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SEC Comment Letters
Company Responses
Letter Text
SOLIGENIX, INC.
Response Received
2 company response(s)
Medium - date proximity
↓
↓
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-29
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2024-07-30
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2024-01-19
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2024-04-02
SOLIGENIX, INC.
Summary
Generating summary...
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Company responded
2024-04-02
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2024-04-03
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2024-04-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2024-04-15
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-09-12
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2023-12-06
SOLIGENIX, INC.
Summary
Generating summary...
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Company responded
2023-12-14
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2023-04-07
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2023-04-19
SOLIGENIX, INC.
References: April 7, 2023
Summary
Generating summary...
↓
Company responded
2023-05-04
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2023-11-30
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-01-22
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2021-01-27
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-07-24
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2020-07-31
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2020-08-26
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-11-28
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2017-11-28
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-05-16
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2017-08-09
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2016-10-17
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-11-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-11-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-11-16
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-11-22
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-11-22
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-04-26
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-04-26
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2016-04-13
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2016-04-13
SOLIGENIX, INC.
References: April 13, 2016
Summary
Generating summary...
↓
Company responded
2016-04-14
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-08-20
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2015-08-21
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2014-11-14
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2014-11-17
SOLIGENIX, INC.
References: November 14, 2014
Summary
Generating summary...
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Company responded
2014-12-17
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2014-12-17
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2014-12-17
SOLIGENIX, INC.
References: November 14, 2014
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2014-10-14
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2014-11-04
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2012-11-20
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2013-02-28
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2013-06-12
SOLIGENIX, INC.
References: November 19, 2012
Summary
Generating summary...
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Company responded
2013-06-19
SOLIGENIX, INC.
References: June 19, 2013
Summary
Generating summary...
↓
Company responded
2013-06-20
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-06-19
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-02-13
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2006-08-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2006-08-18
SOLIGENIX, INC.
References: August 15, 2006
Summary
Generating summary...
↓
Company responded
2006-09-08
SOLIGENIX, INC.
References: August 15, 2006
Summary
Generating summary...
↓
Company responded
2010-08-25
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2010-09-02
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2011-12-07
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2011-12-23
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2012-02-07
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-01-20
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-12-05
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-09-07
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-08-30
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-08-24
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2010-07-02
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2010-07-09
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2010-07-12
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2009-02-25
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2009-04-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2009-04-15
SOLIGENIX, INC.
References: February 25, 2009
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2008-02-15
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2008-03-31
SOLIGENIX, INC.
References: February 15, 2008
Summary
Generating summary...
↓
Company responded
2008-04-02
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2007-03-13
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2007-04-17
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-02-05
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2006-12-07
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2006-12-11
SOLIGENIX, INC.
References: December 7, 2006
Summary
Generating summary...
↓
Company responded
2006-12-18
SOLIGENIX, INC.
References: December 5, 2006
Summary
Generating summary...
↓
Company responded
2007-01-25
SOLIGENIX, INC.
References: December 5, 2006
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-12-05
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-09-19
SOLIGENIX, INC.
Summary
Generating summary...
SOLIGENIX, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2005-03-28
SOLIGENIX, INC.
Summary
Generating summary...
↓
Company responded
2005-03-31
SOLIGENIX, INC.
References: March 28, 2005
Summary
Generating summary...
↓
Company responded
2005-04-05
SOLIGENIX, INC.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2025-09-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2025-09-02 | SEC Comment Letter | SOLIGENIX, INC. | DE | 377-08384 | Read Filing View |
| 2024-07-30 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-07-29 | SEC Comment Letter | SOLIGENIX, INC. | DE | 333-280993 | Read Filing View |
| 2024-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-03 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-01-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | 333-276511 | Read Filing View |
| 2023-12-14 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-12-06 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-11-30 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-09-12 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-05-04 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-04-19 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-04-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2021-01-27 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2021-01-22 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-08-26 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-07-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-07-24 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-11-28 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-11-28 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-08-09 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-05-16 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-22 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-22 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-16 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-10-17 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-26 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-26 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-14 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2015-08-21 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2015-08-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-14 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-04 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-10-14 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-20 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-19 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-12 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-02-28 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-02-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-02-07 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-01-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-07 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-09-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-09-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-30 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-25 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-24 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-12 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-09 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-02 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-03-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-02-15 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-04-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-03-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-02-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-01-25 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-18 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-11 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-09-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-09-08 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-08-18 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-08-15 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-04-05 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-03-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-03-28 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-02 | SEC Comment Letter | SOLIGENIX, INC. | DE | 377-08384 | Read Filing View |
| 2024-07-29 | SEC Comment Letter | SOLIGENIX, INC. | DE | 333-280993 | Read Filing View |
| 2024-01-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | 333-276511 | Read Filing View |
| 2023-09-12 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-04-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2021-01-22 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-07-24 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-11-28 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-05-16 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-10-17 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-26 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2015-08-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-14 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-10-14 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-11-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-02-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-01-20 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-09-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-30 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-24 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-02 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-02-15 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-03-13 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-02-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-07 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-05 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-09-19 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-08-15 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-03-28 | SEC Comment Letter | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2025-09-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-03 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2024-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-12-14 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-12-06 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-11-30 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-05-04 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2023-04-19 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2021-01-27 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-08-26 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2020-07-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-11-28 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2017-08-09 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-22 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-22 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-16 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-11-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-26 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-14 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2015-08-21 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-12-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2014-11-04 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-20 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-19 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-06-12 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2013-02-28 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2012-02-07 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-23 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2011-12-07 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-09-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-08-25 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-12 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2010-07-09 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2009-04-15 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-04-02 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2008-03-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-04-17 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2007-01-25 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-18 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-12-11 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-09-08 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2006-08-18 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-04-05 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
| 2005-03-31 | Company Response | SOLIGENIX, INC. | DE | N/A | Read Filing View |
2025-09-23 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 September 23, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No: 333-290413 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00pm Eastern Time on September 25, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-09-23 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 September 23, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No. 333-290413 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (File No. 333-290413), as amended, be declared effective on September 25, 2025, at 5:00 p.m., Eastern Daylight Time, or as soon as practicable thereafter. The Company hereby authorizes its counsel, Driscoll R. Ugarte of Duane Morris LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Ugarte at (561) 962-2139 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2025-09-02 - UPLOAD - SOLIGENIX, INC. File: 377-08384
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 2, 2025 Christopher Schaber Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 Re: Soligenix, Inc. Draft Registration Statement on Form S-1 Submitted August 27, 2025 CIK No. 0000812796 Dear Christopher Schaber: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. 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 Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Driscoll R. Ugarte, Esq. </TEXT> </DOCUMENT>
2024-07-30 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 July 30, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No. 333-280993 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (File No. 333-280993), as amended, be declared effective on August 2, 2024, at 4:00 p.m., Eastern Daylight Time, or as soon as practicable thereafter. The Company hereby authorizes its counsel, Driscoll R. Ugarte of Duane Morris LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Ugarte at (561) 962-2139 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2024-07-29 - UPLOAD - SOLIGENIX, INC. File: 333-280993
July 29, 2024
Christopher Schaber
Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
Re:Soligenix, Inc.
Registration Statement on Form S-1
Filed July 24, 2024
File No. 333-280993
Dear Christopher Schaber:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Driscoll R. Ugarte
2024-04-15 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28th Floor New York, NY 10022 April 15, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Soligenix, Inc. Registration Statement on Form S-1, as amended File No: 333-276511 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 4:30pm Eastern Time on April 15, 2024 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2024-04-15 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 April 15, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No. 333-276511 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (File No. 333-276511), as amended, be declared effective on April 15, 2024, at 4:30 p.m., Eastern Daylight Time, or as soon as practicable thereafter. The Company hereby authorizes its counsel, Driscoll R. Ugarte of Duane Morris LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Ugarte at (561) 962-2139 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2024-04-03 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 April 3, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Withdrawal of Request for Acceleration of Effectiveness of Registration Statement Registration Statement on Form S-1, as amended Commission File No. 333-276511 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on April 2, 2024, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for April 3, 2024, at 4:30 p.m. Eastern Daylight Time. 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. Very truly yours, Soligenix, Inc. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, Esq. Duane Morris LLP
2024-04-02 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28th Floor New York, NY 10022 April 2, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Soligenix, Inc. Registration Statement on Form S-1, as amended File No: 333-276511 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 4:30pm Eastern Time on April 3, 2024 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2024-04-02 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 April 2, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No. 333-276511 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (File No. 333-276511), as amended, be declared effective on April 3, 2024, at 4:30 p.m., Eastern Daylight Time, or as soon as practicable thereafter. The Company hereby authorizes its counsel, Driscoll R. Ugarte of Duane Morris LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Ugarte at (561) 962 2139 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2024-01-19 - UPLOAD - SOLIGENIX, INC. File: 333-276511
United States securities and exchange commission logo
January 19, 2024
Christopher Schaber
Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, New Jersey 08540
Re:Soligenix, Inc.
