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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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For the Quarterly Period Ended September 30, 2018
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Or
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¨
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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For the transition period from ________ to ___________
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Delaware
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13-3864870
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(State or other jurisdiction of
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(IRS Employer Identification. No.)
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incorporation or organization)
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31 East 62nd Street
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10065
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New York, NY
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(zip code)
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(Address of principal executive offices)
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Large accelerated filer
¨
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Accelerated filer
x
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Non-accelerated filer
¨
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Smaller reporting company
x
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Emerging growth company
¨
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Page No.
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September 30, 2018
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December 31, 2017
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||||
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ASSETS
|
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|
||||
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Current assets
|
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|
||||
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Cash and cash equivalents
|
$
|
103,985,265
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$
|
19,857,833
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Restricted cash, short-term
|
4,095,369
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|
10,701,305
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||
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Accounts receivable
|
1,539,538
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1,802,107
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|
||
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Inventory
|
2,908,249
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|
|
2,983,249
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|
||
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Prepaid expenses and other current assets
|
1,134,925
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|
|
2,019,999
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|
||
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Total current assets
|
113,663,346
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|
37,364,493
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||
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||||
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Property, plant and equipment, net
|
117,864
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|
|
138,640
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||
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Restricted cash, long-term
|
—
|
|
|
6,542,448
|
|
||
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Deferred costs
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—
|
|
|
96,592,334
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|
||
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Deferred tax assets, net
|
27,952,578
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2,431,963
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|
||
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Goodwill
|
898,334
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|
|
898,334
|
|
||
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Other assets
|
1,095,199
|
|
|
702,167
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||
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Total assets
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$
|
143,727,321
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$
|
144,670,379
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|
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LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIENCY)
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||||
