 30, 2015, between Galena Biopharma, Inc. and Bijan Nejadnik, M.D. * **
|
|
|
|
|
|
|
|
|
|
31.1
|
|
Sarbanes-Oxley Act Section 302 Certification of Mark W. Schwartz, Ph.D.**
|
|
|
|
|
|
31.2
|
|
Sarbanes-Oxley Act Section 302 Certification of Ryan M. Dunlap.**
|
|
|
|
|
|
32.1
|
|
Sarbanes-Oxley Act Section 906 Certification of Mark W. Schwartz, Ph.D., and Ryan M. Dunlap.**
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document.**
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema.**
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation.**
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition.**
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label.**
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation.**
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation.**
|
|
*
|
Indicates a management contract or compensatory plan or arrangement.
|
|
|
**
|
Filed herewith.
|
|
|
(1)
|
Previously filed as an Exhibit to the Registrant's Form 8-K filed on March 16, 2015 and incorporated herein by reference.
|
|
|
(2)
|
Previously filed as Annex B to the Registrant's Proxy Statement on Schedule 14A filed on April 30, 2015 and incorporated by reference herein by reference.
|
|
|
(3)
|
Portions of the Exhibit filed herewith have been omitted pursuant to a request for confidential treatment.
|
|
GALENA BIOPHARMA, INC.
|
||
|
|
|
|
|
By:
|
|
/s/
Mark W. Schwartz
|
|
|
|
|
|
|
|
Mark W. Schwartz, Ph.D.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
|
Date: November 9, 2015
|
|
|
|
|
|
By:
|
|
/s/
Ryan M. Dunlap
|
|
|
|
|
|
|
|
Ryan M. Dunlap
|
|
|
|
Vice President and Chief Financial Officer
|
|
|
|
|
|
|
|
Date: November 9, 2015
|
a.
|
It may have sustained Losses that are presently unknown and unsuspected, and that such Losses might give rise to Losses in the future. Nevertheless, each Party acknowledges and agrees that this Agreement has been negotiated and agreed upon, notwithstanding the existence of such possible Losses and that such unknown Losses are released under Section 2.
|
b.
|
This Agreement may be pleaded as a full and complete defense to, and used as a basis for injunction against, any proceeding that may be instituted, prosecuted or attempted in breach hereof.
|
c.
|
In connection with this Agreement, the Parties and all of their Affiliates and each of their respective predecessors, successors, assigns, agents, officers, directors, shareholders, employees and representatives expressly waive and relinquish all rights and benefits afforded by Section 1542 of the California Civil Code, which provides as follows:
|
a.
|
Acceleration of License Grant. The License Effective Date will be accelerated to the earlier of the following dates: (i) the date on which a Third
|
b.
|
[…***…]
. (1) Beginning on the earlier of
[…***…]
or one hundred and eighty (180) days prior to an Authorized Third Party Launch and
[…***…]
, Orexo grants Actavis and its Affiliates
[…***…]
to the Licensed Patents, (i) to make, have made, use, import, offer for sale and sell Actavis Product in or for the Territory, and (ii) to make and have made the Actavis Product outside the Territory only for use, sale and importation in or for the Territory and Actavis
[…***…]
prior to the
[…***…]
, based upon
[…***…]
. Galena will provide
[…***…]
. In the event there is an Authorized Third Party Launch before
[…***…]
, Galena shall provide
[…***…]
or as soon as reasonably practical after such Authorized Third Party Launch date is known, and continuing until
[…***…]
has been provided or until Actavis is permitted to launch under this Section 5(b), whichever occurs first. (2) Beginning on the
[…***…]
.
|
c.
|
Pre-Marketing Activities. Notwithstanding the License Effective Date and the restrictions contained herein, Actavis and its Affiliates shall be permitted to: (a)
[…***…]
(or 180 days prior to an Authorized Third Party Launch)
[…***…]
(or 180 days prior to an Authorized Third Party Launch), and (b)
[…***…]
(including disclosure of the License Effective Date)
[…***…]
(or 180 days prior to and Authorized Third Party Launch)
[…***…]
(or 180 days prior to and Authorized Third Party Launch).
|
a.
|
Each Party hereto represents and warrants to the other Party that, as of the date hereof:
|
i.
|
this Agreement is a legal, valid and binding obligation of the warranting Party, enforceable against such Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity;
|
ii.
|
the warranting Party is not subject to any judgment, order, injunction, decree or award of any court, administrative agency or governmental body that would or might interfere with its performance of any of its material obligations hereunder; and
|
iii.
|
the warranting Party has full power and authority to enter into and perform its obligations under this Agreement in accordance with its terms.
