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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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Emerging growth 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 March 31, 2017 (unaudited) and December 31, 2016
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Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2017 and 2016
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Condensed Consolidated Statement of Stockholders' Equity (unaudited) for the three months ended March 31, 2017
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Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2017 and 2016
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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-10.1
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EX-10.3
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EX-10.4
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EX-10.5
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EX-10.6
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EX-31.1
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EX-32.1
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March 31, 2017
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December 31, 2016
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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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27,640
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$
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18,083
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Restricted cash
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13,590
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18,022
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||
Prepaid expenses and other current assets
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449
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581
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Current assets of discontinued operations
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367
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813
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Total current assets
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42,046
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37,499
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Equipment and furnishings, net
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173
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199
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In-process research and development
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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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5,898
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Deposits and other assets
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96
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96
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Total assets
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$
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70,332
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$
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65,811
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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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1,163
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$
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840
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Accrued expenses and other current liabilities
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3,189
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4,292
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Litigation settlement payable
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950
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950
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Fair value of warrants potentially settleable in cash
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8,325
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1,860
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Current portion of long-term debt
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12,597
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16,397
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Current liabilities of discontinued operations
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10,045
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6,059
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Total current liabilities
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36,269
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30,398
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Deferred tax liability
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5,661
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5,661
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Contingent purchase price consideration
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1,208
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1,095
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Total liabilities
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43,138
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37,154
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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, $0.0001 par value; 350,000,000 shares authorized, 37,182,066 shares issued and 37,148,316 shares outstanding at March 31, 2017; 15,224,223 shares issued and 15,190,473 shares outstanding at December 31, 2016
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4
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2
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Additional paid-in capital
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345,689
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335,436
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Accumulated deficit
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(314,650
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)
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(302,932
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)
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Less treasury shares at cost, 33,750 shares
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(3,849
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)
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(3,849
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)
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Total stockholders’ equity
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27,194
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28,657
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Total liabilities and stockholders’ equity
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$
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70,332
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$
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65,811
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Three Months Ended March 31,
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||||||
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2017
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2016
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||||
Operating expenses:
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Research and development
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$
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2,362
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$
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5,443
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General and administrative
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2,726
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3,525
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Total operating expenses
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5,088
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8,968
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Operating loss
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(5,088
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)
