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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
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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PART I.
|
FINANCIAL INFORMATION
|
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PART II.
|
OTHER INFORMATION
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SIGNATURES
|
|
||
|
|
|
|
EXHIBIT INDEX
|
|
•
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the potential advantages of our product candidates;
|
•
|
our expectation to complete dosing in our Phase II clinical trial for azficel-T for chronic dysphonia by year-end 2015 and announce efficacy results in the second quarter of 2016;
|
•
|
our interpretation of the FDA's feedback relating to our IND for FCX-007 and our plans to address such feedback and submit an amended IND in the first quarter of 2016;
|
•
|
the initiation, design and timing of the additional toxicology study requested by the FDA;
|
•
|
the initiation, design and timing of a Phase I/II clinical trial for FCX-007;
|
•
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our expectation to complete preclinical proof-of-concept studies for FCX-013 in the first half of 2016 and submit an IND application to the FDA in the fourth quarter of 2016;
|
•
|
our plan to seek orphan drug designation for FCX-013;
|
•
|
our ability to complete, or obtain modifications to, the postmarketing study that the FDA required as a condition for the approval of LAVIV;
|
•
|
the potential for our collaboration with UCLA to provide new development programs; and
|
•
|
the sufficiency of our cash and cash equivalents to fund our operations into the fourth quarter of 2016.
|
|
September 30, 2015
|
|
December 31, 2014
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
36,931
|
|
|
$
|
37,495
|
|
Accounts receivable, net of allowance for doubtful accounts of $12 and $17, respectively
|
—
|
|
|
4
|
|
||
Inventory
|
566
|
|
|
571
|
|
||
Prepaid expenses and other current assets
|
467
|
|
|
1,279
|
|
||
Total current assets
|
37,964
|
|
|
39,349
|
|
||
Property and equipment, net of accumulated depreciation of $1,191 and $1,051, respectively
|
1,697
|
|
|
1,598
|
|
||
Intangible assets, net of accumulated amortization of $2,067 and $1,653, respectively
|
4,273
|
|
|
4,687
|
|
||
Total assets
|
$
|
43,934
|
|
|
$
|
45,634
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
2,624
|
|
|
$
|
1,124
|
|
Accrued expenses
|
1,731
|
|
|
1,675
|
|
||
Deferred revenue
|
473
|
|
|
416
|
|
||
Warrant liability, current
|
505
|
|
|
278
|
|
||
Total current liabilities
|
5,333
|
|
|
3,493
|
|
||
Warrant liability, long term
|
6,459
|
|
|
11,008
|
|
||
Deferred rent
|
776
|
|
|
724
|
|
||
Total liabilities
|
12,568
|
|
|
15,225
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 100,000,000 shares authorized; 43,898,785 and 40,856,815 shares issued and outstanding, respectively
|
44
|
|
|
41
|
|
||
Additional paid-in capital
|
160,842
|
|
|
143,086
|
|
||
Accumulated deficit
|
(129,520
|
)
|
|
(112,718
|
)
|
||
Total stockholders’ equity
|
31,366
|
|
|
30,409
|
|
||
Total liabilities and stockholders’ equity
|
$
|
43,934
|
|
|
$
|
45,634
|
|
|
Three months ended September 30, 2015
|
|
Three months ended September 30, 2014
|
|
Nine months ended September 30, 2015
|
|
Nine months ended September 30, 2014
|
