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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
06-1562417
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Page
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PART I
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ITEM 1.
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ITEM 2.
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ITEM 3.
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ITEM 4.
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PART II
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ITEM 1A.
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ITEM 2.
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ITEM 6.
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Item 1.
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Financial Statements
|
|
March 31, 2015
|
|
December 31, 2014
|
||||
ASSETS
|
|
|
|
||||
Cash and cash equivalents
|
$
|
79,304,207
|
|
|
$
|
25,714,519
|
|
Short-term investments
|
—
|
|
|
14,509,570
|
|
||
Inventories
|
88,200
|
|
|
95,700
|
|
||
Accounts Receivable
|
2,533,668
|
|
|
463,007
|
|
||
Prepaid expenses
|
2,480,448
|
|
|
1,247,548
|
|
||
Other current assets
|
747,437
|
|
|
639,957
|
|
||
Total current assets
|
85,153,960
|
|
|
42,670,301
|
|
||
|
|
|
|
||||
Plant and equipment, net of accumulated amortization and depreciation of $28,676,061 and $28,369,982 at March 31, 2015 and December 31, 2014, respectively
|
5,879,575
|
|
|
5,996,687
|
|
||
Goodwill
|
18,268,662
|
|
|
17,869,023
|
|
||
Acquired intangible assets, net of accumulated amortization of $609,846 and $462,248 at March 31, 2015 and December 31, 2014, respectively
|
6,815,169
|
|
|
6,773,722
|
|
||
Other long-term assets
|
1,206,932
|
|
|
1,216,795
|
|
||
Total assets
|
$
|
117,324,298
|
|
|
$
|
74,526,528
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current portion, long-term debt
|
$
|
423,838
|
|
|
$
|
1,257,178
|
|
Current portion, deferred revenue
|
9,586,244
|
|
|
184,421
|
|
||
Accounts payable
|
3,972,920
|
|
|
1,710,946
|
|
||
Accrued liabilities
|
6,253,883
|
|
|
5,501,527
|
|
||
Other current liabilities
|
762,088
|
|
|
575,351
|
|
||
Total current liabilities
|
20,998,973
|
|
|
9,229,423
|
|
||
|
|
|
|
|
|||
Other long-term debt
|
11,078,526
|
|
|
4,769,359
|
|
||
Deferred revenue
|
17,243,611
|
|
|
3,009,568
|
|
||
Contingent royalty obligation
|
14,800,000
|
|
|
15,279,000
|
|
||
Contingent purchase price consideration
|
3,958,000
|
|
|
16,420,300
|
|
||
Other long-term liabilities
|
2,986,004
|
|
|
2,800,491
|
|
||
Commitments and contingencies
|
|
|
|
|
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STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Preferred stock, par value $0.01 per share; 5,000,000 shares authorized:
|
|
|
|
||||
Series A-1 convertible preferred stock; 31,620 shares designated, issued, and outstanding at March 31, 2015 and December 31, 2014; liquidation value of $32,063,092 at March 31, 2015
|
316
|
|
|
316
|
|
||
Common stock, par value $0.01 per share; 140,000,000 shares authorized; 70,836,180 and 62,720,065 shares issued at March 31, 2015 and December 31, 2014, respectively
|
708,362
|
|
|
627,201
|
|
||
Additional paid-in capital
|
756,804,409
|
|
|
715,667,633
|
|
||
Accumulated other comprehensive loss
|
(1,206,099
|
)
|
|
(1,970,420
|
)
|
||
Accumulated deficit
|
(710,047,804
|
)
|
|
(691,306,343
|
)
|
||
Total stockholders’ equity
|
46,259,184
|
|
|
23,018,387
|
|
||
Total liabilities and stockholders’ equity
|
$
|
117,324,298
|
|
|
$
|
74,526,528
|
|
|
Three Months Ended March 31,
|
||||||
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2015
|
|
2014
|
||||
Revenue:
|
|
|
|
||||
Research and development revenue
|
3,953,299
|
|
|
720,856
|
|
||
Total revenues
|
3,953,299
|
|
|
720,856
|
|
||
Operating expenses:
|
|
|
|
||||
Research and development
|
(9,220,143
|
)
|
|
(4,472,533
|
)
|
||
General and administrative
|
(5,487,109
|
)
|
|
(5,163,493
|
)
|
||
Contingent purchase price consideration fair value adjustment
|
(7,537,700
|
)
|
|
(909,000
|
)
|
||
Operating loss
|
(18,291,653
|
)
|
|
(9,824,170
|
)
|
||
