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Delaware
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87-0458888
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(State or other jurisdiction of incorporation)
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(I.R.S. Employer Identification No.)
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
ý
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Emerging growth company
o
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PAGE
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•
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our expectation that our existing cash resources will be sufficient to enable us to fund our operations into the second quarter of 2018;
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•
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future expenses and capital expenditures;
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•
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our plans to address our future capital requirements and the consequences of failing to do so;
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•
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our expectation to have three-month data for the Phase 1 portion of our Phase 1/2 clinical trial of FCX-007 in the third quarter of 2017 and to initiate the Phase 2 portion of the trial in the fourth quarter of 2017;
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•
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our expectation to complete a toxicology/biodistribution study and submit an Investigational New Drug application (IND) for FCX-013 to the United States Food and Drug Administration (FDA) in the fourth quarter of 2017;
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•
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our product development goals under our collaborations with Intrexon Corporation for all of our product candidates;
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•
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the potential benefits of Fast Track, Orphan Drug and Rare Pediatric Disease designations;
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•
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the potential advantages of our product candidates and technologies; and
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•
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the effect of legal and regulatory developments;
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March 31,
2017
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December 31,
2016
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||||
Assets
|
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Current assets:
|
|
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Cash and cash equivalents
|
$
|
20,560
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$
|
17,515
|
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Prepaid expenses and other current assets
|
564
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|
513
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Total current assets
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21,124
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18,028
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Property and equipment, net of accumulated depreciation of $1,636 and $1,561, respectively
|
1,468
|
|
|
1,489
|
|
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Other assets
|
99
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|
|
65
|
|
||
Total assets
|
$
|
22,691
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$
|
19,582
|
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||||
Liabilities and Stockholders’ Equity
|
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Current liabilities:
|
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Accounts payable
|
$
|
566
|
|
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$
|
440
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Related party payable
|
1,509
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|
|
942
|
|
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Accrued expenses
|
856
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|
|
1,551
|
|
||
Warrant liability, current
|
29
|
|
|
54
|
|
||
Total current liabilities
|
2,960
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|
|
2,987
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|
||
Convertible promissory notes, net of debt discount of $18,088 (see Note 4)
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—
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|
|
—
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Accrued interest payable
|
411
|
|
|
228
|
|
||
Warrant liability, long term
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6,010
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|
5,980
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|
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Derivative liability
|
2,047
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|
|
1,735
|
|
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Deferred rent
|
794
|
|
|
791
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|
||
Total liabilities
|
12,222
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|
11,721
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|
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||||
Stockholders’ equity:
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Preferred stock, $0.001 par value; 5,000,000 shares authorized:
|
|
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||||
Series A nonredeemable convertible preferred stock; 8,000 shares designated, 8,000 shares issued and outstanding as of March 31, 2017; no shares designated, issued or outstanding as of December 31, 2016; aggregate liquidation preference of $8,020 at March 31, 2017
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—
|
|
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—
|
|
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Common stock, $0.001 par value; 150,000,000 shares authorized, 14,695,076 and 14,688,135 shares issued and outstanding, respectively
|
15
|
|
|
15
|
|
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Additional paid-in capital
|
178,024
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|
|
170,409
|
|
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Accumulated deficit
|
(167,570
|
)
|
|
(162,563
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)
|
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Total stockholders’ equity
|
10,469
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|
|
7,861
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|
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Total liabilities and stockholders’ equity
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$
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22,691
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$
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19,582
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|
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Three Months Ended March 31,
|
||||||
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2017
|
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2016
|
||||
Revenue from product sales
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$
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—
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$
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12
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Collaboration revenue
|
—
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4
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|
||
Total revenue
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—
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|
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16
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|
||
Cost of product sales
|
—
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17
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|
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Cost of collaboration revenue
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—
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1
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|
||
Total cost of revenue
|
—
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18
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|
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Gross loss
|
—
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(2
