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Form 10-Q Galena Biopharma, Inc. For: Sep 30

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November 9, 2015 5:56 PM EST
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 ________________________________
FORM 10-Q
 ________________________________
ý
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2015
OR
¨


TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-33958
  _______________________________
Galena Biopharma, Inc.
(Exact name of registrant as specified in its charter)
  ________________________________
Delaware
 
20-8099512
(State of incorporation)
 
(I.R.S. Employer Identification No.)
2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583
(855) 855-4253
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)

4640 SW Macadam Avenue, Suite 270, Portland, OR 97239
(Former address, if changed since last report)
  ________________________________
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ý    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter time that the registrant was required to submit and post such files).   Yes  ý    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):
Large accelerated filer
 
¨
 
Accelerated filer
 
ý
 
 
 
 
Non-accelerated filer
 
¨
(Do not check if a smaller reporting company)
Smaller reporting company
 
¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):    ¨  Yes    ý  No

As of October 31, 2015, Galena Biopharma, Inc. had outstanding 161,906,753 shares of common stock, $0.0001 par value per share, exclusive of treasury shares.
 


GALENA BIOPHARMA, INC.
FORM 10-Q - Quarterly Report
For the Three and Nine Months Ended September 30, 2015

TABLE OF CONTENTS
 
Part
No.
 
Item
No.
 
Description
Page
No.
I
 
 
 
 
 
 
1
 
 
 
 
 
Condensed Consolidated Balance Sheets as of September 30, 2015 (unaudited) and December 31, 2014
 
 
 
 
Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2015 and 2014
 
 
 
 
Condensed Consolidated Statement of Stockholders' Equity (unaudited) for the nine months ended September 30, 2015
 
 
 
 
Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2015 and 2014
 
 
 
 
 
 
2
 
 
 
3
 
 
 
4
 
II
 
 
 
 
 
 
1
 
Legal Proceedings
 
 
1A
 
Risk Factors
 
 
6
 
EX-10.6
 
EX-10.7
 
EX-31.1
 
EX-31.2
 
EX-32.1
 


1


PART I FINANCIAL INFORMATION
ITEM  1. FINANCIAL STATEMENTS

GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
 
September 30, 2015
 
December 31, 2014
 
(Unaudited)
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
34,812

 
$
23,650

Restricted cash
401

 
200

Prepaid expenses and other current assets
1,174

 
1,237

Current assets held for sale, net
17,801

 
27,013

Total current assets
54,188

 
52,100

Equipment and furnishings, net
288

 
285

In-process research and development
12,864

 
12,864

GALE-401 rights
9,255

 
9,255

Goodwill
5,898

 
5,897

Deposits and other assets
176

 
87

Total assets
$
82,669

 
$
80,488

LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
1,238

 
$
1,886

Accrued expenses and other current liabilities
7,329

 
8,885

Fair value of warrants potentially settleable in cash
16,661

 
5,383

Current portion of long-term debt
4,166

 
3,910

Current liabilities held for sale
7,697

 
7,169

Total current liabilities
37,091

 
27,233

Deferred tax liability
5,053

 
5,053

Contingent purchase price consideration
6,582

 
6,651

Long-term debt, net of current portion
1,526

 
4,492

Total liabilities
50,252

 
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, 162,575,446 shares issued and 161,900,446 shares outstanding at September 30, 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
295,956

 
256,377

Accumulated deficit
(259,705
)
 
(215,481
)
Less treasury shares at cost, 675,000 shares
(3,849
)
 
(3,849
)
Total stockholders’ equity
32,417

 
37,059

Total liabilities and stockholders’ equity
$
82,669

 
$
80,488


See accompanying notes to condensed consolidated financial statements.

2
GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
(Unaudited)

 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Operating expenses:
 
 
 
 
 
 
 
Research and development
$
5,740

 
$
7,025

 
$
18,762

 
$
21,463

General and administrative
2,895

 
3,542

 
7,869

 
12,744

Total operating expenses
8,635

 
10,567

 
26,631

 
34,207

Operating loss
(8,635
)
 
(10,567
)
 
(26,631
)
 
(34,207
)
Non-operating income (expense):
 
 
 
 
 
 
 
Change in fair value of warrants potentially settleable in cash
2,134

 
6,735

 
(981
)
 
13,174

Interest income (expense), net
(158
)
 
(297
)
 
(607
)
 
(925
)
Other income (expense)
307

 
597

 
69

 
(59
)
Total non-operating income (expense), net
2,283

 
7,035

 
(1,519
)
 
12,190

Loss from continuing operations
(6,352
)
 
(3,532
)
 
(28,150
)
 
(22,017
)
Discontinued operations
 
 
 
 
 
 
 
Loss from discontinued operations, including $8,071 impairment charge from classification as held for sale for three and nine months ended September 30, 2015
(11,674
)
 
(2,641
)
 
(16,074
)
 
(6,633
)
Net loss
$
(18,026
)
 
$
(6,173
)
 
$
(44,224
)
 
$
(28,650
)
 
 
 
 
 
 
 
 
Net loss per common share:
 
 
 
 
 
 
 
Basic and diluted net loss per share, continuing operations
$
(0.04
)
 
$
(0.03
)
 
$
(0.18
)
 
$
(0.19
)
Basic and diluted net loss per share, discontinued operations
$
(0.07
)
 
$
(0.02
)
 
$
(0.11
)
 
$
(0.06
)
Basic net loss per share
$
(0.11
)
 
$
(0.05
)
 
$
(0.29
)
 
$
(0.25
)
Weighted-average common shares outstanding: basic and diluted
161,857,522

 
119,038,656

 
153,000,857

 
117,767,791

See accompanying notes to condensed consolidated financial statements.

3
GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
(Amounts in thousands, except share amounts)
(Unaudited)

 
Common Stock
 
Additional Paid-In Capital
 
Accumulated Deficit
 
Treasury Stock
 
Total
 
Shares Issued
 
Amount
 
 
 
 
 
 
 
 
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
—

 
—

 
2,122

 
—

 
—

 
2,122

Exercise of stock options
39,108

 
—

 
31

 
—

 
—

 
31

Net loss
—

 
—

 
—

 
(44,224
)
 
—

 
(44,224
)
Balance at September 30, 2015
162,575,446

 
$
15

 
$
295,956

 
$
(259,705
)
 
$
(3,849
)
 
$
32,417


See accompanying notes to condensed consolidated financial statements.

4
GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)


 
For the Nine Months Ended September 30,
 
2015
 
2014
Cash flows from operating activities:
 
 
 
Cash flows from continuing operating activities:
 
 
 
Net loss from continuing operations
$
(28,150
)
 
$
(22,017
)
Adjustment to reconcile net loss to net cash used in operating activities:
 
 
 
Depreciation and amortization expense
304

 
340

Non-cash stock-based compensation
1,334

 
3,878

Change in fair value of common stock warrants
982

 
(13,174
)
Change in fair value of contingent consideration
(69
)
 
59

Changes in operating assets and liabilities:
 
 
 
Prepaid expenses and other assets
(26
)
 
(348
)
Accounts payable
(648
)
 
54

Accrued expenses and other current liabilities
(1,556
)
 
2,465

Net cash used in continuing operating activities
(27,829
)
 
(28,743
)
Cash flows from discontinued operating activities:
 
 
 
Net loss from discontinued operations
(16,074
)
 
(6,633
)
Impairment charge from classification of assets held for sale
8,071

 
—

Changes in operating assets and liabilities attributable to discontinued operations
2,956

 
3,241

Net cash used in discontinued operating activities
(5,047
)
 
(3,392
)
Net cash used in operating activities
(32,876
)
 
(32,135
)
Cash flows from investing activities:
 
 
 
Change in restricted cash
(201
)
 
—

Cash paid for acquisition of GALE-401 rights
—

 
(2,315
)
Cash paid for purchase of equipment and furnishings
(81
)
 
(48
)
Net cash used in continuing investing activities
(282
)
 
(2,363
)
Net cash used in discontinued investing activities
(534
)
 
(3,056
)
Net cash used in investing activities
(816
)
 
(5,419
)
Cash flows from financing activities:
 
 
 
Net proceeds from issuance of common stock
47,416

 
—

Net proceeds from exercise of stock options
31

 
4,342

Proceeds from exercise of warrants
—

 
10,717

Proceeds from common stock issued in connection with ESPP
309

 
263

Principle payments on long-term debt
(2,902
)
 
(908
)
Net cash provided by financing activities
44,854

 
14,414

Net increase (decrease) in cash and cash equivalents
11,162

 
(23,140
)
Cash and cash equivalents at the beginning of period
23,650

 
47,787

Cash and cash equivalents at end of period
$
34,812

 
$
24,647

 
 
 
 
Supplemental disclosure of cash flow information:
 
 
 
Cash received during the periods for interest
$
12

 
$
13

Cash paid during the periods for interest
$
437

 
$
632

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

 
$
27,026

Reclassification of warrant liabilities upon exercise
$
—

 
$
27,020

See accompanying notes to condensed consolidated financial statements.

5
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)



1. Business and Basis of Presentation

Overview
 
Galena Biopharma, Inc. (“we,” “us,” “our,” “Galena” or the “company”) is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S),GALE-301 and GALE-302. NeuVax is currently in a pivotal, Phase 3 clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers in addition to GALE-302 in combination with GALE-301 in ovarian and breast cancers. 
Novel Cancer Immunotherapies

Our targeted cancer immunotherapy approach is currently based upon two key areas: preventing secondary recurrence of cancer, which is becoming increasingly important as the number of cancer survivors continues to grow; and, transitioning earlier in the breast cancer treatment spectrum via primary prevention. Once a patient’s tumor becomes metastatic, the outcome is most often fatal, making the prevention of recurrence a potentially critical component of overall patient care. Our programs primarily target patients in the adjuvant (after-surgery) setting who have relatively healthy immune systems, but may still have minimal residual disease. Minimal residual disease, or single cancer cells (occult cancer cells) or micrometastasis, are undetectable by current radiographic scanning technologies, but we know can result in disease recurrence.
Our therapies utilize an immunodominant peptide combined with the immune adjuvant, recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF), and work by harnessing the patient’s own immune system to seek out and attack any residual cancer cells. Using peptide immunogens has many potential clinical advantages, including a favorable safety profile, since these drugs may lack the toxicities typical of most cancer therapies. They also have the potential to evoke long-lasting protection through activation of the immune system and a convenient, intradermal mode of delivery. We are currently engaged in multiple clinical trials with NeuVax™ (nelipepimut-S), GALE-301, and GALE-302, targeting the prevention of recurrence in breast, gastric, ovarian and endometrial cancers.

NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S), our lead product candidate, is a cancer immunotherapy targeting human epidermal growth factor receptor (HER2) expressing cancers. NeuVax is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established and validated target for therapeutic intervention in breast and gastric carcinomas. The NeuVax vaccine is combined with GM-CSF for injection under the skin, or intradermal administration. Data has shown that an increased presence of circulating tumor cells (CTCs) may predict Disease Free Survival (DFS) and Overall Survival (OS)-suggesting a dormancy of isolated micrometastases, which, over time, may lead to recurrence. After binding to specific HLA molecules on antigen presenting cells, the nelipepimut-S sequence stimulates specific cytotoxic T lymphocyte (CTLs). These activated CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.

6
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

We have multiple trials currently ongoing for NeuVax. For our pivotal, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node- Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial, NeuVax is targeting the 30,000-40,000 of the 230,000 female breast cancer patients annually diagnosed in the U.S. who are at a higher risk of their breast cancer recurring, which we refer to as “disease recurrence,” after achieving “no evidence of disease” (NED) status, (or becoming a “survivor”) with standard-of-care therapy (surgery, chemotherapy, radiation). These high-risk patients have a particular molecular signature and disease status: HER2 IHC 1+/2+ (oncoprotein associated with aggressive tumor growth), node positive (disease present in the axillary lymph nodes prior to surgery), and HLA A2/A3 (human leukocyte antigen from A2/A3 patients who have the same loci of genes which represents approximately 65% of the population). Up to 25% of resectable, node-positive breast cancer patients, having no radiographic evidence of disease following surgery and adjuvant chemo/radiation therapy, are expected to relapse within three years following diagnosis. The prognosis upon recurrence is very poor. These cancer patients presumably still had isolated, undetected tumor CTCs that led to a recurrence of cancer in the breast (local recurrence) or in another location (metastatic disease). In addition to our Phase 3 trial, we currently have two additional Phase 2 breast cancer trials ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche) targeting the prevention of recurrence in expanded indications.
We also recently announced our intent to initiate a Phase 2 trial with NeuVax as a single agent in patients with ductal carcinoma in situ (DCIS) in collaboration with the National Cancer Institute (NCI), potentially transitioning NeuVax earlier in the treatment cycle towards primary prevention. The trial will have an immunological endpoint evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients. DCIS, is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues, and at this time, there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2014 there were an estimated 51,933 diagnoses of DCIS.
We currently have a number of ongoing or planned clinical trials designed to expand the clinical and geographical footprint of NeuVax:
•
Phase 3 Ongoing: Our Phase 3 PRESENT (Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study targeted enrollment of 700 HER2 1+/2+ patients under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The multinational, multicenter, randomized, double-blinded PRESENT trial is ongoing in North America, Western and Eastern Europe, and Israel. The trial is fully enrolled with 758 patients.
•
Phase 2b Ongoing: A randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial is enrolling HER2 1+/2+ node-positive and high-risk node-negative breast cancer patients who are HLA A2+, A3+, A24+ or A26+ to study NeuVax in combination with trastuzumab in the adjuvant setting. This trial is co-funded by Genentech/Roche (providing both trastuzumab and monetary support) and Galena (providing NeuVax and monetary support).
•
Phase 2 Ongoing: An investigator-sponsored trial is ongoing to study NeuVax in combination with trastuzumab. The study will enroll 100 node positive and negative HER2 IHC 3+ patients or HER2 gene-amplified breast cancer patients who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence. Partial funding for this trial comes from the Department of Defense (DoD) through the Congressionally Directed Medical Research Program via legislation known as the Defense Appropriations Act. The grant was awarded under a Breast Cancer Research Program with the Breakthrough Award given to the lead investigator for the trial.


7
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

•
Phase 2 Planned: A clinical trial, entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast is planned to initiate by the end of 2015/early 2016. The Phase 2 trial will be a single-blind, double arm, randomized, controlled trial in pre- or post-menopausal patients with DCIS and are HLA-A2 positive. VADIS will be co-funded and run in collaboration with the National Cancer Institute (NCI).
•
Phase 2 Planned: A Phase 2 clinical trial in patients with gastric cancer is expected to initiate in 2016. The trial will be run in India by our partner, Dr. Reddy’s Laboratories, Ltd., as part of our NeuVax commercialization agreement in that region with Dr. Reddy’s.
GALE-301 and GALE-302

Our second immunotherapy franchise targets folate binding protein (FBP) receptor-alpha, a well-validated therapeutic target, which is highly over-expressed (20-80 fold) in ovarian, endometrial and breast cancers. Both GALE-301 (E39) and GALE-302 (E39’) are immunogenic peptides that can stimulate CTLs to recognize and destroy FBP-expressing cancer cells. GALE-301 consists of the FBP peptide E39 combined with GM-CSF, and is currently in a Phase 2a clinical trial for the prevention of recurrence in patients with ovarian and endometrial cancers. GALE-302 is an attenuated version of the E39 peptide and is currently in a Phase 1b randomized, single-center trial investigating a novel vaccination series using GALE-301 and GALE-302 to evaluate the immune response and monitor long-term immunity. Current treatments after surgery for these diseases are principally with platinum based chemotherapeutic agents and patients suffer a high recurrence rate; and, most patients relapse with an extremely poor prognosis. Although not powered for efficacy, promising preliminary results from the Phase 2a clinical trial of GALE-301 were presented in September 2015 at the European Cancer Congress and demonstrated statistically significant data with the estimate for disease free survival at two years at 85.7% (1000 mcg dose group) vs. 33.6% for the control group (p < .02), and that GALE-301 was well-tolerated with primarily Grade 1 and 2 toxicities and elicited a strong in vivo immune response.

According to the NCI Surveillance, Epidemiology, and End Results (SEER) Program, new cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015.  Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 - 2012 data).  The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse. Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%. Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.

According to the NCI SEER Program, new cases of endometrial cancer occur at an annual rate of 25.1 per 100,000 women in the U.S., with an estimated 54,870 cases for 2015. Although endometrial cancer represents about 3.3% of all cancers, it represents about 1.7% of all cancer deaths, or an estimated 10,170 deaths in 2015.  Approximately 2.8% of women will be diagnosed with endometrial cancer at some point during their lifetime (2010 - 2012 data).  The prevalence of endometrial cancer in the U.S. is about 620,000 women, and the five-year survivorship for women with endometrial cancer is 81.7%. 


8
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Hematology

GALE-401 (anagrelide controlled release (CR))

In January 2014, we announced the acquisition of the worldwide rights to anagrelide controlled release (CR), which we renamed GALE-401, through our acquisition of Mills Pharmaceuticals, LLC. GALE-401 contains the active ingredient anagrelide, an FDA-approved product, for the treatment of patients with myeloproliferative neoplasms (MPNs) to lower abnormally elevated platelet levels. The currently available immediate release (IR) version of anagrelide causes adverse events that are believed to be dose and plasma concentration dependent. Therefore, reducing the maximum concentration (Cmax) is hypothesized to reduce the side effects, but preserve efficacy.

Multiple Phase 1 studies in 98 healthy subjects have shown GALE-401 reduces the Cmax of anagrelide following oral administration, appears to be well-tolerated at the doses administered, and to be capable of reducing platelet levels. The Phase 1 program provided the desired PK/PD (pharmacokinetic/pharmacodynamic) profile to enable the initiation of the ongoing Phase 2 proof-of-concept trial. The Phase 2, open label, single arm, proof-of-concept trial enrolled 18 patients in the United States for the treatment of thrombocytosis, or elevated platelet counts in patients with MPNs. Phase 2 top-line safety and efficacy data was presented in June 2015 at the European Hematology Association 20th Congress, and we expect to present a more mature data set at the 57th American Society of Hematology Annual Meeting in December 2015. Based on a regulatory meeting with the FDA, Galena believes a 505(b)(2) regulatory filing is an acceptable pathway for development and potential approval of GALE-401.

Strategic Review of Commercial Operations

During the quarter ended September 30, 2015, we completed a strategic review of the company’s commercial business including the ongoing sale, distribution and marketing of our two commercial products, Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film (our “commercial business” asset group). As a result of the review, we made a determination to sell or otherwise dispose of our commercial business.

Basis of Presentation and Significant Accounting Policies

The accompanying consolidated financial statements included herein have been prepared by Galena pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Unless the context otherwise indicates, references in these notes to the “company,” “we,” “us” or “our” refer to Galena, our wholly owned subsidiary, Apthera, Inc., or “Apthera,” and our wholly owned subsidiary, Mills Pharmaceuticals, LLC or "Mills."

Discontinued Operations - As described in Note 12, we met the relevant criteria for reporting our commercial business as held for sale and in discontinued operations in the accompanying unaudited interim financial statements as of the three and nine month periods ended September 30, 2015 and 2014, pursuant to FASB Topic 205-20, Presentation of Financial Statements - Discontinued Operations, and FASB Topic 360, Property, Plant, and Equipment.

Uses of Estimates in Preparation of Financial Statements — The preparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.

Principles of Consolidation — The consolidated financial statements include the accounts of Galena and its wholly owned subsidiaries. All material intercompany accounts have been eliminated in consolidation.

Reclassifications — Certain prior year amounts have been reclassified to conform to current year presentation. These reclassifications had no effect on net loss per share.

