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): June 27, 2016
GALENA BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-33958 | | 20-8099512 |
| (State or other jurisdiction of incorporation or organization) | | (Commission
File Number)
| | (I.R.S. Employer
Identification No.) |
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| | | 2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583
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| | | (Address of Principal Executive Offices) (Zip Code)
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Registrant’s telephone number, including area code: (855) 855-4253
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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):
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| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
NeuVax™ (nelipepimut-S) PRESENT Clinical Trial
On June 29, 2016, Galena Biopharma, Inc. issued a press release announcing that it had received the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for the Company’s Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. A copy of the above referenced press release and the letter from the IDMC are filed as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The Company will stop the PRESENT Trial and evaluate its other clinical development programs.
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| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
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| Exhibit No. | | Description |
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| 99.1 |
| | Press Release of Galena Biopharma, Inc. dated June 29, 2016. |
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| 99.2 |
| | Letter from the Independent Data Monitoring Committee dated June 27, 2016. |
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.
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| | | | | GALENA BIOPHARMA, INC. |
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| Date: | | June 29, 2016 | | | | By: | | /s/ Mark W. Schwartz |
| | | | | | | | | Mark W. Schwartz Ph.D. President and Chief Executive Officer |
