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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.06 | 4.84% | 1.30 | 1.28 | 1.29 | 1.4399 | 1.12 | 1.30 | 9,517,165 | 00:59:30 |
|
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
|
|
¨
|
|
•
|
Develop hematology and oncology assets through clinical development with a focus in areas of unmet medical need. Our hematology asset is targeting the treatment of patients with ET to reduce elevated platelet counts. 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 prevent ductal carcinoma
in situ
(DCIS) from becoming invasive breast cancer.
|
•
|
Evaluating strategic alternatives that may include continuing to advance the clinical programs as a stand-alone entity, a sale of the company, a business combination, merger or reverse merger, and a license or other disposition of corporate assets of the company.
|
•
|
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.
|
Drug Candidate
|
Indication
|
Scope
|
Estimated
Exclusivity
Period
|
GALE-401 (Anagrelide Controlled Release)
|
Platelet Lowering
|
Pending and/or issued
|
2029
|
NeuVax™ (nelipepimut-S)
|
Breast cancer recurrence
|
Pending and/or issued
|
2028
|
NeuVax™ (nelipepimut-S)
|
Gastric
|
Pending and/or issued
|
2028
|
NeuVax™ (nelipepimut-S)
|
DCIS
|
Pending and/or issued
|
2028
|
NeuVax™ in combination with trastuzumab
|
Breast cancer
|
Pending and/or issued
|
2026
|
NeuVax™ in combination with other compounds
|
Breast cancer
|
Pending and/or issued
|
2037
|
GALE-301 & GALE-302
|
Breast, ovarian and endometrial cancer
|
Pending and/or issued
|
2036
|
•
|
impairment of our business reputation;
|
•
|
costs of related litigation;
|
•
|
distraction of management’s attention from our primary business; or
|
•
|
substantial monetary awards to patients or other claimants.
|
•
|
difficulties or delays in enrolling patients in our planned clinical trials in conformity with required protocols or projected timelines;
|
•
|
conditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
|
•
|
difficulties or delays in arranging for third parties to conduct clinical trials of our product candidates;
|
•
|
problems in engaging IRBs to oversee trials or problems in obtaining or maintaining IRB approval of studies;
|
•
|
third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
|
•
|
our drug candidates having very different chemical and pharmacological properties in humans than in laboratory testing and interacting with human biological systems in unforeseen, ineffective or harmful ways, and the possibility that our previous Phase 1 or Phase 2 trials will not be indicative of our drug candidates’ performance in larger patient populations;
|
•
|
the need to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
|
•
|
insufficient or inadequate supply or quality of our drug candidates or other necessary materials necessary to conduct our clinical trials;
|
•
|
disruption at our clinical trial sites resulting from local social or political unrest or other geopolitical factors;
|
•
|
effects of our drug candidates not having the desired effects or including undesirable side effects or the drug candidates having other unexpected characteristics;
|
•
|
negative or inconclusive results from our clinical trials or the clinical trials of others for drug candidates similar to our own or inability to generate statistically significant data confirming the efficacy of the product being tested;
|
•
|
adverse results obtained by other companies developing similar drugs;
|
•
|
modification of the drug during testing;
|
•
|
our capital resources; and
|
•
|
reallocation of our financial and other resources to other clinical programs.
|
•
|
differing regulatory requirements for drug approvals and regulation of approved drugs in foreign countries;
|
•
|
unexpected changes in tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance
|
•
|
foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating in another country;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the U.S.;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism.
|
•
|
reports of the results of our clinical trials regarding the safety or efficacy of our product candidates and surrogate markers;
|
•
|
announcements of regulatory developments or technological innovations by us or our competitors;
|
•
|
announcements of business or strategic transactions or our success in finalizing such a transaction;
|
•
|
announcements of legal or regulatory actions against us or any adverse outcome of any such actions;
|
•
|
changes in our relationship with our licensors, licensees and other strategic partners;
|
•
|
our quarterly operating results;
|
•
|
developments in patent or other technology ownership rights;
|
•
|
additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stockholders;
|
•
|
government regulation of drug pricing; and
|
•
|
general changes in the economy, the financial markets or the pharmaceutical or biotechnology industries.
|
•
|
divide our board of directors into three classes, with members of each class to be elected for staggered three-year terms;
|
•
|
limit the right of security holders to remove directors;
|
•
|
prohibit stockholders from acting by written consent;
|
•
|
regulate how stockholders may present proposals or nominate directors for election at annual meetings of stockholders; and
|
•
|
authorize our board of directors to issue preferred stock in one or more series, without stockholder approval.
|
|
High
|
|
Low
|
||||
2015
|
|
|
|
||||
First Quarter
|
$
|
42.40
|
|
|
$
|
26.60
|
|
Second Quarter
|
47.80
|
|
|
25.40
|
|
||
Third Quarter
|
38.40
|
|
|
22.00
|
|
||
Fourth Quarter
|
36.60
|
|
|
27.40
|
|
||
2016
|
|
|
|
||||
First Quarter
|
$
|
30.00
|
|
|
$
|
11.80
|
|
Second Quarter
|
49.80
|
|
|
5.60
|
|
||
Third Quarter
|
15.40
|
|
|
6.20
|
|
||
Fourth Quarter
|
7.00
|
|
|
1.84
|
|
|
(a)
|
|
(b)
|
|
Number of
Securities
Remaining
Available for
Issuance
Under Equity
Compensation
Plans
(Excluding
Securities
Reflected in
Column (a))
|
||||
Plan Category
|
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options,
Warrants and
Rights
|
|
Weighted-
Average
Exercise Price
of Outstanding
Options,
Warrants and
Rights
|
|
|||||
Equity compensation plans approved by our security holders:
|
|
|
|
|
|
||||
Amended and Restated 2016 Incentive Plan
|
560,925
|
|
|
$
|
41.50
|
|
|
500,692
|
|
Equity compensation plans not approved by our security holders:
|
|
|
|
|
|
||||
Employee Stock Purchase Plan
|
NA
|
|
|
NA
|
|
|
20,930
|
|
|
Outstanding warrants
(1)
|
124,109
|
|
|
$
|
20.15
|
|
|
—
|
|
Total
|
685,034
|
|
|
$
|
37.63
|
|
|
521,622
|
|
(1)
|
The warrants shown were issued in discrete transactions from time to time as compensation for services rendered by consultants, advisers or other third parties, and do not include warrants sold in private placement or public offering transactions. The material terms of such warrants were determined based upon arm’s-length negotiations with the services providers. The warrant exercise prices approximated the market price of our common stock at or about the date of grant, and the warrant terms range from three to ten years from the grant date.
|
|
As of December 31,
|
||||||||||||||||||||||
|
2011
|
|
2012
|
|
2013
|
|
2014
|
|
2015
|
|
2016
|
||||||||||||
Galena Biopharma, Inc.
(1)
|
$
|
100.00
|
|
|
$
|
325.53
|
|
|
$
|
1,055.32
|
|
|
$
|
321.28
|
|
|
$
|
312.77
|
|
|
$
|
20.64
|
|
S&P 500
|
100.00
|
|
|
115.88
|
|
|
153.01
|
|
|
173.68
|
|
|
176.07
|
|
|
196.78
|
|
||||||
NASDAQ Composite
|
100.00
|
|
|
117.70
|
|
|
164.65
|
|
|
188.87
|
|
|
202.25
|
|
|
220.13
|
|
||||||
NASDAQ Biotechnology
|
100.00
|
|
|
132.72
|
|
|
220.22
|
|
|
202.25
|
|
|
330.71
|
|
|
260.12
|
|
(amounts in thousands, except share and per share data)
|
Years Ended December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
(1)
|
$
|
19,860
|
|
|
$
|
23,611
|
|
|
$
|
27,674
|
|
|
$
|
20,424
|
|
|
$
|
14,614
|
|
General, and administrative
(1)
|
12,007
|
|
|
10,609
|
|
|
16,226
|
|
|
8,065
|
|
|
6,585
|
|
|||||
Non-operating income (loss)
(1)
|
21,009
|
|
|
(4,371
|
)
|
|
15,616
|
|
|
(41,786
|
)
|
|
(13,178
|
)
|
|||||
Loss from continuing operations
(1)
|
(11,101
|
)
|
|
(38,956
|
)
|
|
(28,284
|
)
|
|
(71,327
|
)
|
|
(33,325
|
)
|
|||||
Loss from continuing operations per share, basic and diluted
(1)
|
$
|
(1.11
|
)
|
|
$
|
(5.02
|
)
|
|
$
|
(4.74
|
)
|
|
$
|
(15.82
|
)
|
|
$
|
(10.60
|
)
|
|
As of December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Total assets
(1)
|
$
|
65,811
|
|
|
$
|
82,144
|
|
|
$
|
80,488
|
|
|
$
|
87,976
|
|
|
$
|
54,986
|
|
Total debt
(1)
|
16,397
|
|
|
4,739
|
|
|
8,402
|
|
|
9,892
|
|
|
—
|
|
|||||
Other long-term obligations
(1)
|
6,756
|
|
|
11,560
|
|
|
11,704
|
|
|
11,874
|
|
|
11,311
|
|
|||||
Total stockholders' equity
(1)
|
28,657
|
|
|
13,513
|
|
|
37,059
|
|
|
5,886
|
|
|
27,756
|
|
•
|
Develop hematology and oncology assets through clinical development with a focus in areas of unmet medical need. Our hematology asset is targeting the treatment of patients with ET to reduce elevated platelet counts. 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 prevent ductal carcinoma
in situ
(DCIS) from becoming invasive breast cancer.
