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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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56-2181648
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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101 Hudson Street
Suite 3610
Jersey City, New Jersey
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07302-6548
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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ý
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Page
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Item 1.
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Item 2.
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Item 3.
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Item 4.
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Item 1A.
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Item 2.
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Item 6.
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Item 1.
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Financial Statements
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June 30, 2015
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December 31, 2014
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||||
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Assets
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||||
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Current assets:
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||||
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Cash and cash equivalents
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$
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57,057
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$
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32,243
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Prepaid expenses and other current assets
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1,502
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|
703
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Assets held for sale, net (Note 14)
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6,086
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6,701
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Total current assets
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64,645
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39,647
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Other assets
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33
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25
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Total assets
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$
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64,678
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$
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39,672
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Liabilities and stockholders’ equity
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||||
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Current liabilities:
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||||
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Accounts payable
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$
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477
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$
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426
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Accrued expenses
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2,835
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|
2,245
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Accrued severance and retention costs, current portion (Note 13)
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1,408
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—
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||
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Deferred revenue, current portion
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232
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257
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Liabilities related to assets held for sale (Note 14)
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2,099
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2,420
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Total current liabilities
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7,051
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5,348
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Deferred revenue, net of current portion
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764
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893
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|
||
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Accrued severance and retention costs, net of current portion (Note 13)
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91
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—
|
|
||
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Total liabilities
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7,906
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|
6,241
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|
||
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Commitments and contingencies (Note 5)
|
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||||
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Stockholders’ equity:
|
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|
||||
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Common stock, $0.001 par value, 125,000,000 shares authorized as of June 30, 2015, and December 31, 2014; 13,903,832 and 8,512,103 shares issued and outstanding as of June 30, 2015, and December 31, 2014, respectively
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14
|
|
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8
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|
||
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Additional paid-in capital
|
190,150
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150,934
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Accumulated deficit
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(133,392
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)
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(117,511
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)
|
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Total stockholders’ equity
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56,772
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33,431
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|
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Total liabilities and stockholders’ equity
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$
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64,678
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$
|
39,672
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Three months ended June 30,
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Six months ended June 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
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||||||||
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Total revenue and gross profit
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$
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64
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$
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65
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$
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129
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$
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130
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Operating expenses:
|
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||||||||
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Research and development
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3,282
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1,823
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7,069
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3,143
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||||
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Selling, general and administrative
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3,275
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2,255
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5,485
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3,461
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||||
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Total operating expenses
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6,557
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4,078
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12,554
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6,604
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||||
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Loss from operations
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(6,493
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)
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(4,013
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)
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(12,425
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)
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(6,474
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)
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||||
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Other (income) expense:
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||||||||
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Amortization of deferred financing costs and debt discount
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—
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219
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|
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—
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|
755
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||||
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Loss on extinguishment of debt
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—
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1,389
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—
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1,389
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||||
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Interest (income) expense
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(1
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)
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5
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(2
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)
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49
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||||
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Derivative fair value adjustment
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—
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(7,297
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)
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—
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(10,080
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)
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||||
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Other expense
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—
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—
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—
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10
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||||
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Total other (income) expense
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(1
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)
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(5,684
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)
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(2
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(7,877
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)
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||||
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(Loss) income from continuing operations
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(6,492
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)
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1,671
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(12,423
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)
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1,403
