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): September 5, 2017
 
 
 
 
 
 
  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

 
 
 
 
 


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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨




Item 1.01 Entry into a Material Definitive Agreement.
On September 5, 2017, Mills Pharmaceuticals, LLC (“MPI”), a wholly owned subsidiary of Galena Biopharma, Inc. (“Galena”) and BioVascular, Inc. (“BVI”), entered into an amendment (“Amendment”) of the Exclusive License Agreement between MPI and BVI dated December 20, 2013 (the “License Agreement”), pursuant to which parties agreed to resolve their outstanding disputes over the License Agreement and to modify the certain terms of the License Agreement, including but not limited to, (i) eliminating the 3% royalty rate on annual net sales of $50 million and the 4% royalty now applies to annual net sales of up to $100 million, (ii) making an advance payment of $350,000 for the milestone related to the initiation of the Phase 3 clinical trial payable in two tranches with the first payment of $200,000 payable on or before October 31, 2017 and the second payment of $150,000 payable 30 days after the “Effective Time” as that term is defined in the Agreement and Plan of Merger and Reorganization dated August 7, 2017 by and among Galena Biopharma, Inc., Sellas Intermediate Holdings I, Inc., Sellas Intermediate Holdings II, Inc., Galena Bermuda Merger Sub, Ltd., and SELLAS Life Sciences Group Ltd. but no later than December 31, 2017, (iii) adding a payment for a sublicense by MPI to a third party of 25% of any cash received for upfront fees or milestone payments if the sublicense is executed prior to first patient enrolled in the Phase 3 clinical trial and 17.5% of any cash received for upfront fees or milestone payments if the sublicense is executed after the first patient is enrolled in the Phase 3 clinical trial, and (iv) if the first patient is not enrolled in the Phase 3 clinical trial by December 31, 2018, BVI shall have the right to terminate the License Agreement and the advance payment shall not be repaid to MPI. Under the terms of a consent among Comerica Bank, BVI and MPI dated September 5, 2017, Comerica Bank shall receive $100,000 of the $350,000 advance payment from MPI.
BVI also withdrew its notice of termination as of September 5, 2017.
The preceding summary does not purport to be complete and is qualified in its entirety by reference to the Amendment, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and which is incorporated herein by reference.
Additional Information about the Proposed Merger between Galena Biopharma, Inc. and SELLAS Life Sciences Group Ltd and Where to Find It

In connection with the proposed merger, Galena Biopharma, Inc. and SELLAS Life Sciences Group Ltd intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S-4 that will contain a proxy statement /prospectus /information statement. Galena and SELLAS will mail the final proxy statement / prospectus / information statement to their respective stockholders. Investors and stockholders of Galena and SELLAS are urged to read these materials when they become available because they will contain important information about Galena, SELLAS and the proposed merger. The proxy statement /prospectus /information statement and other relevant materials (when they become available), and any other documents filed by Galena with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov . In addition, copies of the documents filed with the SEC by Galena will be available free of charge on the Company’s website at www.galenabiopharma.com (under “Investors” - “Financials”) or by directing a written request to: Galena Biopharma, Inc., 2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583, Attention: Investor Relations or by email to: ir@galenabiopharma.com . Investors and stockholders are urged to read the proxy statement /prospectus /information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.

Non-Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in the Solicitation

Galena and its directors and executive officers and SELLAS and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Galena in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement /prospectus /information statement referred to above.




Additional information regarding the directors and executive officers of Galena is also included in Galena’s proxy statement for its 2017 Annual Meeting of Stockholders, which was filed with the SEC on April 20, 2017. These documents are available free of charge at the SEC’s web site ( www.sec.gov ) and from Investor Relations at Galena at the addresses provided above.