Other (expense) income:
|
|
|
|
||||
Non-operating (expense) income
|
(52,945
|
)
|
|
9,822,466
|
|
||
Interest expense, net
|
(396,863
|
)
|
|
(355,809
|
)
|
||
Net loss
|
(18,741,461
|
)
|
|
(357,513
|
)
|
||
Dividends on Series A-1 convertible preferred stock
|
(50,620
|
)
|
|
(51,026
|
)
|
||
Net loss attributable to common stockholders
|
$
|
(18,792,081
|
)
|
|
$
|
(408,539
|
)
|
Per common share data:
|
|
|
|
||||
Basic and diluted net loss attributable to common stockholders
|
$
|
(0.28
|
)
|
|
$
|
(0.01
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
||||
Basic and diluted
|
66,667,290
|
|
|
50,556,807
|
|
||
|
|
|
|
||||
Other comprehensive income (loss):
|
|
|
|
||||
Foreign currency translation gain
|
$
|
764,321
|
|
|
$
|
215,417
|
|
Other comprehensive income
|
764,321
|
|
|
215,417
|
|
||
Comprehensive loss
|
$
|
(18,027,760
|
)
|
|
$
|
(193,122
|
)
|
|
Three Months Ended March 31,
|
|
||||||
|
2015
|
|
2014
|
|
||||
Cash flows from operating activities:
|
|
|
|
|
||||
Net loss
|
$
|
(18,741,461
|
)
|
|
$
|
(357,513
|
)
|
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
|
||||
Depreciation and amortization
|
445,497
|
|
|
266,528
|
|
|
||
Share-based compensation
|
1,492,791
|
|
|
953,836
|
|
|
||
Non-cash interest expense
|
203,347
|
|
|
153,146
|
|
|
||
Loss on disposal of assets
|
—
|
|
|
1,150
|
|
|
||
Change in fair value of contingent obligations
|
7,058,700
|
|
|
(8,894,974
|
)
|
|
||
Loss on extinguishment of debt
|
154,117
|
|
|
—
|
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
||||
Accounts receivable
|
(2,055,256
|
)
|
|
1,200
|
|
|
||
Inventories
|
7,500
|
|
|
—
|
|
|
||
Prepaid expenses
|
(973,812
|
)
|
|
(279,825
|
)
|
|
||
Accounts payable
|
2,273,733
|
|
|
184,008
|
|
|
||
Deferred revenue
|
23,635,860
|
|
|
(688,904
|
)
|
|
||
Accrued liabilities and other current liabilities
|
724,760
|
|
|
(1,433,230
|
)
|
|
||
Other operating assets and liabilities
|
(10,930,439
|
)
|
|
(29,768
|
)
|
|
||
Net cash provided by (used in) operating activities
|
3,295,337
|
|
|
(10,124,346
|
)
|
|
||
Cash flows from investing activities:
|
|
|
|
|
||||
Cash acquired in acquisition
|
—
|
|
|
514,470
|
|
|
||
Purchases of plant and equipment
|
(323,552
|
)
|
|
(172,592
|
)
|
|
||
Proceeds from sale of available-for-sale securities
|
14,534,486
|
|
|
—
|
|
|
||
Net cash provided by investing activities
|
14,210,934
|
|
|
341,878
|
|
|
||
Cash flows from financing activities:
|
|
|
|
|
||||
Net proceeds from sale of equity
|
35,000,000
|
|
|
56,667,252
|
|
|
||
Proceeds from employee stock purchases and option exercises
|
1,108,906
|
|
|
84,271
|
|
|
||
Financing of plant and equipment
|
—
|
|
|
(9,505
|
)
|
|
||
Proceeds from issuance of long-term debt
|
9,000,000
|
|
|
—
|
|
|
||
Payments of debt
|
(833,334
|
)
|
|
(833,333
|
)
|
|
||
Payment of contingent purchase price consideration
|
(8,180,000
|
)
|
|
—
|
|
|
||
Net cash provided by financing activities
|
36,095,572
|
|
|
55,908,685
|
|
|
||
Effect of exchange rate changes on cash
|
(12,155
|
)
|
|
13,105
|
|
|
||
Net increase in cash and cash equivalents
|
53,589,688
|
|
|
46,139,322
|
|
|
||
Cash and cash equivalents, beginning of period
|
25,714,519
|
|
|
27,351,969
|
|
|
||
Cash and cash equivalents, end of period
|
$
|
79,304,207
|
|
|
$
|
73,491,291
|
|
|
Supplemental cash flow information:
|
|
|
|
|
||||
Cash paid for interest
|
$
|
201,731
|
|
|
$
|
193,893
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
||||
Issuance of common stock, $0.01 par value, for payment of contingent purchase price consideration
|
$
|
216,567
|
|
|
$
|
—
|
|
|
Issuance of common stock, $0.01 par value, for acquisition of 4-Antibody AG
|
—
|
|
|
10,102,259
|
|
|
||
Contingent purchase price consideration issued in connection with the acquisition of 4-Antibody AG
|
—
|
|
|
9,721,000
|
|
|
•
|
our antibody platforms, including our proprietary Retrocyte Display™ and SECANT
®
technologies (see Note M), and our antibody programs, including checkpoint modulators, or CPMs;
|
•
|
our heat shock protein (HSP)-based vaccines; and
|
•
|
our saponin-based vaccine adjuvants, principally our QS-21 Stimulon
®
adjuvant, or QS-21 Stimulon.