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||||
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Discontinued operations (Note 14):
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||||||||
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(Loss) income from discontinued operations, including $1,350 impairment charge on classification as held for sale for the three and six months ended June 30, 2015
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(3,005
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)
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562
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(3,458
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)
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1,242
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|
||||
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Net (loss) income
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(9,497
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)
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2,233
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(15,881
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)
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2,645
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||||
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Deemed dividends, accretion, and allocation of net income to convertible preferred stockholders (Note 10)
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—
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(262
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)
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—
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(1,936
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)
|
||||
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Net (loss) income attributable to common stockholders - basic
|
(9,497
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)
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|
1,971
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(15,881
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)
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|
709
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|
||||
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Derivative fair value adjustment
|
—
|
|
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(7,297
|
)
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—
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(10,080
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)
|
||||
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Net loss attributable to common stockholders - diluted
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$
|
(9,497
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)
|
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$
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(5,326
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)
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$
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(15,881
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)
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$
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(9,371
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)
|
|
(Loss) income per share attributable to common stockholders - basic
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|
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|
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|
||||||||
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Continuing operations
|
$
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(0.53
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)
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$
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0.27
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$
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(1.20
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)
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$
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(0.19
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)
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Discontinued operations
|
(0.25
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)
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0.11
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(0.33
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)
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0.45
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|
||||
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Net (loss) income per share - basic
|
$
|
(0.78
|
)
|
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$
|
0.38
|
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|
$
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(1.53
|
)
|
|
$
|
0.26
|
|
|
(Loss) income per share attributable to common stockholders - diluted
|
|
|
|
|
|
|
|
||||||||
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Continuing operations
|
$
|
(0.53
|
)
|
|
$
|
(1.08
|
)
|
|
$
|
(1.20
|
)
|
|
$
|
(3.49
|
)
|
|
Discontinued operations
|
(0.25
|
)
|
|
0.10
|
|
|
(0.33
|
)
|
|
0.41
|
|
||||
|
Net loss per share - diluted
|
$
|
(0.78
|
)
|
|
$
|
(0.98
|
)
|
|
$
|
(1.53
|
)
|
|
$
|
(3.08
|
)
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
|
Basic
|
12,249,487
|
|
|
5,181,174
|
|
|
10,393,289
|
|
|
2,771,020
|
|
||||
|
Diluted
|
12,249,487
|
|
|
5,454,371
|
|
|
10,393,289
|
|
|
3,044,729
|
|
||||
|
|
Six months ended
June 30, |
||||||
|
|
2015
|
|
2014
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net (loss) income
|
$
|
(15,881
|
)
|
|
$
|
2,645
|
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
|
Impairment loss on classification of assets as held for sale
|
1,350
|
|
|
—
|
|
||
|
Gain on insurance recovery
|
—
|
|
|
(165
|
)
|
||
|
Loss on extinguishment of debt
|
—
|
|
|
1,389
|
|
||
|
Recovery of bad debt
|
—
|
|
|
(75
|
)
|
||
|
Depreciation
|
447
|
|
|
615
|
|
||
|
Stock-based compensation expense
|
1,115
|
|
|
382
|
|
||
|
Amortization of deferred financing costs and debt discount
|
—
|
|
|
755
|
|
||
|
Change in fair value of derivative liability
|
—
|
|
|
(10,080
|
)
|
||
|
Changes in deferred rent
|
(122
|
)
|
|
(56
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable and unbilled services
|
(214
|
)
|
|
(394
|
)
|
||
|
Prepaid expenses, other assets, and deferred costs
|
(1,262
|
)
|
|
(351
|
)
|
||
|
Accounts payable and accrued expenses
|
467
|
|
|
557
|
|
||
|
Accrued severance and retention cost obligations
|
1,499
|
|
|
389
|
|
||
|
Deferred revenue
|
(218
|
)
|
|
321
|
|
||
|
Net cash used in operating activities
|
(12,819
|
)
|
|
(4,068
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Proceeds from insurance recovery
|
—
|
|
|
216
|
|
||
|
Purchases of property and equipment
|
(527
|
)
|
|
(323
|
)
|
||
|
Net cash used in investing activities
|
(527
|
)
|
|
(107
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from public offerings
|
41,400
|
|
|
62,000
|
|
||
|
Proceeds from sale of preferred stock
|
—
|
|
|
544
|
|
||
|
Repayment of debt
|
—
|
|
|
(15,000
|
)
|
||
|
Payments of deferred offering costs and underwriting discounts and commissions
|
(3,335
|
)
|
|
(6,410
|
)
|
||
|
Proceeds from employee stock purchase plan issuance
|
95
|
|
|
—
|
|
||
|
Proceeds from exercise of stock warrants
|
—
|
|
|
55
|
|
||
|
Proceeds from exercise of stock options
|
—
|
|
|
9
|
|
||
|
Net cash provided by financing activities
|
38,160
|
|
|
41,198
|
|
||
|
Net increase in cash and cash equivalents
|
24,814
|
|
|
37,023
|
|
||
|
Cash and cash equivalents, beginning of period
|
32,243
|
|
|
1,402
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
57,057
|
|
|
$
|
38,425
|
|
|
Supplemental cash flow information:
|
|
|
|
||||
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
49
|
|
|
Noncash financing and investing activities:
|
|
|
|
||||
|
Beneficial conversion feature on sale of Series D-2 preferred stock
|
$
|
—
|
|
|
$
|
909
|
|
|
Beneficial conversion feature for antidilution adjustment
|
$
|
—
|
|
|
$
|
214
|
|
|
Adjustment of preferred stock to redemption value
|
$
|
—
|
|
|
$
|
510
|
|
|
Deferred offering costs included in accounts payable and accrued expenses
|
$
|
53
|
|
|
$
|
465
|
|
|
Equipment purchases in accounts payable and accrued expenses
|
$
|
20
|
|
|
$
|
6
|
|
|
Impairment of fixed asset
|
$
|
—
|
|
|
$
|
51
|
|
|
Deferred offering costs reclassified to additional paid-in capital
|
$
|
3,388
|
|
|
$
|
4,127
|
|
|
Warrant derivative liability reclassified to additional paid-in capital
|
$
|
—
|
|
|
$
|
2,701
|
|
|
Conversion of convertible preferred stock to common stock
|
$
|
—
|
|
|
$
|
88,790
|
|
|
1.
|
Description of Business and Basis of Preparation
|
|
2.
|
Summary of Significant Accounting Policies
|
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
||||||||||
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||
|
Research and development expense, gross
|
|
$
|
3,820
|
|
|
$
|
1,823
|
|
|
7,801
|
|
|
3,143
|
|
|
Less: Reimbursement of research and development expense
|
|
538
|
|
|
—
|
|
|
732
|
|
|
—
|
|
||
|
Research and development expense, net of reimbursements
|
|
$
|
3,282
|
|
|
$
|
1,823
|
|
|
7,069
|
|
|
3,143
|
|
|
3.
|
Property and Equipment
|
|
|
June 30,
2015 |
|
December 31,
2014 |
||||
|
Equipment
|
$
|
9,046
|
|
|
$
|
8,552
|
|
|
Furniture and fixtures
|
375
|
|
|
375
|
|
||
|
Leasehold improvements
|
13,212
|
|
|
13,193
|
|
||
|
Total property and equipment
|
22,633
|
|
|
22,120
|
|
||
|
Less accumulated depreciation
|
17,732
|
|
|
17,285
|
|
||
|
Property and equipment, net of accumulated depreciation
|
4,901
|
|
|
4,835
|
|
||
|
Less impairment charge on classification of property and equipment as assets held for sale
|
1,350
|
|
|
—
|
|
||
|
Property and equipment, net of accumulated depreciation and impairment charge
|
3,551
|
|
|
4,835
|
|
||
|
Property and equipment reclassified to assets held for sale, net
|
(3,551
|
)
|
|
(4,835
|
)
|
||
|
Property and equipment, net of assets classified as held for sale
|
$
|
—
|
|
|
$
|
—
|
|
|
4.
|
|
|
5.
|
Commitments and Contingencies
|
|
|
|
||
|
2015
|
$
|
550
|
|
|
2016
|
1,122
|
|
|
|
2017
|
1,140
|
|
|
|
2018
|
1,161
|
|
|
|
2019
|
291
|
|
|
|
Thereafter
|
—
|
|
|
|
Total
|
$
|
4,264
|
|
|
6.
|
Convertible Preferred Stock
|
|
7.
|
Common Stock
|
|
|
Shares of
Common Stock
|
|
|
Balance, December 31, 2014
|
8,512,103
|
|
|
Common stock issued through April 2015 Offering
|
5,376,622
|
|
|
Common stock issued through employee stock purchase plan
|
15,107
|
|
|
Balance, June 30, 2015
|
13,903,832
|
|
|
|
As of
|
|
As of
|
||
|
|
June 30,
2015 |
|
December 31,
2014 |
||
|
Outstanding stock options
|
1,153,369
|
|
|
615,322
|
|
|
Outstanding Series C-1 Preferred warrants
|
14,033
|
|
|
14,033
|
|
|
For possible future issuance under 2014 Equity Incentive Plan (Note 8)
|
618,773
|
|
|
180,610
|
|
|
For possible future issuance under Employee Stock Purchase Plan (Note 8)
|
52,050
|
|
|
37,746
|
|
|
For possible future issuance under 2015 Inducement Plan (Note 8)
|
325,000
|
|
|
—
|
|
|
Total common shares reserved for future issuance
|
2,163,225
|
|
|
847,711
|
|
|
8.
|
Stock-based Compensation
|
|
•
|
On June 4, 2015, the Company's board of directors approved an extension to the existing
90
-day post-employment option exercise period to a period ranging from
36
to
48
months for
three
directors who resigned from the board effective June 4, 2015. The directors held outstanding options to purchase
48,283
shares of the Company's common stock at a weighted average exercise price of
$9.01
per share. All outstanding options were fully vested prior to June 4, 2015.
|
|
•
|
In connection with the Company's sale of its Services Business (Note 13), the Company designed a compensatory plan to promote the retention of services of non-executive employees supporting that business (the "Services Business Plan"). The complete terms of the Service Business Plan are described in Note 13. The Company terminated certain employees in June 2015 (the "June 2015 terminated employees") who became eligible for severance benefits pursuant to the terms of the Services Business Plan. The outstanding stock options held by the June 2015 terminated employees were modified to provide: (i) accelerated vesting of all unvested stock options as of the closing of the sale transaction and (ii) an extension to the existing 90-day post-employment option exercise period, which varies for each employee based upon years of service, with a maximum exercise period of
48
months. As of June 30, 2015, the June 2015 terminated employees held outstanding options to purchase
17,715
shares of the Company's common stock at a weighted average exercise price of
$9.64
per share, including aggregate unvested options to purchase
8,331
shares at a weighted average exercise price of
$9.64
per share.