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(8,968
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)
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Non-operating income (expense):
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Change in fair value of warrants potentially settleable in cash
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3,892
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(3,873
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)
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Interest expense, net
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(973
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)
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(91
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)
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Change in fair value of the contingent purchase price liability
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(113
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)
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(170
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)
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Total non-operating income (expense), net
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2,806
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(4,134
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)
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Loss from continuing operations
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(2,282
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)
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(13,102
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)
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Loss from discontinued operations
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(9,436
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)
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(3,391
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)
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Net loss
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$
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(11,718
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)
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$
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(16,493
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)
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Net loss per common share:
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Basic and diluted net loss per share, continuing operations
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$
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(0.09
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)
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$
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(1.46
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)
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Basic and diluted net loss per share, discontinued operations
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$
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(0.36
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)
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$
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(0.38
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)
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Basic and diluted net loss per share
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$
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(0.45
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)
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$
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(1.84
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)
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Weighted-average common shares outstanding: basic and diluted
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26,406,356
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8,968,616
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Common Stock
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Additional Paid-In Capital
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Accumulated Deficit
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Treasury Stock
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Total
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|||||||||||||
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Shares Issued
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Amount
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|||||||||||
Balance at December 31, 2016
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15,224,223
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$
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2
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$
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335,436
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$
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(302,932
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)
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$
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(3,849
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)
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$
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28,657
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Issuance of common stock, net of $356 in issuance costs
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17,000,000
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2
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15,522
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—
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—
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15,524
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|||||
Fair value of common stock warrants granted in connection with 2016 common stock offerings
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—
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—
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(10,357
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)
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—
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—
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(10,357
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)
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|||||
Issuance of common stock as repayment of principal and interest on long-term debt
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4,933,068
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—
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4,814
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—
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—
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4,814
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|
|||||
Issuance of common stock in connection with employee stock purchase plan
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4,048
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—
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5
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|
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—
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—
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|
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5
|
|
|||||
Stock-based compensation for directors and employees
|
—
|
|
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—
|
|
|
228
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|
|
—
|
|
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—
|
|
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228
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|
|||||
Fair value of common stock in exchange for services
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20,727
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|
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—
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|
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41
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|
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—
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|
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—