|
|
March 31,
|
|||||
|
2015
|
|
2014
|
|
||
Warrants
|
4,351,450
|
|
|
2,951,450
|
|
|
Stock options
|
7,834,555
|
|
|
4,267,655
|
|
|
Nonvested shares
|
67,578
|
|
|
109,747
|
|
|
Convertible preferred stock
|
333,333
|
|
|
333,333
|
|
|
Convertible Notes
|
—
|
|
|
382,769
|
|
|
Balance, December 31, 2014
|
|
$
|
17,869
|
|
Foreign currency translation adjustment
|
|
400
|
|
|
Balance, March 31, 2015
|
|
$
|
18,269
|
|
|
Amortization period (years)
|
|
Gross carrying amount
|
|
Accumulated amortization
|
|
Net carrying amount
|
||||||
Intellectual Property
|
15 years
|
|
$
|
4,461
|
|
|
$
|
(335
|
)
|
|
$
|
4,126
|
|
Trademarks
|
4.5 years
|
|
836
|
|
|
(209
|
)
|
|
627
|
|
|||
Other
|
3 years
|
|
177
|
|
|
(66
|
)
|
|
111
|
|
|||
In-process research and development
|
Indefinite
|
|
1,951
|
|
|
—
|
|
|
1,951
|
|
|||
Total
|
|
|
$
|
7,425
|
|
|
$
|
610
|
|
|
$
|
6,815
|
|
|
March 31, 2015
|
|
December 31, 2014
|
||||||||||||
|
Cost
|
|
Estimated Fair Value
|
|
Cost
|
|
Estimated Fair Value
|
||||||||
Institutional Money Market Funds
|
$
|
69,444
|
|
|
$
|
69,444
|
|
|
$
|
25,149
|
|
|
$
|
25,149
|
|
U.S. Treasury Bills
|
—
|
|
|
—
|
|
|
14,508
|
|
|
14,510
|
|
||||
|
$
|
69,444
|
|
|
$
|
69,444
|
|
|
$
|
39,657
|
|
|
$
|
39,659
|
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
|
Aggregate
Intrinsic
Value
|
|||||
Outstanding at December 31, 2014
|
6,525,724
|
|
|
$
|
4.40
|
|
|
|
|
|
||
Granted
|
1,796,244
|
|
|
4.94
|
|
|
|
|
|
|||
Exercised
|
(275,621
|
)
|
|
3.86
|
|
|
|
|
|
|||
Forfeited
|
(179,743
|
)
|
|
3.18
|
|
|
|
|
|
|||
Expired
|
(32,049
|
)
|
|
8.40
|
|
|
|
|
|
|||
Outstanding at March 31, 2015
|
7,834,555
|
|
|
$
|
4.56
|
|
|
7.94
|
|
$
|
8,838,984
|
|
Vested or expected to vest at March 31, 2015
|
7,155,578
|
|
|
$
|
4.63
|
|
|
7.84
|
|
$
|
7,878,403
|
|
Exercisable at March 31, 2015
|
3,593,394
|
|
|
$
|
5.39
|
|
|
6.89
|
|
$
|
3,345,678
|
|
|
Nonvested
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|||
Outstanding at December 31, 2014
|
78,828
|
|
|
$
|
3.93
|
|
Granted
|
—
|
|
|
—
|
|
|
Vested
|
(11,250
|
)
|
|
4.18
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
Outstanding at March 31, 2015
|
67,578
|
|
|
|
|
|
Three Months Ended March 31,
|
||||||
|
2015
|
|
2014
|
||||
Research and development
|
$
|
570
|
|
|
254
|
|
|
General and administrative
|
923
|
|
|
700
|
|
||
Total share-based compensation expense
|
$
|
1,493
|
|
|
$
|
954
|
|
|
March 31, 2015
|
|
December 31, 2014
|
||||
Professional fees
|
$
|
1,685
|
|
|
$
|
1,438
|
|
Payroll
|
2,297
|
|
|
3,134
|
|
||
Other
|
2,272
|
|
|
930
|
|
||
|
$
|
6,254
|
|
|
$
|
5,502
|
|
Description
|
|
March 31, 2015
|
|
Quoted Prices in Active
Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs (Level 2)
|
|
