Current Report Filing (8-k)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): October 30, 2015

Galena Biopharma, Inc.

(Exact name of registrant as specified in its charter)



Delaware	001-33958	20-8099512
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

	2000 Crow Canyon Place Suite 380 San Ramon, CA 94583
	(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (855) 855-4253

	2000 Crow Canyon Place Suite 300 San Ramon, CA 94583
	(Former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



Item 5.02	Departure of Directors or Certain Directors; Election of directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(c) On October 30, 2015, the Company announced that Bijan Nejadnik, M.D., will serve as the Company’s Executive Vice President and Chief Medical Officer, effective October 30, 2015. Dr. Nejadnik was the Executive Director of Jazz Pharmaceuticals plc, from April 2013. He also served as Medical Director of Johnson & Johnson Pharmaceuticals from March 2006 to April 2013, and Research Physician at Purdue Pharma L.P, as part of a joint program with Cornell University Medical School from July 2001 to July 2002. He has held various positions at Stanford University, School of Medicine from 2009 to the present and had a research and clinical fellowship in GI-Hepatology at Johns Hopkins University School of Medicine, Baltimore, Maryland, from July 2002 to June 2005. He attended University of Louvain (Université Catholique de Louvain), School of Medicine and performed his residency at University of Louvain (Université Catholique de Louvain) Program and St. Etienne Hospital, Brussels, Belgium.

Dr. Nejadnik and the Company have entered into an employment agreement, dated as of October 30, 2015 (the "Employment Agreement"), the term of which continues until terminated by the Company or Dr. Nejadnik. Under the Employment Agreement, Dr. Nejadnik will receive an annual base salary of $400,000. In addition to his base salary, he is entitled to receive $100,000 signing bonus and eligible to receive an annual cash bonus award targeted at 30% of his annual base salary based on the performance of certain criteria set by the Board. Further, effective October 30, 2015, the Company will grant 350,000 stock options on the terms and conditions set forth in the Company’s form Incentive Stock Option Agreement filed as Exhibit 10.5 to the Company’s annual report on Form 10-K filed for the fiscal year ended December 31, 2014, and which will 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 of the employment agreement.

There are no arrangements or understandings between Dr. Nejadnik and any other person pursuant to which he was elected as an executive officer of the Company.

As an executive officer of the Company, Dr. Nejadnik will be eligible to receive other benefits available to an executive officer.



Item 9.01	Financial Statements and Exhibits.

(d) Exhibits

The following exhibit relating to Item 5.02 shall be deemed to be furnished and not filed:

99.1 Press Release issued by the registrant on October 30, 2015.

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 hereunto duly authorized.




		GALENA BIOPHARMA, INC.

Date:	October 30, 2015	By:	/s/ Ryan Dunlap
			Ryan Dunlap Chief Financial Officer

Galena Biopharma Appoints Bijan Nejadnik, M.D., as Executive Vice President and Chief Medical Officer

San Ramon, California, October 30, 2015— Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that Bijan Nejadnik, M.D., has been hired as the Company’s Executive Vice President and Chief Medical Officer, effective today.

Dr. Nejadnik will be responsible for managing all of Galena’s clinical development programs, which consist of multiple mid- to late-stage clinical assets, including immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301 (Folate Binding Protein). NeuVax is currently in a pivotal, Phase 3 clinical trial with several concurrent Phase 2 trials both as a single agent and in combination with other therapies. GALE-301 recently completed a Phase 2a clinical trial in ovarian and endometrial cancer.

“The appointment of Dr. Bijan Nejadnik as our new Chief Medical Officer comes at an important juncture for Galena as the company anticipates reaching several key milestones across our clinical development pipeline,” said Mark W. Schwartz, Ph.D., President and CEO. “Bijan’s knowledge in oncology and immunotherapy, as well as his experience leading the design, planning and execution of early and late-stage clinical programs, will be instrumental to Galena as we continue to advance and expand our product portfolio, including our immunotherapy franchise, led by NeuVax. We are thrilled to have Bijan join the Galena team and look forward to his contributions.”

Dr. Bijan Nejadnik has more than 22 years of academic and industry experience, including twelve years with pharmaceutical and biotech companies including Jazz Pharmaceuticals, Johnson & Johnson, and Purdue Pharma. During his career, he has managed numerous clinical development teams and programs with a therapeutic focus in hematology-oncology, immunology and central nervous system diseases. In this capacity, Dr. Nejadnik has successfully developed numerous biologics and small molecules, advancing these agents towards Biologics License Application (BLA) and New Drug Application (NDA) submissions.

Dr. Nejadnik joins Galena from Jazz Pharmaceuticals where he was the Executive Director, Hematology-Oncology and led the clinical team towards a recently filed NDA. Prior to Jazz, he spent seven years at Johnson & Johnson working on numerous compounds in early and late stage registrational trials in immunology and oncology. Dr. Nejadnik spent more than 13 years in teaching, research and caring for patients at world-renowned academic institutions including Stanford University School of Medicine, Johns Hopkins University School of Medicine, University of California, Davis, and State University of New York, Syracuse. Dr. Nejadnik graduated from the University of Louvain in Belgium for both his undergraduate degree in premedical studies, graduating Summa Cum Laude, and his medical degree, graduating Magna Cum Laude. He completed his internship and residency programs specializing in internal medicine focused on hematology-oncology at the University of Louvain and Oregon Health Sciences University. He completed his fellowships at Cornell University’s Weill Medical College and Johns Hopkins University School of Medicine. Dr. Nejadnik has led or participated in more than 20 peer-reviewed publications.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.

NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting node positive HER2 IHC 1+/2+ patients (clinicaltrials.gov identifier: NCT01479244). Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About GALE-301

GALE-301 is a cancer immunotherapy that consists of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Enrollment has been completed in the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696).

About Galena Biopharma

Galena Biopharma, Inc. (NASDAQ: GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena’s development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company’s commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena’s clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of our commercial products and development of Galena’s product candidates, including NeuVax, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.

Contact:

Remy Bernarda

SVP, Investor Relations & Corporate Communications

(503) 405-8258

rbernarda@galenabiopharma.com

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