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Share Name | Share Symbol | Market | Type |
---|---|---|---|
SELLAS Life Sciences Group Inc | NASDAQ:SLS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0144 | -1.07% | 1.3356 | 1.33 | 1.34 | 1.37 | 1.29 | 1.36 | 615,462 | 19:35:09 |
|
þ
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
20-8099512
|
(State of incorporation)
|
|
(I.R.S. Employer Identification No.)
|
Securities registered pursuant to Section 12(b) of the Exchange Act:
|
||
|
|
|
Title of Each Class
|
|
Name of Exchange on Which Registered
|
Common Stock, $0.0001 Par Value per Share
|
|
The NASDAQ Capital Market
|
|
|
|
Securities registered pursuant to Section 12(b) of the Exchange Act:
|
||
|
None
|
|
Large accelerated filer
|
|
¨
|
|
Accelerated filer
|
|
þ
|
Non-accelerated filer
|
|
¨
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
|
¨
|
|
|
Page No.
|
|
December 31, 2015
|
|
December 31, 2014
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
29,730
|
|
|
$
|
23,650
|
|
Restricted cash
|
401
|
|
|
200
|
|
||
Litigation settlement insurance recovery
|
21,700
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
1,398
|
|
|
1,237
|
|
||
Current assets of discontinued operations
|
392
|
|
|
27,013
|
|
||
Total current assets
|
53,621
|
|
|
52,100
|
|
||
Equipment and furnishings, net
|
335
|
|
|
285
|
|
||
GALE-401 rights
|
9,255
|
|
|
9,255
|
|
||
In-process research and development
|
12,864
|
|
|
12,864
|
|
||
Goodwill
|
5,898
|
|
|
5,897
|
|
||
Deposits and other assets
|
171
|
|
|
87
|
|
||
Total assets
|
$
|
82,144
|
|
|
$
|
80,488
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
1,597
|
|
|
$
|
1,886
|
|
Accrued expenses and other current liabilities
|
5,292
|
|
|
8,885
|
|
||
Litigation settlement payable
|
25,000
|
|
|
—
|
|
||
Fair value of warrants potentially settleable in cash
|
14,518
|
|
|
5,383
|
|
||
Current portion of long-term debt
|
4,739
|
|
|
3,910
|
|
||
Current liabilities of discontinued operations
|
5,925
|
|
|
7,169
|
|
||
Total current liabilities
|
57,071
|
|
|
27,233
|
|
||
Deferred tax liability
|
5,418
|
|
|
5,053
|
|
||
Contingent purchase price consideration
|
6,142
|
|
|
6,651
|
|
||
Long-term debt, net of current portion
|
—
|
|
|
4,492
|
|
||
Total liabilities
|
68,631
|
|
|
43,429
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 275,000,000 shares authorized, 162,581,753 shares issued and 161,906,753 shares outstanding at December 31, 2015; 200,000,000 shares authorized, 130,146,341 shares issued and 129,471,341 shares outstanding at December 31, 2014
|
15
|
|
|
12
|
|
||
Additional paid-in capital
|
296,730
|
|
|
256,377
|
|
||
Accumulated deficit
|
(279,383
|
)
|
|
(215,481
|
)
|
||
Less treasury shares at cost, 675,000 shares
|
(3,849
|
)
|
|
(3,849
|
)
|
||
Total stockholders’ equity
|
13,513
|
|
|
37,059
|
|
||
Total liabilities and stockholders’ equity
|
$
|
82,144
|
|
|
$
|
80,488
|
|
|
For the Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
23,611
|
|
|
$
|
27,674
|
|
|
$
|
20,424
|
|
General and administrative
|
10,609
|
|
|
16,226
|
|
|
8,065
|
|
|||
Total operating expenses
|
34,220
|
|
|
43,900
|
|
|
28,489
|
|
|||
Operating loss
|
(34,220
|
)
|
|
(43,900
|
)
|
|
(28,489
|
)
|
|||
Non-operating income (expense):
|
|
|
|
|
|
||||||
Litigation settlement
|
(5,282
|
)
|
|
—
|
|
|
—
|
|
|||
Gain (loss) on warrant derivative liability
|
1,162
|
|
|
16,556
|
|
|
(44,001
|
)
|
|||
Interest expense, net
|
(760
|
)
|
|
(1,110
|
)
|
|
(807
|
)
|
|||
Other income
|
509
|
|
|
170
|
|
|
3,022
|
|
|||
Total non-operating income (expense), net
|
(4,371
|
)
|
|
15,616
|
|
|
(41,786
|
)
|
|||
Loss from continuing operations before income taxes
|
(38,591
|
)
|
|
(28,284
|
)
|
|
(70,275
|
)
|
|||
Income tax expense
|
365
|
|
|
—
|
|
|
1,052
|
|
|||
Loss from continuing operations
|
(38,956
|
)
|
|
(28,284
|
)
|
|
(71,327
|
)
|
|||
Loss from discontinued operations
|
(24,946
|
)
|
|
(8,322
|
)
|
|
(5,351
|
)
|
|||
Net loss
|
$
|
(63,902