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|
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41
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|
|||||
Exercise of stock options
|
—
|
|
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—
|
|
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—
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|
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—
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|
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—
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|
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—
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|
|||||
Net loss
|
—
|
|
|
—
|
|
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—
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|
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(11,718
|
)
|
|
—
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|
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(11,718
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)
|
|||||
Balance at March 31, 2017
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37,182,066
|
|
|
$
|
4
|
|
|
$
|
345,689
|
|
|
$
|
(314,650
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
27,194
|
|
|
For the Three Months Ended March 31,
|
|||||||
|
2017
|
|
2016
|
|||||
Cash flows from operating activities:
|
|
|
|
|||||
Cash flows from continuing operating activities:
|
|
|
|
|||||
Net loss from continuing operations
|
$
|
(2,282
|
)
|
|
$
|
(13,102
|
)
|
|
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
|||||
Depreciation and amortization expense
|
26
|
|
|
6
|
|
|||
Non-cash accretion of debt issuance costs
|
650
|
|
|
67
|
|
|||
Repayment of interest associated with the Debenture with common stock
|
364
|
|
|
—
|
|
|||
Non-cash stock-based compensation
|
228
|
|
|
656
|
|
|||
Fair value of common stock issued in exchange for services
|
41
|
|
|
—
|
|
|||
Change in fair value of common stock warrants
|
(3,892
|
)
|
|
3,872
|
|
|||
Change in fair value of contingent consideration
|
113
|
|
|
170
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|||||
Prepaid expenses and other assets
|
132
|
|
|
418
|
|
|||
Litigation settlement insurance recovery
|
—
|
|
|
20,000
|
|
|||
Litigation settlement payable
|
—
|
|
|
(20,000
|
)
|
|||
Accounts payable
|
323
|
|
|
(578
|
)
|
|||
Accrued expenses and other current liabilities
|
(1,103
|
)
|
|
(1,250
|
)
|
|||
Net cash used in continuing operating activities
|
(5,400
|
)
|
|
(9,741
|
)
|
|||
Cash flows from discontinued operating activities:
|
|
|
|
|||||
Net loss from discontinued operations
|
(9,436
|
)
|
|
(3,391
|
)
|
|||
Changes in operating assets and liabilities attributable to discontinued operations
|
4,432
|
|
|
(84
|
)
|
|||
Net cash used in discontinued operating activities
|
(5,004
|
)
|
|
(3,475
|
)
|
|||
Net cash used in operating activities
|
(10,404
|
)
|
|
(13,216
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|||||
Change in restricted cash
|
(18
|
)
|
|
—
|
|
|||
Cash paid for purchase of equipment and furnishings
|
—
|
|
|
(6
|
)
|
|||
Net cash used in continuing investing activities
|
(18
|
)
|
|
(6
|
)
|
|||
Selling costs paid for sale of commercial assets
|
—
|
|
|
(1,050
|
)
|
|||
Net cash used in discontinued investing activities
|
—
|
|
—
|
|
(1,050
|
)
|
||
Net cash used in investing activities
|
(18
|
)
|
|
(1,056
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|||||
Net proceeds from issuance of common stock
|
15,524
|
|
|
20,189
|
|
|||
Net proceeds from exercise of stock options
|
—
|
|
|
14
|
|
|||
Proceeds from common stock issued in connection with Employee Stock Purchase Plan
|
5
|
|
|
78
|
|
|||
Change in restricted cash related to Debenture principal paid in common stock
|
4,450
|
|
|
—
|
|
|||
Principal payments on long-term debt
|
—
|
|
|
(1,030
|
)
|
|||
Net cash provided by financing activities
|
19,979
|
|
|
19,251
|
|
|||
Net increase in cash and cash equivalents
|
9,557
|
|
|
4,979
|
|
|||
Cash and cash equivalents at the beginning of period
|
18,083
|
|
|
29,730
|
|
|||
Cash and cash equivalents at end of period
|
$
|
27,640
|
|
|
$
|
34,709
|
|
|
|
|
|
|
|||||
Supplemental disclosure of cash flow information:
|
|
|
|
|||||
Cash received during the periods for interest
|
$
|
42
|
|
|
$
|
21
|
|
|
Cash paid during the periods for interest
|
$
|
—
|
|
|
$
|
112
|
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|||||
Fair value of warrants issued in connection with common stock recorded as issuance cost
|
$
|
10,357
|
|
|
$
|
5,590
|
|
|
Debt principal and interest repaid through issuance of common stock
|
$
|
4,814
|
|
|
$
|
—
|
|
|
Reclassification of warrant liabilities upon exercise
|
$
|
—
|
|
|
$
|
46
|
|
Description
|
March 31, 2017
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
26,096
|
|
|
$
|
26,096
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash equivalents
|
13,189
|
|
|
13,189
|
|
|
—
|
|
|
—
|
|
||||
Total assets measured and recorded at fair value
|
$
|
39,285
|
|
|
$
|
39,285
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
8,325
|
|
|
$
|
—
|
|
|
$
|
8,325
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
1,208
|
|
|
—
|
|
|
—
|
|
|
1,208
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
9,533
|
|
|
$
|
—
|
|
|
$
|
8,325
|
|
|
$
|
1,208
|
|
Description
|
December 31, 2016
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
16,192
|
|
|
$
|
16,192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash equivalents
|
17,622
|
|
|
17,622
|
|
|
—
|
|
|
—
|
|
||||
Total assets measured and recorded at fair value
|
$
|
33,814
|
|
|
$
|
33,814
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
1,860
|
|
|
$
|
—
|
|
|
$
|
1,860
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
1,095
|
|
|
—
|
|
|
—
|
|
|
1,095
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
2,955
|
|
|
$
|
—
|
|
|
$
|
1,860
|
|
|
$
|
1,095
|
|
|
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
|
||
Balance, January 1, 2017
|
$
|
1,095
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
113
|
|
|
Balance at March 31, 2017
|
$
|
1,208
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Clinical trial costs
|
$
|
2,199
|
|
|
$
|
3,088
|
|
Professional fees
|
317
|
|
|
229
|
|
||
Compensation and related benefits
|
673
|
|
|
975
|
|
||
Accrued expenses and other current liabilities
|
$
|
3,189
|
|
|
$
|
4,292
|
|
•
|
With respect to interest accruing on the outstanding principal amount under the Debenture for the period prior to November 10, 2016, the Company was permitted to satisfy such interest payments in kind by adding such amount to the outstanding principal.
|
•
|
The Purchaser can from time to time during the term of the Debenture require the Company to prepay in cash all or a portion of the outstanding principal plus accrued and unpaid interest (the “Outstanding Amount”) on written notice to the Company, provided, that such prepayment amount shall not exceed the lesser of
$18,500,000
and the Outstanding Amount. If the holder elects such prepayment of the Debenture, then the number of shares subject to the warrants issued to the holder will be reduced in proportion to the percentage of principal and accrued interest required to be prepaid by the Company. In addition, the Company shall have the right to prepay in cash all (but not less than all) of the Outstanding Amount (1) at any time after November 10, 2017, or (2) upon a “change of control” (as such term is used un the Debenture), in each case with a
10%
premium on the Outstanding Amount.
|
•
|
The Purchaser shall continue to have the right, which commenced on November 10, 2016, to require the Company to redeem the Outstanding Amount, except that the maximum monthly amount of such redemptions was increased from
$1,100,000
to
$1,500,000
; provided, that if the trading price of Common Stock is at least
$8.00
per share (as may be further adjusted appropriately for stock splits, combinations or similar events) during such calendar month, then such monthly maximum redemption amount may be increased to
$2,200,000
at the Purchaser’s election and if the Company has already elected to satisfy such redemptions in shares of Common Stock. In addition, notwithstanding the foregoing limitations on the monthly redemption amount, the Purchaser may elect up to
three
times in any
12
-month period to increase the monthly maximum to
$2,500,000
.