Significant Unobservable
Inputs (Level 3)
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Contingent royalty obligation
|
|
$
|
14,800
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,800
|
|
Contingent purchase price consideration
|
|
3,958
|
|
|
—
|
|
|
—
|
|
|
3,958
|
|
||||
|
|
$
|
18,758
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,758
|
|
|
|
|
|
|
|
|
|
|
||||||||
Description
|
|
December 31, 2014
|
|
Quoted Prices in Active
Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs (Level 2)
|
|
Significant Unobservable
Inputs (Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Short-term investments
|
|
$
|
14,510
|
|
|
$
|
14,510
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Contingent royalty obligation
|
|
15,279
|
|
|
—
|
|
|
—
|
|
|
15,279
|
|
||||
Contingent purchase price consideration
|
|
16,420
|
|
|
—
|
|
|
—
|
|
|
16,420
|
|
||||
|
|
$
|
31,699
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,699
|
|
Balance, December 31, 2014
|
|
$
|
31,699
|
|
Change in fair value of contingent royalty obligation during the period
|
|
(479
|
)
|
|
Change in fair value of contingent purchase price consideration during the period
|
|
7,538
|
|
|
Achievement of contingent purchase price milestone
|
|
(20,000
|
)
|
|
Balance, March 31, 2015
|
|
$
|
18,758
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
our antibody platform, including our proprietary Retrocyte Display and SECANT
technologies, and our antibody programs, including checkpoint modulators, or CPMs;
|
•
|
our heat shock protein (HSP)-based vaccines; and
|
•
|
our saponin-based vaccine adjuvants, principally our QS-21 Stimulon adjuvant, or QS-21 Stimulon.
|
Research and
Development Program
|
|
Product
|
|
Three Months Ended March 31,
|
|
Year Ended December 31,
|
|
Prior to
2012
|
|
Total
|
||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
||||||||||||||||||
Heat shock proteins for cancer
|
|
Prophage
Series
Vaccines
|
|
$
|
1,178
|
|
|
$
|
6,153
|
|
|
$
|
5,882
|
|
|
$
|
5,613
|
|
|
$
|
292,033
|
|
|
$
|
310,859
|
|
Heat shock proteins for infectious diseases
|
|
HerpV
|
|
227
|
|
|
2,443
|
|
|
6,358
|
|
|
4,862
|
|
|
19,088
|
|
|
32,978
|
|
||||||
Vaccine adjuvant
|
|
QS-21 Stimulon
|
|
72
|
|
|
321
|
|
|
753
|
|
|
85
|
|
|
12,498
|
|
|
13,729
|
|
||||||
Checkpoint modulator programs*
|
|
|
|
7,608
|
|
|
13,422
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21,030
|
|
||||||
Other research and development programs
|
|
|
|
135
|
|
|
10
|
|
|
12
|
|
|
4
|
|
|
33,540
|
|
|
33,701
|
|
||||||
Total research and development expenses
|
|
|
|
$
|
9,220
|
|
|
$
|
22,349
|
|
|
$
|
13,005
|
|
|
$
|
10,564
|
|
|
$
|
357,159
|
|
|
$
|
412,297
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1A.