Registration Statement on Form S-1
Filed January 16, 2024
File No. 333-276511
Dear Christopher Schaber:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Driscoll Ugarte
2023-12-14 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 December 14, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-3 Commission File No. 333-274265 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-3 (Commission File No. 333-274265) filed with the U.S. Securities and Exchange Commission (the “Commission”) on August 30, 2023, as amended by Amendment No. 1 to Form S-3 Registration Statement filed with the Commission on December 8, 2023, be declared effective on December 15, 2023, at 4:00 p.m., Eastern Standard Time, or as soon as practicable thereafter. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2023-12-06 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 December 6, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-3 Commission File No. 333-274265 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on November 30, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for December 1, 2023, at 4:00 p.m. Eastern Standard Time, or as soon as practicable thereafter. 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. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2023-11-30 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 November 30, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 333-271049 Re: Soligenix, Inc. Registration Statement on Form S-3 File No. 333-274265 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-3 (Commission File No. 333-274265) filed with the U.S. Securities and Exchange Commission (the “Commission”) on August 30, 2023 (the “Registration Statement”), be declared effective on December 1, 2023, at 4:00 p.m., Eastern Standard Time, or as soon as practicable thereafter. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2023-09-12 - UPLOAD - SOLIGENIX, INC.
United States securities and exchange commission logo
September 12, 2023
Christopher Schaber
Chief Executive Officer
SOLIGENIX, INC.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
Re:SOLIGENIX, INC.
Registration Statement on Form S-3
Filed August 30, 2023
File No. 333-274265
Dear Christopher Schaber:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Driscoll Ugarte
2023-05-04 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, NJ 08540 May 4, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Soligenix, Inc. Registration Statement on Form S-1 File No. 333-271049 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (File No. 333-271049), as amended, be declared effective on May 5, 2023, at 9:00 a.m., Eastern Daylight Time, or as soon as practicable thereafter. The Company hereby authorizes its counsel, Driscoll R. Ugarte of Duane Morris LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Ugarte at (561) 962 2139 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very truly yours, SOLIGENIX, INC. By: /s/ Christopher J. Schaber Christopher J. Schaber, PhD President and Chief Executive Officer cc: Driscoll R. Ugarte, P.A. Duane Morris LLP
2023-04-19 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm NEW YORK LONDON SINGAPORE PHILADELPHIA CHICAGO WASHINGTON, DC SAN FRANCISCO SILICON VALLEY SAN DIEGO LOS ANGELES BOSTON HOUSTON DALLAS FORT WORTH AUSTIN FIRM and AFFILIATE OFFICES HANOI HO CHI MINH CITY SHANGHAI ATLANTA BALTIMORE WILMINGTON MIAMI BOCA RATON PITTSBURGH NEWARK LAS VEGAS CHERRY HILL LAKE TAHOE MYANMAR ALLIANCES IN MEXICO www.duanemorris.com April 19, 2023 Via EDGAR PHONE: +1 561 962 2100 FAX: +1 561 962 2101 Dillon Hagius Alan Campbell U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention:Dillon Hagius Alan Campbell Re: Soligenix, Inc. Registration Statement on Form S-1 Filed March 31, 2023 File No. 333-271049 Ladies and Gentlemen: On behalf of our client, Soligenix, Inc. (the “Company”), we are submitting this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in a letter, dated April 7, 2023, with respect to the Company’s Registration Statement on Form S-1 (the “Registration Statement”) filed with the Commission on March 31, 2023. We also are electronically filing an amended version of the Registration Statement (the “Amended Registration Statement”). For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Page references in the responses of this letter correspond to the pages of the Amended Registration Statement. The responses to the Staff’s comments set forth below, as well as the changes in the disclosure referenced in the responses, are the responses and changes of the Company, and we are providing them to you on its behalf. Duane Morris llp 1875 NW Corporate Boulevard, SUITE 300 PHONE: +1 561 962 2100 FAX: +1 561 962 2101 BOCA RATON, FL 33431-8561 U.S. Securities and Exchange Commission April 19, 2023 Page 2 Registration Statement on Form S-1 Cover Page 1. We note your disclosure on page 27 that the Common Warrants are exercisable upon issuance. Please revise the heading on the prospectus cover page to reflect that you are also registering the shares of Common Stock underlying the Common Warrants. Response: The Company respectfully advises the Staff that it has revised the heading on the prospectus cover page, as well as the information included on the back cover page of the prospectus, in response to the Staff’s comment. 2. Please revise your disclosure to include all of the information that is required by Item 501(b)(8)(iii) of Regulation S-K, including (i) the date that the offering will end, (ii) any minimum purchase requirements and (iii) any arrangements to place the funds in escrow. If you have not made these arrangements, please state this fact and describe the effect on investors. Additionally, we note your disclosure that delivery of the shares of common stock, pre-funded warrants or common warrants is expected to be made on or about a certain date. Please disclose whether this offering will end in a single closing. Response: The Company respectfully advises the Staff that it has revised the disclosure on the prospectus cover page in response to the Staff’s comment. The revised disclosure is as follows: “The shares of our common stock, pre-funded warrants or common warrants being offered will be sold in a single closing. The shares issuable upon exercise of the pre-funded warrants or common warrants, will be issued upon the exercise thereof. Because there is no minimum number of securities or minimum aggregate amount of proceeds for this offering to close, we may sell fewer than all of the securities offered hereby, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus. Because there is no escrow account and there is no minimum offering amount, investors could be in a position where they have invested in our company, but we are unable to fulfill our objectives due to a lack of interest in this offering. Also, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. The offering of the shares of our common stock, pre-funded warrants or common warrants will end no later than five trading days from the date of this prospectus; however, the shares of our common stock underlying the pre-funded warrants and the common warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”).” ***** U.S. Securities and Exchange Commission April 19, 2023 Page 3 If the Staff has any other comments or requires any additional information, kindly contact the undersigned at (561) 962-2139. Very truly yours, DUANE MORRIS LLP /s/ Driscoll R. Ugarte Driscoll R. Ugarte cc:Christopher J. Schaber, PhD, Soligenix, Inc. Jonathan Guarino, Soligenix, Inc.
2023-04-07 - UPLOAD - SOLIGENIX, INC.
United States securities and exchange commission logo
April 7, 2023
Christopher Schaber, Ph.D.
President and Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, New Jersey 08540
Re:Soligenix, Inc.
Registration Statement on Form S-1
Filed March 31, 2023
File No. 333-271049
Dear Christopher Schaber:
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-1
Cover Page
1.We note your disclosure on page 27 that the Common Warrants are exercisable upon
issuance. Please revise the heading on the prospectus cover page to reflect that you are
also registering the shares of Common Stock underlying the Common Warrants.
2.Please revise your disclosure to include all of the information that is required by Item
501(b)(8)(iii) of Regulation S-K, including (i) the date that the offering will end, (ii) any
minimum purchase requirements and (iii) any arrangements to place the funds in escrow.
If you have not made these arrangements, please state this fact and describe the effect on
investors. Additionally, we note your disclosure that delivery of the shares of common
stock, pre-funded warrants or common warrants is expected to be made on or about a
certain date. Please disclose whether this offering will end in a single closing.
FirstName LastNameChristopher Schaber, Ph.D.
Comapany NameSoligenix, Inc.
April 7, 2023 Page 2
FirstName LastName
Christopher Schaber, Ph.D.
Soligenix, Inc.
April 7, 2023
Page 2
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 Dillon Hagius at 202-551-7967 or Alan Campbell at 202-551-4224 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Driscoll R. Ugarte
2021-01-27 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton,
NJ 08540
January 27, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-3
Filed January 15, 2021
File No. 333-252153
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the
Company’s Registration Statement on Form S-3 (File No. 333-252153) filed with the U.S. Securities and Exchange Commission
on January 15, 2021, be declared effective on January 29, 2021, at 4:00 p.m., Eastern Standard Time, or as soon as practicable
thereafter.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc:
Driscoll R. Ugarte, P.A.
Duane Morris LLP
2021-01-22 - UPLOAD - SOLIGENIX, INC.
United States securities and exchange commission logo
January 22, 2021
Christopher J. Schaber, Ph.D.
President and Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
Re:Soligenix, Inc.
Registration Statement on Form S-3
Filed January 15, 2021
File No. 333-252153
Dear Dr. Schaber:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Driscoll R. Ugarte, Esq.
2020-08-26 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton,
NJ 08540
August 26, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Amendment No. 2 to Registration Statement on Form S-3
Commission File No. 333-239928
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that
the Company’s Amendment No. 2 to Registration Statement on Form S-3 (Commission File No. 333-239928) filed with the U.S.
Securities and Exchange Commission (the “Commission”) on August 14, 2020 (the “Registration Statement”),
be declared effective on August 28, 2020, at 4:00 p.m., Eastern Daylight Time, or as soon as practicable thereafter.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc:
Driscoll R. Ugarte, P.A.
Duane Morris
LLP
2020-07-31 - CORRESP - SOLIGENIX, INC.
CORRESP
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NEW YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
LOS ANGELES
TAIWAN
BOSTON
HOUSTON
AUSTIN
HANOI
HO CHI MINH CITY
FIRM and AFFILIATE OFFICES
SHANGHAI
ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR
OMAN A GCC REPRESENTATIVE OFFICE
OF DUANE MORRIS
ALLIANCES IN MEXICO
AND SRI LANKA
www.duanemorris.com
July 31, 2020
Via EDGAR
U.S. Securities and Exchange Commission,
Division of Corporation Finance,
100 F Street, N.E.,
Washington, D.C. 20549.
Attn:
Chris Edwards
Celeste Murphy
Re:
Soligenix, Inc.