9
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Cash and Cash Equivalents — The company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts and demand deposits.

Restricted Cash — Restricted cash consists of certificates of deposit on hand with the company’s financial institutions as collateral for its corporate credit cards.

Fair Value of Financial Instruments — The carrying amounts reported in the balance sheet for cash equivalents, accounts receivable, accounts payable, and capital leases approximate their fair values due to their short-term nature and market rates of interest.

Equipment and Furnishings — Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years) of the related assets.

Goodwill and Intangible Assets — Goodwill and indefinite-lived intangible assets are not amortized but are tested annually for impairment at the reporting unit level, or more frequently if events and circumstances indicate impairment may have occurred. Factors the company considers important that could trigger an interim review for impairment include, but are not limited to, the following:
•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.

Goodwill and other intangible assets with indefinite lives are evaluated for impairment first by a qualitative assessment to determine the likelihood of impairment. If it is determined that impairment is more likely than not, the company will then proceed to the two step impairment test. The first step is to compare the fair value of the reporting unit to the carrying amount of the reporting unit. If the carrying amount exceeds the fair value, a second step must be followed to calculate impairment. Otherwise, if the fair value of the reporting unit exceeds the carrying amount, the goodwill is not considered to be impaired as of the measurement date. In its review of the carrying value of the goodwill for its single reporting unit and its indefinite-lived intangible assets, the company determines fair values of its goodwill using the market approach, and its indefinite-lived intangible assets using the income approach.

Intangible assets not considered indefinite-lived are reviewed for impairment when facts or circumstances suggest that the carrying value of these assets may not be recoverable. The company’s policy is to identify and record impairment losses, if necessary, on intangible assets when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts.

The company performed its review for impairment using the qualitative assessment for both goodwill and indefinite-lived intangible assets, as well as assets not considered to be indefinite-lived, and has determined that there has been no impairment to these assets as of September 30, 2015.


10
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Assets Held for Sale - The company generally considers assets to be held for sale when (i) when the transaction has been approved by the board of directors or management vested with authority to approve the transaction, (ii) the assets are available for immediate sale in their present condition, (iii) the company has initiated an active program to locate a buyer and other actions required to complete the plan to sell the assets, (iv) consummation of the transaction is probable, (v) the assets are being actively marketing for sale at a price that is reasonable in relation to the current fair value, and (vi) the transaction is expected to qualify for recognition as a completed sale, within one year. Following the classification of property and equipment for sale, the company discontinues depreciating the asset and writes down the asset to the lower of the carrying value or fair market value, if needed. As described in Note 12, actions taken by the company's management vested with the board of directors' authority caused the company to meet the relevant criteria for reporting the commercial operations as held for sale.

Acquisitions and In-Licensing — For all in-licensed products and technologies, we perform an analysis to determine whether we hold a variable interest or a controlling financial interest in a variable interest entity. On the basis of our interpretations and conclusions, we determine whether the acquisition falls under the purview of variable interest entity accounting and if so, consider the necessity to consolidate the acquisition. As of September 30, 2015, we determined there were no variable interest entities required to be consolidated.

We also perform an analysis to determine if the assets and liabilities acquired in an acquisition qualify as a "business." The excess of the purchase price over the fair value of the net assets acquired can only be recognized as goodwill in a business combination. The Company completes its valuation analysis no later than twelve months from the date of the acquisition.

Contingent Purchase Price Consideration — Contingent consideration in business combinations is recorded at the estimated fair value as of the acquisition date. The fair value of the contingent consideration is re-measured at each reporting period with any adjustments in fair value included in our consolidated statement of comprehensive loss.

Patents and Patent Application Costs — Although the company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred.

Share-based Compensation — The company follows the provisions of the FASB ASC Topic 718, “Compensation — Stock Compensation” (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based payment awards made to employees, non-employee directors, and consultants, including stock options and warrants. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.

For stock options and warrants granted as consideration for services rendered by non-employees, the company recognizes compensation expense in accordance with the requirements of FASB ASC Topic 505-50 (“ASC 505-50”), “ Equity Based Payments to Non- Employees.” Non-employee option and warrant grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to vesting, the value of these options and warrants, as calculated using the Black-Scholes option-pricing model, is re-measured using the fair value of the company’s common stock and the non-cash compensation recognized during the period is adjusted accordingly. Since the fair market value of options and warrants granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options are fully vested.

Research and Development Expenses — Research and development costs are expensed as incurred. Included in research and development costs are wages, benefits and other operating costs, facilities, supplies, external services and overhead related to our research and development departments, and clinical trial expenses.


11
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Clinical trial expenses include direct costs associated with contract research organizations (CROs), as well as patient-related costs at sites at which our trials are being conducted.

Direct costs associated with our CROs are generally payable on a time and materials basis, or when certain enrollment and monitoring milestones are achieved. Expense related to a milestone is recognized in the period in which the milestone is achieved or in which we determine that it is more likely than not that it will be achieved.

The invoicing from clinical trial sites can lag several months. We accrue these site costs based on our estimate of upfront set-up costs upon the screening of the first patient at each site, and the patient related costs based on our knowledge of patient enrollment status at each site.

Income Taxes — The company recognizes liabilities or assets for the deferred tax consequences of temporary differences between the tax basis of assets or liabilities and their reported amounts in the financial statements in accordance with FASB ASC 740-10, “Accounting for Income Taxes” (“ASC 740-10”). These temporary differences will result in taxable or deductible amounts in future years when the reported amounts of the assets or liabilities are recovered or settled. ASC 740-10 requires that a valuation allowance be established when management determines that it is more likely than not that all or a portion of a deferred asset will not be realized. The company evaluates the realizability of its net deferred income tax assets and valuation allowances as necessary, at least on an annual basis. During this evaluation, the company reviews its forecasts of income in conjunction with other positive and negative evidence surrounding the realizability of its deferred income tax assets to determine if a valuation allowance is required. Adjustments to the valuation allowance will increase or decrease the company’s income tax provision or benefit. The recognition and measurement of benefits related to the company’s tax positions requires significant judgment, as uncertainties often exist with respect to new laws, new interpretations of existing laws, and rulings by taxing authorities. Differences between actual results and the company’s assumptions or changes in the company’s assumptions in future periods are recorded in the period they become known.

There was no income tax expense or benefit for the three and nine months periods ended September 30, 2015 and 2014. We continue to maintain a full valuation allowance against our net deferred tax assets.

Concentrations of Credit Risk — Financial instruments that potentially subject the company to significant concentrations of credit risk consist principally of cash and cash equivalents. The company maintains cash balances in several accounts with two banks, which at times are in excess of federally insured limits. As of September 30, 2015, the company’s cash equivalents were invested in money market mutual funds. The company’s investment policy does not allow investment in any debt securities rated less than “investment grade” by national ratings services. The company has not experienced any losses on its deposits of cash and cash equivalents. The company maintains significant cash and cash equivalents at two financial institutions that are in excess of federally insured limits.

Comprehensive Loss — Comprehensive loss consists of our net loss, with no other comprehensive income items for the periods presented.


12
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Effect of Recent Accounting Pronouncements

In April 2014, the FASB issued ASU 2014-08, Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity, or ASU 2014-08. Under ASU 2014-08, only disposals representing a strategic shift in operations that have a major effect on the company’s operations and financial results should be presented as discontinued operations. Additionally, ASU 2014-08 requires expanded disclosures about discontinued operations that will provide financial statement users with more information about the assets, liabilities, income, and expenses of discontinued operations. The amendments in ASU 2014-08 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2014. The company adopted this guidance in the first quarter of 2015 and has applied it in the accompanying interim financial statements for presentation and disclosure of the commercial business as discontinued operations (see Note 12).

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers: Topic 606, or ASU 2014-09. ASU 2014-09 establishes the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP. The standard outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. In applying the new revenue recognition model to contracts with customers, an entity: (1) identifies the contract(s) with a customer; (2) identifies the performance obligations in the contract(s); (3) determines the transaction price; (4) allocates the transaction price to the performance obligations in the contract(s); and (5) recognizes revenue when (or as) the entity satisfies a performance obligation. The accounting standards update applies to all contracts with customers except those that are within the scope of other topics in the FASB Accounting Standards Codification. The accounting standards update also requires significantly expanded quantitative and qualitative disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. This guidance is effective for fiscal years and interim periods within those years beginning after December 15, 2016, which is effective for the company for the year ending December 31, 2017. The FASB delayed in the effective date of the accounting standards update to fiscal years and interim periods within those years beginning on or after December 15, 2017, which is pending approval. The company is currently evaluating the impact that the implementation of ASU 2014-09 will have on the company’s financial statements.

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, or ASU 2014-15. ASU 2014-15 will explicitly require management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The new standard will be effective for all entities in the first annual period ending after December 15, 2016. Earlier adoption is permitted. The company is not early adopting ASU 2014-15. The company is currently evaluating the impact that the implementation of ASU 2014-15 will have on the company’s financial statements, and the actual impact will be dependent upon the company’s liquidity and the nature or significance of future events or conditions that exist upon adopting the updated standard.

In January 2015, the FASB issued ASU No. 2015-01, Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items, or ASU 2015-01. ASU 2015-01 eliminates from GAAP the concept of extraordinary items. ASU 2015-01 is effective for fiscal years and interim periods beginning after December 15, 2015. Early adoption is permitted. The company does not expect that the adoption of ASU 2015-01 will have a material impact on its consolidated financial statements.


13
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

2. Fair Value Measurements

The company follows ASC 820, “Fair Value Measurements and Disclosures,” (“ASC 820”) for the company’s financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and are re-measured and reported at fair value at least annually using a fair value hierarchy that is broken down into three levels. Level inputs are defined as follows:
Level 1 — quoted prices in active markets for identical assets or liabilities.
Level 2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.
Level 3 — significant unobservable inputs that reflect management’s best estimate of what market participants would use to price the assets or liabilities at the measurement date.

The company categorized its cash equivalents as Level 1. The valuations for Level 1 were determined based on a “market approach” using quoted prices in active markets for identical assets. Valuation of these assets does not require a significant degree of judgment. The company categorized its warrants potentially settleable in cash as Level 2 inputs. The warrants are measured at market value on a recurring basis and are being marked to market each quarter-end until they are completely settled. The warrants are valued using an appropriate pricing model, using assumptions consistent with our application of ASC 718. The contingent purchase price consideration is categorized as Level 3 inputs and is measured at its estimated fair value on a recurring basis and is adjusted at each quarter-end until it is completely settled. The contingent purchase price consideration is valued based on the expected timing of milestones, the expected probability of success for each milestone and discount rates based on a corporate debt interest rate index publicly issued.

As discussed in Note 12, the Company met the relevant criteria for reporting the commercial operations as held for sale as of September 30, 2015, and as a result, assessed the commercial asset group for impairment pursuant to ASC Topic 360, Property, Plant, and Equipment. The net carrying value of the commercial asset group was compared to its fair value as of September 30, 2105. The Company determined that the fair value using a risk adjusted net present value of deal consideration received from bids from potential acquirers, which the Company concluded was a Level 3 input. The Company determined that the carrying value exceeded its fair value and as a result recorded an $8.1 million impairment charge on assets classified as held for sale in the quarterly period ended September 30, 2015.

The following tables present information about our assets and liabilities measured at fair value on a recurring basis in the condensed consolidated balance sheets (in thousands):
 
Description
September 30, 2015
 
Quoted Prices In    
Active Markets
(Level 1)
 
Significant Other
Observable 
Inputs (Level 2)
 
Unobservable 
Inputs
(Level 3)
Assets:
 
 
 
 
 
 
 
Cash equivalents
$
32,618

 
$
32,618

 
$
—

 
$
—

Assets held for sale
17,801

 
—

 
—

 
17,801

Total assets measured and recorded at fair value
$
50,419

 
$
32,618

 
$
—

 
$
17,801

Liabilities:
 
 
 
 
 
 
 
Warrants potentially settleable in cash
$
16,661

 
$
—

 
$
16,661

 
$
—

Contingent purchase price consideration
6,582

 
—

 
—

 
6,582

Total liabilities measured and recorded at fair value
$
23,243

 
$
—

 
$
16,661

 
$
6,582



14
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Description
December 31, 2014
 
Quoted Prices In    
Active Markets
(Level 1)
 
Significant Other
Observable 
Inputs (Level 2)
 
Unobservable 
Inputs
(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


The company did not transfer any financial instruments into or out of Level 3 classification during the three and nine months ended September 30, 2015 or 2014. A reconciliation of the beginning and ending Level 3 liabilities for the nine months ended September 30, 2015 is as follows (in thousands):
 
 
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
(69
)
Balance at September 30, 2015
$
6,582


The fair value of the contingent purchase price consideration is measured at the end of each reporting period using Level 3 inputs in a probability-weighted, discounted cash-outflow model. The significant unobservable assumptions include the probability of achieving each milestone, the date we expect to reach the milestone, and a determination of present value factors used to discount future expected cash outflows.

3. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

 
September 30, 2015
 
December 31, 2014
Clinical trial costs
$
5,179

 
$
6,967

Compensation and related benefits
992

 
1,040

Professional fees
1,121

 
821

Interest expense
37

 
57

Accrued expenses and other current liabilities
$
7,329

 
$
8,885


4. Long-term Debt

On May 8, 2013 we entered into a loan and security agreement with Oxford Finance LLC, as collateral agent, and related lenders under which we borrowed the first tranche of $10 million (the "Loan"). The Loan payment terms include 12 months of interest-only payments at the fixed coupon rate of 8.45%, followed by 30 months of amortization of principal and interest until maturity in November 2016. In connection with the Loan, we paid the lender a 1% cash facility fee and a 5.5% cash final payment and granted to the lenders seven-year warrants to purchase up to 182,186 shares of our common stock at an exercise price of $2.47, which equaled a 20-day average market price of our common stock prior to the date of the grant.

15
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

5. Legal Proceedings, Commitments and Contingencies
Legal Proceedings

In re Galena Biopharma, Inc. Securities Litigation and In Re Galena Biopharma, Inc. Derivative Litigation

On August 4, 2015, plaintiffs in the voluntarily dismissed Delaware derivative action have filed a motion seeking to file under seal a derivative complaint in the District Court. That motion was granted and on August 31, 2015, that action was consolidated with In Re Galena Biopharma, Inc. Derivative Litigation.

On or about September 15, 2015, a federal securities lawsuit was filed in the U.S. District Court for the District of Oregon entitled, Riley v. Galena Biopharma, Inc., et al. The time to answer or otherwise plead has been extended by agreement of the parties.

We intend to vigorously defend against and seek resolution to the foregoing claims. As of September 30, 2015, we have not recorded any liabilities with respect to the claims in our consolidated financial statements. We believe that claims are covered under our liability insurance, and we have notified our insurance carriers of the claims. The insurers have responded by requesting additional information and by reserving their rights under the policies, including the rights to deny coverage under various policy exclusions. Subject to their reservation of rights, we are being reimbursed by our insurance carriers for significant portion of all legal fees relating to our defense of the claims. We have entered into certain undertaking agreements with our directors related to the litigation by which we have agreed to advance reasonable legal fees and costs for the litigation under certain conditions.

SEC Investigation

We are aware that the Securities and Exchange Commission (SEC) is investigating certain matters relating to the use of certain outside investor-relations professionals by us and other public companies. We have been in contact with the SEC staff through our counsel and are cooperating with the investigation.

ANDA Litigation

On October 23, 2015, Orexo AB (“Orexo”) and Galena Biopharma, Inc. (the “Company”) entered into a settlement and license agreement with Actavis Laboratories FL, Inc. (“Actavis”) to resolve pending patent litigation brought by the Orexo against Actavis involving Abstral® (fentanyl) sublingual tablets. The pending patent litigation was filed by Orexo in the U.S. District Court for the District of New Jersey in response to Actavis’ submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”), seeking marketing approval for a generic version of Abstral. As a result of the settlement and license agreement, Actavis will be permitted to enter the market with a generic or authorized generic version of Abstral in the United States June 2018 or earlier under certain circumstances. The Court has entered an order dismissing with prejudice the litigation against Actavis. Details of the settlement are confidential, and the parties have submited the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The expiration date for the latest expiring Abstral patent listed in the FDA’s Orange Book is September 2019.

Commitments

The company acquires assets still in development and enters into research and development arrangements with third parties that often require milestone and royalty payments based on the progress of the asset through development stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency. In certain agreements, the company is required to make royalty payments based upon a percentage of the sales.

These arrangements may be material individually, and in the unlikely event that milestones for multiple products covered by these arrangements were reached in the same period, the aggregate charge to expense could be material to the results of operations. In addition, these arrangements often give the company the discretion to unilaterally terminate development of the product, which the company might do for clinical, business or other reasons, which would allow the company to avoid making the contingent payments.

16
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

The company applies the disclosure provisions FASB ASC Topic 460 (“ASC 460”), “ Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others ”, to its agreements that contain guarantee or indemnification clauses. The company provides (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to us. These indemnifications give rise only to the disclosure provisions of ASC 460. To date, the company has not incurred costs as a result of these obligations and does not expect to incur material costs in the future. Accordingly, the company has not accrued any liabilities in its financial statements related to these indemnifications.

6. Stockholders’ Equity

Preferred Stock — The company has authorized up to 5,000,000 shares of preferred stock, $0.0001 par value per share, for issuance. The preferred stock will have such rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the company’s Board of Directors upon its issuance. To date, the company has not issued any preferred shares.

Common Stock — The company has authorized up to 275,000,000 shares of common stock, $0.0001 par value per share, for issuance.

November 2014 Purchase Agreement with Lincoln Park Capital, LLC - On November 18, 2014, the company entered into a purchase agreement with Lincoln Park Capital, LLC (LPC), pursuant to which the company has the right to sell to LPC up to $50 million in shares of the company's common stock, subject to certain limitations and conditions over the 36 month term of the purchase agreement. Pursuant to the purchase agreement, LPC initially purchased 2.5 million shares of the company's common stock at $2.00 per share and the company issued 631,221 shares of common stock to LPC as a commitment fee, which was recorded as a cost of capital. As a result of this initial issuance, the company received initial net proceeds of $4.9 million, after deducting commissions and other offering expenses. In addition to LPC’s initial purchase of our common stock under the purchase agreement, during the first quarter of 2015, we received net proceeds of $4.4 million from LPC’s subsequent purchases of a total of 2.7 million shares of our common stock, excluding the commitment fee shares.

At Market Issuance Sales Agreements - On May 24, 2013 the Company entered into At Market Issuance Sales Agreements (ATM) with MLV & Co. LLC and Maxim Group LLC (the Agents). From time to time during the term of the ATM, we may issue and sell through the Agents, shares of our common stock, and the Agents collect a fee equal to 3% of the gross proceeds from the sale of shares, up to a total limit of $20 million in gross proceeds. The ATM is available to the company until it is terminated by the Agents or the company. During the first quarter of 2015, we received $2.3 million in net proceeds from the sale of 1.4 million shares of our common stock through the ATM. There were no sales of our common stock under the ATM during the three months ended September 30, 2015 or during the three and nine months ended September 30, 2014.

March 2015 Underwritten Public Offering - On March 18, 2015 the company closed an underwritten public offering of 24,358,974 units at a price to the public of $1.56 per unit for gross proceeds of $38 million (the "March 2015 Offering"). Each unit consists of one share of common stock, and a warrant to purchase 0.50 of a share of common stock at an exercise price of $2.08 per share. The March 2015 Offering included an over-allotment option for the underwriters to purchase an additional 3,653,846 shares of common stock and/or warrants to purchase up to 1,826,923 shares of common stock. On March 18, 2015, the underwriters exercised their over-allotment option to purchase warrants to purchase an aggregate of 1,826,923 shares of common stock. On April 10, 2015, the underwriters exercised their over-allotment option to purchase 3,653,846 shares of common stock for additional net proceeds of $5.4 million. The total net proceeds of the March 2015 Offering, including the exercise of the over-allotment option to purchase the warrants, were $40.8 million, after deducting underwriting discounts and commissions and offering expenses payable by the company.