|
•
|
Evaluating strategic alternatives that may include continuing to advance the clinical programs as a stand-alone entity, a sale of the company, a business combination, merger or reverse merger, and a license or other disposition of corporate assets of the company.
|
•
|
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.
|
|
|
2016
|
|
2015
|
||
Risk free interest rate
|
|
1.54
|
%
|
|
1.67
|
%
|
Volatility
|
|
101.13
|
%
|
|
73.97
|
%
|
Expected lives (years)
|
|
6.04
|
|
|
6.16
|
|
Expected dividend yield
|
|
0.00
|
%
|
|
0.00
|
%
|
|
|
2016
|
|
2015
|
Risk free interest rate
|
|
1.77%
|
|
1.41%
|
Volatility
|
|
119.08%
|
|
73.41%
|
Expected lives (years)
|
|
5
|
|
5
|
Expected dividend yield
|
|
0.00%
|
|
0.00%
|
•
|
significant changes in the manner of its use of acquired assets or the strategy for its overall business;
|
•
|
significant negative industry or economic trends;
|
•
|
significant decline in stock price for a sustained period; and
|
•
|
significant decline in market capitalization relative to net book value.
|
|
|
|
|
|
|
|
% Change
|
||||||||||
(dollars in thousands)
|
2016
|
|
2015
|
|
2014
|
|
2016 vs. 2015
|
|
2015 vs. 2014
|
||||||||
Operating loss
|
$
|
(31,867
|
)
|
|
$
|
(34,220
|
)
|
|
$
|
(43,900
|
)
|
|
(7
|
)%
|
|
(22
|
)%
|
Non-operating income (expense)
|
21,009
|
|
|
(4,371
|
)
|
|
15,616
|
|
|
N/A
|
|
|
N/A
|
|
|||
Income tax
|
(243
|
)
|
|
(365
|
)
|
|
—
|
|
|
(33
|
)%
|
|
N/A
|
|
|||
Loss from discontinued operations
|
(12,448
|
)
|
|
(24,946
|
)
|
|
(8,322
|
)
|
|
(50
|
)%
|
|
200
|
%
|
|||
Net loss
|
$
|
(23,549
|
)
|
|
$
|
(63,902
|
)
|
|
$
|
(36,606
|
)
|
|
(63
|
)%
|
|
75
|
%
|
|
|
|
|
|
|
|
|
|
|
||||||||
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
||||||||
Basic and diluted net loss per share, continuing operations
|
$
|
(1.11
|
)
|
|
$
|
(5.02
|
)
|
|
$
|
(4.74
|
)
|
|
(78
|
)%
|
|
6
|
%
|
Basic and diluted net loss per share, discontinued operations
|
$
|
(1.25
|
)
|
|
$
|
(3.21
|
)
|
|
$
|
(1.39
|
)
|
|
(61
|
)%
|
|
131
|
%
|
Basic and diluted net loss per share
|
$
|
(2.36
|
)
|
|
$
|
(8.23
|
)
|
|
$
|
(6.13
|
)
|
|
(71
|
)%
|
|
34
|
%
|
|
Year Ended December 31,
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2016
|
|
2015
|
|
% Change
|
|
2015
|
|
2014
|
|
% Change
|
||||||||||
Research and development expense
|
$
|
19,860
|
|
|
$
|
23,611
|
|
|
(16
|
)%
|
|
$
|
23,611
|
|
|
$
|
27,674
|
|
|
(15
|
)%
|
|
Year Ended December 31,
|
|||||||||
|
2016
|
|
2015
|
|
% Change
|
|||||
General and administrative expense
|
$
|
12,007
|
|
|
$
|
10,609
|
|
|
13
|
%
|
|
Year Ended December 31,
|
|||||||||
|
2015
|
|
2014
|
|
% Change
|
|||||
General and administrative expense
|
$
|
10,609
|
|
|
$
|
16,226
|
|
|
(35
|
)%
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
$ Change
|
||||||
Non-operating income (expense):
|
|
|
|
|
|
|
||||||
Litigation settlement
|
|
$
|
(2,750
|
)
|
|
$
|
(5,282
|
)
|
|
$
|
2,532
|
|
Change in fair value of warrants potentially settleable in cash
|
|
22,220
|
|
|
1,162
|
|
|
21,058
|
|
|||
Interest expense, net
|
|
(3,508
|
)
|
|
(760
|
)
|
|
(2,748
|
)
|
|||
Change in fair value of the contingent purchase price liability
|
|
5,047
|
|
|
509
|
|
|
4,538
|
|
|||
Total non-operating income (expense), net
|
|
$
|
21,009
|
|
|
$
|
(4,371
|
)
|
|
$
|
25,380
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
$ Change
|
||||||
Non-operating income (expense):
|
|
|
|
|
|
|
||||||
Litigation settlement
|
|
$
|
(5,282
|
)
|
|
$
|
—
|
|
|
$
|
(5,282
|
)
|
Change in fair value of warrants potentially settleable in cash
|
|
$
|
1,162
|
|
|
$
|
16,556
|
|
|
$
|
(15,394
|
)
|
Interest income (expense), net
|
|
(760
|
)
|
|
(1,110
|
)
|
|
350
|
|
|||
Change in fair value of the contingent purchase price liability
|
|
509
|
|
|
170
|
|
|
339
|
|
|||
Total non-operating income (expense), net
|
|
$
|
(4,371
|
)
|
|
$
|
15,616
|
|
|
$
|
(19,987
|
)
|
|
2016
|
|
2015
|
|
2014
|
||||||
Net revenue
|
$
|
—
|
|
|
$
|
9,734
|
|
|
$
|
9,319
|
|
Additional channel obligations
|
(2,886
|
)
|
|
—
|
|
|
—
|
|
|||
Cost of revenue
|
—
|
|
|
(1,780
|
)
|
|
(1,403
|
)
|
|||
Amortization of certain acquired intangible assets
|
—
|
|
|
(921
|
)
|
|
(440
|
)
|
|||
Research and development
|
—
|
|
|
(355
|
)
|
|
(680
|
)
|
|||
Selling, general, and administrative
|
(9,562
|
)
|
|
(17,655
|
)
|
|
(15,118
|
)
|
|||
Impairment charge from 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
|
$
|
(12,448
|
)
|
|
$
|
(24,946
|
)
|
|
$
|
(8,322
|
)
|
|
For the Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|||||
Cash flows from continuing operations:
|
|
|
|
|||||
Cash flows used in continuing operating activities
|
$
|
(33,230
|
)
|
|
$
|
(38,802
|
)
|
|
Cash flows used in continuing investing activities
|
(6
|
)
|
|
(354
|
)
|
|||
Cash flows provided by continuing financing activities
|
34,324
|
|
|
43,845
|
|
|||
Total cash flows provided by continuing operations
|
1,088
|
|
|
4,689
|
|
|||
|
|
|
|
|||||
Cash flows from discontinued operations:
|
|
|
|
|||||
Cash flows used in discontinued operating activities
|
(11,685
|
)
|
|
(9,358
|
)
|
|||
Cash flows provided by (used in) discontinued investing activities
|
(1,050
|
)
|
—
|
|
10,749
|
|
||
Total cash flows provided by (used in) discontinued operations
|
(12,735
|
)
|
|
1,391
|
|
|||
|
|
|
|
|||||
Total cash flows:
|
|
|
|
|||||
Cash flows used in operating activities
|
(44,915
|
)
|
|
(48,160
|
)
|
|||
Cash flows provided by (used in) investing activities
|
(1,056
|
)
|
|
10,395
|
|
|||
Cash flows provided by financing activities
|
34,324
|
|
|
43,845
|
|
|||
Total increase (decrease) in cash and cash equivalents
|
$
|
(11,647
|
)
|
|
$
|
6,080
|
|
|
|
Payment Due by Period
|
||||||||||||||
|
|
Less than 1 Year
|
|
1 to 3 Years
|
|
3 to 5 Years
|
|
Total
|
||||||||
Long-term debt
(1)
|
|
$
|
16,397
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,397
|
|
Cancelable license agreements
(2)
|
|
1,391
|
|
|
700
|
|
|
7,700
|
|
|
9,791
|
|
||||
Non-cancelable employment agreements
(2)
|
|
1,601
|
|
|
—
|
|
|
—
|
|
|
1,601
|
|
||||
Non-cancelable operating leases
(2)
|
|
241
|
|
|
497
|
|
|
236
|
|
|
974
|
|
||||
Total
|
|
$
|
19,630
|
|
|
$
|
1,197
|
|
|
$
|
7,936
|
|
|
$
|
28,763
|
|
|
Page No.