|
)
|
|
$
|
(36,606
|
)
|
|
$
|
(76,678
|
)
|
Net loss per common share:
|
|
|
|
|
|
||||||
Basic and diluted per share, continuing operations
|
$
|
(0.25
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.79
|
)
|
Basic and diluted loss per share, discontinued operations
|
$
|
(0.16
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.06
|
)
|
Basic and diluted net loss per share
|
$
|
(0.41
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.85
|
)
|
Weighted-average common shares outstanding: basic and diluted
|
155,264,729
|
|
|
119,388,366
|
|
|
90,181,501
|
|
|||
Comprehensive loss
|
|
|
|
|
|
||||||
Net loss
|
$
|
(63,902
|
)
|
|
$
|
(36,606
|
)
|
|
$
|
(76,678
|
)
|
Reclassification of unrealized gain upon sale of marketable securities
|
—
|
|
|
—
|
|
|
(2,678
|
)
|
|||
Tax effect of reclassification of unrealized gain upon sale of marketable securities
|
—
|
|
|
—
|
|
|
1,052
|
|
|||
Total comprehensive loss
|
$
|
(63,902
|
)
|
|
$
|
(36,606
|
)
|
|
$
|
(78,304
|
)
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Accumulated Deficit
|
|
Treasury Stock
|
|
Total
|
|||||||||||||||
|
Shares Issued
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2012
|
83,595,837
|
|
|
$
|
8
|
|
|
$
|
132,168
|
|
|
$
|
1,626
|
|
|
$
|
(102,197
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
27,756
|
|
Issuance of common stock
|
20,125,000
|
|
|
2
|
|
|
37,537
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37,539
|
|
||||||
Common stock warrants issued in connection with September 2013 common stock offering
|
—
|
|
|
—
|
|
|
(8,238
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,238
|
)
|
||||||
Issuance of common stock upon exercise of warrants
|
5,320,669
|
|
|
—
|
|
|
22,064
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22,064
|
|
||||||
Issuance of common stock in settlement of contingent purchase price consideration
|
492,988
|
|
|
—
|
|
|
1,247
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,247
|
|
||||||
Issuance of common stock warrants with long-term debt financing
|
—
|
|
|
—
|
|
|
351
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
351
|
|
||||||
Issuance of common stock in exchange for services
|
99,998
|
|
|
—
|
|
|
211
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
211
|
|
||||||
Issuance of common stock in connection with employee stock purchase plan
|
52,532
|
|
|
—
|
|
|
163
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
163
|
|
||||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
1,886
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,886
|
|
||||||
Stock based compensation for services
|
—
|
|
|
—
|
|
|
644
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
644
|
|
||||||
Reclassification of unrealized gain upon the sale of marketable securities, net of tax of $1,052
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,626
|
)
|
|
—
|
|
|
—
|
|
|
(1,626
|
)
|
||||||
Exercise of stock options
|
413,677
|
|
|
—
|
|
|
567
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
567
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(76,678
|
)
|
|
—
|
|
|
(76,678
|
)
|
||||||
Balance at December 31, 2013
|
110,100,701
|
|
|
$
|
10
|
|
|
$
|
188,600
|
|
|
$
|
—
|
|
|
$
|
(178,875
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
5,886
|
|
Issuance of common stock
|
6,633,008
|
|
|
1
|
|
|
10,704
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,705
|
|
||||||
Issuance of common stock under milestone achievement
|
4,381,215
|
|
|
—
|
|
|
9,340
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,340
|
|
||||||
Issuance of common stock upon exercise of warrants
|
5,467.027
|
|
|
1
|
|
|
37,741
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37,742
|
|
||||||
Issuance of common stock in connection with employee stock purchase plan
|
114,630
|
|
|
—
|
|
|
263
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
263
|
|
||||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
5,253
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,253
