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Letter Text
SELLAS Life Sciences Group, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
↓
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-04-02
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
↓
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
↓
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
↓
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
↓
SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
Medium - date proximity
↓
Company responded
2019-10-04
SELLAS Life Sciences Group, Inc.
References: October 1, 2019
Summary
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Company responded
2019-10-09
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-05-29
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2019-06-13
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2019-06-13
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2018-07-25
SELLAS Life Sciences Group, Inc.
Summary
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SEC wrote to company
2018-07-26
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2018-06-01
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-06-26
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-06-26
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-06-28
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-07-11
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-07-11
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-05-17
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2018-05-17
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2017-10-23
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2017-10-27
SELLAS Life Sciences Group, Inc.
References: October 20, 2017
Summary
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Company responded
2017-11-06
SELLAS Life Sciences Group, Inc.
References: November 3, 2017
Summary
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Company responded
2017-11-06
SELLAS Life Sciences Group, Inc.
References: November 6, 2017
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-11-06
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2017-11-06
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-11-03
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2016-10-14
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2016-10-14
SELLAS Life Sciences Group, Inc.
References: October 13, 2016
Summary
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Company responded
2016-10-17
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2016-09-21
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2016-09-28
SELLAS Life Sciences Group, Inc.
References: September 21, 2016
Summary
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Company responded
2016-10-06
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-09-20
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2010-11-10
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2010-11-23
SELLAS Life Sciences Group, Inc.
References: November 10, 2010
Summary
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Company responded
2010-12-15
SELLAS Life Sciences Group, Inc.
References: November 10, 2010
Summary
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Company responded
2010-12-15
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2013-12-26
SELLAS Life Sciences Group, Inc.
References: December 13, 2013
Summary
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Company responded
2014-01-29
SELLAS Life Sciences Group, Inc.
References: January 14, 2014
Summary
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Company responded
2014-03-13
SELLAS Life Sciences Group, Inc.
References: March 10, 2014
Summary
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Company responded
2016-09-19
SELLAS Life Sciences Group, Inc.
References: September 19, 2016
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2016-09-19
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-08-04
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
↓
Company responded
2016-08-04
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2015-12-16
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2015-12-18
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2015-12-18
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2015-12-30
SELLAS Life Sciences Group, Inc.
Summary
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Company responded
2015-12-30
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-12-16
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2014-10-31
SELLAS Life Sciences Group, Inc.
Summary
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↓
Company responded
2014-10-31
SELLAS Life Sciences Group, Inc.
References: October 30, 2014
Summary
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Company responded
2014-11-19
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2014-04-23
SELLAS Life Sciences Group, Inc.
Summary
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↓
Company responded
2014-05-02
SELLAS Life Sciences Group, Inc.
References: April 23, 2014
Summary
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Company responded
2014-05-13
SELLAS Life Sciences Group, Inc.
Summary
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SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-04-18
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-03-11
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-01-15
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-12-13
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2013-08-13
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2013-06-03
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
↓
Company responded
2013-06-10
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-06-03
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-01-20
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2009-05-18
SELLAS Life Sciences Group, Inc.
Summary
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↓
Company responded
2009-05-19
SELLAS Life Sciences Group, Inc.
References: May 18, 2009
Summary
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Company responded
2009-05-20
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2007-11-26
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
↓
Company responded
2008-02-13
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-02-12
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
SELLAS Life Sciences Group, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-01-25
SELLAS Life Sciences Group, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-21 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2024-04-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2024-04-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2024-04-02 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | 333-278334 | Read Filing View |
| 2024-04-02 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | 333-278337 | Read Filing View |
| 2021-04-27 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2021-04-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-08-21 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-08-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-06-05 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-09 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-04 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-01 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-05-29 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-26 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-25 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-11 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-11 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-28 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-01 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-05-17 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-05-17 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-10-27 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-10-23 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-17 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-28 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-20 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-19 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-18 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-18 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-11-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-10-31 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-10-31 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-05-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-05-02 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-04-23 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-04-18 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-03-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-03-11 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-01-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-01-15 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-12-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-12-13 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-08-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-10 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2011-01-20 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-11-23 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-11-10 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-20 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-18 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-02-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-02-12 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-01-25 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2007-11-26 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2024-04-02 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | 333-278334 | Read Filing View |
| 2024-04-02 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | 333-278337 | Read Filing View |
| 2021-04-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-08-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-06-05 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-01 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-05-29 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-26 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-01 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-05-17 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-10-23 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-21 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-20 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-19 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-10-31 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-04-23 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-04-18 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-03-11 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-01-15 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-12-13 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-03 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2011-01-20 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-11-10 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-18 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-02-12 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-01-25 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2007-11-26 | SEC Comment Letter | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-21 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2024-04-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2024-04-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2021-04-27 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-08-21 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2020-06-09 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-09 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-10-04 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-25 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-11 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-07-11 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-28 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-06-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2018-05-17 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-11-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2017-10-27 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-17 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-10-06 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-28 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-09-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2016-08-04 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-18 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2015-12-18 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-11-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-10-31 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-05-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-05-02 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-03-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2014-01-29 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-12-26 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-08-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2013-06-10 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2010-11-23 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-20 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2009-05-19 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
| 2008-02-13 | Company Response | SELLAS Life Sciences Group, Inc. | DE | N/A | Read Filing View |
2025-11-21 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm SELLAS Life Sciences Group, Inc. 7 Times Square, Suite 2503 New York, New York 10036 November 21, 2025 Via EDGAR Alan Campbell United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-3 Filed October 10, 2025 File No. 333-290829 Acceleration Request Dear Mr. Campbell, Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the "Registrant") hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-290829), so that it may become effective at 5:00 p.m. (Washington, D.C. time) on Tuesday, November 25, 2025, or as soon thereafter as practicable. Please call Daniel A. Bagliebter, of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6856 with any comments or questions regarding the Registration Statement. Very truly yours, SELLAS Life Sciences Group, Inc. /s/ Angelos M. Stergiou, M.D., Sc.D., h.c. By: Angelos M. Stergiou, M.D., Sc.D., h.c. Its: President and Chief Executive Officer cc: Stacy E. Yeung, Esq., SELLAS Life Sciences Group, Inc. Daniel A. Bagliebter, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2024-04-29 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
filename1.htm
SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, New York 10036
April 29, 2024
Via
EDGAR
Chris Edwards
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed March 28, 2024
File No. 333-278334
Acceleration Request
Dear Mr. Edwards,
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”)
hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-278334),
so that it may become effective at 5:00 p.m. (Washington, D.C. time) on Wednesday, May 1, 2024, or as soon thereafter as practicable.
Please call Daniel A. Bagliebter,
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6856 with any comments or questions regarding
the Registration Statement.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By:
Angelos M. Stergiou, M.D., Sc.D., h.c.
Its:
President and Chief Executive Officer
cc: Stacy E. Yeung, Esq., SELLAS Life Sciences Group, Inc.
Daniel A. Bagliebter, Esq., Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
2024-04-29 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
filename1.htm
SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, New York 10036
April 29, 2024
Via
EDGAR
Chris Edwards
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed March 28, 2024
File No. 333-278337
Acceleration Request
Dear Mr. Edwards,
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”)
hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-278337),
so that it may become effective at 5:00 p.m. (Washington, D.C. time) on Wednesday, May 1, 2024, or as soon thereafter as practicable.
Please call Daniel A. Bagliebter,
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6856 with any comments or questions regarding
the Registration Statement.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By:
Angelos M. Stergiou, M.D., Sc.D., h.c.
Its:
President and Chief Executive Officer
cc: Stacy E. Yeung, Esq., SELLAS
Life Sciences Group, Inc.
Daniel A. Bagliebter, Esq., Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C.
2024-04-02 - UPLOAD - SELLAS Life Sciences Group, Inc. File: 333-278334
United States securities and exchange commission logo
April 2, 2024
Angelos M. Stergiou, M.D., ScD h.c.
President and Chief Executive Officer
SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, NY 10036
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed March 28, 2024
File No. 333-278334
Dear Angelos M. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel A. Bagliebter, Esq.
2021-04-27 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, New York 10036
April 27, 2021
Via
EDGAR
Margaret Schwartz
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
File No. 333-255318
Acceleration Request
Dear Ms. Schwartz,
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-255318), so that it may
become effective at 5:00 p.m. (Washington, D.C. time) on Thursday, April 29, 2021, or as soon thereafter as practicable.
Please call Daniel A. Bagliebter,
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6856 with any comments or questions regarding
the Registration Statement.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By: Angelos M. Stergiou, M.D., Sc.D., h.c.
Its: President and Chief Executive Officer
cc: Barbara A. Wood, SELLAS Life Sciences Group, Inc.
Daniel A. Bagliebter, Esq., Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo, P.C.
2021-04-21 - UPLOAD - SELLAS Life Sciences Group, Inc.
United States securities and exchange commission logo
April 21, 2021
Angelos M. Stergiou, M.D., ScD h.c
President and Chief Executive Officer
SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, NY 10036
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed April 16, 2021
File No. 333-255318
Dear Dr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Bagliebter, Esq.
2020-08-21 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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SELLAS Life
Sciences Group, Inc.
7 Times Square,
Suite 2503
New York, New
York 10036
August 21, 2020
VIA EDGAR
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 3561
Washington, D.C. 20549
Re: SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed August 14, 2020
File No. 333-246333
Dear Mr. Campbell:
Pursuant to Rule 461 of the Rules and Regulations
promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Company”) hereby requests
that the effectiveness of the above-captioned Registration Statement on Form S-3 be accelerated to Monday, August 24, 2020, at
5:00 p.m., Eastern Time, or as soon as thereafter practicable.
The cooperation of
the staff in meeting the timetable described above is very much appreciated.
Any questions should
be addressed to Daniel A. Bagliebter, Esq., at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Chrysler Center, 666 Third
Avenue, New York, New York 10017, telephone (212) 692-6856.
Thank you very much.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By: Angelos M. Stergiou, M.D., Sc.D., h.c.
Title: President and Chief Executive Officer
2020-08-21 - UPLOAD - SELLAS Life Sciences Group, Inc.
United States securities and exchange commission logo
August 21, 2020
Angelos M. Stergiou
President and Chief Executive Officer
SELLAS Life Sciences Group, Inc.
7 Times Square, Suite 2503
New York, New York 10036
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed August 14, 2020
File No. 333-246333
Dear Dr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel A. Bagliebter, Esq.
2020-06-09 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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SELLAS Life Sciences Group, Inc.
15 West 38th St., 10th
Floor
New York, New York 10018
June 9, 2020
Via
EDGAR
Sonia Bednarowski
United States Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-1
File No. 333-238799
Acceleration Request
Dear Ms. Bednarowski,
Pursuant to Rule 461
of Regulation C promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-238799), so that
it may become effective at 4:00 p.m. (Washington, D.C. time) on Thursday, June 11, 2020, or as soon thereafter as practicable.
Please call Daniel
A. Bagliebter, of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (212) 692-6856 with any comments
or questions regarding the Registration Statement.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By: Angelos M. Stergiou, M.D., Sc.D., h.c.
Its: President and Chief Executive Officer
cc:
Barbara A. Wood, SELLAS Life Sciences Group, Inc.
Daniel A. Bagliebter, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2020-06-05 - UPLOAD - SELLAS Life Sciences Group, Inc.
United States securities and exchange commission logo
June 5, 2020
Barbara Wood
General Counsel
SELLAS Life Sciences Group, Inc.
15 West 38th St., 10th Floor
New York, NY 10018
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-1
Filed May 29, 2020
File No. 333-238799
Dear Ms. Wood:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Laura Crotty at (202) 551-7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Bagliebter
2019-10-09 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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SELLAS Life Sciences Group, Inc.
15 West 38th St., 10th
Floor
New York, New York 10018
October 9, 2019
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3/A
Commission File No. 333- 233869
Acceleration Request
Ladies and Gentlemen:
Pursuant to Rule 461 of the Rules and Regulations
promulgated under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Company”) hereby
respectfully requests that the effectiveness of the above-captioned Registration Statement on Form S-3 be accelerated to Friday,
October 11, 2019, at 4:30 p.m. Eastern Time, or as soon as practicable thereafter.
The Company acknowledges that:
•
should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
•
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
•
the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
The cooperation of the staff in meeting the timetable
described above is very much appreciated.
Any questions regarding this request should be addressed
to Daniel A. Bagliebter, Esq., at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 666 Third Avenue, New York, New York, 10017,
telephone (212) 692-6856.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos M. Stergiou
By: Angelos M. Stergiou, M.D., Sc.D., h.c.
Its: President and Chief Executive Officer
cc: Cliff M. Silverman, Esq., Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
2019-10-04 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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Chrysler Center
666 Third Avenue
New York, NY 10017
212-935-3000
212-983-3115 fax
mintz.com
October 4, 2019
VIA EDGAR & OVERNIGHT MAIL
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E. Washington, D.C. 20549
Attention: Tonya K. Aldave
Re: SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed September 20, 2019
File No. 333-233869
Ladies and Gentlemen:
We are submitting this letter on behalf of SELLAS Life Sciences
Group, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) received by letter dated October 1, 2019 from the Division of Corporation
Finance, Office of Life Sciences, to Angelos Stergiou, President and Chief Executive Officer of the Company, relating to the above-referenced
Registration Statement. In conjunction with this letter, the Company is filing Amendment No. 1 to the Registration Statement (the
“Amended Registration Statement”) with the Commission.
For convenient reference, we have reproduced below the Staff’s
comment and the Company’s response is below it. This response is based on information provided to Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C. by representatives of the Company. As indicated below, the Company has responded to the Staff’s comment
by making changes to the disclosure in the Amended Registration Statement and future periodic filings.
Registration Statement on Form S-3
General
Comment 1: We note that your forum selection provision
identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please include a description of capital stock section in the prospectus to describe this provision and disclose
whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section
27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by
the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules
and regulations thereunder. If the provision applies to Securities Act claims, please also revise your prospectus to state that
there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. If this provision does not apply to actions arising under the Securities
Act or Exchange Act, please also tell us how you will inform investors in future filings that the provision does not apply to any
actions arising under the Securities Act or Exchange Act.
Boston London Los
Angeles New York San Diego San
Francisco Washington
MINTZ,
LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C.
October 4, 2019
Page 2
Response 1: In response to the Staff’s comment,
the Company has amended the Risk Factors section of the Amended Registration Statement on page 4 thereof. In addition to
those risk factors incorporated by reference, the Risk Factors section in the Amended Registration Statement now physically includes
the risk factor below, which is a revised version of the Company’s existing risk factor on this topic from its periodic reports.
(For your ease of reference, the revisions are emphasized below by italicized text). As revised, we believe it addresses
the Staff’s comment. Starting with its next Form 10-Q, the Company will also prospectively include this revised disclosure
in the risk factor sections of its future quarterly and annual reports.
“Anti-takeover provisions of our Amended
and Restated Certificate of Incorporation and our Amended and Restated Bylaws and provisions of Delaware law could delay or prevent
a change of control.
Anti-takeover provisions of our Amended and Restated
Certificate of Incorporation and our Amended and Restated Bylaws may discourage, delay or prevent a merger or other change of control
that stockholders may consider favorable or may impede the ability of the holders of our common stock to change our management
and may be constrained by other contractual agreements with third parties. These provisions of our Amended and Restated Certificate
of Incorporation and our Amended and Restated Bylaws, among other things:
· divide our Board of Directors into three classes, with members of each class to be elected for staggered three-year terms;
· limit the right of securityholders to remove directors;
· prohibit stockholders from acting by written consent;
· regulate how stockholders may present proposals or nominate directors for election at annual meetings of stockholders; and
· authorize our Board to issue preferred stock in one or more series, without stockholder approval.
In addition, Section 203 of the Delaware General
Corporation Law provides that, subject to limited exceptions, persons that acquire, or are affiliated with a person that acquires,
more than 15% of the outstanding voting stock of a Delaware corporation shall not engage in any business combination with that
corporation, including by merger, consolidation or acquisitions of additional shares for a three-year period following the date
on which that person or our affiliate crosses the 15% stock ownership threshold. Section 203 could operate to delay or prevent
a change of control of us.
In addition, our Amended and Restated Bylaws, to
the fullest extent permitted by law, provide that the Court of Chancery of the State of Delaware shall be the sole and exclusive
forum for: any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty owed by any
director, officer or other employee; any action asserting a claim against us arising pursuant to the Delaware General Corporation
Law, or the DGCL, our Amended and Restated Certificate of Incorporation, or our Amended and Restated Bylaws; or any action asserting
a claim against us that is governed by the internal affairs doctrine. This exclusive forum provision does not apply to suits brought
to enforce a duty or liability created by the Securities Exchange Act of 1934. It could apply, however, to a suit that falls within
one or more of the categories enumerated in the exclusive forum provision and asserts claims under the Securities Act, inasmuch
as Section 22 of the Securities Act of 1933, as amended, or the Securities Act, creates concurrent jurisdiction for federal
and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations
thereunder. There is uncertainty as to whether a court would enforce this provision with respect to claims under the Securities
Act, and our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations
thereunder.
October 4, 2019
Page 3
This choice of forum provision may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, or
other employees, which may discourage lawsuits with respect to such claims. Alternatively, if a court were to find the choice of
forum provisions contained in our restated certificate of incorporation to be inapplicable or unenforceable in an action, we may
incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of
operations and financial condition.
Provisions in our Amended and Restated Certificate
of Incorporation, our Amended and Restated Bylaws or other provisions of Delaware law could limit the price that investors are
willing to pay in the future for shares of our common stock. ”
* * * * *
We hope that the above responses and the related revisions
reflected in the Amended Registration Statement will be acceptable to the Staff. Please do not hesitate to contact me at (212)
692-6856 or DABagliebter@mintz.com with any comments or questions regarding the Amended Registration Statement and this
letter. We thank you for your time and attention.
