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Delaware
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001-31564
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87-0458888
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(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer
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of incorporation)
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Identification No.)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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PAGE
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March 31, 2015
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December 31, 2014
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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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33,301
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$
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37,495
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Accounts receivable, net of allowance for doubtful accounts of $17 and $17, respectively
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3
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|
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4
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Inventory
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544
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571
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Prepaid expenses and other current assets
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1,078
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1,279
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Total current assets
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34,926
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39,349
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Property and equipment, net of accumulated depreciation of $1,053 and $1,051, respectively
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1,704
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1,598
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Intangible assets, net of accumulated amortization of $1,791 and $1,653, respectively
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4,549
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4,687
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Total assets
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$
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41,179
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$
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45,634
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Liabilities and Stockholders’ Equity
|
|
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Current liabilities:
|
|
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Accounts payable
|
$
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1,898
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$
|
1,124
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Accrued expenses
|
2,697
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|
1,675
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||
Deferred revenue
|
588
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416
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Warrant liability, current
|
851
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278
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|
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Total current liabilities
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6,034
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3,493
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Warrant liability, long term
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12,098
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11,008
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Other long term liabilities
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771
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724
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Total liabilities
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18,903
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15,225
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Stockholders’ equity:
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares outstanding
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—
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—
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Common stock, $0.001 par value; 100,000,000 shares authorized; 40,888,065 and 40,856,815 shares issued and outstanding, respectively
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41
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41
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Additional paid-in capital
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143,478
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143,086
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Accumulated deficit
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(121,243
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)
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(112,718
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)
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Total stockholders’ equity
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22,276
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30,409
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Total liabilities and stockholders’ equity
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$
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41,179
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$
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45,634
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Three months ended March 31, 2015
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Three months ended March 31, 2014
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||||
Product sales
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$
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113
|
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$
|
46
|
|
Collaboration revenue
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81
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|
—
|
|
||
Total revenues
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194
|
|
|
46
|
|
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Cost of revenues
|
147
|
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|
793
|
|
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Gross profit (loss)
|
47
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(747
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)
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Research and development expense
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3,987
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7,915
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Selling, general and administrative expense
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2,924
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2,338
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Operating loss
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(6,864
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)
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(11,000