||||||||
Revenue from product sales
|
$
|
49
|
|
|
$
|
20
|
|
|
$
|
217
|
|
|
$
|
124
|
|
Collaboration revenue
|
30
|
|
|
—
|
|
|
193
|
|
|
—
|
|
||||
Total revenue
|
79
|
|
|
20
|
|
|
410
|
|
|
124
|
|
||||
Cost of product sales
|
62
|
|
|
512
|
|
|
283
|
|
|
1,852
|
|
||||
Cost of collaboration revenue
|
142
|
|
|
—
|
|
|
230
|
|
|
—
|
|
||||
Total cost of revenue
|
204
|
|
|
512
|
|
|
513
|
|
|
1,852
|
|
||||
Gross loss
|
(125
|
)
|
|
(492
|
)
|
|
(103
|
)
|
|
(1,728
|
)
|
||||
Research and development expense
|
4,221
|
|
|
3,069
|
|
|
11,902
|
|
|
13,909
|
|
||||
Selling, general and administrative expense
|
2,477
|
|
|
2,630
|
|
|
9,041
|
|
|
8,150
|
|
||||
Operating loss
|
(6,823
|
)
|
|
(6,191
|
)
|
|
(21,046
|
)
|
|
(23,787
|
)
|
||||
Other income:
|
|
|
|
|
|
|
|
|
|
||||||
Warrant revaluation and other finance income
|
5,301
|
|
|
177
|
|
|
4,240
|
|
|
1,135
|
|
||||
Other income
|
—
|
|
|
—
|
|
|
—
|
|
|
370
|
|
||||
Interest income
|
1
|
|
|
2
|
|
|
4
|
|
|
4
|
|
||||
Loss before income taxes
|
(1,521
|
)
|
|
(6,012
|
)
|
|
(16,802
|
)
|
|
(22,278
|
)
|
||||
Income tax benefit
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Net loss
|
$
|
(1,521
|
)
|
|
$
|
(6,012
|
)
|
|
$
|
(16,802
|
)
|
|
$
|
(22,278
|
)
|
|
|
|
|
|
|
|
|
||||||||
Per Share Information:
|
|
|
|
|
|
|
|
|
|
||||||
Net loss:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.40
|
)
|
|
$
|
(0.55
|
)
|
Diluted
|
$
|
(0.07
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.60
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||
Basic
|
43,021,121
|
|
|
40,856,815
|
|
|
41,598,632
|
|
|
40,766,741
|
|
||||
Diluted
|
43,712,918
|
|
|
41,300,105
|
|
|
41,829,231
|
|
|
41,045,861
|
|
|
Common Stock
|
|
Additional paid-in capital
|
|
Accumulated deficit
|
|
Total Equity
|
|||||||||||
|
Shares
|
|
Amount
|
|
|
|
||||||||||||
Balance, December 31, 2014
|
40,856,815
|
|
|
$
|
41
|
|
|
$
|
143,086
|
|
|
$
|
(112,718
|
)
|
|
$
|
30,409
|
|
Proceeds from common stock offering, net
|
2,974,136
|
|
|
3
|
|
|
15,869
|
|
|
—
|
|
|
15,872
|
|
||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
1,550
|
|
|
—
|
|
|
1,550
|
|
||||
Exercise of stock options
|
56,250
|
|
|
—
|
|
|
255
|
|
|
—
|
|
|
255
|
|
||||
Exercise of warrants
|
11,584
|
|
|
—
|
|
|
82
|
|
|
—
|
|
|
82
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,802
|
)
|
|
(16,802
|
)
|
||||
Balance, September 30, 2015
|
43,898,785
|
|
|
$
|
44
|
|
|
$
|
160,842
|
|
|
$
|
(129,520
|
)
|
|
$
|
31,366
|
|
|
Nine months ended September 30, 2015
|
|
Nine months ended September 30, 2014
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(16,802
|
)
|
|
$
|
(22,278
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Stock-based compensation expense
|
1,550
|
|
|
1,005
|
|
||
Stock issued for supplemental stock issuance agreement
|
—
|
|
|
5,154
|
|
||
Warrant revaluation and other finance income
|
(4,240
|
)
|
|
(1,135
|
)
|
||
Depreciation and amortization
|
554
|
|
|
673
|
|
||
Provision for doubtful accounts
|
(5
|
)
|
|
15
|
|
||
Change in operating assets and liabilities:
|
|
|
|
|
|
||
Accounts receivable
|
9
|
|
|
11
|
|
||
Inventory
|
5
|
|
|
(13
|
)
|
||
Prepaid expenses and other current assets
|
812
|
|
|
722
|
|
||
Other assets
|
—
|
|
|
214
|
|
||
Accounts payable
|
1,469
|
|
|
(1,904
|
)
|
||
Accrued expenses and deferred rent
|
111
|
|
|
1,693
|
|
||