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Current liabilities
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|
||||
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Accounts payable
|
$
|
894,792
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$
|
1,328,867
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|
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Accrued expenses and other current liabilities
|
4,310,917
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|
|
5,481,579
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|
||
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Total current liabilities
|
5,205,709
|
|
|
6,810,446
|
|
||
|
Deferred revenue
|
—
|
|
|
377,641,485
|
|
||
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Warrant liability
|
10,729,818
|
|
|
11,466,162
|
|
||
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Other liabilities
|
903,953
|
|
|
840,253
|
|
||
|
Long-term debt
|
74,414,036
|
|
|
71,050,324
|
|
||
|
Total liabilities
|
91,253,516
|
|
|
467,808,670
|
|
||
|
Commitments and contingencies
|
|
|
|
||||
|
Stockholders’ equity/(deficiency)
|
|
|
|
||||
|
Common stock ($.0001 par value, 600,000,000 shares authorized, 80,320,535 and 79,039,000 issued and outstanding at September 30, 2018, and December 31, 2017, respectively)
|
8,032
|
|
|
7,904
|
|
||
|
Additional paid-in capital
|
220,647,968
|
|
|
214,229,581
|
|
||
|
Accumulated deficit
|
(168,182,195
|
)
|
|
(537,375,776
|
)
|
||
|
Total stockholders’ equity/(deficiency)
|
52,473,805
|
|
|
(323,138,291
|
)
|
||
|
Total liabilities and stockholders’ equity/(deficiency)
|
$
|
143,727,321
|
|
|
$
|
144,670,379
|
|
|
|
Three months ended September 30,
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Nine months ended September 30,
|
||||||||||||
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2018
|
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2017
|
|
2018
|
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2017
|
||||||||
|
Revenues
|
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|
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|
||||||||
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Product sales and supportive services
|
$
|
468,865,229
|
|
|
$
|
—
|
|
|
$
|
468,865,229
|
|
|
$
|
—
|
|
|
Research and development
|
2,210,095
|
|
|
1,390,254
|
|
|
6,619,245
|
|
|
10,856,601
|
|
||||
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Total revenues
|
471,075,324
|
|
|
1,390,254
|
|
|
475,484,474
|
|
|
10,856,601
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|
||||
|
|
|
|
|
|
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|
|
||||||||
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Operating expenses
|
|
|
|
|
|
|
|
||||||||
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Cost of sales and supportive services
|
95,166,271
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—
|
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|
95,166,271
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|
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—
|
|
||||
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Selling, general and administrative
|
3,114,678
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|
|
3,093,926
|
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|
9,051,617
|
|
|
9,022,039
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|
||||
|
Research and development
|
3,723,198
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|
|
2,470,835
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|
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10,043,205
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|
|
13,899,162
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|
||||
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Patent expenses
|
186,028
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|
|
250,857
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|
582,833
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|
|
688,471
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|
||||
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Lease termination
|
—
|
|
|
1,225,421
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|
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—
|
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|
1,225,421
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|
||||
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Total operating expenses
|
102,190,175
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7,041,039
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114,843,926
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24,835,093
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|
||||
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Operating income (loss)
