SEC Company Response from SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478) (SLS) — Oct 27, 2017
SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478)
Date: Oct. 27, 2017 · CIK: 0001390478 · Accession: 0001193125-17-323500
AI Filing Summary & Sentiment
File numbers found in text: 333-220592
Referenced dates: October 20, 2017
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CORRESP 1 filename1.htm CORRESP 1(212) 318-6053 keithpisani@paulhastings.com October 27, 2017 VIA EDGAR AND BY COURIER Ms. Christine Westbrook Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-4 Filed September 22, 2017 File No. 333-220592 Ladies and Gentlemen: On behalf of Galena Biopharma, Inc. (“Galena”), we are transmitting for filing one copy of Amendment No. 1 (the “Amendment”) to Galena’s above-referenced Registration Statement on Form S-4 (the “Registration Statement”) marked to show the changes made to Galena’s Registration Statement filed with the Securities and Exchange Commission (the “Commission”) on September 22, 2017. This Amendment is being filed in response to comments with respect to the Registration Statement received from the Commission (the “Staff”) by letter dated October 20, 2017. The numbering of the paragraphs below corresponds to the numbering of the Staff’s comments which, for your convenience, we have incorporated into this response letter in italics. Page references in the text of Galena’s responses correspond to the page numbers of the Amendment. Capitalized terms used herein but not defined herein shall have the meanings assigned to them in the Amendment. Registration Statement on Form S-4 General 1. Please limit your prospectus cover page to one page. See Item 501(b) of Regulation S-K. Galena has revised the prospectus cover page in response to the Staff’s comment. 2. Please disclose on the cover that there is no adjustment to the number of shares of Galena common stock to be issued in the merger and the market value of the shares of Galena common stock could vary significantly from the market value as of the date of the proxy statement/prospectus/consent solicitation. Ms. Christine Westbrook October 27, 2017 Page 2 Galena has revised the disclosure on the prospectus cover page in response to the Staff’s comment. Prospectus Summary, page 1 3. Please revise to balance the disclosure in your prospectus summary by discussing the most significant risks, including, but not limited to, the following: (1) Galena’s non-compliance with NASDAQ Listing Rules and the condition to completion of the merger that Galena maintain the listing on NASDAQ; (2) the discontinuation of the Phase 3 PRESENT clinical trial, including that Galena’s other product candidates have a similar mechanism of action and therefore may no longer be viable products; and (3) Galena’s significant involvement in legal proceedings, included settled and pending cases. Galena has revised the disclosure on pages 9 and 10 in response to the Staff’s comment. The Companies, page 1 4. Please explain what you mean by the statement “Galena has completed the majority of the work for initial of a Phase 3 trial in patients with essential thrombocythemia...” and revise the statement to remove any implication that the FDA has signed off on a Phase 3 trial. Please also remove the references on page 1 and throughout the prospectus, including in pipeline development charts, to any drug candidate as “Phase-3 ready” and include disclosure regarding material contingencies to continued development of your and SELLAS’ product candidates. Galena has revised the disclosure on page 1 in response to the Staff’s comment. Galena has removed references through the Amendment to completing a majority of the work for the initial Phase 3 trial on pages 1, 83, 181 and 226. Galena has also removed references to drug candidates as “Phase 3 ready” on pages 1, 44, 46, 87, 148, 196, 200, 245 and F-92. Overview of the Merger Agreement and Agreements Related to the Merger Ms. Christine Westbrook October 27, 2017 Page 3 Conditions to the Completion of the Merger, page 6 5. Please amend your disclosure to include the material closing conditions to the completion of the Merger under the Merger Agreement. Galena has revised the disclosure on page 6 in response to the Staff’s comment. Nasdaq Stock Market Listing, page 8 6. Please amend your disclosure to include the anticipated timing of such initial listing application, that approval of the listing application is a condition to completion of the merger, and that the initial listing criteria requires that Galena have a minimum bid price of $4.00 per share. Please also disclose the trading price of Galena common stock as of the most recent practicable date. Galena has revised the disclosure on page 9 in response to the Staff’s comment. Risk Factors Galena may become involved in securities class action litigation...., page 14 7. Please expand your disclosure to include the pending shareholder litigation described under the heading “Legal Proceedings.” Please also include, where appropriate, disclosure concerning the risk of dilution from the proposed issuance of Galena stock to settle the Patel litigation described on page 187 and potential impact of the resale of such shares on the trading price of Galena stock. Galena respectfully advises the Staff that the referenced risk factor relates to