|
|
December 31, 2016
|
|
December 31, 2015
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
18,083
|
|
|
$
|
29,730
|
|
Restricted cash and cash equivalents
|
18,022
|
|
|
401
|
|
||
Litigation settlement insurance recovery
|
—
|
|
|
21,700
|
|
||
Prepaid expenses and other current assets
|
581
|
|
|
1,398
|
|
||
Current assets of discontinued operations
|
813
|
|
|
392
|
|
||
Total current assets
|
37,499
|
|
|
53,621
|
|
||
Equipment and furnishings, net
|
199
|
|
|
335
|
|
||
GALE-401 rights
|
9,255
|
|
|
9,255
|
|
||
In-process research and development
|
12,864
|
|
|
12,864
|
|
||
Goodwill
|
5,898
|
|
|
5,898
|
|
||
Deposits and other assets
|
96
|
|
|
171
|
|
||
Total assets
|
$
|
65,811
|
|
|
$
|
82,144
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
840
|
|
|
$
|
1,597
|
|
Accrued expenses and other current liabilities
|
4,292
|
|
|
5,292
|
|
||
Litigation settlement payable
|
950
|
|
|
25,000
|
|
||
Fair value of warrants potentially settleable in cash
|
1,860
|
|
|
14,518
|
|
||
Current portion of long-term debt
|
16,397
|
|
|
4,739
|
|
||
Current liabilities of discontinued operations
|
6,059
|
|
|
5,925
|
|
||
Total current liabilities
|
30,398
|
|
|
57,071
|
|
||
Deferred tax liability
|
5,661
|
|
|
5,418
|
|
||
Contingent purchase price consideration
|
1,095
|
|
|
6,142
|
|
||
Total liabilities
|
37,154
|
|
|
68,631
|
|
||
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; 350,000,000 shares authorized, 15,224,223 shares issued and 15,190,473 shares outstanding at December 31, 2016; 275,000,000 shares authorized, 8,129,087 shares issued and 8,095,337 shares outstanding at December 31, 2015
|
15
|
|
|
15
|
|
||
Additional paid-in capital
|
335,423
|
|
|
296,730
|
|
||
Accumulated deficit
|
(302,932
|
)
|
|
(279,383
|
)
|
||
Less treasury shares at cost, 33,750 shares
|
(3,849
|
)
|
|
(3,849
|
)
|
||
Total stockholders’ equity
|
28,657
|
|
|
13,513
|
|
||
Total liabilities and stockholders’ equity
|
$
|
65,811
|
|
|
$
|
82,144
|
|
|
For the Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
19,860
|
|
|
$
|
23,611
|
|
|
$
|
27,674
|
|
General and administrative
|
12,007
|
|
|
10,609
|
|
|
16,226
|
|
|||
Total operating expenses
|
31,867
|
|
|
34,220
|
|
|
43,900
|
|
|||
Operating loss
|
(31,867
|
)
|
|
(34,220
|
)
|
|
(43,900
|
)
|
|||
Non-operating income (expense):
|
|
|
|
|
|
||||||
Litigation settlement
|
(2,750
|
)
|
|
(5,282
|
)
|
|
—
|
|
|||
Change in fair value of warrants potentially settleable in cash
|
22,220
|
|
|
1,162
|
|
|
16,556
|
|
|||
Interest expense, net
|
(3,508
|
)
|
|
(760
|
)
|
|
(1,110
|
)
|
|||
Change in fair value of the contingent purchase price liability
|
5,047
|
|
|
509
|
|
|
170
|
|
|||
Total non-operating income (expense), net
|
21,009
|
|
|
(4,371
|
)
|
|
15,616
|
|
|||
Loss from continuing operations before income taxes
|
(10,858
|
)
|
|
(38,591
|
)
|
|
(28,284
|
)
|
|||
Income tax expense
|
243
|
|
|
365
|
|
|
—
|
|
|||
Loss from continuing operations
|
(11,101
|
)
|
|
(38,956
|
)
|
|
(28,284
|
)
|
|||
Loss from discontinued operations
|
(12,448
|
)
|
|
(24,946
|
)
|
|
(8,322
|
)
|
|||
Net loss
|
$
|
(23,549
|
)
|
|
$
|
(63,902
|
)
|
|
$
|
(36,606
|
)
|
Net loss per common share:
|
|
|
|
|
|
||||||
Basic and diluted per share, continuing operations
|
$
|
(1.11
|
)
|
|
$
|
(5.02
|
)
|
|
$
|
(4.74
|
)
|
Basic and diluted loss per share, discontinued operations
|
$
|
(1.25
|
)
|
|
$
|
(3.21
|
)
|
|
$
|
(1.39
|
)
|
Basic and diluted net loss per share
|
$
|
(2.36
|
)
|
|
$
|
(8.23
|
)
|
|
$
|
(6.13
|
)
|
Weighted-average common shares outstanding: basic and diluted
|
9,958,802
|
|
|
7,763,236
|
|
|
5,969,418
|
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Treasury Stock
|
|
Total
|
|||||||||||||
|
Shares Issued
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2013
|
5,505,035
|
|
|
$
|
10
|
|
|
$
|
188,600
|
|
|
$
|
(178,875
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
5,886
|
|
Issuance of common stock
|
331,650
|
|
|
1
|
|
|
10,704
|
|
|
—
|
|
|
—
|
|
|
10,705
|
|
|||||
Issuance of common stock under milestone achievement
|
219,061
|
|
|
—
|
|
|
9,340
|
|
|
—
|
|
|
—
|
|
|
9,340
|
|
|||||
Issuance of common stock upon exercise of warrants
|
273,351
|
|
|
1
|
|
|
37,741
|
|
|
—
|
|
|
—
|
|
|
37,742
|
|
|||||
Issuance of common stock in connection with employee stock purchase plan
|
5,732
|
|
|
—
|
|
|
263
|
|
|
—
|
|
|
—
|
|
|
263
|
|
|||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
5,253
|
|
|
—
|
|
|
—
|
|
|
5,253
|
|
|||||
Stock based compensation for services
|
—
|
|
|
—
|
|
|
134
|
|
|
—
|
|
|
—
|
|
|
134
|
|
|||||
Exercise of stock options
|
172,488
|
|
|
—
|
|
|
4,342
|
|
|
—
|
|
|
—
|
|
|
4,342
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,606
|
)
|
|
—
|
|
|
(36,606
|
)
|
|||||
Balance at December 31, 2014
|
6,507,317
|
|
|
$
|
12
|
|
|
$
|
256,377
|
|
|
$
|
(215,481
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
37,059
|
|
Issuance of common stock
|
1,607,934
|
|
|
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
|
11,566
|
|
|
—
|
|
|
309
|
|
|
—
|
|
|
—
|
|
|
309
|
|
|||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
2,896
|
|
|
—
|
|
|
—
|
|
|
2,896
|
|
|||||
Exercise of stock options
|
2,270
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
—
|
|
|
31
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(63,902
|
)
|
|
—
|
|
|
(63,902
|
)
|
|||||
Balance at December 31, 2015
|
8,129,087
|
|
|
$
|
15
|
|
|
$
|
296,730
|
|
|
$
|
(279,383
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
13,513
|
|
Issuance of common stock
|
2,872,803
|
|
|
—
|
|
|
33,534
|
|
|
—
|
|
|
—
|
|
|
33,534
|
|
|||||
Common stock warrants issued in connection with common stock offerings
|
—
|
|
|
—
|
|
|
(9,886
|
)
|
|
—
|
|
|
—
|
|
|
(9,886
|
)
|
|||||
Issuance of common stock to satisfy principal and interest on long-term debt
|
3,981,208
|
|
|
—
|
|
|
8,079
|
|
|
—
|
|
|
—
|
|
|
8,079
|
|
|||||
Common stock warrants issued in connection with debt financing
|
—
|
|
|
—
|
|
|
1,139
|
|
|
—
|
|
|
—
|
|
|
1,139
|
|
|||||
Issuance of common stock in connection with settlement of litigation
|
206,903
|
|
|
—
|
|
|
557
|
|
|
—
|
|
|
—
|
|
|
557
|
|
|||||
Issuance of common stock upon exercise of warrants