|
|
•
|
As described in Note 13, Charles F. Osborne, Jr., the Company’s former chief financial officer, resigned from the Company effective June 30, 2015. The Company's compensation committee of the board of directors approved the following modifications to Mr. Osborne's outstanding options to purchase the Company's common stock: (i) accelerated vesting of all unvested stock options as of June 30, 2015, and (ii) an extension to the existing 90-day post-employment option exercise period to
36
months. As of June 30, 2015, Mr. Osborne held outstanding options to purchase an aggregate of
74,490
shares of the Company's common stock at a weighted average exercise price of
$9.53
per share, including unvested options to purchase
50,814
shares at a weighted average exercise price of
$9.49
per share.
|
|
•
|
As described in Note 13, the Company designed a compensatory plan for its non-executive employees in connection with the relocation of its operations to Jersey City, New Jersey (the "Retention Plan"). Pursuant to the terms of the Retention Plan, all stock options held by non-executive employees eligible under the Retention Plan were modified to provide: (i) accelerated vesting of all unvested stock options as of December 31, 2015, and (ii) an extension to the existing 90-day post-employment option exercise period, which varies for each employee based upon years of service, with a maximum exercise period of
48
months. As of June 30, 2015, the retained employees eligible for participation in the Retention Plan held outstanding options to purchase
121,550
shares of the Company's common stock at a weighted average exercise price of
$9.13
per share, including aggregate unvested options to purchase
85,990
shares at a weighted average exercise price of
$8.95
per share.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Research and development
|
62
|
|
|
100
|
|
|
114
|
|
|
162
|
|
||||
|
Selling, general and administrative
|
689
|
|
|
135
|
|
|
900
|
|
|
170
|
|
||||
|
Discontinued operations
|
68
|
|
|
37
|
|
|
101
|
|
|
50
|
|
||||
|
|
$
|
819
|
|
|
$
|
272
|
|
|
$
|
1,115
|
|
|
$
|
382
|
|
|
9.
|
Income Taxes
|
|
10.
|
Net Loss Per Share
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Income (loss) attributable to common stock - basic:
|
|
|
|
|
|
|
|
||||||||
|
Income (loss) from continuing operations
|
$
|
(6,492
|
)
|
|
$
|
1,671
|
|
|
$
|
(12,423
|
)
|
|
$
|
1,403
|
|
|
Deemed dividend for beneficial conversion feature on Series D-2 Preferred
|
—
|
|
|
—
|
|
|
—
|
|
|
(909
|
)
|
||||
|
Deemed dividend for antidilution adjustments to convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
(214
|
)
|
||||
|
Accretion of convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
(510
|
)
|
||||
|
Allocation of net income to convertible preferred stockholders
|
—
|
|
|
(262
|
)
|
|
—
|
|
|
(303
|
)
|
||||
|
Income (loss) from continuing operations attributable to common stock - basic
|
(6,492
|
)
|
|
1,409
|
|
|
(12,423
|
)
|
|
(533
|
)
|
||||
|
Income (loss) from discontinued operations attributable to common stock - basic
|
(3,005
|
)
|
|
562
|
|
|
(3,458
|
)
|
|
1,242
|
|
||||
|
Net income (loss) attributable to common stock - basic
|
$
|
(9,497
|
)
|
|
$
|
1,971
|
|
|
$
|
(15,881
|
)
|
|
$
|
709
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Income (loss) attributable to common stock - diluted:
|
|
|
|
|
|
|
|
||||||||
|
Income (loss) from continuing operations attributable to common stock - basic
|
$
|
(6,492
|
)
|
|
$
|
1,409
|
|
|
$
|
(12,423
|
)
|
|
$
|
(533
|
)
|
|
Derivative fair value adjustment
|
—
|
|
|
(7,297
|
)
|
|
—
|
|
|
(10,080
|
)
|
||||
|
Loss from continuing operations attributable to common stock - diluted
|
(6,492
|
)
|
|
(5,888
|
)
|
|
(12,423
|
)
|
|
(10,613
|
)
|
||||
|
Loss from discontinued operations attributable to common stock - diluted
|
(3,005
|
)
|
|
562
|
|
|
(3,458
|
)
|
|
1,242
|
|
||||
|
Net income (loss) attributable to common stock - diluted
|
$
|
(9,497
|
)
|
|
$
|
(5,326
|
)
|
|
$
|
(15,881
|
)
|
|
$
|
(9,371
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Weighted-average common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
|
Weighted-average common shares outstanding - basic
|
12,249,487
|
|
|
5,181,174
|
|
|
10,393,289
|
|
|
2,771,020
|
|
||||
|
Allocation of common stock warrants as participating securities
|
—
|
|
|
273,197
|
|
|
—
|
|
|
273,709
|
|
||||
|
Weighted-average common shares outstanding - diluted
|
12,249,487
|
|
|
5,454,371
|
|
|
10,393,289
|
|
|
3,044,729
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Income (loss) per share - basic:
|
|
|
|
|
|
|
|
||||||||
|
Continuing operations
|
$
|
(0.53
|
)
|
|
$
|
0.27
|
|
|
$
|
(1.20
|
)
|
|
$
|
(0.19
|
)
|
|
Discontinued operations
|
(0.25
|
)
|
|
0.11
|
|
|
(0.33
|
)
|
|
0.45
|
|
||||
|
Net income (loss) per share - basic
|
$
|
(0.78
|
)
|
|
$
|
0.38
|
|
|
$
|
(1.53
|
)
|
|
$
|
0.26
|
|
|
Income (loss) per share - diluted:
|
|
|
|
|
|
|
|
||||||||
|
Continuing operations
|
$
|
(0.53
|
)
|
|
$
|
(1.08
|
)
|
|
$
|
(1.20
|
)
|
|
$
|
(3.49
|
)
|
|
Discontinued operations
|
(0.25
|
)
|
|
0.10
|
|
|
(0.33
|
)
|
|
0.41
|
|
||||
|
Net income (loss) per share - diluted
|
$
|
(0.78
|
)
|
|
$
|
(0.98
|
)
|
|
$
|
(1.53
|
)
|
|
$
|
(3.08
|
)
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
|
Convertible preferred stock:
|
|
|
|
|
|
|
|
||||
|
Series A Preferred
|
—
|
|
|
6,149
|
|
|
—
|
|
|
6,149
|
|
|
Series B Preferred
|
—
|
|
|
131,685
|
|
|
—
|
|
|
131,685
|
|
|
Series C Preferred
|
—
|
|
|
783,515
|
|
|
—
|
|
|
783,515
|
|
|
Series C-2 Preferred
|
—
|
|
|
173,213
|
|
|
—
|
|
|
173,213
|
|
|
Series D-1 Preferred
|
—
|
|
|
296,773
|
|
|
—
|
|
|
296,773
|
|
|
Series D-2 Preferred
|
—
|
|
|
300,549
|
|
|
—
|
|
|
300,549
|
|
|
Series C-1 Preferred warrants
|
14,033
|
|
|
14,033
|
|
|
14,033
|
|
|
14,033
|
|
|
Stock options
|
1,153,369
|
|
|
215,467
|
|
|
1,153,369
|
|
|
215,467
|
|
|
ESPP
|
7,298
|
|
|
—
|
|
|
7,298
|
|
|
—
|
|
|
11.