Sincerely,
/s/ Daniel A. Bagliebter
Daniel A. Bagliebter
cc: Securities and Exchange Commission
Dietrich King
SELLAS Life Sciences, Inc.
Barbara Wood, General Counsel and Corporate Secretary
Angelos Stergiou, President and Chief Executive Officer
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C.
Joel I. Papernik
2019-10-01 - UPLOAD - SELLAS Life Sciences Group, Inc.
October 1, 2019
Angelos Stergiou
Chief Executive Officer
SELLAS Life Sciences Group, Inc.
15 W. 38th Street, 10th Floor
New York, NY 10018
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed September 20, 2019
File No. 333-233869
Dear Dr. Stergiou:
We have limited our review of your registration statement to those issues we have
addressed in our 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-3
General
1.We note that your forum selection provision identifies the Court of Chancery of the
State of Delaware as the exclusive forum for certain litigation, including any
“derivative action.” Please include a description of capital stock section in the prospectus
to describe this provision and disclose whether this provision applies to actions arising
under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any
duty or liability created by the Exchange Act or the rules and regulations thereunder, and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts
over all suits brought to enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder. If the provision applies to Securities Act claims, please
FirstName LastNameAngelos Stergiou
Comapany NameSELLAS Life Sciences Group, Inc.
October 1, 2019 Page 2
FirstName LastName
Angelos Stergiou
SELLAS Life Sciences Group, Inc.
October 1, 2019
Page 2
also revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. If this provision does not apply to
actions arising under the Securities Act or Exchange Act, please also tell us how you will
inform investors in future filings that the provision does not apply to any actions arising
under the Securities Act or Exchange Act.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Tonya K. Aldave at (202) 551-3601 or Dietrich King at (202) 551-
8071 with any other questions.
Sincerely,
Division of Corporation Finance
CF Office of Life Sciences
cc: Daniel Bagliebter, Esq.
2019-06-13 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
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SELLAS Life Sciences Group, Inc.
15 West 38th St., 10th
Floor
New York, New York 10018
June 13,
2019
Via
EDGAR
Sonia Bednarowski
United States Securities and Exchange Commission
Division of Corporate Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549
Re: SELLAS Life
Sciences, Inc.
Registration Statement on Form S-1
File No. 333-231723
Acceleration Request
Dear Ms. Bednarowski,
With respect to the
above-referenced Registration Statement on Form S-1 (the “Registration Statement”), and pursuant to Rule 461 of Regulation
C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of SELLAS
Life Sciences Group, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”)
accelerate the effective date of the Registration Statement to Thursday, June 13, 2019, at 4:30 p.m. Eastern Time, or as soon
as practicable thereafter.
In connection with
the foregoing request, the Company acknowledges the following:
· should
the Commission or the staff, acting pursuant to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to
the filing;
· the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not relieve the Company from its full responsibility for the
adequacy and accuracy of the disclosure in the filing; and
· the
Company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities
laws of the United States.
The cooperation of
the staff in meeting the timetable described above is very much appreciated.
Please call Daniel
A. Bagliebter, of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (212) 692-6856 with any comments
or questions regarding the Registration Statement.
Very truly yours,
SELLAS Life Sciences Group, Inc.
/s/ Angelos
M. Stergiou
By: Angelos M. Stergiou, M.D., Sc.D., h.c.
Its: President and Chief Executive Officer
cc: Daniel A. Bagliebter,
Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2019-06-13 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
filename1.htm
A.G.P./Alliance
Global Partners
590 Madison Avenue, 36th Floor
New York, New York 10022
June 13, 2019
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Sonia Bednarowski
Re:
SELLAS Life Sciences Group, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-231723)
Ladies and Gentlemen:
In connection with
the above-captioned registration statement on form S-1 (the “Registration Statement”), and pursuant to Rule
461 under the Securities Act of 1933, as amended (the “Act”), we, as the representative of the several underwriters,
hereby join in the request of the Company that the effective date of the Registration Statement be accelerated to 4:30 p.m. Eastern
Time on June 13, 2019, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C., may orally request via telephone call that such Registration Statement be declared
effective.
Pursuant to Rule 460
under the Act, we, the representative of the several underwriters, wish to advise you that there will be distributed to each prospective
underwriter, institution or dealer who is reasonably anticipated to participate in the distribution of the securities as many copies
of the Company’s preliminary prospectus, dated June 13, 2019, as amended and as included in the Registration Statement, as
appears to be reasonable to secure adequate distribution of the preliminary prospectus. We further advise you that we have complied
and will continue to comply, and we have been informed by the participating underwriters and dealers that they have complied with
and will continue to comply, with the requirements of Rule 15c2-8 under the Act.
[Signature Page Follows]
Very truly yours,
A.G.P./Alliance Global
Partners
As the Representative of the Underwriters
By:
/s/ Thomas J. Higgins
Name:
Thomas J. Higgins
Title:
Managing Director
2019-05-29 - UPLOAD - SELLAS Life Sciences Group, Inc.
May 29, 2019
Angelos Stergiou
Chief Executive Officer
SELLAS Life Sciences Group, Inc.
15 West 38th St., 10th Floor
New York, NY 10018
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-1
Filed May 23, 2019
File No. 333-231723
Dear Dr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Sonia Bednarowski at 202-551-3666 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-26 - UPLOAD - SELLAS Life Sciences Group, Inc.
July 25, 2018
Angelos M. Stergiou, MD, ScD h.c.
Chief Executive Officer
SELLAS Life Sciences Group, Inc.
315 Madison Avenue, 4th Floor
New York, NY 10017
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed July 19, 2018
File No. 333-226251
Dear Mr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Yvan-Claude Pierre, Esq.
2018-07-25 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP July 25, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Office of Healthcare & Insurance Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-3 Filed July 19, 2018 File No. 333-226251 Acceleration Request Requested Date: Thursday, July 26, 2018 Requested Time: 4:30 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-226251) to become effective on July 26, 2018, at 4:30 P.M., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of Yvan-Claude Pierre and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request on its behalf. In connection with this request, the Registrant acknowledges that: • should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and 1 • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, SELLAS Life Sciences Group, Inc. By: /s/ Angelos M. Stergiou Angelos M. Stergiou, MD, ScD h.c. President and Chief Executive Officer cc: Gene Mack, SELLAS Life Sciences Group, Inc. Barbara A. Wood, SELLAS Life Sciences Group, Inc. Yvan-Claude Pierre, Cooley LLP Marianne Sarrazin, Cooley LLP 2
2018-07-11 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request SELLAS Life Sciences Group, Inc. 315 Madison Avenue, 4th Floor New York, NY 10017 VIA EDGAR July 11, 2018 Ms. Irene Paik Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-1 File No. 333-225140 Request for Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), SELLAS Life Sciences Group, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to July 11, 2018 at 4:30 PM., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Cooley LLP, by calling Yvan-Claude Pierre of Cooley LLP at (212) 479-6721 or Marianne Sarrazin of Cooley LLP at (415) 693-2157. If you have any questions regarding this request, please contact Yvan-Claude Pierre of Cooley LLP at (212) 479-6721 or Marianne Sarrazin of Cooley LLP at (415) 693-2157. Thank you for your assistance with this matter. Sincerely, SELLAS LIFE SCIENCES GROUP, INC. /s/ Barbara A. Wood Barbara A. Wood Executive Vice President, General Council and Corporate Secretary cc: Angelos M. Stergiou, SELLAS Life Sciences Group, Inc. Gene Mack, SELLAS Life Sciences Group, Inc. Yvan-Claude Pierre, Cooley LLP Marianne Sarrazin, Cooley LLP
2018-07-11 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request Cantor Fitzgerald & Co. Oppenheimer & Co. Inc. As Representatives of the several Underwriters, c/o Cantor Fitzgerald & Co. 499 Park Avenue New York, NY 10022 c/o Oppenheimer & Co. Inc. 85 Broad Street, 26th Floor New York, NY 10004 VIA EDGAR July 11, 2018 Ms. Irene Paik United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-1 File No. 333-225140 Request for Effectiveness Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of SELLAS Life Sciences Group, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:30 PM, Eastern Time, on July 11, 2018, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, CANTOR FITZGERALD & CO. OPPENHEIMER & CO. INC. Acting severally on behalf of themselves and the several Underwriters CANTOR FITZGERALD & CO. By: /s/ Sage Kelley Name: Sage Kelley Title: Head of Investment Banking OPPENHEIMER & CO. INC. By: /s/ Eric Helenek Name: Eric Helenek Title: Managing Director [Signature Page to Underwriters’ Acceleration Request]
2018-06-28 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP June 28, 2018 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Irene Paik Re: Sellas Life Sciences Group, Inc. Registration Statement on Form S-1 File No. 333-225140 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on June 26, 2018, in which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-225140) to Wednesday, June 27, 2018, at 4:30 p.m., Eastern Time (which was later changed orally to Thursday, June 28, 2018 at 4:30 p.m., Eastern Daylight Time), in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date thereof. Please note that we intent to file as correspondence a new acceleration request tomorrow morning requesting the acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-225140) to Monday, July 2, 2018, at 9:00 a.m., Eastern Time. Very truly yours, Sellas Life Sciences Group, Inc. By: /s/ Barbara A. Wood Barbara A. Wood Executive Vice President, General Counsel and Corporate Secretary cc: Yvan-Claude Pierre, Cooley LLP
2018-06-26 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request SELLAS Life Sciences Group, Inc. 315 Madison Avenue, 4th Floor New York, NY 10017 VIA EDGAR June 26, 2018 Ms. Irene Paik Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-1 File No. 333-225140 Request for Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), SELLAS Life Sciences Group, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to June 27, 2018, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Cooley LLP, by calling Yvan-Claude Pierre of Cooley LLP at (212) 479-6721 or Marianne Sarrazin of Cooley LLP at (415) 693-2157. If you have any questions regarding this request, please contact Yvan-Claude Pierre of Cooley LLP at (212) 479-6721 or Marianne Sarrazin of Cooley LLP at (415) 693-2157. Thank you for your assistance with this matter. Sincerely, SELLAS LIFE SCIENCES GROUP, INC. /s/ Angelos M. Stergiou Angelos M. Stergiou President and Chief Executive Officer cc: Gene Mack, SELLAS Life Sciences Group, Inc. Barbara A. Wood, SELLAS Life Sciences Group, Inc. Yvan-Claude Pierre, Cooley LLP Marianne Sarrazin, Cooley LLP
2018-06-26 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request RBC Capital Markets, LLC Cantor Fitzgerald & Co. As Representatives of the several Underwriters, c/o RBC Capital Markets, LLC 200 Vesey Street New York, New York 10281-8098 VIA EDGAR June 26, 2018 Ms. Irene Paik United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-1 File No. 333-225140 Request for Effectiveness Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of SELLAS Life Sciences Group, Inc. (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:30 PM, Eastern Time, on June 27, 2017, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, RBC CAPITAL MARKETS, LLC CANTOR FITZGERALD & CO. Acting severally on behalf of themselves and the several Underwriters RBC CAPITAL MARKETS, LLC By: /s/ David Lauffer Name: David Lauffer Title: Managing Director CANTOR FITZGERALD & CO. By: /s/ John Belle Name: John Belle Title: COO [Signature Page to Underwriters’ Acceleration Request]
2018-06-01 - UPLOAD - SELLAS Life Sciences Group, Inc.
May 31, 2018
Angelos M. Stergiou
President and Chief Executive Officer
SELLAS Life Sciences Group, Inc.
315 Madison Avenue, 4th Floor
New York, NY 10017
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-1
Filed May 23, 2018
File No. 333-225140
Dear Dr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Irene Paik at 202-551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Marianne C. Sarrazin, Esq. - Cooley LLP
2018-05-17 - UPLOAD - SELLAS Life Sciences Group, Inc.
May 17, 2018
Angelos M. Stergiou, MD, ScD h.c.
Chief Executive Officer
SELLAS Life Sciences Group, Inc.
315 Madison Avenue, 4th Floor
New York, NY 10017
Re:SELLAS Life Sciences Group, Inc.
Registration Statement on Form S-3
Filed May 10, 2018
File No. 333-224845
Dear Mr. Stergiou:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Yvan-Claude Pierre, Esq.
2018-05-17 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP May 17, 2018 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Office of Healthcare & Insurance Re: SELLAS Life Sciences Group, Inc. Registration Statement on Form S-3 Filed May 10, 2018 File No. 333-224845 Acceleration Request Requested Date: Monday, May 21, 2018 Requested Time: 4:15 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, SELLAS Life Sciences Group, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-224845) to become effective on May 21, 2018, at 4:15 P.M., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of Yvan-Claude Pierre and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request on its behalf. In connection with this request, the Registrant acknowledges that: • should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, SELLAS Life Sciences Group, Inc. By: /s/ Barbara A. Wood Barbara A. Wood Executive Vice President, General Counsel and Corporate Secretary cc: Angelos M. Stergiou, MD, ScD h.c., SELLAS Life Sciences Group, Inc. Gene Mack, SELLAS Life Sciences Group, Inc. Yvan-Claude Pierre, Cooley LLP Marianne Sarrazin, Cooley LLP -2-
2017-11-06 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP (212) 318-6053 keithpisani@paulhastings.com November 6, 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. Amendment No. 1 to Registration Statement on Form S-4 Filed October 30, 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. 2 (the “Amendment”) to Galena’s above-referenced Registration Statement on Form S-4, as amended (the “Registration Statement”) marked to show the changes made to Amendment No. 1 to the Registration Statement filed with the Securities and Exchange Commission (the “Commission”) on October 27, 2017. This Amendment is being filed in response to comments with respect to Amendment No. 1 to the Registration Statement received from the Commission (the “Staff”) by letter dated November 3, 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. Amendment No. 1 to Registration Statement on Form S-4 Galena Business Overview, page 182 1. We note your response to comment 30, which we reissue in part. Please tell us why you believe it is appropriate to indicate that you have completed Phase 1 trials for NeuVax for gastric cancer. Paul Hastings LLP | 200 Park Avenue | New York, NY 10166 t: +1.212.318.6000 | www.paulhastings.com Ms. Christine Westbrook November 6, 2017 Page 2 Galena has revised the disclosure on page 188 in response to the Staff’s comment. Galena respectfully advises the Staff that it believes that it is important to make it clear to investors that, if Galena and/or Dr. Reddy’s determines to pursue a Phase 2 trial for NeuVax, the Phase 1 work has already been completed. Unaudited Pro Forma Condensed Combined Financial Statements 4. Pro Forma Adjustments, page F-111 2. For pro forma adjustment H, please show in detailed disclosure how the number of pro forma weighted average shares outstanding was determined. Galena has revised the disclosure on page F-114 in response to the Staff’s comment. * * * If you have any questions, or if it would expedite your review in any way, please do not hesitate to contact the undersigned at (212) 318-6053 or Thomas Pollock at (415) 856-7047. We thank the Staff in advance for its assistance. Sincerely, /s/ Keith D. Pisani Keith D. Pisani for PAUL HASTINGS LLP Enclosures
2017-11-06 - UPLOAD - SELLAS Life Sciences Group, Inc.
November 6, 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.
Amendment No. 2 to Registration Statement on Form S-4
Filed November 6, 2017
File No. 333-220592
Dear Mr. Ghiglieri:
We have reviewed your amended 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.
S-4/A filed on 11/6/17
Exhibit 5.1 Legal Opinion, page II-6
1.We note you have assumed the authority, legal right and power of each of the officers
and other persons and entities signing or whose signatures appear upon each of said
documents. It is not appropriate to assume that officers have the legal authority to sign
the identified documents as this is a conclusion of law which is a necessary requirement
of the legality opinion. Please file a legal opinion that does not assume the officers have
the authority sign the identified documents.
FirstName LastNameStephen Ghiglieri
Comapany NameGalena Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastName
Stephen Ghiglieri
Galena Biopharma, Inc.
November 6, 2017
Page 2
2.Additionally, we note that in rendering your opinion, you limited your review to the
documents identified without stating whether you reviewed all documents you deemed
necessary for the purposes of providing your opinion. Please file a legal opinion that
clarifies that you reviewed all documents you considered necessary for the purpose of
rendering your opinion.
You may contact Vanessa Robertson at (202) 551-3649 or Angela Connell at (202) 551-
3426 if you have questions regarding comments on the financial statements and related
matters. Please contact Christine Westbrook at (202) 551-5019 or Suzanne Hayes at (202) 551-
3675 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Keith D. Pisani, Esq.