|
)
|
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Research and development expense
|
1,464
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2,602
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|
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Research and development expense - related party (see Note 8)
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1,509
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1,324
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Selling, general and administrative expense
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1,481
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2,740
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|
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Operating loss
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(4,454
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)
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(6,668
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)
|
||
Other income (expense):
|
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Warrant revaluation income (expense)
|
(46
|
)
|
|
5,257
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|
||
Derivative revaluation expense
|
(312
|
)
|
|
—
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|
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Interest expense
|
(183
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)
|
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—
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Other income (expense), net
|
(12
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)
|
|
4
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|
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Loss before income taxes
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(5,007
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)
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(1,407
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)
|
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Income tax benefit
|
—
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|
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—
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Net loss
|
(5,007
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)
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(1,407
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)
|
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Dividend paid in-kind to preferred stockholders
|
(20
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)
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—
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|
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Deemed dividend on preferred stock (see Note 10)
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(3,734
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)
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—
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|
||
Net loss attributable to common stockholders
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$
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(8,761
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)
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$
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(1,407
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)
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|
||||
Per Share Information:
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|
||||
Net loss:
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|
||||
Basic
|
$
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(0.60
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)
|
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$
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(0.10
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)
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Diluted
|
$
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(0.60
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)
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$
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(0.23
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)
|
Weighted average number of common shares outstanding:
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|
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Basic
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14,694,613
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14,632,988
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Diluted
|
14,697,210
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14,657,011
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Series A Convertible
Preferred Stock
|
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Common Stock
|
|
Additional paid-in capital
|
|
Accumulated deficit
|
|
Total Equity
|
||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||
Balance, December 31, 2016
|
—
|
|
|
$
|
—
|
|
|
14,688,135
|
|
|
$
|
15
|
|
|
$
|
170,409
|
|
|
$
|
(162,563
|
)
|
|
$
|
7,861
|
|
Issuance of Series A convertible preferred stock with detachable warrants, net of issuance costs of $377
|
8,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,623
|
|
|
—
|
|
|
7,623
|
|
|||||
Stock-based compensation (income) expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(49
|
)
|
|
—
|
|
|
(49
|
)
|
|||||
Exercise of liability-classified warrants
|
—
|
|
|
—
|
|
|
6,941
|
|
|
—
|
|
|
41
|
|
|
—
|
|
|
41
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,007
|
)
|
|
(5,007
|
)
|
|||||
Balance, March 31, 2017
|
8,000
|
|
|
$
|
—
|
|
|
14,695,076
|
|
|
$
|
15
|
|
|
$
|
178,024
|
|
|
$
|
(167,570
|
)
|
|
$
|
10,469
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(5,007
|
)
|
|
$
|
(1,407
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Stock-based compensation (income) expense
|
(49
|
)
|
|
545
|
|
||
Warrant revaluation expense (income)
|
46
|
|
|
(5,257
|
)
|
||
Derivative revaluation expense
|
312
|
|
|
—
|
|
||
Depreciation and amortization
|
91
|
|
|
217
|
|
||
Loss on disposal or impairment of property and equipment
|
30
|
|
|
—
|
|
||
Recovery of doubtful accounts
|
—
|
|
|
(10
|
)
|
||
Decrease (increase) in operating assets:
|
|
|
|
|
|
||
Accounts receivable
|
—
|
|
|
10
|
|
||
Inventory
|
—
|
|
|
7
|
|
||
Prepaid expenses and other current assets
|
(51
|
)
|
|
299
|
|
||
Other assets
|
(34
|
)
|
|
(30
|
)
|
||
Increase (decrease) in operating liabilities:
|
|
|
|
||||
Accounts payable
|
(55
|
)
|
|
338
|
|
||
Related party payable
|
567
|
|
|
(9,642
|
)
|
||
Accrued expenses and deferred rent
|
(787
|
)
|
|
(1,138
|
)
|
||
Accrued interest payable
|
183
|
|
|
—
|
|
||
Deferred revenue
|
—
|
|
|
5
|
|
||
Net cash used in operating activities
|
(4,754
|
)
|
|
(16,063
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
||
Purchase of property and equipment
|
(87
|
)
|
|
(58
|
)
|
||
Net cash used in investing activities
|
(87
|
)
|
|
(58
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
|
||
Proceeds from 2017 Series A Preferred Stock Offering, net
|
7,886
|
|
|
—
|
|
||
Payment of deferred offering costs
|
—
|
|
|
(50
|
)
|
||
Principal payments on capital lease obligations
|
—
|
|
|
(2
|
)
|
||
Net cash provided by (used in) financing activities
|
7,886
|
|
|
(52
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
3,045
|
|
|
(16,173
|
)
|
||
Cash and cash equivalents, beginning of period
|
17,515
|
|
|
29,268
|
|
||
Cash and cash equivalents, end of period
|
$
|
20,560
|
|
|
$
|
13,095
|
|
|
|
|
|
||||
Supplemental disclosures of cash flow information:
|
|
|
|
||||
Non-cash investing and financing activities:
|
|
|
|
||||
Property and equipment in accounts payable
|
$
|
13
|
|
|
$
|
15
|
|
Offering costs in accounts payable and accrued expenses
|
$
|
263
|
|
|
$
|
41
|
|
Reduction of warrant liability upon cashless exercise of warrants
|
$
|
41
|
|
|
$
|
—
|
|
Dividend paid in-kind to preferred stockholders
|
$
|
20
|
|
|
$
|
—
|
|
Deemed dividend on preferred stock
|
$
|
3,734
|
|
|
$
|
—
|
|
•
|
Fair value method - The instrument being analyzed is allocated a portion of the proceeds equal to its fair value, with the remaining proceeds allocated to the other instruments as appropriate.
|
•
|
Relative fair value method - The instrument being analyzed is allocated a portion of the proceeds based on the proportion of its fair value to the sum of the fair values of all the instruments covered in the allocation.
|
•
|
Residual value method - The instrument being analyzed is allocated the remaining proceeds after an allocation is made to all other instruments covered in the allocation.