|
|
||||||
Stock based compensation for services
|
—
|
|
|
—
|
|
|
134
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
134
|
|
||||||
Exercise of stock options
|
3,449,760
|
|
|
—
|
|
|
4,342
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,342
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,606
|
)
|
|
—
|
|
|
(36,606
|
)
|
||||||
Balance at December 31, 2014
|
130,146,341
|
|
|
$
|
12
|
|
|
$
|
256,377
|
|
|
$
|
—
|
|
|
$
|
(215,481
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
37,059
|
|
Issuance of common stock
|
32,158,685
|
|
|
3
|
|
|
47,413
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
47,416
|
|
||||||
Common stock warrants issued in connection with March 2015 common stock offering
|
—
|
|
|
—
|
|
|
(10,296
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,296
|
)
|
||||||
Issuance of common stock in connection with employee stock purchase plan
|
231,312
|
|
|
—
|
|
|
309
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
309
|
|
||||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
2,896
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,896
|
|
||||||
Exercise of stock options
|
45,415
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(63,902
|
)
|
|
—
|
|
|
(63,902
|
)
|
||||||
Balance at December 31, 2015
|
162,581,753
|
|
|
$
|
15
|
|
|
$
|
296,730
|
|
|
$
|
—
|
|
|
$
|
(279,383
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
13,513
|
|
|
For the Year Ended December 31,
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||||
Cash flows from continuing operating activities:
|
|
|
|
|
|
||||||||
Net loss from continuing operations
|
$
|
(38,956
|
)
|
|
$
|
(28,284
|
)
|
|
$
|
(71,327
|
)
|
||
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||||
Depreciation and amortization expense
|
355
|
|
|
362
|
|
|
286
|
|
|||||
Gain on sale of marketable securities
|
—
|
|
|
—
|
|
|
(3,911
|
)
|
|||||
Deferred taxes
|
365
|
|
|
—
|
|
|
1,052
|
|
|||||
Non-cash stock-based compensation
|
1,931
|
|
|
4,666
|
|
|
2,307
|
|
|||||
Litigation settlement payable in common stock
|
1,000
|
|
—
|
|
—
|
|
|
—
|
|
||||
Fair value of common stock issued in exchange for services
|
—
|
|
|
—
|
|
|
211
|
|
|||||
Change in fair value of common stock warrants
|
(1,161
|
)
|
|
(16,556
|
)
|
|
44,001
|
|
|||||
Change in fair value of contingent consideration
|
(509
|
)
|
|
(170
|
)
|
|
926
|
|
|||||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||||
Prepaid expenses and other assets
|
(245
|
)
|
|
(1,078
|
)
|
|
437
|
|
|||||
Litigation settlement insurance recovery
|
(21,700
|
)
|
|
—
|
|
|
—
|
|
|||||
Litigation settlement payable
|
24,000
|
|
|
—
|
|
|
—
|
|
|||||
Accounts payable
|
(289
|
)
|
|
(21
|
)
|
|
(69
|
)
|
|||||
Accrued expenses and other current liabilities
|
(3,593
|
)
|
|
4,044
|
|
|
2,811
|
|
|||||
Net cash used in continuing operating activities
|
(38,802
|
)
|
|
(37,037
|
)
|
|
(23,276
|
)
|
|||||
Cash flows from discontinued operating activities:
|
|
|
|
|
|
||||||||
Net loss from discontinued operations
|
(24,946
|
)
|
|
(8,322
|
)
|
|
(5,351
|
)
|
|||||
Loss on sale of commercial assets
|
4,549
|
|
|
—
|
|
|
—
|
|
|||||
Impairment charge from classification of assets held for sale
|
8,071
|
|
|
—
|
|
|
—
|
|
|||||
Changes in operating assets and liabilities attributable to discontinued operations
|
2,968
|
|
|
2,490
|
|
|
(302
|
)
|
|||||
Net cash used in discontinued operating activities
|
(9,358
|
)
|
|
(5,832
|
)
|
|
(5,653
|
)
|
|||||
Net cash used in operating activities
|
(48,160
|
)
|
|
(42,869
|
)
|
|
(28,929
|
)
|
|||||
Cash flows from investing activities:
|
|
|
|
|
|
||||||||
Change in restricted cash
|
(201
|
)
|
|
—
|
|
|
(99
|
)
|
|||||
Cash paid for acquisition of GALE-401
|
—
|
|
|
(2,415
|
)
|
|
—
|
|
|||||
Purchase of short-term investments
|
—
|
|
|
—
|
|
|
3,911
|
|
|||||
Cash paid for purchase of equipment and furnishings
|
(153
|
)
|
|
(57
|
)
|
|
(320
|
)
|
|||||
Net cash provided by (used in) continuing investing activities