|
Related-Party Transactions
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Revenue
|
$
|
988
|
|
|
$
|
1,822
|
|
|
$
|
1,975
|
|
|
$
|
3,644
|
|
|
Selling, general and administrative expense
|
$
|
—
|
|
|
$
|
500
|
|
|
$
|
—
|
|
|
$
|
500
|
|
|
12.
|
Fair Value Measurements
|
|
|
|
Three months ended
|
|
Six months ended
|
||||
|
|
|
June 30, 2014
|
|
June 30, 2014
|
||||
|
Balance at beginning of period
|
|
$
|
9,998
|
|
|
$
|
12,237
|
|
|
Issuance of warrants
|
|
—
|
|
|
544
|
|
||
|
Excess of fair value of warrants over proceeds
|
|
—
|
|
|
362
|
|
||
|
Adjustment to fair value
|
|
(7,297
|
)
|
|
(10,442
|
)
|
||
|
Reclassification to additional paid-in capital upon exercise of warrants
|
|
(2,701
|
)
|
|
(2,701
|
)
|
||
|
Balance at end of period
|
|
$
|
—
|
|
|
$
|
—
|
|
|
13.
|
Compensatory Plan Obligations
|
|
14.
|
Discontinued Operations, Assets Held for Sale, Impairment Charges
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
||||
|
Carrying amounts of assets included as part of discontinued operations:
|
|
|
|
|
||||
|
Accounts and unbilled receivables, net
|
|
$
|
1,715
|
|
|
$
|
1,501
|
|
|
Prepaid expenses and other current assets
|
|
761
|
|
|
289
|
|
||
|
Property and equipment, net
|
|
4,901
|
|
|
4,835
|
|
||
|
Other assets
|
|
59
|
|
|
76
|
|
||
|
Disposal loss recognized on classification as held for sale
|
|
(1,350
|
)
|
|
—
|
|
||
|
Assets held for sale, net
|
|
$
|
6,086
|
|
|
$
|
6,701
|
|
|
|
|
|
|
|
||||
|
Carrying amounts of liabilities included as part of discontinued operations:
|
|
|
|
|
||||
|
Accounts payable and accrued expenses
|
|
$
|
546
|
|
|
$
|
681
|
|
|
Deferred revenue
|
|
381
|
|
|
445
|
|
||
|
Deferred rent
|
|
1,172
|
|
|
1,294
|
|
||
|
Liabilities related to assets held for sale
|
|
$
|
2,099
|
|
|
$
|
2,420
|
|
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
||||||||||||
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
Major line items constituting income (loss) of discontinued operations:
|
|
|
|
|
|
|
|
|
||||||||
|
Total revenue
|
|
$
|
3,617
|
|
|
$
|
4,577
|
|
|
$
|
6,849
|
|
|
$
|
9,217
|
|
|
Cost of revenue
|
|
(3,599
|
)
|
|
(4,180
|
)
|
|
(6,830
|
)
|
|
(8,140
|
)
|
||||
|
Research and development
|
|
(422
|
)
|
|
—
|
|
|
(853
|
)
|
|
—
|
|
||||
|
Selling, general and administrative
|
|
(198
|
)
|
|
—
|
|
|
(221
|
)
|
|
—
|
|
||||
|
Gain on insurance recovery
|
|
—
|
|
|
165
|
|
|
—
|
|
|
165
|
|
||||
|
Severance and exit costs (Note 13)
|
|
(1,053
|
)
|
|
—
|
|
|
(1,053
|
)
|
|
—
|
|
||||
|
Impairment charge from classification of assets as held for sale
|
|
(1,350
|
)
|
|
—
|
|
|
(1,350
|
)
|
|
—
|
|
||||
|
Income (loss) from discontinued operations
|
|
$
|
(3,005
|
)
|
|
$
|
562
|
|
|
$
|
(3,458
|
)
|
|
$
|
1,242
|
|
|
|
Six months ended June 30,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Depreciation expense
|
$
|
391
|
|
|
$
|
562
|
|
|
Purchases of property and equipment
|
(527
|
)
|
|
(323
|
)
|
||
|
Stock-based compensation
|
101
|
|
|
50
|
|
||
|
Changes in deferred rent
|
(122
|
)
|
|
(56
|
)
|
||
|
Equipment purchases in accounts payable and accrued expenses
|
20
|
|
|
6
|
|
||
|
15.
|
Subsequent Events
|
|
Aggregate purchase price of Services Business sale transaction
1
|
|
$
|
3.9
|
|
|
Less: Estimated selling costs
2
|
|
0.8
|
|
|
|
Estimated net proceeds
|
|
3.1
|
|
|
|
Estimated incremental cash compensation costs:
|
|
|
||
|
Cash severance benefit costs
3
|
|
1.0
|
|
|
|
Incentive compensation payments at closing
4
|
|
0.2
|
|
|
|
Maximum cash retention compensation payments
5
|
|
0.8
|
|
|
|
Total estimated cash compensation costs
|
|
2.0
|
|
|
|
|
|
|
||
|
Estimated net proceeds, less estimated incremental cash compensation
|
|
$
|
1.1
|
|
|
|
|
|
||
|
1
Includes $0.5 million paid into escrow at closing and is subject to escrow for a period of 12 months.
|
||||
|
2
Includes a success fee due to a third party firm, estimated legal fees, and other estimated fees directly related to the sale transaction.
|
||||
|
3
Relates to cash severance benefits to be paid to the June 2015 Terminated Employees (described below) pursuant to the Services Business Plan.
|
||||
|
4
Relates to cash incentive payments made to non-executive employees of the Services Business upon closing of the sale transaction, pursuant to the Services Business Plan. This amount will be recognized during the quarterly period ended September 30, 2015.
|
||||
|
5
Represents maximum cash retention compensation payments that may be paid to non-executive employees of the Services Business, pursuant to the Services Business Plan. This amount will be recognized during the quarterly period ended September 30, 2015.
|
||||
|
•
|
On April 1, 2015, we granted options to purchase
425,967
shares of common stock to officers and other key employees, including an award to Dr. Marco Taglietti, our new Chief Executive Officer, to purchase 330,000
|
|
•
|
On June 4, 2015, our stockholders approved an amendment of the 2014 Plan to increase the aggregate number of shares of common stock that may be issued pursuant to awards under the 2014 Plan by an additional 510,726 shares. All other material terms of the 2014 Plan otherwise remain unchanged.
|
|
•
|
On June 4, 2015, we granted options to purchase 125,000 shares of common stock to Dr. David Angulo, our new Chief Medical Officer, under our 2015 Inducement Plan. The options have a ten-year term, with one-fourth of the shares subject to the option vesting on the one-year anniversary of the date of grant and the remainder vesting in equal monthly installments for thirty-six months thereafter, provided Dr. Angulo continues to provide service to us.