|
($ in thousands)
|
March 31,
2017
|
|
December 31,
2016
|
||||
Convertible promissory notes
|
$
|
18,088
|
|
|
$
|
18,088
|
|
Debt discount - warrants
|
(9,643
|
)
|
|
(9,643
|
)
|
||
Debt discount - compound bifurcated derivatives
|
(1,273
|
)
|
|
(1,273
|
)
|
||
Debt discount - beneficial conversion feature
|
(7,172
|
)
|
|
(7,172
|
)
|
||
Convertible promissory notes, net
|
$
|
—
|
|
|
$
|
—
|
|
($ in thousands except per share data)
|
March 31,
2017
|
|
December 31,
2016
|
||||
Calculated aggregate value
|
$
|
2,047
|
|
|
$
|
1,735
|
|
Closing price per share of common stock
|
$
|
2.00
|
|
|
$
|
1.89
|
|
Contractual remaining term
|
9 years, 5 months
|
|
|
9 years, 8 months
|
|
||
Contractual interest rate
|
4.0
|
%
|
|
4.0
|
%
|
||
Volume-weighted average conversion rate
|
$
|
3.40985
|
|
|
$
|
3.40985
|
|
Risk-free interest rate (term structure)
|
0.74% - 2.39%
|
|
|
0.44% - 2.45%
|
|
||
Dividend yield
|
—
|
|
|
—
|
|
||
Credit Rating
|
CC
|
|
|
CC
|
|
||
Credit Spread
|
35.56
|
%
|
|
33.27
|
%
|
||
Volatility
|
99.3
|
%
|
|
99.9
|
%
|
|
Number of warrants
|
|
|
|
|
||||||
|
March 31, 2017
|
|
December 31, 2016
|
|
Exercise
Price
|
|
Expiration
Dates
|
||||
Liability-classified Warrants
|
|
|
|
|
|
|
|
||||
Issued in Series E Preferred Stock offering
|
46,430
|
|
|
71,430
|
|
|
$
|
2.10
|
|
|
Dec 2017
|
Issued with June 2012 Convertible Notes
|
375,194
|
|
|
375,194
|
|
|
$
|
7.50
|
|
|
Jun 2018
|
Issued in Series E Preferred Stock offering
|
523,045
|
|
|
523,045
|
|
|
$
|
22.50
|
|
|
Dec 2018
|
Issued with September 2016 Convertible Notes
|
6,029,174
|
|
|
6,029,174
|
|
|
$
|
4.50
|
|
|
Sep 2021
|
|
6,973,843
|
|
|
6,998,843
|
|
|
|
|
|
||
Equity-classified Warrants
|
|
|
|
|
|
|
|
||||
Issued in 2017 Series A Preferred Stock Offering
|
3,437,334
|
|
|
—
|
|
|
$
|
2.54
|
|
|
Mar 2022
|
|
3,437,334
|
|
|
—
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
||||
Total outstanding warrants
|
10,411,177
|
|
|
6,998,843
|
|
|
|
|
|
|
|
Number of warrants
|
|
Weighted-
average
exercise
price
|
|||||||
|
Liability-classified
|
Equity-classified
|
Total
|
|
||||||
Outstanding at December 31, 2016
|
6,998,843
|
|
—
|
|
6,998,843
|
|
|
$
|
5.98
|
|
Granted
|
—
|
|
3,437,334
|
|
3,437,334
|
|
|
2.54
|
|
|
Exercised
|
(25,000
|
)
|
—
|
|
(25,000
|
)
|
|
2.10
|
|
|
Expired
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
Outstanding at March 31, 2017
|
6,973,843
|
|
3,437,334
|
|
10,411,177
|
|
|
$
|
4.85
|
|
|
|
|
|
||||
($ in thousands except per share data)
|
March 31, 2017
|
|
December 31, 2016
|
||||
Calculated aggregate value
|
$
|
6,039
|
|
|
$
|
6,034
|
|
Weighted average exercise price per share
|
$
|
6.00
|
|
|
$
|
5.98
|
|
Closing price per share of common stock
|
$
|
2.00
|
|
|
$
|
1.89
|
|
Volatility
|
83.5
|
%
|
|
85.6
|
%
|
||
Weighted average remaining expected life
|
4 years
|
|
|
4 years, 3 months
|
|
||
Risk-free interest rate
|
1.71
|
%
|
|
1.75
|
%
|
||
Dividend yield
|
—
|
|
|
—
|
|
•
|
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
|
•
|
Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
|
•
|
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
|
|
March 31, 2017
|
||||||||||||||
($ in thousands)
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
20,560
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,560
|
|
Total Assets
|
$
|
20,560
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,560
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,039
|
|
|
$
|
6,039
|
|
Derivative liability
|
—
|
|
|
—
|
|
|
2,047
|
|
|
2,047
|
|
||||
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8,086
|
|
|
$
|
8,086
|
|
|
December 31, 2016
|
||||||||||||||
($ in thousands)
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
17,515
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,515
|
|
Total Assets