|
368,885,149
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(5,650,785
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)
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360,640,548
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(13,978,492
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)
|
||||
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Loss from change in fair value of warrant liability
|
(2,328,674
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)
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(295,771
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)
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(5,271,503
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)
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(627,624
|
)
|
||||
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Interest expense
|
(3,924,124
|
)
|
|
(3,737,175
|
)
|
|
(11,516,103
|
)
|
|
(10,995,900
|
)
|
||||
|
Other income, net
|
5,067
|
|
|
2,021
|
|
|
151,454
|
|
|
11,818
|
|
||||
|
Income (loss) before income taxes
|
362,637,418
|
|
|
(9,681,710
|
)
|
|
344,004,396
|
|
|
(25,590,198
|
)
|
||||
|
Benefit (provision) for income taxes
|
25,412,995
|
|
|
(134,668
|
)
|
|
25,412,498
|
|
|
(342,563
|
)
|
||||
|
Net and comprehensive income (loss)
|
$
|
388,050,413
|
|
|
$
|
(9,816,378
|
)
|
|
$
|
369,416,894
|
|
|
$
|
(25,932,761
|
)
|
|
Basic earnings (loss) per share
|
$
|
4.85
|
|
|
$
|
(0.12
|
)
|
|
$
|
4.64
|
|
|
$
|
(0.33
|
)
|
|
Diluted earnings (loss) per share
|
$
|
4.71
|
|
|
$
|
(0.12
|
)
|
|
$
|
4.53
|
|
|
$
|
(0.33
|
)
|
|
Weighted average shares outstanding: basic
|
80,023,044
|
|
|
78,908,929
|
|
|
79,650,373
|
|
|
78,842,611
|
|
||||
|
Weighted average shares outstanding: diluted
|
82,929,476
|
|
|
78,908,929
|
|
|
82,744,227
|
|
|
78,842,611
|
|
||||
|
|
|
Nine months ended September 30,
|
||||||
|
|
|
2018
|
|
2017
|
||||
|
Cash flows from operating activities:
|
|
|
|
|
||||
|
Net Income (loss)
|
|
$
|
369,416,894
|
|
|
$
|
(25,932,761
|
)
|
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
||||
|
Depreciation and other amortization
|
|
48,639
|
|
|
105,212
|
|
||
|
Increase in fair value of warrant liability
|
|
5,271,503
|
|
|
627,624
|
|
||
|
Lease termination
|
|
—
|
|
|
1,225,421
|
|
||
|
Stock-based compensation
|
|
1,866,279
|
|
|
773,671
|
|
||
|
Net realization of deferred revenue and costs due to FDA approval
|
|
(281,950,853
|
)
|
|
—
|
|
||
|
Deferred income taxes (benefit) provision
|
|
(25,520,615
|
)
|
|
20,383
|
|
||
|
Write down of inventory
|
|
—
|
|
|
536,000
|
|
||
|
Non-cash interest expense
|
|
3,363,712
|
|
|
3,363,712
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
|
||||
|
Accounts receivable
|
|
369,872
|
|
|
2,542,204
|
|
||
|
Inventory
|
|
—
|
|
|
22,690,715
|
|
||
|
Deferred costs
|
|
—
|
|
|
(24,091,967
|
)
|
||
|
Prepaid expenses and other current assets
|
|
960,074
|
|
|
(137,970
|
)
|
||
|
Other assets
|
|
(393,032
|
)
|
|
—
|
|
||
|
Accounts payable, accrued expenses and other current liabilities
|
|
(1,033,651
|
)
|
|
(1,719,229
|
)
|
||
|
Deferred revenue
|
|
—
|
|
|
9,963,188
|
|
||
|
Other liabilities
|
|
63,700
|
|
|
(199,501
|
)
|
||
|
Net cash provided by (used in) operating activities
|
|
72,462,522
|
|
|
(10,233,298
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
|
||||
|
Capital expenditures
|
|
(27,863
|
)
|
|
(54,242
|
)
|
||
|
Net cash (used in) investing activities
|
|
(27,863
|
)
|
|
(54,242
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
|
||||
|
Net proceeds from exercise of stock options
|
|
252,679
|
|
|
27,497
|
|
||
|
Buy back of stock options
|
|
—
|
|
|
(84,000
|
)
|
||
|
Payment of employee tax obligations for common stock tendered
|
|
(1,708,290
|
)
|
|
(193,052
|
)
|
||
|
Net cash (used in) financing activities
|
|
(1,455,611
|
)
|
|
(249,555
|
)
|
||
|
Net increase (decrease) in cash and cash equivalents
|
|
70,979,048
|
|
|
(10,537,095
|
)
|
||
|
Cash, cash equivalents and restricted cash at the beginning of period
|
|
37,101,586
|
|
|
56,174,046
|
|
||
|
Cash, cash equivalents and restricted cash at end of period
|
|
$
|
108,080,634
|
|
|
$
|
45,636,951
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
||||
|
Supplemental disclosure of cash flows information:
|
|
|
|
|
||||
|
Conversion of warrants to common stock
|
|
$
|
6,007,847
|
|
|
$
|
—
|
|
|
|
|
|
|
|
||||
|
|
|
As of September 30, 2018
|
||
|
Balance at December 31, 2017
|
|
$
|
378,896,803
|
|
|
Cumulative effect of accounting change
|
|
(1,780,050
|
)
|
|
|
Billings in advance of revenue recognized
|
|
—
|
|
|
|
Revenue recognized
|
|
(376,432,521
|
)
|
|
|
Balance at September 30, 2018, included in Accrued expenses and other current liabilities
|
|
$
|
684,232
|
|
|
|
|
As of
|
||||||
|
|
|
September 30, 2018
|
|
December 31, 2017
|
||||
|