|
|
•
|
costs related to executing preclinical and clinical trials, including related drug formulation, manufacturing and other development;
|
|
•
|
salaries and personnel-related costs, including benefits and any stock-based compensation for personnel in research and development functions;
|
|
•
|
fees paid to consultants and other third parties who support our product candidate development and intellectual property protection;
|
|
•
|
other costs in seeking regulatory approval of our products; and
|
|
•
|
allocated overhead.
|
|
|
For the Three Months Ended June 30,
|
|
For the Six Months Ended June 30,
|
||||||||||||
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
|
|
(dollars in thousands)
|
|
(dollars in thousands)
|
||||||||||||
|
SCY-078
|
$
|
3,233
|
|
|
$
|
1,198
|
|
|
$
|
6,928
|
|
|
$
|
2,039
|
|
|
Cyclophilin Inhibitor Platform
|
49
|
|
|
625
|
|
|
141
|
|
|
1,104
|
|
||||
|
Total research and development
|
$
|
3,282
|
|
|
$
|
1,823
|
|
|
$
|
7,069
|
|
|
$
|
3,143
|
|
|
•
|
a related party guarantee of our outstanding credit facility;
|
|
•
|
fair value adjustments to our derivative liability for warrants issued in conjunction with the related party convertible debt; and
|
|
•
|
a loss on extinguishment of debt.
|
|
•
|
Revenue
included in discontinued operations comprises revenue from the provision of our contract research and development services, which were provided by our Services Business. Our revenue recognition policy is described within Note 2 to our unaudited interim financial statements in Item 1 of this quarterly report.
|
|
•
|
Cost of revenue
included in discontinued operations primarily consists of salaries and personnel-related costs, including employee benefits and any stock-based compensation, incurred to generate our contract research and development services revenues. Additional expenses include facilities and equipment costs directly associated with generating revenue, allocated overhead, materials, contracted consultants and other direct costs. We allocate expenses associated with our facilities, information technology costs, and depreciation and amortization, between cost of revenue and operating expenses. Allocations are based on employee headcount or facility square footage utilization, and are determined by the nature of work performed.
|
|
•
|
Research and development expense
included in discontinued operations consists of expenses incurred under an animal health research and development project being conducted by our Services Business to advance and secure intellectual property protection for certain existing proprietary technology in the field of animal health. Research and development expense incurred under this project totaled $
0.4 million
and $
0.9 million
for the three and six months ended June 30, 2015, respectively, and zero for both the three and six months ended June 30, 2014. The nature of and accounting for research and development expenses included in discontinued operations is consistent with the research and development expenses included in continuing operations, as described above.
|
|
•
|
Gain on insurance recovery
included in discontinued operations relates to a reimbursement received from our insurance carrier in the quarter ended June 30, 2014, for the replacement cost of a fixed asset that was damaged by severe weather. The asset’s net book value was reduced upon occurrence of the damage. The proceeds received from the insurance recovery exceeded the net book value of the asset in the amount of $0.2
|
|
•
|
Severance costs
included in discontinued operations are exit and disposal costs directly attributable to the sale of the Services Business. As described in "Recent Developments" above, we terminated certain Service Business employees in June 2015 who became eligible for severance benefits pursuant to the terms of the Service Business Plan.
|
|
•
|
Impairment charge from classification of assets as held for sale
included in discontinued operations relates to the carrying value of Services Business property and equipment, net that was in excess of fair value less cost to sell. As described in Note 14 to our unaudited interim financial statements in Item 1, we met the relevant criteria for reporting the Services Business as held for sale and in discontinued operations as of June 30, 2015, pursuant to FASB Topic 205-20,
Presentation of Financial Statements--Discontinued Operations
, and FASB Topic 360,
Property, Plant, and Equipment
. As a result, we were required to assess the Services Business asset group for impairment pursuant to FASB Topic 360, which identified an impairment charge of
$1.4 million
for the three and six months ending June 30, 2015. To determine the impairment charge, pursuant to FASB Topic 360, the net carrying value of the Services Business asset group was compared to its fair value as of May 4, 2015. We determined that the selling price paid by Accuratus to acquire the Services Business asset group was the best estimate of fair value. Our valuation methodology is described further in Note 12 of the accompanying unaudited interim financial statements in Item I.
|
|
|
Six Months Ended
|
|||||||||||||||||||
|
|
June 30, 2015
|
|
June 30, 2014
|
|
Period-to-Period
Change
|
|||||||||||||||
|
|
Amount
|
|
Percentage of
Revenue
|
|
Amount
|
|
Percentage of
Revenue
|
|
Amount
|
|
Percentage
|
|||||||||
|
Total revenue and gross profit
|
$
|
129
|
|
|
100.0
|
%
|
|
$
|
130
|
|
|
100.0
|
%
|
|
$
|
(1
|
)
|
|
(0.8
|
)%
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Research and development
|
7,069
|
|
|
5,479.8
|
%
|
|
3,143
|
|
|
2,417.7
|
%
|
|
3,926
|
|
|
124.9
|
%
|
|||
|
Selling, general and administrative
|
5,485
|
|
|
4,251.9
|
%
|
|
3,461
|
|
|
2,662.3
|
%
|
|
2,024
|
|
|
58.5
|
%
|
|||
|
Total operating expenses
|
12,554
|
|
|
9,731.8
|
%
|
|
6,604
|
|
|
5,080.0
|
%
|
|
5,950
|
|
|
90.1
|
%
|
|||
|
Loss from operations
|
(12,425
|
)
|
|
(9,631.8
|
)%
|
|
(6,474
|
)
|
|
(4,980.0
|
)%
|
|
(5,951
|
)
|
|
91.9
|
%
|
|||
|
Other (income) expense:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Amortization of deferred financing costs and debt discount
|
—
|
|
|
—
|
|
|
755
|
|
|
580.8
|
%
|
|
(755
|
)
|
|
(100.0
|
)%
|
|||
|
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
1,389
|
|
|
—
|
|
|
(1,389
|
)
|
|
(100.0
|
)%
|
|||
|
Interest (income) expense
|
(2
|
)
|
|
—
|
|
|
49
|
|
|
37.7
|
%
|
|
(51
|
)
|
|
(104.1
|
)%
|
|||
|
Derivative fair value adjustment
|
—
|
|
|
—
|
|
|
(10,080
|
)
|
|
—
|
|
|
10,080
|
|
|
(100.0
|
)%
|
|||
|
Other expense
|
—
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
(10
|
)
|
|
(100.0
|
)%
|
|||
|
Total other (income) expense
|
(2
|
)
|
|
(1.6
|
)%
|
|
(7,877
|
)
|
|
(6,059.2
|
)%
|
|
7,875
|
|
|
(100.0
|
)%
|
|||
|
(Loss) income from continuing operations
|
(12,423
|
)
|
|
(9,630.2
|
)%
|
|
1,403
|
|
|
1,079.2
|
%
|
|
(13,826
|
)
|
|
(985.5
|
)%
|
|||
|