17
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Shares of common stock for future issuance are reserved for as follows (in thousands):

 
As of September 30, 2015
Warrants outstanding
22,308

Stock options outstanding
11,188

Options reserved for future issuance under the Company’s 2007 Incentive Plan
10,251

Shares reserved for future issuance under the Employee Stock Purchase Plan
528

Total reserved for future issuance
44,275


7. Warrants

The following is a summary of warrant activity for the nine months ended September 30, 2015 (in thousands):
 
 
March 2015 Warrants
 
September
2013
Warrants
 
December
2012
Warrants
 
April 2011
Warrants
 
March
2011
Warrants
 
March
2010
Warrants
 
Consultant
and Oxford Warrants
 
Total
Outstanding, January 1, 2015
—

 
3,973

 
3,031

 
615

 
176

 
25

 
720

 
8,540

Issued
14,006

 
—

 
—

 
—

 
—

 
—

 
—

 
14,006

Expired
—

 
—

 
—

 
—

 
—

 
—

 
(238
)
 
(238
)
Outstanding, September 30, 2015
14,006

 
3,973

 
3,031

 
615

 
176

 
25

 
482

 
22,308

Expiration
March 2020
 
September 2018
 
December 2017
 
April 2017
 
March 2016
 
March 2016
 
Varies 2014-2020
 
 

Warrants consist of warrants potentially settleable in cash, which are liability-classified warrants, and equity-classified warrants.

Warrants classified as liabilities

Liability-classified warrants consist of warrants to purchase common stock issued in connection with equity financings in March 2015, September 2013, December 2012, April 2011, March 2011, and March 2010. These warrants are potentially settleable in cash and were determined not to be indexed to our common stock.

The estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the condensed consolidated statement of comprehensive loss as other income (expense). The fair value of the warrants is estimated using an appropriate pricing model with the following inputs:
 
 
As of September 30, 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)
4.47

 
2.97

 
2.23

 
1.56

 
0.43

 
0.49

Volatility %
74.99
%
 
76.85
%
 
75.45
%
 
69.48
%
 
72.42
%
 
68.33
%
Risk-free rate %
1.25
%
 
0.91
%
 
0.70
%
 
0.50
%
 
0.06
%
 
0.08
%
 

18
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

 
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
%

The expected volatility assumptions are based on the company's implied volatility in combination with the implied volatilities of similar publicly traded entities. The expected life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero coupon rates in effect at the time of valuation. The dividend yield used in the pricing model is zero, because the company has no present intention to pay cash dividends.
The changes in fair value of the warrant liability for the nine months ended September 30, 2015 were as follows (in thousands):
 
 
March 2015 Warrants
 
September
2013
Warrants
 
December
2012
Warrants
 
April 2011
Warrants
 
March
2011
Warrants
 
March
2010
Warrants
 
Total
Warrant liability, January 1, 2015
$
—

 
$
2,560

 
$
2,027

 
$
625

 
$
163

 
$
8

 
$
5,383

Fair value of warrants issued
10,296

 
—

 
—

 
—

 
—

 
—

 
10,296

Change in fair value of warrants
1,313

 
(157
)
 
(162
)
 
(10
)
 
2

 
(4
)
 
982

Warrant liability, September 30, 2015
$
11,609

 
$
2,403

 
$
1,865

 
$
615

 
$
165

 
$
4

 
$
16,661


Warrants classified as equity

Equity-classified warrants consist of warrants issued in connection with consulting services provided to us. Additionally, on May 8, 2013 as a part of our Loan financing, we granted Oxford Financial LLC warrants to purchase up to 182,186 shares of common stock at an exercise price of $2.47, which equaled to the 20-day average market price of our common stock prior to the date of the grant. The warrants were valued using an appropriate pricing model as described in Note 9, below. The fair value assumptions for the grant included a volatility of 75.34%, expected term of seven years, risk-free rate of 1.20%, and a dividend rate of 0.00%. The fair value of the warrants granted was $1.93 per share. These warrants are recorded in equity at fair value upon issuance, and not as liabilities, and are not subject to adjustment to fair value in subsequent reporting periods.


19
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

8. Stock-Based Compensation

Options to Purchase Shares of Common Stock — The company follows the provisions ASC 718, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, non-employee directors, including employee stock options. Stock compensation expense based on the grant date fair value estimated in accordance with the provisions of ASC 718 is recognized as an expense over the requisite service period.

For stock options and warrants granted in consideration for services rendered by non-employees, the company recognizes compensation expense in accordance with the requirements of ASC Topic 505-50. Non-employee option and warrant grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to vesting, the value of these options and warrants, as calculated using the Black-Scholes option-pricing model, is re-measured using the fair value of the company’s common stock and the non-cash compensation recognized during the period is adjusted accordingly. Since the fair market value of options and warrants granted to non-employees is subject to change in the future, the amount of the future compensation expense will include fair value re-measurements until the stock options and warrants are fully vested.

The following table summarizes the components of stock-based compensation expense in the condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2015 and 2014, respectively (in thousands):

 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Research and development
$
83

 
$
92

 
$
253

 
$
438

General and administrative
492

 
990

 
1,081

 
3,440

Total stock-based compensation from continuing operations
$
575

 
$
1,082

 
$
1,334

 
$
3,878

Stock based compensation from discontinued operations
$
275

 
$
217

 
$
788

 
$
557


The company uses the Black-Scholes option-pricing model and the following weighted-average assumptions to determine the fair value of all its stock options granted:
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Risk free interest rate
—
%
 
2.02
%
 
1.50
%
 
2.02
%
Volatility
—
%
 
79.10
%
 
74.20
%
 
79.47
%
Expected lives (years)
0.00

 
6.12

 
6.09

 
6.15

Expected dividend yield
—
%
 
—
%
 
—
%
 
—
%

The weighted-average fair value of options granted during the nine months ended September 30, 2015 was $1.14 per share. There were no stock options granted during the three months ended September 30, 2015.


20
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

The company’s expected common stock price volatility assumption is based upon the company's own implied volatility in combination with the implied volatility of a basket of comparable companies. The expected life assumptions for employee grants were based upon the simplified method provided for under ASC 718-10, which averages the contractual term of the company’s options of ten years with the average vesting term of four years for an average of six years. The expected life assumptions for non-employees were based upon the contractual term of the option. The dividend yield assumption is zero, because the company has never paid cash dividends and presently has no intention to do so. The risk-free interest rate used for each grant was also based upon prevailing short-term interest rates. The company has estimated an annualized forfeiture rate of 15% for options granted to its employees, 8% for options granted to senior management and zero for non-employee directors. The company will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated.

As of September 30, 2015, there was $4,815,000 of unrecognized compensation cost related to outstanding options that is expected to be recognized as a component of the company’s operating expenses over a weighted-average period of 2.34 years.

As of September 30, 2015, an aggregate of 26,500,000 shares of common stock were reserved for issuance under the company’s 2007 Incentive Plan, including 11,188,000 shares subject to outstanding common stock options granted under the plan and 10,251,000 shares available for future grants. The administrator of the plan determines the times when an option may become exercisable. Vesting periods of options granted to date have not exceeded four years. The options will expire, unless previously exercised, no later than ten years from the grant date.

The following table summarizes option activity of the company:

 
Total
Number of
Shares
(In Thousands)
 
Weighted
Average
Exercise
Price
 
Aggregate
Intrinsic
Value
(In Thousands)
Outstanding at January 1, 2015
8,590

 
$
3.25

 


Granted
3,682

 
1.73

 


Exercised
(39
)
 
0.79

 
$
37

Cancelled
(1,045
)
 
2.44

 
$
21

Outstanding at September 30, 2015
11,188

 
$
2.83

 
$
690

Options exercisable at September 30, 2015
6,622

 
$
3.32

 
$
618


The aggregate intrinsic values of outstanding and exercisable options at September 30, 2015 were calculated based on the closing price of the company’s common stock as reported on The NASDAQ Capital Market on September 30, 2015 of $1.58 per share. The aggregate intrinsic value equals the positive difference between the closing fair market value of the company’s common stock and the exercise price of the underlying options.

9. Other Income (Expense)

Other income (expense) is summarized as follows (in thousands):
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Change in fair value of the contingent purchase price liability
$
307

 
$
597

 
$
69

 
$
(59
)
Total other income (expense)
$
307

 
$
597

 
$
69

 
$
(59
)


21
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

10. Net Loss Per Share

The company accounts for and discloses net loss per common share in accordance with FASB ASC Topic 260 “Earnings per Share.” Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares that would have been outstanding during the period assuming the issuance of common shares for all potential dilutive common shares outstanding. Potential common shares consist of shares issuable upon the exercise of stock options and warrants.

The following table sets forth the potentially dilutive common shares excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive (in thousands):
 
 
 Three and Nine Months Ended September 30,
 
2015
 
2014
Warrants to purchase common stock
22,308

 
8,540

Options to purchase common stock
11,188

 
8,994

Total
33,496

 
17,534


11. License Agreements

As part of its business, the company enters into licensing agreements with third parties that often require milestone and royalty payments based on the progress of the licensed assets through development and commercial stages. Milestone payments may be required, for example, upon approval of the product for marketing by a regulatory agency, and the company may be required to make royalty payments based upon a percentage of net sales of the product. The expenditures required under these arrangements in any period may be material and are likely to fluctuate from period to period.

These arrangements sometimes permit the company to unilaterally terminate development of the product and thereby avoid future contingent payments; however, the company is unlikely to cease development if the compound successfully achieves clinical testing objectives.

In conjunction with the acquisition of NeuVaxTM, the company acquired rights and assumed obligations under a license agreement among Apthera and The University of Texas M. D. Anderson Cancer Center (“MDACC”) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (“HJF”) which grants exclusive worldwide rights to a U.S. patent covering the nelipepimut-S peptide and several U.S. and foreign patents and patent applications covering methods of using the peptide as a vaccine. Under the terms of this license, we are required to pay an annual maintenance fee of $200,000, a milestone payment of $200,000 upon commencing the Phase 3 PRESENT trial of NeuVax and other clinical milestone payments, as well as royalty payments based on sales of NeuVax or other therapeutic products developed from the licensed technologies.

Effective April 30, 2009, we entered into a license agreement with Kwangdong Pharmaceutical Co, Ltd (Kwangdong). Under the agreement, we granted Kwangdong exclusive rights to seek marketing approval in The Republic of Korea (South Korea) for our NeuVax product candidate for the treatment of breast cancer following its approval by the FDA or the European Medicines Agency, and to market, sell and distribute NeuVax in South Korea assuming such approval is obtained.

22
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

Effective December 3, 2012, we entered into a license and supply agreement with ABIC Marketing Limited, a subsidiary of Teva Pharmaceuticals (“ABIC”), under which we granted ABIC exclusive rights to seek marketing approval in Israel for our NeuVax product candidate for intradermal injection for the treatment of breast cancer following its approval by the FDA or the European Medicines Agency, and to market, sell and distribute NeuVax in Israel assuming such approval is obtained. ABIC’s rights also include a right of first refusal in Israel for all future indications for which NeuVax may be approved. Under the license and supply agreement, ABIC will assume responsibility for regulatory registration of NeuVax in Israel, provide financial support for local development, and commercialize the product in the region in exchange for making royalty payments to us based on future sales of NeuVax. ABIC also agrees in the license and supply agreement to purchase from us all supplies of NeuVax at a price determined according to a specified formula.

Effective January 14, 2014, we entered into a strategic development and commercialization partnership with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), under which we licensed commercial rights in India to Dr. Reddy’s for NeuVax in breast and gastric cancers. Under the agreement, Dr. Reddy’s will lead the Phase 2 development of NeuVax in India in gastric cancer, significantly expanding the potential patient population addressable with NeuVax.
On January 12, 2014, we acquired worldwide rights to anagrelide controlled release (CR) formulation, which we renamed GALE-401, through our acquisition of Mills Pharmaceuticals, LLC ("Mills") and Mills became a wholly owned subsidiary. GALE-401 contains the active ingredient anagrelide, an FDA-approved product that has been in use since the late 1990s for the treatment of essential thrombocythemia (ET). Mills holds an exclusive license to develop and commercialize anagrelide CR formulation, pursuant to a license agreement with BioVascular, Inc. Under the terms of the license agreement, Mills has agreed to pay BioVascular, Inc. a mid-to-low single digit royalty on net revenue from the sale of licensed products as well as future cash milestone payments based on the achievement of specified regulatory milestones. Mills is also responsible for patent prosecution and maintenance.

12. Discontinued Operations, Assets Held for Sale

As part of the company's strategic objective to focus its resources on its development pipeline, our management and board of directors have decided and committed to pursue a plan to sell or otherwise divest the company’s commercial business. A brief summary of each product in our commercial business is provided below.

Abstral® (fentanyl) Sublingual Tablets, is a treatment option for inadequately controlled breakthrough cancer pain (BTcP), which is estimated to affect more than 50% of all cancer patients. Abstral is approved by the FDA, and is a sublingual (under the tongue) tablet for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a sublingual tablet that is designed to dissolve under the tongue in seconds and provide relief of breakthrough pain within minutes. Abstral is a transmucosal immediate release fentanyl (TIRF) product with product class oversight by the TIRF Risk Evaluation and Mitigation Strategy (REMS) access program.

Zuplenz® (ondansetron) Oral Soluble Film, is approved by the FDA in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients treated with moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. Zuplenz utilizes MonoSol’s proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than 30 seconds, therefore eliminating the burden of swallowing pills during periods of emesis. The active pharmaceutical ingredient in Zuplenz, ondansetron, belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.


23
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

The company met the relevant criteria for reporting the commercial business as held for sale and in discontinued operations in the accompanying unaudited interim financial statements as of and for the three and nine month periods ended September 30, 2015, and 2014, pursuant to FASB Topic 205-20, Presentation of Financial Statements--Discontinued Operations, and FASB Topic 360, Property, Plant, and Equipment. The company has assessed the commercial business net asset group for impairment pursuant to FASB Topic 360, as discussed in Note 2, determining that the carrying value exceed the fair value of the assets, therefore has recorded a $8.1 million impairment charge as of September 30, 2015.

The company entered into an agreement with a third party firm to assist the company with the divestiture of its commercial operations including identifying potential acquirers. Pursuant to the terms of the agreement, in the event the company successfully completes a divestiture through the sale of its commercial operations to a third-party, the company is obligated to pay a success fee to the third party firm in an amount up to $900,000 of cash consideration received, 5% of realized future revenue and payment streams, as well as reimbursement for reasonable out-of-pocket expenses.

The company has also entered into compensatory arrangements related to the divestiture of our commercial business with certain members of commercial management. Under the terms of these arrangements, if the company meets certain sales and margin numbers in the fourth quarter of 2015 and successfully completes a divestiture through sale of its commercial operations to a third-party, the company may pay a retention fee to the three employees in a combined total amount equal to the lesser of $400,000 or 3% of cash consideration received as upfront payment in the transaction, with payment to each employee portion conditioned on his or her continued employment through the closing date of such a divestiture of one or both products and satisfaction of other terms. These employees may also receive severance payments equal to one month’s salary for between four and seven months in event the divestiture does not result in continued employment with the acquirer.

The following table presents a reconciliation of the carrying amounts of assets and liabilities of the commercial operations to assets held for sale, net in the balance sheets (in thousands):
 
September 30, 2015
 
December 31, 2014
Carrying amounts of assets included as part of discontinued operations:
Accounts receivable
$
1,238

 
$
1,535

Inventories
1,318

 
655

Prepaid expenses and other current assets
1,064

 
1,747

Equipment and furnishings, net
241

 
270

Abstral rights, net
13,738

 
14,533

Zuplenz rights
8,101

 
8,101

Goodwill
172

 
172

Impairment charge from classification as assets held for sale
(8,071
)
 
—

Total current assets held for sale
17,801

 
27,013

 
 
 
 
Carrying amounts of liabilities included as part of discontinued operations:
Accounts payable
$
1,359

 
$
385

Accrued expenses and other current liabilities
6,338

 
6,784

Total current liabilities held for sale
$
7,697

 
$
7,169



24
GALENA BIOPHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued
(Unaudited)

The following table represents the components attributable to the commercial operations that are presented in the consolidated statement of comprehensive loss as discontinued operations (in thousands):
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Net revenue
$
2,166

 
$
1,620

 
$
8,298

 
$
6,124

Cost of revenue
(712
)
 
(247
)
 
(1,573
)
 
(925
)
Amortization of certain acquired intangible assets
(208
)
 
(70
)
 
(795
)
 
(259
)
Research and development
(160
)
 
(219
)
 
(339
)
 
(619
)
Selling, general, and administrative
(4,672
)
 
(3,725
)
 
(13,577
)
 
(10,954
)
Non-operating income (expense)
(17
)
 
—

 
(17
)
 
—

Impairment charge from classification as assets held for sale
(8,071
)
 
—

 
(8,071
)
 
—

Loss from discontinued operations
$
(11,674
)
 
$
(2,641
)
 
$
(16,074
)
 
$
(6,633
)

The following table presents significant operating non-cash items and capital expenditures related to discontinued operations (in thousands):

 
September 30, 2015
 
September 30, 2014
Impairment of assets held for sale
$
8,071

 
$
—

Depreciation and amortization
$
858

 
$
319

Stock-based compensation
$
788

 
$
557

Purchases of property and equipment
$
(34
)
 
$
—

Cash paid for acquisition of Zuplenz rights
$
(500
)
 
$
(3,056
)

13. Subsequent Events

The company evaluated all events or transactions that occurred after September 30, 2015 up through the date these financial statements were issued. Other than as disclosed elsewhere in the notes to the condensed consolidated financial statements, the company did not have any material recognizable or unrecognizable subsequent events.



25

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

In this section, "Galena," “we,” “our,” “ours” and “us” refer to Galena Biopharma, Inc. and its consolidated subsidiaries, Apthera, Inc., or “Apthera,” and Mills Pharmaceuticals, LLC, or "Mills."

This management’s discussion and analysis of financial condition as of September 30, 2015 and results of operations for the three and nine months ended September 30, 2015 and 2014, respectively, should be read in conjunction with management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2014 which was filed with the SEC on March 5, 2015.

The discussion and analysis below includes certain forward-looking statements related to the commercialization of our products in the U.S., our future financial condition and results of operations and potential for profitability, the sufficiency of our cash resources, our ability to obtain additional equity or debt financing, possible partnering or other strategic opportunities for the development of our products, as well as other statements related to the progress and timing of our product commercialization and development activities, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods, which are all forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These statements represent, among other things, the expectations, beliefs, plans and objectives of management and/or assumptions underlying or judgments concerning the future financial performance and other matters discussed in this document. The words “may,” “will,” “should,” “plan,” “believe,” “estimate,” “intend,” “anticipate,” “project,” and “expect” and similar expressions are intended to connote forward-looking statements. All forward-looking statements involve certain risks, including the uncertainties and other factors described in our Annual Report on Form 10-K for the year ended December 31, 2014 that could cause our actual commercialization efforts, development activities, financial condition and results of operations, and business prospects and opportunities to differ materially from these expressed in, or implied by, those forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless another date is indicated) and we undertake no obligation to update or revise forward-looking statements.


