|
x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
DELAWARE
|
|
33-0969592
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(State or other jurisdiction of
incorporation or organization)
|
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(I.R.S. Employer
Identification No.)
|
|
|
|
660 W. GERMANTOWN PIKE, SUITE 110
PLYMOUTH MEETING, PA
|
|
19462
|
(Address of principal executive offices)
|
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(Zip Code)
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COMMON STOCK, $0.001 PAR VALUE
|
|
Nasdaq Global Select Market
|
(Title of Class)
|
|
(Name of Each Exchange on Which Registered)
|
|
Large accelerated filer
|
☐
|
|
Accelerated filer
|
x
|
|
|
|
|
|
Non-accelerated filer
|
☐
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(Do not check if a smaller reporting company)
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Smaller reporting company
|
☐
|
|
|
|
|
|
|
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Emerging growth company
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☐
|
|
|
|
|
March 31,
2018 |
|
December 31,
2017 |
||||
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(Unaudited)
|
|
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
37,508,863
|
|
|
$
|
23,786,579
|
|
Short-term investments
|
75,259,889
|
|
|
103,638,844
|
|
||
Accounts receivable
|
5,147,851
|
|
|
6,003,205
|
|
||
Accounts receivable from affiliated entities
|
2,242,569
|
|
|
486,619
|
|
||
Prepaid expenses and other current assets
|
2,002,015
|
|
|
2,600,906
|
|
||
Prepaid expenses and other current assets from affiliated entities
|
1,674,981
|
|
|
1,846,007
|
|
||
Total current assets
|
123,836,168
|
|
|
138,362,160
|
|
||
Fixed assets, net
|
17,486,103
|
|
|
18,320,176
|
|
||
Investment in affiliated entity - GeneOne
|
10,467,711
|
|
|
9,069,401
|
|
||
Investment in affiliated entity - PLS
|
3,307,192
|
|
|
2,325,079
|
|
||
Intangible assets, net
|
5,605,667
|
|
|
6,009,729
|
|
||
Goodwill
|
10,513,371
|
|
|
10,513,371
|
|
||
Other assets
|
2,448,628
|
|
|
2,639,354
|
|
||
Total assets
|
$
|
173,664,840
|
|
|
$
|
187,239,270
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
15,825,207
|
|
|
$
|
23,278,798
|
|
Accounts payable and accrued expenses due to affiliated entities
|
1,298,741
|
|
|
926,943
|
|
||
Accrued clinical trial expenses
|
8,428,881
|
|
|
8,611,892
|
|
||
Common stock warrants
|
488,636
|
|
|
360,795
|
|
||
Deferred revenue
|
24,088,288
|
|
|
1,175,353
|
|
||
Deferred revenue from affiliated entities
|
56,167
|
|
|
174,110
|
|
||
Deferred rent
|
928,098
|
|
|
877,535
|
|
||
Other liabilities
|
261,325
|
|
|
—
|
|
||
Total current liabilities
|
51,375,343
|
|
|
35,405,426
|
|
||
Deferred revenue, net of current portion
|
203,322
|
|
|
215,853
|
|
||
Deferred rent, net of current portion
|
8,966,846
|
|
|
9,104,416
|
|
||
Deferred tax liabilities
|
24,766
|
|
|
24,766
|
|
||
Total liabilities
|
60,570,277
|
|
|
44,750,461
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