2017-11-06 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP GALENA BIOPHARMA, INC. 2000 Crown Canyon Place, Suite 380 San Ramon, CA 94583 November 6, 2017 VIA EDGAR U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-4, as may be amended from time to time File No. 333- 220592 Request for Acceleration of Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc. (the “Company”) hereby requests that the effectiveness of the above-referenced Registration Statement on Form S-4 (the “Registration Statement”) be accelerated so that the Registration Statement will become effective on November 6, 2017 at 4:30 p.m. Eastern time, or as soon thereafter as practicable. In connection with the Registration Statement, the Company hereby acknowledges that: • should the U.S. Securities and Exchange Commission (the “Commission”) or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; • the action of the Commission, or the Staff acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and • the Company may not assert the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you have any questions, please do not hesitate to contact Keith Pisani of Paul Hastings LLP at (212) 318-6053. The Company respectfully requests that it be notified of the effectiveness of the Registration Statement by a telephone call to Keith Pisani and that such effectiveness also be confirmed in writing. U.S. Securities and Exchange Commission November 6, 2017 Page 2 Very truly yours, GALENA BIOPHARMA, INC. By: /s/ Stephen F. Ghiglieri Stephen F. Ghiglieri Interim Chief Executive Officer & Chief Financial Officer cc: Keith D. Pisani, Esq. Paul Hastings LLP
2017-11-06 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP (212) 318-6053 keithpisani@paulhastings.com November 6, 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. Amendment No. 2 to Registration Statement on Form S-4 Filed November 6, 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. 3 (the “Amendment”) to Galena’s above-referenced Registration Statement on Form S-4, as amended (the “Registration Statement”) marked to show the changes made to Amendment No. 2 to the Registration Statement filed with the Securities and Exchange Commission (the “Commission”) on November 6, 2017. This Amendment is being filed in response to comments with respect to Amendment No. 2 to the Registration Statement received from the Commission (the “Staff”) by letter dated November 6, 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. S-4/A filed on 11/6/17 Exhibit 5.1 Legal Opinion, page II-6 1. We note you have assumed the authority, legal right and power of each of the officers and other persons and entities signing or whose signatures appear upon each of said documents. It is not appropriate to assume that officers have the legal authority to sign the identified documents as this is a conclusion of law which is a necessary requirement of the legality opinion. Please file a legal opinion that does not assume the officers have the authority sign the identified documents. Paul Hastings LLP | 200 Park Avenue | New York, NY 10166 t: +1.212.318.6000 | www.paulhastings.com Galena has revised the Registration Statement to include a revised legal opinion as Exhibit 5.1. 2. Additionally, we note that in rendering your opinion, you limited your review to the documents identified without stating whether you reviewed all documents you deemed necessary for the purposes of providing your opinion. Please file a legal opinion that clarifies that you reviewed all documents you considered necessary for the purpose of rendering your opinion. Galena has revised the Registration Statement to include a revised legal opinion as Exhibit 5.1. * * * If you have any questions, or if it would expedite your review in any way, please do not hesitate to contact the undersigned at (212) 318-6053 or Thomas Pollock at (415) 856-7047. We thank the Staff in advance for its assistance. Sincerely, /s/ Keith D. Pisani Keith D. Pisani for PAUL HASTINGS LLP Enclosures
2017-11-03 - UPLOAD - SELLAS Life Sciences Group, Inc.
November 3, 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.
Amendment No. 1 to Registration Statement on Form S-4
Filed October 30, 2017
File No. 333-220592
Dear Mr. Ghiglieri:
We have reviewed your amended 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. Unless we note
otherwise, our references to prior comments are to comments in our October 20, 2017 letter.
Amendment No. 1 to Registration Statement on Form S-4
Galena Business
Overview, page 182
1.We note your response to comment 30, which we reissue in part. Please 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 2
FirstName LastName
Stephen Ghiglieri
Galena Biopharma, Inc.
November 3, 2017
Page 2
Unaudited Pro Forma Condensed Combined Financial Statements
4. Pro Forma Adjustments, page F-111
2.For pro forma adjustment H, please show in detailed disclosure how the number of pro
forma weighted average shares outstanding was determined.
You may contact Vanessa Robertson at (202) 551-3649 or Angela Connell at (202) 551-
3426 if you have questions regarding comments on the financial statements and related
matters. Please contact Christine Westbrook at (202) 551-5019 or Erin Jaskot at (202) 551-
3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Keith D. Pisani, Esq.
2017-10-27 - CORRESP - SELLAS Life Sciences Group, Inc.
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
2017-10-23 - UPLOAD - SELLAS Life Sciences Group, Inc.
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
2016-10-17 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Document October 17, 2016 VIA EDGAR U.S. Securities and Exchange Commission Attn: Erin Jaskot and Dorrie Yale Office of Insurance and Healthcare 100 F Street NE Washington, DC 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed September 30, 2016 File No. 333- 213908 Dear Ms. Jaskot: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc. (the “Company”) requests acceleration of the effective date of the above-referenced Registration Statement so that the same shall become effective as of 4:30 p.m., Washington, DC time, on October 19, 2016, or as soon thereafter as possible. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, /s/ John T. Burns John T. Burns Vice President of Finance and Corporate Controller (Principal Accounting Officer)
2016-10-14 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP GALENA BIOPHARMA, INC. 2000 Crow Canyon Place, Suite 380 San Ramon, CA 94583 October 14, 2016 VIA EDGAR TRANSMISSION Mr. Suzanne Hayes Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 File No. 333-213908 Dear Ms. Hayes: On behalf of Galena Biopharma, Inc. (the “Company”), this letter will respond to your comment letter dated October 13, 2016 with respect to the above-referenced registration statement (the “Comment Letter”). Enclosed herewith for filing via Edgar is the Company’s Amendment No. 1 to the Registration Statement on Form S-3 (the “Registration Statement”). The following response corresponds to the numbered comments contained in the Comment Letter, as follows: 1. Please update this section to incorporate by reference your Current Report on Form 8-K filed on October 6, 2016. Response: The Company has revised the Registration Statement to incorporate the referenced Form 8-K. * * * On behalf of the Company, the undersigned hereby acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; Ms. Suzanne Hayes U.S. Securities and Exchange Commission October 14, 2016 Page 2 • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact the undersigned at (925) 498-7734 if you have any questions with respect to the responses contained in this letter or the Registration Statement. Sincerely, /s/ Thomas J. Knapp Thomas J. Knapp Interim General Counsel and Corporate Secretary cc: Dr. Mark W. Schwartz, Ph.D. Mr. John T. Burns
2016-10-14 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4546 October 13, 2016 Dr. Mark W. Schwartz President & Chief Executive Officer Galena Biopharma, Inc. 2000 Crow Canyon Place, Suite 380 San Ramon, California 94583 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed September 30, 2016 File No. 333-213908 Dear Dr. Schwartz : We have limited our review of your registration statement to those issues w e have addressed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our com ment appl ies 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 the comment, we may have additional comments. Incorporation of Certain Documents by Reference, page 29 1. Please update this section to incorporate by reference your Current Report on Form 8 -K filed on October 6 , 2016 . For reference, please see Compliance and Disclosure Interpretations, Securities Act Forms , Question 123.05 . We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration . Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Dr. Mark W. Schwartz Galena Biopharma, Inc. October 13, 2016 Page 2 Please contact Dorrie Yale at 202 -551-8776 or Mary Beth Breslin at 202 -551-3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Thomas J. Knap p
2016-10-06 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP October 6, 2016 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Attn: Suzanne Hayes 100 F Street NE Washington, DC 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed September 2, 2016 File No. 333-213493 Dear Ms. Hayes: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc. (the “Company”) requests acceleration of the effective date of the above-referenced Registration Statement so that the same shall become effective as of 4:30 p.m., Washington, DC time, on October 11, 2016, or as soon thereafter as possible. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2016-09-28 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP
1
filename1.htm
CORRESP
GALENA BIOPHARMA, INC.
2000 Crow Canyon Place, Suite 380
San Ramon, CA 94583
September 28, 2016
VIA EDGAR TRANSMISSION
Ms. Suzanne Hayes
Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Re:
Galena Biopharma, Inc.
Registration Statement on Form S-3
File No. 333-213493
Dear Ms. Hayes:
On behalf of Galena Biopharma, Inc. (the “Company”), this letter will respond to your comment letter dated September 21, 2016 with
respect to the above-referenced registration statement (the “Comment Letter”). Enclosed herewith for filing via Edgar is the Company’s Amendment No. 1 to the Registration Statement on Form S-3 (the “Registration
Statement”).
The following response corresponds to the numbered comments contained in the Comment Letter, as follows:
1.
Please update this section to incorporate by reference your Current Report on Form 8-K filed on August 12, 2016.
Response: The Company has revised the Registration Statement to incorporate the referenced Form 8-K.
* * *
On behalf of the Company, the undersigned hereby acknowledges the following:
•
should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;
Ms. Suzanne Hayes
U.S. Securities and Exchange Commission
September 28, 2016
Page 2
•
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and
•
the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact the undersigned at (925) 498-7734 if you have any questions with respect to the responses contained in this
letter or the Registration Statement.
Sincerely,
/s/ Thomas J. Knapp
Thomas J. Knapp
Interim General Counsel and
Corporate Secretary
cc:
Dr. Mark W. Schwartz, Ph.D.
Mr. John T. Burns
Mr. Christopher J. Melsha, Esq.
2016-09-21 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4546 September 21 , 2016 Dr. Mark W. Schwartz President & Chief Executive Officer Galena Biopharma, Inc. 2000 Crow Canyon Place, Suite 380 San Ramon, California 94583 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed September 2, 2016 File No. 333-213493 Dear Dr. Schwartz : We have limited our review of your registration statement to those issues w e have addressed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our com ment applies 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 this comment, we may have additional comments. Incorporation of Certain Documents by Reference, page 29 1. Please update this section to incorporate by reference your Current Report on Form 8 -K filed on August 12, 2016. We urge all persons who are responsible for the a ccuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts rel ating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request acceleration of the effective date of the pending registration statement , pleas e provide a written statement from the company acknowledging that: Dr. Mark W. Schwartz Galena Biopharma, Inc. September 2 1, 2016 Page 2 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Dorrie Yale at 202-551-8776 or Mary Beth Breslin at 202 -551-3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Christopher J. Melsha — Fredrikson & Byron, P.A
2016-09-20 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4 546 September 20, 2016 Dr. Mark W. Schwartz President & Chief Executive Officer Galena Biopharma, Inc. 2000 Crow Canyon Place, Suite 380 San Ramon, California 94583 Re: Galena Biopharma, Inc. Preliminary Proxy Statement on Schedule 14A Filed September 9, 2016 Revised Preliminary Proxy Statement on Schedule 14A Filed September 19, 2016 File No. 001 -33958 Dear Dr. Schwartz : We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceedi ng initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the informati on the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance
2016-09-19 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4 546 September 19 , 2016 Dr. Mark W. Schwartz President & Chief Executive Officer Galena Biopharma, Inc. 2000 Crow Canyon Place, Suite 380 San Ramon, California 94583 Re: Galena Biopharma, Inc. Preliminary Proxy Statement on Schedule 14A Filed September 9, 2016 File No. 001-33958 Dear Dr. Schwartz : We have limited our review of your preliminary proxy statement to those issues w e have addressed in our comment . 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 comment within ten busine ss days by providing the requested information or advis e us as soon as possible when you wi ll respond. If you do not believe our comment applies to your facts and circumstances , please tell us why in your response. After reviewing your response to this comment, we may have additional comments. Proposal No. 2, page 17 1. We refer to your discussion that you amended the Debenture to allow you to repay the Debenture with your common stock and allow the holder of the Debenture to convert some or all of the Debenture into stock. Please revise your disclosure to discuss the effect upon the rights of existing security holders if you issue common stock in connection with your repay ment of the Debenture or the holder’s conversion rights under the Debenture . This disclosure should in particular describe the dilutive impact of such issuances on existing security holders. For reference, see Item 11(d) of Schedule 14A. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Secur ities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they ha ve made. Dr. Mark W. Schwartz Galena Biopharma, Inc. September 19 , 2016 Page 2 In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in respo nse to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Dorrie Yale at 202-551-8776 or Erin Jaskot, Special Counsel, at 202 -551- 3442 with any questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance
2016-09-19 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP September 19, 2016 VIA EDGAR TRANSMISSION Mr. Suzanne Hayes Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. (the “Company”) Preliminary Proxy Statement on Schedule 14A Filed September 9, 2016 File No. 001-33958 Dear Ms. Hayes: On behalf of the Company, this letter will respond to your comment letter dated September 19, 2016, with respect to the above-referenced preliminary proxy statement (the “Comment Letter”). Enclosed herewith for filing via Edgar is the Company’s Amendment No. 1 to the Preliminary Proxy Statement on Schedule 14A (the “Preliminary Proxy Statement”). On the Company’s behalf, we hereby respond to the numbered comments contained in the Comment Letter, as follows: 1. We refer to your discussion that you amended the Debenture to allow you to repay the Debenture with your common stock and allow the holder of the Debenture to convert some or all of the Debenture into stock. Please revise your disclosure to discuss the effect upon the rights of existing security holders if you issue common stock in connection with your repayment of the Debenture or the holder’s conversion rights under the Debenture. This disclosure should in particular describe the dilutive impact of such issuances on existing security holders. For reference, see Item 11(d) of Schedule 14A. Response: The Company has revised the Preliminary Proxy Statement to describe the impact of the issuances of the Company’s common stock in satisfaction of the Debenture. See page 17 of the Preliminary Proxy Statement. On behalf of the Company, it hereby acknowledges the following: • The Company is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and • The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. * * * Please contact the undersigned at (925) 498-7734 if you have any questions with respect to the responses contained in this letter or the Preliminary Proxy Statement. Sincerely, /s/ Thomas J. Knapp Thomas J. Knapp Interim General Counsel and Corporate Secretary cc: Dr. Mark W. Schwartz, Ph.D. Mr. John Burns Mr. Christopher J. Melsha 2000 Crow Canyon Place, Suite 380, San Ramon, CA 94583 Phone: +1 (925) 498-7700 ● Fax: +1 (925) 498-7799 Email: info@galenabiopharma.com ● www.galenabiopharma.com
2016-08-04 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP August 4, 2016 VIA EDGAR U.S. Securities and Exchange Commission Attn: Erin Jaskot and Dorrie Yale Office of Insurance and Healthcare 100 F Street NE Washington, DC 20549 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed July 25, 2016 File No. 333-212674 Dear Ms. Jaskot: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc. (the “Company”) requests acceleration of the effective date of the above-referenced Registration Statement so that the same shall become effective as of 4:30 p.m., Washington, DC time, on August 5, 2016, or as soon thereafter as possible. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2016-08-04 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4 546 August 4, 2016 Dr. Mark W. Schwartz President and Chief Executive Officer Galena Biopharma, Inc . 2000 Crow Canyon Place, Suite 380 San Ramon, California 94583 Re: Galena Biopharma, Inc . Registration Statement on Form S-3 Filed July 25, 2016 File No. 333-212674 Dear Dr. Schwartz : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Dr. Schwartz Galena Biopharma, Inc . August 4, 2016 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Dorrie Yale at 202 -551-8776 and Erin Jaskot at 202-551-3442 with any questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Christopher J. Melsha - Fredrikson & Byron P.A.
2015-12-30 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP December 31, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Post-Effective Amendment No. 1 to Registration Statement on Form S-3 (Reg. No. 333-208330) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc., a Delaware corporation (“Galena”), respectfully requests that the effective date of the Post-Effective Amendment referred to above be accelerated to 5:00 P.M., Washington, D.C. time, Thursday, December 31, 2015, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • Galena may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Galena Biopharma, Inc. By: /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2015-12-30 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP December 30, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Post-Effective Amendment No. 1 to Registration Statement on Form S-3 (Reg. No. 333-208331) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc., a Delaware corporation (“Galena”), respectfully requests that the effective date of the Post-Effective Amendment referred to above be accelerated to 5:00 P.M., Washington, D.C. time, Thursday, December 31, 2015, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • Galena may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Galena Biopharma, Inc. By: /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2015-12-18 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request 333-208330 December 18, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-208330) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc., a Delaware corporation (“Galena”), respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:00 P.M., Washington, D.C. time, on Tuesday, December 22, 2015, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • Galena may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Galena Biopharma, Inc. By: /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2015-12-18 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Acceleration Request 333-208331 December 18, 2015 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-208331) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Galena Biopharma, Inc., a Delaware corporation (“Galena”), respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:00 P.M., Washington, D.C. time, on Tuesday, December 22, 2015, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • Galena may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Galena Biopharma, Inc. By: /s/ Mark W. Schwartz Mark W. Schwartz, Ph.D. President and Chief Executive Officer
2015-12-16 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4720
December 16 , 2015
Via E -mail
Mark W. Schwartz, Ph.D.
President and Chief Executive Officer
Galena Biopharma, Inc.
2000 Crow Canyon Place, Suite 380
San Ramon, CA 94583
Re: Galena Biopharma, Inc.
Registration Statement on Form S -3
Filed December 4 , 2015
File No. 333-208330
Dear Dr. Schwartz :
We have limited our review of you r registration statement to the issue we have addressed
in our comment .
After reviewing any amendment to your registration statement and the information you
provide in response to our comment , we may have additional comments.
General
1. We note that you have a pending confidential treatment request. We will not be in a
position to accelerate the effectiveness of your registration statement until we have
completed processing your confidential treatment request.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Notwithstanding our comment , in the event you request acceleration of the effective date
of the pending regis tration statement please provide a written statement from the company
acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;
Mark W. Schwartz, Ph.D.
Galena Biopharma , Inc.
December 16 , 2015
Page 2
the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act o f 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
Please contact Alla Berenshteyn at (202) 551 -4325 or me at (202) 551 -3675 with any
questions .
Sincerely,
/s/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
2014-11-19 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Galena-S-3Correspondence November 19, 2014 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-199517) Ladies and Gentlemen: On behalf of Galena Biopharma, Inc. (“Galena”), the undersigned hereby requests that the Securities and Exchange Commission issue an order declaring the above-referenced Registration Statement effective at 4:00 P.M., Washington, D.C. time, on Thursday, November 20, 2014, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, that act will not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosures in the Registration Statement; and • Galena may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Galena also understands that this request for acceleration will be considered a confirmation of its awareness of its obligations under the Securities Act of 1933 and the Securities Exchange Act of 1934 with respect to the offering of securities pursuant to the Registration Statement. Very truly yours, /s/ Mark W. Schwartz, Ph.D. Mark W. Schwartz President and Chief Executive Officer - .
2014-10-31 - UPLOAD - SELLAS Life Sciences Group, Inc.