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)
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Other income (expense):
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Warrant revaluation and other finance expense
|
(1,663
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)
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(3,050
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)
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Other income
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—
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|
|
40
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|
||
Interest income
|
2
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|
|
1
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|
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Loss before income taxes
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(8,525
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)
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(14,009
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)
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Deferred tax benefit
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—
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—
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Net loss
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$
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(8,525
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)
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$
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(14,009
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)
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||||
Per Share Information:
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Net loss:
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||||
Basic and diluted
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$
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(0.21
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)
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$
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(0.35
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)
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Weighted average number of common shares outstanding
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Basic and diluted
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40,861,329
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40,583,591
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Common Stock
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Additional paid-in capital
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Accumulated deficit
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Total Equity
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|||||||||||
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Shares
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Amount
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||||||||||||
Balance, December 31, 2014
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40,856,815
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$
|
41
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$
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143,086
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$
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(112,718
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)
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$
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30,409
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Stock-based compensation expense
|
—
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—
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240
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|
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—
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240
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|
||||
Exercise of stock options
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31,250
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|
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—
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152
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—
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152
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|
||||
Net loss
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—
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—
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—
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(8,525
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)
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(8,525
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)
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||||
Balance, March 31, 2015
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40,888,065
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$
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41
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$
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143,478
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$
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(121,243
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)
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$
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22,276
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Three months ended March 31, 2015
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Three months ended March 31, 2014
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||||
Cash flows from operating activities:
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Net loss
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$
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(8,525
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)
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$
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(14,009
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)
|
Adjustments to reconcile net loss to net cash used in operating activities:
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|
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Stock-based compensation expense
|
240
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|
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303
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|
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Stock issued for supplemental stock issuance agreement
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—
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5,154
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|
||
Warrant revaluation and other finance expense
|
1,663
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|
|
3,050
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|
||
Depreciation and amortization
|
140
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|
|
222
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|
||
Provision for doubtful accounts
|
—
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|
5
|
|
||
Change in operating assets and liabilities:
|
|
|
|
|
|
||
Accounts receivable
|
1
|
|
|
(35
|
)
|
||
Inventory
|
27
|
|
|
91
|
|
||
Prepaid expenses and other current assets
|
201
|
|
|
317
|
|
||
Other assets
|
—
|