litigation surrounding the Merger. However, Galena has revised the risk factor titled “Galena is, and in the future may be, subject to legal or administrative actions that could adversely affect Galena’s business financial condition and Galena’s business” on pages 35-37 and added a new risk factor on page 37 in response to the Staff’s comment. Galena will continue to be responsible for certain liabilities . . ., page 19 8. Please disclose the period of time during which Galena is responsible for specified liabilities relating to Abstral and Zuplenz and the amount up to which Galena has agreed to indemnify Sentynl and Midatech. Galena has revised the disclosure on page 22 to clarify the period of time during which Ms. Christine Westbrook October 27, 2017 Page 4 Galena is responsible for specified liabilities relating to Abstral and Zuplenz. Galena acknowledges the Staff’s comment regarding the amount up to which Galena has agreed to indemnify Sentynyl and Midatech. Galena respectfully advises the Staff that any indemnification for breach of Galena’s representation, warranties and covenants under the agreements with Sentynyl and Midatech is limited and immaterial as there is very little product that remains subject to these agreements. In addition, Galena respectfully advises the Staff that it received confidential treatment pursuant to an order granting confidential treatment dated April 29, 2016, with respect to certain information in the Midatech agreement, including the indemnification cap amount. Therefore, Galena respectfully submits to the Staff that Galena does not believe that the indemnification cap amounts for these agreements is material, nor that inclusion of such information would provide any meaningful information to stockholders. Galena’s Phase 3 PRESENT clinical trial was stopped due to futility..., page 20 9. Please revise this risk factor to remove mitigating language. Please also disclose the reasons that the Independent Data Monitoring Committee recommended stopping the trial and the risks to Galena’s other clinical trials of NeuVax, and Galena’s other product candidates, that could result based on observations of the IDMC. Galena has revised the disclosure on pages 21-22 in response to the Staff’s comment to address the fact that GALE-301 and GALE-302 have a similar mechanism of action to NeuVax and may no longer be viable product candidates as monotherapies. Galena respectfully advises the Staff that it does not believe that results of a study on the use of NeuVax as a monotherapy can be extrapolated to the use of NeuVax in combination with other therapies. Accordingly, Galena has not added disclosure regarding risks to Galena’s programs involving use of NeuVax in combination with other therapies resulting from the failure of the PRESENT trial. In the clinical trials using NeuVax, Leukine is also administered . . ., page 23 10. We note that you are dependent on Genzyme’s supply of Leukine for your ongoing NeuVax and GALE-301/GALE-302 trials. Please disclose if you have entered into a supply agreement with Genzyme and, if so, please file the supply agreement as an exhibit to the registration statement. Galena has revised the disclosure on page 24 in response to the Staff’s comment. GALE-401 must successfully complete a Phase 3 clinical trial..., page 24 Ms. Christine Westbrook October 27, 2017 Page 5 11. Please disclose the adverse events caused by the immediate release version of anagrelide. Galena has revised the disclosure on pages 25 and 182 in response to the Staff’s comment. SELLAS will require substantial additional financing ..., page 38 12. Please disclose here and elsewhere as appropriate the particular levels of funding SELLAS is required to obtain under the MSK license agreement and the particular deadlines for such funding. Galena has revised the disclosure on pages 42, 213 and 247 in response to the Staff’s comment. Market Price and Dividend Information, page 72 13. Please amend your disclosure to include in this section disclosure of the reverse stock split effected in November 2016. Galena has revised the disclosure on page 76 in response to the Staff’s comment. The Merger Background of the Merger, page 79 14. It appears that the certain presentations provided by Peter J. Solomon Company, LLC were material to the Board’s determination to pursue a strategic transaction. We note that if a report, opinion or appraisal materially related to the transaction has been received from an outside party and referred to in the prospectus, your disclosure must provide the information required by Item 1015(b) of Regulation M-A with respect to such report, opinion or appraisal. In addition, any written materials contained or used in the report, opinion or appraisal, as well as the consent of the outside party, must be filed as exhibits to the Form S-4. Please refer to Items 4(b) and 21(c) of Form S-4. In the alternative, please tell us why you do not believe Items 4(b) and 21(c) apply. Galena respectfully advises the Staff that Galena has determined that the materials provided by Peter J. Solomon Company, LLC (“PJSC”) and provided to the Galena Board on February 24, 2017 and June 8, 2017 (such materials, the “PJSC Materials”) are not materially related to the transaction, and as such, Galena does not believe that any additional disclosure about the PJSC Ms. Christine Westbrook October 27, 2017 Page 6 Materials is required to be included in the proxy statement/prospectus/consent solicitation statement pursuant to Item 4 of Form S-4 and Item 1015(b) of Regulation M-A. The Galena Board retained PJSC as its strategic advisor to assist the Galena Board in determining what strategic options were available to Galena to maximize stockholder value. The PJSC Materials contained preliminary analyses related to certain alternatives that PJSC determined would be worth exploring. The PJSC Materials did not contain any analyses regarding the Merger or SELLAS and at no point did PJSC provide any such analyses or otherwise opine on the Merger or SELLAS. 