October 30, 2014 Via E -mail Mark W. Schwartz, Ph.D. President and Chief Executive Officer Galena Biopharma, Inc. 4640 SW Macadam Ave., Suite 270 Portland, Oregon 97239 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed October 22, 2014 File No. 333 -199517 Dear Dr. Schwartz: We have limited our review of your registration statement to the issues we have addressed in our comments. Please respond to this letter by amending your registration statement and providing the requested information. Where 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 our comments, we may have additional comments. General 1. We note that the shares of common stock being registered for resale un der this registration statement will be issued to the selling stockholder, MonoCol Rx, LLC on November 11, 2014 in partial payment of the first milestone payment under the license and supply agreement dated as of July 17, 2014 between the company and MonoC ol Rx, LLC. Please provide us with an analysis as to why it is appropriate to register the offering of shares of common stock that have not yet been issued. Incorporation of Certain Documents by Reference, page 36 2. Please amend your registration statemen t to incorporate by reference your Form 8 -Ks filed January 13, 2014 and January 14, 2014. Please see Item 12(a)(2) of Form S -3 for guidance. Mark W. Schwartz, Ph.D. Galena Biopharma , Inc. October 30 , 2014 Page 2 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certa in that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the ac curacy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that : should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for a cceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Johnny Gharib at (202) 551 -3170 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Dale E. Short, Esq. TroyGould PC
2014-10-31 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm GALE-2014.10.31 - CORRESP S-3 Dale E. Short • (310) 789-1259 • dshort@troygould.com File No. 3143-6 October 31, 2014 VIA FEDERAL EXPRESS AND EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler, Assistant Director Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed October 22, 2014 File No. 333-199517 Ladies and Gentlemen: By letter dated October 30, 2014, the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided Galena Biopharma, Inc. (the “Company”) with a comment on the Company’s Registration Statement on Form S-3 (the “Registration Statement”). This letter contains the Company’s response to the Staff’s comment. The numbered responses and the headings set forth below correspond to the numbered comments and heading in the Staff’s letter dated October 30, 2014. The Company has revised the Registration Statement in response to the Staff’s comments and concurrently is filing pre-effective Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”). In addition to changes made in response to the Staff’s comments, the Amended Registration Statement contains some updated information that appeared in the Registration Statement, none of which is material in the Company’s view. To facilitate the Staff’s review of the Amended Registration Statement, we are providing supplementally with this letter a blacklined copy of the Registration Statement marked to show changes from the Registration Statement. Securities and Exchange Commission October 31, 2014 Page 2 General 1. We note that the shares of common stock being registered for resale under this registration statement will be issued to the selling stockholder, MonoCol [sic] Rx, LLC on November 11, 2014 in partial payment of the first milestone payment under the license and supply agreement dated as of July 17, 2014 between the company and MonoCol [sic] Rx, LLC. Please provide us with an analysis as to why it is appropriate to register the offering of shares of common stock that have not yet been issued. COMPANY’S RESPONSE: As described in the Registration Statement, on July 17, 2014, the Company entered a license and supply agreement (the “License Agreement”) with MonoSol Rx, LLC (“MonoSol”), under which the Company acquired the exclusive license to commercialize Zuplenz® Oral Soluble Film in the U.S. Under the terms of the License Agreement, upon the completion of the transfer to the Company of the "NDA” as defined in the License Agreement (the “First Milestone Event”), the Company agreed to pay MonoSol in two installments a first milestone payment totaling $5,000,000, plus certain FDA registration fees, in cash, or a combination of cash and shares of Company common stock (the “First Milestone Payment”). The Company has paid to MonoSol $3,056,249 in cash, and intends to pay the second installment of the First Milestone Payment of $2,500,000 in shares of the Company’s common stock (the “Milestone Shares”). Under the terms of the License Agreement, the Milestone Shares are to be valued for this purpose at the closing sale price of the common stock as reported on The NASDAQ Capital Market on November 10, 2014 and issued by the Company by November 11, 2014. The License Agreement provides; however, that the Company may pay the $2,500,000 by means of the Milestone Shares only if the Milestone Shares would be subject to an effective registration statement under the Securities Act of 1933 covering the offer for resale by MonoSol of the Milestone Payment Shares. The Milestone Shares are issuable without payment by MonoSol of any additional consideration or the performance by MonoSol of any additional acts, and without any investment decision by MonoSol. General Instruction I.B.3 to Form S-3 provides that an issuer is eligible to use Form S-3 to register “[o]utstanding securities to be offered for the account of any person other than the issuer, . . . if securities of the same class are listed and registered on a national Securities and Exchange Commission October 31, 2014 Page 3 securities exchange or are quoted on the automated quotation system of a national securities association.” In its Compliance and Disclosure Interpretations (“C&DIs”) for the Securities Act Forms, the Staff previously addressed whether shares that are issuable in a merger transaction, but are not yet outstanding, can be registered on Form S-3 pursuant to General Instruction I.B.3. Specifically, Question 116.05 provides: Question: In reliance on Securities Act Section 4(2), a merger transaction will not be registered. May resales of earnout shares to be issued in connection with the merger be registered on Form S-3 pursuant to General Instruction I.B.3 after the consummation of the merger, even though the shares have not been earned and are not outstanding at the time the registration statement is filed? Answer: Yes. [Feb. 27, 2009] We respectfully submit that the offering for resale of the Milestone Shares is eligible for registration for resale on Form S-3, because such shares are substantively identical to “earnout” shares in accordance with the Staff’s guidance provided in C&DI Question 116.05. In Question 116.05, the Staff confirmed that so-called earnout shares issuable in the future in a merger context are eligible for registration for resale on Form S-3. There is no meaningful legal distinction for purposes of the Staff's guidance between such “earnout shares” and “milestone shares” issuable in a license context. In both cases, when the merger agreement or the license agreement is entered into, the issuer is contractually obligated or entitled to issue the shares upon the occurrence of future events, whether the events are based on financial metrics, the receipt of regulatory approvals or some other event, or at a future payment date. Affording such "earnout shares" and "milestone shares" the same treatment for purposes of Form S-3 also is consistent with the equivalent treatment afforded securities acquired as contingent payment of the purchase price for the sale of an equity interest in a business (as in a merger) or the assets of a business (as in an asset purchase) for purposes of calculating the holding period under Rule 144(d)(3)(iii). In each case, such securities are deemed to have been acquired at the time the acquisition agreement was entered into so long as the future issuance of such securities is not subject to the payment of additional consideration or other new investment decision. Under the terms of the License Agreement, the Milestone Shares became issuable by the Company by reason of the achievement of the First Milestone Event relating to the transfer of the NDA to the Company. The Company's issuance of the Milestone Shares involves no additional consideration or new investment decision by MonoSol. Securities and Exchange Commission October 31, 2014 Page 4 Accordingly, the offering by MonoSol for resale of the Milestone Shares is eligible for registration under the Company's Amended Registration Statement. Incorporation of Certain Documents by Reference, page 36 2. Please amend your registration statement to incorporate by reference your Form 8‑Ks filed January 13, 2014 and January 14, 2014. Please see Item 12(a)(2) of Form S-3 for guidance. COMPANY’S RESPONSE The Company has revised the disclosures under “Incorporation of Certain Documents By Reference” on page 36 of the Amended Registration Statement to do as the Staff requests. * * * If you have any questions regarding this response, please direct them to the undersigned at (310) 789-1259 or at dshort@troygould.com. Very truly yours, /s/ Dale E. Short Dale E. Short DES/wp
2014-05-13 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP May 13, 2014 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-195260) Ladies and Gentlemen: On behalf of Galena Biopharma, Inc. (“Galena”), the undersigned hereby requests that the Securities and Exchange Commission issue an order declaring the above-referenced Registration Statement effective at 5:00 P.M., Washington, D.C. time, on Thursday, May 15, 2014, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, that act will not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosures in the Registration Statement; and • Galena may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Securities and Exchange Commission May 13, 2014 Page 2 Galena also understands that this request for acceleration will be considered a confirmation of its awareness of its obligations under the Securities Act of 1933 and the Securities Exchange Act of 1934 with respect to the offering of securities pursuant to the Registration Statement. Very truly yours, /s/ Mark J. Ahn, Ph.D. Mark J. Ahn President and Chief Executive Officer
2014-05-02 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP May 2, 2014 VIA EDGAR Jeffrey P. Riedler Assistant Director 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-3 Filed April 14, 2014 File No. 333-195260 Dear Mr. Riedler: You recently provided Galena Biopharma, Inc. (the “Company”) with a comment letter dated April 23, 2014 regarding the Company’s above-referenced filing. This letter contains the Company’s response to the comment in your comment letter, which we have reproduced below for your convenience. 1. Please be advised that we cannot accelerate the effective date of your registration statement until resolution of your pending confidential treatment request and the filing of the information required by Part III of your Form 10-K filed on March 17, 2014. In regard to the Part III information, we note that your Form 10-K indicates that you plan to incorporate this information by reference from your definitive proxy statement which has not been filed yet. COMPANY’S RESPONSE: On April 30, 2014, the Company filed its definitive proxy statement setting forth the information incorporated by reference in Part III of the Company’s Annual Report on Form 10-K. A revised definitive proxy statement, which corrected a few figures contained in the definitive proxy statement, was filed on May 1, 2014. Jeffrey P. Riedler May 2, 2014 Page 2 Last evening, on May 1, 2014, the Company sent to the Staff by overnight courier a revised confidential treatment request (“CTR”) which complied with the Staff’s comments on the Company’s initial CTR. The Company is awaiting any further comments by the Staff or confirmation that its CTR has been granted. As soon as the Company is notified that its revised CTR has been granted by the Staff, the Company will file its request for acceleration of the effectiveness of the Company’s Registration Statement. In the meantime, please contact the undersigned if you have any questions or comments regarding this response letter. Very truly yours, /s/ Mark J. Ahn, Ph.D. Mark J. Ahn, Ph.D. President and Chief Executive Officer Cc: Johnny Gharib (SEC) Dale E. Short
2014-04-23 - UPLOAD - SELLAS Life Sciences Group, Inc.
April 23 , 2014 Via E -mail Mark J. Ahn, Ph.D. President and Chief Executive Officer Galena Biopharma, Inc. 4640 SW Macadam Ave., Suite 270 Portland, Oregon 97239 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed April 14, 2014 File No. 333-195260 Dear Dr. Ahn : We have limited our review of your registration statement to the issue we have addressed in our comment . Please respond to this letter by providing the requested information . Where you do not believe our comment applies to your facts and circumstances , please tell us why in your response. After reviewing the information you provide in response to our comment , we may have additional comments. 1. Please be advised that we cannot accelerate the effective date of your registrat ion statement until resolution of your pending confidential treatment request and the filing of the information required by Part III of your Form 10 -K filed on March 17, 2014. In regard to the Part III information, we note that you r Form 10 -K indicates that you plan to incorporate this information by reference from yo ur definitive proxy statement which has not been filed yet. We urge all persons who are respons ible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request acceleration of the effective date of the pending registration sta tement please provide a written statement from the company acknowledging that: Mark J. Ahn, Ph.D. Galena Biopharma, Inc. April 23 , 2014 Page 2 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respe ct to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing ; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regar ding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requeste d effective date of the registration statement. Please co ntact J ohnny Gharib at (202) 551 -3170 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Dale E. Short, Esq. TroyGould PC
2014-04-18 - UPLOAD - SELLAS Life Sciences Group, Inc.
April 17, 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 File No. 001-33958 Dear Dr. Ahn: We have completed our review of your filings. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities la ws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2014-03-13 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP March 13, 2014 VIA EDGAR Jim B. Rosenberg Senior Assistant Chief Accountant Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 2012 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 Mr. Rosenberg: You recently provided Galena Biopharma, Inc., a Delaware corporation (the “Company”), with a comment letter dated March 10, 2014 regarding the Company’s above-referenced filings. This letter contains the Company’s response to the comment in your comment letter, which we have reproduced below for your convenience. 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 demonstrated 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,” co-authored by 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 observed in the vaccinated patients compared to the control patients (10.6% vs 20.3%, p=0.098). Jim B. Rosenberg March 13, 2014 Page 2 While not entirely clear, there does appear to be some inconsistency between these two statements. Please provide us with a concise explanation that reconciles 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. COMPANY’S RESPONSE The statements made in our disclosure on page 22 are based on peer-reviewed data that we presented and published at 35th Annual CTRC-AACR San Antonio Breast Cancer Symposium in December 2012 (please see the attached link to the related press release): http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=725551). Please note that there were two different clinical trials being reported—SN-33 (Node Positive) and SN-34 (Node Negative)—out of five total clinical studies conducted with NeuVax. Trials SN-33 (NP) (n=97) and SN-34 (NN) (n=90) enrolled eligible patients defined as those who were rendered disease-free after completion of standard of care multi-modality (surgery, chemotherapy, radiation) therapy. Treatment assignment was then based on HLA type (human leukocyte antigen from A2/A3 patients who have the same loci of genes, which represent 65% of population), with HLA-A2/A3 patients vaccinated and HLA-A2/A3 negative patients followed prospectively as controls for comparison in recurrence rates (also known as “disease free survival (DFS)”). The open label trial results were reported both in combination and separately at multiple time points. However, SN-33 is of particular importance, because only node positive patients are the target for the Company’s ongoing Phase 3 registrational study (p=0.0358).1 Below is a graph which represents the Company’s Phase 3 study population under an FDA-approved SPA (Special Protocol Assessment).2 If successful, the Company would seek commercial approval only for the node positive patient group. 1 A value is a measure of significance of results. For example, a p value of 0.05 would suggest that if the study were conducted again, there is a 95% chance that the same results would be observed. The NeuVax Phase 3 program, for example, would be deemed successful with a p value of <0.05. 2 A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that a proposed and yet uncompleted Phase 3 trial’s design, clinical endpoints, and statistical analyses are acceptable for FDA approval providing the resulting data support the efficacy and safety of the investigational product. Jim B. Rosenberg March 13, 2014 Page 3 The article by Vreeland et al (2013) noted: “After a median follow-up of 60 months, there has been a persistent decrease in recurrences observed in the vaccinated patients compared to the control patients (10.6% vs 20.3%, p=0.098).” These data refer to the combined node positive and node negative populations in the two studies. Please note these were results observed prior to the booster series in same patients. The same article also emphasizes the use of boosters, as has been demonstrated for other immunologically active therapies (i.e., vaccines).3 As noted above, only node positive patients are the subject of the ongoing Phase 3 study protocol (please see link below), which includes the boosters, and therefore the ongoing research is design to confirm this result in a large scale randomized, double-blinded multinational, multicenter clinical study in 700 patients which, if successful, would be the basis to apply for commercial approval. (http://clinicaltrials.gov/ct2/show/NCT01479244?term=e75&rank=3). 3 Mittendorf E,A Clifton GT, Holmes JP, Clive KS, Patil R, et al. (2011) Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: From US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. Jim B. Rosenberg March 13, 2014 Page 4 Regarding the language in laymen’s terms, we propose to include the following in our upcoming Form 10-K: “NeuVax™ (nelipepimut-S), our lead cancer immunotherapy, is being developed for the prevention of cancer recurrence in HER2 expressing cancers. NeuVax is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast and gastric carcinomas. The NeuVax vaccine, nelipepimut-S peptide, is combined with the immune adjuvant, recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) for administration. Data has shown that an increased presence of circulating tumor cells (CTCs) predict Disease Free Survival (DFS) and Overall Survival (OS)—suggesting a dormancy of isolated micrometastases, which over time, lead to recurrence. After binding to the HLA A2/A3 molecules on antigen presenting cells, the nelipepimut-S sequence stimulates specific cytotoxic T lymphocyte (CTLs). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is a targeted cancer immunotherapy for approximately 30,000-40,000 of the 230,000 breast cancer patients annually diagnosed in the US who are at high risk of their breast cancer recurring, which we refer to as “disease recurrence,” after achieving remission (or becoming a “survivor”) with standard therapy (surgery, chemotherapy, radiation). These high-risk patients have a particular molecular signature and disease status: HER2 IHC 1+/2+ (oncoprotein associated with aggressive tumor growth), node positive (disease present in the axillary lymph nodes prior to surgery), and HLA A2/A3 (human leukocyte antigen from A2/A3 patients who have the same loci of genes who which represents 65% of population). Up to 25% of resectable node-positive breast cancer patients, having no radiographic evidence of disease following surgery and adjuvant chemo/radiation therapy, still relapse within three years following diagnosis. These cancer patients presumably still had isolated, undetected tumor cells also known as circulating tumor cells which, over time, led to a recurrence of cancer, either in the breast area (local recurrence) or at a remote location (metastatic disease).” Jim B. Rosenberg March 13, 2014 Page 5 Please contact the undersigned if you have any questions or comments regarding this response letter. Very truly yours, /s/ Mark J. Ahn, PhD Mark J. Ahn, PhD President and Chief Executive Officer Cc: Frank Wyman (SEC) Joel Parker (SEC) Ryan Dunlap (VP and CFO, Galena Biopharma, Inc.)
2014-03-11 - UPLOAD - SELLAS Life Sciences Group, Inc.