|
b.
|
Orexo represents and warrants that it owns all right and title to the Licensed Patents and Orexo has the right to grant the licenses hereunder and to settle the Litigation.
|
c.
|
Orexo and Galena represent and warrant that as of the Effective Date, Orexo and its Affiliates and Galena and its Affiliates shall not, and shall not cause or encourage any Affiliate or Third Party to initiate or otherwise undertake any activity, directly or indirectly, against the Actavis ANDA or Actavis Product to: (i) interfere with Actavis’s efforts to obtain and maintain FDA approval of the Actavis ANDA or the Actavis Product, including, but not limited to, the filing of suit against FDA, and/or the filing or submission of any Citizen Petitions, correspondence or other written submissions with FDA or any regulatory or governmental authority, or (ii) interfere with Actavis’s efforts to market the Actavis Product in accordance with the terms of this Agreement, unless Orexo or its Affiliates and Galena and its Affiliates undertakes such activity defined in subparts (i) or (ii) pursuant to court order or as otherwise requested by FDA or required by law.
|
d.
|
Orexo and its Affiliates and Galena and its Affiliates represent and warrant that they shall not Officially Discontinue Abstral
®
prior to the expiration of the Licensed Patents, unless required, requested or recommended in writing by the FDA or other governmental authority or applicable law. For avoidance of doubt, nothing in this Paragraph prohibits Orexo or its Affiliates and Galena and its Affiliates from taking any action, or causing others to take any action, Orexo or Galena reasonably determines is necessary to provide for the safety and efficacy of any Orexo or Galena product. “Officially Discontinue” shall mean any of: (i) delisting Abstral
®
with the FDA; (ii) delisting the Licensed Patents from the Orange Book unless Orexo reasonably determines in good faith that such delisting is required under applicable law; (iii) seeking action with the FDA to withdraw Abstral
®
from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (iv) deleting, removing or canceling any National Drug Code(s) for Abstral
®
from the applicable National Drug File.
|
e.
|
Actavis represents and warrants that it has produced to Orexo’s counsel in this Patent Litigation all correspondence with FDA regarding Actavis’s ANDA, and that the produced correspondence contains an accurate representation of the Actavis Product as it exists as of the Effective Date.
|
f.
|
Actavis represents and warrants that, as of the Effective Date, (i) Actavis or its Affiliates own all right, title and interest in, to and under the Actavis ANDA, and Actavis and its Affiliates have not granted or assigned to any Third Party, directly or indirectly, any rights under or to the Actavis ANDA or the Actavis Product, (ii) Actavis and its Affiliates will not transfer ownership, in whole or in part, of said Actavis ANDA, except to an Affiliate of Actavis or in accordance with Section 14, until the expiration of the license granted herein, and (iii) Actavis has the right to settle the Litigation.
|
ACTAVIS LABORATORIES FL, INC.
|
OREXO AB
|
||
By:
|
_____/S/_____________________
|
By:
|
_____/S/________________________
|
Name:
|
A. Robert D. Bailey__________
|
Name:
|
Nikolaj Sorenson_______________
|
Title:
|
EVP & Chief Legal Officer_____
|
Title:
|
CEO & President_______________
|
|
|
|
|
|
|
|
|
|
|
|
GALENA BIOPHARMA INC.
|
|
|
By:
|
_____/S/___________________
|
|
|
Name:
|
Mark W. Schwartz____________
|
|
|
Title:
|
President & CEO_____________
|
OREXO AB,
Plaintiff
,
v.
ACTAVIS LABORATORIES FL, INC.
Defendant
.
|
Civil Action No. 3:15-cv-00826 (PGS/DEA)
|
|
EMPLOYER
|
|
|
|
Galena Biopharma, Inc.
|
|
|
|
|
|
By:
/s/ Mark W. Schwartz
|
|
Mark W. Schwartz, Ph.D.
|
|
President and Chief Executive Officer
|
|
|
|
|
|
EMPLOYEE
|
|
|
|
|
|
/s/ Bijan Nejadnik
|
|
Bijan Nejadnik, M.D.
|
|
|
|
/s/ Mark W. Schwartz
|
|
Mark W. Schwartz
|
|
President and Chief Executive Officer
|
|
/s/ Ryan M. Dunlap
|
|
Ryan M. Dunlap
|
|
Vice President, Chief Financial Officer
|
/s/ Mark W. Schwartz
|
|
/s/ Ryan M. Dunlap
|
Mark W. Schwartz
|
|
Ryan M. Dunlap
|
President and Chief Executive Officer
|
|
Vice President, Chief Financial Officer
|
|
|
|
November 9, 2015
|
|
November 9, 2015
|