Forward-Looking Statements

This Form 8-K contains 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 and otherwise. Forward-looking statements are neither historical facts nor assurances of future performance. All statements, other than statements of historical facts, included in this Form 8-K regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the the proposed merger.Galena may not actually achieve the plans disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with stockholder approval of and the ability to consummate the proposed merger through the process being conducted by Galena and SELLAS. Additional risks and uncertainties relating to Galena and its business can be found under the caption “Risk Factors” and elsewhere in the Company’s SEC filings and reports, including in Galena’s Annual Report on Form 10-K, filed with the SEC on March 15, 2017 and the Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2017 and in subsequently filed Form 10-Qs. Galena and SELLAS each disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
Item 8.01 Other Events.
On September 11, 2017, Galena issued a press release relating to the Amendment. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
Exhibit Index




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:
 
September 11, 2017
 
 
 
By:
 
/s/ Thomas J. Knapp
 
 
 
 
 
 
 
 
Thomas J. Knapp
Interim General Counsel and Corporate Secretary





Exhibit 10.1



Amendment to EXCLUSIVE LICENSE Agreement
This Amendment to the Exclusive License Agreement, dated as of September 5, 2017 (the “Amendment”), by and between Mills Pharmaceuticals, LLC., a Delaware limited liability MPI (the “MPI”), and BioVascular, Inc., a Delaware MPI (the “BVI”), amends the Exclusive License Agreement, dated as of December 20, 2013, by and between the MPI and BVI (the “License Agreement”). Capitalized terms shall of the meaning set forth in the License Agreement unless otherwise set forth herein.
WITNESS:
WHEREAS, the MPI and the BVI wish to resolve the dispute regarding MPI’s Commercially Reasonable Efforts to Develop the controlled release formulation of anagrelide by making certain amendments to the License Agreement.
NOW, THEREFORE , for good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the MPI and the BVI hereby agree as follows:
1.
Royalties . Section 3.2(a) of the License Agreement is hereby amended by deleting the chart contained therein and substituting the following chart:
Cumulative Net Sales 1  in a Calendar Year ("Annual Net Sales")
Rate
Portion of Annual Net Sales under $100,000,000
4%
Portion of Annual Net Sales equal to or greater than $100,000,000
6%
In calculating the Annual Net Sales for the purposes of determining the applicable royalty rate, Annual Net Sales shall include the cumulative Net Sales of MPI, its Affiliates and all Sublicensees (including U.S. Sublicensees) in a calendar Year. For the avoidance of doubt, the Net Sales of U.S. Sublicensees shall not be included in the calculation of royalties due under Section 3.2(a).
2.
Milestone Payments . Section 3.5 of the License Agreement is hereby amended by adding after the last paragraph of Section 3.5 the following paragraph:

3. Subject to payments to be made to Comerica Bank pursuant to Section 3.8, MPI shall make the following payments (“Advance Payments”) to BVI: (i) two hundred thousand dollars ($200,000) with one hundred thousand dollars ($100,000) of such amount paid to Comerica Bank, all such payments being made on or before October 31, 2017, and (ii) one hundred fifty thousand dollars ($150,000) within 30 days after the Effective Time as that term is defined in the Agreement and Plan of Merger and Reorganization dated August 7, 2017 by and among Galena Biopharma, Inc., Sellas Intermediate Holdings I, Inc., Sellas Intermediate Holdings II, Inc., Galena Bermuda Merger Sub, Ltd., and SELLAS Life Sciences Group Ltd. but no later than December 31, 2017. Such Advance payments shall credited against the applicable Milestone Payments set forth in the first paragraph of this Section 3.5. 




4. Sublicenses . Section 3.10 of the License Agreement is hereby amended by adding after the first paragraph of Section 3.10 the following paragraph:

In the event MPI sublicenses to Third Parties any rights under BVI Technology, MPI shall pay BVI the following payments:
Sublicense to Third Party prior to first patient enrolled in Phase 3 trial of controlled release formulation of anagrelide   for   patients with essential thrombocythemia
25% of any cash received by MPI for upfront fess or milestone payments
Sublicense to Third Party after first patient enrolled in Phase 3 trial of controlled release formulation of anagrelide for   patients with essential thrombocythemia
17.5% of any cash received by MPI for upfront fess or milestone payments