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
2014-01-29 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP January 29, 2014 VIA EDGAR Jim B. Rosenberg Senior Assistant Chief Accountant Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 2012 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 Mr. Rosenberg: You recently provided Galena Biopharma, Inc., a Delaware corporation (the “Company”), with a comment letter dated January 14, 2014 regarding the Company’s above-referenced filings. This letter contains the Company’s response to the comment in your comment letter, which we have reproduced below for your convenience. Form 10-Q for the Quarterly Period Ended September 30, 2013 Notes to Condensed Consolidated Financial Statements (unaudited) 1. Business and Basis of Presentation Acquisitions and In-Licensing, page 9 1. Please refer to your response to comment one. As Abstral was an approved product when you licensed it, please provide us with an analysis supporting your conclusion that the license of Abstral was an asset acquisition and not a business combination. Please refer to ASC- 805-10-55-4 to 9. Jim B. Rosenberg January 29, 2014 Page 2 COMPANY’S RESPONSE Background The discussion below lists several key facts about our acquisition of Abstral (the “Product”) and its history in the U.S. market. We support our conclusion that the Product acquisition was the purchase of an asset and not a business combination: • The Product was approved by the U.S. Food and Drug Administration (FDA) in 2011, and had a largely unsuccessful product launch by Orexo’s former licensee, ProStrakan, in April 2011. In November 2012, ProStrakan and Orexo agreed to abandon the Product, and that Orexo would reacquire the Product over a transition period ending on June 30, 2013. As part of their Product abandonment, the key activities and processes ProStrakan once used to integrate inputs to produce sales of Abstral were also disintegrated and disbanded. Some Product sold by ProStrakan remained in the distribution channel, and limited demand for the Product from certain prescribers lingered on after the launch was abandoned, which allowed us to purchase from a third party the REMS data and demand visibility used to support our revenue recognition and return estimates. This channel movement and limited prescription activity, however, did not include inputs, activities and processes necessary to support an ongoing business as further discussed below. • We acquired the Product on March 18, 2013, four months after the launch was abandoned by ProStrakan. We did not receive transfer of the New Drug Application (NDA) until May 1, 2013, record any sales of the Product until July 2013, receive manufacturing approval until September 2013, or implement an official launch with field sales force activity until October 2013. This length of time between the ProStrakan Product abandonment, our Product acquisition and the key operational milestones reflected the lack of business continuity and our related need to build the key activities and processes needed to operate a business involving the Product. • The assets purchased from Orexo in the Product acquisition (primarily intellectual property and relatively small amount of remaining inventory in the U.S.) did not include essential inputs, activities, and processes needed to carry on the business of producing, selling and distributing the Product, such as employees (both management and field sales), sales training manuals and territory data, contracts and relationships with customers such as distributors, wholesalers, specialty Jim B. Rosenberg January 29, 2014 Page 3 pharmacies and group purchasing organizations, approval to manufacture and manufacturing contracts, contracts and relationships with managed care organizations, among others. In response to your comment, our consideration of FASB Accounting Standards Codification Topic 805, Business Combinations (“ASC 805”) with respect to the treatment of the Product acquisition as an asset purchase and not a business combination is included in the following paragraphs, each beginning with the relevant paragraphs from the literature in italics: Definition of a business 805-10-55-4 - A business consists of inputs and processes applied to those inputs that have the ability to create outputs. Although businesses usually have outputs, outputs are not required for an integrated set to qualify as a business. The three elements of a business are defined as follows: a. Input. Any economic resource that creates, or has the ability to create, outputs when one or more processes are applied to it. Examples include long-lived assets (including intangible assets or rights to use long-lived assets), intellectual property, the ability to obtain access to necessary materials or rights, and employees. b. Process. Any system, standard, protocol, convention, or rule that when applied to an input or inputs, creates or has the ability to create outputs. Examples include strategic management processes, operational processes, and resource management processes. These processes typically are documented, but an organized workforce having the necessary skills and experience following rules and conventions may provide the necessary processes that are capable of being applied to inputs to create outputs. Accounting, billing, payroll, and other administrative systems typically are not processes used to create outputs. c. Output. The result of inputs and processes applied to those inputs that provide or have the ability to provide a return in the form of dividends, lower costs, or other economic benefits directly to investors or other owners, members, or participants. We purchased from Orexo assets and rights representing only limited inputs necessary to carry on the Product as a business, and no liabilities were acquired or assumed. The assets and rights acquired in the transaction include: • Exclusive, perpetual rights to manufacture, market, sell, and distribute Abstral in the U.S., and the related trademark • Certain finished goods and in-process inventory remaining in the pipeline • The maintenance of certain regulatory and licensure activities necessary for continued regulatory compliance underlying the commercial feasibility of Abstral in the U.S. Jim B. Rosenberg January 29, 2014 Page 4 • All Abstral related books and records held by Orexo. • First right of refusal to any future Fentanyl products that Orexo might develop and obtain approval for in the U.S. The group of assets, or inputs, acquired was absent several key inputs and substantially all the key processes and activities needed to integrate with inputs to produce, or being capable of producing, outputs. The most important missing inputs, processes and activities include: • Employees – no employees were acquired from Orexo or ProStrakan as part of the transaction, and we had to source, interview, screen and hire the entire commercialization team, including commercial executive management, senior account management, managed care administration and field sales force. We also had to develop processes for expense reporting and reimbursement, fuel and expense usage, including establishing contracts and compensation programs. • Sales data materials – we had to purchase from outside vendors the data and information needed to effectively direct and manage the sales force and sales efforts, including the REMS data, the IMS data, and the consulting contract needed to use that information to delineate sales territories and direct sales activities based on prescription trends. We also had to develop and implement our own product specific sales training and procedural manuals. • Warehousing, logistics and distribution – we did not acquire or assume any warehousing, inventory management, or logistics contracts or capabilities, and had to procure a new contract with our third party logistics organization to provide warehousing and inventory management services. • Customer contracts and relationships – we acquired no customer contracts or relationships in the transaction, and had to establish our own new contracts and relationships with the distributors, wholesalers, specialty distributors, specialty pharmacies and group purchasing organizations that make up our customer base. • Manufacturing approval and contracts – we did not acquire in the transaction any pre-existing manufacturing contracts, and had to reestablish the commercial scale manufacturing via a Commercial Supply Agreement and Quality Agreement with our contract manufacturer. While the manufacturing processes associated with the NDA had been previously implemented by ProStrakan, and our agreements with Orexo gave us the right to assume those approved manufacturing processes, we were still required resubmit an application for approval of a change to the manufacturing process (known as a CBE-30), which was approved by the FDA in September 2013, six months after our Product acquisition. • Managed care contracts and relationships – we did not acquire or assume any contracts with managed care payor organizations, and had to hire a managed care director and negotiate these contracts subsequent to the acquisition. Jim B. Rosenberg January 29, 2014 Page 5 Given the pervasive lack of key inputs, activities and processes, the asset group purchased does not contain the elements necessary to be deemed a business based on the definition provided by ASC 805. Market participant viewpoint 805-10-55-5 - To be capable of being conducted and managed for the purposes defined, an integrated set of activities and assets requires two essential elements—inputs and processes applied to those inputs, which together are or will be used to create outputs. However, a business need not include all of the inputs or processes that the seller used in operating that business if market participants are capable of acquiring the business and continuing to produce outputs, for example, by integrating the business with their own inputs and processes. 805-10-55-8 - Determining whether a particular set of assets and activities is a business should be based on whether the integrated set is capable of being conducted and managed as a business by a market participant. Thus, in evaluating whether a particular set is a business, it is not relevant whether a seller operated the set as a business or whether the acquirer intends to operate the set as a business. While the matter of whether a market participant would be “capable of” operating the acquired set of inputs as a business is somewhat subjective, we believe that in our case the missing activities and processes as noted above are so pervasive and significant that it is clear that a market participant would not be able to reasonably continue the business without a substantial amount of incremental effort and build-out of the activities and processes, similar to the efforts we had to undertake. As noted in the Ernst & Young publication, Definition of a Business Under ASC 805 (dated November 11, 2009), “If a market participant, which in many cases would be a competitor of the acquirer, would have the missing inputs or processes, or could easily replace or replicate the missing inputs and processes (i.e., the missing elements are not more than minor), the acquired set is likely a business. However, if the acquired set has no processes (e.g., only assets, and no activities, were acquired), the acquired set in most cases would not constitute a business.” The above is relevant to our fact pattern. We believe that a market participant, or competitor of ours, would not have the ability to easily replace the missing processes in this transaction, as the missing elements are more than minor, Jim B. Rosenberg January 29, 2014 Page 6 particularly given no activities or processes were acquired as part of this transaction. Moreover, the missing processes and activities are difficult to obtain and take time to build as a result of the high degree of specificity inherent in the nature of the Product, including the following examples: • The sales force requires requisite experience and training related to the sale of a transmucosal immediate release fentanyl (TIRF) product, including the related indications and REMS regulations. Also, while TIRF products (including the Product in ProStrakan’s unsuccessful launch) have historically been directed toward pain management specialists, our Product strategy focuses on oncologists in the palliative care context, which required us to source and retain sales personnel with oncology experience, primarily, and pain management experience, secondarily. • The NDA transfer requirements apply before any company or we would have the capability to legal promote and sell the product, and the NDA transfer application process is thorough and takes time. • FDA guidelines prohibit the transfer of manufacturing contracts for the Product. Therefore, resubmission of the application to change the manufacturing process (CBE-30) and approval by the FDA was required prior to our commencement of manufacturing on the product in the U.S. The process to obtain FDA approval to manufacture required six months from the date of the acquisition. We believe this requirement would have applied to any other market participant. • Before we could legally sell and distribute the Product, we had to obtain a specific license to sell TIRF products in substantially every U.S. state, and had to apply for and become a member of REMS program, a process that also takes time and would also apply to virtually every other market participant (excepting the 3-4 other current REMS participants. Development stage considerations 805-10-55-6 - The nature of the elements of a business varies by industry and by the structure of an entity’s operations (activities), including the entity’s stage of development. Established businesses often have many different types of inputs, processes, and outputs, whereas new businesses often have few inputs and processes and sometimes only a single output (product). Nearly all businesses also have liabilities, but a business need not have liabilities. 805-10-55-7 An integrated set of activities and assets in the development stage might not have outputs. If not, the acquirer should consider other factors to determine whether the set is a business. Those factors include, but are not limited to, whether the set: a. Has begun planned principal activities Jim B. Rosenberg January 29, 2014 Page 7 b. Has employees, intellectual property, and other inputs and processes that could be applied to those inputs c. Is pursuing a plan to produce outputs d. Will be able to obtain access to customers that will purchase the outputs. Not all of those factors need to be present for a particular integrated set of activities and assets in the development stage to qualify as a business. We have considered several factors, including those listed in (a) – (d) above. As discussed above, we have acquired inputs consisting primarily of intangible assets but we did not acquire any complementary inputs, processes or ongoing activities that would constitute a business. Also as discussed above, the planned principal activities took several months to get up and running as a result of our need to establish and build the key processes needed to conduct the Product business. Therefore, while we were pursuing a plan to produce outputs and were eventually able to obtain the necessary customer access (per c. and d. above), we believe the lack of activities and processes, and the need to build those activities and processes prior to commencing principal activities, s
2014-01-15 - UPLOAD - SELLAS Life Sciences Group, Inc.
January 14, 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 December 26 , 2013 response to our December 13 , 2013 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 req uested 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 the 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 Notes to Condensed Consolidated Financial Statements (unaudited) 1. Business and Basis of Presentation Acquisitions and In -Licensing, page 9 1. Please refer to your response to comment one. As Abstral was an approved product when you licensed it , please provide us with an analysis supporting your conclusion that the license of Abstral was an a sset acquisition and not a business combination. Please refer to ASC - 805-10-55-4 to 9. Dr. Mark J. Ahn Galena Biopharma, Inc. January 14, 2014 Page 2 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, Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2013-12-26 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP December 26, 2013 VIA EDGAR Jim B. Rosenberg Senior Assistant Chief Accountant Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Galena Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 2012 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 Mr. Rosenberg: You recently provided Galena Biopharma, Inc., a Delaware corporation (the “Company”), with a comment letter dated December 13, 2013 regarding the Company’s above-referenced filings. This letter contains the Company’s response to the single comment in your comment letter, which we have reproduced below for your convenience. Form 10-Q for the Quarterly Period Ended September 30, 2013 Notes to Condensed Consolidated Financial Statements (unaudited) 1. Business and Basis of Presentation Revenue Recognition, page 8 1. In light of your recent launch of Abstral, please provide us an analysis of each condition in ASC 605-15-25-1 that supports that you met each condition. Also, provide us an analysis of each of factor in ASC 605-15-25-3 to demonstrate you had the ability to make a reasonable estimate of future returns. Further, provide us an analysis supporting that you were able to reasonably estimate provisions for prompt pay discounts, wholesaler discounts, rebates, chargebacks, patient assistance program rebates and other deductions. Jim B. Rosenberg December 26, 2013 Page 2 COMPANY’S RESPONSE Background The discussion below lists several key facts about our single commercial product, Abstral, and the commercial environment in which Abstral is sold in the United States. We consider these factors to be pertinent to and form the foundation upon which our revenue recognition policies are based and supported: • While we entered our license agreement for Abstral in March of 2013, and commenced our launch thereafter, Abstral was originally introduced and launched in the United States in April 2011 by the previous licensee. Thus, there is historical prescription information available to us from the prior launch. • Abstral is a transmucosal immediate release fentanyl (TIRF), and like all TIRF products, can only be manufactured, distributed, sold and prescribed under a program called the Risk Evaluation and Mitigation strategy (REMS). Under the REMS program, all manufacturers, distributors, dispensaries and prescribers who make, transport, sell, carry or prescribe TIRF products are required to register and meet certain compliance criteria, and are also required to comply with stringent reporting requirements. Based on these REMS reporting requirements, we have real-time access to complete prescription information, including quantity of tablets filled in each prescriptions, strength prescriber, name location and information of the prescriber, along with other information. This REMS information provides us visibility into the product’s historical prescription information and trends, which allows us to reliably estimate demand and sell-through expectations. • Along with other TIRF products, Abstral is considered a class two narcotic, and as such, the costs and risks associated with transporting and carrying the product are abnormally high. Thus, there is significant disincentive for wholesalers, distributors and dispensaries to carry more product than they believe will sell through in a reasonable period of time. Beginning in the third quarter of 2013, we adopted our policy to recognize revenue when the product is shipped from our third party logistics provider (3PL) distribution center and received by our customers (FOB destination), with appropriate reserves applied against sales for estimated prompt pay discounts, wholesaler discounts, rebates, chargebacks, right of return and patient assistance program obligations. Jim B. Rosenberg December 26, 2013 Page 3 In response to your comment, our consideration of FASB Accounting Standard Codification Topic 605, Revenue Recognition (“ASC 605”) with respect to the right of return and other relevant provisions of our customer agreements is included in the following paragraphs. Right of Return Our customer agreements allow for a right of return for product that is approaching expiration (generally within 6-12 months of product expiry), or in certain other special circumstances, including: • Newly-launched product (generally within 6 months of their initial introduction) • Discontinued products • Products experiencing decreased market demand due to extraneous circumstances (e.g., launch of a generic) • Termination of the customer agreement None of these provisions are relevant at this time. ASC 605-15-25-1 provides that an entity can recognize revenue upon the sale of product when the buyer has the right to return the product only if all the following conditions are met: • The seller’s price to the buyer is substantially fixed or determinable at the date of sale. • The buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product. • The buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product. Jim B. Rosenberg December 26, 2013 Page 4 • The buyer acquiring the product for resale has economic substance apart from that provided by the seller. • The seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer. • The amount of future returns can be reasonably estimated The seller’s price to the buyer is substantially fixed or determinable at the date of sale. The price to our customers for Abstral, known as the Wholesaler Acquisition Cost (“WAC”), is predetermined and fixed, and any all discounts provided to our customers are known and contractually established at the time of sale. The buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product. Payment is due to us within a certain number of days, generally between 30 and 35, as contractually stipulated, from the date of sale to our customers, and that payment is not contingent on any future events, including sell-through. The buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product. Title and risk of loss is transferred to our customers upon receipt of the product (FOB destination shipping terms), as contractually agreed upon. The buyer acquiring the product for resale has economic substance apart from that provided by the seller. Our customers have independent ownership, and economic substance apart from that provided by us, in that they purchase products from multiple manufacturers, sell to multiple pharmacies/dispensaries and have leverage to determine where and to whom to sell the product. They maintain distribution centers and employees, and act as a principal in the sales of the product, assuming the normal risks associated with a wholesale arrangement. Jim B. Rosenberg December 26, 2013 Page 5 The seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer. We carry no obligation for future performance after the product is delivered to our customers. While we do maintain a sales force, tasked with providing educational assistance to providers to promote prescription demand, this is not a contractual obligation to our customers, and, outside of certain contractual obligations to the licensor we maintain full control and authority to determine the size of our sales force and the nature and extent of our sales and marketing activities, and our customer agreements to not have provisions that impact these decisions. The amount of future returns can be reasonably estimated. While the ability to reasonably estimate returns is driven by facts and circumstances, and could vary from situation to situation, ASC 605-15-25-3 provides the following factors that might impair the ability to reasonably estimate returns: • The susceptibility of the product to significant external factors, such as technological obsolescence or changes in demand. • Relatively long periods in which a particular product may be returned • Absence of historical experience with similar types of sales of similar products, or inability to apply such experience because of changing circumstances, for example, changes in the selling entity’s marketing policies or relationships with its customers • Absence of a large volume of relatively homogeneous transactions. With consideration given to the factors above, and other facts and circumstances specific to our selling model and industry, we believe that we have the ability to reasonably estimate returns at the time product is sold to our customers, based on the following key considerations: • As noted in the ‘Background’ section above, since Abstral was originally introduced in the United states in 2011, we have access to complete, relevant real-time prescription data and trends for our product through the REMS reporting. Jim B. Rosenberg December 26, 2013 Page 6 • Abstral is produced in bulk batches with specific, label identified expiry dates. Using this data, we can reliably predict when we would expect product to be returned for expiry reasons, and therefore can establish reliable expectations about how much product, based on the aforementioned demand visibility, will be sold through prior to expiry. • Given the nature of our product, and the relative difficulty getting approval for similar products, at present we believe there if very low risk of returns being affected by external factors, such as technical obsolescence, unforeseen market competition, or other significant changes to the selling environment. • The long period of time over which product can be returned relates to the relatively long time to expiry of our product, with approximately a four year window from tableting to expiry, and generally over three years to expiry from the time our product is sold. As noted above, our visibility into the relationship between sales, demand and product expiry substantially mitigates the risk associated with the long return period. • The prescription transactions contained in the REMS reporting represent a large volume of homogeneous transactions, which provide relevant support for our returns estimates. Estimation of Other Provisions Other deductions from gross sales to arrive at net sales, along with our support for our ability to reasonably estimate the deductions, are summarized as follows: Prompt Pay Discounts - These are contractual amounts of 2% of all sales to all of our customers. As a general rule, our customers take advantage of these discounts, and thus the prompt pay discount is assumed at 2% of all sales to all customers, recorded as a gross-to-net sales deduction at the time revenue is recognized. Any prompt pay discounts not taken would be recognized as revenue in the period in which the discount terms lapse, but we do not expect more than a nominal amount of these discounts to be foregone, if any. Wholesaler Discounts - The contracts we have with our wholesaler and distributor customers stipulate fixed discount terms. Thus, the discounts granted to our direct customers are readily determinable at the time of sale, based on those contractual terms. Jim B. Rosenberg December 26, 2013 Page 7 Rebates – There are generally two types of rebates we offer with respect to our sales of Abstral: 1) sales channel rebates (rebates offered to certain group purchasing organizations and specialty pharmacy chains) and 2) managed care rebates (rebates offered to payor organizations). Sales channel rebates are based on agreed upon contractual percentages, applied to all product ultimately purchased and consumed by the member pharmacies of the group purchasing organization (GPO) or specialty pharmacy chain. Thus, while there can be some uncertainty regarding the exact amount of product ultimately sold through to one of the groups members at the time of sale, we generally know which customers do business through which GPO or specialty pharmacy chain, and therefore can estimate the amount of rebates that will ultimately come due based on the customer to which our sales are made. Managed care rebates are based on contractual percentages applied to amount of product prescribed to patients who are covered by the plan or organization with which we contract. These rebates are reasonably estimable using historical amount of rebates processed for each managed care organization as a percentage of all prescriptions filled using the REMS prescription data. Chargebacks – patients who are covered under certain government sponsored managed care programs (Medicare, Medicaid, VA, etc.) receive product prescriptions under a special discounted rebate structure. These organizations deduct the difference between WAC and listed government reimbursement rates to their payment made to our customers, and we are obligated to reimburse our customers for those deductions. Chargebacks are reasonably estimable using historical amount of chargebacks processed for each organization as a percentage of all prescriptions filled using the REMS prescription data. Patient Assistance Program Rebates – We provide a patient assistance program (“PAP”) through a third party service provider, through which patients can obtain their first month of Abstral for free, and can also receive a certain amount of co-pay assistance thereafter. The PAP obligation is a separate and distinct obligation we arrange directly with the end user patient, and does not affect the price charged or cash received from sales to our customers; rather it is recorded as a separate obligation, with a debit to revenue. Also, based on our access to historical prescription information through the REMS program, and the weekly and monthly reporting of the amount of patient assistance program benefit used from our vendor, we can estimate the PAP reserve based on the historical percentage of prescriptions for which patient assistance benefit were used. Furthermore, we can use benchmarks from publicly traded competitors with similar PAP programs to gauge the Jim B. Rosenberg December 26, 2013 Page 8 pattern of PAP usage as a percentage of overall and paid prescriptions. Lastly, the patient assistance program can be terminated at our discretion, at any time, and such termination would not have any direct affect on the sales to our customers, the price we charge our customers, or the ability to collect cash on the sales to our customers. Other deductions – there are no other significant deductions that warrant revenue recognition analysis. Based on the above analysis, we have concluded that our revenue recognition policies are in accordance with ASC 605. Please contact the undersigned if you have any questions or comments regarding this response letter. Very truly yours, /s/ Ryan M. Dunlap Senior Director of Finance, Chief Accounting Officer and Treasurer Cc: Frank Wyman (SEC) Joel Parker (SEC) Mark J. Ahn, (President and CEO, Galena Biopharma, Inc.)