15. Please provide us supplementally with copies of all materials prepared by Conaccord Genuity and shared with the Galena Board, including copies of all board books and all transcripts and summaries, that were material to the Board’s decision to approve the merger agreement and the transactions contemplated thereby. Please also tell us whether the meeting between Canaccord Genuity and the Board planned for February 24, 2017 occurred, and if not, why this meeting was not held. Galena acknowledges the Staff’s comment and Galena has supplementally sent to the Staff via overnight courier copies of all materials prepared by Canaccord Genuity shared with the Galena Board, including copies of all board books and all transcripts and summaries that were material to the Galena Board’s decision to approve the Merger Agreement and the transactions contemplated thereby. In addition, Galena has revised the disclosure on page 84 in response to the Staff’s comment to clarify that Canaccord Genuity was in attendance at the February 24, 2017 Galena Board meeting. 16. Please expand your disclosure of the failed Phase 3 trial in the second paragraph to quantify the impact on Galena’s stock, disclose the particular Phase 3 clinical trial that failed, and disclose the impact of this trial on the prospects for Galena’s remaining pipeline. Please also disclose what specifically about “current market conditions” prompted the board to evaluate strategic opportunities. Please also expand your description of the January 17, 2017 meeting to explain the current condition of the company and the clinical programs, the current financial condition, cash burn rate, and the proposed strategic alternatives and potential financing options. Please make similar revisions throughout this section where you note that the board or Special Committee discussed possible alternatives or strategic alternatives. Galena has revised the disclosure on page 83 in response to the Staff’s comment and has Ms. Christine Westbrook October 27, 2017 Page 7 eliminated the reference to “market conditions.” With respect to the Staff’s comment that Galena expand its description of the January 17, 2017 meeting, Galena has disclosed the strategic alternatives presented by management on page 82 in response to the Staff’s comments. Galena respectfully submits the remainder of the information requested by the Staff does not lend itself to summary disclosure, and that all material information regarding the January 17, 2017 meeting is disclosed in the Amendment. 17. Please revise your disclosure to clarify what you mean that the Patel litigation prevented you from raising capital. Galena has revised the disclosure on page 86 in response to the Staff’s comment. 18. Please discuss the particular strategic alternatives presented by PJSC on February 24, 2017 and how the board determined that Galena should pursue the sale of clinical assets and simultaneously pursue a strategic combination. Please disclose similar details relating to discussions with PJSC on April 27, 2017 and on June 8, 2017. Galena has revised the disclosure on pages 85 and 86 in response to the Staff’s comment. Galena respectfully advises the Staff that there was no Galena Board meeting on April 27, 2017 and no discussions took place between the Galena Board and PJSC on April 27, 2017. 19. Please explain what was discussed about SELLAS’ past financings and recent capital raising and its impact on the valuation of SELLAS at the July 14, 2017 and July 17, 2017 meetings. Please also explain the potential impact of such financings on the ability to proceed with the transaction and the impact on valuations. Please explain how such financings impacted negotiations of the exchange ratio. Please also explain Galena’s consideration of the convertible note held by Equilibria Capital Management Limited and the pending issuance of shares to Sely I in determining the proposed exchange ratio. Galena has revised the disclosure on pages 93 and 94 in response to the Staff’s comment. In addition, Galena respectfully advises the Staff that Galena’s management and the Galena Board did not spend a significant amount of time considering the Sely I note in determining the exchange ratio, as the conversion of this note was to occur prior to the closing of the Merger and, thus, would not affect the relative ownership of Galena and SELLAS securityholders in the continuing company. Ms. Christine Westbrook October 27, 2017 Page 8 20. Please explain what was discussed regarding pending legal issues regarding Galena at the July 24, 2017 meeting. Please also disclose any material discussions of the SELLAS board regarding th