Deferred revenue
|
57
|
|
|
331
|
|
||
Net cash used in operating activities
|
(16,480
|
)
|
|
(15,512
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
||
Purchase of property and equipment
|
(208
|
)
|
|
(307
|
)
|
||
Net cash used in investing activities
|
(208
|
)
|
|
(307
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
|
||
Proceeds from common stock offering, net
|
15,872
|
|
|
—
|
|
||
Proceeds from the exercise of stock options
|
255
|
|
|
—
|
|
||
Principle payments on capital lease obligations
|
(3
|
)
|
|
—
|
|
||
Net cash provided by financing activities
|
16,124
|
|
|
—
|
|
||
Effect of exchange rate changes on cash balances
|
—
|
|
|
1
|
|
||
Net decrease in cash and cash equivalents
|
(564
|
)
|
|
(15,818
|
)
|
||
Cash and cash equivalents, beginning of period
|
37,495
|
|
|
60,033
|
|
||
Cash and cash equivalents, end of period
|
$
|
36,931
|
|
|
$
|
44,215
|
|
|
|
|
|
||||
|
|
|
|
||||
Supplemental Cash Flow Disclosures:
|
|
|
|
||||
Non Cash Investing and Financing Activities:
|
|
|
|
||||
Property and equipment in accounts payable
|
$
|
31
|
|
|
$
|
—
|
|
Reduction of warrant liability upon issuance of shares
|
$
|
82
|
|
|
$
|
—
|
|
($ in thousands)
|
September 30, 2015
|
|
December 31, 2014
|
|||||
Raw materials (LAVIV and product candidates)
|
$
|
398
|
|
|
$
|
357
|
|
|
Work in process (LAVIV)
|
168
|
|
|
214
|
|
|||
Total Inventory
|
$
|
566
|
|
|
$
|
571
|
|
|
Number of Warrants
|
|
|
|
|
||||||
Liability-classified warrants
|
September 30, 2015
|
|
December 31, 2014
|
|
Exercise
Price
|
|
Expiration
Dates
|
||||
Issued in Series A, B and D Preferred Stock offerings
|
2,231,118
|
|
|
2,247,118
|
|
|
$
|
6.25
|
|
|
Oct 2015 - Dec 2016
|
Issued in March 2010 financing
|
319,789
|
|
|
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
|
74,800
|
|
|
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
|
5,942,103
|
|
|
6,033,050
|
|
|
|
|
|
|
|
Number of
warrants
|
|
Weighted-
average
exercise
price
|
|||
Outstanding at December 31, 2014
|
6,033,050
|
|
|
$
|
7.08
|
|
Granted
|
—
|
|
|
—
|
|
|
Exercised
(1)
|
(90,947
|
)
|
|
(6.20
|
)
|
|
Expired
|
—
|
|
|
—
|
|
|
Outstanding at September 30, 2015
|
5,942,103
|
|
|
$
|
7.09
|
|
($ in thousands except share and per share data)
|
September 30, 2015
|
|
December 31, 2014
|
||||
Calculated aggregate value
|
$
|
6,964
|
|
|
$
|
11,286
|
|
Weighted average exercise price per share
|
$
|
7.09
|
|
|
$
|
7.08
|
|
Closing price per share of common stock
|
$
|
3.85
|
|
|
$
|
2.59
|
|
Volatility
|
86.3
|
%
|
|
67.6
|
%
|
||
Weighted average remaining expected life
|
1 year, 10 months
|
|
|
2 years, 7 months
|
|
||
Risk-free interest rate
|
0.60
|
%
|
|
0.86
|
%
|
||
Dividend yield
|
—
|
|
|
—
|
|
|
September 30, 2015
|
||||||||||||||
($ in thousands)
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
36,931
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
36,931
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,964
|
|
|
$
|
6,964
|
|
|
December 31, 2014
|
||||||||||||||
($ in thousands)
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
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
(1)
|
(82
|
)
|
|
Change in fair value of warrant liability
|
(4,240
|
)
|
|
Balance at September 30, 2015
|
$
|
6,964
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Stock-based compensation expense for employees and directors