|
(354
|
)
|
|
(2,472
|
)
|
|
3,492
|
|
|||||
Net proceeds received from sale of commercial assets
|
11,283
|
|
|
—
|
|
|
—
|
|
|||||
Cash paid for commercial assets
|
(534
|
)
|
|
(3,056
|
)
|
|
(15,532
|
)
|
|||||
Net cash provided by (used in) discontinued investing activities
|
10,749
|
|
—
|
|
(3,056
|
)
|
—
|
|
(15,532
|
)
|
|||
Net cash provided by (used in) investing activities
|
10,395
|
|
|
(5,528
|
)
|
|
(12,040
|
)
|
|||||
Cash flows from financing activities:
|
|
|
|
|
|
||||||||
Net proceeds from issuance of common stock
|
47,416
|
|
|
10,704
|
|
|
37,539
|
|
|||||
Net proceeds from exercise of stock options
|
31
|
|
|
4,342
|
|
|
567
|
|
|||||
Proceeds from exercise of warrants
|
—
|
|
|
10,717
|
|
|
7,815
|
|
|||||
Proceeds from common stock issued in connection with ESPP
|
309
|
|
|
263
|
|
|
163
|
|
|||||
Net proceeds from issuance of long-term debt
|
—
|
|
|
—
|
|
|
9,865
|
|
|||||
Principal payments on long-term debt
|
(3,911
|
)
|
|
(1,766
|
)
|
|
—
|
|
|||||
Net cash provided by financing activities
|
43,845
|
|
|
24,260
|
|
|
55,949
|
|
|||||
Net increase (decrease) in cash and cash equivalents
|
6,080
|
|
|
(24,137
|
)
|
|
14,980
|
|
|||||
Cash and cash equivalents at the beginning of period
|
23,650
|
|
|
47,787
|
|
|
32,807
|
|
|||||
Cash and cash equivalents at end of period
|
$
|
29,730
|
|
|
$
|
23,650
|
|
|
$
|
47,787
|
|
|
For the Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash received during the periods for interest
|
$
|
18
|
|
|
$
|
15
|
|
|
$
|
19
|
|
Cash paid during the periods for interest
|
$
|
541
|
|
|
$
|
800
|
|
|
$
|
547
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Fair value of warrants issued in connection with common stock recorded as cost of equity
|
$
|
10,296
|
|
|
$
|
—
|
|
|
$
|
8,238
|
|
Reclassification of warrant liabilities upon exercise
|
$
|
—
|
|
|
$
|
27,026
|
|
|
$
|
14,249
|
|
Common stock issued in settlement of contingent purchase price consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,247
|
|
Change in fair value of marketable securities before settlement
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(2,678
|
)
|
Issuance of common stock in settlement of GALE-401 milestone
|
$
|
—
|
|
|
$
|
6,840
|
|
|
$
|
—
|
|
Fair value of shares issued to acquire Zuplenz rights
|
$
|
—
|
|
|
$
|
2,500
|
|
|
$
|
—
|
|
Future obligations for Zuplenz rights included in accrued expenses
|
$
|
—
|
|
|
$
|
2,716
|
|
|
$
|
—
|
|
•
|
Develop novel cancer immunotherapies to address unmet medical needs through the use of peptide-based vaccines targeting well-established tumor antigens. One of our key strategies is to target the adjuvant setting in patients with higher risk of recurrence, who had their primary treatment for cancer and have no evidence of disease, and are more likely to benefit from treatment via immunotherapy. Our immunotherapy programs are currently targeting two key areas: secondary prevention intended to significantly decrease the risk of disease recurrence in breast, gastric, and ovarian cancers; and primary prevention intended to cease or delay ductal carcinoma
in situ
(DCIS) from becoming invasive breast cancer.
|
•
|
Expand our development pipeline by enhancing the clinical and geographic footprint of our technologies. We intend to accomplish this through the initiation of new clinical trials and potentially through acquisition of additional oncology programs.
|
•
|
Leverage partnerships and collaborations, as well as investigator-sponsored trial arrangements, to maximize the scope of potential clinical opportunities in a cost effective and efficient manner.
|
•
|
Focus our resources on our valuable and expanding clinical development programs. On November 19, 2015 we sold our Abstral
®
(fentanyl) Sublingual Tablets product and related assets and on December 24, 2015 we sold Zuplenz (ondansetron) Oral Soluble Film product and related assets, and as of December 31, 2015, we ceased our commercial operations.