||
Common stock
|
90,705
|
|
|
90,358
|
|
||
Additional paid-in capital
|
668,844,504
|
|
|
665,775,504
|
|
||
Accumulated deficit
|
(555,475,779
|
)
|
|
(523,356,317
|
)
|
||
Accumulated other comprehensive loss
|
(461,136
|
)
|
|
(117,005
|
)
|
||
Total Inovio Pharmaceuticals, Inc. stockholders’ equity
|
112,998,294
|
|
|
142,392,540
|
|
||
Non-controlling interest
|
96,269
|
|
|
96,269
|
|
||
Total stockholders’ equity
|
113,094,563
|
|
|
142,488,809
|
|
||
Total liabilities and stockholders’ equity
|
$
|
173,664,840
|
|
|
$
|
187,239,270
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Revenues:
|
|
|
|
||||
Revenue under collaborative research and development arrangements
|
$
|
1,289,046
|
|
|
$
|
4,288,586
|
|
Revenue under collaborative research and development arrangements with affiliated entities
|
148,008
|
|
|
233,330
|
|
||
Grants and miscellaneous revenue
|
92,590
|
|
|
5,240,233
|
|
||
Grants and miscellaneous revenue from affiliated entity
|
—
|
|
|
614,036
|
|
||
Total revenues
|
1,529,644
|
|
|
10,376,185
|
|
||
Operating expenses:
|
|
|
|
||||
Research and development
|
24,577,751
|
|
|
24,542,504
|
|
||
General and administrative
|
9,698,015
|
|
|
7,767,589
|
|
||
Total operating expenses
|
34,275,766
|
|
|
32,310,093
|
|
||
Loss from operations
|
(32,746,122
|
)
|
|
(21,933,908
|
)
|
||
Other income (expense):
|
|
|
|
||||
Interest and other income, net
|
312,523
|
|
|
340,341
|
|
||
Change in fair value of common stock warrants
|
(127,841
|
)
|
|
116,477
|
|
||
Gain (loss) on investment in affiliated entities
|
2,380,423
|
|
|
(1,608,817
|
)
|
||
Net loss before provision for income taxes
|
(30,181,017
|
)
|
|
(23,085,907
|
)
|
||
Provision for income taxes
|
(2,169,811
|
)
|
|
—
|
|
||
Net loss
|
$
|
(32,350,828
|
)
|
|
$
|
(23,085,907
|
)
|
Net loss per share
|
|
|
|
||||
Basic
|
$
|
(0.36
|
)
|
|
$
|
(0.31
|
)
|
Diluted
|
$
|
(0.36
|
)
|
|
$
|
(0.31
|
)
|
Weighted average number of common shares outstanding
|
|
|
|
||||
Basic
|
90,451,791
|
|
|
74,152,609
|
|
||
Diluted
|
90,451,791
|
|
|
74,300,884
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net loss
|
$
|
(32,350,828
|
)
|
|
$
|
(23,085,907
|
)
|
Other comprehensive income (loss):
|
|
|
|
||||
Unrealized loss on investment in affiliated entity
|
—
|
|
|
(749,961
|
)
|
||
Unrealized gain (loss) on short-term investments
|
(112,765
|
)
|
|
203,540
|
|
||
Comprehensive loss
|
$
|
(32,463,593
|
)
|
|
$
|
(23,632,328
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(32,350,828
|
)
|
|
$
|
(23,085,907
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation
|
897,709
|
|
|
522,298
|
|
||
Amortization of intangible assets
|
404,062
|
|
|
406,299
|
|
||
Change in value of common stock warrants
|
127,841
|
|
|
(116,477
|
)
|
||
Stock-based compensation
|
3,575,750
|
|
|
5,372,797
|
|
||
Amortization of premiums on investments
|
55,522
|
|
|
69,004
|
|
||
Loss on short-term investments
|
253,316
|
|
|
51,706
|
|
||
Deferred rent
|