Cash and cash equivalents
|
|
$
|
103,985,265
|
|
|
$
|
19,857,833
|
|
|
Restricted cash - short-term
|
|
4,095,369
|
|
|
10,701,305
|
|
||
|
Restricted cash - long-term
|
|
—
|
|
|
6,542,448
|
|
||
|
Cash, cash equivalents and restricted cash
|
|
$
|
108,080,634
|
|
|
$
|
37,101,586
|
|
|
|
|
|
|
|
||||
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
|
Cash and cash equivalents
|
|
$
|
25,798,125
|
|
|
$
|
28,701,824
|
|
|
Restricted cash - short-term
|
|
10,408,810
|
|
|
10,138,890
|
|
||
|
Restricted cash - long-term
|
|
9,430,016
|
|
|
17,333,332
|
|
||
|
Cash, cash equivalents and restricted cash
|
|
$
|
45,636,951
|
|
|
$
|
56,174,046
|
|
|
|
As of
|
|||||
|
|
September 30, 2018
|
|
December 31, 2017
|
|||
|
Work in-process
|
$
|
1,950,445
|
|
|
2,025,445
|
|
|
Finished goods
|
957,804
|
|
|
957,804
|
|
|
|
Inventory
|
$
|
2,908,249
|
|
|
2,983,249
|
|
|
|
As of
|
||||||
|
|
September 30, 2018
|
|
December 31, 2017
|
||||
|
Leasehold improvements
|
$
|
2,420,028
|
|
|
$
|
2,420,028
|
|
|
Computer equipment
|
558,118
|
|
|
701,762
|
|
||
|
Furniture and fixtures
|
363,588
|
|
|
363,588
|
|
||
|
|
3,341,734
|
|
|
3,485,378
|
|
||
|
Less - accumulated depreciation
|
(3,223,870
|
)
|
|
(3,346,738
|
)
|
||
|
Property, plant and equipment, net
|
$
|
117,864
|
|
|
$
|
138,640
|
|
|
|
As of
|
||||||
|
|
September 30, 2018
|
|
December 31, 2017
|
||||
|
Bonus
|
$
|
1,284,707
|
|
|
$
|
2,538,340
|
|
|
Deferred revenue-R&D for TPOXX® intravenous formulation
|
684,232
|
|
|
1,255,318
|
|
||
|
Professional fees
|
411,290
|
|
|
381,980
|
|
||
|
Vacation
|
323,651
|
|
|
328,588
|
|
||
|
Other (primarily R&D vendors and CMOs)
|
1,607,037
|
|
|
977,353
|
|
||
|
Accrued expenses and other current liabilities
|
$
|
4,310,917
|
|
|
$
|
5,481,579
|
|
|
•
|
Level 1 – Quoted prices for identical instruments in active markets.
|
|
•
|
Level 2 – Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable.
|
|
•
|
Level 3 – Instruments where significant value drivers are unobservable to third parties.
|
|
|
Fair Value Measurements of Level 3 liability-classified warrant
|
||
|
Warrant liability at December 31, 2017
|
$
|
11,466,162
|
|
|
Increase in fair value of warrant liability
|
5,271,503
|
|
|
|
Exercise of warrants
|
(6,007,847
|
)
|
|
|
Warrant liability at September 30, 2018
|
$
|
10,729,818
|
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Net income (loss) for basic earnings per share
|
$
|
388,050,413
|
|
|
$
|
(9,816,378
|
)
|
|
$
|
369,416,894
|
|
|
$
|
(25,932,761
|
)
|
|
Less: Change in fair value of warrants
|
(2,328,674
|
)
|
|
—
|
|
|
(5,271,503
|
)
|
|
—
|
|
||||
|
Net income (loss), adjusted for change in fair value of warrants for diluted earnings per share
|
$
|
390,379,087
|
|
|
$
|
(9,816,378
|
)
|
|
$
|
374,688,397
|
|
|
$
|
(25,932,761
|
)
|
|
Weighted-average shares
|
80,023,044
|
|
|
78,908,929
|
|
|
79,650,373
|
|
|
78,842,611
|
|
||||
|
Effect of potential common shares
|
2,906,432
|
|
|
—
|
|
|
3,093,854
|
|
|
—
|
|
||||
|
Weighted-average shares: diluted
|
82,929,476
|
|
|
78,908,929
|
|
|
82,744,227
|
|
|
78,842,611
|
|
||||
|
Earnings (loss) per share: basic
|
$
|
4.85
|
|
|
$
|
(0.12
|
)
|
|
$
|
4.64
|
|
|
$
|
(0.33
|
)
|
|
Earnings (loss) per share: diluted
|
$
|
4.71
|
|
|
$
|
(0.12
|
)
|
|
$
|
4.53
|
|
|
$
|
(0.33
|
)
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||
|
|
2017
|
|
2017
|
||
|
Stock Options
|
1,200,123
|
|
|
1,485,466
|
|
|
Stock-Settled Stock Appreciation Rights
|
360,031
|
|
|
360,031
|
|
|
Restricted Stock Units
|
1,472,001
|
|
|
1,371,364
|
|
|
Warrants
|
2,690,950
|
|
|
2,690,950
|
|
|
|
Lease Termination liability
|
||
|
Balance at December 31, 2017
|
$
|
814,622
|
|
|
Charges (included in selling, general and administrative expenses)
|
14,149
|
|
|
|
Cash payments, net of sublease income
|
(239,309
|
)
|
|
|
Balance at September 30, 2018
|
$
|
589,462
|
|
|
•
|
successful development, formulation and cGMP scale-up of drug manufacturing that meets FDA requirements;
|
|
•
|
successful development of animal models;
|
|
•
|
successful completion of non-clinical development, including studies in approved animal models;
|
|
•
|
our ability to pay the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
|
|
•
|
successful completion of clinical trials;
|
|
•
|
receipt of marketing approvals from FDA for IV TPOXX® and similar foreign regulatory authorities;
|
|
•
|
establishing arrangements on reasonable terms with suppliers and contract manufacturers;
|
|
•
|
manufacturing stable commercial supplies of drug candidates, including availability of raw materials;
|
|
•
|
launching commercial sales of the product, whether alone or in collaboration with others; and
|
|
•
|
acceptance of the product by potential government customers, public health experts, physicians, patients, healthcare payors and others in the medical community.