|
|
December 31, 2015
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
29,171
|
|
|
$
|
29,171
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured and recorded at fair value
|
$
|
29,171
|
|
|
$
|
29,171
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
14,518
|
|
|
$
|
—
|
|
|
$
|
14,518
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
6,142
|
|
|
—
|
|
|
—
|
|
|
6,142
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
20,660
|
|
|
$
|
—
|
|
|
$
|
14,518
|
|
|
$
|
6,142
|
|
|
December 31, 2014
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
19,477
|
|
|
$
|
19,477
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured and recorded at fair value
|
$
|
19,477
|
|
|
$
|
19,477
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
5,383
|
|
|
$
|
—
|
|
|
$
|
5,383
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
6,651
|
|
|
—
|
|
|
—
|
|
|
6,651
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
12,034
|
|
|
$
|
—
|
|
|
$
|
5,383
|
|
|
$
|
6,651
|
|
|
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
|
||
Balance, January 1, 2014
|
$
|
6,821
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
(170
|
)
|
|
Balance, December 31, 2014
|
6,651
|
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
(509
|
)
|
|
Balance at December 31, 2015
|
$
|
6,142
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Clinical development expense
|
$
|
3,294
|
|
|
$
|
6,967
|
|
Compensation and related benefits
|
1,535
|
|
|
1,040
|
|
||
Professional fees
|
435
|
|
|
821
|
|
||
Interest expense
|
28
|
|
|
57
|
|
||
Accrued expenses and other current liabilities
|
$
|
5,292
|
|
|
$
|
8,885
|
|
2016 Principal Payments
|
|
$
|
4,254
|
|
Add - 5.5% cash final payment (less Unamortized debt issuance costs)
|
|
485
|
|
|
Carrying value of long-term debt
|
|
$
|
4,739
|
|
|
Amount
|
||
Class action settlement
|
$
|
20,000
|
|
Derivative settlement
|
5,000
|
|
|
Total settlement payable
|
25,000
|
|
|
|
|
||
Payable by the insurance carriers
|
21,700
|
|
|
Payable by the company in cash
|
2,300
|
|
|
Payable by the company in common stock
|
1,000
|
|
|
Total settlement payable
|
$
|
25,000
|
|
|
Operating
Leases
(1)
|
|
Non-Cancelable
Employment
Agreements
(2)
|
|
Subtotal
|
|
Cancelable
License
Agreements
(3)
|
|
Total
|
||||||||||
2016
|
$
|
316
|
|
|
$
|
850
|
|
|
$
|
1,166
|
|
|
$
|
350
|
|
|
$
|
1,516
|
|
2017
|
323
|
|
|
—
|
|
|
323
|
|
|
350
|
|
|
673
|
|
|||||
2018
|
316
|
|
|
—
|
|
|
316
|
|
|
350
|
|
|
666
|
|
|||||
2019
|
251
|
|
|
—
|
|
|
251
|
|
|
4,200
|
|
|
4,451
|
|
|||||
2020 and thereafter
|
236
|
|
|
—
|
|
|
236
|
|
|
2,965
|
|
|
3,201
|
|
|||||
Total
|
$
|
1,442
|
|
|
$
|
850
|
|
|
$
|
2,292
|
|
|
$
|
8,215
|
|
|
$
|
10,507
|
|
(1)
|
Operating leases are primarily facility and equipment related obligations with third party vendors. Operating lease expenses during the years ended December 31, 2015, 2014, and 2013 were approximately
$116,000
,
$72,000
and
$77,000
, respectively.
|
(2)
|
Employment agreement obligations include management contracts, as well as scientific advisory board member compensation agreements. Certain agreements, which have been revised from time to time, provide for minimum salary levels, adjusted annually at the discretion of the Compensation Committee, as well as for minimum bonuses that are payable.
|
(3)
|
License agreements generally relate to the company’s obligations with The Board of Regents, University of Texas and Henry M. Jackson Foundation for our oncology therapies. The company continually assesses the progress of its licensed technology and the progress of its research and development efforts as it relates to its licensed technology and may terminate with notice to the licensor at any time. In the event these licenses are terminated, no amounts will be due.