Registration Statement on Form S-3
Filed July 17, 2020
File No. 333-239928
Dear Ladies and Gentlemen:
On behalf of our client,
Soligenix, Inc. (the “Company”), we are submitting this letter in response to comments from the staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in a letter, dated July 24, 2020, with respect to the Company’s Registration Statement on Form S-3 (the “Registration
Statement”) filed with the Commission on July 17, 2020. We are also electronically filing an amended version of the
Registration Statement (the “Amended Registration Statement”).
For the Staff’s
convenience, we have incorporated your comments into this response letter in italics. Page references in the responses of this
letter correspond to the page numbers in the Amended Registration Statement. The responses to the Staff’s comments set forth
below, as well as the changes in the disclosure referenced in the responses, are the responses and changes of the Company, and
we are providing them to you on its behalf.
Registration Statement
on Form S-3
General
1. We note that Section 10.7 of your Bylaws provides for the Court of Chancery of the State of
Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether
this provision is intended to apply to actions arising under the 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. If this provision is not intended to apply to actions arising under the Exchange Act,
please tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the
Exchange Act.
U.S. Securities and Exchange Commission
July 31, 2020
Response:
As discussed with the Staff verbally, the exclusive forum provisions in the Company’s Bylaws are not intended to apply to
claims arising under the Exchange Act. The Company respectfully advises the Staff that it has revised its disclosure on page 10
in response to the Staff’s comment. Further, the Company will file as an exhibit to the Amended Registration Statement an
updated version of the description of its securities, previously filed as Exhibit 4.6 to the Company’s Annual Report on
Form 10-K filed on March 30, 2020, reflecting the revised disclosure on page 10 and will incorporate by reference such exhibit
into the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and into future filings made pursuant
to the Exchange Act and the Securities Act, as required by applicable law.
2. We note that your forum selection
provision identifies the federal district courts of the United States as the exclusive
forum for the resolution of any complaint asserting a cause of action arising under the
Securities Act of 1933, as amended. In that regard, we note that 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. Please disclose 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.
Response:
The Company respectfully advises the Staff that it has revised its disclosure on page 10 in response to the Staff’s comment.
* * * * *
Please contact me
at (561) 962-2139 if you wish to discuss the response to the Staff’s comments.
Very truly yours,
/s/ Driscoll R. Ugarte
Driscoll R. Ugarte
cc:
Christopher J. Schaber,
PhD, Soligenix, Inc.
Jonathan Guarino, Soligenix, Inc
2020-07-24 - UPLOAD - SOLIGENIX, INC.
United States securities and exchange commission logo
July 24, 2020
Christopher J. Schaber, Ph.D.
President and Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, New Jersey 08540
Re:Soligenix, Inc.
Registration Statement on Form S-3
Filed July 17, 2020
File No. 333-239928
Dear Dr. Schaber:
We have limited our review of your registration statement to those issues we have
addressed in our comments.
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 Section 10.7 of your Bylaws provides for the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please disclose whether this provision is intended to apply to actions arising
under the 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. If this provision is
not intended to apply to actions arising under the Exchange Act, please tell us how you
will inform investors in future filings that the provision does not apply to any actions
arising under the Exchange Act.
2.We note that your forum selection provision identifies the federal district courts of
the United States as the exclusive forum for the resolution of any complaint asserting a
FirstName LastNameChristopher J. Schaber, Ph.D.
Comapany NameSoligenix, Inc.
July 24, 2020 Page 2
FirstName LastName
Christopher J. Schaber, Ph.D.
Soligenix, Inc.
July 24, 2020
Page 2
cause of action arising under the Securities Act of 1933, as amended. In that regard, we
note that 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. Please disclose 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.
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 Chris Edwards at (202) 551-6761 or Celeste Murphy at (202) 551-3257
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Driscoll R. Ugarte
2017-11-28 - UPLOAD - SOLIGENIX, INC.
November 28, 2017
Christopher J. Schaber
President and Chief Executive Officer
Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
Soligenix, Inc.
Registration Statement on Form S-1
Filed November 20, 2017
File No. 333-221681Re:
Dear Dr. Schaber:
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 Christine Westbrook at (202) 551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Driscoll R. Ugarte, Esq.
2017-11-28 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite B-10
Princeton, NJ 08540
November 28, 2017
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Soligenix,
Inc.
Registration Statement on Form S-1 (SEC File No. 333-221681)
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1, SEC File No. 333-221681 (the “Registration Statement”),
be declared effective on November 30, 2017, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff (the
“Staff”) of the Commission, 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 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,
Soligenix, Inc.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Driscoll R. Ugarte, Esq.
Duane Morris LLP
2017-08-09 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton,
NJ 08540
August 9, 2017
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-3
Commission File No. 333-217738
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the
Company’s Registration Statement on Form S-3 (Commission File No. 333-217738), as amended by Amendment No. 1 to Form S-3
Registration Statement filed with the Securities and Exchange Commission (the “Commission”) on August 8, 2017 (the
“Registration Statement”), be declared effective on Friday, August 11, 2017, at 4:00 p.m., Eastern Daylight Time, or
as soon as practicable thereafter.
In
making this request for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Commission or the staff (the
“Staff”) of the Commission, 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.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Driscoll R. Ugarte, P.A.
Duane Morris LLP
2017-05-16 - UPLOAD - SOLIGENIX, INC.
Mail Stop 4546 May 16 , 2017 Christopher J. Schaber, Ph.D. President and Chie f Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, NJ 08540 Re: Soligenix, Inc. Registration Statement on Form S-3 Filed May 5 , 2017 File No. 333-217738 Dear Dr. Schaber : 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 Christine Westbrook at (202) 551 -5019 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Driscoll Ugarte , Esq. Duane Morris LLP
2016-11-22 - CORRESP - SOLIGENIX, INC.
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AEGIS CAPITAL CORP.
810 Seventh Avenue, 18th Floor
New York, New York 10019
November 22, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc. (the “Company”)
Registration Statement on Form S-1 (File
No. 333-214038)
Ladies and Gentlemen:
Pursuant to Rule 461 of
the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933, as
amended (the “Securities Act”), we, as representative of the several underwriters, hereby join in the Company’s
request to accelerate the effective date of the above-referenced Registration Statement so that it will become effective at 12:00
P.M., Washington D.C. time, on Tuesday, November 22, 2016, or as soon thereafter as practicable.
We, acting on behalf
of the several underwriters, wish to advise you that, between November 21, 2016 and November 22, 2016, we distributed and will
distribute to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of
the securities, as many copies, as well as “E-red” copies of the Preliminary Prospectus, dated November 21, 2016,
as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus.
The undersigned confirms
that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers
that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended,
in connection with the above-referenced issue.
Very truly yours,
Aegis CAPITAL CORP.
By:
/s/ David Hentschel
Name: David Hentschel
Title: Chief Compliance Officer
2016-11-22 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
November 22, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1 (SEC File No. 333-214038)
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1 (SEC File No. 333-214038), as amended (the “Registration Statement”),
be declared effective on November 22, 2016, at 12:00 p.m., Eastern Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff (the
“Staff”) of the Commission, 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 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,
Soligenix, Inc.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber
President and Chief Executive Officer
cc:
Driscoll R. Ugarte, Esq.
Duane Morris LLP
2016-11-16 - CORRESP - SOLIGENIX, INC.
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
November 16, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re: Soligenix, Inc.
Withdrawal of Request for Acceleration
of Effectiveness of Registration Statement
Registration Statement on Form
S-1 (SEC File No. 333-214038)
Ladies and Gentlemen:
Reference is made
to our letter, filed as correspondence via EDGAR on November 16, 2014, in which we requested the acceleration of the effective
date of the above-referenced Registration Statement for November 16, 2016, at 5:00 p.m. Eastern Time. 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.
Very truly yours,
Soligenix, Inc.
By: /s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc
Driscoll R. Ugarte, Esq.
Duane Morris LLP
AEGIS CAPITAL CORP.
810 Seventh Avenue, 18th Floor
New York, New York 10019
November 16, 2016
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention Michael Gerson
Re: Soligenix, Inc. (the
“Company”)
Withdrawal of Request for Acceleration of Effectiveness of Registration Statement
Registration Statement on Form S-1 (SEC File No. 333-214038)
Ladies and Gentlemen:
Reference is made
to our letter, filed as correspondence via EDGAR on November 16, 2016, in which we, as representative of the several underwriters,
joined in the Company’s request to accelerate the effective date of the above-referenced Registration Statement so that it
would become effective at 5:00 P.M., Washington D.C. time, on Wednesday, November 16, 2016, or as soon thereafter as practicable.
The Company is 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.
Very truly yours,
Aegis CAPITAL CORP.
By:
/s/ David Hentschel
Name: David Hentschel
Title: Chief Compliance Officer
2016-11-15 - CORRESP - SOLIGENIX, INC.
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AEGIS CAPITAL CORP.
810 Seventh Avenue, 18th Floor
New York, New York 10019
November 15, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc. (the “Company”)
Registration Statement on Form S-1 (File
No. 333-214038)
Ladies and Gentlemen:
Pursuant to Rule 461 of
the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933, as
amended (the “Securities Act”), we, as representative of the several underwriters, hereby join in the Company’s
request to accelerate the effective date of the above-referenced Registration Statement so that it will become effective at 5:00
P.M., Washington D.C. time, on Wednesday, November 16, 2016, or as soon thereafter as practicable.
We, acting on behalf of
the several underwriters, wish to advise you that, between November 14, 2016 and November 15, 2016, we distributed and will distribute
to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities,
as many copies, as well as “E-red” copies of the Preliminary Prospectus, dated November 14, 2016, as appears to be
reasonable to secure adequate distribution of the Preliminary Prospectus.