|
20,403
|
|
|
—
|
|
|
95
|
|
|
—
|
|
|
—
|
|
|
95
|
|
|||||
Issuance of common stock in connection with employee stock purchase plan
|
5,477
|
|
|
—
|
|
|
2,650
|
|
|
—
|
|
|
—
|
|
|
2,650
|
|
|||||
Stock based compensation for directors and employees
|
—
|
|
|
—
|
|
|
2,264
|
|
|
—
|
|
|
—
|
|
|
2,264
|
|
|||||
Exercise of stock options
|
8,342
|
|
|
—
|
|
|
261
|
|
|
—
|
|
|
—
|
|
|
261
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(23,549
|
)
|
|
—
|
|
|
(23,549
|
)
|
|||||
Balance at December 31, 2016
|
15,224,223
|
|
|
$
|
15
|
|
|
$
|
335,423
|
|
|
$
|
(302,932
|
)
|
|
$
|
(3,849
|
)
|
|
$
|
28,657
|
|
|
For the Year Ended December 31,
|
||||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||||
Cash flows from continuing operating activities:
|
|
|
|
|
|
||||||||
Net loss from continuing operations
|
$
|
(11,101
|
)
|
|
$
|
(38,956
|
)
|
|
$
|
(28,284
|
)
|
||
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||||
Depreciation
|
142
|
|
|
107
|
|
|
86
|
|
|||||
Non-cash accretion of debt issuance costs
|
3,054
|
|
|
248
|
|
|
276
|
|
|||||
Deferred taxes
|
243
|
|
|
365
|
|
|
—
|
|
|||||
Non-cash stock-based compensation
|
2,264
|
|
|
1,931
|
|
|
4,666
|
|
|||||
Litigation settlement payable in common stock
|
2,650
|
|
—
|
|
1,000
|
|
|
—
|
|
||||
Change in fair value of common stock warrants
|
(22,220
|
)
|
|
(1,161
|
)
|
|
(16,556
|
)
|
|||||
Change in fair value of contingent consideration
|
(5,047
|
)
|
|
(509
|
)
|
|
(170
|
)
|
|||||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||||
Prepaid expenses and other assets
|
892
|
|
|
(245
|
)
|
|
(1,078
|
)
|
|||||
Litigation settlement insurance recovery
|
21,700
|
|
|
(21,700
|
)
|
|
—
|
|
|||||
Litigation settlement payable
|
(25,000
|
)
|
|
24,000
|
|
|
—
|
|
|||||
Accounts payable
|
(757
|
)
|
|
(289
|
)
|
|
(21
|
)
|
|||||
Accrued expenses and other current liabilities
|
(50
|
)
|
|
(3,593
|
)
|
|
4,044
|
|
|||||
Net cash used in continuing operating activities
|
(33,230
|
)
|
|
(38,802
|
)
|
|
(37,037
|
)
|
|||||
Cash flows from discontinued operating activities:
|
|
|
|
|
|
||||||||
Net loss from discontinued operations
|
(12,448
|
)
|
|
(24,946
|
)
|
|
(8,322
|
)
|
|||||
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
|
763
|
|
|
2,968
|
|
|
2,490
|
|
|||||
Net cash used in discontinued operating activities
|
(11,685
|
)
|
|
(9,358
|
)
|
|
(5,832
|
)
|
|||||
Net cash used in operating activities
|
(44,915
|
)
|
|
(48,160
|
)
|
|
(42,869
|
)
|
|||||
Cash flows from investing activities:
|
|
|
|
|
|
||||||||
Change in restricted cash
|
—
|
|
|
(201
|
)
|
|
—
|
|
|||||
Cash paid for acquisition of GALE-401
|
—
|
|
|
—
|
|
|
(2,415
|
)
|
|||||
Cash paid for purchase of equipment and furnishings
|
(6
|
)
|
|
(153
|
)
|
|
(57
|
)
|
|||||
Net cash provided by (used in) continuing investing activities
|
(6
|
)
|
|
(354
|
)
|
|
(2,472
|
)
|
|||||
Net proceeds received from sale of commercial assets (selling costs paid)
|
(1,050
|
)
|
|
11,283
|
|
|
—
|
|
|||||
Cash paid for commercial assets
|
—
|
|
|
(534
|
)
|
|
(3,056
|
)
|
|||||
Net cash provided by (used in) discontinued investing activities
|
(1,050
|
)
|
—
|
|
10,749
|
|
—
|
|
(3,056
|
)
|
|||
Net cash provided by (used in) investing activities
|
(1,056
|
)
|
|
10,395
|
|
|
(5,528
|
)
|
|||||
Cash flows from financing activities:
|
|
|
|
|
|
||||||||
Net proceeds from issuance of common stock
|
33,534
|
|
|
47,416
|
|
|
10,704
|
|
|||||
Net proceeds from exercise of stock options
|
261
|
|
|
31
|
|
|
4,342
|
|
|||||
Proceeds from exercise of warrants
|
233
|
|
|
—
|
|
|
10,717
|
|
|||||
Proceeds from common stock issued in connection with ESPP
|
95
|
|
|
309
|
|
|
263
|
|
|||||
Net proceeds from issuance of long-term debt
|
23,401
|
|
|
—
|
|
|
—
|
|
|||||
Minimum cash covenant on long-term debt
|
(17,621
|
)
|
|
—
|
|
|
—
|
|
|||||
Principal payments on long-term debt
|
(5,579
|
)
|
|
(3,911
|
)
|
|
(1,766
|
)
|
|||||
Net cash provided by financing activities
|
34,324
|
|
|
43,845
|
|
|
24,260
|
|
|||||
Net increase (decrease) in cash and cash equivalents
|
(11,647
|
)
|
|
6,080
|
|
|
(24,137
|
)
|
|||||
Cash and cash equivalents at the beginning of period
|
29,730
|
|
|
23,650
|
|
|
47,787
|
|
|||||
Cash and cash equivalents at end of period
|
$
|
18,083
|
|
|
$
|
29,730
|
|
|
$
|
23,650
|
|
|
For the Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash received during the periods for interest
|
$
|
117
|
|
|
$
|
18
|
|
|
$
|
15
|
|
Cash paid during the periods for interest
|
$
|
636
|
|
|
$
|
541
|
|
|
$
|
800
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Fair value of warrants issued in connection with common stock recorded as cost of equity
|
$
|
9,886
|
|
|
$
|
10,296
|
|
|
$
|
—
|
|
Fair value of warrants issued in connection with long-term debt recorded as debt issuance costs
|
$
|
1,139
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Principal and interest repaid through issuance of common stock
|
$
|
8,079
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Reclassification of warrant liabilities upon exercise
|
$
|
324
|
|
|
$
|
—
|
|
|
$
|
27,026
|
|
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
|
|
•
|
Significant changes in the manner of its use of acquired assets or the strategy for its overall business;
|
|
December 31, 2016
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
16,192
|
|
|
$
|
16,192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash equivalents
|
17,622
|
|
|
17,622
|
|
|
—
|
|
|
—
|
|
||||
Total assets measured and recorded at fair value
|
$
|
33,814
|
|
|
$
|
33,814
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrants potentially settleable in cash
|
$
|
1,860
|
|
|
$
|
—
|
|
|
$
|
1,860
|
|
|
$
|
—
|
|
Contingent purchase price consideration
|
1,095
|
|
|
—
|
|
|
—
|
|
|
1,095
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
2,955
|
|
|
$
|
—
|
|
|
$
|
1,860
|
|
|
$
|
1,095
|
|
|
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
|
|
|
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
|
||
Balance, January 1, 2015
|
$
|
6,651
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
(509
|
)
|
|
Balance, December 31, 2015
|
6,142
|
|
|