|
|
March
2015 Warrants |
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
Other Warrant Issuances
|
|
Consultant
and Oxford Warrants
|
|
Total
|
|||||||
Outstanding, January 1, 2014
|
—
|
|
|
6,442
|
|
|
4,917
|
|
|
1,158
|
|
|
1,444
|
|
|
889
|
|
|
14,850
|
|
Granted
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
300
|
|
|
300
|
|
Exercised
|
—
|
|
|
(2,469
|
)
|
|
(1,886
|
)
|
|
(543
|
)
|
|
(327
|
)
|
|
(469
|
)
|
|
(5,694
|
)
|
Expired
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(916
|
)
|
|
—
|
|
|
(916
|
)
|
Outstanding, December 31, 2014
|
—
|
|
|
3,973
|
|
|
3,031
|
|
|
615
|
|
|
201
|
|
|
720
|
|
|
8,540
|
|
Granted
|
14,006
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,006
|
|
Expired
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(238
|
)
|
|
(238
|
)
|
Outstanding, December 31, 2015
|
14,006
|
|
|
3,973
|
|
|
3,031
|
|
|
615
|
|
|
201
|
|
|
482
|
|
|
22,308
|
|
Expiration
|
March 2020
|
|
September 2018
|
|
December 2017
|
|
April 2017
|
|
Varies 2014-2016
|
|
Varies 2014-2020
|
|
|
|
As of December 31, 2015
|
||||||||||||||||||||||
|
March
2015
Warrants
|
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
||||||||||||
Strike price
|
$
|
2.08
|
|
|
$
|
2.50
|
|
|
$
|
1.83
|
|
|
$
|
0.65
|
|
|
$
|
0.65
|
|
|
$
|
2.02
|
|
Expected term (years)
|
4.22
|
|
|
2.72
|
|
|
1.98
|
|
|
1.31
|
|
|
0.18
|
|
|
0.24
|
|
||||||
Volatility %
|
75.85
|
%
|
|
74.70
|
%
|
|
76.37
|
%
|
|
65.60
|
%
|
|
47.98
|
%
|
|
71.41
|
%
|
||||||
Risk-free rate %
|
1.58
|
%
|
|
1.24
|
%
|
|
1.05
|
%
|
|
0.77
|
%
|
|
—
|
%
|
|
—
|
%
|
|
As of December 31, 2014
|
||||||||||||||||||
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
March
2011
Warrants
|
|
March
2010
Warrants
|
||||||||||
Strike price
|
$
|
2.50
|
|
|
$
|
1.90
|
|
|
$
|
0.65
|
|
|
$
|
0.65
|
|
|
$
|
2.15
|
|
Expected term (years)
|
3.72
|
|
|
2.98
|
|
|
2.31
|
|
|
1.18
|
|
|
1.24
|
|
|||||
Volatility %
|
75.60
|
%
|
|
76.85
|
%
|
|
78.24
|
%
|
|
77.38
|
%
|
|
77.12
|
%
|
|||||
Risk-free rate %
|
1.30
|
%
|
|
1.09
|
%
|
|
0.80
|
%
|
|
0.32
|
%
|
|
0.35
|
%
|
|
March
2015 Warrants |
|
September
2013
Warrants
|
|
December
2012
Warrants
|
|
April 2011
Warrants
|
|
Other Warrant Issuances
|
|
Total
|
||||||||||||
Warrant liability, January 1, 2014
|
$
|
—
|
|
|
$
|
22,950
|
|
|
$
|
18,060
|
|
|
$
|
5,069
|
|
|
$
|
2,886
|
|
|
$
|
48,965
|
|
Fair value of warrants granted
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Fair value of warrants exercised
|
—
|
|
|
(12,713
|
)
|
|
(10,086
|
)
|
|
(2,906
|
)
|
|
(1,321
|
)
|
|
(27,026
|
)
|
||||||
Change in fair value of warrants
|
—
|
|
|
(7,677
|
)
|
|
(5,947
|
)
|
|
(1,538
|
)
|
|
(1,394
|
)
|
|
(16,556
|
)
|
||||||
Warrant liability, December 31, 2014
|
—
|
|
|
2,560
|
|
|
2,027
|
|
|
625
|
|
|
171
|
|
|
5,383
|
|
||||||
Fair value of warrants granted
|
10,296
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,296
|
|
||||||
Fair value of warrants exercised
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Change in fair value of warrants
|
41
|
|
|
(627
|
)
|
|
(462
|
)
|
|
(88
|
)
|
|
(25
|
)
|
|
(1,161
|
)
|
||||||
Warrant liability, December 31, 2015
|
$
|
10,337
|
|
|
$
|
1,933
|
|
|
$
|
1,565
|
|
|
$
|
537
|
|
|
$
|
146
|
|
|
$
|
14,518
|
|
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development
|
$
|
350
|
|
|
$
|
484
|
|
|
$
|
754
|
|