(87,007
|
)
|
|
1,208,085
|
|
||
Loss (gain) on equity investment in affiliated entities
|
(2,380,423
|
)
|
|
1,608,817
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
855,354
|
|
|
5,956,611
|
|
||
Accounts receivable from affiliated entity
|
(1,755,950
|
)
|
|
(484,550
|
)
|
||
Prepaid expenses and other current assets
|
598,891
|
|
|
(2,457,068
|
)
|
||
Prepaid expenses and other current assets from affiliated entity
|
171,026
|
|
|
(304,345
|
)
|
||
Other assets
|
190,726
|
|
|
587,993
|
|
||
Accounts payable and accrued expenses
|
(6,363,762
|
)
|
|
(5,643,054
|
)
|
||
Accrued clinical trial expenses
|
(183,011
|
)
|
|
(458,516
|
)
|
||
Accounts payable and accrued expenses due to affiliated entity
|
371,798
|
|
|
(543,410
|
)
|
||
Deferred revenue
|
22,900,404
|
|
|
2,207,277
|
|
||
Deferred revenue from affiliated entity
|
(117,943
|
)
|
|
(125,000
|
)
|
||
Other liabilities
|
261,325
|
|
|
—
|
|
||
Net cash used in operating activities
|
(12,575,200
|
)
|
|
(15,227,440
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of investments
|
(9,568,082
|
)
|
|
(5,925,232
|
)
|
||
Maturities of investments
|
37,525,434
|
|
|
24,882,273
|
|
||
Purchases of capital assets
|
(1,153,465
|
)
|
|
(789,257
|
)
|
||
Net cash provided by investing activities
|
26,803,887
|
|
|
18,167,784
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds (payments) for stock option and warrant exercises, net of tax payments
|
(506,403
|
)
|
|
826,437
|
|
||
Net cash (used in) provided by financing activities
|
(506,403
|
)
|
|
826,437
|
|
||
Increase in cash and cash equivalents
|
13,722,284
|
|
|
3,766,781
|
|
||
Cash and cash equivalents, beginning of period
|
23,786,579
|
|
|
19,136,472
|
|
||
Cash and cash equivalents, end of period
|
$
|
37,508,863
|
|
|
$
|
22,903,253
|
|
|
|
|
|
||||
Supplemental disclosure of non-cash activities
|
|
|
|
||||
Change in amounts accrued for purchases of property and equipment
|
$
|
164,288
|
|
|
$
|
511,052
|
|
|
Balances Without Adoption of Topic 606 at March 31, 2018
|
|
Impact of Adopting Topic 606
|
|
As reported at March 31, 2018
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Revenue under collaborative research and development arrangements
|
$
|
1,289,046
|
|
|
$
|
—
|
|
|
$
|
1,289,046
|
|
Revenue under collaborative research and development arrangements with affiliated entities
|
148,008
|
|
|
—
|
|
|
148,008
|
|
|||
Grants and miscellaneous revenue
|
1,850,341
|
|
|
(1,757,751
|
)
|
|
92,590
|
|
|||
Grants and miscellaneous revenue from affiliated entity
|
464,400
|
|
|
(464,400
|
)
|
|
—
|
|
|||
Total revenues
|
3,751,795
|
|
|
(2,222,151
|
)
|
|
1,529,644
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
22,355,600
|
|
|
(2,222,151
|
)
|
|
24,577,751
|
|
|||
General and administrative
|
9,698,015
|
|
|
—
|
|
|
9,698,015
|
|
|||
Total operating expenses
|
$
|
32,053,615
|
|
|
$
|
(2,222,151
|
)
|
|
$
|
34,275,766
|
|
Equity:
|
Balance at December 31, 2017
|
|
Adjustments due to ASU No. 2016-01
|
|