The undersigned confirms
that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers
that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended,
in connection with the above-referenced issue.
Very truly yours,
Aegis CAPITAL CORP.
By:
/s/ David Hentschel
Name: David Hentschel
Title: Chief Compliance Officer
2016-11-15 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
November 15, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1 (SEC File No. 333-214038)
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1 (SEC File No. 333-214038), as amended (the “Registration Statement”),
be declared effective on November 16, 2016, at 5:00 p.m., Eastern Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff (the
“Staff”) of the Commission, 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 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,
Soligenix, Inc.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber
President and Chief Executive Officer
cc: Driscoll R. Ugarte, Esq.
Duane Morris LLP
2016-10-17 - UPLOAD - SOLIGENIX, INC.
Mail Stop 4546 October 14, 2016 Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed October 7 , 2016 File No. 333-214038 Dear Dr. Schaber : 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 Michael Gershon at (202) 551 -6598 or Mary Beth Breslin at (202) 551 - 3625 with a ny questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Leslie J. Croland, Esq.
2016-04-26 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
April 26, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1
SEC File No. 333-210665
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s
Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “Commission”) on April 8,
2016 (the “Registration Statement”), be declared effective on April 28, 2016, at 4:00 p.m., Eastern Daylight Time,
or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
●
should the Commission or the staff (the “Staff”) of the Commission, 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.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Driscoll R. Ugarte, Duane
Morris LLP
2016-04-26 - UPLOAD - SOLIGENIX, INC.
Mail Stop 4720 April 25, 2016 Via E -mail Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed April 8 , 2016 File No. 333-210665 Dear Dr. Schaber : 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 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. Christopher J. Schaber, Ph.D. Soligenix, Inc. April 25, 2016 Page 2 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 registered securities . Please contact S cot Foley at (202) 551 -3383 or me at (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director cc: Leslie J. Croland, Esq. Driscoll R. Ugarte, Esq. Duane Morris LLP
2016-04-14 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton,
NJ 08540
April 14, 2016
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Post-Effective Amendment No. 4 to Registration Statement
on Form S-1
Commission File No. 333-192908
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 and on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Post-Effective Amendment No. 4 to Registration Statement on Form S-1 filed with the Securities and Exchange
Commission (the “Commission”) on April 13, 2016 (the “Registration Statement”), be declared effective on
Thursday, April 14, 2016, at 4:00 p.m., Eastern Daylight Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Commission or the staff (the
“Staff”) of the Commission, 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.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Driscoll R. Ugarte, P.A.
Duane
Morris LLP
2016-04-13 - CORRESP - SOLIGENIX, INC.
CORRESP
1
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NEW
YORK
LONDON
SINGAPORE
PHILADELPHIA
CHICAGO
WASHINGTON, DC
SAN FRANCISCO
SILICON VALLEY
SAN DIEGO
SHANGHAI
BOSTON
HOUSTON
LOS ANGELES
HANOI
HO CHI MINH CITY
FIRM
and AFFILIATE OFFICES
driscoll
r. ugarte, P.A.
E-MAIL: drugarte@duanemorris.com
www.duanemorris.com
ATLANTA
BALTIMORE
WILMINGTON
MIAMI
BOCA RATON
PITTSBURGH
NEWARK
LAS VEGAS
CHERRY HILL
LAKE TAHOE
MYANMAR
OMAN A GCC REPRESENTATIVE OFFICE
OF DUANE MORRIS
MEXICO CITY
ALLIANCE WITH
MIRANDA & ESTAVILLO SRI LANKA
ALLIANCE WITH
GOWERS INTERNATIONAL
April 13, 2016
VIA EDGAR AND FEDEX
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re Soligenix, Inc.
Post-Effective Amendment No. 3 to Form S-1
Filed March 31, 2016
File No. 333-192908
Dear Ms. Hayes:
On behalf of our
client, Soligenix, Inc. (the “Company”), we are responding to the comment of the staff (the “Staff”) of
the Securities and Exchange Commission contained in its letter dated April 13, 2016 (the “Letter”) relating to the
captioned Post-Effective Amendment No. 3 to Form S-1 (“Registration Statement”).
Set forth below
is our response to the Staff’s comment. For your convenience we have incorporated the Staff’s comment into this response
letter.
General
1. The financial statements and related disclosure in this filing have not been updated to reflect
the results for the year ended December 31, 2015 as required by Item 8-08 of Regulation S-X. Please amend this filing to include
the required financial statements and related information.
Duane
Morris llp
200
SOUTH BISCAYNE BOULEVARD, SUITE 3400 MIAMI, FL 33131-2318 PHONE: +1 305 960 2200 FAX:
+1 305 960 2201
Page 2
Response:
In response to the Staff’s comment, the Company
has amended the Registration Statement to include the required financial statements and related information
When the Company
requests acceleration of the effective date of the Registration Statement, as amended, the Company will provide a written statement
acknowledging the matters noted in the three bullet points included in the Letter.
Please contact me
at (561) 962-2139 with any questions or further comments regarding our response to the Staff’s comments.
Sincerely,
Duane Morris LLP
/s/ Driscoll R. Ugarte
Driscoll
R. Ugarte
cc: Mr. Scot Foley, Division of Corporation Finance
Christopher J. Schaber,
Ph.D., Chief Executive Officer and President
2016-04-13 - UPLOAD - SOLIGENIX, INC.
Mail Stop 4720 April 1 3, 2016 Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Post-Effective Amendment No. 3 to Form S-1 Filed March 31, 2016 File No. 333-192908 Dear Dr. Schaber : We have reviewed your post-effective amendment and have the following comment. Please respond to this letter by amending your registration statement as requested . If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in a response. After reviewing any amendment to your regist ration statement and the information you provide in response to this comment, we may have additional comments. General 1. The financial statements and related disclosure in this filing have not been updated to reflect the results for the year ended December 31, 2015 as required by Item 8 -08 of Regulation S -X. Please amend this filing to include the required financial statements and related information . 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 rule s 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, before we can declare th e amended registration statement effective, the company should provide us with a letter, 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; Christopher J. Schaber, Ph.D. Soligenix, Inc. April 1 3, 2016 Page 2 the action of the Commission or the staff, acting pursuant t o 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 effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact S cot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Leslie J. Croland, Esq. Duane Morris LLP
2015-08-21 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
August 21, 2015
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1
SEC File No. 333-206055
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “Commission”)
on August 3, 2015, as amended by Amendment No. 1 to Registration Statement on Form S-1 filed with the Commission on August 21,
2015 (as amended, the “Registration Statement”), be declared effective on August 25, 2015, at 4:00 p.m., Eastern Standard
Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
●
should the Commission or the staff (the “Staff”) of the Commission, 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.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Leslie J. Croland, Duane Morris LLP
2015-08-20 - UPLOAD - SOLIGENIX, INC.
August 20, 2015 Via E -mail Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed August 3, 2015 File No. 333-206055 Dear Dr. Schaber : 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 with respect to the filing; the action of the Commission or the staff, acting pursuant t o 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 effect iveness 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 acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under Christopher J. Schaber, Ph.D. Soligenix, Inc. August 20, 2015 Page 2 the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . You may contact Tara Keating Brooks at (202) 551 -8336 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Driscoll R. Ugarte Duane Morris LLP
2014-12-17 - CORRESP - SOLIGENIX, INC.
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Roth
Capital Partners, LLC
888
San Clemente Drive
Newport
Beach, CA 92660
December 17, 2014
Securities
and Exchange Commission
100 F Street,
N.E.
Washington,
D.C. 20549
Re:
Soligenix, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-199761)
Ladies and
Gentlemen:
In
connection with the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended
(the “Act”), the undersigned hereby joins in the request of the Company that the effective date of such registration
statement be accelerated to 4:00 p.m. (New York Time) on Thursday, December 18, 2014, or as soon thereafter as practicable.
In
making this request the undersigned acknowledges that it is aware of its obligations under the Act as they relate to the public
offering of securities pursuant to the registration statement.
Very truly
yours,
Roth Capital Partners, LLC
By:
/s/
Aaron Gurewitz
Name:
Aaron Gurewitz
Title:
Head of Equity Capital Markets
2014-12-17 - CORRESP - SOLIGENIX, INC.
CORRESP
1
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
December 17, 2014
VIA FACSIMILE AND EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1 (SEC File No. 333-199761)
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1 (SEC File No. 333-199761), as amended (the “Registration Statement”)
be declared effective on December 18, 2014, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
· should the Securities and Exchange Commission (the “Commission”) or the staff (the
“Staff”) of the Commission, 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 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,
Soligenix, Inc.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Leslie J. Croland, Esq.
Duane Morris LLP
2014-12-17 - CORRESP - SOLIGENIX, INC.
CORRESP
1
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NEW YORK
LONDON
BALTIMORE
WILMINGTON
SINGAPORE
MIAMI
PHILADELPHIA
FIRM and AFFILIATE OFFICES
BOCA RATON
CHICAGO
PITTSBURGH
WASHINGTON, DC
LESLIE J. CROLAND
NEWARK
SAN FRANCISCO
PERSONAL FAX: +1 305 397 1882
LAS VEGAS
SILICON VALLEY
E-MAIL: ljcroland@duanemorris.com
CHERRY HILL
SAN DIEGO
LAKE TAHOE
BOSTON
MYANMAR
HOUSTON
OMAN
LOS ANGELES
A GCC REPRESENTATIVE OFFICE
HANOI
OF DUANE MORRIS
HO CHI MINH CITY
ATLANTA
MEXICO CITY
ALLIANCE WITH
MIRANDA & ESTAVILLO
December 16, 2014
VIA EDGAR AND FEDEX
Jeffrey P. Riedler
Assistant Director
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re Soligenix, Inc.
