ANNUAL REPORT 201 OUR MISSION GALENA BIOPHARMA DEVELOPS AND COMMERCIALIZES INNOVATIVE, TARGETED ONCOLOGY TREATMENTS THAT ADDRESS MAJOR UNMET MEDICAL NEEDS TO ADVANCE CANCER CARE. MANAGEMENT TEAM Mark J. Ahn, Ph.D., President & Chief Executive Officer Remy Bernarda, Vice President, Marketing & Communications Gavin Choy, Pharm.D., Senior Vice President, Clinical Operations & Cinical Science Ryan Dunlap, CPA, Vice President, Chief Financial Officer Brian Hamilton, M.D., Ph.D., Executive Vice President & Chief Medical Officer Robert Laliberte, MS, Vice President, Clinical Operations & Clinical Science Christopher Lento, Vice President, Sales & Commercial Operations Hana B. Moran, Ph.D., Senior Vice President, Regulatory & Compliance Patricia Murphy, Vice President, Regulatory Affairs & Compliance Mark W. Schwartz, Ph.D., Executive Vice President & Chief Operating Officer SCIENTIFIC ADVISORY BOARD COL George Peoples, M.D., F.A.C.S., Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program, San Antonio Military Medical Center Hope S. Rugo, M.D., Clinical Professor of Medicine, Division of Hematology and Oncology at the University of California San Francisco Helen Diller Family Comprehensive Cancer Care Center Robert Figlin, M.D., F.A.C.P., Dr. Figlin is a fellow of the American College of Physicians and the International Society for Biologic Therapy as well as a member of the American Society of Clinical Oncology, the American Association for Cancer Research, and the American Urological Association. Dr. Gabriel N. Hortobagyi, M.D., F.A.C.P., is a Professor of Medicine and Chairman of the Department of Breast Medical Oncology and holds the Nellie B. Connally Chair in Breast Cancer Research at the University of Texas MD Anderson Cancer Center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d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2013 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 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.) 4640 SW Macadam Ave., Suite 270, Portland, OR 97239 (Address of principal executive office) (Zip code) Registrant’s telephone number: (855) 855-4253 Securities registered pursuant to Section 12(b) of the Exchange Act: Title of Each Class Name of Exchange on Which Registered Common Stock, $0.0001 Par Value per Share The NASDAQ Capital Market Securities registered pursuant to Section 12(b) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes No 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 No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10- K. Yes No Indicate by check mark whether the registrant has submitted electronically and posted on it 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 any such shorter time that the registrant was required to submit and post such files). Yes 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 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 No Based on the closing price of the Registrant's common stock as reported on the NASDAQ Capital Market, the aggregate market value of the Registrant's common stock held by non-affiliates on June 28, 2013 (the last business day of the Registrant's most recently completed second fiscal quarter) was approximately $185,711,000. As of February 28, 2014, Galena Biopharma, Inc. had outstanding 117,879,459 shares of common stock, $0.0001 par value per share, exclusive of treasury shares. GALENA BIOPHARMA, INC. FORM 10-K — FISCAL YEAR ENDED DECEMBER 31, 2013 INDEX Part Item Page No. No. Description No. I1Business 3 1A Risk Factors 13 1B Unresolved Staff Comments 41 2 Properties 41 3 Legal Proceedings 41 4 Mine Safety Disclosures 41 II 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 42 6 Selected Financial Data 45 7 Management's Discussion and Analysis of Financial Condition and Results of Operations 45 7A Quantitative and Qualitative Disclosures About Market Risk 55 II 8 Financial Statements and Supplementary Data 56 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosures 86 9A Controls and Procedures 86 9B Other Information 87 III 10 Directors, Executive Officers and Corporate Governance 89 11 Executive Compensation 89 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 89 13 Certain Relationships and Related Transactions, and Director Independence 89 14 Principal Accountant Fees and Services 89 Index to Exhibits 90 Signatures 94 EX-3.1 EX-3.2 EX-10.1 EX-31.1 EX-31.2 EX-32.1 1 "SAFE HARBOR" STATEMENT Some of the information contained in this annual report may include forward-looking statements that reflect our current views with respect to our commercial and development programs, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and our industry, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events