|
|
72
|
|
||
Accounts payable
|
774
|
|
|
(2,055
|
)
|
||
Accrued expenses and other long-term liabilities
|
1,069
|
|
|
931
|
|
||
Deferred revenue
|
172
|
|
|
1
|
|
||
Net cash used in operating activities
|
(4,238
|
)
|
|
(5,953
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
||
Purchase of property and equipment
|
(108
|
)
|
|
(79
|
)
|
||
Net cash used in investing activities
|
(108
|
)
|
|
(79
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
|
||
Proceeds from the issuance of common stock
|
152
|
|
|
—
|
|
||
Net cash provided by financing activities
|
152
|
|
|
—
|
|
||
Net decrease in cash and cash equivalents
|
(4,194
|
)
|
|
(6,032
|
)
|
||
Cash and cash equivalents, beginning of period
|
37,495
|
|
|
60,033
|
|
||
Cash and cash equivalents, end of period
|
$
|
33,301
|
|
|
$
|
54,001
|
|
($ in thousands)
|
March 31, 2015
|
|
December 31, 2014
|
|||||
Raw materials
|
$
|
355
|
|
|
$
|
357
|
|
|
Work in process
|
189
|
|
|
214
|
|
|||
Inventory
|
$
|
544
|
|
|
$
|
571
|
|
|
Number of Warrants
|
|
|
|
|
||||||
Liability-classified warrants
|
March 31, 2015
|
|
December 31, 2014
|
|
Exercise
Price
|
|
Expiration
Dates
|
||||
Issued in Series A, B and D Preferred Stock offerings
|
2,247,118
|
|
|
2,247,118
|
|
|
$
|
6.25
|
|
|
Oct 2015 - Dec 2016
|
Issued in March 2010 financing
|
393,416
|
|
|
393,416
|
|
|
$
|
6.25
|
|
|
Mar 2016
|
Issued in June 2011 financing
|
6,113
|
|
|
6,113
|
|
|
$
|
22.50
|
|
|
Jun 2016
|
Issued in August 2011 financing
|
565,759
|
|
|
565,759
|
|
|
$
|
18.75
|
|
|
Aug 2016
|
Issued to placement agents in August 2011 financing
|
50,123
|
|
|
50,123
|
|
|
$
|
13.635
|
|
|
Aug 2016
|
Issued in Series B, D and E Preferred Stock offerings
|
76,120
|
|
|
76,120
|
|
|
$
|
2.50
|
|
|
Nov 2015 - Dec 2017
|
Issued with Convertible Notes
|
1,125,578
|
|
|
1,125,578
|
|
|
$
|
2.50
|
|
|
Jun 2018
|
Issued in Series E Preferred Stock offering
|
1,568,823
|
|
|
1,568,823
|
|
|
$
|
7.50
|
|
|
Dec 2018
|
Total
|
6,033,050
|
|
|
6,033,050
|
|
|
|
|
|
|
($ in thousands)
|
March 31, 2015
|
|
December 31, 2014
|
||||
Calculated aggregate value
|
$
|
12,949
|
|
|
$
|
11,286
|
|
Weighted average exercise price per share
|
$
|
7.08
|
|
|
$
|
7.08
|
|
Closing price per share of common stock
|
$
|
4.51
|
|
|
$
|
2.59
|
|
Volatility
|
78.5
|
%
|
|
67.6
|
%
|
||
Weighted average remaining expected life
|
2 years, 4 months
|
|
|
2 years, 7 months
|
|
||
Risk-free interest rate
|
0.63
|
%
|
|
0.86
|
%
|
||
Dividend yield
|
—
|
|
|
—
|
|
|
Fair value measurement using
|
||||||||||||||
($ in thousands)
|
Quoted prices in
active markets (Level 1)
|
|
Significant
other
observable
inputs (Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Balance at March 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
33,301
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,301
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,949
|
|
|
$
|
12,949
|
|
|
Fair value measurement using
|
||||||||||||||
($ in thousands)
|
Quoted prices in
active markets (Level 1)
|
|
Significant
other
observable
inputs (Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Balance at December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
37,495
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
37,495
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,286
|
|
|
$
|
11,286
|
|
|
Warrant
|
||
($ in thousands)
|
Liability
|
||
Balance at December 31, 2014
|
$
|
11,286
|
|
Exercise of warrants
|
—
|
|
|
Change in fair value of warrant liability
|
1,663
|
|
|
Balance at March 31, 2015
|
$
|
12,949
|
|
|
Three months ended March 31,
|
||||||
($ in thousands)
|
2015
|
|
2014
|
||||
Stock option compensation expense for employees and directors
|
$
|
240
|
|
|
$
|
300
|
|
Equity awards for non-employees issued for services
|
—
|
|
|
3
|
|
||
Total stock-based compensation expense
|
$
|
240
|
|
|
$
|
303
|
|
($ in thousands except share and per share data)
|
Number of
shares
|
|
Weighted-
average
exercise
price
|
|
Weighted-average
remaining
contractual
term (in
years)
|
|
Aggregate
intrinsic
value ($ in thousands)
|
|||||
Outstanding at December 31, 2014
|
2,086,450
|
|
|
$
|
7.43
|
|
|
8 years
|
|
$
|
—
|
|
Granted
|
830,300
|
|
|
4.13
|
|
|
|
|
|
|
||
Exercised
|
(31,250
|
)
|
|
4.86
|
|
|
|
|
|
|
||
Forfeited
|
—
|
|
|
—
|
|
|
|
|
|
|
||
Expired
|
—
|
|
|
—
|
|
|
|
|
|
|
||
Outstanding at March 31, 2015
|
2,885,500
|
|
|
$
|
6.51
|
|
|
8 years, 4 months
|
|
$
|
1,510
|
|
Exercisable at March 31, 2015
|
1,162,250
|
|
|
$
|
10.25
|
|
|
7 years, 3 months
|
|
$
|
349
|
|
|
March 31, 2015
|
|
March 31, 2014
|
||
Expected life
|
6 years, 2 months
|
|
|
6 years, 3 months
|
|
Interest rate
|
1.48
|
%
|
|
1.99
|
%
|
Dividend yield
|
—
|
|
|
—
|
|
Volatility
|
106.3
|
%
|
|
71.0
|
%
|
•
|
the progress and results of our pre-clinical studies and human clinical trials of our cell and gene-therapy drug candidates, including, in particular, those for chronic dysphonia caused by vocal cord scarring or atrophy, recessive dystrophic epidermolysis bullosa and linear scleroderma, and such other target indications as we may identify and pursue, can be conducted within the timeframe that we expect, whether such studies and trials will yield positive results, or whether additional applications for the commercialization of autologous cell therapy can be identified by us and advanced into human clinical trials;
|
•
|
the cost of manufacturing related to our pre-clinical studies and clinical trials;
|
•
|
our ability to meet requisite regulations or receive regulatory approvals in the United States and in Europe, our ability to retain any regulatory approvals that we may obtain and the absence of adverse regulatory developments in the United States and Europe;
|
•
|
the costs, timing and outcome of regulatory review of our drug candidates;
|
•
|
the dependence on our facility in Exton, Pennsylvania for the research, development and manufacturing operations of our cell therapy products, and the potential that such facility is damaged or if we are otherwise required to discontinue research, development and production at such facility;
|
•
|
the dependence on our third party facility in Mountainview, California for the research, development and manufacturing operations of our gene-therapy products, and the potential that such facility is damaged or if we are otherwise required to discontinue research, development and production at such facility;
|
•
|
whether our collaboration with Intrexon can be advanced with positive results within the timeframe and budget that we expect;
|
•
|
our dependence on suppliers for cell and gene-therapy products which are critical to the completion of our gene-therapy applications;
|
•
|
the scope, progress, results and costs of pre-clinical development, laboratory testing and clinical trials for our cell and gene-therapy applications;
|
•
|
the number and development requirements of other product candidates that we pursue;
|
•
|
the emergence of competing technologies and other adverse market developments;
|
•
|
the extent to which we acquire or invest in businesses, products and technologies;
|
•
|
our ability to establish collaborations and obtain milestone, royalty or other payments from any such collaborators;
|
•
|
any adverse claims relating to our intellectual property and the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property related claims; and
|
•
|
our dependence on physicians to correctly follow our established protocols for the safe and optimal administration of our product.