26

Overview

Galena Biopharma, Inc. (“we,” “us,” “our,” “Galena” or the “company”) is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S), GALE-301 and GALE-302.  NeuVax is currently in a pivotal, Phase 3 clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers in addition to GALE-302 in combination with GALE-301 in ovarian and breast cancers. 
We are seeking to build value for shareholders through pursuit of the following objectives:
•
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, minimum residual disease setting, in high risk patients who are more likely to benefit from treatment via immunotherapy. Our immunotherapy programs are currently targeting two key areas: secondary prevention to seek to significantly decrease the risk of disease recurrence in breast cancer, gastric cancer, endometrial and ovarian cancers; and moving towards primary prevention in breast cancer.
•
Expand our development pipeline by enhancing the clinical and geographic footprint of our technologies. We can accomplish this through the initiation of new clinical trials as well as through acquisition of additional development stage products in oncology indications.
•
Leverage valuable 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.
•
Maximize the value of our commercial assets through divestiture. During the quarter ended September 30, 2015, we completed a strategic review of our commercial business and operations, and as a result of that review have decided to sell or otherwise divest our commercial business. We believe this disposition will allow us to focus our resources on our valuable and expanding clinical development programs and maximize the value of these assets to our shareholders.

27

The chart below summarizes the current status of our clinical development pipeline:


Novel Cancer Immunotherapies

Our targeted cancer immunotherapy approach is currently based upon two key areas: preventing secondary recurrence of cancer, which is becoming increasingly important as the number of cancer survivors continues to grow; and, transitioning earlier in the breast cancer treatment spectrum via primary prevention. Once a patient’s tumor becomes metastatic, the outcome is most often fatal, making the prevention of recurrence a potentially critical component of overall patient care. Our programs primarily target patients in the adjuvant (after-surgery) setting who have relatively healthy immune systems, but may still have minimal residual disease. Minimal residual disease, or single cancer cells (occult cancer cells) or micrometastasis, are undetectable by current radiographic scanning technologies, but we know can result in disease recurrence.
Our therapies utilize an immunodominant peptide combined with the immune adjuvant, recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF), and work by harnessing the patient’s own immune system to seek out and attack any residual cancer cells. Using peptide immunogens has many potential clinical advantages, including a favorable safety profile, since these drugs may lack the toxicities typical of most cancer therapies. They also have the potential to evoke long-lasting protection through activation of the immune system and a convenient, intradermal mode of delivery. We are currently engaged in multiple clinical trials with NeuVax™ (nelipepimut-S), GALE-301, and GALE-302, targeting the prevention of recurrence in breast, gastric, ovarian and endometrial cancers.




28

NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S), our lead product candidate, is a cancer immunotherapy targeting human epidermal growth factor receptor (HER2) expressing cancers. NeuVax is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established and validated target for therapeutic intervention in breast and gastric carcinomas. The NeuVax vaccine is combined with GM-CSF for injection under the skin, or intradermal administration. Data has shown that an increased presence of circulating tumor cells (CTCs) may predict Disease Free Survival (DFS) and Overall Survival (OS)-suggesting a dormancy of isolated micrometastases, which, over time, may lead to recurrence. After binding to specific HLA molecules on antigen presenting cells, the nelipepimut-S sequence stimulates specific cytotoxic T lymphocyte (CTLs). These activated CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.
Breast Cancer: According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. While improved diagnostics and targeted therapies have decreased breast cancer mortality in the U.S., metastatic breast cancer remains incurable. Approximately 75% of breast cancer patients have tissue test positive for some increased amount of the HER2 receptor, which is associated with disease progression and decreased survival. Only approximately 20% to 30% of all breast cancer patients-those with HER2 immunohistochemistry (IHC) 3+ disease, or IHC 2+ and fluorescence in situ hybridization (FISH) positive-have a HER2 directed, approved treatment option available. This leaves the majority of breast cancer patients with low-to-intermediate HER2 IHC 1+/2+ ineligible for therapy and without an effective targeted treatment option to prevent cancer recurrence.
We have multiple trials currently ongoing for NeuVax. For our pivotal, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node- Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial, NeuVax is targeting the 30,000-40,000 of the 230,000 female breast cancer patients annually diagnosed in the U.S. who are at a higher risk of their breast cancer recurring, which we refer to as “disease recurrence,” after achieving “no evidence of disease” (NED) status, (or becoming a “survivor”) with standard-of-care therapy (surgery, chemotherapy, radiation). These high-risk patients have a particular molecular signature and disease status: HER2 IHC 1+/2+ (oncoprotein associated with aggressive tumor growth), node positive (disease present in the axillary lymph nodes prior to surgery), and HLA A2/A3 (human leukocyte antigen from A2/A3 patients who have the same loci of genes which represents approximately 65% of the population). Up to 25% of resectable, node-positive breast cancer patients, having no radiographic evidence of disease following surgery and adjuvant chemo/radiation therapy, are expected to relapse within three years following diagnosis. The prognosis upon recurrence is very poor. These cancer patients presumably still had isolated, undetected tumor CTCs that led to a recurrence of cancer in the breast (local recurrence) or in another location (metastatic disease). In addition to our Phase 3 trial, we currently have two additional Phase 2 breast cancer trials ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche) targeting the prevention of recurrence in expanded indications.
We also recently announced our intent to initiate a Phase 2 trial with NeuVax as a single agent in patients with ductal carcinoma in situ (DCIS) in collaboration with the National Cancer Institute (NCI), potentially transitioning NeuVax earlier in the treatment cycle towards primary prevention. The trial will have an immunological endpoint evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients. DCIS, is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues, and at this time, there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2014 there were an estimated 51,933 diagnoses of DCIS.



29

We currently have a number of ongoing or planned clinical trials designed to expand the clinical and geographical footprint of NeuVax:
•
Phase 3 Ongoing: Our Phase 3 PRESENT (Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study targeted enrollment of 700 HER2 1+/2+ patients under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). The multinational, multicenter, randomized, double-blinded PRESENT trial is ongoing in North America, Western and Eastern Europe, and Israel. The trial is fully enrolled with 758 patients.
•
Phase 2b Ongoing: A randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial is enrolling HER2 1+/2+ node-positive and high-risk node-negative breast cancer patients who are HLA A2+, A3+, A24+ or A26+ to study NeuVax in combination with trastuzumab in the adjuvant setting. This trial is co-funded by Genentech/Roche (providing both trastuzumab and monetary support) and Galena (providing NeuVax and monetary support).
•
Phase 2 Ongoing: An investigator-sponsored trial is ongoing to study NeuVax in combination with trastuzumab. The study will enroll 100 node positive and negative HER2 IHC 3+ patients or HER2 gene-amplified breast cancer patients who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence. Partial funding for this trial comes from the Department of Defense (DoD) through the Congressionally Directed Medical Research Program via legislation known as the Defense Appropriations Act. The grant was awarded under a Breast Cancer Research Program with the Breakthrough Award given to the lead investigator for the trial.
•
Phase 2 Planned: A clinical trial, entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast is planned to initiate by the end of 2015/early 2016. The Phase 2 trial will be a single-blind, double arm, randomized, controlled trial in pre- or post-menopausal patients with DCIS and are HLA-A2 positive. VADIS will be co-funded and run in collaboration with the National Cancer Institute (NCI).
•
Phase 2 Planned: A Phase 2 clinical trial in patients with gastric cancer is expected to initiate in 2016. The trial will be run in India by our partner, Dr. Reddy’s Laboratories, Ltd., as part of our NeuVax commercialization agreement in that region with Dr. Reddy’s.
Gastric Cancer: Gastric cancer (also known as stomach cancer) is a disease in which the cells forming the inner lining of the stomach become abnormal and start to divide uncontrollably, forming a cancerous tumor mass. Cancer can develop in any of the five sections of the stomach. Symptoms and outcomes of the disease will vary depending on the location of the cancer. Stomach cancer is one of the leading causes of cancer deaths in several areas of the world, most notably Republic of Korea and other Asian countries. Annually, almost one million people will be diagnosed worldwide with stomach cancer and over 700,000 will die from the disease. More than 90% of stomach cancers are caused by adenocarcinomas, malignant cancers that originate in glandular tissues. Overexpression of the HER2 receptor occurs in approximately 20% of gastric and gastro-esophageal junction adenocarcinomas, predominantly those of the intestinal type. Overall, without regard to the stage of cancer, only approximately 28% of patients with stomach cancer live at least five years following diagnosis and new adjuvant treatments are needed to prevent disease recurrence


30

GALE-301 and GALE-302

Our second immunotherapy franchise targets folate binding protein (FBP) receptor-alpha, a well-validated therapeutic target, which is highly over-expressed (20-80 fold) in ovarian, endometrial and breast cancers. Both GALE-301 (E39) and GALE-302 (E39’) are immunogenic peptides that can stimulate CTLs to recognize and destroy FBP-expressing cancer cells. GALE-301 consists of the FBP peptide E39 combined with GM-CSF, and is currently in a Phase 2a clinical trial for the prevention of recurrence in patients with ovarian and endometrial cancers. GALE-302 is an attenuated version of the E39 peptide and is currently in a Phase 1b randomized, single-center trial investigating a novel vaccination series using GALE-301 and GALE-302 to evaluate the immune response and monitor long-term immunity. Current treatments after surgery for these diseases are principally with platinum based chemotherapeutic agents and patients suffer a high recurrence rate; and, most patients relapse with an extremely poor prognosis. Although not powered for efficacy, promising preliminary results from the Phase 2a clinical trial of GALE-301 were presented in September 2015 at the European Cancer Congress and demonstrated statistically significant data with the estimate for disease free survival at two years at 85.7% (1000 mcg dose group) vs. 33.6% for the control group (p < .02), and that GALE-301 was well-tolerated with primarily Grade 1 and 2 toxicities and elicited a strong in vivo immune response.

Ovarian and Endometrial Cancer: According to the NCI Surveillance, Epidemiology, and End Results (SEER) Program, new cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015.  Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 - 2012 data).  The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse. Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%. Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.

According to the NCI SEER Program, new cases of endometrial cancer occur at an annual rate of 25.1 per 100,000 women in the U.S., with an estimated 54,870 cases for 2015. Although endometrial cancer represents about 3.3% of all cancers, it represents about 1.7% of all cancer deaths, or an estimated 10,170 deaths in 2015.  Approximately 2.8% of women will be diagnosed with endometrial cancer at some point during their lifetime (2010 - 2012 data).  The prevalence of endometrial cancer in the U.S. is about 620,000 women, and the five-year survivorship for women with endometrial cancer is 81.7%. 

Hematology

GALE-401 (anagrelide controlled release (CR))

In January 2014, we announced the acquisition of the worldwide rights to anagrelide controlled release (CR), which we renamed GALE-401, through our acquisition of Mills Pharmaceuticals, LLC. GALE-401 contains the active ingredient anagrelide, an FDA-approved product, for the treatment of patients with myeloproliferative neoplasms (MPNs) to lower abnormally elevated platelet levels. The currently available immediate release (IR) version of anagrelide causes adverse events that are believed to be dose and plasma concentration dependent. Therefore, reducing the maximum concentration (Cmax) is hypothesized to reduce the side effects, but preserve efficacy.


31

Multiple Phase 1 studies in 98 healthy subjects have shown GALE-401 reduces the Cmax of anagrelide following oral administration, appears to be well-tolerated at the doses administered, and to be capable of reducing platelet levels. The Phase 1 program provided the desired PK/PD (pharmacokinetic/pharmacodynamic) profile to enable the initiation of the ongoing Phase 2 proof-of-concept trial. The Phase 2, open label, single arm, proof-of-concept trial enrolled 18 patients in the United States for the treatment of thrombocytosis, or elevated platelet counts in patients with MPNs. Phase 2 top-line safety and efficacy data was presented in June 2015 at the European Hematology Association 20th Congress, and we expect to present a more mature data set at the 57th American Society of Hematology Annual Meeting in December 2015. Based on a regulatory meeting with the FDA, Galena believes a 505(b)(2) regulatory filing is an acceptable pathway for development and potential approval of GALE-401.

Myeloproliferative neoplasms: MPNs are a closely related group of hematological malignancies in which the bone marrow cells that produce the body’s blood cells develop and function abnormally. The main MPNs are Polycythemia Vera (PV), Essential Thrombocythemia (ET), Primary Myelofibrosis (PMF), and Chronic Myelogenous Leukemia (CML), all of which are associated with high platelet counts. The MPNs are progressive blood cancers that can strike anyone at any age, and for which there is no known cure.

Strategic Review of Commercial Operations

During the quarter ended September 30, 2015, we completed a strategic review of the company’s commercial business including the ongoing sale, distribution and marketing of our two commercial products, Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film (our “commercial business” asset group). As a result of the review, we made a determination to sell or otherwise dispose of our commercial business.

Abstral® (fentanyl) Sublingual Tablets

Abstral® (fentanyl) Sublingual Tablets, is a treatment option for inadequately controlled breakthrough cancer pain (BTcP), which is estimated to affect more than 50% of all cancer patients. Abstral is approved by the FDA, and is a sublingual (under the tongue) tablet for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a sublingual tablet that is designed to dissolve under the tongue in seconds and provide relief of breakthrough pain within minutes. Abstral is a transmucosal immediate release fentanyl (TIRF) product with product class oversight by the TIRF Risk Evaluation and Mitigation Strategy (REMS) access program.
Zuplenz® (ondansetron) Oral Soluble Film

Zuplenz® (ondansetron) Oral Soluble Film, is approved by the FDA in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients treated with moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. Zuplenz utilizes MonoSol’s proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than 30 seconds, therefore eliminating the burden of swallowing pills during periods of emesis. The active pharmaceutical ingredient in Zuplenz, ondansetron, belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.



32


Recent Operational Developments (in reverse chronological order)

GALE-302 Immunological Data Optimizing GALE-301 Presented - We presented preliminary immunologic data for our GALE-301 and GALE-302 Phase 1b clinical trial at the Society for Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting.
On November 7, 2015 we presented the poster, entitled, "Preliminary report of a clinical trial supporting the sequential use of an attenuated E39 peptide (E39’) to optimize the immunologic response to the FBP (E39+GM-CSF) vaccine," that compared three primary vaccine series (PVS) sequences of GALE-301 (E39) and GALE-302 (E39’) in ovarian and breast cancer patients to optimize the ex vivo immune responses, local reactions (LR), and delayed type hypersensitivity (DTH) reactions. The data demonstrated that the in vivo immune response is enhanced with the use of the attenuated E39’ (GALE-302) after E39 (GALE-301). The optimal vaccination sequence utilizing three inoculations of GALE-301 followed by three inoculations of GALE-302 produced the most prominent and statistically significant LR and DTH responses.

Patent Infringement Litigation - We have settled the patent infringement litigation involving Abstral.

On October 23, 2015, we, Orexo AB and Actavis Laboratories Fl, Inc. (“Actavis”) entered into a settlement and license agreement, which will permit Actavis to enter the market with a generic or authorized generic version of Abstral in June 2018 or earlier under certain circumstances. The litigation, Orexo AB v. Actavis Laboratories FL, Inc., CA No. 3:15-cv-00826, has been dismissed with prejudice by the United States District Court for the District of New Jersey and the agreement has been filed with the Federal Trade Commission and the Department of Justice under applicable law.

Strategic Review of Commercial Operations - We conducted a strategic review of our commercial operations and decided to divest our commercial assets and discontinue our commercial operations.

During the quarter ended September 30, 2015, we completed a strategic review of the commercial assets and operations and have decided to focus our resources on our pipeline of product development candidates. As a result, we have decided to sell or otherwise dispose of our marketed products, Abstral and Zuplenz, and discontinue our commercial operations.

Collaboration with the National Cancer Institute on NeuVax - We announced a Phase 2 clinical trial with NeuVax in Ductal Carcinoma in Situ Patients.
On September 30, 2015, we announced a collaboration with the National Cancer Institute (NCI) to initiate a Phase 2 clinical trial with NeuVax in patients diagnosed with Ductal Carcinoma in Situ (DCIS). The trial will be entitled VADIS: Phase 2 trial of the Nelipepimut-S Peptide Vaccine in Women with DCIS of the Breast. The University of Texas M.D. Anderson Cancer Center (MDACC) Cancer Prevention Agent Development Program, Early Phase Clinical Research Consortium Organization will be the lead clinical trial site for this multi-center trial. The Consortium is funded through the Division of Cancer Prevention at NCI, which will provide financial and administrative support for the trial. We will provide NeuVax, as well as additional financial and administrative support. The single-blind, double arm, randomized, controlled trial is expected to initiate in the fourth quarter of 2015/first quarter of 2016.
GALE-301 Phase 2a Clinical Trial Data Presented - We announced positive data for our GALE-301 Phase 2a clinical trial.
On September 28, 2015 we announced the poster presentation of positive data from the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial at the European Cancer Congress 2015, providing updated data for all ovarian and endometrial cancer patients who have received at least twelve months of treatment on the study. The poster was entitled, entitled, Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine GALE-301 (E39) + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence, and as presented, the clinical recurrence rate based on all treatment cohorts was 41% in the Vaccine Group (VG) (n=29) versus 55% in the Control Group (CG) (n=22), p=0.41. However, in the 1000 mcg VG cohort (n=15), there have only been two clinical recurrences (13.3% versus 55% CG, p=0.02), and the two-year Disease Free Survival (DFS)

33


estimate is 85.7% (1000 mcg patients) versus 33.6% (CG), p < 0.02, as compared by Kaplan-Meir and Log rank tests. Safety, immunologic, and clinical recurrence data are continuing to be collected. 
IDMC Recommends Reduction in Cardiac Monitoring in the PRESENT Trial - We announced that the Independent Data Monitoring Committee (IDMC) for the NeuVax Phase 3 clinical trial recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in our PRESENT study.
On August 24, 2015 we announced that the Independent Data Monitoring Committee (IDMC) for the NeuVax Phase 3 clinical trial recommended to the Company that we can reduce the cardiac toxicity monitoring for patients in our PRESENT study. Following its most recent meeting in June 2015, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.
GALE 401 Phase 2 Clinical Trial Data Presented - We presented data from our Phase 2 clinical trial of GALE-401 at the European Hematology Association 20th Congress
On June 15, 2015, we announced our poster presentation entitled Phase 2 Study of a Novel Controlled-Release Formulation of Anagrelide (GALE-401) in Subjects with Myeloproliferative Neoplasm (MPN)-Related Thrombocytosis, which was presented on June 13, 2015. The Phase 2 study demonstrated that GALE-401 was well tolerated with primarily Grade 1 and 2 toxicities in 16 of the 18 subjects enrolled. The efficacy shown in the trial compares favorably to historical anagrelide immediate release (IR) response rates with the following platelet response: overall response rate (ORR) of 78% (14/18); complete response (CR) of 39% (7/18); partial response (PR) of 39% (7/18). The median time to response was 5 weeks (range, 3-10), and the median duration of response has not yet been reached.
Published Abstracts related to GALE-301 and Leica Biosystem’s Companion Diagnostic - We presented two abstract publications at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
On May 27, 2015, we announced two abstract publications at the ASCO 2015 Annual Meeting related to our cancer immunotherapy programs:
We presented data related to GALE-301 in abstract #e14031, entitled, Preliminary Results of the Phase I/IIa Dose Finding Trial of a Folate Binding Protein Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence. The more mature data set from this trial was presented in September 2015 as mentioned above.
We presented data related to our NeuVax Phase 3 PRESENT trial companion diagnostic in abstract #e11609, entitled, Analytical Validation of BOND Oracle HER2 IHC System for Identifying Low to Intermediate HER2 Expressing Breast Cancer in NeuVax PRESENT Phase 3 Clinical Trial. This data demonstrated a direct correlation between cell line receptor load, quantitative measure of HER2 protein, and IHC score. The ability to discriminate HER2 protein expression at the low and intermediate levels in breast cancer tumors will identify patients for new treatments in development such as NeuVax. Specifically, the validation of the Bond Oracle HER2 IHC System to distinguish lower levels of HER2+ expressions supports its use as a companion diagnostic.
NeuVax Phase 3 PRESENT Over-Enrollment Completed - We announced the completion of enrollment in our NeuVax Phase 3 PRESENT clinical trial.
On April 14, 2015, we announced the completion of enrollment in the NeuVax™ Phase 3 PRESENT clinical trial. As anticipated, we over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The PRESENT protocol called for 700 patients; and we expect this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after a total of 141 events (recurrence or death) occur, or the last patient dosed reaches her 36th month of treatment, whichever comes later.