(Loss) income from discontinued operations
|
(3,458
|
)
|
|
(2,680.6
|
)%
|
|
1,242
|
|
|
955.4
|
%
|
|
(4,700
|
)
|
|
(378.4
|
)%
|
|||
|
Net (loss) income
|
$
|
(15,881
|
)
|
|
(12,310.9
|
)%
|
|
$
|
2,645
|
|
|
2,034.6
|
%
|
|
$
|
(18,526
|
)
|
|
(700.4
|
)%
|
|
|
Three Months Ended
|
|||||||||||||||||||
|
|
June 30, 2015
|
|
June 30, 2014
|
|
Period-to-Period
Change
|
|||||||||||||||
|
|
Amount
|
|
Percentage of
Revenue
|
|
Amount
|
|
Percentage of
Revenue
|
|
Amount
|
|
Percentage
|
|||||||||
|
Total revenue and gross profit
|
$
|
64
|
|
|
100.0
|
%
|
|
$
|
65
|
|
|
100.0
|
%
|
|
$
|
(1
|
)
|
|
(1.5
|
)%
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Research and development
|
3,282
|
|
|
5,128.1
|
%
|
|
1,823
|
|
|
2,804.6
|
%
|
|
1,459
|
|
|
80.0
|
%
|
|||
|
Selling, general and administrative
|
3,275
|
|
|
5,117.2
|
%
|
|
2,255
|
|
|
3,469.2
|
%
|
|
1,020
|
|
|
45.2
|
%
|
|||
|
Total operating expenses
|
6,557
|
|
|
10,245.3
|
%
|
|
4,078
|
|
|
6,273.8
|
%
|
|
2,479
|
|
|
60.8
|
%
|
|||
|
Loss from operations
|
(6,493
|
)
|
|
(10,145.3
|
)%
|
|
(4,013
|
)
|
|
(6,173.8
|
)%
|
|
(2,480
|
)
|
|
61.8
|
%
|
|||
|
Other (income) expense:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Amortization of deferred financing costs and debt discount
|
—
|
|
|
—
|
|
|
219
|
|
|
336.9
|
%
|
|
(219
|
)
|
|
(100.0
|
)%
|
|||
|
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
1,389
|
|
|
—
|
|
|
(1,389
|
)
|
|
(100.0
|
)%
|
|||
|
Interest (income) expense
|
(1
|
)
|
|
—
|
|
|
5
|
|
|
7.7
|
%
|
|
(6
|
)
|
|
(120.0
|
)%
|
|||
|
Derivative fair value adjustment
|
—
|
|
|
—
|
|
|
(7,297
|
)
|
|
—
|
|
|
7,297
|
|
|
(100.0
|
)%
|
|||
|
Total other (income) expense
|
(1
|
)
|
|
(1.6
|
)%
|
|
(5,684
|
)
|
|
(8,744.6
|
)%
|
|
5,683
|
|
|
(100.0
|
)%
|
|||
|
(Loss) income from continuing operations
|
(6,492
|
)
|
|
(10,143.8
|
)%
|
|
1,671
|
|
|
2,570.8
|
%
|
|
(8,163
|
)
|
|
(488.5
|
)%
|
|||
|
(Loss) income from discontinued operations
|
(3,005
|
)
|
|
(4,695.3
|
)%
|
|
562
|
|
|
864.6
|
%
|
|
(3,567
|
)
|
|
(634.7
|
)%
|
|||
|
Net (loss) income
|
$
|
(9,497
|
)
|
|
(14,839.1
|
)%
|
|
$
|
2,233
|
|
|
3,435.4
|
%
|
|
$
|
(11,730
|
)
|
|
(525.3
|
)%
|
|
|
For the Six Months Ended June 30,
|
||||||
|
|
2015
|
|
2014
|
||||
|
|
(unaudited; dollars in thousands)
|
||||||
|
Cash and cash equivalents, January 1
|
$
|
32,243
|
|
|
$
|
1,402
|
|
|
Net cash used in operating activities
|
(12,819
|
)
|
|
(4,068
|
)
|
||
|
Net cash used in investing activities
|
(527
|
)
|
|
(107
|
)
|
||
|
Net cash provided by financing activities
|
38,160
|
|
|
41,198
|
|
||
|
Net increase in cash and cash equivalents
|
24,814
|
|
|
37,023
|
|
||
|
Cash and cash equivalents, June 30
|
$
|
57,057
|
|
|
$
|
38,425
|
|
|
•
|
the progress, costs, and the clinical development of SCY-078;
|
|
•
|
the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;
|
|
•
|
the ability of product candidates to progress through clinical development successfully;
|
|
•
|
our need to expand our research and development activities;
|
|
•
|
the costs associated with the divestiture of our Services Business, including the costs associated with the Services Business Plan described in the "Recent Developments" section above;
|
|
•
|
the costs associated with the relocation of our corporate headquarters and operating activities to Jersey City, New Jersey, including the costs associated with the Retention Plan described in the "Recent Developments" section above;
|
|
•
|
the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;
|
|
•
|
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
|
|
•
|
our need and ability to hire additional management and scientific and medical personnel;
|
|
•
|
our need to implement additional internal systems and infrastructure, including financial and reporting systems associated with our pending relocation to New Jersey; and
|
|
•
|
the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
|
|
•
|
In May 2015, our board of directors approved, and we communicated, the material terms of our compensatory plan for the non-executive employees of our Services Business.
The compensatory plan is designed to promote the retention of services of such non-executive employees in connection with such a potential sale.
Our obligations under the compensatory plan were contingent upon the successful closing of the sale of the Services Business, which occurred in July 2015.
The material terms of the compensatory plan are described in the "Recent Developments" section above.
|
|
•
|
In May 2015, in connection with our planned relocation of our continuing operations to Jersey City, New Jersey, we designed a compensatory plan to promote the retention of services of non-executive employees supporting our continuing operations, which we refer to as the Retention Plan. The Retention Plan terms provide for certain cash compensation payments and severance payments, as well as modifications to the terms of currently outstanding stock options held by such non-executive employees. The material terms of the compensatory plan are described in the "Recent Developments" section above.
|
|
•
|
In May 2015, o
ur compensation committee of the board of directors approved a compensatory arrangement for our former chief financial officer that provided for certain payments and benefits in connection with his resignation effective June 30, 2015. The material terms of the compensatory arrangement are described in the "Recent Developments" section above.
|
|
•
|
In July 2015, we entered into a
compensatory arrangement for our former president that provided for certain payments and benefits in connection with his resignation effective July 21, 2015. The material terms of the compensatory arrangement are described in the "Recent Developments" section above.
|
|
•
|
In July 2015, we entered into a Commitment to Services Agreement with Accuratus pursuant to which Accuratus shall provide us with certain contract research and development services for eighteen months following the closing of the sale of the Services Business for a minimum, non-cancellable purchase price obligation on the part of us of at least $3.3 million over the initial term of the Services Agreement.
|
|
•
|
In July 2015, as a condition to the execution of the Asset Purchase Agreement, Accuratus assumed our post-closing obligation under our facility lease in Durham, North Carolina. We will continue to operate from the Durham facility immediately after the closing for a period of up to six months pursuant to a facility license and a transition services agreement. In addition, under a Transition Services Agreement, Accuratus will provide accounting, IT, payroll, personnel and human resources support, and equity compensation plan administration support services to us at rates ranging from
one hundred
to
two hundred
dollars per hour for a period of time not to extend beyond December 31, 2015.