|
$
|
506
|
|
|
$
|
266
|
|
|
$
|
1,550
|
|
|
$
|
1,002
|
|
Equity awards for non-employees issued for services
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
||||
Total stock-based compensation expense
|
$
|
506
|
|
|
$
|
266
|
|
|
$
|
1,550
|
|
|
$
|
1,005
|
|
($ 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, 2014
|
2,086,450
|
|
|
$
|
7.43
|
|
|
8 years
|
|
$
|
—
|
|
Granted
|
1,352,114
|
|
|
4.48
|
|
|
|
|
|
|
||
Exercised
|
(56,250
|
)
|
|
4.53
|
|
|
|
|
|
|
||
Forfeited
|
(178,970
|
)
|
|
5.63
|
|
|
|
|
|
|
||
Expired
|
(12,000
|
)
|
|
10.50
|
|
|
|
|
|
|
||
Outstanding at September 30, 2015
|
3,191,344
|
|
|
$
|
6.32
|
|
|
8 years, 1 month
|
|
$
|
602
|
|
Exercisable at September 30, 2015
|
1,469,897
|
|
|
$
|
8.81
|
|
|
7 years
|
|
$
|
189
|
|
|
September 30, 2015
|
|
September 30, 2014
|
||
Expected life
|
6 years, 1 month
|
|
|
5 years, 11 months
|
|
Interest rate
|
1.56
|
%
|
|
1.91
|
%
|
Dividend yield
|
—
|
|
|
—
|
|
Volatility
|
103.2
|
%
|
|
70.3
|
%
|
|
For the three months ended September 30,
|
|
For the nine months ended September 30,
|
||||||||||||
($ in thousands except share and per share data)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||||||
Loss per share - basic:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Numerator for basic loss per share
|
$
|
(1,521
|
)
|
|
$
|
(6,012
|
)
|
|
$
|
(16,802
|
)
|
|
$
|
(22,278
|
)
|
Denominator for basic loss per share
|
43,021,121
|
|
|
40,856,815
|
|
|
41,598,632
|
|
|
40,766,741
|
|
||||
Basic loss per common share
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.40
|
)
|
|
$
|
(0.55
|
)
|
Loss per share - diluted:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Numerator for diluted loss per share
|
$
|
(1,521
|
)
|
|
$
|
(6,012
|
)
|
|
$
|
(16,802
|
)
|
|
$
|
(22,278
|
)
|
Adjustment for income (expense) for change in fair value of warrant liability for dilutive warrants
|
1,529
|
|
|
1,098
|
|
|
1,529
|
|
|
2,364
|
|
||||
Net loss attributable to common share
|
$
|
(3,050
|
)
|
|
$
|
(7,110
|
)
|
|
$
|
(18,331
|
)
|
|
$
|
(24,642
|
)
|
Denominator for basic loss per share
|
43,021,121
|
|
|
40,856,815
|
|
|
41,598,632
|
|
|
40,766,741
|
|
||||
Plus: Incremental shares underlying dilutive “in the money” warrants outstanding
|
691,797
|
|
|
443,290
|
|
|
230,599
|
|
|
279,120
|
|
||||
Denominator for diluted loss per share
|
43,712,918
|
|
|
41,300,105
|
|
|
41,829,231
|
|
|
41,045,861
|
|
||||
Diluted net loss per common share
|
$
|
(0.07
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.60
|
)
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||
|
2015
|
|
2014
|
|
2015
|
|
2014
|
||||
“In the money” stock options
|
2,733,864
|
|
|
35,000
|
|
|
1,923,926
|
|
|
741,000
|
|
“Out of the money” stock options
|
457,480
|
|
|
2,231,200
|
|
|
1,113,960
|
|
|
1,571,546
|
|
“In the money” warrants
|
—
|
|
|
—
|
|
|
801,132
|
|
|
400,566
|
|
“Out of the money” warrants
|
4,741,725
|
|
|
4,831,352
|
|
|
4,801,476
|
|
|
4,831,352
|
|
|
|
|
|
|
|
|
|
||||
Other securities excluded from the calculation of diluted loss per share:
|
|
|
|
|
|
|
|
||||
Stock options with performance condition
|
—
|
|
|
—
|
|
|
66,667
|
|
|
—
|
|
•
|
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 Form 10-K for 2014, as well as the information contained under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for 2014.