|
Risk Factors
|
•
|
our ability to successfully develop, manufacture and commercialize CPM product candidates, including pursuant to our collaboration agreement with Incyte;
|
•
|
the scope, progress, results and costs of researching and developing our future product candidates, and conducting pre-clinical and clinical trials, including with respect to our GITR and OX40 antibody programs, for which we have agreed to share all costs and profits with Incyte on a 50:50 basis;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for our and our licensees' product candidates;
|
•
|
our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property rights;
|
•
|
the costs associated with any successful commercial operations; and
|
•
|
After the first anniversary of the effective date of the collaboration agreement, Incyte may terminate the agreement or any individual program for convenience upon 12 months’ notice;
|
•
|
We may have disagreements with Incyte that are not settled amicably or in our favor, particularly on the joint steering committee where Incyte will under most circumstances have the deciding vote in the event of a disagreement;
|
•
|
Incyte may change the focus of its development and commercialization efforts or prioritize other programs more highly and, accordingly, reduce the efforts and resources allocated to our collaboration;
|
•
|
Incyte may choose not to develop and commercialize CPM products, if any, in all relevant markets or for one or more indications, if at all; and
|
•
|
If Incyte is acquired during the term of our collaboration, the acquirer may have competing programs or different strategic priorities that could cause it to reduce its commitment to our collaboration.
|
•
|
discover technologies that may result in medical insights or breakthroughs, which render our drugs or vaccines obsolete, possibly before they generate any revenue, if ever; or
|
•
|
difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies;
|
•
|
incurrence of substantial debt or dilutive issuances of securities to pay for development, acquisition or in-licensing of new technologies, products or product candidates;
|
•
|
disruption of our business and diversion of our management's time and attention;
|
•
|
higher than expected development, acquisition or in-license and integration costs;
|
•
|
exposure to unknown liabilities;
|
•
|
difficulty and cost in combining the technologies, operations and personnel of any acquired businesses with our technologies, operations and personnel, including without limitation, the assets we recently acquired from Celexion, LLC;
|
•
|
inability to retain key employees of any acquired businesses;
|
•
|
difficulty in managing multiple product development programs; and
|
•
|
inability to successfully develop new products or clinical failure.
|
•
|
adversely affect the marketing of any products we or our licensees or collaborators develop;
|
•
|
impose significant additional costs on us or our licensees or collaborators;
|
•
|
diminish any competitive advantages that we or our licensees or collaborators may attain;
|
•
|
limit our ability to receive royalties and generate revenue and profits; and
|
•
|
adversely affect our business prospects and ability to obtain financing.
|
•
|
we or our collaborators may initiate litigation or other proceedings against third parties to enforce our patent rights;
|
•
|
third parties may initiate litigation or other proceedings seeking to invalidate patents owned by or licensed to us or to obtain a declaratory judgment that their product or technology does not infringe our patents or patents licensed to us;
|
•
|
third parties may initiate opposition proceedings, post-grant review, inter partes review, or reexamination proceedings challenging the validity or scope of our patent rights, requiring us or our collaborators and/or licensors to participate in such proceedings to defend the validity and scope of our patents;
|
•
|
there may be a challenge or dispute regarding inventorship or ownership of patents currently identified as being owned by or licensed to us;
|
•
|
the USPTO may initiate an interference or derivation proceeding between patents or patent applications owned by or licensed to us and those of our competitors, requiring us or our collaborators and/or licensors to participate in an interference or derivation proceeding to determine the priority of invention, which could jeopardize our patent rights; or
|
•
|
third parties may seek approval to market biosimilar versions of our future approved products prior to expiration of relevant patents owned by or licensed to us, requiring us to defend our patents, including by filing lawsuits alleging patent infringement.
|
•
|
others may be able to develop a platform that is similar to, or better than, ours in a way that is not covered by the claims of our patents;
|
•
|
others may be able to make compounds that are similar to our product candidates but that are not covered by the claims of our patents;
|
•
|
we might not have been the first to make the inventions covered by patents or pending patent applications;
|
•
|
we might not have been the first to file patent applications for these inventions;
|
•
|
any patents that we obtain may not provide us with any competitive advantages or may ultimately be found invalid or unenforceable; or
|
•
|
we may not develop additional proprietary technologies that are patentable.