34


Expanded Patient Population in NeuVax Combination Trial - We announced the expansion of the patient population in the NeuVax and trastuzumab combination trial in HER2 1+/2+ patients to include HLA A24+ or HLA-A26+ patients.
On March 26, 2015, we announce that women with the human leukocyte antigen (HLA) - A24+ or HLA-A26+ allele are now eligible for enrollment into the ongoing Phase 2b clinical trial with NeuVax in combination with trastuzumab. The trial evaluates node positive and triple negative, node negative breast cancer patients with immunohistochemistry (IHC) HER2 1+/2+ expressing tumors who are disease-free after standard of care therapy.
Enrolled 700th Patient in NeuVax Phase 3 PRESENT Clinical Trial -We announced enrollment of the 700th patient in our Phase 3 PRESENT clinical trial.
On February 9, 2015, we announced the enrollment in the NeuVax Phase 3 PRESENT clinical trial of the 700th patient, which is the patient enrollment target as defined by the PRESENT Phase 3 clinical trial protocol.





35

Results of Operations for the Three and Nine Months Ended September 30, 2015 and 2014

Our net loss for the three months ended September 30, 2015 increased approximately $11.9 million, primarily attributable to a $8.1 million impairment charge from classification of our commercial asset group as held for sale for the three months ended September 30, 2015 and a $6.7 million non-cash gain on our warrant liability for the three months ended September 30, 2014, compared to a $2.1 million non-cash gain on our warrant liability for the three months ended September 30, 2015. This was partially offset by a $1.9 million reduction in operating loss for the three months ended September 30, 2015 compared to the three months ended September 30, 2014.

(dollars in thousands)
Three Months Ended September 30,
 
2015
 
2014
 
% Change
Operating loss
$
(8,635
)
 
$
(10,567
)
 
18
 %
Non-operating income (expense)
2,283

 
7,035

 
(68
)%
Loss from discontinued operations
(11,674
)
 
(2,641
)
 
(342
)%
Net loss
$
(18,026
)
 
$
(6,173
)
 
(192
)%
 
 
 
 
 
 
Net loss per common share:
 
 
 
 
 
Basic and diluted net loss per share, continuing operations
$
(0.04
)
 
$
(0.03
)
 
(33
)%
Basic and diluted net loss per share, discontinued operations
$
(0.07
)
 
$
(0.02
)
 
(250
)%
Basic net loss per share
$
(0.11
)
 
$
(0.05
)
 
(120
)%

Or net loss for the nine months ended September 30, 2015 increased approximately $15.6 million, primarily attributable to a $8.1 million impairment charge from classification of our commercial asset group as held for sale for the three months ended September 30, 2015 and a $13.2 million non-cash gain on our warrant liability for the nine months ended September 30, 2014, compared to a $1.0 million non-cash loss on our warrant liability for the nine months ended September 30, 2015. This was partially offset by a $7.6 million reduction in operating loss for the nine months ended September 30, 2015 compared to the nine months ended September 30, 2014.

(dollars in thousands)
Nine Months Ended September 30,
 
2015
 
2014
 
% Change
Operating loss
$
(26,631
)
 
$
(34,207
)
 
22
 %
Non-operating income (expense)
(1,519
)
 
12,190

 
(112
)%
Loss from discontinued operations
(16,074
)
 
(6,633
)
 
(142
)%
Net loss
$
(44,224
)
 
$
(28,650
)
 
(54
)%
 
 
 
 
 
 
Net loss per common share:
 
 
 
 
 
Basic and diluted net loss per share, continuing operations
$
(0.18
)
 
$
(0.19
)
 
5
 %
Basic and diluted net loss per share, discontinued operations
$
(0.11
)
 
$
(0.06
)
 
(83
)%
Basic net loss per share
$
(0.29
)
 
$
(0.25
)
 
(16
)%


36

Research and Development Expense

Research and development expense consists primarily of clinical trial expenses, compensation-related costs for our employees dedicated to research and development activities, compensation paid to our Scientific Advisory Board (“SAB”) members, and licensing fees and patent prosecution costs. Research and development expense for the three and nine months ended September 30, 2015 and 2014, respectively, was as follows (dollars in thousands):

 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
% Change
 
2015
 
2014
 
% Change
Research and development expense
$
5,740

 
$
7,025

 
(18
)%
 
$
18,762

 
$
21,463

 
(13
)%

The decreases of 18% and 13% for the three and nine months ended September 30, 2015 compared to the three and nine months ended September 30, 2014 in research and development expense was primarily related to the completion of our enrollment efforts for the Phase 3 PRESENT clinical trial in the second quarter of 2015. We expect research and development expense related to our PRESENT trial to decrease throughout 2015 as we transition to the monitoring and follow-up phase. The expected decrease in costs could be partially offset by the increase in research and development expense related to enrollment efforts in our NeuVax combination clinical trials, ongoing trial costs related to our GALE-301 Phase 2 clinical trial, and completion of our Phase 2 clinical trial of the GALE-401 program.

General and Administrative Expense

General and administrative expense includes compensation-related costs for our employees dedicated to general and administrative activities, legal fees, audit and tax fees, consultants and professional services, and general corporate expenses. General and administrative expense for the three and nine months ended September 30, 2015 and 2014, respectively, was as follows (dollars in thousands):

 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
% Change
 
2015
 
2014
 
% Change
General and administrative expense
$
2,895

 
$
3,542

 
(18
)%
 
$
7,869

 
$
12,744

 
(38
)%

The 18% and 38% decreases in selling, general, and administrative expense for the three and nine months ended September 30, 2015 compared to the three and nine months ended September 30, 2014, respectively, was driven by the $0.7 million and $3 million incurred in legal expenses during the three and nine months ended September 30, 2014, respectively, related to the ongoing litigation and proceedings described in Part II, Item 1 of this report. During the third quarter of 2014 we exceeded the retention (deductible) under our insurance policy and have been realizing significant insurance recoveries against the fees associated with the litigation and proceedings referenced above.

Non-Operating Income

Non-operating income for the three and nine months ended September 30, 2015 and 2014, respectively, was as follows (dollars in thousands):
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
% Change
 
2015
 
2014
 
% Change
Change in fair value of warrants potentially settleable in cash
$
2,134

 
$
6,735

 
(68
)%
 
$
(981
)
 
$
13,174

 
(107
)%
Interest income (expense), net
(158
)
 
(297
)
 
(47
)%
 
(607
)
 
(925
)
 
(34
)%
Other income (expense)
307

 
597

 
(49
)%
 
69

 
(59
)
 
(217
)%
Total non-operating income (expense), net
$
2,283

 
$
7,035

 
(68
)%
 
$
(1,519
)
 
$
12,190

 
(112
)%

37

The decrease in our non-operating income (increase in our net non-operating expense) during the three and nine months ended September 30, 2015 compared to the three and nine months ended September 30, 2014 was primarily due to a increase in the change in fair value of warrants accounted for as liabilities. This increase in the estimated fair value of our warrant liabilities was primarily due to the increase in our common stock price, which is one of the most impactful inputs into the pricing model we use to estimate the fair value of our warrant liabilities.

Income Taxes

For the three and nine months ended September 30, 2015 and 2014, there was no income tax benefit or expense recognized.

Discontinued Operations

During the quarter ended September 30, 2015, we conducted a strategic review of our commercial business and operations, and as a result of that review have decided to sell or otherwise divest our commercial business. We believe this disposition will allow us to focus our resources on our valuable and expanding clinical development programs and maximize the value of these assets to our shareholders.

The following table represents the components attributable to the commercial operations that are presented in the consolidated statement of operations as discontinued operations (in thousands):
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2015
 
2014
 
2015
 
2014
Net revenue
$
2,166

 
$
1,620

 
$
8,298

 
$
6,124

Cost of revenue
(712
)
 
(247
)
 
(1,573
)
 
(925
)
Amortization of certain acquired intangible assets
(208
)
 
(70
)
 
(795
)
 
(259
)
Research and development
(160
)
 
(219
)
 
(339
)
 
(619
)
Selling, general, and administrative
(4,672
)
 
(3,725
)
 
(13,577
)
 
(10,954
)
Non-operating income (loss)
(17
)
 
—

 
(17
)
 
—

Impairment charge from classification of assets held for sale
(8,071
)
 
—

 
(8,071
)
 
—

Loss from discontinued operations
$
(11,674
)
 
$
(2,641
)
 
$
(16,074
)
 
$
(6,633
)

Discontinued operations comprise net revenue, cost of revenue, and expenses attributable to our commercial operations, which we plan to divest.

•Net Revenue included in discontinued operations comprises revenue from the sale of Abstral, which were provided by our commercial operations.

•Cost of revenue included in discontinued operations consists of direct products costs and related overhead, Abstral royalties based on net revenue, inventory obsolescence, and other direct costs.

•Research and development expense included in discontinued operations consists of expenses related to our Abstral RELIEF trial and other product stability costs.

•Selling, general and administrative included in discontinued operations consists of all other expenses of our commercial operations that are required in order to market and sell our marketed products. These expenses include all personnel related costs, marketing, data, consulting, legal, consulting, and other outsider services necessary to support the commercial operations.

•Impairment charge from classification of assets held for sale included in discontinued operations relates the carrying value of the intangible assets, net that was in excess of fair value by $8.1 million for the three and nine months ended September 30, 2015.


38

Liquidity and Capital Resources

We had cash and cash equivalents of approximately $34.8 million as of September 30, 2015, compared with $23.7 million as of December 31, 2014.
 
The increase of approximately $11.2 million in our cash and cash equivalents from December 31, 2014 to September 30, 2015 was attributable primarily to $47.4 million in net proceeds from issuance of common stock and warrants to purchase common stock, partially offset by $32.9 million used in operating activities, $2.9 million in payments on long-term debt, and $0.5 million for a milestone related to our acquisition of U.S. rights to Zuplenz.

On March 18, 2015, we announced the closing of our underwritten public offering of 24,358,974 shares of common stock and 12,179,487 warrants to purchase our common stock at an exercise price of $2.08. The underwriters also exercised their over-allotment option to purchase warrants to purchase an aggregate of 1,826,923 shares of our common stock. On April 10, 2015 the underwriters exercised their option to purchase an additional 3,653,846 shares of common stock for additional net proceeds of $5.4 million. The total net proceeds to us were approximately $40.8 million.

We expect to continue to incur losses from our discontinued operations in the fourth quarter of 2015 as management actively focuses on locating a buyer for our commercial operations. In the absence of revenue from the commercialization of Abstral, Zuplenz or our product candidates, our potential sources of operational funding are proceeds from the sale of equity and funded research and development payments and payments received under partnership and collaborative agreements.

Cash Flows

The following table summarizes our cash flows from operating, investing, and financing activities for the nine months ended September 30, 2015 and September 30, 2014 ($ in thousands):

 
For the Nine Months Ended September 30,
 
2015
 
2014
Cash flows from continuing operations:
 
 
 
Cash flows used in continuing operating activities
$
(27,829
)
 
$
(28,743
)
Cash flows used in continuing investing activities
(282
)
 
(2,363
)
Cash flows provided by continuing financing activities
44,854

 
14,414

Total cash flows provided by (used in) continuing operating activities
16,743

 
(16,692
)
 
 
 
 
Cash flows from discontinued operations:
 
 
 
Cash flows used in discontinued operating activities
(5,047
)
 
(3,392
)
Cash flows used in discontinued investing activities
(534
)
 
(3,056
)
Total cash flows provided by (used in) discontinued operating activities
(5,581
)
 
(6,448
)
 
 
 
 
Total cash flows:
 
 
 
Cash flows used in operating activities
(32,876
)
 
(32,135
)
Cash flows used in investing activities
(816
)
 
(5,419
)
Cash flows provided by financing activities
44,854

 
14,414

Total increase (decrease) in cash and cash equivalents
$
11,162

 
$
(23,140
)


39

Net Cash Flow from Operating Activities

Net cash used in operating activities increased $0.7 million for the nine months ended September 30, 2015, compared to the nine months ended September 30, 2014. The increase in cash used in operating activities was driven by an increase of $1.7 million cash used in our discontinued operations activities, partially offset by a reduction of $0.9 million for the continuing operating activities. The increase in total net cash used in continuing operating activities was due to a $11.4 million increase in non-cash charges, partially offset by an increase in net loss from continuing operations of $6.1 million and an increase in payments on accounts payable and other current liabilities of $4.7 million for the nine months ended September 30, 2015, compared to the nine months ended September 30, 2014.

Net Cash Flow from Investing Activities

Net cash used in investing activities was $0.8 million for the nine months ended September 30, 2015, compared with $5.4 million for the nine months ended September 30, 2014. The decrease was due to the $2.1 million initial payment for GALE-401 rights and the $3.1 million initial cash payment for U.S. right to Zuplenz during the nine months ended September 30, 2014 compared to the $0.5 million milestone payment for U.S. rights to Zuplenz during the nine months ended September 30, 2015.

Net Cash Flow from Financing Activities

Net cash provided by financing activities was $44.9 million for the nine months ended September 30, 2015, compared with $14.4 million for the nine months ended September 30, 2014. The increase was primarily attributable to $42.2 million in net proceeds from the issuance of common stock and warrants to purchase common stock during the nine months ended September 30, 2015 compared to net proceeds of common stock warrant exercises of $10.7 million and net proceeds of common stock option exercises of $4.1 million during the nine months ended September 30, 2014. The cash flows provided by financing activities were partially offset by principle payments on long-term debt of $2.9 million and $0.9 million for the nine month periods ended September 30, 2015 and 2014, respectively.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet financing arrangements other than operating leases.

Critical Accounting Policies and Estimates

In our Annual Report on Form 10-K for the year ended December 31, 2014, we disclosed our critical accounting policies and estimates upon which our financial statements are derived. There have been no changes to these policies since December 31, 2014 that are not included in Note 1 of the accompanying condensed consolidated financial statements for the three and nine months ended September 30, 2015. Readers are encouraged to read our Annual Report on Form 10-K in conjunction with this report.

 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

The primary objective of our investment activities is to preserve capital. We do not utilize hedging contracts or similar instruments.

We are exposed to certain market risks relating primarily to interest rate risk on our cash and cash equivalents and risks relating to the financial viability of the institutions which hold our capital and through which we have invested our funds. We manage the latter risks by investing primarily in money market mutual funds.
In addition, we are exposed to foreign currency exchange rate fluctuations relating to payments we make to certain vendors and suppliers and license partners using foreign currencies. We do not hedge against foreign currency risks. Consequently, changes in exchange rates could adversely affect our operating results and stock price. Such losses have not been significant to date.


40

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

As of the end of the period covered by this quarterly report on Form 10-Q, our principal executive officer and our principal financial officer (the “Certifying Officers”), evaluated the effectiveness of our disclosure controls and procedures. Disclosure controls and procedures are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 (the “Exchange Act”), such as this quarterly report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. Disclosure controls and procedures are also designed to reasonably assure that such information is accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure. Based on these evaluations, the Certifying Officers have concluded, that, as of the end of the period covered by this quarterly report on Form 10-Q:

(a)
our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and

(b)
our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during the three months ended September 30, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


41

PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Legal Proceedings

In re Galena Biopharma, Inc. Securities Litigation and In Re Galena Biopharma, Inc. Derivative Litigation

On August 4, 2015, plaintiffs in the voluntarily dismissed Delaware derivative action have filed a motion seeking to file under seal a derivative complaint in the District Court. That motion was granted and on August 31, 2015, that action was consolidated with In Re Galena Biopharma, Inc. Derivative Litigation.

On or about September 15, 2015, a federal securities lawsuit was filed in the U.S. District Court for the District of Oregon entitled, Riley v. Galena Biopharma, Inc., et al. The time to answer or otherwise plead has been extended by agreement of the parties.

We intend to vigorously defend against and seek resolution to the foregoing claims. As of September 30, 2015, we have not recorded any liabilities with respect to the claims in our consolidated financial statements. We believe that claims are covered under our liability insurance, and we have notified our insurance carriers of the claims. The insurers have responded by requesting additional information and by reserving their rights under the policies, including the rights to deny coverage under various policy exclusions. Subject to their reservation of rights, we are being reimbursed by our insurance carriers for significant portion of all legal fees relating to our defense of the claims. We have entered into certain undertaking agreements with our directors related to the litigation by which we have agreed to advance reasonable legal fees and costs for the litigation under certain conditions.

SEC Investigation

We are aware that the Securities and Exchange Commission (SEC) is investigating certain matters relating to the use of certain outside investor-relations professionals by us and other public companies. We have been in contact with the SEC staff through our counsel and are cooperating with the investigation.

ANDA Litigation

On October 23, 2015, Orexo AB (“Orexo”) and Galena Biopharma, Inc. (the “Company”) entered into a settlement and license agreement with Actavis Laboratories FL, Inc. (“Actavis”) to resolve pending patent litigation brought by the Orexo against Actavis involving Abstral® (fentanyl) sublingual tablets. The pending patent litigation was filed by Orexo in the U.S. District Court for the District of New Jersey in response to Actavis’ submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”), seeking marketing approval for a generic version of Abstral. As a result of the settlement and license agreement, Actavis will be permitted to enter the market with a generic or authorized generic version of Abstral in the United States June 2018 or earlier under certain circumstances. The Court has entered an order dismissing with prejudice the litigation against Actavis. Details of the settlement are confidential, and the parties have submited the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law. The expiration date for the latest expiring Abstral patent listed in the FDA’s Orange Book is September 2019.





42

ITEM 1A. RISK FACTORS

In addition the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2014 and in our previously filed Quarterly Reports on Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015 filed with the SEC, you should consider the following new or updated risk factors:

Risks Related to Our Business
We have determined to sell or otherwise dispose of our marketed products, Abstral, and Zuplenz, and we do not know whether the process will result in significant value for our stockholders.
We have determined to sell or otherwise dispose of our marketed products, Abstral and Zuplenz, and discontinue our commercial operations in order to focus our resources on our clinical development programs. There can be no assurance that any sale of our marketed products could be completed in a timely manner, on a cost-effective basis, on terms favorable to us, or at all. The sale of assets entails numerous potential risks, including:
•
diversion of resources and management’s attention from the operation of our business;
•
loss of key employees in anticipation of or following such a sale;
•
insufficient sale proceeds to offset transaction-related expenses;
•
negative effects on our reported results of operations from discontinued operations, disposition-related charges, amortization of expenses related to intangibles and charges for impairment of long-term assets; and
•
damage to our existing investor, customer and supplier relationships.