Balance at January 1, 2018
|
||||||
Accumulated deficit
|
$
|
(523,356,317
|
)
|
|
$
|
231,366
|
|
|
$
|
(523,124,951
|
)
|
Accumulated other comprehensive loss
|
$
|
(117,005
|
)
|
|
$
|
(231,366
|
)
|
|
$
|
(348,371
|
)
|
|
Balance at January 1, 2018
|
|
Additions
|
|
Deductions
|
|
Balance at March 31, 2018
|
||||||||
Contract assets
|
|
|
|
|
|
|
|
||||||||
Accounts receivable from MedImmune
|
$
|
1,693,530
|
|
|
$
|
1,339,961
|
|
|
$
|
(3,750
|
)
|
|
$
|
3,029,741
|
|
Contract liabilities
|
|
|
|
|
|
|
|
||||||||
Deferred revenue - MedImmune
|
1,145,500
|
|
|
582,500
|
|
|
(531,583
|
)
|
|
1,196,417
|
|
||||
Deferred revenue - ApolloBio
|
—
|
|
|
23,000,000
|
|
|
—
|
|
|
23,000,000
|
|
||||
Deferred revenue - Other
|
$
|
271,894
|
|
|
$
|
—
|
|
|
$
|
(120,534
|
)
|
|
$
|
151,360
|
|
|
|
|
As of March 31, 2018
|
||||||||||||||
|
Contractual
Maturity (in years)
|
Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Market Value
|
|||||||||
Mutual funds
|
---
|
|
$
|
54,509,756
|
|
|
$
|
—
|
|
|
$
|
(306,308
|
)
|
|
$
|
54,203,448
|
|
US corporate debt securities
|
Less than 2
|
|
21,211,005
|
|
|
—
|
|
|
(154,564
|
)
|
|
21,056,441
|
|
||||
Investment in affiliated entity (PLS)
|
---
|
|
—
|
|
|
3,307,192
|
|
|
—
|
|
|
3,307,192
|
|
||||
Total investments
|
|
|
$
|
75,720,761
|
|
|
$
|
3,307,192
|
|
|
$
|
(460,872
|
)
|
|
$
|
78,567,081
|
|
|
|
|
As of December 31, 2017
|
||||||||||||||
|
Contractual
Maturity (in years)
|
Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Market Value
|
|||||||||
Mutual funds
|
---
|
|
$
|
68,776,165
|
|
|
$
|
42,097
|
|
|
$
|
(252,373
|
)
|
|
$
|
68,565,889
|
|
US corporate debt securities
|
Less than 2
|
|
35,210,121
|
|
|
3,032
|
|
|
(140,198
|
)
|
|
35,072,955
|
|
||||
Investment in affiliated entity (PLS)
|
---
|
|
—
|
|
|
2,325,079
|
|
|
—
|
|
|
2,325,079
|
|
||||
Total investments
|
|
|
$
|
103,986,286
|
|
|
$
|
2,370,208
|
|
|
$
|
(392,571
|
)
|
|
$
|
105,963,923
|
|
|
Fair Value Measurements at
|
||||||||||||||
|
March 31, 2018
|
||||||||||||||
|
Total
|
|
Quoted Prices
in Active Markets
(Level 1)
|
|
Significant
Other Unobservable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
1,590,607
|
|
|
$
|
1,590,607
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Mutual funds
|
54,203,448
|
|
|
—
|
|
|
54,203,448
|
|
|
—
|
|
||||
US corporate debt securities
|
21,056,441
|
|
|
—
|
|
|
21,056,441
|
|
|
—
|
|
||||
Investment in affiliated entities
|
13,774,903
|
|
|
13,774,903
|
|
|
—
|
|
|
—
|
|
||||
Total Assets
|
$
|
90,625,399
|
|
|
$
|
15,365,510
|
|
|
$
|
75,259,889
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
488,636
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
488,636
|
|
|
Total Liabilities
|
$
|
488,636
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
488,636
|
|
|
Fair Value Measurements at
|
||||||||||||||
|
December 31, 2017
|
||||||||||||||
|
Total
|
|
Quoted Prices
in Active Markets
(Level 1)
|
|
Significant
Other Unobservable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