|
•
|
we or our collaborators may initiate litigation or other proceedings against third parties seeking to invalidate the patents held by those third parties or to obtain a judgment that our products or processes do not infringe those third parties’ patents;
|
•
|
if our competitors file patent applications that claim technology also claimed by us or our licensors, we or our licensors may be required to participate in interference, derivation or other proceedings to determine the priority of invention, which could jeopardize our patent rights and potentially provide a third party with a dominant patent position;
|
•
|
if third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we and our collaborators will need to defend against such proceedings; and
|
•
|
if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes or products infringe or misappropriate their patent or other intellectual property rights and/or that we breached our obligations under the license agreement, and we and our collaborators would need to defend against such proceedings.
|
•
|
decreased demand for our product candidates;
|
•
|
regulatory investigations;
|
•
|
injury to our reputation;
|
•
|
withdrawal of clinical trial volunteers;
|
•
|
costs of related litigation; and
|
•
|
substantial monetary awards to plaintiffs.
|
•
|
continuing operating losses, which we expect over the next several years as we continue our development activities;
|
•
|
announcements of decisions made by public officials;
|
•
|
results of our pre-clinical studies and clinical trials;
|
•
|
announcements of new collaboration agreements with strategic partners or developments by our existing collaborative partners;
|
•
|
announcements of acquisitions;
|
•
|
announcements of technological innovations, new commercial products, failures of products, or progress toward commercialization by our competitors or peers;
|
•
|
failure to realize the anticipated benefits of acquisitions, including our acquisition of 4-AB and certain assets from Celexion, LLC;
|
•
|
developments concerning proprietary rights, including patent and litigation matters;
|
•
|
publicity regarding actual or potential results with respect to product candidates under development;
|
•
|
quarterly fluctuations in our financial results;
|
•
|
variations in the level of expenses related to any of our product candidates or clinical development programs;
|
•
|
additions or departures of key management or scientific personnel;
|
•
|
conditions or trends in the biotechnology and biopharmaceutical industries;
|
•
|
other events or factors, including those resulting from war, incidents of terrorism, natural disasters or responses to these events;
|
•
|
changes in accounting principles;
|
•
|
general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies; and
|
•
|
sales of common stock by us or our stockholders in the future, as well as the overall trading volume of our common stock.
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 6.
|
Exhibits
|
|
|
|
Date:
|
May 1, 2015
|
AGENUS INC.
|
|
|
|
|
|
/s/ CHRISTINE M. KLASKIN
|
|
|
Christine M. Klaskin
VP, Finance, Principal Financial Officer, Principal Accounting Officer
|
Exhibit No.
|
|
Description
|
|
|
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Antigenics Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on June 10, 2002 and incorporated herein by reference.
|
|
|
|
3.1.1
|
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Antigenics Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on June 11, 2007 and incorporated herein by reference.
|
|
|
|
3.1.2
|
|
Certificate of Ownership and Merger changing the name of the corporation to Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on January 6, 2011 and incorporated herein by reference.
|
|
|
|
3.1.3
|
|
Certificate of Second Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on September 30, 2011 and incorporated herein by reference.
|
|
|
|
3.1.4
|
|
Certificate of Third Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1.4 to our Quarterly Report on Form 10-Q (File No. 000-29089) for the quarter ended June 30, 2012 and incorporated herein by reference.
|
|
|
|
3.1.5
|
|
Certificate of Fourth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on April 25, 2014 and incorporated herein by reference.
|
|
|
|
3.2
|
|
Fifth Amended and Restated By-laws of Agenus Inc. Filed as Exhibit 3.2 to our Current Report on Form 8-K (File No. 000-29089) filed on January 6, 2011 and incorporated herein by reference.
|
|
|
|
3.3
|
|
Certificate of Designation, Preferences and Rights of the Series A Convertible Preferred Stock of Agenus Inc. filed with the Secretary of State of the State of Delaware on September 24, 2003. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on September 25, 2003 and incorporated herein by reference.
|
|
|
|
3.4
|
|
Certificate of Designations, Preferences and Rights of the Class B Convertible Preferred Stock of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on September 5, 2007 and incorporated herein by reference.
|
|
|
|
3.5
|
|
Certificate of Designations, Preferences and Rights of the Series A-1 Convertible Preferred Stock of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 000-29089) filed on February 5, 2013 and incorporated herein by reference.
|
|
|
|
4.1
|
|
Stock Purchase Agreement dated as of January 9, 2015, by and between Agenus Inc. and Incyte Corporation. Filed as Exhibit 4.21 to our Annual Report on Form 10-K (File No. 000-29089) for the year ended December 31, 2014 and incorporated herein by reference.