|
$
|
17,515
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,515
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,034
|
|
|
$
|
6,034
|
|
Derivative liability
|
—
|
|
|
—
|
|
|
1,735
|
|
|
1,735
|
|
||||
Total Liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,769
|
|
|
$
|
7,769
|
|
|
Warrant
|
||
($ in thousands)
|
Liability
|
||
Balance at December 31, 2016
|
$
|
6,034
|
|
Exercise of warrants
|
(41
|
)
|
|
Change in fair value of warrant liability
|
46
|
|
|
Balance at March 31, 2017
|
$
|
6,039
|
|
|
Derivative
|
||
($ in thousands)
|
Liability
|
||
Balance at December 31, 2016
|
$
|
1,735
|
|
Change in fair value of derivative liability
|
312
|
|
|
Balance at March 31, 2017
|
$
|
2,047
|
|
|
March 31, 2017
|
|
March 31, 2016
|
||
Expected term
|
6 years, 3 months
|
|
|
6 years, 3 months
|
|
Interest rate
|
2.17
|
%
|
|
1.44
|
%
|
Dividend rate
|
—
|
|
|
—
|
|
Volatility
|
89.3
|
%
|
|
93.5
|
%
|
($ in thousands except share and per share data)
|
Number of
shares
|
|
Weighted-
average
exercise
price
|
|
Weighted- average
remaining
contractual
term
|
|
Aggregate
intrinsic
value
|
|||||
Outstanding at December 31, 2016
|
1,279,379
|
|
|
$
|
15.16
|
|
|
7 years, 2 months
|
|
$
|
—
|
|
Granted
|
95,000
|
|
|
2.25
|
|
|
|
|
|
|
||
Exercised
|
—
|
|
|
—
|
|
|
|
|
|
|
||
Forfeited
|
(240,321
|
)
|
|
10.29
|
|
|
|
|
|
|
||
Expired
|
(5,491
|
)
|
|
19.50
|
|
|
|
|
|
|
||
Outstanding at March 31, 2017
(1)
|
1,128,567
|
|
|
$
|
15.09
|
|
|
6 years, 3 months
|
|
$
|
—
|
|
Exercisable at March 31, 2017
|
749,637
|
|
|
$
|
20.88
|
|
|
4 years, 8 months
|
|
$
|
—
|
|
(1)
|
Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition.
|
|
Three months ended March 31,
|
||||||
($ in thousands except share and per share data)
|
2017
|
|
2016
|
||||
Loss per share - basic:
|
|
|
|
|
|
||
Net loss
|
$
|
(5,007
|
)
|
|
$
|
(1,407
|
)
|
Less: Dividend paid in-kind to preferred stockholders
|
(20
|
)
|
|
—
|
|
||
Less: Deemed dividend on preferred stock
|
(3,734
|
)
|
|
—
|
|
||
Net loss attributable to common stockholders - basic
|
$
|
(8,761
|
)
|
|
$
|
(1,407
|
)
|
|
|
|
|
||||
Numerator for basic loss per share
|
$
|
(8,761
|
)
|
|
$
|
(1,407
|
)
|
Denominator for basic loss per share
|
14,694,613
|
|
|
14,632,988
|
|
||
Basic loss per common share
|
$
|
(0.60
|
)
|
|
$
|
(0.10
|
)
|
|
|
|
|
||||
Loss per share - diluted:
|
|
|
|
|
|
||
Numerator for basic loss per share
|
$
|
(8,761
|
)
|
|
$
|
(1,407
|
)
|
Adjust: Warrant revaluation income for dilutive warrants
|
7
|
|
|
1,958
|
|
||
Net loss attributable to common stockholders - diluted
|
$
|
(8,768
|
)
|
|
$
|
(3,365
|
)
|
|
|
|
|
||||
Denominator for basic loss per share
|
14,694,613
|
|
|
14,632,988
|
|
||
Plus: Incremental shares underlying dilutive “in the money” warrants outstanding
|
2,597
|
|
|
24,023
|
|
||
Denominator for diluted loss per share
|
14,697,210
|
|
|
14,657,011
|
|
||
Diluted net loss per common share
|
$
|
(0.60
|
)
|
|
$
|
(0.23
|
)
|
|
Three months ended March 31,
|
||||
|
2017
|
|
2016
|
||
“In the money” stock options
|
89,801
|
|
|
291,668
|
|
“Out of the money” stock options
|
1,038,682
|
|
|
1,044,473
|
|
“In the money” warrants
|
—
|
|
|
—
|
|
“Out of the money” warrants
|
10,364,747
|
|
|
1,387,338
|
|
Shares underlying convertible notes
|
5,304,533
|
|
|
—
|
|
Shares underlying convertible accrued interest on convertible notes
|
120,441
|
|
|
—
|
|
Shares underlying convertible preferred stock
|
3,440,000
|
|
|
—
|
|
•
|
our unaudited Condensed Consolidated Financial Statements and accompanying notes included in Part I, Item 1 of this Form 10-Q; and
|
•
|
our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for 2016 (2016 Form 10-K), as well as the information contained under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2016 Form 10-K.