Change in the estimated fair value of the contingent purchase price consideration
|
(5,047
|
)
|
|
Balance at December 31, 2016
|
$
|
1,095
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Clinical development expense
|
$
|
3,088
|
|
|
$
|
3,294
|
|
Professional fees
|
229
|
|
|
435
|
|
||
Compensation and related benefits
|
975
|
|
|
1,535
|
|
||
Interest expense
|
—
|
|
|
28
|
|
||
Accrued expenses and other current liabilities
|
$
|
4,292
|
|
|
$
|
5,292
|
|
|
|||
|
Amount
|
||
Class action settlement in 2015
|
$
|
20,000
|
|
Derivative settlement in 2015
|
5,000
|
|
|
Shareholders securities litigation settlements in 2016
|
1,800
|
|
|
SEC settlement in 2016
|
950
|
|
|
Total settlements
|
$
|
27,750
|
|
|
|
||
Payable by the Company in cash as of December 31, 2016
|
$
|
950
|
|
Paid by the insurance carriers in 2016
|
21,700
|
|
|
Paid by the Company in cash in 2016
|
2,450
|
|
|
Paid by the Company in common stock in 2016
|
2,650
|
|
|
Total settlements
|
$
|
27,750
|
|
|
Operating
Leases
(1)
|
|
Non-Cancelable
Employment
Agreements
(2)
|
|
Subtotal
|
|
Cancelable
License
Agreements
(3)
|
|
Total
|
||||||||||
2017
|
$
|
241
|
|
|
$
|
1,601
|
|
|
$
|
1,842
|
|
|
$
|
1,391
|
|
|
$
|
3,233
|
|
2018
|
246
|
|
|
—
|
|
|
246
|
|
|
350
|
|
|
596
|
|
|||||
2019
|
251
|
|
|
—
|
|
|
251
|
|
|
350
|
|
|
601
|
|
|||||
2020
|
236
|
|
|
—
|
|
|
236
|
|
|
7,350
|
|
|
7,586
|
|
|||||
2021 and thereafter
|
—
|
|
|
—
|
|
|
—
|
|
|
8,815
|
|
|
8,815
|
|
|||||
Total
|
$
|
974
|
|
|
$
|
1,601
|
|
|
$
|
2,575
|
|
|
$
|
18,256
|
|
|
$
|
20,831
|
|
(1)
|
Operating leases are primarily facility and equipment related obligations with third party vendors. Operating lease expenses during the years ended December 31, 2016, 2015, and 2014 were approximately
$291,000
,
$116,000
and
$72,000
, 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 M.D. Anderson Cancer Center and the Henry M. Jackson Foundation for our oncology therapies and the obligations with Biovascular Inc. and Mills Pharma for our GALE-401 asset. 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.
|
Warrant Issuance
|
Outstanding, December 31, 2015
|
|
Granted
|
|
Exercised
|
|
Expired
|
|
Outstanding, December 31, 2016
|
|
Expiration
|
|||||
July 2016
|
—
|
|
|
700
|
|
|
—
|
|
|
—
|
|
|
700
|
|
|
January 2022
|
January 2016
|
—
|
|
|
682
|
|
|
—
|
|
|
—
|
|
|
682
|
|
|
January 2021
|
March 2015
|
700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
700
|
|
|
March 2020
|
September 2013
|
199
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
199
|
|
|
September 2018
|
December 2012
|
152
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
December 2017
|
April 2011
|
31
|
|
|
—
|
|
|
(18
|
)
|
|
—
|
|
|
13
|
|
|
April 2017
|
March 2011
|
9
|
|
|
—
|
|
|
(1
|
)
|
|
(8
|
)
|
|
—
|
|
|
March 2016
|
March 2010
|
1
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
March 2016
|
Other
|
24
|
|
|
100
|
|
|
—
|
|
|
—
|
|
|
124
|
|
|
November 2021
|
|
1,116
|
|
|
1,482
|
|
|
(19
|
)
|
|
(9
|
)
|
|
2,570
|
|
|
|
Warrant Issuance
|
Outstanding, January 1, 2015
|
|
Granted
|
|
Exercised
|
|
Expired
|
|
Outstanding, December 31, 2015
|
|
Expiration
|
|||||
March 2015
|
—
|
|
|
700
|
|
|
—
|
|
|
—
|
|
|
700
|
|
|
March 2020
|
September 2013
|
199
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
199
|
|
|
September 2018
|
December 2012
|
152
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
December 2017
|
April 2011
|
31
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31
|
|
|
April 2017
|
March 2011
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|
March 2016
|
March 2010
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
March 2016
|
Other
|
36
|
|
|
—
|
|
|
—
|
|
|
(12
|
)
|
|
24
|
|
|
November 2021
|
|
428
|
|
|
700
|
|
|
—
|
|
|
(12
|
)
|
|
1,116
|
|
|
|
As of December 31, 2016
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||
Warrant Issuance
|
Outstanding
|
|
Strike price
|
|
Expected term
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
July 2016
|
700
|
|
|
$
|
13.00
|
|
|
4.54
|
|
117.82
|
%
|
|
1.82
|
%
|
January 2016
|
682
|
|
|
$
|
28.40
|
|
|
4.03
|
|
120.38
|
%
|
|
1.71
|
%
|
March 2015
|
700
|
|
|
$
|
41.60
|
|
|
3.22
|
|
131.46
|
%
|
|
1.52
|
%
|
September 2013
|
199
|
|
|
$
|
50.00
|
|
|
1.72
|
|
164.01
|
%
|
|
1.10
|
%
|
December 2012
|
152
|
|
|
$
|
31.60
|
|
|
0.98
|
|
204.55
|
%
|
|
0.84
|
%
|
April 2011
|
13
|
|
|
$
|
13.00
|
|
|
0.31
|
|
103.79
|
%
|
|
0.53
|
%
|
|
|
|
|
|
|
|
|
|
|
|||||
As of December 31, 2015
|
||||||||||||||
Warrant Issuance
|
Outstanding
|
|
Strike price
|
|
Expected term
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
March 2015
|
700
|
|
|
$
|
41.60
|
|
|
4.22
|
|
75.85
|
%
|
|
1.58
|
%
|
September 2013
|
199
|
|
|
$
|
50.00
|
|
|
2.72
|
|
74.70
|
%
|
|
1.24
|
%
|
December 2012
|
152
|
|
|
$
|
31.60
|
|
|
1.98
|
|
76.37
|
%
|
|
1.05
|
%
|
April 2011
|
31
|
|
|
$
|
13.00
|
|
|
1.31
|
|
65.60
|
%
|
|
0.77
|
%
|
March 2011
|
9
|
|
|
$
|
13.00
|
|
|
0.18
|
|
47.98
|
%
|
|
—
|
%
|
March 2010
|
1
|
|
|
$
|
40.04
|
|
|
0.24
|
|
71.41
|
%
|
|
—
|
%
|
Warrant Issuance
|
Warrant liability, December 31, 2015
|
|
Fair value of warrants granted
|
|
Fair value of warrants exercised
|
|
Change in fair value of warrants
|
|
Warrant liability, December 31, 2016
|
||||||||||
July 2016
|
$
|
—
|
|
|
$
|
4,296
|
|
|
$
|
—
|
|
|
$
|
(3,543
|
)
|
|
$
|
753
|
|
January 2016
|
—
|
|
|
5,590
|
|
|
—
|
|
|
(5,061
|
)
|
|
529
|
|
|||||
March 2015
|
10,337
|
|
|
—
|
|
|
—
|
|
|
(9,905
|
)
|
|
432
|
|
|||||
September 2013
|
1,933
|
|
|
—
|
|
|
—
|
|
|
(1,852
|
)
|
|
81
|
|
|||||
December 2012
|
1,565
|
|
|
—
|
|
|
—
|
|
|
(1,500
|
)
|
|
65
|
|
|||||
April 2011
|
537
|
|
|
—
|
|
|
(278
|
)
|
|
(259
|
)
|
|
—
|
|
|||||
March 2011
|
144
|
|
|
—
|
|
|
(46
|
)
|
|
(98
|
)
|
|
—
|
|
|||||
March 2010
|
2
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
—
|
|
|||||
|
$
|
14,518
|
|
|
$
|
9,886
|
|
|
$
|
(324
|
)
|
|
$
|
(22,220
|
)
|
|
$
|
1,860
|
|
Warrant Issuance
|
Warrant liability, January 1, 2015
|
|
Fair value of warrants granted
|
|
Fair value of warrants exercised
|
|
Change in fair value of warrants
|
|
Warrant liability, December 31, 2015
|
|||||
March 2015
|
—
|
|
|
10,296
|
|
|
—
|
|
|
41
|
|
|
10,337
|
|
September 2013