|
|
Three months ended
September 30, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Revenue from product sales
|
$
|
49
|
|
|
$
|
20
|
|
|
$
|
29
|
|
|
145.0
|
%
|
Collaboration revenue
|
30
|
|
|
—
|
|
|
30
|
|
|
100.0
|
%
|
|||
Total revenue
|
79
|
|
|
20
|
|
|
59
|
|
|
295.0
|
%
|
|||
Cost of product sales
|
62
|
|
|
512
|
|
|
(450
|
)
|
|
(87.9
|
)%
|
|||
Cost of collaboration revenue
|
142
|
|
|
—
|
|
|
142
|
|
|
100.0
|
%
|
|||
Total cost of revenue
|
204
|
|
|
512
|
|
|
(308
|
)
|
|
(60.2
|
)%
|
|||
Gross loss
|
$
|
(125
|
)
|
|
$
|
(492
|
)
|
|
$
|
367
|
|
|
(74.6
|
)%
|
|
Three months ended
September 30, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
azficel-T for chronic dysphonia
|
$
|
218
|
|
|
$
|
183
|
|
|
$
|
35
|
|
|
19.1
|
%
|
FCX-007
|
1,298
|
|
|
1,135
|
|
|
163
|
|
|
14.4
|
%
|
|||
FCX-013
|
512
|
|
|
74
|
|
|
438
|
|
|
591.9
|
%
|
|||
Other
|
23
|
|
|
210
|
|
|
(187
|
)
|
|
(89.0
|
)%
|
|||
Total direct costs
|
2,051
|
|
|
1,602
|
|
|
449
|
|
|
28.0
|
%
|
|||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
236
|
|
|
246
|
|
|
(10
|
)
|
|
(4.1
|
)%
|
|||
Intangible amortization
|
138
|
|
|
138
|
|
|
—
|
|
|
—
|
|
|||
Compensation and related expense
|
1,165
|
|
|
752
|
|
|
413
|
|
|
54.9
|
%
|
|||
Process development
|
481
|
|
|
—
|
|
|
481
|
|
|
100.0
|
%
|
|||
Other indirect R&D costs
|
150
|
|
|
331
|
|
|
(181
|
)
|
|
(54.7
|
)%
|
|||
Total indirect costs
|
2,170
|
|
|
1,467
|
|
|
703
|
|
|
47.9
|
%
|
|||
Total research and development expense
|
$
|
4,221
|
|
|
$
|
3,069
|
|
|
$
|
1,152
|
|
|
37.5
|
%
|
•
|
azficel-T for chronic dysphonia
— Our Phase II clinical trial began enrollment in the second quarter of 2014. Costs were relatively constant for the three months ended September 30, 2015 as compared to the same period last year.
|
•
|
FCX-007
— Costs increased approximately
$0.2 million
for the three months ended September 30, 2015 as compared to the same period last year. The increase was primarily due to the progression of our preclinical development program and additional IND enabling development work performed related to the IND filed with the FDA in July 2015.
|
•
|
FCX-013
— Costs increased approximately $
0.4 million
for the three months ended September 30, 2015 as compared to the same period last year due to increases in costs incurred with Intrexon related to the advancement of our preclinical work, specifically for gene screening and selection, construct build and optimization, vector optimization, assay development, RheoSwitch® and ligand optimization and early animal model work.
|
•
|
Other
- Other direct research and development expenses decreased approximately $0.2 million for the three months ended September 30, 2015 as compared to the same period last year due to the reduction of efforts on our azficel-T program for the treatment of restrictive burn scarring. Enrollment for the Phase II clinical trial for this indication was closed in the fourth quarter of 2014 and the trial is continuing with the subjects currently enrolled.