|
•
|
Among the various conditions that must be satisfied (or waived) in order for the Company to be able to elect to satisfy the monthly redemption amounts in shares of Common Stock, the Original Minimum Price Condition of
$15.00
was decreased to a volume-weighted average price of
$4.00
per share (the “Amended Minimum Price Condition”).
|
•
|
Following November 10, 2016, the Purchaser may elect to convert any portion of the Outstanding Amount into shares of Common Stock at a fixed price of
$12.00
per share (as adjusted appropriately for stock splits, combinations or similar events).
|
•
|
Under the Initial Debenture, the Company was required to maintain a minimum of
$24,000,000
of unencumbered cash in a restricted account as security for its obligations under the Initial Debenture. Such minimum amount has been reduced to the lesser of
$18,500,000
or the Outstanding Amount.
|
|
As of March 31, 2017
|
|
Warrants outstanding
|
19,570
|
|
Stock options outstanding
|
558
|
|
Options reserved for future issuance under the Company’s 2007 Incentive Plan
|
483
|
|
Shares reserved for future issuance under the Employee Stock Purchase Plan
|
17
|
|
Total reserved for future issuance
|
20,628
|
|
Warrant Issuance
|
Outstanding, December 31, 2016
|
|
Granted
|
|
Exercised
|
|
Expired
|
|
Outstanding, March 31, 2017
|
|
Expiration
|
|||||
February 2017
|
—
|
|
|
17,000
|
|
|
—
|
|
|
—
|
|
|
17,000
|
|
|
February 2022
|
July 2016
|
700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
700
|
|
|
January 2022
|
January 2016
|
682
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
682
|
|
|
January 2021
|
March 2015
|
700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
700
|
|
|
March 2020
|
September 2013
|
199
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
199
|
|
|
September 2018
|
December 2012
|
152
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
December 2017
|
April 2011
|
13
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|
April 2017
|
Other
|
124
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
124
|
|
|
November 2021
|
|
2,570
|
|
|
17,000
|
|
|
—
|
|
|
—
|
|
|
19,570
|
|
|
|
As of March 31, 2017
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||
Warrant Issuance
|
Outstanding
|
|
Strike price
|
|
Expected term
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
February 2017
|
17,000
|
|
|
$
|
1.10
|
|
|
4.87
|
|
120.00
|
%
|
|
1.90
|
%
|
July 2016
|
700
|
|
|
$
|
13.00
|
|
|
4.29
|
|
124.29
|
%
|
|
1.78
|
%
|
January 2016
|
682
|
|
|
$
|
28.40
|
|
|
3.78
|
|
130.71
|
%
|
|
1.67
|
%
|
March 2015
|
700
|
|
|
$
|
41.60
|
|
|
2.97
|
|
140.28
|
%
|
|
1.49
|
%
|
September 2013
|
199
|
|
|
$
|
50.00
|
|
|
1.47
|
|
192.86
|
%
|
|
1.14
|
%
|
December 2012
|
152
|
|
|
$
|
10.32
|
|
|
0.73
|
|
121.39
|
%
|
|
0.97
|
%
|
April 2011
|
13
|
|
|
$
|
1.00
|
|
|
0.05
|
|
61.08
|
%
|
|
0.16
|
%
|
|
|
|
|
|
|
|
|
|
|
|||||
As of December 31, 2016
|
||||||||||||||
Warrant Issuance
|
Outstanding
|
|
Strike price
|
|
Expected term
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
July 2016
|
700
|
|
|
$
|
13.00
|
|
|
4.54
|
|
117.82
|
%
|
|
1.82
|
%
|
January 2016
|
682
|
|
|
$
|
28.40
|
|
|
4.03
|
|
120.38
|
%
|
|
1.71
|
%
|
March 2015
|
700
|
|
|
$
|
41.60
|
|
|
3.22
|
|
131.46
|
%
|
|
1.52
|
%
|
September 2013
|
199
|
|
|
$
|
50.00
|
|
|
1.72
|
|
164.01
|
%