|
2,560
|
|
|
—
|
|
|
—
|
|
|
(627
|
)
|
|
1,933
|
|
December 2012
|
2,027
|
|
|
—
|
|
|
—
|
|
|
(462
|
)
|
|
1,565
|
|
April 2011
|
625
|
|
|
—
|
|
|
—
|
|
|
(88
|
)
|
|
537
|
|
March 2011
|
144
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
144
|
|
March 2010
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
5,358
|
|
|
10,296
|
|
|
—
|
|
|
(1,136
|
)
|
|
14,518
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Research and development
|
$
|
298
|
|
|
$
|
350
|
|
|
$
|
484
|
|
General and administrative
|
1,966
|
|
|
1,591
|
|
|
4,903
|
|
|||
Total stock-based compensation
|
$
|
2,264
|
|
|
$
|
1,941
|
|
|
$
|
5,387
|
|
|
2016
|
|
2015
|
|
2014
|
|||
Risk free interest rate
|
1.47
|
%
|
|
1.67
|
%
|
|
2.01
|
%
|
Volatility
|
102.62
|
%
|
|
73.97
|
%
|
|
79.37
|
%
|
Expected lives (years)
|
5.93
|
|
|
6.16
|
|
|
6.16
|
|
Expected dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
|
Total
Number of
Shares
(In Thousands)
|
|
Weighted
Average
Exercise
Price
|
|||
Outstanding at December 31, 2015
|
663
|
|
|
$
|
51.60
|
|
Granted
|
146
|
|
|
9.40
|
|
|
Exercised
|
(8
|
)
|
|
31.44
|
|
|
Cancelled
|
(240
|
)
|
|
50.28
|
|
|
Outstanding at December 31, 2016
|
561
|
|
|
$
|
41.50
|
|
Options exercisable at December 31, 2016
|
329
|
|
|
$
|
56.06
|
|
|
December 31,
|
||||
|
2016
|
|
2015
|
||
Warrants to purchase common stock
|
2,570
|
|
|
1,115
|
|
Options to purchase common stock
|
561
|
|
|
663
|
|
Total
|
3,131
|
|
|
1,778
|
|
|
|
As of December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Current
|
|
|
|
|
|
|
||||||
Federal
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total current
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Deferred expense
|
|
|
|
|
|
|
||||||
Federal
|
|
210
|
|
|
332
|
|
|
—
|
|
|||
State
|
|
33
|
|
|
33
|
|
|
—
|
|
|||
Total deferred
|
|
243
|
|
|
365
|
|
|
—
|
|
|||
Total income tax expense
|
|
$
|
243
|
|
|
$
|
365
|
|
|
$
|
—
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Net operating loss carryforwards
|
|
$
|
97,168
|
|
|
$
|
75,221
|
|
Tax credit carryforwards
|
|
4,083
|
|
|
3,866
|
|
||
Stock based compensation
|
|
5,757
|
|
|
5,050
|
|
||
Other
|
|
58
|
|
|
1,430
|
|
||
Licensing deduction deferral
|
|
10,263
|
|
|
9,910
|
|
||
Gross deferred tax assets
|
|
117,329
|
|
|
95,477
|
|
||
Valuation allowance
|
|
(117,329
|
)
|
|
(95,477
|
)
|
||
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
As of December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
In-process research and development not subject to future amortization for tax purposes
|
|
$
|
5,661
|
|
|
$
|
5,418
|
|
Gross deferred tax liability
|
|
$
|
5,661
|
|
|
$
|
5,418
|
|
|
|
As of December 31,
|
||||||||||
|
|
2016
|
|
2015
|
|
2014
|
||||||
Expected federal income tax benefit
|
|
$
|
(7,977
|
)
|
|
$
|
(21,603
|
)
|
|
$
|
(12,447
|
)
|
State income taxes after credits
|
|
(1,575
|
)
|
|
(2,375
|
)
|
|
(1,283
|
)
|
|||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Changes in warrant value
|
|
(8,728
|
)
|
|
(456
|
)
|
|
(6,503
|
)
|
|||
Stock compensation
|
|
(1,782
|
)
|
|
508
|
|
|
3,996
|
|
|||
Effect of change in valuation allowance
|
|
21,852
|
|
|
24,029
|
|
|
17,275
|
|
|||
Income tax credits
|
|
(217
|
)
|
|
(276
|
)
|
|
(42
|
)
|
|||
Other
|
|
(1,330
|
)
|
|
538
|
|
|
(996
|
)
|
|||
|
|
$
|
243
|
|
|
$
|
365
|
|
|
$
|
—
|
|
|
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
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
Net revenue
|
$
|
—
|
|
|
$
|
9,734
|
|
|
$
|
9,319
|
|
Cost of revenue
|
—
|
|
|
(1,780
|
)
|
|
(1,403
|
)
|
|||
Additional channel obligations
|
(2,886
|
)
|
|
—
|
|
|
—
|
|
|||
Amortization of certain acquired intangible assets
|
—
|
|
|
(921
|
)
|
|
(440
|
)
|
|||
Research and development
|
—
|
|
|
(355
|
)
|
|
(680
|
)
|
|||
Selling, general, and administrative
|
(9,562
|
)
|
|
(17,655
|
)
|
|
(15,118
|
)
|
|||
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
|
$
|
(12,448
|
)
|
|
$
|
(24,946
|
)
|
|
$
|
(8,322
|
)
|
|
|
1st Quarter
|
|
2nd Quarter
|
|
3rd Quarter
|
|
4th Quarter
|
||||||||
2016
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss)
|
|
$
|
(16,493
|
)
|
|
$
|
5,389
|
|
|
$
|
(6,929
|
)
|
|
$
|
(5,516
|
)
|
Net income (loss) per share, basic and diluted
|
|
$
|
(1.84
|
)
|
|
$
|
0.59
|
|
|
$
|
(0.66
|
)
|
|
$
|
(0.51
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
2015
|
|
|
|
|
|
|
|
|
||||||||
Net revenue
|
|
$
|
2,750
|
|
|
$
|
3,382
|
|
|
$
|
2,166
|
|
|
$
|
1,436
|
|
Gross profit on net revenue
|
|
$
|
2,357
|
|
|
$
|
2,914
|
|
|
$
|
1,454
|
|
|
$
|
1,229
|
|
Net loss
|
|
$
|
(10,537
|
)
|
|
$
|
(15,660
|
)
|
|
$
|
(18,026
|
)
|
|
$
|
(19,678
|
)
|
Net loss per share, basic and diluted
|
|
$
|
(1.55
|
)
|
|
$
|
(1.94
|
)
|
|
$
|
(2.23
|
)
|
|
$
|
(2.51
|
)
|
|
GALENA BIOPHARMA, INC.
|
||
|
|
|
|
|
By:
|
|
/s/ Stephen F. Ghiglieiri
|
|
|
|
|
|
|
|
Stephen F. Ghiglieri
|
|
|
|
Interim Chief Executive Officer and Chief Financial Officer
|
|
|
|
|
|
|
|
Date: March 15, 2017
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Stephen F. Ghiglieri
|
|
Interim Chief Executive Officer and Chief Financial Officer (Principal Executive and Accounting Officer)
|
|
March 15, 2017
|
Stephen F. Ghiglieri
|
|
|
|
|
|
|
|
|
|
/s/ Sanford J. Hillsberg
|
|
Director, Chairman of the Board
|
|
March 15, 2017
|
Sanford J. Hillsberg
|
|
|
|
|
|
|
|
|
|
/s/ William L. Ashton
|
|
Director
|
|
March 15, 2017
|
William L. Ashton
|
|
|
|
|
|
|
|
|
|
/s/ Richard Chin
|
|
Director
|
|
March 15, 2017
|
Richard Chin, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Irving M. Einhorn
|
|
Director
|
|
March 15, 2017
|
Irving M. Einhorn
|
|
|
|
|
|
|
|
|
|
/s/ Stephen S. Galliker
|
|
Director
|
|
March 15, 2017
|
Stephen S. Galliker
|
|
|
|
|
|
|
|
|
|
/s/ Mary Ann Gray
|
|
Director
|
|
March 15, 2017
|
Mary Ann Gray
|
|
|
|
|
|
|
|
|
|
/s/ Rudolph Nisi
|
|
Director
|
|
March 15, 2017
|
Rudolph Nisi, M.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exhibit Number
|
Exhibit Description
|
Form
|
Exhibit
|
Filing Date/Period End Date
|
|
1.1
|
Underwriting Agreement dated as of March 13, 2015 by and between Galena Biopharma, Inc. and Raymond James & Associates,
|
8-K
|
1.1
|
|
16-Mar-15
|
Inc.
