SEC Comment Letter for SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478) (SLS) — Mar 11, 2014
SELLAS Life Sciences Group, Inc. (SLS) (CIK 0001390478)
Date: March 11, 2014 · CIK: 0001390478 · Accession: 0000000000-14-012084
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 001-33958
Letter
March 10, 2014 Via E-mail Dr. Mark J. Ahn, PhD President and C hief Executive Officer Galena Biopharma, Inc. 4640 SW Macadam Avenue, Suite 270 Portland, Oregon 97239
Re: Galena Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 201 2 Filed March 12 , 2013 Form 10 -Q for the Quarterly Period Ended September 30, 2013 Filed November 6, 2013 and amended on November 7, 2013 File No. 001-33958
Dear Dr. Ahn:
We have reviewed your January 29, 2014 response to our January 14, 2014 letter and have the following comment.
Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the reque sted response. If you do not believe the comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response to our comment.
After reviewing t he information provided, we may raise additional comments and/or request that you amend your filings.
Form 10 -Q for the Quarterly Period Ended September 30, 2013 Management’s Discussion and Analysis of Financial Condition and Results of Operations Developing Novel Cancer Immunotherapies, page 21
1. We note the following statement on page 22: “after establishing statistical significance in the prevention of recurrence in 24 - and 36 -month analyses, the 60 - month median follow -up from the Phase 1/2 trial de monstrated a 5.6% recurrence rate with NeuVax versus 25.9% recurrence rate in the control arm, a reduction of 78.4%.” We compare this statement to the following statement from an abstract entitled “Peptide Vaccine Strategies in the Treatment of Cancer,” c o-authored by
Dr. Mark J. Ahn Galena Biopharma, Inc. March 10 , 2014 Page 2
a number of individuals, including your principal investigator on NeuVax, which abstract appeared in J Proteomics Bioinform 6: 081 -084 (2013):
After a median follow -up of 60 months, there has been a persistent decrease in recurrences observe d in the vaccinated patients compared to the control patients (10.6% vs 20.3%, p=0.098).
While not entirely clear, there does appear to be some inconsisten cy between these two statements. Please provide us with a concise explanation that r econciles the two statements. In addition, please provide draft language for inclusion in future filings which explains in layman’s terms what you mean by “recurrence,” how the rate is determined, and how the recurrence rate impacts the determination of a vaccine’s efficacy.
Please contact Frank Wyman, Staff Accountant, at (202) 551 -3660 or Joel Parker, Accounting Branch Chief , at (202) 551 -3651 if you have any questions regarding th e comment. In this regard, do not hesitate to contact me at (202) 551-3679.
Sincerely,
/s/ Joel Parker for
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March 10, 2014 Via E-mail Dr. Mark J. Ahn, PhD President and C hief Executive Officer Galena Biopharma, Inc. 4640 SW Macadam Avenue, Suite 270 Portland, Oregon 97239 Re: Galena Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 201 2 Filed March 12 , 2013 Form 10 -Q for the Quarterly Period Ended September 30, 2013 Filed November 6, 2013 and amended on November 7, 2013 File No. 001-33958 Dear Dr. Ahn: We have reviewed your January 29, 2014 response to our January 14, 2014 letter and have the following comment. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the reque sted response. If you do not believe the comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response to our comment. After reviewing t he information provided, we may raise additional comments and/or request that you amend your filings. Form 10 -Q for the Quarterly Period Ended September 30, 2013 Management’s Discussion and Analysis of Financial Condition and Results of Operations Developing Novel Cancer Immunotherapies, page 21 1. We note the following statement on page 22: “after establishing statistical significance in the prevention of recurrence in 24 - and 36 -month analyses, the 60 - month median follow -up from the Phase 1/2 trial de monstrated a 5.6% recurrence rate with NeuVax versus 25.9% recurrence rate in the control arm, a reduction of 78.4%.” We compare this statement to the following statement from an abstract entitled “Peptide Vaccine Strategies in the Treatment of Cancer,” c o-authored by Dr. Mark J. Ahn Galena Biopharma, Inc. March 10 , 2014 Page 2 a number of individuals, including your principal investigator on NeuVax, which abstract appeared in J Proteomics Bioinform 6: 081 -084 (2013): After a median follow -up of 60 months, there has been a persistent decrease in recurrences observe d in the vaccinated patients compared to the control patients (10.6% vs 20.3%, p=0.098). While not entirely clear, there does appear to be some inconsisten cy between these two statements. Please provide us with a concise explanation that r econciles the two statements. In addition, please provide draft language for inclusion in future filings which explains in layman’s terms what you mean by “recurrence,” how the rate is determined, and how the recurrence rate impacts the determination of a vaccine’s efficacy. Please contact Frank Wyman, Staff Accountant, at (202) 551 -3660 or Joel Parker, Accounting Branch Chief , at (202) 551 -3651 if you have any questions regarding th e comment. In this regard, do not hesitate to contact me at (202) 551-3679. Sincerely, /s/ Joel Parker for Jim B. Rosenberg Senior Assistant Chief Accountant