|
|
Three months ended
September 30, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Compensation and related expense
|
$
|
1,304
|
|
|
$
|
1,102
|
|
|
$
|
202
|
|
|
18.3
|
%
|
Professional fees
|
461
|
|
|
769
|
|
|
(308
|
)
|
|
(40.1
|
)%
|
|||
Facilities and related expense and other
|
712
|
|
|
759
|
|
|
(47
|
)
|
|
(6.2
|
)%
|
|||
Total selling, general and administrative expense
|
$
|
2,477
|
|
|
$
|
2,630
|
|
|
$
|
(153
|
)
|
|
(5.8
|
)%
|
|
Nine months ended September 30,
|
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Revenue from product sales
|
$
|
217
|
|
|
$
|
124
|
|
|
$
|
93
|
|
|
75.0
|
%
|
Collaboration revenue
|
193
|
|
|
—
|
|
|
193
|
|
|
100.0
|
%
|
|||
Total revenue
|
410
|
|
|
124
|
|
|
286
|
|
|
230.6
|
%
|
|||
Cost of product sales
|
283
|
|
|
1,852
|
|
|
(1,569
|
)
|
|
(84.7
|
)%
|
|||
Cost of collaboration revenue
|
230
|
|
|
—
|
|
|
230
|
|
|
100.0
|
%
|
|||
Total cost of revenue
|
513
|
|
|
1,852
|
|
|
(1,339
|
)
|
|
(72.3
|
)%
|
|||
Gross profit (loss)
|
$
|
(103
|
)
|
|
$
|
(1,728
|
)
|
|
$
|
1,625
|
|
|
(94.0
|
)%
|
|
Nine months ended September 30,
|
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
azficel-T for chronic dysphonia
|
$
|
942
|
|
|
$
|
381
|
|
|
$
|
561
|
|
|
147.2
|
%
|
FCX-007
|
3,527
|
|
|
2,757
|
|
|
770
|
|
|
27.9
|
%
|
|||
FCX-013
|
1,216
|
|
|
336
|
|
|
880
|
|
|
261.9
|
%
|
|||
Ehlers-Danlos Syndrome (hypermobility type)
|
—
|
|
|
5,176
|
|
|
(5,176
|
)
|
|
(100.0
|
)%
|
|||
Other
|
122
|
|
|
501
|
|
|
(379
|
)
|
|
(75.6
|
)%
|
|||
Total direct costs
|
5,807
|
|
|
9,151
|
|
|
(3,344
|
)
|
|
(36.5
|
)%
|
|||
|
|
|
|
|
|
|
|
|||||||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
716
|
|
|
638
|
|
|
78
|
|
|
12.2
|
%
|
|||
Intangible amortization
|
414
|
|
|
414
|
|
|
—
|
|
|
—
|
|
|||
Compensation and related expense
|
2,981
|
|
|
2,185
|
|
|
796
|
|
|
36.4
|
%
|
|||
Process development
|
552
|
|
|
37
|
|
|
515
|
|
|
1,391.9
|
%
|
|||
Other indirect R&D costs
|
1,432
|
|
|
1,484
|
|
|
(52
|
)
|
|
(3.5
|
)%
|
|||
Total indirect costs
|
6,095
|
|
|
4,758
|
|
|
1,337
|
|
|
28.1
|
%
|
|||
Total research and development expense
|
$
|
11,902
|
|
|
$
|
13,909
|
|
|
$
|
(2,007
|
)
|
|
(14.4
|
)%
|
•
|
azficel-T for chronic dysphonia
— Our Phase II clinical trial began enrollment in the second quarter of 2014. Costs increased approximately $
0.6 million
for the nine months ended September 30, 2015 as compared to the same period last year due to costs for additional patient enrollment, clinical site fees and clinical manufacturing costs.
|
•
|
FCX-007
— Costs increased approximately $
0.8 million
for the nine months ended September 30, 2015 as compared to the same period last year due to the progression of our preclinical development program, specifically our animal studies and preclinical product manufacturing costs, as well as additional IND enabling development work performed related to the IND filed with the FDA in July 2015.
|
•
|
FCX-013
— Costs increased approximately $
0.9 million
for the nine months ended September 30, 2015 as compared to the same period last year due to the advancement of our preclinical work, specifically for gene screening and selection, construct build and optimization, vector optimization, assay development, RheoSwitch® and ligand optimization and some early animal model work.
|
•
|
Ehlers-Danlos Syndrome (hypermobility type)
— Costs decreased approximately $
5.2 million
for the nine months ended September 30, 2015 as compared to the same period last year due to supplemental stock issuance costs incurred in 2014 in connection with the second amendment to the exclusive channel collaboration agreement with Intrexon. In the third quarter of 2015, we and Intrexon mutually agreed to terminate this development program.
|
•
|
Other
— Other direct research and development expenses decreased approximately
$0.4 million
for the nine months ended September 30, 2015 as compared to the same period last year due to the reduction of efforts on our azficel-T program for the treatment of restrictive burn scarring. Enrollment for the Phase II clinical trial for this indication was closed in the fourth quarter of 2014 and the trial is continuing with the subjects currently enrolled.