|
•
|
the cost of clinical activities and outcomes related to our Phase 1/2 clinical trial of FCX-007;
|
•
|
the costs of pre-clinical activities and outcomes related to FCX-013, for which we expect to file an IND with the FDA in the fourth quarter of 2017;
|
•
|
the cost of research related to our gene-therapy product candidate for arthritis and related conditions under the 2015 ECC;
|
•
|
the cost of additional pre-clinical studies and clinical trials in order to obtain regulatory approvals for our product candidates;
|
•
|
the cost of regulatory submissions, as well as the preparation, initiation and execution of clinical trials in potential new clinical indications; and
|
•
|
the cost of filing, surveillance around, prosecuting, defending and enforcing patent claims.
|
•
|
significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives;
|
•
|
seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
|
•
|
sell or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.
|
|
Three months ended March 31,
|
||||||
($ in thousands)
|
2017
|
|
2016
|
||||
Net cash flows (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(4,754
|
)
|
|
$
|
(16,063
|
)
|
Investing activities
|
$
|
(87
|
)
|
|
$
|
(58
|
)
|
Financing activities
|
$
|
7,886
|
|
|
$
|
(52
|
)
|
|
Three months ended
March 31, |
|
Increase
(Decrease)
|
|
|||||||||||
($ in thousands)
|
2017
|
|
2016
|
|
$
|
|
%
|
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
FCX-007
|
$
|
1,242
|
|
|
$
|
1,023
|
|
|
$
|
219
|
|
|
21.4
|
%
|
(1)
|
FCX-013
|
659
|
|
|
310
|
|
|
349
|
|
|
112.6
|
%
|
(2)
|
|||
Other
|
1
|
|
|
69
|
|
|
(68
|
)
|
|
(98.6
|
)%
|
|
|||
Total direct costs
|
1,902
|
|
|
1,402
|
|
|
500
|
|
|
35.7
|
%
|
|
|||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
47
|
|
|
175
|
|
|
(128
|
)
|
|
(73.1
|
)%
|
(3)
|
|||
Intangible amortization
|
—
|
|
|
138
|
|
|
(138
|
)
|
|
(100.0
|
)%
|
(4)
|
|||
Compensation and related expense
|
466
|
|
|
1,096
|
|
|
(630
|
)
|
|
(57.5
|
)%
|
(5)
|
|||
Process development
|
—
|
|
|
598
|
|
|
(598
|
)
|
|
(100.0
|
)%
|
(6)
|
|||
Other indirect R&D costs
|
558
|
|
|
517
|
|
|
41
|
|
|
7.9
|
%
|
|
|||
Total indirect costs
|
1,071
|
|
|
2,524
|
|
|
(1,453
|
)
|
|
(57.6
|
)%
|
|
|||
Total research and development expense
|
$
|
2,973
|
|
|
$
|
3,926
|
|
|
$
|
(953
|
)
|
|
(24.3
|
)%
|
|
(1)
|
Costs for our FCX-007 program increased approximately
$0.2 million
, or
21.4%
, for the quarter ended March 31, 2017 compared to the same period in 2016 due primarily to the progression of FCX-007 into clinical development, and costs specifically related to the Phase 1 portion of our Phase 1/2 clinical trial of FCX-007 in adults in which we dosed our first patient in the first quarter of 2017. More specifically, these costs include clinical research organization and clinical site fees, as well as product manufacturing costs. Costs incurred in the prior period related to completion of pre-clinical development activities.
|
(2)
|
Costs for our FCX-013 program increased approximately
$0.3 million
, or
112.6%
, for the quarter ended March 31, 2017 compared to the same period in 2016 due primarily to progression of the pre-clinical development of FCX-013. Costs incurred during 2017 related primarily to the execution of a pre-clinical dose-ranging study which commenced in the fourth quarter of 2016, pre-clinical product manufacturing (i.e. vector manufacturing) and certain IND-enabling work while costs incurred during the 2016 period related primarily to the completion of our proof-of-concept study.
|
(3)
|
Regulatory costs decreased approximately
$0.1 million
, or
73.1%
, for the quarter ended March 31, 2017 as compared to the same period in 2016, due primarily to a decrease in costs incurred with the FDA for fees levied under the Prescription Drug User Fee Act (PDUFA). The decrease in fees resulted from our decision to wind-down azficel-T (including LAVIV), which, beginning in the fourth quarter of 2016, exempted us from being assessed annual product registration and establishment fees imposed under PDUFA, which will result in cost savings.
|
(4)
|
Intangible amortization decreased approximately
$0.1 million
, or
100.0%
, for the quarter ended March 31, 2017 as compared to the same period in 2016, due to the impairment of our intangible assets during the second quarter of 2016 which resulted in no subsequent amortization expense.
|
(5)
|
Compensation and related expense decreased approximately
$0.6 million
, or
57.5%
, for the quarter ended March 31, 2017 as compared to the same period in 2016, due primarily to decreases in salaries, benefits and bonus expense resulting from the reduction in workforce associated with the aforementioned wind-down of azficel-T operations which occurred in June 2016.
|
(6)
|
Process development costs decreased approximately
$0.6 million
, or
100.0%
, for the quarter ended March 31, 2017 as compared to the same period in 2016, as a result primarily of internal process development work being halted in June 2016 in connection with the aforementioned wind-down of azficel-T operations and related restructuring initiatives.