If there is not sufficient interest from potential purchasers, we may seek to transfer Abstral and Zuplenz back to the companies from which we acquired the products, and cease our commercial operations, including separating our commercial operation employees. We do not know whether or at what cost we would be able to transfer the products, or if there would be any continuing obligations required of us following the transfer of either or both products. We would expect to incur significant costs associated with separating our commercial operations employees from our company.
We believe that our strategy will result in significant future net savings to us, but there is no assurance that we will obtain any significant proceeds from the sale or other disposition of our commercial operations or that the process will result in significant value for our stockholders. If we sell or discontinue our commercial operations, we will have no recurring revenue unless and until we are able to obtain marketing approval of one or more of our product candidates.
We are subject, directly or indirectly, to U.S. federal and state health care fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such investigations or litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.
Our commercial operations are directly, or indirectly through our customers and health care professionals, subject to various U.S. federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, federal False Claims Act, federal Sunshine Act, and federal Foreign Corrupt Practices Act. These laws may impact, among other things, our product sales, and marketing and education programs.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made under a federal health care program such as the Medicare and Medicaid programs. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal health care covered business, the statute has been violated. The Anti-Kickback Statute is broad, and despite a series of narrow safe harbors, prohibits many arrangements and practices that are lawful in businesses outside of the health care industry. Penalties for violations of the federal Anti-Kickback Statute include criminal penalties and civil and administrative sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal health care programs. An alleged violation of the Anti-Kickback Statute may be used as a predicate offense to establish liability pursuant to other federal laws and regulations such as the federal False Claims Act. Many states

43

have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for health care items or services reimbursed by any source, not only Medicare and Medicaid programs.
The federal False Claims Act prohibits persons from knowingly filing, or causing to be filed, a false claim to, or the knowing use of false statements to obtain payment from, the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “relators” or “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of health care companies to have to defend a False Claim Act action. The federal Patient Protection and Affordable Care Act includes provisions expanding the ability of certain relators to bring actions that would have been dismissed under prior law. When an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. The Deficit Reduction Act of 2005 encouraged states to enact or modify their state false claims acts to be at least as effective as the federal False Claims Act by granting states a portion of any federal Medicaid funds recovered through Medicaid-related actions. Most states have enacted state false claims laws, and many of those states included laws including qui tam provisions.
The federal Patient Protection and Affordable Care Act includes provisions known as the Physician Payments Sunshine Act, which requires manufacturers of drugs, biologics, devices and medical supplies covered under Medicare and Medicaid to record any transfers of value to physicians and teaching hospitals and to report this data beginning in 2013 to the Centers for Medicare and Medicaid Services for subsequent public disclosures. Manufacturers must also disclose investment interests held by physicians and their family members. Failure to submit the required information may result in civil monetary penalties of up to $1 million per year for knowing violations and may result in liability under other federal laws or regulations. Similar reporting requirements have also been enacted on the state level in the U.S., and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with health care professionals. In addition, some states such as Massachusetts and Vermont imposed an outright ban on certain gifts to physicians. These laws could affect our product promotional activities by limiting the kinds of interactions we could have with hospitals, physicians or other potential purchasers or users of our system. Both the disclosure laws and gift bans also will impose administrative, cost and compliance burdens on us.
We are unable to predict whether we could become subject to actions under any of these laws, or the impact of such actions. If we are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, or an administrative action of suspension or exclusion from government health care reimbursement programs and the curtailment or restructuring of our commercial operations.
In addition, to the extent we commence commercial operations and conduct clinical trials overseas, we will be subject to the Foreign Corrupt Practices Act and other countries’ anti-corruption/anti-bribery regimes, such as the U.K. Bribery Act. The Foreign Corrupt Practices Act prohibits improper payments or offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business. Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, sales agents or distributors may be ineffective, and violations of the Foreign Corrupt Practices Act and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, financial conditions and results of operations.
Risks associated with operating in foreign countries could materially adversely affect our product development.
We conduct our Phase 3 PRESENT study of NeuVax in countries outside of the U.S. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated with conducting operations in foreign countries include:
•
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

44

with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign taxes, including withholding of payroll taxes;
•
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.

In addition, there may be political instability, including war, terrorism, riots, civil insurrection or social unrest, and natural or man-made disasters, including famine, flood, fire, earthquake, storm or disease, which could seriously harm the progress of our clinical trials at sites in particular foreign countries or regions. For example, approximately 39% of our Phase 3 PRESENT trial sites and approximately 44% of patients who have been randomized in the trial are in Russia and The Ukraine. The occupation of certain portions of Ukrainian territory by Russian-backed separatists and ongoing political and civil unrest there could disrupt activities at these trial sites. It is also possible that Russia could retaliate against the imposition of sanctions by the U.S. and the European Union by banning or restricting business activities in Russia by U.S. companies, including the conduct of clinical trials, which could have a material, adverse effect on patient enrollment or ongoing activities at our Phase 3 PRESENT sites in Russia.
We may not be successful in obtaining approval as a biological product or obtain favorable market exclusivity in the U.S. or in foreign jurisdictions for our NeuVax product candidates.

We intend to seek data exclusivity or market exclusivity provided under the Federal Food, Drug and Cosmetic Act, or FDCA, and similar laws in other countries. We believe that NeuVax will qualify for 12 years of data exclusivity under the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which was enacted as part of the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the Affordable Care Act or ACA) enacted in March 2010. Under the BPCIA, an application for a biosimilar product cannot be submitted to the FDA until four years, or approved by the FDA until 12 years, after the original brand product identified as the reference product is approved under a BLA, The BPCIA provides an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The new abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as interchangeable based on its similarity to an existing brand product. The new law is complex and is only beginning to be interpreted and implemented by the FDA. While it is uncertain when any such processes may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our biological products. There is also a risk that the U.S. Congress could amend the BPCIA to shorten this exclusivity period as proposed by President Obama, potentially creating the opportunity for biosimilar competition sooner than anticipated after the expiration of our patent protection. Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference product in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

If NeuVax is not considered a biologic that would qualify for exclusivity under the BPCIA, it may be eligible for market exclusivity as a drug under the FDCA. The FDCA provides a five-year period of non-patent marketing exclusivity within the U.S. to the first applicant to gain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA, submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by FDA to be essential to the approval of the application, for example, for new indications, dosages, or strengths of an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.


45

In some countries outside of the U.S., peptide vaccines, such as NeuVax, are regulated as chemical drugs rather than as biologics and may or may not be eligible for non-patent exclusivity.
Risks Related to Our Capital Structure

Our outstanding warrants may result in dilution to our stockholders.
Our outstanding March 2011 and April 2011 warrants to purchase a total of 791,398 shares of common stock as of December 31, 2014 at a current exercise price of $0.65 per share contain so-called full-ratchet anti-dilution provisions. Our outstanding March 2010 and December 2012 warrants to purchase 25,000 and 3,031,311 shares of common stock as of December 31, 2014 at current exercise prices of $2.02 per share and $1.83 per share, respectively, contain so-called weighted-average anti-dilution provisions. These anti-dilution provisions may be triggered by the issuance of the shares being offered hereby or upon any future issuance by us of shares of our common stock or common stock equivalents at a price per share below the then-exercise price of the warrants, subject to some exceptions.
To the extent that these anti-dilution provisions are triggered in the future, we would be required to reduce the exercise price of all of the warrants on either a full-ratchet or weighted-average basis, which would have a dilutive effect on our stockholders.




46

ITEM 6. EXHIBITS
 
Exhibit
Number
  
Description
 
 
 
 
 
 
 
 
10.6
 
Settlement and License agreement dated October 23, 2015 between Galena Biopharma, Inc., Actavis Laboratories FL, Inc., and Orexo AB. (3) **
 
 
 
10.7
 
Employment Offer Letter effective October 30, 2015, between Galena Biopharma, Inc. and Bijan Nejadnik, M.D. * **
 
 
 
 
 
 
31.1
 
Sarbanes-Oxley Act Section 302 Certification of Mark W. Schwartz, Ph.D.**
 
 
 
31.2
 
Sarbanes-Oxley Act Section 302 Certification of Ryan M. Dunlap.**
 
 
 
32.1
 
Sarbanes-Oxley Act Section 906 Certification of Mark W. Schwartz, Ph.D., and Ryan M. Dunlap.**
 
 
 
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.
 
 
(1)
Previously filed as an Exhibit to the Registrant's Form 8-K filed on March 16, 2015 and incorporated herein by reference.

 
 
(2)
Previously filed as Annex B to the Registrant's Proxy Statement on Schedule 14A filed on April 30, 2015 and incorporated by reference herein by reference.

 
 
(3)
Portions of the Exhibit filed herewith have been omitted pursuant to a request for confidential treatment.

47

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
GALENA BIOPHARMA, INC.
 
 
 
 
 
By:
 
/s/ Mark W. Schwartz
 
 
 
 
 
 
 
Mark W. Schwartz, Ph.D.
 
 
 
President and Chief Executive Officer
 
 
 
 
 
 
 
Date: November 9, 2015
 
 
 
 
 
By:
 
/s/ Ryan M. Dunlap
 
 
 
 
 
 
 
Ryan M. Dunlap
 
 
 
Vice President and Chief Financial Officer
 
 
 
 
 
 
 
Date: November 9, 2015

48
Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

SETTLEMENT AND LICENSE AGREEMENT
This Settlement and License Agreement (hereinafter referred to as “Agreement”) dated as of this 23rd day of October, 2015 (the “Effective Date”), by and among Actavis Laboratories FL, Inc., a company organized and existing under the laws of the State of Florida, having a principal place of business at 4955 Orange Drive, Davie, FL 33314 (“Actavis”), Orexo AB, a company organized and existing under the laws of Sweden, having a principal place of business at Virdings allé 32 A, 05 Uppsala, Sweden SE-751 (“Orexo”), and Galena Biopharma Inc., having a principle place of business at 4640 SW Macadam Avenue, Portland, OR 97239 (“Galena”). Actavis, Orexo and Galena each are sometimes referred to herein as a “Party” and collectively referred to herein as “Parties.”

WHEREAS, Orexo is the owner of U.S. Patent Nos. 6,759,059, 6,761,910 and 7,910,132, which are listed in the United States Food and Drug Administration’s (“FDA”) publication Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) for Abstral®, Fentanyl Sublingual Tablets, Eq 0.1 mg base, Eq 0.2 mg base, Eq 0.3 mg base, Eq 0.4 mg base, Eq 0.6 mg base and Eq 0.8 mg base.
WHEREAS, Galena is the holder of the Galena New Drug Application (“NDA”) No. 022510 and currently manufacturers and markets Fentanyl Sublingual Tablets, Eq 0.1 mg base, Eq 0.2 mg base, Eq 0.3 mg base, Eq 0.4 mg base, Eq 0.6 mg base and Eq 0.8 mg base under NDA No. 022510 (“Abstral”); and
WHEREAS, Actavis filed Abbreviated New Drug Application (“ANDA”) No. 207338 with the FDA, containing certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and seeking approval to market generic versions of Abstral before the expiration of U.S. Patent Nos. 6,759,059, 6,761,910 and 7,910,132, which is pending approval at the FDA; and
WHEREAS, Orexo and Actavis are parties to a patent infringement litigation captioned, Orexo AB v. Actavis Laboratories FL, Inc., No. 3:15-cv-00826, pending in the United States District Court for the District of New Jersey before the Honorable Peter Sheridan (“Litigation”), alleging infringement by Actavis of U.S. Patent Nos. 6,759,059, 6,761,910 and 7,910,132 based on Actavis’s filing of the Actavis ANDA; and
WHEREAS, Orexo and Actavis wish to fully settle the Litigation upon the terms and subject to the conditions set forth below.
NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1.Definitions. The following terms, when used with initial capital letters shall have the meaning set forth below.

a. “Actavis ANDA” shall mean ANDA No. 207338 as of the Effective Date and any later filed amendments, supplements or replacements thereto seeking

1

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

approval of a generic product that is AB-Rated to Abstral, excluding additions or substitutions of ingredients which constitute a major amendment to ANDA No. 207338, or if post approval, the addition or substitution requires FDA approval pursuant 21 CFR 314.70(b).
b.“Actavis Product” shall mean any product made, used, sold, offered for sale, imported or distributed pursuant to the Actavis ANDA.
c.“Affiliate” shall mean with respect to a Party, any Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Party. For the purposes of this definition, “control” (including the terms “controlled by” and “under common control with”) of a business entity means (a) the direct or indirect ownership of more than fifty percent (50%) of the voting stock or other voting interest in such entity, (b) the right to appoint more than fifty percent (50%) of the directors or management of such entity, or (c) the power to otherwise control or direct the decisions of the board of directors or similar body governing the affairs of such entity.
d.“AG Product” shall mean Eq 0.1 mg base, Eq 0.2 mg base, Eq 0.3 mg base, Eq 0.4 mg base, Eq 0.6 mg base and Eq 0.8 mg base of Fentanyl Citrate products that are manufactured, sold or distributed pursuant to the Galena NDA but not under Abstral® trademark or a successor trademark thereto.
e.“FDA” shall mean the United States Food and Drug Administration, and any successor agency thereto.
f.“Galena NDA” shall mean New Drug Application (a “NDA”) No. 022510, and any amendments and supplements thereto.
g.“Generic Equivalent” shall mean: (i) a product approved under an ANDA or pursuant to an application under 21 U.S.C. § 355(b)(2) for which Abstral is the reference listed drug, or (ii) an AG Product.
h.“License Effective Date” shall mean June […***…], 2018, or an earlier date as permitted in Section 5.
i.“Licensed Patents” shall mean U.S. Patent Nos. 6,759,059, 6,761,910 and 7,910,132.
j.“Losses” shall mean all pending and potential claims, demands, all manner of actions, causes of action, suits, debts, liabilities, losses, damages, attorneys’ fees, costs, expenses, judgments, settlements, interest, punitive damages and other damages or costs of whatever nature, whether known or unknown, pending or future, certain or contingent.
k.“Measurement Date” means […***…].

2

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

l.“Person” shall mean any individual, corporation, association, partnership (general or limited), joint venture, trust, estate, limited liability company, limited liability partnership, unincorporated organization, government (or any agency or political subdivision thereof) or other legal Person or organization.
m.“Related Parties” shall mean a Party’s Affiliates, directors, officers, employees, agents, representatives, assigns, predecessors, successors or other related parties.
n.“Territory” shall mean the United States and its territories, possessions and commonwealths, including Puerto Rico.
o.“Third Party” shall mean any Person other than the Parties or their Affiliates.
p.“Wholesaler Affiliate” shall mean a subsidiary or Affiliate of a Party whose primary business is wholesale distribution of pharmaceutical products. A Wholesaler Affiliate shall not be deemed to be an Affiliate of a Party for purposes of this Agreement. For clarity, […***…]
2.Releases. Upon the terms and subject to the conditions of this Agreement, in consideration of the mutual execution of this Agreement and the mutual agreement to be legally bound by the terms hereof, each Party, on behalf of itself and its Related Parties, hereby releases, acquits and forever discharges the other Parties and their Related Parties from any and all Losses arising out of, derived from, predicated upon or relating to (a) the Litigation, including any of the claims or counterclaims that were brought or could have been brought against the other Parties in the Litigation, or (b) under the Licensed Patents with respect to the Actavis Product and/or Actavis ANDA; provided, however, that nothing in this Agreement shall prevent or impair the right of any Party to bring a proceeding in court or any other forum for a breach of this Agreement or any representation, warranty or covenant herein. The Parties agree to stipulate to the dismissal of the Litigation with prejudice, with each side bearing its own costs and attorneys’ fees. Promptly following the execution of this Agreement, the Parties shall file with the United States District Court for the District of New Jersey the Dismissal Order attached as Exhibit A.
3.Release of Unknown Claims. Each Party acknowledges and agrees that:
a.
It may have sustained Losses that are presently unknown and unsuspected, and that such Losses might give rise to Losses in the future. Nevertheless, each Party acknowledges and agrees that this Agreement has been negotiated and agreed upon, notwithstanding the existence of such possible Losses and that such unknown Losses are released under Section 2.

3

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

b.
This Agreement may be pleaded as a full and complete defense to, and used as a basis for injunction against, any proceeding that may be instituted, prosecuted or attempted in breach hereof.
c.
In connection with this Agreement, the Parties and all of their Affiliates and each of their respective predecessors, successors, assigns, agents, officers, directors, shareholders, employees and representatives expressly waive and relinquish all rights and benefits afforded by Section 1542 of the California Civil Code, which provides as follows:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN TO HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.
Further, the Parties and all of their Affiliates and each of their respective predecessors, successors, assigns, agents, officers, directors, shareholders, employees and representatives expressly waive and relinquish all rights and benefits afforded by any law in any other jurisdiction similar to Section 1542 of the California Civil Code.
4.Patent Validity and Infringement. Solely for the purposes of the enforcement of the present Agreement and with applicability exclusively to the Actavis ANDA and the Actavis Product, Actavis, for itself and its Affiliates, acknowledges, agrees and admits that the […***…]. For the avoidance of doubt, Actavis’s admission herein shall not apply and shall have no effect outside the United States or to any product other than the Actavis Product or to any ANDA other than the Actavis ANDA. Further, neither Orexo nor Galena nor their respective Affiliates shall refer to or rely on such admission and any other stipulation, admission or concession regarding the Licensed Patents in any proceeding outside the United States or any proceeding with Actavis or its Affiliates involving a product other than the Actavis Product or an ANDA other than the Actavis ANDA.
5.License Grant. Upon the terms and subject to the conditions of this Agreement, effective as of the License Effective Date, Orexo grants on behalf of itself and its Affiliates to Actavis and its Affiliates a […***…] (subject to Section 14) license to the Licensed Patents, (i) to make, have made, use, import, offer for sale and sell Actavis Product in or for the Territory, and (ii) to make and have made the Actavis Product outside the Territory only for use, sale and importation in or for the Territory, in each case in […***…]. Orexo and its Affiliates and Galena and its Affiliates explicitly retain the right themselves to market at any time an AG Product. Nothing in this Agreement shall prevent Orexo and/or Galena, including their respective Affiliates, from continuing to manufacture and market branded Abstral®.
a.
Acceleration of License Grant. The License Effective Date will be accelerated to the earlier of the following dates: (i) the date on which a Third

4

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

Party is permitted to commercially sell a Generic Equivalent product under authorization from Orexo, Galena and/or their Affiliates (by licenses, sublicense, covenant not to sue or otherwise) (“Authorized Third Party Launch”); (ii) the date that Orexo and/or its Affiliates and/or Galena and/or its Affiliates launches an AG Product (“AG Launch”); (iii) the date of a final, nonappealable judicial order (other than a petition to the Supreme Court for a writ of certiorari) holding that all of the then asserted and adjudicated claims of the Licensed Patents are invalid, canceled, unenforceable or not infringed by a Generic Equivalent (“Final Court Decision”); and (iv) the date on which a Third Party commercially launches a Generic Equivalent product in the Territory without authorization from Orexo or its Affiliates (by license, sublicense, covenant not to sue or otherwise) (“Unauthorized Third Party Launch”), provided that, with respect to this subclause (iv) only, in the event that Orexo, Galena or their respective Affiliates subsequently succeed in having such Third Party cease its sales of Generic Equivalent product, then the license granted to Actavis and its Affiliates in Section 5 shall be suspended at such time as the Third Party’s Generic Equivalent product is no longer being commercially sold in the Territory, and shall resume on the date that the License Effective Date would have occurred but for the Unauthorized Third Party Launch of a Generic Equivalent product. The meaning of “License Effective Date” will thereafter be revised to mean the date of occurrence of the earlier aforementioned circumstance. Pursuant to subclause (iv) only, if each and every unlicensed Third Party is found to infringe a valid, enforceable Licensed Patent and pays damages to Orexo (through either judgment or settlement), then (1) […***…]; (2) […***…]; and (3)  […***…].
b.
[…***…]. (1) Beginning on the earlier of […***…] or one hundred and eighty (180) days prior to an Authorized Third Party Launch and […***…], Orexo grants Actavis and its Affiliates […***…] to the Licensed Patents, (i) to make, have made, use, import, offer for sale and sell Actavis Product in or for the Territory, and (ii) to make and have made the Actavis Product outside the Territory only for use, sale and importation in or for the Territory and Actavis […***…] prior to the […***…], based upon […***…]. Galena will provide […***…]. In the event there is an Authorized Third Party Launch before […***…], Galena shall provide […***…] or as soon as reasonably practical after such Authorized Third Party Launch date is known, and continuing until […***…] has been provided or until Actavis is permitted to launch under this Section 5(b), whichever occurs first. (2) Beginning on the […***…].