|
|
•
|
regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
|
•
|
we may decide, or regulators may require us, to conduct additional pre-clinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our pre-clinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results;
|
|
•
|
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
|
|
•
|
regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements;
|
|
•
|
the cost of our clinical trials could escalate and become cost prohibitive;
|
|
•
|
our governmental regulators may impose requirements on clinical trials, pre-clinical trials or animal efficacy studies that we cannot meet or that may prohibit or limit our ability to perform or complete the necessary testing in order to obtain regulatory approval;
|
|
•
|
any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;
|
|
•
|
we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials; or
|
|
•
|
the effects of our drug candidates may not be the desired effects or may include undesirable side effects or the drug candidates may have other unexpected characteristics.
|
|
•
|
be shown to be safe, non-toxic and effective;
|
|
•
|
otherwise meet applicable regulatory standards;
|
|
•
|
receive the necessary regulatory approvals;
|
|
•
|
develop into commercially viable drugs;
|
|
•
|
be manufactured or produced economically and on a large scale;
|
|
•
|
be successfully marketed;
|
|
•
|
be paid for by governmental procurers or be reimbursed by governmental or private insurers; or
|
|
•
|
achieve customer acceptance.
|
|
Exhibit
No.
|
|
Description
|
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
Amendment of Solicitation/Modification of Contract 0015, dated July 30, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 1, 2018).
|
|
|
|
Second Amended and Restated Employment Agreement, dated August 1, 2018, between SIGA Technologies, Inc. and Robin E. Abrams (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 3, 2018).
|
|
|
|
Addendum, dated August 10, 2018 to Seconded Amended and Restated Employment Agreement, dated April 12, 2016, between SIGA Technologies, Inc. and Dennis E. Hruby (incorporated by reference to the Current Report on Form 8-K of the Company filed on August 10, 2018).
|
|
|
|
Contract, dated as of September 10, 2018, between SIGA Technologies, Inc. and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on September 11, 2018).
|
|
|
|
Amendment of Solicitation/Modification of Contract 0016, dated September 21, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA.
|
|
|
|
Amendment of Solicitation/Modification of Contract 0017, dated September 28, 2018, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment).
|
|
|
|
Amendment of Solicitation/Modification of Contract 0018, dated September 28, 2018, to Agreement, dated June 1, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA.
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
|
|
|
SIGA TECHNOLOGIES, INC.
|
||
|
|
|
(Registrant)
|
||
|
|
|
|
||
|
Date:
|
November 6, 2018
|
By:
|
/s/ Daniel J. Luckshire
|
|
|
|
|
|
Daniel J. Luckshire
|
|
|
|
|
|
Executive Vice President and
|
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
(Principal Financial Officer and
|
|
|
|
|
|
Principal Accounting Officer)
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|