General and administrative
|
1,591
|
|
|
4,903
|
|
|
2,150
|
|
|||
Total stock-based compensation
|
$
|
1,941
|
|
|
$
|
5,387
|
|
|
$
|
2,904
|
|
|
2015
|
|
2014
|
|
2013
|
|||
Risk free interest rate
|
1.67
|
%
|
|
2.01
|
%
|
|
1.57
|
%
|
Volatility
|
73.97
|
%
|
|
79.37
|
%
|
|
77.98
|
%
|
Expected lives (years)
|
6.16
|
|
|
6.16
|
|
|
6.25
|
|
Expected dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
|
Total
Number of
Shares
(In Thousands)
|
|
Weighted
Average
Exercise
Price
|
|||
Outstanding at December 31, 2014
|
8,590
|
|
|
$
|
3.25
|
|
Granted
|
6,743
|
|
|
1.63
|
|
|
Exercised
|
(39
|
)
|
|
0.79
|
|
|
Cancelled
|
(2,032
|
)
|
|
2.31
|
|
|
Outstanding at December 31, 2015
|
13,262
|
|
|
$
|
2.58
|
|
Options exercisable at December 31, 2015
|
7,192
|
|
|
$
|
3.22
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Realized gain on sale of marketable securities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,911
|
|
Change in fair value of the contingent purchase price liability
|
|
509
|
|
|
170
|
|
|
(926
|
)
|
|||
Miscellaneous other income
|
|
—
|
|
|
—
|
|
|
37
|
|
|||
Total other income
|
|
$
|
509
|
|
|
$
|
170
|
|
|
$
|
3,022
|
|
|
|
As of December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Current
|
|
|
|
|
|
|
||||||
Federal
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total current
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Deferred expense (benefit)
|
|
|
|
|
|
|
||||||
Federal
|
|
332
|
|
|
—
|
|
|
894
|
|
|||
State
|
|
33
|
|
|
—
|
|
|
158
|
|
|||
Total deferred
|
|
365
|
|
|
—
|
|
|
1,052
|
|
|||
Total income tax expense (benefit)
|
|
$
|
365
|
|
|
$
|
—
|
|
|
$
|
1,052
|
|
|
|
As of December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
Net operating loss carryforwards
|
|
$
|
75,221
|
|
|
$
|
53,950
|
|
Tax credit carryforwards
|
|
3,866
|
|
|
3,590
|
|
||
Stock based compensation
|
|
5,050
|
|
|
4,676
|
|
||
Other
|
|
1,430
|
|
|
190
|
|
||
Licensing deduction deferral
|
|
9,910
|
|
|
8,919
|
|
||
Gross deferred tax assets
|
|
95,477
|
|
|
71,325
|
|
||
Valuation allowance
|
|
(95,477
|
)
|
|
(71,325
|
)
|
||
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
As of December 31,
|
||||||
|
|
2015
|
|
2014
|
||||
In-process research and development not subject to future amortization for tax purposes
|
|
$
|
5,418
|
|
|
$
|
5,053
|
|
Gross deferred tax liability
|
|
$
|
5,418
|
|
|
$
|
5,053
|
|
|
|
As of December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Expected federal income tax benefit
|
|
$
|
(21,603
|
)
|
|
$
|
(12,447
|
)
|
|
$
|
(25,713
|
)
|
State income taxes after credits
|
|
(2,375
|
)
|
|
(1,283
|
)
|
|
(3,676
|
)
|
|||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
1,052
|
|
|||
Changes in warrant value
|
|
(456
|
)
|
|
(6,503
|
)
|
|
17,283
|
|
|||
Stock compensation
|
|
508
|
|
|
3,996
|
|
|
813
|
|
|||
Effect of change in valuation allowance
|
|
24,029
|
|
|
17,275
|
|
|
11,408
|
|
|||
Income tax credits
|
|
(276
|
)
|
|
(42
|
)
|
|
(240
|
)
|
|||
Other
|
|
538
|
|
|
(996
|
)
|
|
125
|
|
|||
|
|
$
|
365
|
|
|
$
|
—
|
|
|
$
|
1,052
|
|
|
Sale of Abstral and related assets on November 19, 2015
|
|
Sale of Zuplenz and related assets on December 24, 2015
|
||||
Net proceeds from sales
|
|
|
|
||||
Total consideration
|
$
|
8,348
|
|
|
$
|
3,750
|
|
Less selling costs*
|
(815
|
)
|
|
(1,050
|
)
|
||