5

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

c.
Pre-Marketing Activities. Notwithstanding the License Effective Date and the restrictions contained herein, Actavis and its Affiliates shall be permitted to: (a) […***…] (or 180 days prior to an Authorized Third Party Launch) […***…] (or 180 days prior to an Authorized Third Party Launch), and (b) […***…] (including disclosure of the License Effective Date) […***…] (or 180 days prior to and Authorized Third Party Launch) […***…] (or 180 days prior to and Authorized Third Party Launch).
6.Retention of Certain Rights. Nothing set forth herein shall be deemed to give Orexo or its Affiliates or Galena or its Affiliates any control over any marketing exclusivity that may be granted to Actavis by the FDA in connection with the Actavis ANDA or the Actavis Product.
7.Covenant Not to Sue. Provided that Actavis complies with the terms of this Agreement, Orexo and Galena, on behalf of themselves and their Affiliates, covenant to Actavis that they will not sue, assert any claim or counterclaim against, otherwise participate in any action or proceeding against Actavis and its Affiliates or any of their shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the foregoing, or cause, assist, or authorize any person or entity to do any of the foregoing, in each case claiming or otherwise asserting that the Actavis ANDA or the Actavis Product or the manufacture, use, sale, offer for sale, or importation of the Actavis Product, in or for the Territory infringes the Licensed Patents or any other U.S. patents or patent applications owned, licensed or controlled by Orexo, Galena or any of their Affiliates either now or in the future (“Covenant Not To Sue Patents”). Orexo and Galena shall impose this covenant not to sue on any Third Party to which Orexo, Galena or any of their Affiliates may after the Effective Date assign, license or otherwise transfer or grant any patent rights subject to this covenant not to sue.
8.New Patent Listings in the Orange Book. For any new patents that are listed in the future in FDA’s Orange Book for Abstral, the covenant not to sue in Section 7 shall hereby be treated as a non-exclusive license to those new patents so that Actavis and its Affiliates may file a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) in connection with any such patents, with respect to the Actavis ANDA.
9.Covenant Not to Challenge and Assist Challenges to Patents. Actavis, its Affiliates, and its Related Parties shall not (1) […***…] in any litigation or proceeding in any court or administrative agency having jurisdiction to consider the issue, except as may be required pursuant to compulsory legal process in litigation initiated by a Third Party without assistance or encouragement by Actavis, its Affiliates or Related Parties or as expressly permitted in subsections (3)-(5) herein; and/or (2)  […***…] or as expressly permitted in subsections (3)-(5) herein. Notwithstanding this Section 9, Actavis may (3) maintain a “Paragraph IV Certification” in the Actavis ANDA with respect to the Licensed Patents or amend the Actavis ANDA to contain a “Paragraph IV Certification” with respect to any patent listed in the

6

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

Orange Book for Abstral; (4) challenge the infringement, validity, enforceability or patentability of any claim of the Licensed Patents or any other patents listed in the Orange Book for Abstral in any litigation or proceeding in any court with respect to any product other than the Actavis Product or any ANDA other than the Actavis ANDA (for the avoidance of doubt, submitting a Paragraph IV Certification to the Licensed Patents or any other patents listed in the Orange Book for Abstral and sending a notice letter regarding the same qualifies as litigation), or (5) file a petition with the U.S. Patent and Trademark Office requesting reexamination, inter partes review, or other post grant review of any claims of any Licensed Patents or any other patents listed in the Orange Book for Abstral for which Orexo or Galena initiates a district court litigation against Actavis with a claim of infringement with respect to any product other than the Actavis Product or any ANDA other than the Actavis ANDA.
10.Supply of Authorized Generic. In the event that […***…] or one hundred and eighty (180) days prior to an Authorized Third Party Launch (i) FDA has not granted final approval of the Actavis ANDA, or (ii) Actavis cannot manufacture commercial launch quantities of Actavis Product, and upon Actavis providing notice of (i) and/or (ii) to Orexo and Galena at least one hundred and eighty (180) days prior to the foregoing date, Galena and Actavis and/or one or more Affiliates thereof will enter into a non-exclusive supply agreement for the AG Product under mutually agreeable terms consistent with all applicable terms of this Agreement. Such supply agreement will provide that (x) Galena or an Affiliate will deliver to Actavis or an Affiliate of Actavis […***…], (y) […***…] or one hundred and eighty (180) days prior to an Authorized Third Party Launch; and (z) […***…].
11.Most Favored Licensee and Notice. Orexo and Galena represent and covenant to Actavis that the terms of the Agreement being offered to Actavis are and will be equivalent to or better than the terms being offered by Orexo or its Affiliates and/or Galena and its Affiliates to any Third Party with respect to any license(s) or other permissions(s) to Generic Equivalent product(s) (“Third Party Agreement”) with respect to […***…] ([…***…]). If Orexo and/or its Affiliates and/or Galena and/or its Affiliates have entered or enter into a Third Party Agreement providing such Third Party with more favorable terms, then the applicable terms in this Agreement will be automatically amended to provide such more favorable terms to Actavis. Orexo and/or Galena shall notify Actavis of any more favorable terms from […***…] within seven (7) business days. Orexo and Galena further agree that they will provide Actavis at least ninety (90) calendar days’ advance notice of Orexo or its Affiliates’ or Galena or its Affiliates’ or a Third Party’s launch of an AG Product, provided such launch is prior to the dates set forth in […***…].
12.Waiver of Regulatory Exclusivities. To the extent permitted by FDA and applicable statutes and regulations, Orexo and its Affiliates and Galena and its Affiliates hereby waive with respect to the Actavis ANDA and Actavis Product only any and all regulatory exclusivities granted by the FDA to Orexo and/or Galena for Abstral that may prevent approval or marketing of the Actavis Product in the Territory under the Actavis ANDA as of the License Effective Date under the terms of this Agreement. To the extent that FDA has granted any regulatory exclusivities or otherwise prevents approval or launch of the Actavis Product, Orexo, Galena and/or their respective Affiliates agree, at Actavis’s

7

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

request, to confirm with FDA (in a form reasonably acceptable to Actavis) the licenses and waivers granted by Orexo hereunder, and shall do so within ten (10) business days of receiving Actavis’s request.
13.Representations and Warranties.
a.
Each Party hereto represents and warrants to the other Party that, as of the date hereof:
i.
this Agreement is a legal, valid and binding obligation of the warranting Party, enforceable against such Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity;
ii.
the warranting Party is not subject to any judgment, order, injunction, decree or award of any court, administrative agency or governmental body that would or might interfere with its performance of any of its material obligations hereunder; and
iii.
the warranting Party has full power and authority to enter into and perform its obligations under this Agreement in accordance with its terms.
b.
Orexo represents and warrants that it owns all right and title to the Licensed Patents and Orexo has the right to grant the licenses hereunder and to settle the Litigation.
c.
Orexo and Galena represent and warrant that as of the Effective Date, Orexo and its Affiliates and Galena and its Affiliates shall not, and shall not cause or encourage any Affiliate or Third Party to initiate or otherwise undertake any activity, directly or indirectly, against the Actavis ANDA or Actavis Product to: (i) interfere with Actavis’s efforts to obtain and maintain FDA approval of the Actavis ANDA or the Actavis Product, including, but not limited to, the filing of suit against FDA, and/or the filing or submission of any Citizen Petitions, correspondence or other written submissions with FDA or any regulatory or governmental authority, or (ii) interfere with Actavis’s efforts to market the Actavis Product in accordance with the terms of this Agreement, unless Orexo or its Affiliates and Galena and its Affiliates undertakes such activity defined in subparts (i) or (ii) pursuant to court order or as otherwise requested by FDA or required by law.

8

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

d.
Orexo and its Affiliates and Galena and its Affiliates represent and warrant that they shall not Officially Discontinue Abstral® prior to the expiration of the Licensed Patents, unless required, requested or recommended in writing by the FDA or other governmental authority or applicable law. For avoidance of doubt, nothing in this Paragraph prohibits Orexo or its Affiliates and Galena and its Affiliates from taking any action, or causing others to take any action, Orexo or Galena reasonably determines is necessary to provide for the safety and efficacy of any Orexo or Galena product. “Officially Discontinue” shall mean any of: (i) delisting Abstral® with the FDA; (ii) delisting the Licensed Patents from the Orange Book unless Orexo reasonably determines in good faith that such delisting is required under applicable law; (iii) seeking action with the FDA to withdraw Abstral® from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (iv) deleting, removing or canceling any National Drug Code(s) for Abstral® from the applicable National Drug File.
e.
Actavis represents and warrants that it has produced to Orexo’s counsel in this Patent Litigation all correspondence with FDA regarding Actavis’s ANDA, and that the produced correspondence contains an accurate representation of the Actavis Product as it exists as of the Effective Date.
f.
Actavis represents and warrants that, as of the Effective Date, (i) Actavis or its Affiliates own all right, title and interest in, to and under the Actavis ANDA, and Actavis and its Affiliates have not granted or assigned to any Third Party, directly or indirectly, any rights under or to the Actavis ANDA or the Actavis Product, (ii) Actavis and its Affiliates will not transfer ownership, in whole or in part, of said Actavis ANDA, except to an Affiliate of Actavis or in accordance with Section 14, until the expiration of the license granted herein, and (iii) Actavis has the right to settle the Litigation.
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF APPLICABLE LAW, AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS SUCH WARRANTIES.
14.Assignments. No Party hereto may assign any of its rights or obligations under this Agreement without the prior written consent of the other Parties, which consent shall not be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, (a) any Party may assign its rights and obligations under this Settlement Agreement to any of its Affiliates, (b) Orexo may assign its rights and obligations under this Settlement Agreement to any successor in interest to Orexo’s entire business or to the Licensed Patents, (c) Galena

9

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

may assign its rights and obligations under this Settlement Agreement to any Third Party in connection with a sale, transfer or other disposition of its rights to Abstral® and the Galena NDA and (d) Actavis may assign its rights and obligations under this Settlement Agreement to any Third Party in connection with a merger, reorganization, change of control or sale of all or substantially all of the applicable business or assets of Actavis to which this Agreement relates, or to a Third Party in connection with any divestiture of the Actavis ANDA, but without prior written consent. In each case ((a) through (d)), provided that (A) notwithstanding any such assignment, such Party shall remain liable for its and its Affiliates’ performance under this Settlement Agreement as if such Party remained a party hereto; (B) no such assignment shall in any manner relieve, limit or impair the obligations of that Party hereunder; and (C) following a transfer by a Party to its Affiliate, any subsequent transaction that would cause such Affiliate to cease to be an Affiliate of such Party shall be deemed to be an assignment of this Settlement Agreement subject to this Section. Any purported assignment in violation of the foregoing shall be null and void ab initio and of no force or effect.
15.Effect of Bankruptcy. For avoidance of doubt, all rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (the “Bankruptcy Code”), licenses of “intellectual property” as defined under the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code; provided, however, that should Orexo become a party to a bankruptcy proceeding and such proceeding is not dismissed within thirty (30) days then, to the extent permitted by law, this Agreement and the licenses granted by Orexo hereunder shall be adopted by any bankruptcy trustee or relevant third party charged with the disposition of same, and shall not be rejected by same, it being the Parties’ intent that, in such event, Actavis and its Affiliates and sublicensees shall be entitled to retain the rights granted to them hereunder.
16.Medicare Modernization Act Filings. In accordance with the applicable provisions of the Medicare Modernization Act, Orexo and Actavis shall submit this Agreement to the Federal Trade Commission Bureau of Competition and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice as soon as practicable following the Effective Date and in no event later than ten (10) business days following the Effective Date.
17.Continued Cooperation. Each Party shall, at its own cost and expense, take all actions and do all things reasonably necessary or proper, including under applicable law, to make effective and further the intents and purposes of the transactions contemplated by this Agreement, including executing any further instruments reasonably requested by the other Parties. On or after the Effective Date, Actavis shall inform Orexo and Galena of any additions or substitutions of ingredients which constitute a major amendment to ANDA No. 207338, or if post approval, the addition or substitution requires FDA approval pursuant 21 CFR 314.70(b) within thirty (30) calendar days of acceptance of those additions or substitutions by FDA.

10

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

18.Audit by Actavis. Galena and its Affiliates shall keep adequate records of […***…]. […***…], such records (including those of Galena’s Affiliates) shall be kept at each of their principal places of business and shall be open for inspection at Actavis’s cost at reasonable times and upon reasonable notice by an independent certified auditor selected by Actavis, and which is reasonably acceptable to Galena, for the sole purpose of inspecting the amounts reported to Actavis under Section 5(b).
19.Entire Agreement. This Agreement (including all attachments hereto) constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and supersedes all prior agreements or understandings, oral or written, with respect to such matters. The Parties may amend, waive or modify the provisions of this Agreement, including this provision, only by mutual agreement in writing duly executed by the Parties hereto.
20.Interpretation. The Parties agree and acknowledge that this Agreement is the product of both Parties, each of whom have been represented by legal counsel, and shall not be construed against either of the Parties. The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Headings of paragraphs or sections of this Agreement are for reference only and shall not be deemed to be a part of this Agreement.
21.Notices. All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon a Party, if delivered by registered or certified mail (return receipt requested) or by a reputable overnight express courier service (charges prepaid), or such other address as may be designated in writing hereafter, in the same manner, by such person as follows:
In the case of Orexo:

Orexo AB
P.O. Box 303
SE-751 05 Uppsala
Sweden
Attention: Nikolaj Sorensen, CEO and President

In the case of Galena:

Galena Biopharma, Inc.
2000 Crow Canyon Place, Suite 380
San Ramon, CA 94583
Attn: General Counsel

In the case of Actavis:


11

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

Actavis, Inc.
Morris Corporate Center III
400 Interpace Parkway
Parsippany, NJ 07054
Attn: General Counsel

Such notices will be deemed to have been given on the date delivered in the case of hand delivery or delivery by overnight courier, or on the fifth (5th) business day following the date of postmark in the case of delivery by mail.
22.Confidentiality. The terms of this Agreement and the information exchanged between the Parties pursuant to this Agreement shall be maintained in confidence by the Parties and not be used or disclosed to Third Parties except that: (i) the Parties may disclose that the Parties have settled the Litigation and that Actavis has the ability to launch the Actavis Product as of the dates in Sections 1(h) and 5(b), (ii) the Parties may disclose this Agreement to their attorneys, advisors, and representatives who are subject to obligations of confidentiality consistent with this Agreement, (iii) Actavis may disclose the terms of this Agreement to Teva Pharmaceutical Industries Ltd. and its Affiliates and any Third Party in connection with a potential or actual merger, reorganization, change of control or sale of all or substantially all of the applicable business or assets of Actavis to which this Agreement relates, or to a Third Party in connection with any divestiture of the Actavis ANDA, in accordance with confidentiality terms at least as restrictive as the terms hereof, (iv) Galena or Orexo may disclose the terms of this Agreement to any Third Party in connection with a potential or actual sale, transfer or other disposition of the rights to Abstral® and Galena NDA, in accordance with confidentiality terms at least as restrictive as the terms hereof, (v) Orexo may disclose the terms of this Agreement to Third Parties in connection with patent litigation involving the Licensed Patents or in connection with settlement discussions and agreements with alleged infringers of the Licensed Patents, subject to such Third Parties undertaking to keep the terms of this Agreement strictly confidential in accordance with confidentiality terms at least as restrictive as the terms hereof, and (vi) as otherwise required by law, including without limitation SEC reporting requirements, or by the rules or regulations of any stock exchange that the Parties are subject to. In any such event the Party making such disclosure under subsection (vi) shall (A) provide the other Parties with as much advance notice as reasonably practicable of the required disclosure, (B) cooperate with the other Parties in any attempt to prevent or limit the disclosure, and (C) limit any disclosure to the specific purpose at issue. If a Party is subpoenaed or otherwise required by law to give testimony or provide information which in any way relates to this Agreement, such Party shall give the other Parties prompt notice of such requirement and, unless otherwise required by law, shall make no disclosure until the other Parties have had a reasonable opportunity to contest the right of the requesting person to such disclosure. The Parties shall provide each other with all reasonable cooperation and generally make their employees available to give testimony or to provide reasonable assistance in connection with any lawsuits, claims, proceedings and investigations relating to this Agreement.

12

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

23.Choice of Law and Jurisdiction. This Agreement and any dispute arising out of or related to this Agreement shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to its conflict of laws principles. With respect to any proceeding relating to this Agreement, each Party irrevocably agrees and consents to the exclusive jurisdiction of the federal and state courts in New York and waives any objection to venue of any such proceeding brought in any such court.
24. Equitable Relief for Orexo and Galena. Actavis acknowledges and agrees that its obligations and undertakings under this Agreement are reasonable and necessary to protect the legitimate interests of Orexo and Galena, that Orexo and Galena would not have entered into this Agreement in the absence of such provisions, and that Actavis’s threatened breach or failure to comply with material terms of this Agreement shall cause Orexo and Galena significant and irreparable harm, the amount of which shall be extremely difficult to estimate and ascertain, and for which money damages shall not be adequate. Actavis further acknowledges and agrees that Orexo and/or Galena shall have the right to apply to any court of competent jurisdiction for an injunction order restraining any breach or threatened breach of this Agreement and specifically enforcing the terms and provisions of this Agreement, without the necessity of posting any bond or security, in addition to seeking any other remedy available to Orexo and Galena in law or equity. Nothing in the preceding sentence, however, shall limit Actavis’s ability to seek and recover damages for an improperly issued injunction, and, for the avoidance of doubt, Orexo and Galena agree not to assert that the absence of a bond limits restricts Actavis’s ability to seek and recover damages for an improperly issued injunction.