|
|
Nine months ended September 30,
|
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2015
|
|
2014
|
|
$
|
|
%
|
|||||||
Compensation and related expense
|
$
|
3,829
|
|
|
$
|
3,379
|
|
|
$
|
450
|
|
|
13.3
|
%
|
Professional fees
|
3,030
|
|
|
2,508
|
|
|
522
|
|
|
20.8
|
%
|
|||
Facilities and related expense and other
|
2,182
|
|
|
2,263
|
|
|
(81
|
)
|
|
(3.6
|
)%
|
|||
Total selling, general and administrative expense
|
$
|
9,041
|
|
|
$
|
8,150
|
|
|
$
|
891
|
|
|
10.9
|
%
|
Statement of Cash Flows Data:
|
Nine months ended September 30,
|
||||||
($ in thousands)
|
2015
|
|
2014
|
||||
Cash used in operating activities
|
$
|
(16,480
|
)
|
|
$
|
(15,512
|
)
|
Cash used in investing activities
|
$
|
(208
|
)
|
|
$
|
(307
|
)
|
Cash provided by financing activities
|
$
|
16,124
|
|
|
$
|
—
|
|
•
|
Shandong will not represent that it has any current affiliation with us or any rights to the LAVIV product or LAVIV process;
|
•
|
Shandong will not use (and will direct its distributors not to use) our name, U.S. trademarks or our June 21, 2011 U.S. FDA approval for LAVIV in any way that violates the Lanham Act; and
|
•
|
we will continue to allow patients that were recruited by Shandong and who began (but did not complete) their LAVIV treatment, to complete their course of treatment.
|
•
|
test short-term safety;
|
•
|
establish biological plausibility;
|
•
|
identify biologically active dose levels;
|
•
|
establish feasibility and reasonable safety of the investigational product's proposed clinical route of administration;
|
•
|
identify physiologic parameters that can guide clinical monitoring; and/or
|
•
|
establish proof of concept, or the feasibility and rationale for use of an investigational product in the targeted patient population.
|
EXHIBIT NO.
|
|
IDENTIFICATION OF EXHIBIT
|
1.1
|
|
Underwriting Agreement, dated as of July 22, 2015, between Fibrocell Science, Inc. and Wells Fargo Securities, LLC, as representative of the underwriters named therein (incorporated by reference to Exhibit 1.1 to our Form 8-K filed July 22, 2015)
|
10.1
|
|
Employment Agreement, dated September 14, 2015, by and between Fibrocell Science, Inc. and John Maslowski (incorporated by reference to Exhibit 10.1 to our Form 8-K filed September 16, 2015)
|
10.2*
|
|
Letter Agreement to Exclusive Channel Collaboration Agreement, as amended, between Fibrocell Science, Inc. and Intrexon Corporation, dated September 29, 2015
|
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
|
|
Senior Vice President and Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
|
|
Date:
|
November 5, 2015
|
EXHIBIT NO.
|
|
IDENTIFICATION OF EXHIBIT
|
1.1
|
|
Underwriting Agreement, dated as of July 22, 2015, between Fibrocell Science, Inc. and Wells Fargo Securities, LLC, as representative of the underwriters named therein (incorporated by reference to Exhibit 1.1 to our Form 8-K filed July 22, 2015)
|
10.1
|
|
Employment Agreement, dated September 14, 2015, by and between Fibrocell Science, Inc. and John Maslowski (incorporated by reference to Exhibit 10.1 to our Form 8-K filed September 16, 2015)
|
10.2*
|
|
Letter Agreement to Exclusive Channel Collaboration Agreement, as amended, between Fibrocell Science, Inc. and Intrexon Corporation, dated September 29, 2015
|
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.
|
/s/ Don Lehr
|
Don Lehr
|
Chief Legal Officer
|
By:
|
/s/ David Pernock
|
Name:
|
David Pernock
|
Its:
|
Chairman/CEO
|
Date:
|
November 5, 2015
|
By:
|
/s/ David Pernock
|
|
David Pernock
|
|
Chief Executive Officer
|
Date:
|
November 5, 2015
|
By:
|
/s/ Keith A. Goldan
|
|
Keith A. Goldan
|
|
SVP and Chief Financial Officer
|
Date:
|
November 5, 2015
|
By:
|
/s/ David Pernock
|
|
David Pernock
|
|
Chief Executive Officer
|
Date:
|
November 5, 2015
|
By:
|
/s/ Keith A. Goldan
|
|
Keith A. Goldan
|
|
SVP and Chief Financial Officer
|