|
|||||
1.2
|
Underwriting Agreement dated as of January 7, 2016 by and between
|
8-K
|
1.1
|
|
7-Jan-16
|
Galena Biopharma, Inc. and Raymond James Financial, Inc.
|
|||||
2.1
|
Unit Purchase Agreement, dated as of January 12, 2014, between Galena Biopharma, Inc. and Mills Pharmaceuticals, LLC.
|
10-Q
|
2.1
|
|
17-Mar-14
|
3.1
|
Amended and Restated Certificate of Incorporation of
|
|
|
|
|
Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation),
|
|||||
amended as of February 10, 2017**
|
|||||
3.2
|
Certificate of Ownership and Merger
|
8-K
|
3.1
|
|
26-Sep-11
|
3.3
|
Amended and Restated By-Laws of Galena Biopharma, Inc.**
|
|
|
|
|
4.1
|
Form of Common Stock Certificate**
|
|
|
|
|
4.2
|
Form of Warrant Agreement by and Galena Biopharma, Inc., Computershare Inc. and Computershare Trust Company, N.A.
|
8-K
|
4.1
|
|
13-Sep-13
|
4.3
|
Form of Warrant Agreement by and Galena Biopharma, Inc., Computershare Inc. and Computershare Trust Company, N.A.
|
8-K
|
4.1
|
|
16-Mar-15
|
4.4
|
Form of Warrant agreement by and among Galena Biopharma, Inc.,
|
8-K
|
4.1
|
|
7-Jan-16
|
Computershare Inc. and Computershare Trust Company, N.A
|
|||||
4.5
|
Form of Warrant, to be issued by Galena Biopharma, Inc. to the Investors on July 13, 2016.
|
8-K
|
4.1
|
|
8-Jul-16
|
4.6
|
9% Original Issues Discount Senior Secured Debenture of Galena Biopharma, Inc.
|
10-Q
|
4.1
|
|
10-May-16
|
4.7
|
Securities Purchase Agreement dated May 10, 2016 between Galena Biopharma, Inc. and Purchasers
|
10-Q
|
10.1
|
|
9-Aug-16
|
4.8
|
Amended and Restated 9% Original Issue Discount Senior Secured Debenture Due November 10, 2018, issued to JGB (Cayman) Newton Ltd. as of August 22, 2016
|
8-K
|
4.1
|
|
23-Aug-16
|
4.9
|
Series A Common Stock Purchase Warrant assigned to JGB (Cayman) Newton Ltd.
|
10-Q
|
4.2
|
|
9-Aug-16
|
4.1
|
Series B Common Stock Purchase Warrant assigned to JGB (Cayman) Newton Ltd.
|
10-Q
|
4.3
|
|
9-Aug-16
|
4.11
|
Subsidiary Guarantee dated May 10, 2016 between Galena Biopharma, Inc. and JGB Collateral LLC.
|
10-Q
|
10.2
|
|
9-Aug-16
|
4.12
|
Registration Rights Agreement dated May 10, 2016 between Galena Biopharma, Inc. and Purchasers.
|
10-Q
|
10.3
|
|
9-Aug-16
|
4.13
|
Security Agreement dated May 10, 2016 between Galena Biopharma, Inc. and JGB Collateral LLC
|
10-Q
|
10.4
|
|
9-Aug-16
|
4.14
|
Amendment Agreement between Galena Biopharma, Inc. and JGB (Cayman) Newton Ltd. dated August 22, 2016.
|
8-K
|
10.1
|
|
23-Aug-16
|
4.15
|
Form of Securities Purchase Agreement, dated as of July 7, 2016, by and among Galena Biopharma, Inc. and the Investors
|
8-K
|
10.2
|
|
8-Jul-16
|
4.16
|
First Amendment to Securities Purchase Agreement, dated as of July 12, 2016, by and between Galena Biopharma, Inc. and each purchaser identified on the signature pages therein, amending the Securities Purchase Agreement, dated as of July 7, 2016, by and among the Company and the purchasers named therein
|
8-K
|
10.1
|
|
18-Jul-16
|
4.17
|
Form of Common Stock Purchase Warrant issued in April 2011
|
8-K
|
4.1
|
|
15-Apr-11
|
4.18
|
Form of December 2012 Warrant.
|
8-K
|
4.1
|
|
19-Dec-12
|
4.19
|
Form of warrants granted on May 8, 2013 under the Loan and Security
|
10-Q
|
10.7
|
|
9-May-13
|
Agreement
|
|||||
4.2
|
Warrant Agreement, dated as of March 18, 2015, by and among Galena Biopharma, Inc., Computershare, Inc. and Computershare Trust Company,
|
10-Q
|
10.1
|
|
6-Aug-15
|
N.A.
|
|||||
4.21
|
Warrant Agreement, dated as of January 12, 2016, by and among Galena Biopharma, Inc., Computershare Inc. and Computershare Trust Company,
|
10-K
|
4.9
|
|
10-Mar-16
|
N.A.
|
|||||
4.22
|
Registration Rights Agreement, dated January 12, 2014, between Galena Biopharma, Inc. and each former owner of membership units of Mills Pharmaceuticals, LLC
|
10-Q
|
4.9
|
|
17-Mar-14
|
4.23
|
Form of Contingent Value Rights Agreement among Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation), Computershare Trust Company,
|
8-K
|
10.1
|
|
14-Apr-11
|
N.A., Computershare Inc., and Robert E Kennedy, dated April 13, 2011
|
|||||
4.24
|
First Amendment to Contingent Value Rights Agreement among Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation), Computershare Trust Company, N.A., Computershare Inc., and Robert E Kennedy, dated February 15, 2012
|
10-K
|
10.2
|
|
28-Mar-12
|
10.1
|
Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation)
|
Schedule 14A
|
Annex A
|
|
23-Apr-10
|
Amended and Restated 2007 Incentive Plan*
|
|||||
10.2
|
Amendment to Galena Biopharma, Inc. (formerly RXi Pharmaceuticals
|
Schedule 14A
|
Annex A
|
|
31-May-11
|
Corporation) Amended and Restated 2007 Incentive Plan*
|
|||||
10.3
|
Galena Biopharma, Inc. 2016 Incentive Plan*
|
8-K
|
10.3
|
|
22-Aug-16
|
10.4
|
Form of Incentive Stock Option*
|
10-Q
|
10.1
|
|
8-Aug-15
|
10.5
|
Form of Nonstatutory Stock Option*
|
10-Q
|
10.2
|
|
8-Aug-15
|
10.6
|
Patent and Technology License Agreement, dated September 11, 2006, by and among the Board of Regents of the University of
|
10-Q
|
10.1
|
|
15-Aug-11
|
Texas System, the University of Texas M.D. Anderson Cancer Center,
|
|||||
the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
|||||
10.7
|
Amendment No. 1 to Patent and Technology License Agreement, dated
|
10-Q
|
10.2
|
|
15-Aug-11
|
December 21, 2007, by and among the Board of Regents of the
|
|||||
University of Texas System, the University of Texas M.D. Anderson
|
|||||
Cancer Center, the Henry M. Jackson Foundation for the Advancement
|
|||||
of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
|||||
10.8
|
Amendment No. 2 to Patent and Technology License Agreement, dated
|
10-Q
|
10.3
|
|
15-Aug-11
|
September 3, 2008, by and among the Board of Regents of the
|
|||||
University of Texas System, the University of Texas M.D. Anderson
|
|||||
Cancer Center, the Henry M. Jackson Foundation for the Advancement
|
|||||
of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
10.9
|
Amendment No. 3 to Patent and Technology License Agreement, dated
|
10-Q
|
10.4
|
|
15-Aug-11
|
July 8, 2009, by and among the Board of Regents of the University of Texas System, the University of Texas M.D. Anderson Cancer Center, the Henry M. Jackson Foundation for the Advancement
|
|||||
|
|||||
of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
|||||
10.1
|
Amendment No. 4 to Patent and Technology License Agreement, dated
|
10-Q
|
10.5
|
|
15-Aug-11
|
February 11, 2010, by and among the Board of Regents of the
|
|||||
University of Texas System, the University of Texas M.D. Anderson
|
|||||
Cancer Center, the Henry M. Jackson Foundation for the Advancement
|
|||||
of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
|||||
10.11
|
Amendment No. 5 to Patent and Technology License Agreement, dated
|
10-Q
|
10.6
|
|
15-Aug-11
|
January 10, 2011, by and among the Board of Regents of the
|
|||||
University of Texas System, the University of Texas M.D. Anderson
|
|||||
Cancer Center, the Henry M. Jackson Foundation for the Advancement
|
|||||
of Military Medicine, Inc., and Apthera, Inc. (formerly Advanced Peptide Therapeutics, Inc.)