|
|
|
|
4.2(1)
|
|
Amended and Restated Note Purchase Agreement dated as of February 20, 2015, as amended, by and between Agenus Inc. and the Purchasers listed on Schedule 1.1 thereto. Filed herewith.
|
|
|
|
4.3
|
|
Form of Senior Subordinated Note under the Amended and Restated Note Purchase Agreement dated as of February 20, 2015, as amended, by and between Agenus Inc. and the Purchasers listed on Schedule 1.1 thereto. Filed herewith.
|
|
|
|
4.4
|
|
Form of Warrant under the Amended and Restated Note Purchase Agreement dated as of February 20, 2015, as amended, by and between Agenus Inc. and the Purchasers listed on Schedule 1.1 thereto. Filed herewith.
|
|
|
|
10.1(1)
|
|
License, Development and Commercialization Agreement dated as of January 9, 2015 by and among Agenus Inc., 4-Antibody AG, a limited liability company organized under the laws of Switzerland (and wholly-owned subsidiary of Agenus Inc.), Incyte Corporation and Incyte Europe Sarl, a Swiss limited liability company (and wholly-owned subsidiary of Incyte Corporation). Filed as Exhibit 10.22 to our Annual Report on Form 10-K (File No. 000-29089) for the year ended December 31, 2014 and incorporated herein by reference.
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.
|
|
|
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.
|
|
|
|
32.1
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Submitted herewith.
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Label Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Presentation Linkbase Document
|
BORROWER:
|
AGENUS INC.
By:
/s/ Christine Klaskin
Name: Christine Klaskin Title: Vice President, Finance |
EXISTING PURCHASERS:
|
By:
/s/ Mark Berg
Name: Mark Berg
By:
/s/ Nicole Berg
Name: Nicole Berg |
EXISTING PURCHASER:
|
By:
/s/ Alice Saraydarian
Name: Alice Saraydarian
|
EXISTING PURCHASER:
|
By:
/s/ Khajak Keledjian
Name: Khajak Keledjian
|
NEW PURCHASER:
|
E*TRADE Clearing LLC, not in its corporate capacity but solely as Custodian of the Individual Retirement Account of Mark Berg, and at the direction of Mark Berg. Further, all representations, warranties, covenants and agreements set forth herein are being made by Mark Berg as owner of the Individual Retirement Account, and not by E*TRADE Clearing LLC
By:
/s/ Matthew A. Murray
Name: Matthew A. Murray
Title: Vice President
|
NEW PURCHASER:
|
NICKY V LLC
By:
/s/ Nicole Berg
Name: Nicole Berg
Title: Owner
|
NEW PURCHASER:
|
MSB RESEARCH INC.
By:
/s/ Mark Berg
Name: Mark Berg
Title: President
|
NEW PURCHASER:
|
By:
/s/ Khalil Barrage
Name: Khalil Barrage
|
NEW PURCHASER:
|
Jaymon Investments, LLC
By:
/s/ Jack Shevel
Name: Jack Shevel
Title: Manager
|
|
2015 NOTES
|
WARRANTS
|
||||
Purchaser
|
Type of Purchaser
|
2013 Note Principal Rollover Amount
|
New Cash Commitment to Purchase 2015 Notes
|
Total Commitment
|
Outstanding 2013 Warrants
|
Allocation of 2015 Warrants
|
Mark Berg and Nicole Berg
|
Existing Purchaser
|
$4,000,000
|
n/a
|
$4,000,000
|
400,000
|
400,000
|
Alice Saraydarian
|
Existing Purchaser
|
$500,000
|
$500,000
|
$1,000,000
|
50,000
|
100,000
|
Khajak Keledjian
|
Existing Purchaser
|
$500,000
|
n/a
|
$500,000
|
50,000
|
50,000
|
Nicky V LLC
|
New Purchaser
|
n/a
|
$4,500,000
|
$4,500,000
|
n/a
|
450,000
|
MSB Research Inc.