|
|
1.10
|
%
|
December 2012
|
152
|
|
|
$
|
31.60
|
|
|
0.98
|
|
204.55
|
%
|
|
0.84
|
%
|
April 2011
|
13
|
|
|
$
|
13.00
|
|
|
0.31
|
|
103.79
|
%
|
|
0.53
|
%
|
Warrant Issuance
|
Warrant liability, December 31, 2016
|
|
Fair value of warrants granted
|
|
Fair value of warrants exercised
|
|
Change in fair value of warrants
|
|
Warrant liability, March 31, 2017
|
||||||||||
February 2017
|
$
|
—
|
|
|
$
|
10,357
|
|
|
$
|
—
|
|
|
$
|
(2,426
|
)
|
|
$
|
7,931
|
|
July 2016
|
753
|
|
|
—
|
|
|
—
|
|
|
(579
|
)
|
|
174
|
|
|||||
January 2016
|
529
|
|
|
—
|
|
|
—
|
|
|
(410
|
)
|
|
119
|
|
|||||
March 2015
|
432
|
|
|
—
|
|
|
—
|
|
|
(349
|
)
|
|
83
|
|
|||||
September 2013
|
81
|
|
|
—
|
|
|
—
|
|
|
(63
|
)
|
|
18
|
|
|||||
December 2012
|
65
|
|
|
—
|
|
|
—
|
|
|
(65
|
)
|
|
—
|
|
|||||
April 2011
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
$
|
1,860
|
|
|
$
|
10,357
|
|
|
$
|
—
|
|
|
$
|
(3,892
|
)
|
|
$
|
8,325
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Research and development
|
$
|
38
|
|
|
$
|
127
|
|
General and administrative
|
190
|
|
|
529
|
|
||
Total stock-based compensation from continuing operations
|
$
|
228
|
|
|
$
|
656
|
|
|
Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
Risk free interest rate
|
2.01
|
%
|
|
1.41
|
%
|
Volatility
|
108.55
|
%
|
|
75.24
|
%
|
Expected lives (years)
|
6.13
|
|
|
6.25
|
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
Total
Number of
Shares
(In Thousands)
|
|
Weighted
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
(In Thousands)
|
|||||
Outstanding at January 1, 2017
|
561
|
|
|
$
|
41.50
|
|
|
|
|
|
Granted
|
70
|
|
|
1.75
|
|
|
|
|
||
Exercised
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
Canceled
|
(73
|
)
|
|
32.59
|
|
|
$
|
—
|
|
|
Outstanding at March 31, 2017
|
558
|
|
|
$
|
37.68
|
|
|
$
|
—
|
|
Options exercisable at March 31, 2017
|
356
|
|
|
$
|
52.96
|
|
|
$
|
—
|
|
|
For the Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
Warrants to purchase common stock
|
19,570
|
|
|
1,789
|
|
Options to purchase common stock
|
558
|
|
|
600
|
|
Total
|
20,128
|
|
|
2,389
|
|
|
Three months ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Additional channel obligations
|
$
|
(322
|
)
|
|
$
|
(1,010
|
)
|
Selling, general, and administrative
|
(1,614
|
)
|
|
(2,381
|
)
|
||
Settlement associated with USAO NJ and DOJ (Note 5)
|
(7,500
|
)
|
|
—
|
|
||
Loss from discontinued operations
|
$
|
(9,436
|
)
|
|
$
|
(3,391
|
)
|
•
|
Evaluating strategic alternatives that may include continuing to advance the clinical programs as a stand-alone entity, a sale of the company, a business combination, merger or reverse merger, and a license or other disposition of corporate assets of the company.
|
•
|
Develop hematology and oncology assets through clinical development with a focus in areas of unmet medical need. Our hematology asset is targeting the treatment of patients with ET to reduce elevated platelet counts. Our immunotherapy programs are currently targeting two key areas: secondary prevention intended to significantly decrease the risk of disease recurrence in breast, gastric, and ovarian cancers; and primary prevention intended to prevent ductal carcinoma
in situ
(DCIS) from becoming invasive breast cancer.
|
•
|
Leverage 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.