5.
Diligence . Section 4.5 of the License Agreement is hereby amended by adding after the first paragraph of Section 4.5 the following paragraph:
In the event the first patient is not enrolled in the Phase 3 trial of controlled release formulation of anagrelide for patients with essential thrombocythemia by December 31, 2018, BVI shall have the right to terminate all rights and licenses granted to MPI under this Agreement and none of the advanced milestone payments set forth in Section 2 of this Amendment shall be repaid to MPI.
6.
Notices . Section 12.4 of the License Agreement is amended so that notices to the MPI will be address or directed as follows:
Galena Biopharma Inc., 2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583; attention: Thomas J. Knapp, Interim General Counsel; telephone: 925-498-7734; email: tknapp@galenabiopharma.com.
7.
Full Force and Effect . The License Agreement remains in full force and effect as amended by this Amendment.



(Signature page on the next page)








IN WITNESS WHEREOF, the parties hereto have signed this Amendment on the date first above written.
MILLS PHARMACEUTICALS, LLC
By: /s/ Stephen F. Ghiglieri                         
Name:    Stephen F. Ghiglieri                    
Title: Interim Chief Executive Officer and Chief Financial Officer                    

BIOVASCULAR, INC.
By: /s/ John H. Parrish                         
Name:    John H. Parrish                    
Title: President and Chief Executive Officer                         





Exhibit 99.1
LOGO-VERTICALA18.JPG

Galena Biopharma and BioVascular, Inc. Reaffirm GALE-401 Partnership

San Ramon, California, September 11, 2017 - Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, today announced it has reaffirmed its partnership with BioVascular, Inc. regarding the development of GALE-401. Working in conjunction with SELLAS Life Sciences, Galena’s proposed merger candidate, BioVascular has withdrawn its notice of termination, and Galena and BioVascular have amended the previous license agreement to advance the asset either through internal clinical development or by seeking a licensing partner. GALE-401 is a controlled release version of the approved drug anagrelide for the treatment of elevated platelets in patients with myeloproliferative neoplasms (MPNs). Galena has completed the majority of work for initiation of a Phase 3 trial in patients with essential thrombocythemia (ET).

“GALE-401 is a Phase 3-ready asset, and this joint collaboration between Galena, SELLAS, and BioVascular endorses our mutual belief in the value of the program for patients with ET or other MPN disorders,” said Stephen F. Ghiglieri, Interim Chief Executive Officer. “We remain committed to the advancement of GALE-401, and believe the future collaboration with SELLAS and BioVascular can uncover the true value of the asset.”

“Over the last several years, Galena advanced anagrelide controlled release from Phase 1 to now be ready to enter a Phase 3 clinical trial. Given Galena’s proposed merger with SELLAS, we are optimistic that the combined company with experience in the MPN space will share a renewed emphasis on collaborating with BioVascular to determine the most viable path to advance development of GALE-401,” added John H. Parrish, President and CEO of BioVascular, Inc.

About GALE-401 (Anagrelide Controlled Release)

GALE-401 is a controlled release formulation of anagrelide (Anagrelide CR) currently in clinical development for essential thrombocythemia. The currently available immediate release formulation (Agrylin® or anagrelide IR) is approved by the FDA for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Adverse events associated with anagrelide IR, such as nausea, diarrhea, abdominal pain, palpitations, tachycardia, and headache, may be dose and plasma concentration dependent. GALE-401 is a new formulation with, controlled release version of anagrelide that increases the half-life and reduces the maximum plasma concentration (C max ) of the drug and is expected to reduce side effects, but preserve efficacy. A Phase 2 pilot study with GALE-401 has been completed.






About Essential Thrombocythemia

Essential Thrombocythemia (ET) is a chronic myeloproliferative neoplasm (MPN) characterized by the overproduction of platelets by megakaryocytes in the bone marrow. The U.S. prevalence of ET is between 120,000 and 185,000 with approximately seventy-five percent of patients receiving treatment. 1 Common symptoms include headache, vision disturbances or migraines, dizziness or lightheadedness, coldness or blueness of fingers or toes, burning, redness, and pain in the hands and feet. Complications for patients with ET include blood clotting or bleeding or may be thromboembolic in nature such as stroke, heart attack, or transient ischemic attack.