Proceeds from sale, net of selling costs
|
$
|
7,533
|
|
|
$
|
2,700
|
|
|
2015
|
|
2014
|
||||
Carrying amounts of assets included as part of discontinued operations:
|
|||||||
Accounts receivable
|
$
|
392
|
|
|
$
|
1,535
|
|
Inventories
|
—
|
|
|
655
|
|
||
Prepaid expenses and other current assets
|
—
|
|
|
1,747
|
|
||
Equipment and furnishings, net
|
—
|
|
|
270
|
|
||
Abstral rights, net
|
—
|
|
|
14,533
|
|
||
Zuplenz rights
|
—
|
|
|
8,101
|
|
||
Goodwill
|
—
|
|
|
172
|
|
||
Total current assets of discontinued operations
|
$
|
392
|
|
|
$
|
27,013
|
|
|
|
|
|
||||
Carrying amounts of liabilities included as part of discontinued operations:
|
|||||||
Accounts payable
|
$
|
1,491
|
|
|
$
|
385
|
|
Accrued expenses and other current liabilities
|
4,434
|
|
|
6,784
|
|
||
Total current liabilities of discontinued operations
|
$
|
5,925
|
|
|
$
|
7,169
|
|
|
2015
|
|
2014
|
|
2013
|
||||||
Net revenue
|
$
|
9,734
|
|
|
$
|
9,319
|
|
|
$
|
2,487
|
|
Cost of revenue
|
(1,780
|
)
|
|
(1,403
|
)
|
|
(520
|
)
|
|||
Amortization of certain acquired intangible assets
|
(921
|
)
|
|
(440
|
)
|
|
(131
|
)
|
|||
Research and development
|
(355
|
)
|
|
(680
|
)
|
|
(651
|
)
|
|||
Selling, general, and administrative
|
(17,655
|
)
|
|
(15,118
|
)
|
|
(6,536
|
)
|
|||
Impairment charge form classification as held for sale
|
(8,071
|
)
|
|
—
|
|
|
—
|
|
|||
Loss on sale of commercial business assets
|
(4,549
|
)
|
|
—
|
|
|
—
|
|
|||
Severance and exit costs
|
(1,349
|
)
|
|
—
|
|
|
—
|
|
|||
Loss from discontinued operations
|
$
|
(24,946
|
)
|
|
$
|
(8,322
|
)
|
|
$
|
(5,351
|
)
|
|
|
1st Quarter
|
|
2nd Quarter
|
|
3rd Quarter
|
|
4th Quarter
|
||||||||
2015
|
|
|
|
|
|
|
|
|
||||||||
Net revenue
|
|
$
|
2,750
|
|
|
$
|
3,382
|
|
|
$
|
2,166
|
|
|
$
|
1,436
|
|
Gross profit on net revenue
(1)
|
|
$
|
2,357
|
|
|
$
|
2,914
|
|
|
$
|
1,454
|
|
|
$
|
1,229
|
|
Net loss
|
|
$
|
(10,537
|
)
|
|
$
|
(15,660
|
)
|
|
$
|
(18,026
|
)
|
|
$
|
(19,678
|
)
|
Net loss per share
|
|
$
|
(0.08
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.12
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
2014
|
|
|
|
|
|
|
|
|
||||||||
Net revenue
|
|
$
|
2,173
|
|
|
$
|
2,331
|
|
|
$
|
1,620
|
|
|
$
|
3,195
|
|
Gross profit on net revenue
(1)
|
|
$
|
1,751
|
|
|
$
|
1,886
|
|
|
$
|
1,303
|
|
|
$
|
2,536
|
|
Net loss
|
|
$
|
(2,536
|
)
|
|
$
|
(19,941
|
)
|
|
$
|
(6,173
|
)
|
|
$
|
(7,506
|
)
|
Net loss per share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.06
|
)
|
Exhibit
Number
|
|
Description
|
|
23.1
|
|
Consent of Moss Adams LLP, Independent Registered Public Accounting Firm.**
|
|
31.1
|
|
Sarbanes-Oxley Act Section 302 Certification of Mark W. Schwartz, Ph.D.**
|
|
31.2
|
|
Sarbanes-Oxley Act Section 302 Certification of John T. Burns.**
|
|
32.1
|
|
Sarbanes-Oxley Act Section 906 Certification of Mark W. Schwartz, Ph.D., and John T. Burns.**
|
|
101.INS
|
|
XBRL Instance Document.
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema.
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation.
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition.
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label.
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation.
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation.
|
**
|
Filed herewith.
|
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