Registration Statement on Form S-1
Filed October 31, 2014
File No. 333-199761
Dear Mr. Riedler:
On behalf of our
client, Soligenix, Inc. (the “Company”), we are responding to the comment of the staff (the “Staff”) of
the Securities and Exchange Commission contained in its letter dated November 14, 2014 (the “Comment Letter”) relating
to the captioned Registration Statement (“Registration Statement”).
Set forth below
is our response to the Staff’s comment. For your convenience we have incorporated the Staff’s comment into this response
letter.
General
1. Although
Rule 430A of the Securities Act of 1933 permits registrants to omit certain pricing-related information from a registration statement
that is declared effective, your registration statement must include the amount of securities to be offered in a pre-effective
amendment. Please refer to Securities Act Rules C&DI Question 227.02 for guidance. Accordingly, please amend your registration
statement to include the total number of units and the number of warrants in each unit.
Duane Morris llp
5100 Town center circle, ste. 650, boca raton, fl 33486
Division of Corporation Finance
Securities and Exchange Commission
December 16, 2014
Page 2
Response:
In response to the Staff’s comment, the Company has amended the Registration Statement to include the total number of units
and the number of warrants in each unit.
*****
Please contact me
at (305) 960-2250 with any questions or further comments regarding our responses to the Staff’s comments.
Sincerely,
/s/ Leslie J. Croland
Leslie J. Croland
cc: Christopher J. Schaber, Ph.D., Chief Executive
Officer and President
2014-11-17 - CORRESP - SOLIGENIX, INC.
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1
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November
17, 2014
VIA
EDGAR AND FEDEX
Jeffrey
P. Riedler
Assistant
Director
Division
of Corporation Finance
Securities
and Exchange Commission
100 F Street,
N.E.
Washington,
D.C. 20549
Re Soligenix,
Inc.
Registration Statement on Form S-1
Filed October 31, 2014
File
No. 333-199761
Dear
Mr. Riedler:
On
behalf of our client, Soligenix, Inc. (the “Company”), we acknowledge the comment of the staff (the “Staff”)
of the Securities and Exchange Commission contained in its letter dated November 14, 2014 (the “Comment Letter”) relating
to the captioned Registration Statement (“Registration Statement”). The Company is filing Amendment No. 1 to the Registration
Statement (the “Amendment”) to include the Company’s financial statements for the quarter ended September 30,
2014 and to update the disclosure related to the financial statements and certain other items. For the Staff’s convenience,
we are submitting via Federal Express three copies of this letter and six of the Amendment, three of which are clean and three
of which are marked to show all changes made to the Registration Statement.
The
Company will file an additional amendment to the Registration Statement to address the comment of the Staff contained in the Comment
Letter at a later date.
Duane
Morris llp
5100
Town center circle, ste. 650, boca raton, fl 33486
DM3\3081103.1
Division
of Corporation Finance
Securities
and Exchange Commission
November
17, 2014
Page 2
Please
contact me at (305) 960-2250 with any questions or further comments regarding the Registration Statement or the Amendment.
Sincerely,
/s/ Leslie J. Croland
Leslie J. Croland
cc:
Christopher J. Schaber, Ph.D., Chief Executive Officer and President
John
D. Hogoboom, Lowenstein Sandler LLP
Duane Morris llp
5100 Town center circle, ste. 650, boca raton, fl 33486
DM3\3081103.1
2014-11-14 - UPLOAD - SOLIGENIX, INC.
November 14 , 2014 Via E -mail Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed October 31, 2014 File No. 333 -199761 Dear Dr. Schaber: We have limited our review of your registration statement to the issue we have addressed in our comment. Please respond to this letter by amending your registration statement and providing the requested information. Where you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why i n your response. 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. Although Rule 430A of the Securities Act of 1933 permits registrants t o omit certain pricing -related information from a registration statement that is declared effective, your registration statement must include the amount of securities to be offered in a pre - effective amendment. Please refer to Securities Act Rules C&DI Qu estion 227.02 for guidance. Accordingly, please amend your registration statement to include the total number of units and the number of warrants in each unit. 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 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 accuracy and adequacy of the disclosures they have made. Christopher J. Schaber , Ph.D. Soligenix , Inc. November 14 , 2014 Page 2 Notwithstanding our comment, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the compan y 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 st aff, 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 thei r 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 rev iew any amendment prior to the requested effective date of the registration statement. Please contact Johnny Gharib at (202) 551 -3170, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail Leslie J. Croland, Esq. Duane Morris LLP
2014-11-04 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
November
4, 2014
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc.
Registration Statement on Form S-1
SEC File No. 333-199038
Ladies and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests
that the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “Commission”)
on September 30, 2014 as amended by Amendment No. 1 to Registration Statement on Form S-1 filed with the Commission on November
3, 2014 (as amended, the “Registration Statement”), be declared effective on November 5, 2014, at 4:00 p.m., Eastern
Standard Time, or as soon as practicable thereafter.
In making this request
for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
● should the Commission or the staff (the
“Staff”) of the Commission, 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.
Very truly yours,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Leslie J. Croland
Duane Morris LLP
2014-10-14 - UPLOAD - SOLIGENIX, INC.
October 14, 2014 Via E -mail Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed September 30, 2014 File No. 333-199038 Dear Dr. Schaber : 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 . 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 these comments , we may have additional comments. General 1. We note that that you have two pending confidential treatment request s. We will not be in a position to accelerate the effectiveness of your registration statement until we have completed processing your conf idential treatment request s. 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 re quire. 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 event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: Christopher J. Schaber, Ph.D. Soligenix, Inc. October 14, 2014 Page 2 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it d oes 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 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 Matthew Jones at (202) 551 -3786 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Leslie J. Croland, Esq. Duane Morris LLP Suite 3400 200 South Biscayne Boulevard Miami, Florida 33131 -2318
2013-06-20 - CORRESP - SOLIGENIX, INC.
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Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
June 20, 2013
VIA FACSIMILE AND EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Re:
Soligenix, Inc. - Registration Statement on Form S-1
SEC File No. 333-184762
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933 on behalf of Soligenix, Inc. (the “Company”), the undersigned hereby requests that the Company’s Registration Statement on Form S-1 (the “Registration Statement”) filed with the Securities and Exchange Commission (the “Commission”) be declared effective on June 20, 2013, at 4:00 p.m., Eastern Daylight Time, or as soon as practicable thereafter.
In making this request for acceleration of the effective date of the Registration Statement, the Company hereby acknowledges that:
·
should the Commission or the staff (the “Staff”) of the Commission, 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 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,
SOLIGENIX, INC.
By:
/s/ Christopher J. Schaber
Christopher J. Schaber, PhD
President and Chief Executive Officer
cc: Leslie J. Croland, P.A.
Duane Morris LLP
2013-06-19 - CORRESP - SOLIGENIX, INC.
CORRESP
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Duane Morris LLP
200 South Biscayne Boulevard, Suite 3400
Miami, Florida 33131
June 19, 2013
VIA EDGAR
Mr. Jeffrey Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Registration Statement on Form S-1
Filed June 13, 2013
SEC File No. 333-184762
Dear Mr. Riedler:
On behalf of our client, Soligenix, Inc., a Delaware corporation (the “Company”), we are responding to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission to the above-referenced filing of the Company as set forth in the Staff’s letter dated June 19, 2013 (the “Letter”). The Company is filing Pre-Effective Amendment No. 5 to the Company’s Registration Statement on Form S-1 (the “Registration Statement”) to file a revised legal opinion to address the comments of the Staff contained in the Letter.
When the Company requests acceleration of the effective date of the Registration Statement, the Company will provide a written statement acknowledging the matters noted in the three bullet points included in the Letter.
If the Staff has any other comments or requires any additional information, kindly contact the undersigned at (306) 960-2250.
Sincerely,
/s/ Leslie J. Croland
cc: Ms. Amy Reischauer, Division of Corporation Finance
Christopher J. Schaber, Ph.D., Chief Executive Officer and President
2013-06-19 - UPLOAD - SOLIGENIX, INC.
June 19, 2013 Via E -Mail Dr. Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, NJ 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed June 13, 2013 File No. 333-184762 Dear Dr. Schaber : We have reviewed your amended registration statement and have the following comment. We have limited our review of your registration statement to those issues we have addressed in our comments. Please respond to this letter by amending your registration statement as requested. Where you do not believe our comments apply to your facts and circu mstances 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. Exhibit 5.1 Please file a revised legal opinion that opines that: the Units themselves are binding obligations of the registrant in accordance with Section II.B.1.h of Staff Legal Bulletin No. 19; each Warrant included in the Units is a binding obligation of the registrant in accordance with Section II.B.1.f of Staff Legal Bulletin No. 19; and each preferred stock purchase right attached to Soligenix’s common stock is a binding obligation of the registrant in accordance with Section II.B.1.g of Staff Legal Bulletin No. 19. In addition, please delete your assumption that the registrant has an adequate number of authorized shares of common stock in accordance with II.B.3.a of Staff Legal Bulletin No. 19. Dr. Christopher J. Schaber, Ph.D. Soligenix, Inc. June 19, 2013 Page 2 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 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 accuracy 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 t o 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 effect iveness 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 acceler ation 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 Amy Reisch auer at (202) 551 -3793, Daniel Greenspan at (202) 551 -3623 , or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -Mail Leslie J. Croland Duane Morris LLP 200 South Biscayne Boulevard, Suite 3400 Miami, FL 33131 -2318
2013-06-12 - CORRESP - SOLIGENIX, INC.