As with other MPNs, ET is a progressive blood cancer that can strike at any age, and for which there is no known cure; and, there is no single treatment option that is appropriate or effective for all ET sufferers. While some ET patients may be asymptomatic and require no treatment, others may require various treatments and therapies based on the symptoms, their risk factors, and potential complications. The treatment options are limited and are generally hydroxyurea prescribed first line, followed by other treatments including anagrelide immediate release, interferon, aspirin or other agents depending on the patient’s condition. Of these, only anagrelide IR is approved for treatment of ET patients.

1 Sources: Mehta et al, (2014) Epidemiology of myeloproliferative neoplasms in the United States, Leukemia & Lymphoma, 55:3, 595-600, DOI: 10.3109/10428194.2013.813500; United States Census Bureau.

About Myeloproliferative Neoplasms

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), chronic myelogenous leukemia (CML), primary myelofibrosis (PMF), and essential thrombocythemia (ET), 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.

About BioVascular Inc.

BioVascular Inc. is a privately held biotechnology company that develops drugs for control of platelet mediated disorders.

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by its hematology asset, GALE-401, and its novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. For more information, visit www.galenabiopharma.com .





Safe Harbor Statements

Additional Information about the Proposed Merger and Where to Find It

In connection with the proposed merger, Galena Biopharma, Inc. and SELLAS Life Sciences Group Ltd intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S-4 that will contain a proxy statement /prospectus / information statement. Galena and SELLAS will mail the final proxy statement / prospectus / information statement to their respective stockholders. Investors and stockholders of Galena and SELLAS are urged to read these materials when they become available because they will contain important information about Galena, SELLAS and the proposed merger. The proxy statement / prospectus / information statement and other relevant materials (when they become available), and any other documents filed by Galena with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, copies of the documents filed with the SEC by Galena will be available free of charge on the Company’s website at www.galenabiopharma.com (under “Investors” - “Financials”) or by directing a written request to: Galena Biopharma, Inc., 2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583, Attention: Investor Relations or by email to: ir@galenabiopharma.com . Investors and stockholders are urged to read the proxy statement / prospectus / information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.

Non-Solicitation

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in the Solicitation

Galena and its directors and executive officers and SELLAS and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Galena in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement / prospectus / information statement referred to above. Additional information regarding the directors and executive officers of Galena is also included in Galena Annual Report on Form 10-K for the year ended December 31, 2016 and the proxy statement for Galena’s 2017 Annual Meeting of Stockholders. These documents are available free of charge at the SEC website ( www.sec.gov ), the Investors section of Galena Biopharma’s website at the address above, and from Investor Relations at Galena at the mailing address described above.





Forward Looking Statements

This Press Release contains 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 and otherwise. Forward-looking statements are neither historical facts nor assurances of future performance. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to future collaboration between Galena and SELLAS on the advancement of GALE 401, the completion of the proposed merger of a subsidiary of Galena with SELLAS, pursuant to which SELLAS will become a wholly owned subsidiary of Galena; the combined company’s ability to successfully initiate a phase 3 clinical trial within the time periods set forth in the amendment to the license agreement and the ability of the combined company to sublicense the technology of the license agreement. The combined company may not actually achieve the plans disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with stockholder approval of and the ability to consummate the proposed merger through the process being conducted by Galena and SELLAS, Galena’s future cash utilization and reserves needed for contingent future liabilities of the license agreement with BioVascular as amended, the availability of sufficient resources of the combined company to initiate clinical trials, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the intellectual property of the license agreement with BioVascular , risks related to the drug discovery and the regulatory approval process and the impact of competitive products and technological changes. Additional risks and uncertainties relating to Galena and its business can be found under the caption “Risk Factors” and elsewhere in the Company’s SEC filings and reports, including in Galena’s Annual Report on Form 10-K, filed with the SEC on March 15, 2017 and the Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2017 and in subsequently filed Form 10-Qs. Galena and SELLAS each disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

NeuVax is a trademark of Galena Biopharma, Inc.

Contact:

Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com

Source: Galena Biopharma, Inc.