2013-12-13 - UPLOAD - SELLAS Life Sciences Group, Inc.
December 13, 2013 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 limited our review to only your financial statements and related disclosures and do not intend to expand our review to other portions of your document s. In our comment , we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not be lieve 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 the informat ion provided, we may raise additional comments and/or request that you amend your filing s. Form 10 -Q for the Quarterly Period Ended September 30, 2013 Notes to Condensed Consolidated Financial Statements (unaudited) 1. Business and Basis of Presentation Revenue Recognition, page 8 1. In light of you r recent launch of Abstral, please provide us an analysis of each condition in ASC 605 -15-25-1 that supports that you met each condition . Also, provide us an analysis of each of factor in ASC 605 -15-25-3 to demonstrate you had the ability to make a reasonable estimate of future returns. Further, provide Dr. Mark J. Ahn Galena Biopharma, Inc. December 13, 201 3 Page 2 us an analysis supporting that you were able to reasonably estimate provisions for prompt pay discounts, wholesaler discounts, rebates, chargebacks, patient assistance program rebates and other deductions . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment , please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; staff comments or changes to disclosure in response to st aff comments do not foreclose the Commission from taking any action with respect to the filing s; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. 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/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2013-08-13 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm CORRESP August 13, 2013 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-188847) Ladies and Gentlemen: On behalf of Galena Biopharma, Inc. (“Galena”), the undersigned hereby requests that the Securities and Exchange Commission issue an order declaring the above-referenced Registration Statement effective at 5:00 P.M., Washington, D.C. time, on Thursday, August 15, 2013, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, that act will not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosures in the Registration Statement; and • Galena may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Securities and Exchange Commission August 13, 2013 Page 2 Galena also understands that this request for acceleration will be considered a confirmation of its awareness of its obligations under the Securities Act of 1933 and the Securities Exchange Act of 1934 with respect to the offering of securities pursuant to the Registration Statement. Very truly yours, /s/ Mark J. Ahn, Ph.D. Mark J. Ahn President and Chief Executive Officer
2013-06-10 - CORRESP - SELLAS Life Sciences Group, Inc.
CORRESP 1 filename1.htm Correspondence June 10, 2013 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-6010 Re: Galena Biopharma, Inc.; Registration Statement on Form S-3 (Reg. No. 333-188849) Ladies and Gentlemen: On behalf of Galena Biopharma, Inc. (“Galena”), the undersigned hereby requests that the Securities and Exchange Commission issue an order declaring the above-referenced Registration Statement effective at 5:00 P.M., Washington, D.C. time, on Wednesday, June 12, 2013, or as soon thereafter as is practicable. In making its request, Galena acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, that act will not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective does not relieve Galena from its full responsibility for the adequacy and accuracy of the disclosures in the Registration Statement; and • Galena may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Galena also understands that this request for acceleration will be considered a confirmation of its awareness of its obligations under the Securities Act of 1933 and the Securities Exchange Act of 1934 with respect to the offering of securities pursuant to the Registration Statement. Very truly yours, /s/ Mark J. Ahn Mark J. Ahn President and Chief Executive Officer
2013-06-03 - UPLOAD - SELLAS Life Sciences Group, Inc.
June 3 , 2013 Via E -mail Mark J. Ahn, Ph.D. President and Chief Executive Officer Galena Biopharma, Inc. 310 N. State Street, Suite 208 Lake Oswego, OR 97034 Re: Galena Biopharma, Inc. Registration Statement on Form S-3 Filed May 24 , 2013 File No. 333-188849 Dear Dr. Ahn : We have limited our review of your registra tion statement to the issue we have addressed in the comment below. 1. We are currently processing your two pending request s for confidential treatment . Please be advised that we will not be in a position to declare this registration statement effective until we re solve all issues concerning the se confidential treatment request s. We urge all persons who are r esponsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request accelerat ion of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not f oreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and Mark J. Ahn , Ph.D. Galena Biopharma, Inc. June 3 , 2013 Page 2 the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of t he United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleratio n are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Austin Stephenson at (202) 551 -3192 , Daniel Greenspan at (202) 551 - 3623, or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Dale E. Short , Esq. TroyGould PC
2011-01-20 - UPLOAD - SELLAS Life Sciences Group, Inc.
January 20, 2011 Noah D. Beerman President and Chief Executive Officer RXi Pharmaceuticals Corporation 60 Prescott Street Worcester, Massachusetts 01605 Re: RXi Pharmaceuticals Corporation Form 10-K for the Fiscal Year Ended December 31, 2009 Filed March 31, 2010 Schedule 14A filed April 23, 2010 Form 10-Q for the Quarterly Period Ended March 31, 2010 Filed May 17, 2010 File No. 001-33958 Dear Mr. Beerman: We have completed our review of your fili ngs and do not have any further comments at this time. Sincerely, Jeffrey P. Riedler Assistant Director cc: Arthur B. Price (Ropes & Gray LLP)
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ROPES & GRAY LLP
PRUDENTIAL TOWER
800 BOYLSTON STREET
BOSTON, MA 02199-3600
WWW.ROPESGRAY.COM
December 15, 2010
Arthur B. Price
T +1 617 951 7402
F +1 617 235 7341
arthur.price@ropesgray.com
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Re:
RXi Pharmaceuticals Corporation
Form 10-K for the Fiscal Year Ended December 31, 2009 Filed March 31, 2010
Schedule 14A filed April 23, 2010
Form 10-Q for the Quarterly Period Ended March 31, 2010 Filed May 17, 2010
File No. 001-33958
Ladies and Gentlemen:
We are writing on behalf of RXi Pharmaceuticals Corporation (the “Company”), to respond to
the Staff’s comment letter, dated November 10, 2010 (the “Comment Letter”), regarding the
Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 (the “2009
10-K”), the Company’s Definitive Proxy Statement on Schedule 14A filed on April 23, 2010 and
the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2010. To
assist you in your review, we have included the heading and comments from the Comment Letter in
bold below followed by our responses in regular typeface. Please note that the heading and
numbering of the responses set forth below correspond to the heading and numbering of the comments
contained in the Comment Letter.
Form 10-K for the fiscal year ended December 31, 2009
Item 1. Business, page 1
1.
Please file a copy of your in-license agreement with Dr. Michael Czech, as discussed at the
bottom of page 1 under the subheading “Systemic Applications.” Alternatively, please provide
us with an analysis supporting your determination that the agreement is not material to the
company.
ROPES
& GRAY LLP
- 2 -
December 15, 2010
Response: The Company respectfully advises the Staff that its in-license agreement with
Dr. Michael Czech is not material to the Company, because it is unrelated to the technology
platform currently used by the Company.
The Company has identified key areas of therapeutic focus, such as fibrosis (anti-scarring) and
ocular disease, and areas of strategic interest, such as CNS disorders (ALS) and hepatocellular
carcinoma. As disclosed in the Company’s Form 10-Q for the period ending September 30, 2010, the
Company intends to select a development candidate in the area of fibrosis in 2010 and is working
towards identifying a second development candidate in 2011 from active preclinical programs in
fibrosis, ocular, CNS or liver carcinoma. Both development candidates will utilize the Company’s
novel proprietary technology, called self delivering rxRNAs (“sd-rxRNA”). The sd-rxRNA
technology platform is not dependent or even distantly related to intellectual property the
Company in-licenses from Dr. Czech, and thus the Company does not believe that the termination
of such in-license would materially affect the Company or influence its business operations at
this time.
Intellectual Property and Proprietary Rights, page 13
2.
Please provide draft disclosure to be included in your next Form 10-K which indicates the
expiration years of each material patent held by the company, including those relating to your
license with the University of Massachusetts Medical School.
Response: The Company directs the Staff to the section of the 2009 10-K entitled “rxRNA
Platform”, under which the Company discloses the expiration years for any patents that may issue
from the Company’s 12 pending patent applications. Further, the Company informs the Staff that
the Company has licensing rights to 2 patents that are material to the Company: US Patent
6,506,559 and US Patent 5,989,893. As disclosed on page 14 of the 2009 10-K, the expiration
year of US Patent 6,506,559 is 2018. The expiration year of US Patent 5,989,893 is 2018, which
the Company will disclose in its 2010 10-K.
Schedule 14A filed April 23, 2010
Board Leadership Structure and Role in Risk Oversight, page 28
3.
Please provide draft disclosure to be included in your next proxy statement describing the
risk oversight function of the board of directors as required by Item 407(h) of Regulation
S-K.
Response: As requested, below is draft disclosure that describes the risk oversight
function of the board to be substantially included in the Company’s Proxy Statement on Schedule
14A to be filed in 2011.
“Risk Oversight
ROPES
& GRAY LLP
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December 15, 2010
The Board oversees an enterprise-wide approach to risk management, intended to support the
achievement of organizational objectives, including strategic objectives, to improve
long-term organizational performance and enhance stockholder value. The Board is actively
involved in establishing and refining our business strategy, including assessing
management’s appetite for risk and determining the appropriate level of overall risk for us.
We may conduct assessments in the future as circumstances warrant.
While the Board has the ultimate oversight responsibility for the risk management process,
various committees of the Board also have responsibility for risk management. In particular,
the Audit Committee focuses on financial risk, including internal controls, and, from time
to time, discusses and evaluates matters of risk, risk assessment and risk management with
our management team. The Compensation Committee is responsible for overseeing the
management of risk associated with our compensation policies and arrangements. The
Nomination and Corporate Governance Committee ensures that the internal rule processes by
which we are governed are consistent with prevailing best governance practices and
applicable laws and regulations. Finally, the Strategy Committee advises management on
strategic matters and associated risk. Our Code of Ethics, Committee Charters and other
governance documents are regularly reviewed by the appropriate committees to confirm
continued compliance, ensure that the totality of our risk management processes and
procedures is appropriately comprehensive and effective and that those processes and
procedures reflect established best practices.”
Form 10-Q for the Quarterly Period Ended March 31, 2010
4.
Please amend your Form 10-Q for the quarterly period ended March 31, 2010 to file the Stock
Redemption Agreement between the company and CytRx dated March 22, 2010 as an exhibit to the
filing.
Response: The Stock Redemption Agreement between the Company and CytRx dated March 22,
2010, was previously filed as exhibit 10.1 to the Current Report on Form 8-K filed with the
Commission on March 23, 2010.
Closing Comments
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in
the filings reviewed by the staff to be certain that they have provided all information
investors require for an informed decision. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
ROPES
& GRAY LLP
- 4 -
December 15, 2010
In connection with responding to our comments, please provide, in writing, a statement from
the company acknowledging that:
•
the company is responsible for the adequacy and accuracy of the
disclosure in the filing;
•
staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking any action
with respect to the filing; and
•
the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
Response: We have enclosed a separate letter executed by the Company that acknowledges
the statements in the bullet points above.
We hope that the foregoing has been responsive to the Staff’s comments. It would be greatly
appreciated if you could advise me at the number set forth below if the foregoing responses are
acceptable or if any additional comments or questions will be forthcoming. If you should have any
questions about this letter or require any further information, please call me at (617) 951-7402.
Very truly yours,
/s/ Arthur B. Price
Arthur B. Price
Enclosures
cc:
Laura Crotty, SEC
Noah D. Beerman, RXi Pharmaceuticals Corporation
Amy Tata, RXi Pharmaceuticals Corporation
Marc A. Rubenstein, Ropes & Gray LLP
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[RXi Pharmaceuticals Corporation Letterhead]
December 15, 2010
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Re:
RXi Pharmaceuticals Corporation
Form 10-K for the Fiscal Year Ended December 31, 2009 Filed March 31, 2010
Schedule 14A filed April 23, 2010
Form 10-Q for the Quarterly Period Ended March 31, 2010 Filed May 17, 2010
File No. 001-33958
Dear Mr. Riedler:
Please be advised that, in connection with the comments issued by the staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) received by
facsimile on November 10, 2010, with regard to the above referenced filings by RXi Pharmaceuticals
Corporation (the “Company”), the Company hereby acknowledges that (i) the Company is
responsible for the adequacy and accuracy of the disclosure in the filings, (ii) Staff comments or
changes to disclosure in response to Staff comments do not foreclose the Commission from taking any
action with respect to the filings, and (iii) the Company may not assert Staff comments as a
defense in any proceeding initiated by the Commission or any person under the federal securities
laws of the United States.
Please call Arthur Price of Ropes & Gray LLP at (617) 951-7402 if you have any questions.
Very truly yours,
RXI PHARMACEUTICALS CORPORATION
By:
/s/ Noah D. Beerman
Name:
Noah D. Beerman
Title:
President and Chief Executive Officer
2010-11-23 - CORRESP - SELLAS Life Sciences Group, Inc.
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ROPES & GRAY LLP
PRUDENTIAL TOWER
800 BOYLSTON STREET
BOSTON, MA 02199-3600
WWW.ROPESGRAY.COM
November 22, 2010
Arthur B. Price
T +1 617 951 7402
F +1 617 235 7341
arthur.price@ropesgray.com
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Re:
RXi Pharmaceuticals Corporation
Form 10-K for the Fiscal Year Ended December 31, 2009 Filed March 31, 2010
Schedule 14A filed April 23, 2010
Form 10-Q for the Quarterly Period Ended March 31, 2010 Filed May 17, 2010
File No. 001-33958
Ladies and Gentlemen:
On behalf of RXi Pharmaceuticals Corporation (the “Company”), we wish to inform you that we
will respond by December 15, 2010 to the Staff’s letter to the Company dated November 10, 2010.
Very truly yours,
/s/ Arthur B. Price
Arthur B. Price
cc:
Laura Crotty, SEC
Noah D. Beerman, RXi Pharmaceuticals Corporation
Amy Tata, RXi Pharmaceuticals Corporation
Marc A. Rubenstein, Ropes & Gray LLP
2010-11-10 - UPLOAD - SELLAS Life Sciences Group, Inc.