|
|
•
|
In July 2015, in connection with the sale of the Services Business and our planned relocation of our continuing operations to Jersey City, New Jersey, we entered into the Sublease that became effective July 22, 2015, to sublet certain premises consisting of 10,141 square feet of space located at 101 Hudson Street, Jersey City, New Jersey from Optimer Pharmaceutical, Inc. The material terms of the Sublease are described in the "Recent Developments" section above.
|
|
•
|
In July 2015, in connection with the sale of the Services Business, contracts to provide services to Merial Limited and Elanco Animal Health, along with all other contracts directly associated with the Services Business, were assigned to Accuratus.
|
|
Item 3.
|
Quantitative and Qualitative Disclosure about Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
Item 1A.
|
Risk Factors
|
|
•
|
continue the development of SCY-078;
|
|
•
|
conduct ongoing and initiate new clinical trials for SCY-078;
|
|
•
|
seek marketing approvals for SCY-078;
|
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
|
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
|
•
|
hire additional clinical, quality control and scientific personnel; and
|
|
•
|
maintain and create additional infrastructure to support our operations as a public company.
|
|
•
|
the costs associated with developing SCY-078, which are difficult for us to predict;
|
|
•
|
any delays in regulatory review and approval of SCY-078;
|
|
•
|
delays in the timing of submission of a new drug application, or NDA, as well as commencement, enrollment and the timing of clinical testing, of SCY-078 or any other product candidates we may seek to develop;
|
|
•
|
our ability to commercialize product candidates, both in the United States and overseas, if we are able to obtain regulatory approval to do so;
|
|
•
|
the costs associated with obtaining and maintaining regulatory approval and ongoing company compliance and product compliance for SCY-078;
|
|
•
|
market acceptance of SCY-078 and any future product candidates we may seek to develop;
|
|
•
|
changes in regulations and regulatory policies;
|
|
•
|
competition from existing products or new products that may emerge;
|
|
•
|
the ability of patients or healthcare providers to obtain coverage of, or sufficient reimbursement for, any products we are able to develop;
|
|
•
|
our ability to establish or maintain collaborations, licensing or other arrangements;
|
|
•
|
costs related to, and outcomes of, potential litigation;
|
|
•
|
potential product liability claims; and
|
|
•
|
potential liabilities associated with hazardous materials.
|
|
•
|
significantly delay, scale back or discontinue the development or commercialization of SCY-078 and any future product candidates we may seek to develop;
|
|
•
|
seek strategic alliances for research and development programs at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
|
|
•
|
relinquish or license on unfavorable terms our rights to any product candidates that we otherwise would seek to develop or commercialize ourselves.
|
|
•
|
inability to reach agreements on acceptable terms with prospective clinical research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
|
•
|
difficulty identifying and engaging qualified clinical investigators;
|
|
•
|
regulatory objections to commencing a clinical trial or proceeding to the next phase of investigation, including inability to reach agreement with the FDA or non-U.S. regulators regarding the scope or design of our clinical trials or for other reasons such as safety concerns that might be identified during preclinical development or early stage clinical trials;
|
|
•
|
inability to identify and maintain a sufficient number of eligible trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates;
|
|
•
|
withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care;
|
|
•
|
inability to obtain institutional review board (or ethics review committee) approval to conduct a clinical trial at prospective sites;
|
|
•
|
difficulty identifying, recruiting and enrolling eligible patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as product candidates we seek to commercialize;
|
|
•
|
inability to retain patients in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy; and
|
|
•
|
inability to obtain sufficient funding to commence a clinical trial.
|
|
•
|
failure by us, CROs or clinical investigators to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
|
•
|
failed inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;
|
|
•
|
unforeseen safety or efficacy issues or any determination that a clinical trial presents unacceptable health risks; or
|
|
•
|
lack of adequate funding to continue the clinical trial due to unforeseen costs resulting from enrollment delays, requirements to conduct additional trials and studies, increased expenses associated with the services of our CROs and other third parties, or other reasons.
|
|
•
|
limitations or warnings contained in the FDA-approved labeling;
|
|
•
|
changes in the standard of care for the targeted indications;
|
|
•
|
limitations in the approved indications;
|
|
•
|
availability of alternative therapies with potentially advantageous results, or other products with similar results at similar or lower cost, including generics and over-the-counter products;
|
|
•
|
lower demonstrated clinical safety or efficacy compared to other products;
|
|
•
|
occurrence of significant adverse side effects;
|
|
•
|
ineffective sales, marketing and distribution support;
|
|
•
|
lack of availability of reimbursement from managed care plans and other third-party payors;
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•
|
timing of market introduction and perceived effectiveness of competitive products;
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•
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lack of cost-effectiveness;
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•
|
adverse publicity about our product candidates or favorable publicity about competitive products;
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•
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lack of convenience and ease of administration; and
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•
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potential product liability claims.
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•
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regulatory authorities may require the addition of labeling statements, specific warnings, precautions, contraindications or field alerts to physicians and pharmacies;
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•
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we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;
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•
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we may have limitations on how we promote the product;
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•
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sales of the product may decrease significantly;
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•
|
regulatory authorities may require us to take our approved product off the market;
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•
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we may be subject to litigation or product liability claims; and
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•
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our reputation may suffer.
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•
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resources, including capital, personnel and technology;
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•
|
research and development capability;
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•
|
clinical trial expertise;
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•
|
regulatory expertise;
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•
|
intellectual property portfolios;
|
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•
|
expertise in prosecution of intellectual property rights;
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•
|
manufacturing and distribution expertise; and
|
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•
|
sales and marketing expertise.
|
|
•
|
SCY-078 and any future product candidates we may seek to develop may not generate preclinical or clinical data that are deemed sufficient by regulators in a given jurisdiction;
|
|
•
|
SCY-078 may not be approved for all indications requested, or any indications at all, in a given jurisdiction which could limit the uses of SCY-078 and any future product candidates we may seek to develop and have an adverse effect on product sales and potential royalties; and
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•
|
such approval in a given jurisdiction may be subject to limitations on the indicated uses for which the product may be marketed or require costly post-marketing follow-up studies.
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•
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issue warning letters;
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•
|
mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners;
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•
|
require us or our partners to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
|
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•
|
impose other civil or criminal penalties;
|
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•
|
suspend regulatory approval;
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•
|
suspend any ongoing clinical trials;
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•
|
refuse to approve pending applications or supplements to approved applications filed by us, our partners or our potential future partners;
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•
|
impose restrictions on operations, including costly new manufacturing requirements; or
|
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•
|
seize or detain products or require a product recall.
|
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•
|
the possible breach of the manufacturing agreements or violation of regulatory standards by the third parties because of factors beyond our control; and
|
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•
|
the possibility of termination or nonrenewal of the agreements by the third parties because of our breach of the manufacturing agreement or based on their own business priorities.
|
|
•
|
others may be able to make compounds that are similar to SCY-078 and any future product candidates we may seek to develop but that are not covered by the claims of our patents;
|
|
•
|
if we encounter delays in our clinical trials, the period of time during which we could market our drug candidates under patent protection would be reduced;
|
|
•
|
we might not have been the first to conceive, make or disclose the inventions covered by our patents or pending patent applications;
|
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•
|
we might not have been the first to file patent applications for these inventions;
|
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•
|
any patents that we obtain may be invalid or unenforceable or otherwise may not provide us with any competitive advantages; or
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•
|
the patents of others may have a material adverse effect on our business.