|
New Purchaser
|
n/a
|
$1,500,000
|
$1,500,000
|
n/a
|
150,000
|
Khalil Barrage
|
New Purchaser
|
n/a
|
$500,000
|
$500,000
|
n/a
|
50,000
|
E*TRADE Clearing LLC, Custodian FBO: Mark Berg IRA #[**]
|
New Purchaser
|
n/a
|
$1,500,000
|
$1,500,000
|
n/a
|
150,000
|
Jaymon Investments, LLC
|
New Purchaser
|
n/a
|
$500,000
|
$500,000
|
n/a
|
50,000
|
|
|
Total:
$5,000,000
|
Total:
$9,000,000
|
Total:
$14,000,000
|
Total:
500,000
|
Total:
1,400,000
|
•
|
Liens pursuant to that certain Loan and Security Agreement, dated as of April 15, 2013, by and among Silicon Valley Bank, Agenus Inc. and Antigenics Inc.
|
•
|
Liens consisting of and limited to the rights of Ingalls & Snyder Value Partners L.P. and Arthur Koenig (and their successors and assigns) to receive the following payments pursuant to that certain Revenue Interests Assignment Agreement (the “
Revenue Interests Assignment Agreement
”) by and among Agenus Inc., Antigenics Inc., Ingalls & Snyder Value Partners L.P. and Arthur Koenig, dated as of April 15, 2013 (as in effect on April 15, 2013): (i) twenty percent (20.0%) of all revenue payments payable to Borrower and/or its Affiliates pursuant to the GSK and Janssen Agreements (as defined below) (as in effect on April 15, 2013), (ii) one-half of one percent (0.50%) of HerpV Net Sales (as defined in the Revenue Interests Assignment Agreement as in effect on April 15, 2013) and (iii) the greater of [**] percent ([**]%) of the total consideration paid to Borrower and [**] Dollars ($[**]) in the event of the disposition of the [**]. As used herein, “
GSK and Janssen Agreements
” means, collectively, (i) that certain amended and restated manufacturing technology transfer agreement dated January 16, 2009 by and between GlaxoSmithKline Biologicals SA and Antigenics Inc.(as amended by that certain first right to negotiate and amendment agreement effective March 2, 2012, and as further amended or modified from time to time) (ii) that certain license agreement dated as of July 6, 2006 by and between GlaxoSmithKline Biologicals SA and Antigenics Inc. (as amended by that certain binding letter of intent dated July 20, 2007, and as further amended or modified from time to time) and (iii) that certain amended and restated license agreement dated as of September 14, 2009, by and between Antigenics Inc., Elan Pharma International Limited and Elan Pharmaceuticals, Inc. (as amended or modified from time to time), as assigned to Janssen Alzheimer Immunotherapy on July 2, 2009.
|
1.
|
The Warrant is currently exercisable to purchase a total of ________ Warrant Shares.
|
2.
|
The undersigned Holder hereby exercises its right to purchase _______ Warrant Shares pursuant to the Warrant.
|
3.
|
[The Holder shall pay the sum of $_______ to the Company in accordance with the terms of the Warrant.]/ [The Holder elects for a cashless exercise in accordance with the terms of the Warrant.]
|
4.
|
Pursuant to this exercise, the Company shall deliver to the Holder _____ Warrant Shares in accordance with the terms of the Warrant.
|
5.
|
Following this exercise, the Warrant shall be exercisable to purchase a total of _______ Warrant Shares.
|
Dated:
|
Name of Holder:
(Print)
By:
Title:
(Signature must conform in all respects to name of Holder as specified on face of the Warrant)
|
Dated:
|
(Signature must conform in all respects to name of Holder as specified on face of the Warrant)
Address of Transferee:
|
In the presence of:
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
a.
|
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;
|
b.
|
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 U.S. generally accepted accounting principles;
|
c.
|
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
|
d.
|
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
|
5.
|
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 function):
|
a.
|
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
|
b.
|
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.
|
Date:
|
May 1, 2015
|
|
/s/ G
ARO
H. A
RMEN
, P
H
.D.
|
|
|
|
Garo H. Armen, Ph.D.
|
|
|
|
Chief Executive Officer and Principal Executive Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
|
2.
|
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;
|
3.
|
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;
|
4.
|
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:
|
a.
|
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 U.S. 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 function):
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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 1, 2015
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/s/ CHRISTINE M. KLASKIN
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Christine M. Klaskin
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VP, Finance and Principal Financial Officer
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(i)
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
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(ii)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ GARO H. ARMEN, Ph.D.
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Garo H. Armen, Ph.d.
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Chief Executive Officer and Principal Executive Officer
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/s/ CHRISTINE M. KLASKIN
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Christine M. Klaskin
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VP, Finance and Principal Financial Officer
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