9,843,482
|
|
|
$
|
9,843,482
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Mutual funds
|
68,565,889
|
|
|
—
|
|
|
68,565,889
|
|
|
—
|
|
||||
US corporate debt securities
|
35,072,955
|
|
|
—
|
|
|
35,072,955
|
|
|
—
|
|
||||
Investment in affiliated entities
|
11,394,480
|
|
|
11,394,480
|
|
|
—
|
|
|
—
|
|
||||
Total Assets
|
$
|
124,876,806
|
|
|
$
|
21,237,962
|
|
|
$
|
103,638,844
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
360,795
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
360,795
|
|
Total Liabilities
|
$
|
360,795
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
360,795
|
|
Balance at December 31, 2017
|
$
|
360,795
|
|
Increase attributable to change in fair value of common stock warrants
|
127,841
|
|
|
Balance at March 31, 2018
|
$
|
488,636
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||||||||||||
|
Useful
Life
(Yrs)
|
Gross
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Gross
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|||||||||||||
Indefinite lived:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Goodwill(a)
|
|
|
$
|
10,513,371
|
|
|
$
|
—
|
|
|
$
|
10,513,371
|
|
|
$
|
10,513,371
|
|
|
$
|
—
|
|
|
$
|
10,513,371
|
|
Definite lived:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Patents
|
8 – 17
|
|
5,802,528
|
|
|
(5,696,775
|
)
|
|
105,753
|
|
|
5,802,528
|
|
|
(5,681,673
|
)
|
|
120,855
|
|
||||||
Licenses
|
8 – 17
|
|
1,323,761
|
|
|
(1,197,796
|
)
|
|
125,965
|
|
|
1,323,761
|
|
|
(1,190,609
|
)
|
|
133,152
|
|
||||||
CELLECTRA
®
(b)
|
5 – 11
|
|
8,106,270
|
|
|
(7,358,878
|
)
|
|
747,392
|
|
|
8,106,270
|
|
|
(7,252,108
|
)
|
|
854,162
|
|
||||||
GHRH(b)
|
11
|
|
335,314
|
|
|
(279,868
|
)
|
|
55,446
|
|
|
335,314
|
|
|
(271,948
|
)
|
|
63,366
|
|
||||||
Bioject(c)
|
2 – 15
|
|
5,100,000
|
|
|
(1,616,389
|
)
|
|
3,483,611
|
|
|
5,100,000
|
|
|
(1,405,556
|
)
|
|
3,694,444
|
|
||||||
Other(d)
|
18
|
|
4,050,000
|
|
|
(2,962,500
|
)
|
|
1,087,500
|
|
|
4,050,000
|
|
|
(2,906,250
|
)
|
|
1,143,750
|
|
||||||
Total intangible assets
|
|
|
24,717,873
|
|
|
(19,112,206
|
)
|
|
5,605,667
|
|
|
24,717,873
|
|
|
(18,708,144
|
)
|
|
6,009,729
|
|
||||||
Total goodwill and intangible assets
|
|
|
$
|
35,231,244
|
|
|
$
|
(19,112,206
|
)
|
|
$
|
16,119,038
|
|
|
$
|
35,231,244
|
|
|
$
|
(18,708,144
|
)
|
|
$
|
16,523,100
|
|
(a)
|
Goodwill was recorded from the Inovio AS acquisition in January 2005, the acquisition of VGX in June 2009 and the acquisition of Bioject in April 2016 for
$3.9 million
,
$6.2 million
and
$400,000
, respectively.
|
(b)
|
CELLECTRA
®
and GHRH are developed technologies which were recorded from the acquisition of VGX.
|
(c)
|
Bioject intangible assets represent the estimated fair value of developed technology and intellectual property which were recorded from the Bioject asset acquisition.
|
(d)
|
Other intangible assets represent the estimated fair value of acquired intellectual property from the Inovio AS acquisition.