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•
|
successfully attract and recruit new employees with the expertise and experience we will require;
|
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•
|
manage our clinical programs effectively, which we anticipate being conducted at numerous clinical sites;
|
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•
|
develop a marketing and sales infrastructure; and
|
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•
|
continue to develop our operational, financial and management controls, reporting systems and procedures.
|
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•
|
withdrawal of clinical trial participants;
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•
|
termination of clinical trial sites or entire trial programs;
|
|
•
|
costs of related litigation;
|
|
•
|
substantial monetary awards to patients or other claimants;
|
|
•
|
decreased demand for product candidates and loss of revenue;
|
|
•
|
impairment of our business reputation;
|
|
•
|
diversion of management and scientific resources from our business operations; and
|
|
•
|
the inability to commercialize product candidates.
|
|
•
|
the results of our preclinical testing or clinical trials;
|
|
•
|
the ability to obtain additional funding;
|
|
•
|
any delay in filing an NDA or similar foreign applications for SCY-078 and any future product candidate we may seek to develop or any adverse development or perceived adverse development with respect to the FDA’s review of that NDA or a foreign regulator’s review of a similar applications;
|
|
•
|
maintenance of our existing collaborations or ability to enter into new collaborations;
|
|
•
|
our collaboration partners’ election to develop or commercialize product candidates under our collaboration agreements or the termination of any programs under our collaboration agreements;
|
|
•
|
any intellectual property infringement actions in which we or our licensors and collaboration partners may become involved;
|
|
•
|
our ability to successfully develop and commercialize future product candidates;
|
|
•
|
changes in laws or regulations applicable to future products;
|
|
•
|
adverse regulatory decisions;
|
|
•
|
introduction of new products, services or technologies by our competitors;
|
|
•
|
achievement of financial projections we may provide to the public;
|
|
•
|
achievement of the estimates and projections of the investment community;
|
|
•
|
the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
|
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our collaboration partners or our competitors;
|
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
|
•
|
legislation or regulation that mandates or encourages the use of generic products;
|
|
•
|
additions or departures of key scientific or management personnel;
|
|
•
|
significant lawsuits, including patent or stockholder litigation;
|
|
•
|
changes in the market valuations of similar companies;
|
|
•
|
general economic and market conditions and overall fluctuations in the U.S. equity markets;
|
|
•
|
sales of our common stock by us, our executive officers and directors or our stockholders in the future; and
|
|
•
|
trading volume of our common stock.
|
|
•
|
the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
|
|
•
|
the obligation to provide three years of audited financial statements;
|
|
•
|
the “say on pay” provisions, requiring a non-binding stockholder vote to approve compensation of certain executive officers, and the “say on golden parachute” provisions, requiring a non-binding stockholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain other business combinations, of the Dodd-Frank Act and some of the disclosure requirements of the Dodd-Frank Act relating to compensation of our chief executive officer;
|
|
•
|
the requirement to provide detailed compensation discussion and analysis in proxy statements and reports filed under the Exchange Act, and instead provide a reduced level of disclosure concerning executive compensation; and
|
|
•
|
any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
|
Item 6.
|
Exhibits
|
|
SCYNEXIS, INC.
|
||
|
|
|
|
|
By:
|
|
/s/ Marco Taglietti, M.D.
|
|
|
|
Marco Taglietti, M.D.
|
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
Date:
|
|
August 19, 2015
|
|
|
|
|
|
By:
|
|
/s/ Jonathan Sears Woodall
|
|
|
|
Jonathan Sears Woodall
Interim Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
Date:
|
|
August 19, 2015
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
2.1
|
|
Asset Purchase Agreement, dated July 17, 2015, between the Company and Accuratus Lab Services, Inc. (Filed with the SEC as Exhibit 10.1 to our current report on Form 8-K, filed with the SEC on July 23, 2015, SEC File No. 001-36365, and incorporated by reference here).
|
|
|
|
|
|
3.1
|
|
Amended and Restated Certificate of Incorporation (Filed with the SEC as Exhibit 3.1 to our current report on Form 8-K, filed with the SEC on May 12, 2014, SEC File No. 001-36365, and incorporated by reference here).
|
|
|
|
|
|
3.2
|
|
Amended and Restated By-Laws (Filed with the SEC as Exhibit 3.4 to our Registration Statement on Form S-1, filed with the SEC on February 27, 2014, SEC File No. 333-194192, and incorporated by reference here).
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibits 3.1 and 3.2.
|
|
|
|
|
|
4.2
|
|
Fifth Amended and Restated Investor Rights Agreement, dated December 11, 2013 (Filed with the SEC as Exhibit 10.21 to our Registration Statement on Form S-1, filed with the SEC on February 27, 2014, SEC File No. 333-194192).
|
|
|
|
|
|
10.1
|
|
Compensation arrangement with non-employee directors.
|
|
|
|
|
|
10.2
|
|
2015 Inducement Award Plan (Filed with the SEC as 10.34 to our Registration Statement on Form S-1, filed with the SEC on April 9, 2015, SEC File No. 333-203314, and incorporated by reference here).
|
|
|
|
|
|
10.3
|
|
2014 Equity Incentive Plan (Filed with the SEC as Annex A to our proxy statement on Schedule 14A, filed with the SEC on April 22, 2015, SEC File No. 001-36365, and incorporated by reference here).
|
|
|
|
|
|
10.4
|
|
Release and Settlement Agreement, dated June 30, 2015, between the Company and Charles F. Osborne, Jr.
|
|
|
|
|
|
10.5
|
|
Sublease Agreement, dated July 13, 2015, between the Company and Optimer Pharmaceuticals, Inc. (Filed with the SEC as Exhibit 10.2 to our current report on Form 8-K, filed with the SEC on July 23, 2015, SEC File No. 001-36365, and incorporated by reference here).
|
|
|
|
|
|
10.6
|
|
Release And Settlement Agreement, dated July 21, 2015, between the Company and Yves Ribeill (Filed with the SEC as Exhibit 10.3 to our current report on Form 8-K, filed with the SEC on July 23, 2015, SEC File No. 001-36365, and incorporated by reference here).
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rule 13-a-14(a) or Rule 15(d)-14(a) of the Exchange Act
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act
|
|
|
|
|
|
32.1
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 13a-14(b) or 15d-14(b) of the Exchange Act
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Schema Linkbase Document
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Calculation Linkbase Document
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Definition Linkbase Document
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Labels Linkbase Document
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Presentation Linkbase Document
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|