|
|
Three months ended
March 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Product sales
|
$
|
113
|
|
|
$
|
46
|
|
|
$
|
67
|
|
|
145.7
|
%
|
Collaboration revenue
|
81
|
|
|
—
|
|
|
81
|
|
|
100.0
|
%
|
|||
Total revenues
|
194
|
|
|
46
|
|
|
148
|
|
|
321.7
|
%
|
|||
Cost of revenues
|
147
|
|
|
793
|
|
|
(646
|
)
|
|
(81.5
|
)%
|
|||
Gross profit (loss)
|
$
|
47
|
|
|
$
|
(747
|
)
|
|
$
|
794
|
|
|
(106.3
|
)%
|
|
Three months ended
March 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
azficel-T for chronic dysphonia
|
$
|
288
|
|
|
$
|
88
|
|
|
$
|
200
|
|
|
227.3
|
%
|
FCX-007
|
1,322
|
|
|
705
|
|
|
617
|
|
|
87.5
|
%
|
|||
FCX-013
|
450
|
|
|
184
|
|
|
266
|
|
|
144.6
|
%
|
|||
Ehlers-Danlos Syndrome (hypermobility type)
|
—
|
|
|
5,154
|
|
|
(5,154
|
)
|
|
(100.0
|
)%
|
|||
Other
|
38
|
|
|
109
|
|
|
(71
|
)
|
|
(65.1
|
)%
|
|||
Total direct costs
|
2,098
|
|
|
6,240
|
|
|
(4,142
|
)
|
|
(66.4
|
)%
|
|||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
241
|
|
|
165
|
|
|
76
|
|
|
46.1
|
%
|
|||
Intangible amortization
|
138
|
|
|
138
|
|
|
—
|
|
|
—
|
|
|||
Compensation and related expense
|
235
|
|
|
72
|
|
|
163
|
|
|
226.4
|
%
|
|||
Process development
|
20
|
|
|
42
|
|
|
(22
|
)
|
|
(52.4
|
)%
|
|||
Other indirect R&D costs
|
1,255
|
|
|
1,258
|
|
|
(3
|
)
|
|
(0.2
|
)%
|
|||
Total indirect costs
|
1,889
|
|
|
1,675
|
|
|
214
|
|
|
12.8
|
%
|
|||
Total research and development expense
|
$
|
3,987
|
|
|
$
|
7,915
|
|
|
$
|
(3,928
|
)
|
|
(49.6
|
)%
|
|
Three months ended
March 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Compensation and related expense
|
$
|
887
|
|
|
$
|
966
|
|
|
$
|
(79
|
)
|
|
(8.2
|
)%
|
Professional fees
|
370
|
|
|
444
|
|
|
(74
|
)
|
|
(16.7
|
)%
|
|||
Legal expense
|
822
|
|
|
160
|
|
|
662
|
|
|
413.8
|
%
|
|||
Facilities and related expense and other
|
845
|
|
|
768
|
|
|
77
|
|
|
10.0
|
%
|
|||
Total selling, general and administrative expense
|
$
|
2,924
|
|
|
$
|
2,338
|
|
|
$
|
586
|
|
|
25.1
|
%
|
Statement of Cash Flows Data:
|
Three months ended
March 31, |
||||||
($ in thousands)
|
2015
|
|
2014
|
||||
Cash used in operating activities
|
$
|
(4,238
|
)
|
|
$
|
(5,953
|
)
|
Cash used in investing activities
|
$
|
(108
|
)
|
|
$
|
(79
|
)
|
Cash provided by financing activities
|
$
|
152
|
|
|
$
|
—
|
|
EXHIBIT NO.