|
|
|
|
|
|
Outstanding as of
|
||||||
|
Authorized
|
|
Issued
|
|
March 31,
2018 |
|
December 31, 2017
|
||||
Common Stock, par value $0.001 per share
|
600,000,000
|
|
|
90,704,931
|
|
|
90,704,931
|
|
|
90,357,644
|
|
Series C Preferred Stock, par value $0.001 per share
|
1,091
|
|
|
1,091
|
|
|
23
|
|
|
23
|
|
|
|
|
|
|
|
As of March 31, 2018
|
|
As of December 31, 2017
|
||||||||||||
Issued in Connection With:
|
|
Exercise
Price
|
|
Expiration
Date
|
|
Number of
Warrants Outstanding
|
|
Common Stock
Warrant Liability
|
|
Number of
Warrants Outstanding
|
|
Common Stock
Warrant Liability
|
||||||||
March 2013 financing
|
|
$
|
3.17
|
|
|
September 12, 2018
|
|
284,091
|
|
|
$
|
488,636
|
|
|
284,091
|
|
|
$
|
360,795
|
|
Total
|
|
|
|
|
|
284,091
|
|
|
$
|
488,636
|
|
|
284,091
|
|
|
$
|
360,795
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Numerator
|
|
|
|
||||
Net loss
|
$
|
(32,350,828
|
)
|
|
$
|
(23,085,907
|
)
|
Adjustment for decrease in fair value of warrant liability
|
—
|
|
|
(116,477
|
)
|
||
Numerator for use in diluted net loss per share
|
$
|
(32,350,828
|
)
|
|
$
|
(23,202,384
|
)
|
|
|
|
|
||||
Denominator
|
|
|
|
||||
Weighted average number of common shares outstanding
|
90,451,791
|
|
|
74,152,609
|
|
||
Effect of dilutive potential common shares
|
—
|
|
|
148,275
|
|
||
Denominator for use in diluted net loss per share
|
90,451,791
|
|
|
74,300,884
|
|
||
|
|
|
|
||||
Net loss per share, diluted
|
$
|
(0.36
|
)
|
|
$
|
(0.31
|
)
|
|
|
|
|
|
|
||||
Common Stock Equivalents
|
2018
|
|
2017
|
||
Options to purchase common stock
|
9,467,477
|
|
|
7,841,669
|
|
Warrants to purchase common stock
|
284,091
|
|
|
—
|
|
Restricted stock units
|
1,791,886
|
|
|
1,376,893
|
|
Convertible preferred stock
|
8,456
|
|
|
8,456
|
|
Total
|
11,551,910
|
|
|
9,227,018
|
|
|
|
|
|
|
Three Months Ended March 31,
|
||
|
2018
|
|
2017
|
Risk-free interest rate
|
2.72%
|
|
2.24%
|
Expected volatility
|
72%
|
|
73%
|
Expected life in years
|
6.2
|
|
6.0
|
Dividend yield
|
—
|
|
—
|
Remainder of 2018
|
$
|
2,447,000
|
|
2019
|
3,756,000
|
|
|
2020
|
3,891,000
|
|
|
2021
|
3,979,000
|
|
|
2022
|
4,052,000
|
|
|
Thereafter
|
19,975,000
|
|
|
Total
|
$
|
38,100,000
|
|
•
|
developing and securing United States and/or foreign regulatory approvals for our product candidates, including securing regulatory approval for conducting clinical trials with product candidates;
|
•
|
developing our electroporation-based DNA delivery technology; and
|
•
|
commercializing any products for which we receive approval from the FDA and foreign regulatory authorities.
|
•
|
the progress of our current and new product development programs;
|
•
|
the progress, scope and results of our pre-clinical and clinical testing;
|
•
|
the time and cost involved in obtaining regulatory approvals;
|
•
|
the cost of manufacturing our products and product candidates;
|
•
|
the cost of prosecuting, enforcing and defending against patent infringement claims and other intellectual property rights;
|
•
|
competing technological and market developments; and
|
•
|
our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market.
|
•
|
variations in the level of expenses related to our electroporation equipment, product candidates or future development programs;
|
•
|
expenses related to corporate transactions, including ones not fully completed;
|
•
|
addition or termination of clinical trials or funding support;
|
•
|
any intellectual property infringement lawsuit in which we may become involved;
|
•
|
any legal claims that may be asserted against us or any of our officers;
|
•
|
regulatory developments affecting our electroporation equipment and product candidates or those of our competitors;
|
•
|
our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and
|
•
|
if any of our products receives regulatory approval, the levels of underlying demand for our products.