|
|||||
10.12
|
Scientific Advisory Agreement between Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation) and
|
10-K
|
10.19
|
|
12-Mar-13
|
George E. Peoples, Ph.D., dated May 1, 2011 as amended through
|
|||||
November 1, 2017
|
|||||
10.13
|
Exclusive License Agreement, dated as of July 11, 2011, by and among
|
8-K
|
10.1
|
|
21-Sep-11
|
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Galena Biopharma, Inc. (formerly RXi
|
|||||
Pharmaceuticals Corporation) and its wholly-owned subsidiary, Apthera, Inc.
|
|||||
|
|||||
10.14
|
Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation)
|
|
|
|
|
Employee Stock Purchase Plan*
|
|||||
10.15
|
License Agreement, effective as of April 30, 2009, between Kwangdong Pharmaceutical Co., Ltd. and Apthera, Inc.
|
10-K
|
10.45
|
|
28-Mar-12
|
10.16
|
Amendment No. 1 to License Agreement, dated as of January 13, 2012, by and among Apthera, Inc., Kwangdong Pharmaceutical Co.,
|
10-K
|
10.46
|
|
28-Mar-12
|
Ltd., and Galena Biopharma, Inc.
|
|||||
10.17
|
Form of Amendment to Stock Options Granted under Galena Biopharma, Inc. (formerly RXi Pharmaceuticals Corporation) 2007
|
10-Q
|
10.2
|
|
15-Aug-11
|
Incentive Plan, entered into in April 2011 by Galena Biopharma, Inc.
|
|||||
with all directors of Galena Biopharma, Inc., as of April 1, 2011,
|
|||||
and Mark J. Ahn, Ph.D.
|
|||||
10.18
|
License and Supply Agreement, effective December 3, 2012, between
|
10-K
|
10.43
|
|
12-Mar-13
|
Galena Biopharma, Inc. and ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals
|
|||||
10.19
|
Loan and Security Agreement dated May 8, 2013 among Galena Biopharma, Inc., Apthera, Inc., Oxford Finance LLC and the Lenders
|
10-Q
|
10.6
|
|
9-May-13
|
|
|||||
10.2
|
At Market Issuance Sales Agreement dated May 24, 2013 between Galena Biopharma, Inc. and Maxim Group LLC.
|
8-K
|
10.2
|
|
31-May-13
|
10.21
|
At Market Issuance Sales agreements dated May 24, 2013 between Galena Biopharma, Inc. and MLV & Co. LLC
|
8-K
|
10.1
|
|
31-May-13
|
10.22
|
Form of warrants granted on May 8, 2013 under the Loan and Security
|
10-Q
|
10.7
|
|
9-May-13
|
Agreement
|
10.23
|
License and Development Agreement, dated January 13, 2014, between Galena Biopharma, Inc. and Dr. Reddy’s Laboratories, Ltd.
|
10-Q
|
10.36
|
|
17-Mar-14
|
|
|||||
10.24
|
Exclusive License Agreement, dated as of December 20, 2013, between Mills Pharmaceuticals, LLC and BioVascular, Inc.
|
10-Q
|
10.37
|
|
17-Mar-14
|
|
|||||
10.25
|
License and Supply Agreement dated as of July 17, 2014 between Galena Biopharma, Inc. and MonoSol Rx, LLC
|
10-Q
|
10.1
|
|
11-Aug-14
|
10.26
|
Purchase Agreement, dated as of November 18, 2014, by and between
|
8-K
|
10.1
|
|
20-Nov-14
|
Galena Biopharma, Inc. and Lincoln Park Capital Fund, LLC
|
|||||
10.27
|
Amendment dated August 8, 2016 to the Purchase Agreement, dated as of November 18, 2014, by and between Galena Biopharma, Inc. and Lincoln Park Capital Fund, LLC
|
10-Q
|
10.1
|
|
9-Nov-16
|
10.28
|
Separation and Consulting Agreement, dated as of June 24, 2015, by and between Galena Biopharma, Inc. and Margaret Kivinski,
|
10-Q
|
10.4
|
|
6-Aug-15
|
and General Release, dated as of June 24, 2015, by Margaret Kivinski
|
|||||
|
|||||
10.29
|
Employment Offer Letter effective June 25, 2015, between Galena
|
10-Q
|
10.5
|
|
6-Aug-15
|
Biopharma, Inc. and Thomas J. Knapp
|
|||||
10.3
|
Employment Agreement, dated as of October 30, 2015, between Galena Biopharma, Inc. and Bijan Nejadnik, M.D.
|
10-K
|
10.33
|
|
10-Mar-16
|
10.31
|
Asset Purchase Agreement, dated November 19, 2015, between Galena Biopharma, Inc. and Sentynl Therapeutics Inc.
|
10-K
|
10.34
|
|
10-Mar-16
|
10.32
|
Amendment, dated as of December 16, 2015, to License and Supply
|
10-K
|
10.35
|
|
10-Mar-16
|
Agreement dated as of July 17, 2014 between Galena Biopharma, Inc. and MonoSol Rx, LLC
|
|||||
10.33
|
Asset Purchase Agreement, dated December 17, 2015, between Galena Biopharma, Inc. and Midatech Pharma PLC
|
10-K
|
10.36
|
|
10-Mar-16
|
10.34
|
Separation Agreement and Releases, dated December 31, 2015, between Galena Biopharma, Inc. and Ryan Dunlap
|
10-K
|
10.37
|
|
10-Mar-16
|
|
|||||
10.35
|
Amendment, dated December 31, 2015, to Employment Offer Letter
|
10-K
|
10.38
|
|
10-Mar-16
|
effective June 25, 2015, between Galena Biopharma, Inc. and Thomas J. Knapp
|
|||||
|
|||||
10.36
|
Form of Undertaking re Advancement of Expenses between Galena
|
10-K
|
10.39
|
|
10-Mar-16
|
Biopharma, Inc. and certain of its Existing or Former Directors and Executive officers
|
|||||
10.37
|
Placement Agency Agreement, dated as of July 7, 2016, by and between Galena Biopharma, Inc. and Raymond James & Associates, Inc.
|
8-K
|
10.1
|
|
8-Jul-16
|
10.38
|
Severance Agreement, dated as of August 22, 2016, between Galena Biopharma, Inc. and John T. Burns
|
8-K
|
10.1
|
|
22-Aug-16
|
10.39
|
Second Amendment to Employment Agreement, dated as of August 22, 2016, between Galena Biopharma, Inc. and Bijan Nejadnik
|
8-K
|
10.2
|
|
22-Aug-16
|
10.4
|
Second Amendment to Offer Letter between Galena Biopharma, Inc. and Thomas J. Knapp
|
8-K
|
10.1
|
|
6-Oct-16
|
10.41
|
Employment Agreement between Galena Biopharma, Inc. and Stephen Ghiglieri dated November 1, 2016
|
8-K
|
99.2
|
|
3-Nov-16
|
14.1
|
Code of Ethics and Conduct, as amended January 2012
|
10-K
|
14.1
|
|
15-Apr-08
|
21.1
|
Subsidiaries of the Registrant.**
|
|
|
|
|
23.1
|
Consent of Moss Adams LLP, Independent Registered Public Accounting Firm.**
|
|
|
|
|
31.1
|
Sarbanes-Oxley Act Section 302 Certification of Stephen F. Ghiglieri.**
|
|
|
|
|
32.1
|
Sarbanes-Oxley Act Section 906 Certification of Stephen F. Ghiglieri.**
|
|
|
|
|
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.**
|
|
|
|
*
|
Indicates a management contract or compensatory plan or arrangement.
|
**
|
Filed herewith.
|
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