|
Drug Candidate
|
Indication
|
Scope
|
Estimated
Exclusivity
Period
|
GALE-401 (Anagrelide Controlled Release)
|
Platelet Lowering
|
Pending and/or issued
|
2029
|
NeuVax™ (nelipepimut-S)
|
Breast cancer recurrence
|
Pending and/or issued
|
2028
|
NeuVax™ (nelipepimut-S)
|
Gastric
|
Pending and/or issued
|
2028
|
NeuVax™ (nelipepimut-S)
|
DCIS
|
Pending and/or issued
|
2028
|
NeuVax™ in combination with trastuzumab
|
Breast cancer
|
Pending and/or issued
|
2026
|
NeuVax™ in combination with other compounds
|
Breast cancer
|
Pending and/or issued
|
2037
|
GALE-301 & GALE-302
|
Breast, ovarian and endometrial cancer
|
Pending and/or issued
|
2036
|
(dollars in thousands)
|
Three Months Ended March 31,
|
|||||||||
|
2017
|
|
2016
|
|
% Change
|
|||||
Operating loss
|
$
|
(5,088
|
)
|
|
$
|
(8,968
|
)
|
|
43
|
%
|
Non-operating income (expense)
|
2,806
|
|
|
(4,134
|
)
|
|
N/A
|
|
||
Loss from discontinued operations
|
(9,436
|
)
|
|
(3,391
|
)
|
|
(178
|
)%
|
||
Net loss
|
$
|
(11,718
|
)
|
|
$
|
(16,493
|
)
|
|
29
|
%
|
|
|
|
|
|
|
|||||
Net loss per common share:
|
|
|
|
|
|
|||||
Basic and diluted net loss per share, continuing operations
|
$
|
(0.09
|
)
|
|
$
|
(1.46
|
)
|
|
94
|
%
|
Basic and diluted net loss per share, discontinued operations
|
$
|
(0.36
|
)
|
|
$
|
(0.38
|
)
|
|
5
|
%
|
Basic and diluted net loss per share
|
$
|
(0.45
|
)
|
|
$
|
(1.84
|
)
|
|
76
|
%
|
|
Three Months Ended March 31,
|
|||||||||
|
2017
|
|
2016
|
|
% Change
|
|||||
Research and development expense
|
$
|
2,362
|
|
|
$
|
5,443
|
|
|
(57
|
)%
|
|
Three Months Ended March 31,
|
|||||||||
|
2017
|
|
2016
|
|
% Change
|
|||||
General and administrative expense
|
$
|
2,726
|
|
|
$
|
3,525
|
|
|
(23
|
)%
|
|
Three Months Ended March 31,
|
|||||||||
|
2017
|
|
2016
|
|
% Change
|
|||||
Change in fair value of warrants potentially settleable in cash
|
$
|
3,892
|
|
|
$
|
(3,873
|
)
|
|
(200
|
)%
|
Interest expense, net
|
(973
|
)
|
|
(91
|
)
|
|
969
|
%
|
||
Change in fair value of the contingent purchase price liability
|
(113
|
)
|
|
(170
|
)
|
|
(34
|
)%
|
||
Total non-operating income (expense), net
|
$
|
2,806
|
|
|
$
|
(4,134
|
)
|
|
(168
|
)%
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Additional channel obligations
|
(322
|
)
|
|
(1,010
|
)
|
||
Selling, general, and administrative
|
(1,614
|
)
|
|
(2,381
|
)
|
||
Settlement associated with USAO NJ and DOJ (Note 5)
|
(7,500
|
)
|
|
—
|
|
||
Loss from discontinued operations
|
$
|
(9,436
|
)
|
|
$
|
(3,391
|
)
|
|
For the Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Cash flows from continuing operations:
|
|
|
|
||||
Cash flows used in continuing operating activities
|
$
|
(5,400
|
)
|
|
$
|
(9,741
|
)
|
Cash flows used in continuing investing activities
|
(18
|
)
|
|
(6
|
)
|
||
Cash flows provided by continuing financing activities
|
19,979
|
|
|
19,251
|
|
||
Total cash flows provided by continuing operating activities
|
14,561
|
|
|
9,504
|
|
||
|
|
|
|
||||
Cash flows from discontinued operations:
|
|
|
|
||||
Cash flows used in discontinued operating activities
|
(5,004
|
)
|
|
(3,475
|
)
|
||
Cash flows used in discontinued investing activities
|
—
|
|
|
(1,050
|
)
|
||
Total cash flows used in discontinued operations
|
(5,004
|
)
|
|
(4,525
|
)
|
||
|
|
|
|
||||
Total cash flows:
|
|
|
|
||||
Cash flows used in operating activities
|
(10,404
|
)
|
|
(13,216
|
)
|
||
Cash flows used in investing activities
|
(18
|
)
|
|
(1,056
|
)
|
||
Cash flows provided by financing activities
|
19,979
|
|
|
19,251
|
|
||
Total increase in cash and cash equivalents
|
$
|
9,557
|
|
|
$
|
4,979
|
|
(a)
|
our disclosure controls and procedures were not 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 not 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 accumulated and communicated to our management, including the Certifying Officer, as appropriate to allow timely decisions regarding required disclosure.