November 10, 2010 Noah D. Beerman Chief Executive Officer RXi Pharmaceuticals Corporation 60 Prescott Street Worcester, Massachusetts 01605 Re: RXi Pharmaceuticals Corporation Form 10-K for the Fiscal Year Ended December 31, 2009 Filed March 31, 2010 Schedule 14A filed April 23, 2010 Form 10-Q for the Quarterly Period Ended March 31, 2010 Filed May 17, 2010 File No. 001-33958 Dear Mr. Beerman: We have reviewed your filings 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 within ten business days by providing the requested information, by amending your filing or by advising us when you will provide the requested response. If you do not believe our comments apply to your fact s and circumstances or do not believe an amendment is appropriate please tell us why in your response. After reviewing the information you provide in response to these comments and any amendment, we may have additional comments. Form 10-K for the fiscal year ended December 31, 2009 Item 1. Business, page 1 1. Please file a copy of your in-license agreement with Dr. Michael Czech, as discussed at the bottom of page 1 under the subheading “S ystemic Applications.” Alternatively, please provide us with an analysis supporting your determination th at the agreement is not material to the company. Intellectual Property and Pr oprietary Rights, page 13 2. Please provide draft disclosure to be included in your next Form 10-K which indicates the expiration years of each material patent held by the company, including those relating to Noah D. Beerman RXi Pharmaceuticals Corporation November 10, 2010 Page 2 your license agreement with the University of Massachusetts Medical School. Schedule 14A filed April 23, 2010 Board Leadership Structure and Ro le in Risk Oversight, page 28 3. Please provide draft disclosure to be included in your next proxy statement describing the risk oversight function of the board of direct ors as required by Item 407(h) of Regulation S-K. Form 10-Q for the Quarterly Period Ended March 31, 2010 4. Please amend your Form 10-Q for the quarterly period ended March 31, 2001 to file the Stock Redemption Agreement between the company and CytRx dated March 22, 2010 as an exhibit to the filing. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclo sure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. Please contact Laura Crotty at (202) 551- 3563 or myself at (2 02) 551-3715 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director
2009-05-20 - CORRESP - SELLAS Life Sciences Group, Inc.
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RXi
Pharmaceuticals Corporation
60 Prescott Street
Worcester, MA 01605
May 20, 2009
VIA EDGAR
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Nandini Acharya
Re:
RXi Pharmaceuticals Corporation
Registration Statement on Form S-3 (File No. 333-158968)
Dear Ms. Acharya:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, RXi Pharmaceuticals
Corporation (the “Company”) hereby requests that the effective date for the registration statement
referred to above be accelerated so that it will be declared effective by 4:00 p.m. Eastern Time on
Friday, May 22, 2008 or as soon as possible thereafter.
The Company hereby acknowledges
(i)
should the Securities and Exchange Commission (the “Commission”) or the staff,
acting pursuant to delegated authority, declare the filing effective, it does not
foreclose the Commission from taking any action with respect to the filing;
(ii)
the action of the Commission or the staff, acting pursuant to delegated
authority, in declaring the filing effective, does not relieve the Company from its
full responsibility for the adequacy and accuracy of the disclosure in the filing; and
(iii)
the Company may not assert staff comments and the declaration of effectiveness
as a defense in an proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
Please call Stephanie Miller or Marc Rubenstein of Ropes & Gray LLP, counsel to the Company,
at (617) 951-7892 or (617) 951-7826, respectively, as soon as the Registration Statement has been
declared effective.
Very truly yours,
RXI PHARMACEUTICALS CORPORATION
By:
/s/ Tod Woolf
Name:
Tod Woolf, Ph.D.
Title:
President and Chief Executive Officer
2009-05-19 - CORRESP - SELLAS Life Sciences Group, Inc.
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ROPES & GRAY LLP
ONE INTERNATIONAL PLACE
BOSTON, MA 02110-2624
WWW.ROPESGRAY.COM
Marc A. Rubenstein
617-951-7826
marc.rubenstein@ropesgray.com
May 19, 2009
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Nandini Acharya
Re:
RXi Pharmaceuticals Corporation
Registration Statement on Form S-3
Filed May 4, 2009
File No. 333-158968
Ladies and Gentlemen:
On behalf of RXi Pharmaceuticals Corporation (the “Company”), we are responding to the comment
received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) in a letter dated May 18, 2009 with respect to the above
referenced filing Registration Statement on Form S-3, File No. 333-158968 (the “Registration
Statement”). We have reproduced the text of the comment below, followed by the response that we
have been authorized to make on behalf of the Company and the other parties to the above referenced
filings. The number corresponds to the number of the comment in the letter of the Staff.
We greatly appreciate the cooperation of the Staff in reviewing our response.
General
1.
We note that you have filed this registration statement in reliance on the
eligibility requirements of General Instruction I.B.6 of Form S-3. General Instruction
I.B.6 of Form S-3 requires in part that the aggregate market value of securities sold by
or on behalf of the registrant pursuant to Instruction I.B.6 during the period of 12
calendar months immediately prior to, and including, the sale is no more than one-third of
the aggregate market value of the voting and non-voting common equity held by
non-affiliates of the registrant. We further note your disclosure that, prior to the
filing of
Securities and Exchange Commission
-2-
May 19, 2009
this registration statement, you explored the possibility of conducting a private
placement of common stock with certain prospective investors but then terminated all
offering activity related to the proposed private placement on April 29, 2009.
Accordingly, we must consider whether the shares offered pursuant to the abandoned
private placement must be integrated with the shares offered pursuant to this
registration statement when determining whether the size of the offering meets the
eligibility requirements of General Instruction I.B.6 of Form S-3. Rule 155 of the
Securities Act of 1933 provides a non-exclusive safe harbor with respect to integration
of abandoned offerings. Rule 155 states in relevant part that a private offering of
securities will not be considered part of an offering for which the issuer later files
a registration statement if, among other things, the issuer does not file the
registration statement until at least 30 calendar days after the termination of all
offering activity in the private offering, unless securities offered in the private
offering were only offered to accredited investors (as that term is defined in Rule
501(a)) or persons who satisfy the knowledge and experience standard of Rule 506(b)(2).
We note that you have filed this registration statement less than 30 calendar days
after the abandonment of your proposed private placement. Accordingly, please reduce
the size of the offering, withdraw the registration statement or provide us with an
analysis supporting your determination that the private placement should not be
integrated with this registration statement for the purposes of determining that the
number of shares offered meets the eligibility requirements of General Instruction
I.B.6 of Form S-3.
RESPONSE: The Company understands and acknowledges that Rule 155 of the Securities Act of
1933 provides a non-exclusive safe harbor with respect to integration of abandoned
offerings. The Company believes that its proposed private placement, which was terminated
on April 29, 2009 (the “Proposed Private Placement”), should not be considered part of, and
not integrated with, the public offering of securities to be made pursuant to the
Registration Statement (the “Proposed Public Offering”) as the Company has met the
requirements of Rule 155(b) in the manner described below. As background, the Company
engaged Rodman & Renshaw, LLC (“Rodman & Renshaw”) on March 17, 2009 to act as placement
agent in connection with the Proposed Private Placement. Based on advice from Rodman &
Renshaw, the Company determined to terminate the Proposed Private Placement and commence the
Proposed Public Offering and subsequently filed the Registration Statement. In connection
with the termination of the Proposed Private Placement, the Company advises the Commission
as follows:
1)
No securities were sold in the Proposed Private Placement.
2)
All activity related to the Proposed Private Placement by the Company
and, at the Company’s instruction, Rodman & Renshaw, was terminated on April 29,
2009.
3)
Page 7 of the Registration Statement includes a paragraph setting forth
all of the information required by Rule 155(b)(3).
4)
The Company believes, based in part on information provided by Rodman &
Renshaw, that all of the persons who were offered securities in the Proposed
Securities and Exchange Commission
-3-
May 19, 2009
Private Placement were either accredited investors (as that term is defined in
Rule 501(a)) or persons who satisfy the knowledge and experience standard of Rule
506(b)(2).
Consequently, the Company has determined that the Proposed Private Placement should not
be integrated with the Proposed Public Offering. Further, the Company is aware of the
restrictions of General Instruction I.B.6 of Form S-3 limiting the aggregate market
value of securities sold by or on behalf of the Company during the period of 12 calendar
months immediately prior to, and including, the sale to no more than one-third of the
aggregate market value of the voting and non-voting common equity held by non-affiliates
of the Company, and the Company does not intend to sell any securities pursuant to the
Registration Statement beyond the number that would be permitted under General
Instruction I.B.6 of Form S-3 for so long as the restriction applies to the Company.
* * * * *
If you have any questions or if there is anything we can do to facilitate the Staff’s review,
please feel free to contact me at (617) 951-7826 or Stephanie Miller of this firm at (617)
951-7892.
Best regards,
/s/ Marc A. Rubenstein
Marc A. Rubenstein
Enclosures
cc:
Stephen J. DiPalma
2009-05-18 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 4720 May 18, 2009 Tod Woolf Chief Executive Officer RXi Pharmaceuticals Corporation 60 Prescott Street Worcester, MA 01605 Re: RXi Pharmaceuticals Corporation Registration Statement on Form S-3 Filed May 4, 2009 File No. 333-158968 Dear Mr. Woolf: We have limited our review of your filing to those issues we have addressed in the comments below. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revisi on is unnecessary. Please be as detailed as necessary in your explanation. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. General 1. We note that you have filed this registrati on statement in reliance on the eligibility requirements of General Instruction I.B.6 of Form S-3. General Instruction I.B.6 of Form S-3 requires in part that the aggregate market value of securities sold by or on behalf of the registrant pursuant to Instruction I.B.6 dur ing the period of 12 calendar months immediately prior to, and including, the sale is no more than one-third of the aggregate market va lue of the voting and non-voting common equity held by non-affiliates of the registrant. We further note your disclosure that, prior to the filing of this registra tion statement, you explored the possibility of conducting a private placement of co mmon stock with certain prospective investors but then terminated all offeri ng activity related to the proposed private placement on April 29, 2009. Accordingly, we must consider whether the shares Tod Woolf RXi Pharmaceuticals Corporation May 18, 2009 Page 2 offered pursuant to the abandoned private placement must be integrated with the shares offered pursuant to this registra tion statement when determining whether the size of the offering meets the eligibil ity requirements of General Instruction I.B.6 of Form S-3. Rule 155 of th e Securities Act of 1933 provides a non- exclusive safe harbor with respect to integration of abandoned offerings. Rule 155 states in relevant part that a priv ate offering of securities will not be considered part of an offering for whic h the issuer later files a registration statement if, among other things, the issuer does not file the re gistration statement until at least 30 calendar days after the te rmination of all offering activity in the private offering, unless securi ties offered in the private offering were only offered to accredited investors (as that term is defined in Rule 501(a)) or persons who satisfy the knowledge and e xperience standard of Rule 506(b)(2). We note that you have filed this regist ration statement less than 30 calendar days after the abandonment of your proposed private placem ent. Accordingly, please reduce the size of the offering, withdraw the registra tion statement or provide us with an analysis supporting your determination th at the private placement should not be integrated with this registration statem ent for purposes of determining that the number of shares offered meets the eligib ility requirements of General Instruction I.B.6 of Form S-3. * * * As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Act of 1933 and that they have provided all information investors require for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the even t the company requests acceleration of the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose th e Commission from taking any action with respect to the filing; Tod Woolf RXi Pharmaceuticals Corporation May 18, 2009 Page 3 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments a nd the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. In addition, please be advi sed that the Division of En forcement has access to all information you provide to the staff of the Di vision of Corporation Finance in connection with our review of your filing or in response to our comments on your filing. We will consider a written request for acceleration of the effective date of the registration statement as conf irmation of the fact that t hose requesting acceleration are aware of their respective re sponsibilities under the S ecurities Act of 1933 and the Securities Exchange Act of 1934 as they rela te to the proposed public offering of the securities specified in the above registration statement. We will act on the request and, pursuant to delegated authority, grant acce leration of the effective date. We direct your attention to Rules 46 0 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. Please contact Nandini Acharya at (202) 551-3495 or me at (202) 551-3715 with any questions. S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Marc A. Rubenstein, Esq. Ropes & Gray LLP One International Place Boston, MA 02110
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RXi Pharmaceuticals Corporation
60 Prescott Street
Worcester, MA 01605
VIA EDGAR
February 13, 2008
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jeffrey Riedler and Jennifer Riegel
Re:
RXi Pharmaceuticals Corporation
Registration Statement on Form S-1 (File No. 333-147009)
Dear Mr. Riedler and Ms. Riegel:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, RXi Pharmaceuticals
Corporation (the “Company”) hereby requests that the effective date for the Registration Statement
referred to above be accelerated so that it will be declared effective by 2:00 p.m. Eastern Time on
Thursday, February 14, 2008 or as soon as possible thereafter.
The Company hereby acknowledges
(i)
its responsibilities under the Securities Act of 1933, as amended, and the
Securities Exchange Act of 1934, as amended, as they relate to the proposed public
offering of the securities specified in the above-referenced Registration Statement;
(ii)
should the Securities and Exchange Commission (the “Commission”) or the staff,
acting pursuant to delegated authority, declare the Registration Statement effective,
it does not foreclose the Commission from taking any action with respect to the filing;
(iii)
the action of the Commission or the staff, acting pursuant to delegated
authority, in declaring the filing effective, does not relieve the Company from its
full responsibility for the adequacy and accuracy of the disclosure in the filing; and
(iv)
the Company may not assert staff comments and the declaration of effectiveness
as a defense in a proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
Please call Marc Rubenstein or Sara Pritchard of Ropes & Gray LLP, counsel to the Company, at
(617) 951-7826 or (617) 951-7986, respectively, as soon as the Registration Statement has been
declared effective.
Very truly yours,
RXI PHARMACEUTICALS CORPORATION
By:
/s/ TOD WOOLF
Name: Tod Woolf, Ph.D.
Title: President and Chief Executive Officer
2008-02-12 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 6010 February 12, 2008 Tod Woolf, Ph.D. Chief Executive Officer RXi Pharmaceuticals Corporation One Innovation Drive Worcester, Massachusetts 01605
Re: RXi Pharmaceuticals Corporation
Registration Statement on Form S-1/A
Filed February 1, 2008
File No. 333-147009
Dear Dr. Woolf:
We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure. After reviewing th is information, we may raise additional
comments. Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
General
1. In your next amendment, please revise your registration fee table to reflect the fee
calculated in connection with the registra tion of the offer and sale of the common
stock being distributed in the spin-off and the common stock being offered for
resale in the Award and Resale prosp ectuses. The fee regarding the shares
distributed in the spin-off should be calculated using book value in accordance with Rule 457(f)(2) and th e fee regarding the remaining shares being offered
Tod Woolf, Ph.D.
RXi Pharmaceuticals Corporation February 12, 2008 Page 2
should be calculated in accordance w ith Rule 457(a) derived from bona fide
offering price range which will be reflected on the cover page of the Resale Prospectus. Please revise accordingly.
Resale Prospectus
2. We note that you have included a price range of $10 to $20 per share until your
shares are quoted on the NASDAQ Capital Ma rket. Please note that your price
range must be bone fide. We interpret this to mean that your range may not exceed
$2 if you price below $20 and 10% if you price above $20. Please revise
accordingly.
* * *
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date.
You may contact Sasha Parikh at (202) 551-3627 or Mark Brunhofer at (202)
551-3638 if you have questions regarding comm ents on the financial statements and
related matters. Please c ontact Jennifer Riegel at (202) 551-3575, Michael Reedich,
Special Counsel, at (202) 551-3612 or me at (202) 551-3715 with any other questions.
S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Marc Rubenstein, Esq.