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Duane Morris LLP
5100 Town Center Circle, Suite 6500
Boca Raton, Florida 33486
June 12, 2013
VIA EDGAR
Mr. Jeffrey Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Registration Statement on Form S-1
Filed November 5, 2012
SEC File No. 333-184762
Dear Mr. Riedler:
On behalf of our client, Soligenix, Inc., a Delaware corporation (the “Company”), we are responding to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) to the above-referenced filing of the Company as set forth in the Staff’s letter dated November 19, 2012 (the “Letter”). For your reference, we have reproduced the comments from the Letter below, which are followed by the Company’s response.
Registration Statement on Form S-1
1.
Although Rule 430A of the Securities Act of 1933 permits registrants to omit certain pricing-related information from a registration statement that is declared effective, your filing must include the amount of securities to be offered in a pre-effective amendment. Please refer to Securities Act Rules CD&I Question 227.02. Accordingly, please amend your filing to include the total number of units to be offered, as well as the number of shares of common stock issuable upon exercise of each warrant.
Response:
The Company is filing Pre-Effective Amendment No. 3 to the Company’s Registration Statement on Form S-1 the (the “Registration Statement”) to include the total number of units to be offered, as well as the number of shares of common stock issuable upon exercise of each warrant.
2.
Please amend your filing to describe the terms of the warrants to be registered in this registration statement pursuant to Item 202(c) of Regulation S-K.
Response:
The Company is filing the Registration Statement to describe the terms of the warrants to be registered in the Registration Statement pursuant to Item 202(c) of Regulation S-K.
When the Company requests acceleration of the effective date of the Registration Statement, the Company will acknowledge the matters noted in the three bullet points included in the Letter.
If the Staff has any other comments or requires any additional information, kindly contact the undersigned at (306) 960-2250.
Sincerely,
/s/ Leslie J. Croland
cc: Ms. Rose Zukin, Division of Corporation Finance
Christopher J. Schaber, Ph.D., Chief Executive Officer and President
2013-02-28 - CORRESP - SOLIGENIX, INC.
CORRESP
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Edwards Wildman Palmer LLP
525 Okeechobee Boulevard, Suite 1600
West Palm Beach, Florida 33411
March 1, 2013
VIA EDGAR
Mr. Jeffrey Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Registration Statement on Form S-1
Filed November 5, 2012
SEC File No. 333-184762
Dear Mr. Riedler:
On behalf of our client, Soligenix, Inc., a Delaware corporation (the “Company”), we are filing Pre-Effective Amendment No. 1 to the Company’s Registration Statement on Form S-1, File No. 333-184762 (the “Registration Statement”). The Registration Statement has been revised to include audited financial statements for the Company’s fiscal year ended December 31, 2012 and to update and revise certain disclosures in the document.
Please note that the Registration Statement has not been revised at this time to respond to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission that were contained in the Staff’s November 19, 2012 comment letter (the “Comment Letter”). The Company intends to file another pre-effective amendment to the Registration Statement and will address the Staff’s comments at that time.
In the event the Company requests acceleration of the Registration Statement, the Company will include an acknowledgement of the matters noted in the three bullet points included in the Comment Letter.
If the Staff has any other comments or requires any additional information, kindly contact the undersigned at (561) 820-0212.
Sincerely,
/s/ Leslie J. Croland
cc:
Christopher J. Schaber, Ph.D.
Chief Executive Officer and President
2012-11-20 - UPLOAD - SOLIGENIX, INC.
November 19 , 2012 Via E -mail Dr. Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C -10 Princeton, NJ 08540 Re: Soligenix , Inc. Registration Statement on Form S-1 Filed November 5, 2012 File No. 333-184762 Dear Dr. Schaber : 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 . 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 these comments , we may have additional comments. Registration Statement on Form S -1 1. Although Rule 430A of the Securities Act of 1933 permits registrants to omit certain pricing -related information from a registration statement that is declared effective, your filing must include the amount of securities to be offered in a pre -effective amendment. Please refer to Securities Act Rules CD&I Question 227.02. Accordingly, please amend your filing to include the total number of units to be offered, as well as the number of shares of common stock issuable upon exercise of each warrant. 2. Please amend your filing to describe the terms of the warrants to be registered in this registration statement pursuant to Item 202(c) of Regulation S -K. Dr. Christopher J. Schaber, Ph.D. Soligenix, Inc. November 19, 2012 Page 2 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 possess ion 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 event you request acceleration of the effective date of the pending registrat ion 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 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. You may contact Rose Zukin at (202) 551 -3239, Daniel Greenspan at (202) 551 -3623 , or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Leslie J. Croland, Esq. Edwards Wildman Palmer LLP 525 Okeechobee Blvd., Suite 1600 West Palm Beach, FL 33401
2012-02-13 - UPLOAD - SOLIGENIX, INC.
February 13, 2012 Via E-mail Joe Warusz Vice President Administ ration and Controller Soligenix, Inc. 29 Emmons Drive, Suite C-10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Form 10-K Filed March 30, 2011 File No. 000-16929 Dear Mr. Warusz: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan for Jeffrey Riedler Assistant Director
2012-02-07 - CORRESP - SOLIGENIX, INC.
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, New Jersey 08540
Phone: (609) 538-8200
February 7, 2012
VIA EDGAR
Mr. Jeffrey Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Form 10-K
Filed March 30, 2011
SEC File No. 000-16929
Dear Mr. Riedler:
We are responding to your January 20, 2012 comment letter. For your reference, we have included the comments from your letter followed by our responses.
Form 10-K, filed March 30, 2011
1.
We note your responses to our prior comments 2, 3 and 4 and your proposal to include revised disclosure in your upcoming 10-K for the fiscal year ended December 31, 2011. With respect to this disclosure specifically, and for any disclosure that you intend to revise in response to our comments in this letter, please provide us with a draft of your proposed changes as soon as possible, so that we may have the opportunity to review and comment on the revisions.
Response:
A draft of our revised disclosure in response to this comment is set forth on Exhibit A attached hereto and is organized under headings that reference your prior comments 2, 3, and 4. We intend to include such information in appropriate sections of our Form 10-K for the fiscal year ended December 31, 2011.
Business, page 3
2.
We note your response to our prior comment 1 and reissue the comment in part. Please file as an exhibit the written agreement evidencing the grant pursuant to Item 601(b)(10) of Regulation S-K.
Response:
As previously stated in our December 23, 2011 correspondence, the Company has not entered into any material written agreements with The National Institute of Allergy and Infectious Diseases with respect to the grant in question. Therefore, there is no exhibit that can be filed by the Company pursuant to Item 601(b)(10) of Regulation S-K.
orBec® License Agreement, page 15
3.
We note your response to our prior comment 5 that the license agreement with the University of Texas Medical Branch-Galveston contains no financial obligations to which the company is bound. However, we also note the disclosure on page 15 of your Form 10-K discussing this license which states, “Under the license agreements, we will be obligated to make performance-based milestone payments, as well as royalty payments on any sales of oral BDP.” Accordingly, we reissue the comment and ask that you describe the material terms of the license, including the aggregate milestones and royalty payments you will be obligated to make. In addition, please file the license agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K. Given that orBec is your most advanced product and that a confirmatory Phase 3 study is underway, it appears that this license is material to the company.
Response:
The license agreement with the University of Texas Medical Branch-Galveston relating to the application of oral BDP for the treatment of irritable bowel syndrome was terminated effective January 31, 2012. The Company did not generate any revenues from the technology licensed under the agreement and did not conduct any studies related to such technology. Accordingly, this license agreement is not a material contract within the meaning of Item 601(b)(10) of Regulation S-K.
RiVax Intellectual Property, page 15
4.
Please revise your exhibit index to correctly incorporate by reference the license agreement with UTSW as Exhibit 10.2 by referencing to Exhibit 10.9 to Form 10-KSB filed March 30, 2004.
Response:
We will revise our exhibit index to correctly incorporate by reference the license agreement with UTSW as Exhibit 10.2 by referencing to Exhibit 10.9 to Form 10-KSB filed March 30, 2004.
* * * * *
2
In connection with responding to the comment letter, we acknowledge 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.
If you require any additional information, kindly contact our outside legal counsel, Leslie J. Croland with Edwards Wildman Palmer LLP at (561) 833-7700.