|
•
|
reports of the results of our clinical trials regarding the safety or efficacy of our product candidates and surrogate markers;
|
•
|
announcements of regulatory developments or technological innovations by us or our competitors;
|
•
|
announcements of business or strategic transactions or our success in finalizing such a transaction;
|
•
|
announcements of legal or regulatory actions against us or any adverse outcome of any such actions;
|
•
|
changes in our relationship with our licensors, licensees and other strategic partners;
|
•
|
our quarterly operating results;
|
•
|
developments in patent or other technology ownership rights;
|
•
|
additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stockholders;
|
•
|
government regulation of drug pricing; and
|
•
|
general changes in the economy, the financial markets or the pharmaceutical or biotechnology industries.
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
†
|
Indicates management contract or compensatory plan or arrangement.
|
|
GALENA BIOPHARMA, INC.
|
||
|
|
|
|
|
By:
|
|
/s/ Stephen F. Ghiglieiri
|
|
|
|
|
|
|
|
Stephen F. Ghiglieri
|
|
|
|
Interim Chief Executive Officer and Chief Financial Officer
|
|
|
|
|
|
|
|
Date: May 10, 2017
|
9.
|
Release by E
mployee.
|
10.
|
Waiver of Civil Code Section 1
542.
|
15.
|
Confidential I
nformation.
|
◦
|
Raise capital, under best terms available and with approval by the BOD, as soon as possible
|
◦
|
Provide all analytical support to Peter J. Solomon advisors as requested
|
◦
|
Drive Galena to conclude strategic transaction(s)
|
◦
|
Reduce cash burn to level that would permit Company to complete strategic transaction(s)
|
◦
|
Coordinate, supervise and direct the staff of Galena as necessary
|
◦
|
Coordinate and Communicate with the BOD as necessary and appropriate
|
◦
|
Support capital raise, and strategic transactions efforts
|
◦
|
Complete (consistent with budget constraints) projects, analyses etc. that will enhance the value of Galena’s scientific assets in the short run
|
◦
|
“Package” Galena’s scientific assets to demonstrate their value to potential partners
|
◦
|
Coordinate activities with the Interim CEO
|
◦
|
Support capital raise and strategic transactions efforts as requested
|
◦
|
Monitor spending commitments and cash outflow to provide information to the Galena team to ensure available cash lasts until completion of strategic transaction(s)
|
◦
|
Support Solomon advisors and investment bank retained in analyses they may need to accomplish their objectives
|
◦
|
Ensure that Galena public disclosures and filed documents are complete, adequate and timely
|
◦
|
Coordinate with Moss Adams to complete annual audit and interim reviews on a timely and efficient basis
|
◦
|
Support and coordinate with management team as necessary
|
◦
|
Support capital raise and strategic transactions efforts
|
◦
|
Conclude all SEC investigation matters with Galena
|
◦
|
Conclude on the best terms possible the various Astral legal issues
|
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Ensure that Galena public disclosures and filed documents are complete, adequate and timely
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Maximize coverage/payments by Galena’s insurance carriers relative to the various legal issues
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Coordinate activities with the Interim CEO
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/s/ Stephen F. Ghiglieiri
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Stephen F. Ghiglieri
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Interim Chief Executive Officer and Chief Financial Officer
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/s/ Stephen F. Ghiglieiri
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Stephen F. Ghiglieri
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Interim Chief Executive Officer and Chief Financial Officer
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May 10, 2017
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