Ropes & Gray LLP One International Place Boston, MA 02110-2624
2008-01-25 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 6010 January 25, 2008 Tod Woolf, Ph.D. Chief Executive Officer RXi Pharmaceuticals Corporation One Innovation Drive Worcester, Massachusetts 01605 Re: RXi Pharmaceuticals Corporation Registration Statement on Form S-1/A Filed January 10, 2008 File No. 333-147009 Dear Dr. Woolf: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. After reviewing th is information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. General 1. Unless otherwise stated, all comments are applicable to the distribution prospectus, award prospectus and resale prospectus. 2. We are reissuing part of prior comment 6. Throughout the registration statement, you should clearly articulate the basis of the various beliefs and assertions you make. In each of the below statements and each similar case throughout the filing, you should disclose the basis for your belief. If any of your assertions or Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 2 beliefs are not supported by ample evidence or knowledge, you should delete them. Alternatively, in each case and as applicable, clarify that these are goals or beliefs articulating what you hope to achieve. a. Page 2: “There are many well-studied genes associated with numerous diseases that have been identified bu t have been difficult to target with normal medicinal chemistry and which we believe RNAi technology may be able to target and, therefore, potentially treat such diseases.” b. Page 35: “We believe we will be able to discover and develop lead compounds and move them into and through development for potential commercialization more efficiently than traditional drug development approaches.” c. Page 52: “We believe that the RNAi platform will create a successful new class of potent and specific therapeuti cs with significant advantages over traditional drug development methods. These advantages include: high specificity for targeted genes; hi gh potency (low doses); potential interference with the ex pression of any gene; and accelerated development of lead compounds.” In addition, we note you also make similar statements, without support, on page 53, to the extent you cannot support these statements, please delete them. d. Page 53: “rxRNA is an alternativ e to classic siRNA used by other companies developing RNAi therapeu tics and is: up to 100x more active than conventional siRNA (depending on th e target site), nu clease resistant, readily manufactured, comprised of el ements from RXi’s IP portfolio, and potentially more specific for the target gene.” e. Page 54: “We believe that nanotrans porter delivery has the following potential advantages: inhibition of li ver target with 1 mg RNAi compound per kg of body weight; no immune stimulation detected; defined particle size; and readily formulated.” f. Page 55: “We believe RNAi compounds have the potential to target any gene.” g. Page 56: “RNAi reagents targeting mu ltiple genes could be developed to treat cancers originated from malfunctioning of multiple intracellular pathways.” h. Page 56: “RNAi may be used to inhibit cell division in non-cancerous tissues which are damaged by chemothera py in order to pr otect these cells from chemotherapy. RNAi screening methods may potentially also be Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 3 used to rapidly prioritize molecular targets within large gene families by conducting in vitro experiments to id entify which gene family members are the most appropriate targets to pursue.” Prospectus Summary, page 1 3. We note our prior comment 12 and reissue it in part. In the Prospectus Summary, please clarify how much of their profe ssional time your advisory board members will devote to the company, as opposed to other professional endeavors, and explain, if true, that they are not employees of the company, have other professional commitments that require significantly more of their professional time and attention than any obligations th ey have to the company, and that they have no obligations or duties to perform a ny advisory services for the company or remain as advisors to the company. Provide similar disclosure in the Business section. Risk Factors, page 10 “We will be subject to competition and may not be able to compete successfully.” Page 13 4. Please expand your discussion to discuss the additional risk that occurs when a competitor’s drug, which has been granted orphan drug status, is approved by the FDA. “We use biological and hazardous materials…” page 21 5. We are reissuing prior comment 29. Please disclose your level of workers’ compensation insurance coverage and brie fly describe what potential liabilities are and are not covered. Executive Compensation, page 74 2007 Executive Compensation Components, page 75 Performance-Based Compensation, page 76 6. Please disclose any performance goals set by the compensation committee or board for 2007, including, but not limited to, the performance goals in connection with Mr. DiPalma’s and Dr. Samarsky’s awards. 7. Please also revise to state any target performance based compensation amounts for the other executive officers which were set in 2007. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 4 Summary Compensation Table, page 78 8. Please revise the table to provide a foot note which discloses all assumptions made in the valuation of the option awards. S ee Instruction 1 to It em 402(c)(v) and (vi) of Regulation S-K. 9. Please revise footnote 1 to provide disclo sure regarding any formula or criteria that will be used and any other pertin ent information in determining the bonus amount. See Telephone Interpretation J.8B. Director Compensation, page 87 10. Please revise the table to provide a foot note which discloses the aggregate number of option awards outstanding at fiscal y ear end. See the Instruction to Item 402(k)(2)(iii) and (iv) of Regulation S-K. Certain Relationships and Re lated Transactions, page 92 Relationships with Employees, page 92 11. Please file a copy of your license agreement with Invitrogen. Material United States Federal In come Tax Considerations, page 100 12. Please revise to clearly state that the disc losure in this section is the opinion of Troy & Gould, rather than stating that it has delivered an opinion “to the following effects.” Legal Matters, page 103 13. Please disclose in the distribution prosp ectus the required information regarding the interests of Mr. Hillsberg and Troy & Gould pursuant to Item 509 of Regulation S-K, as we not e that Troy & Gould is providing a tax opinion regarding this transaction. RXI Pharmaceuticals Corporation and Predecessor Carve-Out Financial Statements RXI Pharmaceuticals Corporation and Predecessor Carve-Out Statements of Expenses and Statements of Cash Flows, pages F-4 and F-6, respectively. 14. With regards to the cumulative data presented for the period from April 3, 2006 (date of incorporation) to September 30, 2007, please in clude all financial data related to the period from January 1, 2003 through September 30, 2007 which Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 5 would include predecessor financial inform ation. In that regard, please remove the parenthetical reference to Successor unde r that column. Please revise this presentation throughout the filing. Notes to Financial Statements 5. Development Stage Supplemental Equity Disclosure, page F-15 15. We acknowledge your response to our commen t 60. Please revise your disclosure added on pages 28, 35 and 46 to clarify that you include the 462,112 shares of common stock in determining your $5.00 share value because you committed to issue these shares prior to the date of your third-party valuation consistent with your response. 16. In addition, with regards to your common stock issuance of 188,387 on September 28, 2007, please revise throughout the filing, specifically pages 28 and 35, the actual price of $5.19 per share as indicated in this footnote. 17. We acknowledge your response to our commen t 61. Please revise your disclosure added in footnote (B) to your table to clar ify that the pro rata share of offering costs allocated to RXi rela tes to the private offering conducted by CytRx to fund your capital contribution consis tent with your response. 18. In addition, as previously requested in our comment 61, please revise your liquidity discussion in MD&A to provide an indication of the co sts you expect to incur in this offering as indicated on pa ge B-22. We did not note any revision to your disclosure with regards to this comment. 9. Commitments and Con tingencies, page F-16 19. Refer to your response to our comment 62 and we reissue our comment. It appears from footnote 3 that the paym ents included in the table represent minimum annual royalty payment obligat ions. Please revise your footnote disclosure to quantify the milestone pa yment amounts that maybe required under your agreements which you state that you have omitted from the table. In addition, please discuss, similar to the discussion provided in your response, how these potential milestone payments were determined. Resale Prospectus 20. We note your response to prior comment 66. It appears that CytRx’s proposed offering of shares in what you have termed the “Resale Prospectus” would be a primary offering and that CytRx would be an underwriter. Since RXi is not eligible to conduct a primary offering on Form S-3 or “at-the-market” under Rule Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 6 415(a)(4), you should remove CytRx as a selling sharehol der in this offering. If you would like to register the offer and sa le of these shares of RXi common stock, you should register that transaction at a fixed price and name CytRx as an underwriter. 21. As to UMMS’s resale of its RXi shares, in the “Resale Prospectus” please provide the pricing information required by Item 501(b)(3) of Regulation S-K. Absent a market price, disclosing that the shares would be sold at market does not satisfy this Item requirement. Please revise the cover page of the “R esale Prospectus” to state, “The selling shareholder will sell at a price of $x.xx (or a range) per share until our shares are quoted on the NASDAQ Capital Market and thereafter at prevailing market prices or privately negotiated prices.” Selling Stockholders, page B-85 22. It appears that UMMS is offering 462,112 shares under th is “Resale Prospectus;” please revise your table accordingly. Part II Item 17. Undertakings 23. Please review Item 512 of Regulation S-K and provide all undertakings required by that Item. For example, we note that the offering described in the “Resale Prospectus” is an offering under Ru le 415 and you have not provided the undertaking required by Item 512(a). * * * As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments. We direct your attention to Rules 46 0 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation January 25, 2008 Page 7 You may contact Sasha Parikh at (202) 551-3627 or Mark Brunhofer at (202) 551-3638 if you have questions regarding comm ents on the financial statements and related matters. Please c ontact Jennifer Riegel at (202) 551-3575, Michael Reedich, Special Counsel, at (202) 551-3612 or me at (202) 551-3715 with any other questions. S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Marc Rubenstein, Esq. Ropes & Gray LLP One International Place Boston, MA 02110-2624
2007-11-26 - UPLOAD - SELLAS Life Sciences Group, Inc.
Mail Stop 6010 November 26, 2007 Tod Woolf, Ph.D. Chief Executive Officer RXi Pharmaceuticals Corporation One Innovation Drive Worcester, Massachusetts 01605 Re: RXi Pharmaceuticals Corporation Registration Statement on Form S-1 Filed October 30, 2007 File No. 333-147009 Dear Dr. Woolf: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. After reviewing th is information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. FORM S-1 General 1. We note that you are submitting a number of docum ents in a conf idential treatment request. Please note that you will be r eceiving comments to the confidential treatment request under separate cover and that all conf idential treatment issues must be resolved before we will consider a request for acceleration of the registration statement. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 2 2. Please file as promptly as possible al l exhibits required by the Exhibit Table provided in Item 601(a) of Re gulation S-K. We note, fo r example, that you have not filed the opinion or cons ent of your legal counsel. 3. Please note that where we provide exampl es to illustrate what we m ean by our comments, they are examples and not exhaustive lists. If our comments are applicable to portions of th e filing that we have not cited as examples, make the appropriate changes in acco rdance with our comments. 4. Unless otherwise stated, all comments are ap p licable to the dist ribution prospectus, award prospectus and resale prospectus. 5. Throughout the registration statement, you c ite various estim ates, statistics and other figures. For example: a. The statement that “The potential market for RNAi therapeutics is substantial” which is found on page 50 b. Information included under the “N eurology – Market Opportunity” subheading on page 52; c. The first sentence included under th e “Metabolic Disease – Market Opportunity” subheading on page 53; and d. Information included under the “Oncology – Market Opportunity” subheading on page 53. In the prospectus, please attribute these st atem ents and other similar statements to the source from which you obtained the in formation. In addition, where you cite your own estimates, please explain ho w you arrived at those estimates and disclose any third-part y sources you relied upon. 6. Throughout the registration statement, you s hould clearly articulate the basis of the various beliefs and assertions you m ake. As a non-exclusive example, on page 1, you state, “It is believed that this inhibition may potentia lly treat diseases by ‘turning off’ genes that lead to di sease.” In this and each similar case throughout the filing, you should disclose who has expressed the belief and the basis for the belief. If any of your assertions of beliefs are not supported by ample evidence or knowledge, you should dele te them. Also, given that you are a discovery-stage company and none of your therapeutics are in the pre-clinical or clinical stages, you should not make any assertions rega rding the effectiveness of any of your therapeutics. 7. Please update your financial information th roughout the filing in accordance with Rule 3-12 of Regulation S-X. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 3 Prospectus Cover Pages 8. The cover pages of the respective prosp ectuses should contain the information required by Item 501(b) of Regulation S-K and not include the other information you provide. While we recognize that the information regarding taxation and the particulars of the distribution are important to investors, you should articulate that information more prominently at the beginning of the Summary, rather than on the cover page. Prospectus Summary, page 1 9. We note that you state here on page A-1 that all share data in these prospectuses assum es no effect to any possible resale of your shares by CytRx pursuant to the resale prospectus. We further note that on page B-80 of the resale prospectus, you state that CytRx intends to sell all of it s remaining 49% ownership interest in the company. Please revise the disclosure throughout the distribution prospectus and award prospectus to reflect that CytRx plans to sell all of its shares. You should also disclose what specific arrangements, if any, that CytRx has initiated to facilitate the sale of its remaining shares. RXi Pharmaceuticals Corporation, page 1 10. Since you are still a discove ry-stage com pany, please remove all references to commercialization from your business de scription here, pages 5 and 48 and elsewhere as appropriate. 11. We note that the information provided in “Our Business” and “Our Competitive Strengths” is identical to the information provided on pages 48-29 and the information provided in “Business Strate gy” is identical to the information provided on pages 54-55. Please revise this discussion to high light the key points of these topics rather than re peating the same disclosure. 12. Throughout the Summary and rest of the pr ospectus you m ention the contributions of your scientific advisory board members. Please clarify briefly in the Summary and in more detail in the rest of the pr ospectus exactly what role each of these advisors will have in the development of your therapeutics. Also, clarify how much time they will devote to the co mpany, as opposed to other professional endeavors. 13. You state throughout the filing that some of your advisory board members are “lead ing” researchers. In each case, please explain the basis for these assertions or delete them. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 4 The Distribution, page 5 14. Please provide more information on why you believe the partial distribution of the com pany’s common stock will establish your company as one of the leading companies dedicated to developing RXi ther apeutics as stated here and on page 27. 15. Please revise the section entitled “Relationship w ith CytRx after the Distribution,” pages 23 and 30 and elsewhere as appr opriate to state that following the distribution, CytRx intends to sell all of its remaining 49% ownership interest in the company under the Resale Pros pectus as stated on page B-80. 16. In the Summary, and in more detail later in the prospectus, explain why CytRx is not distributing all of the RXi shares it owns, and why it has decided to offer for resale the 49 % stake it will own i mmediately after the distribution. Risk Factors, page 11 “We may be unable to achieve some or all of the benefits that we expect to achieve…” page 11 17. It appears from the last sentence of this risk factor that the com pany faces additional risks other than “not achieving some or all of the benefits” that it expects to achieve. For example, please expand the risk factor or add separate risk factors to discuss why the company may not be able to raise funds as a separate company that might have been available to a combined company. Also, we note from your disclosure on page 44 that the company has and will continue to have significant increased expenses as a separate company. Please describe and quantify these increased expenses. In addition, please revi se the heading of this risk factor to accurately describe this risk, highlighting that, as a separate company, it not be able to receive the same amount of benefits it currently has as a combined company. “You may have difficulty evaluating our business…” page 11 18. Please separate into a separate risk factor the last paragraph of this section which discusses th e risk that the company may not be able to effectively operate as a separate company. Please use the last sent ence of the current risk factor heading as the heading of this new risk factor. “We may not be able to obtain financing…” page 12 19. Please separate into a separately headed risk factor the last paragraph of this section which discusses the risks asso ciated with the company’s issuance of debt Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 5 or equity in the future. Please expa nd your discussion to thoroughly discuss the risks associated with these possible issuances. “We expect to continue to incur significant research and development expenses…” page 12 20. Please delete the statement, “If the actual funds required exceed our estimates” as this appears to be inconsistent with your statem ent in the prior sentence that you are unable to estimate the actual funds re quired to develop and commercialize the products. 21. Please delete the reference to “lower than anticipated revenues” as it appears from your disclosure on page 10 that you do not currently have any anticipated revenues. “We will no longer be able to rely on CytRx…” page 13 22. We note your reference to “commercializing” your products in the last paragraph of this risk f actor. Since you are still in the developing stage, please revise this to be “developing” your products. 23. You state that following the distribution, you will be m ore susceptible to specific risks relating to RNAi technologies. Pleas e add separate risk factors to explain these specific risks to the extent there are any additional risks that you have not disclosed in the other risk factors. “We will rely upon third parties for the manufacture of our clinical product candidates.” page 14 24. Please name the specialty organic chem istry synthesis com pany with which you intend to manufacture nanotransporters. 25. In addition, please describe how th e com pany intends to use these nanotransporters once they are manufactured. For example, does the company intend to use these to identify lead compounds? 26. To the extent the company is aware of any litig ation, threat ened litigation or challenge to the company’s intellectual pr operty, please revise to describe here and in the first complete risk factor on page 19. “Any drug candidates we develop may fail in development…” page 14 27. Please separate into a separately headed ri sk factor the fact th at the company has not yet any nominated lead compounds fo r therapeutic development nor has the Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 6 company begun any pre-clinical trials . Please expand your discussion to thoroughly discuss the risks associated with the fact that no lead compounds have been identified. “We are dependent on technologi es we license…” page 19 28. Please file a copy of your license ag reem ent with Caregie Institution of Washington as discussed here and on page 37. “We use biological and hazardous materials…” page 21 29. Please disclose your level of workers’ com pensation insurance coverage and briefly describe what potential liabilities are and are not covered. Please also disclose the cost to you of such coverage, if material. “The market price of our common stock…” page 22 30. If any of the factors you have listed in the bullets in this risk factor represent m aterial risks to investors in your common stock, you should discuss them in more detail in separate prope rly captioned risk factors. The Founding and Initial Fundiong of RXi, page 28 31. Please clarify here who will own the remaining 14% of the company. Results of the Distribution, page 29 32. Please clarify whether the approximate num ber of holders that you will dis close represents record or beneficial ownership. Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 35 Strategic Licenses and Alliances, page 36 33. Please revise to discuss the company’s planned product research and developm ent over the next 12 months, including, but not limited to, any development within the scope of the described strategic relationships. 34. It appears that your license agreem ent with TriLink is a material agreement pursuant to Item 601(b)(10) of Regulati on S-K. Please file a copy of this agreement with your next amendment. A lternatively, if you do not believe this is a material agreement, please provide an analysis of why you believe this is not a material agreement. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 7 Basis of Presentation, page 37 35. It appears that your sponso red research agreem ent with Massachusetts General Hospital is a material agreement pursuant to Item 601(b)(10) of Regulation S-K. Please file a copy of this agreement with your next amendment. Alternatively, if you do not believe this is a material agreem ent, please provide an analysis of why you believe this is not a material agreement. Liquidity and Capital Resources, page 45 36. We note that you state that you have ad equate working capital to support your currently planned level of operations through the first quarter of 2009. Please expand your discussion to disclose your sources of working capital and your m aterial commitments. Quantitative and Qualitative Disclosu res About Market Risk, page 47 37. To the extent material, please include the inform ation required by Item 305(a) of Regulation S-K. Note that this item lists three possible disclosure alternatives from which you may present this informa tion. Alternatively, if you believe the risk is not material, please revise to so indicate. Business, page 48 License Agreements, page 59 38. Please revise the first sentence of this paragraph to indicate that the UM MS license agreements which were assign ed by CytRx included four exclusive licenses, one co-exclusive license and one non-exclusiv e license. In addition, please revise the name of Exhibit 10. 13 in your exhibit index accordingly. 39. Please revise your discussion of your agreement with Cold Spring Harbor Laboratory to discuss the m aterial terms of this agreement, including, but not limited to any payment provisions, the ex istence of royalty provisions, aggregate milestones, usage restrictions, exclusivity provisions, obligations/rights to defend, other rights obtained and material obliga tions that must be met to keep the agreement in place, duration and termination provisions. Government Regulation, page 62 40. Please define cGMP the first tim e you use the acronym. Tod Woolf, Ph.D. RXi Pharmaceuticals Corporation November 26, 2007 Page 8 Executive Compensation, page 72 41. We note your disclosure that the compa ny did not pay any compensation or grant any equity awards to any em ployee pr ior to 2007, however, pursuant to Item 402(a)(2) of Regulation S-K, the Item re quires “disclosure of all plan and non- plan compensation awarded to, earned by, or paid to the named executive officers designated under paragra ph (a)(3) of this Item, and directors covered by paragraph (k) of this Item, by any person for all services rendered in all capacities to the registrant and its subsidiaries, unless otherwise specifically excluded from disclosure in this Item.” (emphasis added). Please provide the required information for any of the persons covered in Item 402(a)(3) in the last fiscal year. Alternately, if the direct or indirect expenses for such persons render