|
|
Three months ended
March 31, |
|
Increase
(Decrease)
|
|
|||||||||||
($ in thousands)
|
2017
|
|
2016
|
|
$
|
|
%
|
|
|||||||
Compensation and related expense
|
$
|
331
|
|
|
$
|
1,398
|
|
|
$
|
(1,067
|
)
|
|
(76.3
|
)%
|
(1)
|
Severance expense
|
137
|
|
|
—
|
|
|
137
|
|
|
100.0
|
%
|
(2)
|
|||
Professional fees
|
487
|
|
|
584
|
|
|
(97
|
)
|
|
(16.6
|
)%
|
|
|||
Facilities and related expense and other
|
526
|
|
|
758
|
|
|
(232
|
)
|
|
(30.6
|
)%
|
(3)
|
|||
Total selling, general and administrative expense
|
$
|
1,481
|
|
|
$
|
2,740
|
|
|
$
|
(1,259
|
)
|
|
(45.9
|
)%
|
|
(1)
|
Compensation and related expense decreased approximately
$1.1 million
, or
76.3%
, for the quarter ended March 31, 2017 as compared to the same period in 2016 due primarily to decreases in salaries, bonus expense and stock-based compensation resulting from the resignations of certain highly compensated employees in the fourth quarter of 2016 and the first quarter of 2017.
|
(2)
|
Severance expense increased approximately
$0.1 million
, or
100.0%
, for the quarter ended March 31, 2017 as compared to the same period in 2016 as a result of severance payments made in conjunction with the aforementioned resignations of certain senior management in 2017, the terms which are set forth in their respective separation agreements. No such severance related expenses were incurred in the prior period.
|
(3)
|
Facilities and related expense and other decreased approximately
$0.2 million
, or
30.6%
, for the quarter ended March 31, 2017 as compared to the same period in 2016. The decrease is due primarily to approximately $0.2 million of income recognized as a result of the derecognition of certain reserves included in accrued expenses as of December 31, 2016.
|
FIBROCELL SCIENCE, INC.
|
|
|
|
By:
|
/s/ Lisa A. Embon
|
|
Lisa A. Embon
|
|
Vice President of Corporate Accounting/Controller
|
|
(Principal Financial and Accounting Officer)
|
|
|
Date:
|
May 10, 2017
|
EXHIBIT NO.
|
|
IDENTIFICATION OF EXHIBIT
|
3.1
|
|
Certificate of Amendment of the Restated Certificate of Incorporation of Fibrocell Science, Inc., as amended, dated March 10, 2017 (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed on March 10, 2017)
|
3.2
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock dated March 7, 2017 (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed on March 8, 2017)
|
4.1
|
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K, filed on March 8, 2017)
|
10.1
|
|
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed on March 8, 2017)
|
*10.2
|
U
|
Fibrocell Science, Inc. 2009 Equity Incentive Plan, as amended and restated as of March 11, 2017
|
10.3
|
U
|
Separation Agreement and General Release by and between the Company and Michael F. Marino dated January 25, 2017 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed January 26, 2017)
|
10.4
|
U
|
Separation Agreement and General Release by and between the Company and Kimberly M. Smith dated March 3, 2017 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed March 3, 2017)
|
*31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
*31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
*32.1
|
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
*32.1
|
|
Certification of Principal Financial Officer 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.
|
|
|
|
Page
|
1.
|
Purpose and Objectives
|
|
2
|
2.
|
Definitions
|
|
2
|
3
|
Administration
|
|
4
|
4.
|
Grants
|
|
5
|
5.
|
Shares Subject to the Plan
|
|
5
|
6.
|
Eligibility for Participation
|
|
6
|
7.
|
Options
|
|
6
|
8.
|
Stock Units
|
|
9
|
9.
|
Stock Awards
|
|
10
|
10.
|
Stock Appreciation Rights and Other Stock-Based Awards
|
|
10
|
11.
|
Qualified Performance-Based Compensation
|
|
12
|
12.
|
Deferrals
|
|
13
|
13.
|
Withholding of Taxes
|
|
13
|
14.
|
Transferability of Grants
|
|
13
|
15.
|
Consequences of a Change of Control
|
|
14
|
16.
|
Requirements for Issuance of Shares
|
|
14
|
17.
|
Amendment and Termination of the Plan
|
|
15
|
18.
|
Miscellaneous
|
|
15
|
1.
|
Purpose and Objectives
|
2.
|
Definitions
|
3.
|
Administration
|
4.
|
Grants
|
5.
|
Shares Subject to the Plan
|
6.
|
Eligibility for Participation
|
7.
|
Options
|
8.
|
Stock Units
|
9.
|
Stock Awards
|
10.
|
Stock Appreciation Rights and Other Stock-Based Awards
|
11.
|
Qualified Performance-Based Compensation
|
12.
|
Deferrals
|
13.
|
Withholding of Taxes
|
14.
|
Transferability of Grants
|
15.
|
Consequences of a Change of Control
|
16.
|
Requirements for Issuance of Shares
|
17.
|
Amendment and Termination of the Plan
|
18.
|
Miscellaneous
|
1.
|
Grant of Option.
|
2.
|
Exercisability of Option
. The Option shall become exercisable on the following dates, if the Grantee is employed by, or providing service to, the Employer (as defined in the Plan) on the applicable date:
|
Date
|
|
Shares for Which the Option is Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
3.