|
•
|
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our electroporation equipment and a product candidate are safe and effective for any indication;
|
•
|
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
|
•
|
we may not be successful in enrolling a sufficient number of participants in clinical trials;
|
•
|
we may be unable to demonstrate that our electroporation equipment and a product candidate's clinical and other benefits outweigh its safety risks;
|
•
|
we may be unable to demonstrate that our electroporation equipment and a product candidate presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials;
|
•
|
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application or other submission or to obtain regulatory approval in the United States or elsewhere;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of us or third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
obtaining regulatory approval to commence a clinical trial;
|
•
|
adverse results from third party clinical trials involving gene based therapies and the regulatory response thereto;
|
•
|
reaching agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
•
|
future bans or stricter standards imposed on gene based therapy clinical trials;
|
•
|
manufacturing sufficient quantities of our electroporation equipment and product candidates for use in clinical trials;
|
•
|
obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;
|
•
|
slower than expected recruitment and enrollment of patients to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for similar indications;
|
•
|
conducting clinical trials with sites internationally due to regulatory approvals and meeting international standards;
|
•
|
retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up;
|
•
|
collecting, reviewing and analyzing our clinical trial data; and
|
•
|
global unrest, terrorist activities, and economic and other external factors.
|
•
|
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
•
|
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
•
|
unforeseen safety issues; and
|
•
|
lack of adequate funding to continue the clinical trial.
|
•
|
issue Warning Letters or untitled letters;
|
•
|
impose civil or criminal penalties;
|
•
|
suspend regulatory approval;
|
•
|
suspend any ongoing clinical trials;
|
•
|
refuse to approve pending applications or supplements to applications filed by us;
|
•
|
impose restrictions on operations, including costly new manufacturing requirements; or
|
•
|
seize or detain products or require us to initiate a product recall.
|
•
|
decreased demand for our product candidates;
|
•
|
impairment of our business reputation;
|
•
|
withdrawal of clinical trial participants;
|
•
|
costs of related litigation;
|
•
|
distraction of management's attention from our primary business;
|
•
|
substantial monetary awards to patients or other claimants;
|
•
|
loss of revenues; and
|
•
|
inability to commercialize our products.
|
•
|
our ability to provide acceptable evidence of safety and efficacy;
|
•
|
the relative convenience and ease of administration;
|
•
|
|
•
|
the prevalence and severity of any actual or perceived adverse side effects;
|
•
|
limitations or warnings contained in a product's FDA-approved labeling, including, for example, potential “black box” warnings
|
•
|
availability of alternative treatments;
|
•
|
pricing and cost effectiveness;
|
•
|
the effectiveness of our or any future collaborators' sales and marketing strategies;
|
•
|
our ability to obtain sufficient third-party coverage or reimbursement; and
|
•
|
the willingness of patients to pay out of pocket in the absence of third-party coverage.
|
•
|
our ability to set a price we believe is fair for our products;
|
•
|
our ability to generate revenues and achieve or maintain profitability;
|
•
|
the availability of capital; and
|
•
|
our ability to obtain timely approval of our products.
|
•
|
the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, people from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
|
•
|
federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
|
•
|
the ACA expands the government's investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the False Claims Act and the Anti-Kickback Statute to make it easier to bring suit under those statutes;
|
•
|
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
|
•
|
the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;
|
•
|
the U.S. Foreign Corrupt Practices Act, which, among other things, prohibits companies issuing stock in the U.S. from bribing foreign officials for government contracts and other business; and
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
•
|
exposure to unknown liabilities;
|
•
|
disruption of our business and diversion of our management's time and attention to develop acquired products or technologies;
|
•
|
incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
|
•
|
higher than expected acquisition and integration costs;
|
•
|
increased amortization expenses;
|
•
|
difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
|
•
|
impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
|
•
|
inability to retain key employees of any acquired businesses.