Sincerely,
/s/ Christopher J. Schaber
Christopher J. Schaber
Chief Executive Officer and President
cc: Leslie J. Croland
3
Exhibit A
Prior Comment 2
The initial term of the Collaboration and Supply Agreement dated February 11, 2009 between the Company and Sigma-Tau Pharmaceuticals, Inc. (“Sigma-Tau”) expires on a country-by-country basis on the later of: (i) 10 years after the date of the first commercial sale of oral beclomethasone dipropionate (“orBec®”) by Sigma-Tau in such country; or (ii) the expiration of the last to expire of the Company’s patents and patent applications relating to orBec® in such country. Upon the expiration of the initial term, on a country-by-country basis, the agreement is automatically renewed for periods of five years. During such renewal periods, each of Sigma-Tau and the Company has the right to terminate the agreement for convenience upon six months and 18 months, respectively, prior written notice. If the Company terminates the agreement for convenience, the Company is required to transfer to Sigma-Tau or its designee, for no consideration, the U.S. Food and Drug Administration (the “FDA”) and European Medicines Agency (“EMEA”) authorizations which are necessary for the marketing, use, distribution and sale of orBec® and all relevant data and know-how necessary to manufacture and commercialize orBec® in the country and grant to Sigma-Tau a royalty-free, fully paid, perpetual and irrevocable license, with the right to sublicense, to the trademark “orBec” and such know-how.
Either party may terminate the agreement: (i) in the event the other party breaches any material obligation; or (ii) upon the initiation of a proceeding in bankruptcy (voluntary or involuntary), reorganization, dissolution, liquidation or similar proceeding or occurrence. The Company also has the right to terminate the agreement in the event that Sigma-Tau challenges or assists any third party in the challenge of the validity of any of the Company’s patents or patent applications relating to orBec®.
Upon termination other than for breach by Sigma-Tau, Sigma-Tau has the right to process and sell its inventory for a period of three months following the date of termination, subject to the payment of the amounts owed under the agreement to the Company and continued compliance with the terms of the agreement.
Prior Comment 3
On December 1, 2010, we entered into a definitive license agreement with the University of Colorado (“UC”) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures. The Company has an exclusive license to commercially exploit the covered products worldwide, subject to the right of UC, the inventors and future non-profit employers of the inventors, to make and use the covered products for industry-sponsored research, clinical, educational, research or other non-commercial purposes. In consideration for the license, the Company has paid to UC a license fee in the amount of approximately $20,000 and is required to pay to UC (i) certain out-of-pocket expenses incurred by UC in connection with the patent application and issued patent, (ii) milestone payments in the aggregate amount of $1,250,000 and (iii) royalty payments equal to a low single digit percentage of net sales of the covered products, with the minimum annual royalty payments ranging from $15,000 to $50,000 depending upon the stage of commercialization of the covered products.
Additionally, in the event that the Company sublicenses it rights under this license agreement, the Company will be required to pay UC a declining royalty percentage (depending upon when the sublicense is executed) of any income received by the Company from any sublicensee (excluding royalties) to the Company.
4
The license agreement expires upon the expiration of the licensed patents. The Company has the right to terminate this agreement upon 60 days prior written notice to UC provided the Company pays all amounts then due. After such termination, the Company will have the right to sell its inventory for a period not to exceed six months, subject to the payment of the amounts owed under the agreement. UC has the right to terminate the agreement upon: (i) the Company becoming insolvent or declaring bankruptcy; (ii) 60 days notice, if the Company breaches any obligation under the agreement without curing such breach during such notice period; (iii) the Company violating laws or regulations of governmental authorities which have a material adverse effect on the Company; or (iv) the Company instituting action challenging the validity of the licensed patent.
Prior Comment 4
On November 24, 1998, the Company, Enteron Pharmaceuticals, Inc. (“Enteron”) and George B. McDonald (“Dr. McDonald”) entered into an exclusive license agreement for the rights to intellectual property, including know-how, relating to orBec®. The Company has an exclusive license to commercially exploit the covered products worldwide, subject to Dr. McDonald’s right to make and use the technology for research purposes and the U.S. Government’s right to use the technology for government purposes. In consideration for the license, the Company has paid to Dr. McDonald a license fee in the amount of $20,000 and is required to (i) reimburse Dr. McDonald for certain out-of-pocket expenses incurred by Dr. McDonald in connection with the patent applications and issued patents, (ii) pay Dr. McDonald a milestone payment in the amount of $300,000; (iii) issue Dr. McDonald shares of common stock equal to 8% of the Company’s outstanding common stock as of November 24, 1998, with certain anti-dilution protection, and (iv) pay Dr. McDonald royalty payments equal to 6% of net sales of the covered products.
Additionally, in the event that the Company sublicenses it rights under this license agreement, the Company will be required to pay Dr. McDonald 25% of any sublicense fees and royalty payments paid by the sublicense to the Company.
The term of this agreement expires upon the expiration of the licensed patent applications or patents. After five years from the date of the agreement, Dr. McDonald has the right to terminate this agreement in its entirety or to terminate exclusivity under the agreement if the Company or its sublicense has not commercialized or are not actively attempting to commercialize a covered product.
Additionally, the agreement terminates: (i) automatically upon the Company becoming insolvent; (ii) upon 30 days notice, if the Company breaches any obligation under the agreement without curing such breach during the notice period; and (iii) upon 90 days notice by the Company. After any termination, the Company will have the right to sell its inventory for a period not to exceed three months following the date of termination, subject to the payment of the amounts owed under the agreement.
On July 26, 2011, the Company, Enteron, and Dr. McDonald entered into an amendment to their exclusive license agreement. Under the license agreement, Dr. McDonald would have been entitled to receive (i) $1,250,000 upon the closing of the July 26, 2011 amendment executed by the Company and Sigma-Tau; and (ii) $250,000 upon an approval of orBec® by the EMEA. Pursuant to the amendment, the Company agreed to pay Dr. McDonald (i) $612,500 in cash and $400,000 in common stock of the Company (based upon the closing price of the Company’s common stock on July 26, 2011) upon the closing of the amendment between the Company and Sigma-Tau and (ii) $400,000 in cash upon an approval of orBec® by the EMEA.
5
2012-01-20 - UPLOAD - SOLIGENIX, INC.
January 20, 2012 Via E-mail Joe Warusz Vice President Administ ration and Controller Soligenix, Inc. 29 Emmons Drive, Suite C-10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Form 10-K Filed March 30, 2011 File No. 000-16929 Dear Mr. Schaber: We have reviewed your response letter da ted December 28, 2012 and have the following comments. Please respond to this letter within te n business days 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 facts and circumstances or do not be lieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Form 10-K, filed March 30, 2011 1. We note your responses to our prior commen ts 2, 3 and 4 and your proposal to include revised disclosure in your upcoming 10-K for the fiscal year ended December 31, 2011. With respect to this disclosure specifica lly, and for any disclosure that you intend to revise in response to our comments in this le tter, please provide us with a draft of your proposed changes as soon as possible, so that we may have the opportunity to review and comment on the revisions. Business, page 3 2. We note your response to our prior comment 1 and reissue the comment in part. Please file as an exhibit the writte n agreement evidencing the gran t pursuant to Item 601(b)(10) of Regulation S-K. Joe Warusz Soligenix, Inc. January 20, 2012 Page 2 orBec License Agreement, page 15 3. We note your response to our prior comment 5 that the license agreement with the University of Texas Medical Branch-Galveston contains no financial obligations to which the company is bound. However, we also note the disclosure on page 15 of your Form 10-K discussing this license which states, “Under the license agreements, we will be obligated to make performance-based milest one payments, as well as royalty payments on any sales of oral BDP.” Accordingly, we reissue the comment and ask that you describe the material terms of the license, including the aggregate milestones and royalty payments you will be obligated to make. In addition, please file the license agreement as an exhibit pursuant to Item 601(b)(10) of Re gulation S-K. Given th at orBec is your most advanced product and that a confirmatory Phas e 3 study is underway, it appears that this license is material to the company. RiVax Intellectual Property, page 15 4. Please revise your exhibit index to correc tly incorporate by re ference the license agreement with UTSW as E xhibit 10.2 by referencing to Exhibit 10.9 to Form 10-KSB filed March 30, 2004. Please contact Johnny Gharib at (202) 551-3170, Daniel Greenspan at (202) 551-3623 or me at (202) 551-3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey Riedler Assistant Director
2011-12-23 - CORRESP - SOLIGENIX, INC.
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, New Jersey 08540
Phone: (609) 538-8200
December 23, 2011
VIA EDGAR
Mr. Jeffrey Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-0405
RE
Soligenix, Inc. (the “Company”)
Form 10-K
Filed March 30, 2011
SEC File No. 000-16929
Dear Mr. Riedler:
We are responding to your December 5, 2011 letter regarding our Form 10-K (the “Form 10-K”) for the fiscal year ended December 31, 2010. For your reference, we have included in this correspondence each comment from your letter followed by our response.
Form 10-K, filed March 30, 2011
Business, page 3
1.
We note that your main source of revenue has been grant funding from the National Institute of Health (“NIH”) and the National Institute of Allergy and Infectious Diseases (“NIAID”), a division of the NIH. Please revise your disclosure in your business section to disclose the material terms of these grants, including any conditions on funding, obligations under the grants, and the intellectual property rights of each party. Please file as exhibits any written agreements between the company and NIH or NIAID, as these appear to be material contracts within the meaning of Item 601(b)(10) of Regulation S-K.
Response:
As disclosed in the Company’s Form 10-K on pages 10, 11 and 16, the Company was awarded in September 2009 a $9.4 million grant from The National Institute of Allergy and Infectious Diseases (the “NIAID”), a division of the National Institute of Health (“NIH”). It is also disclosed that such grant will fund, over a five-year period, the development of the formulation and manufacturing processes for vaccines that are stable at elevated temperatures, as well as fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
December 23, 2011
Page 2
The Company also disclosed that its academic partner, the Fred Hutchinson Cancer Research Center (“FHCRC”), received a $1 million grant from the NIH to conduct preclinical studies of oral BDP for the treatment GI radiation injury. It is noted on page 11 of the Form 10-K, that the Company does not receive any monetary benefit from the NIH grant, but would benefit if the work being conducted at FHCRC is successful.