|
|
IDENTIFICATION OF EXHIBIT
|
3.1*
|
|
Fourth Amended and Restated Bylaws
|
3.2*
|
|
Amendment to the Fourth Amended and Restated Bylaws, effective April 20, 2015
|
10.1
|
|
Employment Agreement, dated March 18, 2015, by and between Fibrocell Science, Inc. and Keith A. Goldan (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on March 18, 2015)
|
10.2*
|
|
Form of Nonqualified Stock Option Agreement for Employee Grants
|
10.3*
|
|
Form of Nonqualified Stock Option Agreement for Director Grants
|
10.4*
|
|
Form of Incentive Stock Option Agreement for Employee Grants
|
31.1*
|
|
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2*
|
|
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1*
|
|
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2*
|
|
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
101.INS
|
|
XBRL Instance Document.
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
FIBROCELL SCIENCE, INC.
|
|
|
|
|
|
By:
|
/s/ Keith A. Goldan
|
|
|
Keith A. Goldan
|
|
|
SVP and Chief Financial Officer
|
|
|
|
|
Date: May 8, 2015
|
|
EXHIBIT NO.
|
|
IDENTIFICATION OF EXHIBIT
|
3.1*
|
|
Fourth Amended and Restated Bylaws
|
3.2*
|
|
Amendment to the Fourth Amended and Restated Bylaws, effective April 20, 2015
|
10.2*
|
|
Form of Nonqualified Stock Option Agreement for Employee Grants
|
10.3*
|
|
Form of Nonqualified Stock Option Agreement for Director Grants
|
10.4*
|
|
Form of Incentive Stock Option Agreement for Employee Grants
|
31.1*
|
|
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2*
|
|
Certification pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1*
|
|
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2*
|
|
Certification pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
101.INS
|
|
XBRL Instance Document.
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
1.
|
Grant of Option
. Subject to the terms and conditions set forth in this Agreement and in the Plan, the Company hereby grants to the Grantee a nonqualified stock option (the “Option”) to purchase ___________ shares of common stock of the Company (“Shares”) at an exercise price of $_________ per Share. The Option shall become exercisable according to Paragraph 2 below.
|
|
Date
|
Shares for Which the Option is Exercisable
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
3.
|
Term of Option
.
|
4.
|
Exercise Procedures
.
|
1.
|
Grant of Option
. Subject to the terms and conditions set forth in this Agreement and in the Plan, the Company hereby grants to the Grantee a nonqualified stock option (the “Option”) to purchase ___________ shares of common stock of the Company (“Shares”) at an exercise price of $_________ per Share. The Option shall become exercisable according to Paragraph 2 below.
|
|
Date
|
Shares for Which the Option is Exercisable
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
3.
|
Term of Option
. The Option shall have a term of ten years from the Date of Grant and shall terminate at the expiration of that period, unless it is terminated at an earlier date pursuant to the provisions of this Agreement or the Plan. Notwithstanding anything to the contrary in the Plan, the Option shall not terminate due to the termination of service, death, or Disability of the Grantee.
|
1.
|
Grant of Option
.
|
|
Date
|
Shares for Which the Option is Exercisable
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
|
______________________
|
_____________
|
|
3.
|
Term of Option
.
|
4.
|
Exercise Procedures
.
|
5.
|
Designation as Incentive Stock Option
.
|
Date:
|
May 8, 2015
|
|
By:
|
/s/ David Pernock
|
|
|
David Pernock
|
|
|
Chief Executive Officer
|
|
|
|
|
Date:
|
May 8, 2015
|
|
By:
|
/s/ Keith A. Goldan
|
|
|
Keith A. Goldan
|
|
|
SVP and Chief Financial Officer
|
|
|
|
|
Date:
|
May 8, 2015
|
|
By:
|
/s/ David Pernock
|
|
|
David Pernock
|
|
|
Chief Executive Officer
|
|
|
|
|
Date:
|
May 8, 2015
|
|
By:
|
/s/ Keith A. Goldan
|
|
|
Keith A. Goldan
|
|
|
SVP and Chief Financial Officer
|
|
|
|
|