SEC Comment Letter for SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478) (SLS) — Oct 23, 2017
SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478)
Date: Oct. 23, 2017 · CIK: 0001390478 · Accession: 0000000000-17-037394
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File numbers found in text: 333-220592
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October 20, 2017
Stephen Ghiglieri
Interim Chief Executive Officer &Chief Financial Officer
Galena Biopharma, Inc.
200 Crow Canyon Place
Suite 380
San Ramon, CA 94583
Re:Galena Biopharma, Inc.
Registration Statement on Form S-4
Filed September 22, 2017
File No. 333-220592
Dear Mr. Ghiglieri:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
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.
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.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 2
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.
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.
Overview of the Merger Agreement and Agreements Related to the Merger
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.
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.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 3
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 3
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 will contine 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'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.
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.
GALE-401 must successfully complete a Phase 3 clinical trial..., page 24
11.Please disclose the adverse events caused by the immediate release version of anagrelide.
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.
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.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 4
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 4
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.
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.
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.
17.Please revise your disclosure to clarify what you mean that the Patel litigation prevented
you from raising capital.
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.
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
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 5
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 5
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.
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 the various legal proceedings involving Galena, including any risks or
concerns of the Board and the impact on the combined company going forward. Please
also disclose how this impacted the selection of directors for the continuing company,
including the discussion at the July 27, 2017 of the possibility of seeking a waiver from
the SEC disqualification. Please include similar discussion under SELLAS Reasons for
the Merger and its considerations of risks and uncertainties, to the extent applicable.
21.Please revise to discuss details regarding how Galena management determined the
proposed exchange ratio. Please also disclose what was discussed at the July 24, 2017
meeting where Galena management discussed options proposed by SELLAS with the
Special Committee.
22.Please disclose what was discussed about the budget for NeuVax and the GALE-401
program on July 31, 2017. We also note that SELLAS has agreed to use commercially
reasonable efforts to support NeuVax clinical programs through 2018. Please revise to
include discussions relating to such agreement.
23.Please expand your disclosure, where applicable, to include the processes employed to
assess the value of the potential transactions outlined in the indications of interest you
received. As examples, we note that Party 5 proposed the transfer of a licensed asset to
Galena and Party 9 proposed an acquisition by Galena. Similarly, please expand your
disclosure to describe the basis for the Board's determination to pursue negotiations with
Parties 10 and 7, in addition to SELLAS, as referenced on page 86.
Reasons for the Merger, page 94
24.We note your disclosure in the second bullet point on page 94. It appears from your
disclosure that neither the Board nor its financial advisors performed valuation analyses
of SELLAS stock. If true, please revise to so state and indicate the reasons the Board
determined that such valuation analyses were not necessary.
25.We note your disclosure on page 96 that the Board considered the fact that additional
capital will be needed prior to consummation of the Merger to fund the continuing
company. Please include this risk in the Summary section and elsewhere in the
prospectus where appopriate.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 6
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 6
Opinion of Galena Financial Advisor
Selected Peer Group Analysis
Selected Precedent Initial Public Offering Analysis
Selected Precedent Transactions Analysis, page 102
26.Please disclose the relevant selection criteria for each of the companies used in the
analyses, including the underlying data for each of the companies such as the number of
products, the pipeline, and the clinical stage of each of the products, whether any of these
companies had products in the commercial stage, and for the selected precedent
transactions, please disclose whether the companies were public or private companies
and disclose the total transaction value. Please disclose whether any companies or
transactions that met the selection criteria were excluded from the analysis and why.
Please also disclose the implied enterprise value calculated for each of the companies.
Agreements Related to the Merger, page 136
27.Please confirm that support agreements entered into by SELLAS shareholders were
entered into only by executive officers, directors, affiliates and holders of 5% or more of
SELLAS' voting equity securities, and that SELLAS is soliciting consents only from
shareholders who have not signed the agreement and would be ineligible to purchase in a
private offering. Refer to Securities Act Sections Compliance and Disclosure
Interpretations 239.13.
Matters Being Submitted to a Vote of Galena Shareholders
Galena Proposal No. 6: The Bylaws Amendment Amendment Proposal, page 170
28.Please expand your disclosure to include the material amendments to your bylaws that
are being presented for approval.
Galena Business
Overview, page 174
29.Please clearly label the pipeline table to indicate which NeuVax trial failed Phase 3 and
was halted. As currently drafted, it appears that all NeuVax trials are poised for Phase 3.
Please also describe the particular findings of the IDMC in its recommendation that the
Phase 3 clinical trial be stopped in your related disclosure on page 178.
30.Please revise the pipeline table to reflect the current status of each trial. For example,
please remove the “Ph-3 ready” bar from GALE-401. Please also reduce the length of
the Phase 2 bars for those trials that are open for enrollment as the placement of the bars
indicates that they have completed Phase 2, and make similar revisions for GALE-301
and GALE-302 as appropriate. Please also tell us why you believe it is appropriate to
indicate that you have completed Phase 1 trials for NeuVax for gastric cancer.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 7
FirstName LastNameStephen Ghiglieri
Galena Biopharma, Inc.
October 20, 2017
Page 7
GALE-401 (anagrelide controlled release (CR)), page 175
31.Please remove the disclosure stating that GALE-401 reduces platelet levels “effectively”
and that it has demonstrated a prolonged clinical benefit with a potentially improved
safety profile. As these product candidates have not received FDA approval, it is
premature to state that they are safe or effective. Please revise your disclosure
accordingly. Please make similar changes throughout the prospectus as appropriate,
including on page 200 in the discussion of GPS in MPM patients.
32.We note that if the first patient is not enrolled in the Phase 3 clinical trial by December
31, 2018, the licensor of GALE-401 shall have the right to terminate the License
Agreement. Please disclose this elsewhere in the prospectus where you discuss Galena’s
pipeline and GALE-401. Please also disclose your current timeline for beginning a Phase
3 trial.
GALE-301 and GALE-302, page 178
33.Please disclose the details of the clinical trials discussed in this section, including the
number of patients enrolled, the endpoints, the results of the trial and the level of
statistical significance achieved.
Intellectual Property, page 181
34.Please amend your disclosure to specify whether the patents have been issued or are
pending, the relevant jurisdictions, and the type of patent protection (e.g., composition of
mat