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Term of Option.
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4.
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Exercise Procedures.
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5.
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Designation as Incentive Stock Option.
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6.
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Change of Control
. The provisions of the Plan applicable to a Change of Control shall apply to the Option, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the Plan.
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7.
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Restrictions on Exercise
. Only the Grantee may exercise the Option during the Grantee’s lifetime. After the Grantee’s death, the Option shall be exercisable (subject to the limitations specified in the Plan) solely by the legal representatives of the Grantee, or by the person who acquires the right to exercise the Option by will or by the laws of descent and distribution, to the extent that the Option is exercisable pursuant to this Agreement.
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8.
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Grant Subject to Plan Provisions
. This grant is made pursuant to the Plan, the terms of which are incorporated herein by reference, and in all respects shall be interpreted in accordance with the Plan. The grant and exercise of the Option are subject to interpretations, regulations and determinations concerning the Plan established from time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (i) rights and obligations with respect to withholding taxes, (ii) the registration, qualification or listing of the Shares, (iii) changes in capitalization of the Company and (iv) other requirements of applicable law. The Committee shall have the authority to interpret and construe the Option pursuant to the terms of the Plan, and its decisions shall be conclusive as to any questions arising hereunder.
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9.
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No Employment or Other Rights
. The grant of the Option shall not confer upon the Grantee any right to be retained by or in the employ or service of the Employer and shall not interfere in any way with the right of the Employer to terminate the Grantee’s employment or service at any time. The right of the Employer to terminate at will the Grantee’s employment or service at any time for any reason is specifically reserved.
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10.
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No Shareholder Rights
. Neither the Grantee, nor any person entitled to exercise the Grantee’s rights in the event of the Grantee’s death, shall have any of the rights and privileges of a shareholder with respect to the Shares subject to the Option, until certificates for Shares have been issued upon the exercise of the Option.
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11.
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Assignment and Transfers
. The rights and interests of the Grantee under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the death of the Grantee, by will or by the laws of descent and distribution. In the event of any attempt by the Grantee to alienate, assign, pledge, hypothecate, or otherwise dispose of the Option or any right hereunder, except as provided for in this Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby conferred, the Company may terminate the Option by notice to the Grantee, and the Option and all rights hereunder shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company without the Grantee’s consent.
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12.
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Applicable Law
. The validity, construction, interpretation and effect of this instrument shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.
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13.
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Notice
. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the General Counsel at 405 Eagleview Blvd., Exton, PA 19341, and any notice to the Grantee shall be addressed to such Grantee at the current address shown on the payroll of the Employer, or to such other address as the Grantee may designate to the Employer in writing. Any notice shall be delivered by hand, sent by telecopy or enclosed in a properly sealed envelope addressed as stated above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service.
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FIBROCELL SCIENCE, INC.
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By:
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Grantee:
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Date:
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1.
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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.
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2.
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Exercisability of Option
. The Option shall become exercisable on the following dates, if the Grantee is employed by, or providing service to, the Employer (as defined in the Plan) on the applicable date:
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Date
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Shares for Which the Option is Exercisable
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3.
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Term of Option.
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4.
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Exercise Procedures.
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5.
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Change of Control
. The provisions of the Plan applicable to a Change of Control shall apply to the Option, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the Plan.
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6.
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Restrictions on Exercise
. Except as the Committee may otherwise permit pursuant to the Plan, only the Grantee may exercise the Option during the Grantee’s lifetime and, after the Grantee’s death, the Option shall be exercisable (subject to the limitations specified in the Plan) solely by the legal representatives of the Grantee, or by the person who acquires the right to exercise the Option by will or by the laws of descent and distribution, to the extent that the Option is exercisable pursuant to this Agreement.
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7.
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Grant Subject to Plan Provisions
. This grant is made pursuant to the Plan, the terms of which are incorporated herein by reference, and in all respects shall be interpreted in accordance with the Plan. The grant and exercise of the Option are subject to interpretations, regulations and determinations concerning the Plan established from time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (i) rights and obligations with respect to withholding taxes, (ii) the registration, qualification or listing of the Shares, (iii) changes in capitalization of the Company and (iv) other requirements of applicable law. The Committee shall have the authority to interpret and construe the Option pursuant to the terms of the Plan, and its decisions shall be conclusive as to any questions arising hereunder.
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8.
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No Employment or Other Rights
. The grant of the Option shall not confer upon the Grantee any right to be retained by or in the employ or service of the Employer and shall not interfere in any way with the right of the Employer to terminate the Grantee’s employment or service at any time. The right of the Employer to terminate at will the Grantee’s employment or service at any time for any reason is specifically reserved.
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9.