25.Equitable Relief for Actavis. Orexo and Galena acknowledge and agree that their obligations and undertakings under this Agreement are reasonable and necessary to protect the legitimate interests of Actavis, that Actavis would not have entered into this Agreement in the absence of such provisions, and that Orexo and/or Galena’s threatened breach or failure to comply with material terms of this Agreement shall cause Actavis significant and irreparable harm, the amount of which shall be extremely difficult to estimate and ascertain, and for which money damages shall not be adequate. Orexo and Galena further acknowledge and agree that Actavis shall have the right to apply to any court of competent jurisdiction for an injunction order restraining any breach or threatened breach of this Agreement and specifically enforcing the terms and provisions of this Agreement, without the necessity of posting any bond or security, in addition to seeking any other remedy available to Actavis in law or equity. Nothing in the preceding sentence, however, shall limit Orexo and Galena’s ability to seek and recover damages for an improperly issued injunction, and, for the avoidance of doubt, Actavis agrees not to assert that the absence of a bond limits restricts Orexo or Galena’s ability to seek and recover damages for an improperly issued injunction.
26.Counterparts. This Agreement may be executed in any number of counterparts, and execution by each of the Parties of any one of such counterparts will constitute due execution of this Agreement. Each such counterpart hereof shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. Any

13

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

signature exchanged in portable document format (pdf) via facsimile or electronic transmission shall be deemed to be an original signature.
27.Severability. If any provision of this Agreement is held invalid, illegal or unenforceable for any reason, the Parties shall negotiate in good faith for a substitute provision to continue the intent and purpose of such invalid provisions, and the validity, legality and enforceability of the remaining provisions shall not be in any way impaired thereby.
28.No Waiver. The failure of any Party to enforce at any time for any period the provisions of or any rights deriving from this Agreement shall not be construed to be a waiver of such provisions or rights or the right of such Party thereafter to enforce such provisions.
29.Third Party Beneficiaries. Except as expressly provided herein, nothing in this Agreement, either express or implied, is intended to or shall confer upon any Third Party any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
30.Term. This Agreement shall terminate on the date of expiration of the latest expiring patent from among the Licensed Patents and any patents added to the Orange Book after the Effective Date of this Settlement Agreement.
[Signature page follows]

14

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2


This Agreement is signed as indicated below by duly authorized representatives of Orexo, Galena and Actavis, respectively, effective as of the date first written above.
ACTAVIS LABORATORIES FL, INC.
OREXO AB
By:
_____/S/_____________________
By:
_____/S/________________________
Name:
A. Robert D. Bailey__________
Name:
Nikolaj Sorenson_______________
Title:
EVP & Chief Legal Officer_____
Title:
CEO & President_______________
 
 
 
 
 
 
 
 
 
 
GALENA BIOPHARMA INC.
 
 
By:
_____/S/___________________
 
 
Name:
Mark W. Schwartz____________
 
 
Title:
President & CEO_____________






15

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2



16

Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

EXHIBIT A
[District Court Dismissal]



Exhibit 10.7
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2


IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY


OREXO AB,
            Plaintiff,
      v.
ACTAVIS LABORATORIES FL, INC.
            Defendant.

 

Civil Action No. 3:15-cv-00826 (PGS/DEA)



JOINT STIPULATION OF DISMISSAL

Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, Plaintiff Orexo AB and Defendant Actavis Laboratories FL, Inc. hereby stipulate and agree that Civil Action No. 3:15-cv-00826 (PGS/DEA), including all claims, counterclaims, and affirmative defenses asserted, are hereby dismissed with prejudice, and without costs, disbursements or attorneys’ fees to any party. 
SO ORDERED this day of __________________, 2015.

                                                                                             
United States District Judge





EMPLOYMENT AGREEMENT
This Employment Agreement (this “Agreement”) is made and entered into as of October 30, 2015 (the “Effective Date”) by and between Galena Biopharma, Inc., a Delaware corporation (the “Company”, or “Employer”), and Bijan Nejadnik, M.D., an individual and resident of the State of [California] (“Employee”).
BACKGROUND
Employer and Employee desire that Employee serve as the Company’s Chief Medical Officer on the terms set forth in this Agreement.
AGREED TERMS
1.Engagement. Commencing on the Effective Date, Employer shall employ Employee, and Employee shall serve, as the Executive Vice President and Chief Medical Officer of the Company. Employee understands that his duties may change from time to time in the discretion of Employer’s Board of Directors (hereinafter the “Board”), but such duties shall be consistent with the duties customarily assigned to the Chief Medical Officer of a company substantially comparable as of the Effective Date to Employer. As a condition to the Employee’s employment by the Employer, Employee and Employer shall execute the Employee Confidentiality, Non-Competition, and Proprietary Information Agreement attached hereto as Exhibit 1 and made a part hereof (the “Confidentiality Agreement”).
2.    Duties. Employee shall perform faithfully, diligently and to the best of his ability all duties assigned to him by the Board. Employee shall perform the services contemplated under this Agreement in accordance with the policies established by the Board and under the direction of the Company’s President and Chief Executive Officer. Employee shall have such corporate power and authority as shall reasonably be required to enable his to discharge his duties under this Agreement. Employee’s services hereunder shall be rendered at the Company’s principal executive offices, except for travel when and as required in the performance of Employee’s duties hereunder.
3.    Time and Efforts. Employee shall devote all of his business time, efforts, attention and energies to Employer’s business and the discharge of his duties hereunder. Notwithstanding the foregoing, except as otherwise agreed to in writing, Employee shall have the right to perform such incidental services as are necessary in connection with (a) his private, passive investments, (b) charitable or community activities, (c) participation in trade or professional organizations and (d) service on the board of directors (or comparable body) of not more than one third-party entity or organization that does not compete with the Company Business (as defined in the Confidentiality Agreement), so long as the foregoing do not interfere with Employee’s performance of his duties hereunder as determined in good faith by the Company.

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4.    Compensation. As the total consideration for Employee’s services rendered under this Agreement, Employer shall pay or provide Employee the following compensation and benefits:
4.1    Signing Bonus. Employee shall be entitled to a one-time signing bonus (the “Signing Bonus”) of $100,000.00, payable on the first payroll date following the Effective Date.
4.2    Salary. Employee shall be entitled to receive an annual base salary during the Term of $400,000.00 (hereinafter the “Base Salary”), payable in accordance with the usual payroll practices of Employer as established from time to time.
4.3    Discretionary Bonus. Employee shall be eligible to receive during each calendar year, commencing in 2016, a discretionary annual target performance bonus of up to 30% of the Base Salary. The amount of any such bonus shall be determined by the Board, or the Compensation Committee of the Board, in their sole discretion.
4.4    Stock Option. As soon as practicable on or after the Effective Date, the Company shall grant Employee under the Company’s Amended and Restated 2007 Incentive Plan, as amended (the “Plan”), a stock option (“Option”) to purchase 350,000 shares of the Company’s common stock. The Option shall vest in sixteen (16) equal quarterly installments of 21,875 shares each over four years beginning on the first quarterly anniversary of the Effective Date, provided, in each case, that Employee remains in the continuous employ of Employer through such quarterly anniversary date. The Option shall (a) be exercisable at an exercise price per share equal to the closing market price of the Company common stock on the date of the grant, (b) have a term of ten years, and (c) be on such other terms as shall be set forth in the Company’s customary form of stock option agreement under the Plan evidencing the Option.
4.5    Expense Reimbursement. Employer shall reimburse Employee for reasonable business expenses incurred by Employee in connection with the performance of Employee’s duties in accordance with Employer’s usual practices and policies in effect from time to time. Any reimbursements hereunder shall be paid to Employee in accordance with the Company’s expense reimbursement policies and procedures from time to time in effect.
4.6    Vacation. Employee shall be entitled to up to 20 days, prorated for any period of less than a full calendar year, of paid “time off’ (vacation days plus sick time/personal time) for each calendar year in accordance with the Company’s policies from time to time in effect, in addition to holidays observed by the Company. Paid time off may be taken at such times and intervals as the Employee shall determine, subject to the conflicting business needs of the Company, and otherwise shall be subject to the Company’s policies in effect from time to time. The number of paid time off days will accrue per pay period and will stop accruing in a calendar year once 20 days have been accrued.
4.7    Employee Benefits. The Company shall provide Employee and his dependents, if any, with coverage under any and all medical, dental and vision plans and other benefit programs available generally to the Company’s senior executives and their dependents, to

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the extent Employee and his dependents satisfy the applicable eligibility requirements, and the Company shall pay, directly or indirectly, the premiums associated with any such medical plans to the same extent the Company pays such premiums for other senior executives of the Company. Employee shall be eligible to participate in any medical insurance and other employee benefits made available generally by Employer to all senior executives under Employer’s plans and employment policies in effect from time to time. Employee acknowledges and agrees that any such plans or policies now or hereafter in effect may be modified or terminated by Employer at any time in its discretion.
4.8    Payroll Taxes. Employer shall have the right to deduct from the compensation and benefits due to Employee hereunder any and all sums required for social security and withholding taxes and for any other federal, state, or local tax or charge which may be in effect or hereafter enacted or required as a charge on the compensation or benefits of Employee.
5.    Termination. This Agreement and Employee’s employment may be terminated as set forth in this Section 5.
5.1    Termination by Employer for Cause; Termination by Employee. Employer may terminate Employee’s employment hereunder for “Cause” (as hereinafter defined) upon notice to Employee. “Cause” for the purpose of this Agreement shall mean any of the following:
(a)    Employee’s breach of any material term of this Agreement, including its Exhibits; provided that the first occasion of any particular breach shall not constitute Cause unless Employee shall have previously received written notice from Employer stating the nature of such breach and affording Employee at least ten days to correct such breach;
(b)    Employee s conviction of, or plea of guilty or nolo contendere to, any felony or other crime of moral turpitude;
(c)    Employee’s act of fraud or dishonesty injurious to Employer or its reputation;
(d)    Employee’s continual failure or refusal to perform his material duties as required under this Agreement after written notice from Employer stating the nature of such failure or refusal and affording Employee at least ten days to correct the same;
(e)    Employee’s act or omission that, in the reasonable determination of Employer’s Board (or a Committee of the Board), indicates alcohol or drug abuse by Employee; or
(f)    Employee’s act or personal conduct that, in the judgment of the Board (or a Committee of the Board), gives rise to a material risk of liability of Employee or Employer under federal or applicable state law for discrimination, or sexual or other forms of harassment, or other similar liabilities to subordinate employees.

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Employee may terminate his employment hereunder, for any reason or no reason, upon 30 days prior notice to Employer.
Upon termination of Employee’s employment by Employer for Cause or by Employee for any reason, all compensation and benefits to Employee hereunder shall cease except that Employee shall be entitled to payment, not later than the date of termination, of (i) any accrued but unpaid salary and unused paid time off (only as accrued during the then-current year of employment), and (ii) reimbursement of business expenses accrued but unpaid as of the date of termination.
5.2    Termination by Employer without Cause. Employer may also terminate Employee’s employment without Cause; provided, however, that Employer shall remain obligated to continue paying in accordance with Section 4.1 Employee’s Base Salary at the time of termination for a period of six months following the termination. Upon any termination pursuant to this Section 5.2, Employee shall be entitled to payment of any unused vacation time (only as accrued as of the date of such termination as provided in this Agreement and in accordance with applicable law) and reimbursement of business expenses accrued but unpaid as of the date of termination.
5.3    Death or Disability. Employee’s employment will terminate automatically in the event of Employee’s death or upon notice from Employer in event of Employee’s permanent disability. Employee’s “permanent disability” shall have the meaning ascribed to such term in any policy of disability insurance maintained by Employer (or Employee, as the case may be) with respect to Employee, or if no such policy is then in effect, shall mean Employee’s inability to fully perform his duties hereunder with or without reasonable accommodation for any period of at least ninety (90) consecutive days, or for a total of one hundred twenty (120) days, whether or not consecutive, within any period of one hundred eighty (180) consecutive days. Upon termination of Employee’s employment as aforesaid, all compensation and benefits to Employee hereunder shall cease and Employee, or Employee’s heirs or personal representatives, as applicable, shall be entitled to the same compensation and benefits as provided in Section 5.1 for termination by Employer for Cause.
6.    Indemnification; Insurance.
6.1    Indemnification. In the event that Employee is made a party or threatened to be made a party to any action, suit, or proceeding, whether civil, criminal, administrative or investigative (a "Proceeding"), other than any Proceeding initiated by Employee or the Company related to any contest or dispute between Employee and the Company or any of its affiliates with respect to this Agreement or Employee 's employment hereunder, by reason of the fact that the Employee is or was a director or officer of the Company, or any affiliate of the Company, or is or was serving at the request of the Company as a director, officer, member, employee or agent of another corporation or a partnership, joint venture, trust or other enterprise, Employee shall be indemnified and held harmless by the Company to the fullest extent permitted under applicable law and the Company's bylaws from and against any liabilities, costs, claims and expenses, including all costs and expenses incurred in defense of any Proceeding (including reasonable attorneys' fees). Costs and expenses incurred by Employee in defense of such Proceeding

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(including attorneys' fees) shall be paid by the Company in advance of the final disposition of such litigation upon receipt by the Company of: (i) a written request for payment; (ii) appropriate documentation evidencing the incurrence, amount and nature of the costs and expenses for which payment is being sought; and (iii) an undertaking adequate under applicable law made by or on behalf of Employee to repay the amounts so paid if it shall ultimately be determined that Employee is not entitled to be indemnified by the Company under this Agreement.
6.2    Insurance. During the Employment term, the Company shall purchase and maintain, at its own expense, directors' and officers' liability insurance providing coverage to Employee on terms that are no less favorable than the coverage provided to other directors and similarly situated executives of the Company.
7.    Clawback Provisions. Notwithstanding any other provisions in this Agreement to the contrary, any incentive-based compensation, or any other compensation, paid to Employee pursuant to this Agreement or any other agreement or arrangement with the Company which is or may become subject to recovery under any law, government regulation or stock exchange listing requirement, will be subject to such deductions and clawback as may be required to be made pursuant to such law, government regulation or stock exchange listing requirement (or any policy adopted by the Company pursuant to any such law, government regulation or stock exchange listing requirement). The Company will make any determination for clawback or recovery in its sole discretion and in accordance with any applicable law or regulation.
8.    Severable Provisions. The provisions of this Agreement are severable and if any one or more provisions is determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions, and any partially unenforceable provisions to the extent enforceable, shall nevertheless be binding and enforceable.
9.    Successors and Assigns. This Agreement shall inure to the benefit of and shall be binding upon and enforceable by the parties and their respective successors, assigns, heirs and representatives; provided, however, that neither party may assign this Agreement without the prior written consent of the other party; and, provided further, that this Agreement may be assigned by the Company to a successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of Employer.
10.    Entire Agreement. This Agreement, including the Confidentiality Agreement, contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made no agreements, representations or warranties relating to the subject matter of this Agreement that are not set forth otherwise therein or herein. Except as expressly provided herein, this Agreement (including the Confidentiality Agreement) supersedes any and all prior or contemporaneous agreements, written or oral, between Employee and Employer relating to the subject matter hereof.
11.    Amendment. No modification of this Agreement shall be valid unless made in writing, approved by the Board (or a committee of the Board) and signed by the parties hereto. The parties hereto agree that in no event shall an oral modification of this Agreement be enforceable or valid.

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12.    Governing Law; Arbitration.
12.1    Governing Law. This Agreement is and shall be governed and construed in accordance with the laws of the State of California without giving effect to the choice-of-law rules of California.
12.2    Employer and Employee agree that arbitration pursuant to this Section 12.2 shall be the sole and exclusive method for resolving any claim or dispute arising out of or relating to the rights and obligations of the Company and Employee pursuant to this Agreement. Employer and Employee shall mutually agree on the arbitrator; provided, however, that if Employer and Employee cannot mutually agree on the arbitrator, either Employer or Employee can request that JAMS, Inc. (“JAMS”) select the arbitrator. The arbitrator shall have at least ten (10) years’ experience with respect to employment matters. Any such arbitration shall be held in San Francisco, California, under JAMS’s Employment Arbitration Rules & Procedures (the “JAMS Rules & Procedures”) then in effect. A copy of the current JAMS Rules & Procedures is attached hereto as Exhibit A. The JAMS Rules & Procedures are also available online at www.jamsadr.com/rules-employment arbitration . The arbitrator shall set a limited time period and establish procedures designed to reduce the cost and time for discovery while allowing Employer and Employee an opportunity, adequate in the sole judgment of the arbitrator, to discover relevant information from the opposing parties about the subject matter of the dispute. The arbitrator shall rule upon motions to compel or limit discovery and shall have the authority to impose sanctions, including attorneys’ fees and costs, to the same extent as a court of law or equity, should the arbitrator determine that discovery was sought without substantial justification or that discovery was refused or objected to without substantial justification. The decision of the arbitrator shall be written, shall be in accordance with applicable law, and shall be supported by written findings of fact and conclusions of law which shall set forth the basis for the decision of the arbitrator. The arbitrator shall render a written decision on the claim or dispute presented as soon as practicable and in any event not more than forty-five (45) days after the close of evidence and briefing. The decision of the arbitrator as to the validity and amount of any claim disputed by Employer and Employee shall be binding and conclusive upon such parties to this Agreement, and notwithstanding anything in this Section 12.2, such parties shall be required to act in accordance with such decision. Judgment upon any award rendered by the arbitrator may be entered in any court having jurisdiction. Employer will pay all costs of the arbitration, including administrative and arbitrator fees, other than costs the parties would normally incur in a civil action. In the event that a judgment is made pursuant to this Section 12.2, all reasonable out of pocket costs and reasonable legal costs incurred by the prevailing party shall be paid by the non-prevailing party. Any decision, judgment, ruling, finding, award or other determination of the arbitrator and any information disclosed in the course of any arbitration hereunder shall be kept confidential by Employer and Employee, and any court order to enforce the decision, judgment, ruling, finding, award or other determination of the arbitrator shall be filed under seal. This agreement to arbitrate is freely negotiated between Employee and Employer and is mutually entered into between the parties. Each party fully understands and agrees that they are giving up certain rights otherwise afforded them by civil court actions, including, but not limited to, the right to a jury trial.

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/s/ BN By initialing here, Employee acknowledges he has read this Section 12.2 and agrees with the arbitration provisions herein.
13.    Notice. All notices and other communications under this Agreement shall be in writing and mailed, electronically mailed, telecopied (in case of notice to Employer only) or delivered by hand or by a nationally recognized courier service guaranteeing overnight delivery to a party at the following address (or to such other address as such party may have specified by notice given to the other party pursuant to the provision):
If to Employer:

Galena Biopharma, Inc.
Attention: Chief Executive Officer
2000 Crow Canyon Place, Suite 380
San Ramon, California 95483
Phone: 855-855-4253

If to Employee:

Through the Company e-mail or the Company regular mail box, if utilized by the Company, or if Employee shall no longer be employed, to Employee’s address as reflected in the books and records of Employer.

14.    Survival. Sections 6 through 13 and Section 16 shall survive the termination of this Agreement.
15.    Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement. Each party may sign this Agreement using an electronic or handwritten signature, whether on an original or an electronic counterpart of this Agreement.
16.    Attorney’s Fees. In any action or proceeding to construe or enforce any provision of this Agreement the prevailing party shall be entitled to recover its or his reasonable attorneys’ fees and other costs of suit in addition to any other recoveries.
[Signature Page Follows]

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By signing below, each party acknowledges that it or he has read and understands this Agreement, and each party agrees to be bound by the terms of this Agreement.
 
EMPLOYER
 
 
 
Galena Biopharma, Inc.
 
 
 
 
 
By: /s/ Mark W. Schwartz
 
   Mark W. Schwartz, Ph.D.
 
   President and Chief Executive Officer
 
 
 
 
 
EMPLOYEE
 
 
 
 
 
/s/ Bijan Nejadnik
 
Bijan Nejadnik, M.D.
 
 


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Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Mark W. Schwartz, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Galena Biopharma, 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 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 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 functions):
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.
Dated: November 9, 2015
 
 
/s/ Mark W. Schwartz
 
Mark W. Schwartz
 
President and Chief Executive Officer




Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ryan M. Dunlap, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Galena Biopharma, 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 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 functions):
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.
Dated: November 9, 2015

 
/s/ Ryan M. Dunlap
 
Ryan M. Dunlap
 
Vice President, Chief Financial Officer




Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Quarterly Report of Galena Biopharma, Inc., (the “Company”) on Form 10-Q for the quarter ended September 30, 2015 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officers of the Company certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to their knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the Company’s financial condition and result of operations.
 
/s/ Mark W. Schwartz
 
/s/ Ryan M. Dunlap
Mark W. Schwartz
 
Ryan M. Dunlap
President and Chief Executive Officer
 
Vice President, Chief Financial Officer
 
 
 
November 9, 2015
 
November 9, 2015



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