|
•
|
we, or the parties from whom we have acquired or licensed patent rights, may not have been the first to file the underlying patent applications or the first to make the inventions covered by such patents;
|
•
|
the named inventors or co-inventors of patents or patent applications that we have licensed or acquired may be incorrect, which may give rise to inventorship and ownership challenges;
|
•
|
others may develop similar or alternative technologies, or duplicate any of our products or technologies that may not be covered by our patents, including design-arounds;
|
•
|
pending patent applications may not result in issued patents;
|
•
|
the issued patents covering our products and technologies may not provide us with any competitive advantages or have any commercial value;
|
•
|
the issued patents may be challenged and invalidated, or rendered unenforceable;
|
•
|
the issued patents may be subject to reexamination, which could result in a narrowing of the scope of claims or cancellation of claims found unpatentable;
|
•
|
we may not develop or acquire additional proprietary technologies that are patentable;
|
•
|
our trademarks may be invalid or subject to a third party's prior use; or
|
•
|
our ability to enforce our patent rights will depend on our ability to detect infringement, and litigation to enforce patent rights may not be pursued due to significant financial costs, diversion of resources, and unpredictability of a favorable result or ruling.
|
•
|
we may become involved in time-consuming and expensive litigation, even if the claim is without merit, the third party's patent is invalid or we have not infringed;
|
•
|
we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a third party's patent;
|
•
|
we may be enjoined by a court to stop making, selling or licensing our products or technologies without a license from a patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and
|
•
|
we may have to redesign our products so that they do not infringe upon others' patent rights, which may not be possible or could require substantial investment or time.
|
•
|
developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations;
|
•
|
fluctuating public or scientific interest in the potential for influenza pandemic or other applications for our vaccine or other product candidates;
|
•
|
our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;
|
•
|
fluctuations in our operating results;
|
•
|
announcements of technological innovations;
|
•
|
new products or services that we or our competitors offer;
|
•
|
the initiation, conduct and/or outcome of intellectual property and/or litigation matters;
|
•
|
changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;
|
•
|
conditions or trends in bio-pharmaceutical or other healthcare industries;
|
•
|
regulatory developments in the United States and other countries;
|
•
|
negative perception of gene based therapy;
|
•
|
changes in the economic performance and/or market valuations of other biotechnology and medical device companies;
|
•
|
additions or departures of key personnel;
|
•
|
sales or other transactions involving our common stock;
|
•
|
changes in our capital structure;
|
•
|
sales or other transactions by executive officers or directors involving our common stock;
|
•
|
changes in accounting principles;
|
•
|
global unrest, terrorist activities, and economic and other external factors; and
|
•
|
catastrophic weather and/or global disease pandemics.
|
•
|
the authority of our board of directors to issue shares of undesignated preferred stock and to determine the rights, preferences and privileges of these shares, without stockholder approval;
|
•
|
all stockholder actions must be effected at a duly called meeting of stockholders and not by written consent; and
|
•
|
the elimination of cumulative voting.
|
Exhibit
Number
|
|
Description of Document
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
101.INS
|
|
XBRL Instance Document.
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
*
|
This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
|
|
|
Inovio Pharmaceuticals, Inc.
|
|
|
|
|
|
Date:
|
May 9, 2018
|
By
|
/s/ J. JOSEPH KIM
|
|
|
|
J. Joseph Kim
President, Chief Executive Officer and Director (On Behalf of the Registrant)
|
|
|
|
|
Date:
|
May 9, 2018
|
By
|
/s/ PETER KIES
|
|
|
|
Peter Kies
Chief Financial Officer (Principal Financial and Accounting Officer)
|
1.
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I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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May 9, 2018
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/s/ J. J
OSEPH
K
IM
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J. Joseph Kim
President, Chief Executive Officer and Director (Principal Executive Officer)
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1.
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I have reviewed this quarterly report on Form 10-Q of Inovio Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date:
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May 9, 2018
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/s/ P
ETER
K
IES
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Peter Kies
Chief Financial Officer (Principal Financial and Accounting Officer)
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Date:
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May 9, 2018
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/s/ J. J
OSEPH
K
IM
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J. Joseph Kim
President, Chief Executive Officer and Director
(Principal Executive Officer)
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Date:
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May 9, 2018
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/s/ P
ETER
K
IES
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Peter Kies
Chief Financial Officer
(Principal Financial and Accounting Officer)
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