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No Shareholder Rights
. Neither the Grantee, nor any person entitled to exercise the Grantee’s rights in the event of the Grantee’s death, shall have any of the rights and
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10.
|
Assignment and Transfers
. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of the Grantee under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the death of the Grantee, by will or by the laws of descent and distribution. In the event of any attempt by the Grantee to alienate, assign, pledge, hypothecate, or otherwise dispose of the Option or any right hereunder, except as provided for in this Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby conferred, the Company may terminate the Option by notice to the Grantee, and the Option and all rights hereunder shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company without the Grantee’s consent.
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11.
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Applicable Law
. The validity, construction, interpretation and effect of this instrument shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.
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12.
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Notice
. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the General Counsel at 405 Eagleview Blvd., Exton, PA 19341, and any notice to the Grantee shall be addressed to such Grantee at the current address shown on the payroll of the Employer, or to such other address as the Grantee may designate to the Employer in writing. Any notice shall be delivered by hand, sent by telecopy or enclosed in a properly sealed envelope addressed as stated above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service.
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FIBROCELL SCIENCE, INC.
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By:
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Grantee:
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Date:
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1.
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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.
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2.
|
Exercisability of Option
. The Option shall become exercisable on the following dates, if the Grantee is providing service to the Company as a member of its Board of Directors on the applicable date:
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Date
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Shares for Which the Option is Exercisable
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3.
|
Term of Option
. The Option shall have a term of 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.
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4.
|
Exercise Procedures.
|
5.
|
Change of Control
. The provisions of the Plan applicable to a Change of Control shall apply to the Option, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the Plan.
|
6.
|
Restrictions on Exercise
. Except as the Committee may otherwise permit pursuant to the Plan, only the Grantee may exercise the Option during the Grantee’s lifetime and, after the Grantee’s death, the Option shall be exercisable (subject to the limitations specified in the Plan) solely by the legal representatives of the Grantee, or by the person
|
7.
|
Grant Subject to Plan Provisions
. This grant is made pursuant to the Plan, the terms of which are incorporated herein by reference, and in all respects shall be interpreted in accordance with the Plan. The grant and exercise of the Option are subject to interpretations, regulations and determinations concerning the Plan established from time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (i) rights and obligations with respect to withholding taxes, (ii) the registration, qualification or listing of the Shares, (iii) changes in capitalization of the Company and (iv) other requirements of applicable law. The Committee shall have the authority to interpret and construe the Option pursuant to the terms of the Plan, and its decisions shall be conclusive as to any questions arising hereunder.
|
8.
|
No Service or Other Rights
. The grant of the Option shall not confer upon the Grantee any right to be retained by or in the service of the Company.
|
9.
|
No Shareholder Rights
. Neither the Grantee, nor any person entitled to exercise the Grantee’s rights in the event of the Grantee’s death, shall have any of the rights and privileges of a shareholder with respect to the Shares subject to the Option, until certificates for Shares have been issued upon the exercise of the Option.
|
10.
|
Assignment and Transfers
. Except as the Committee may otherwise permit pursuant to the Plan, the rights and interests of the Grantee under this Agreement may not be sold, assigned, encumbered or otherwise transferred except, in the event of the death of the Grantee, by will or by the laws of descent and distribution. In the event of any attempt by the Grantee to alienate, assign, pledge, hypothecate, or otherwise dispose of the Option or any right hereunder, except as provided for in this Agreement, or in the event of the levy or any attachment, execution or similar process upon the rights or interests hereby conferred, the Company may terminate the Option by notice to the Grantee, and the Option and all rights hereunder shall thereupon become null and void. The rights and protections of the Company hereunder shall extend to any successors or assigns of the Company and to the Company’s parents, subsidiaries, and affiliates. This Agreement may be assigned by the Company without the Grantee’s consent.
|
11.
|
Applicable Law
. The validity, construction, interpretation and effect of this instrument shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.
|
12.
|
Notice
. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the General Counsel at 405 Eagleview Blvd., Exton, PA 19341, and any notice to the Grantee shall be addressed to such Grantee at the current address shown on the books and records of the Company, or to such other address as the Grantee may designate to the Company in writing. Any notice shall be delivered by hand, sent by telecopy or enclosed in a properly sealed envelope addressed as stated above, registered
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FIBROCELL SCIENCE, INC.
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By:
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|
|
Grantee:
|
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|
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|
|
|
|
|
|
|
Date:
|
|
Date:
|
May 10, 2017
|
By:
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/s/ John M. Maslowski
|
|
John M. Maslowski
|
|
President and Chief Executive Officer
|
Date:
|
May 10, 2017
|
By:
|
/s/ Lisa A. Embon
|
|
Lisa A. Embon
|
|
Vice President of Corporate Accounting/Controller
|
|
(Principal Financial and Accounting Officer)
|
Date:
|
May 10, 2017
|
By:
|
/s/ John M. Maslowski
|
|
John M. Maslowski
|
|
President and Chief Executive Officer
|
Date:
|
May 10, 2017
|
By:
|
/s/ Lisa A. Embon
|
|
Lisa A. Embon
|
|
Vice President of Corporate Accounting/Controller
|
|
(Principal Financial and Accounting Officer)
|