At the present time, the Company is the direct recipient of only one grant from the NIAID. The NIAID supports research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID has established research programs to facilitate development of countermeasures to select pathogens and toxins.
Through requests for applications, the NIAID invites research applications for projects that will lead to development of, among other things, new vaccines, vaccine technologies and therapeutics. In 2009, the Company submitted an application in response to a specific NIAID request and was awarded a $9.4 million grant, which, as disclosed in the Form 10-K, will cover a five-year period. Although the grant has specific requirements with which the Company must comply, such as periodic reporting of scientific activity and requests for reimbursement of expenses incurred under the grant and related facilities and administrative costs of the Company for direct employees working on the grant and other administrative costs, there is no separate written agreement entered into between the Company and NIAID or NIH that would constitute a material contract within the meaning of Item 601(b)(10) of Regulation S-K.
The relationship between the Company and NIAID under the grant in question does not involve any intellectual property rights or any other material terms. However, as with all U.S. Government grants like our NIAID grant, the U.S. Government retains the right (“march in rights”) to utilize the products being developed by the Company with the grant funds in the event that the U.S. Government determines that such use is in the national interest. It should be noted that this right has never been exercised by the U.S. Government. Accordingly, it is the Company’s position that there are no other disclosures that are required to be made in the Company’s Form 10-K with respect to the NIAID grant.
Commercialization and Market, page 6
2.
Please revise your disclosure to include the duration and termination provisions of your collaboration and supply agreement with Sigma-Tau Pharmaceuticals, Inc.
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
December 23, 2011
Page 3
Response:
The Company’s February 11, 2009 agreement with Sigma-Tau Pharmaceuticals, Inc. (“Sigma-Tau”) is incorporated into the Form 10-K by reference to Exhibit 10.43 of the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on February 13, 2009. The amendment to the agreement was also filed with the SEC on July 28, 2011. Although certain sections of the documents with regard to milestone payments and royalty rate computation have been redacted pursuant to confidential treatment requests which have been granted by the SEC, the duration and termination provisions of the agreement, which the Company believes are standard for an agreement of this nature, have not been redacted. Since the Company will be filing its Form 10-K for the fiscal year ending December 31, 2011 within less than four months from the date of this letter, we propose disclosing the duration and termination provisions of the agreement with Sigma-Tau in our next Form 10-K.
BioDefense Overview, page 10
3.
We note that in January 2011, you entered into a definitive license agreement with the University of Colorado. Please describe the material terms of this agreement, including, but not limited to any payment provisions, royalty rates, aggregate milestones, usage restrictions, exclusivity provisions, obligations/rights to defend, other rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions. Also, please file the agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K.
Response:
The Company’s retention of the $9.4 million grant from NIAID does not depend upon the Company retaining its rights under the University of Colorado license agreement. Accordingly, the license agreement with the University of Colorado is not presently generating any revenues for the Company and may never do so in the future unless the Company is able to commercialize the intellectual property licensed to it under the University of Colorado license agreement.
In addition, the Company initially paid the University of Colorado a license fee of $20,000 and is only obligated to make minimum annual royalty payments of approximately $15,000 and certain additional payments if the Company achieves specified milestones.
In view of the fact that the Company’s financial obligations under the license agreement are not material to the Company at this time and that the Company is not presently generating any revenues as a result of the intellectual property rights granted to the Company under the license agreement, the Company does not consider the agreement to be a material contract within the meaning of Item 601(b)(10) of Regulation S-K. If and when the Company is successful in commercializing the intellectual property covered by the University of Colorado license agreement and is generating revenues from products utilizing the intellectual property, the Company will file the agreement as a material contract at such time. In addition, the Company proposes to describe all material terms of the license agreement in the Company’s Form 10-K that will be filed with the SEC within four months from the date of this letter. The Company however, will seek confidential treatment of any information relating to milestone payments. We trust that this proposal is acceptable to the staff.
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
December 23, 2011
Page 4
orBec® License Agreement, page 15
4.
We note that in November 1998, you entered into an exclusive, worldwide, royalty bearing license agreement with Dr. George B. McDonald for the rights to the intellectual property and know-how relating to orBec®. Please describe the material terms of this agreement, including, but not limited to, any payment provisions, royalty rates, aggregate milestones, obligations/rights to defend, other rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions.
Response:
The Company filed its license agreement with Dr. McDonald on February 13, 2009 with the Company’s Registration Statement on Form S-1, and has incorporated such agreement into the Form 10-K. In addition, the amendment with Dr. McDonald was also filed on July 28, 2011 as an exhibit to the Company’s Form 8-K. Therefore, the company has in effect disclosed all material terms of such license agreement, as amended. Since the Company will be filing its Form 10-K for the fiscal year ending December 31, 2011 within the next four months, we propose to include all material terms of the license agreement, as amended, in our next Form 10-K.
5.
We note that you also executed an exclusive license to patent applications for “Use of Anti-Inflammatories to Treat Irritable Bowel Syndrome” from the University of Texas Medical Branch-Galveston. Please describe the material terms of these license agreements, including, but not limited to any payment provisions, royalty rates, aggregate milestones, usage restrictions, obligations/rights to defend, other rights obtained and material obligations that must be met to keep the agreements in place, duration and termination provisions. Also, please file the license agreements as exhibits pursuant to Item 601(b)(10) of Regulation S-K.
Response:
The license agreement with University of Texas Medical Branch-Galveston contains no financial obligations to which the Company is bound, and the Company does not generate any revenues from the agreement. Accordingly, the Company does not believe that this license agreement is a material contract within the meaning of Item 601(b)(10) of Regulation S-K.
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
December 23, 2011
Page 5
RiVax Intellectual Property, page 15
6.
We note that in June 2004, you entered into a license agreement with UTSW for the injectable rights to the ricin vaccine, and in October 2004, you negotiated the remaining oral rights to the ricin vaccine. Please describe the material terms of the license agreement, including, but not limited to royalty rates, aggregate milestones, usage restrictions, exclusivity provisions, obligations, rights to defend, other rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions. Also, please file the license agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K.
Response:
The Company’s license agreement with the University of Texas Southwestern Medical Center (“UTSW”) is described on page 15 of the Form 10-K. In addition, the license agreement is incorporated into the Form 10-K as Exhibit 10.2 by reference to Exhibit 10.8 of the Company’s Form 10-KSB, as amended, for the fiscal year ended December 31, 2004. As with the other license agreements mentioned in this letter, the Company does not believe that its financial obligations under the agreement are material and presently does not generate any revenues from the intellectual property licensed to it by UTSW. In view of the fact that the UTSW license agreement has not generated any revenues for the Company and does not contain any material financial obligations to which the Company is bound, the Company does not believe that this license agreement is a material contract within the meaning of Item 601(b)(10) of Regulation S-K.
In connection with responding to the comment letter, we acknowledge 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.
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
December 23, 2011
Page 6
If you require any additional information, please contact our outside legal counsel, Leslie J. Croland with Edwards Wildman Palmer LLP at (561) 833-7700.
Sincerely,
/s/ Christopher J. Schaber
Christopher J. Schaber, Ph.D.
Chief Executive Officer and President
cc: Leslie J. Croland, P.A.
2011-12-07 - CORRESP - SOLIGENIX, INC.
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Edwards Wildman Palmer LLP
525 Okeechobee Boulevard, Suite 1600
West Palm Beach, FL 33401
December 7, 2011
VIA EDGAR
Mr. Jeffrey Riedler
Assistant Director
Division of Corporations Finance
United States Securities & Exchange Commission
100 F Street, N.E.
Washington, DC 20549-0405
Re:
Soligenix, Inc.
Form 10-K
Filed March 30, 2011
SEC File No. 000-16929
Dear Mr. Riedler:
On behalf of our client, Soligenix, Inc. (the “Company”), we hereby advise you that it is the Company’s intention to respond to your December 5, 2011 letter by no later than December 29, 2011. If the staff has any questions regarding this letter, please do not hesitate to contact me at 561-820-0212.
Sincerely,
/s/ Leslie J. Croland
Leslie J. Croland
LJC
2011-12-05 - UPLOAD - SOLIGENIX, INC.
December 5, 2011 Via E-mail Joe Warusz Vice President Administ ration and Controller Soligenix, Inc. 29 Emmons Drive, Suite C-10 Princeton, New Jersey 08540 Re: Soligenix, Inc. Form 10-K Filed March 30, 2011 File No. 000-16929 Dear Mr. Schaber: We have reviewed your filing and have the following comments. Please respond to this letter within te n business days 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 facts and circumstances or do not be lieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we ma y have additional comments. Form 10-K, filed March 30, 2011 Business, page 3 1. We note that your main source of revenue has been grant funding from the National Institute of Health (“NIH”) and the National In stitute of Allergy and Infectious Diseases (“NIAID”), a division of the NI H. Please revise your disclo sure in your business section to disclose the material terms of thes e grants, including any conditions on funding, obligations under the grants, and the intellectua l property rights of each party. Please file as exhibits any written agreements between the company and NIH or NIAID, as these appear to be material contract s within the meaning of Item 601(b)(10) of Regulation S-K. Commercialization and Market, page 6 2. Please revise your disclosure to include th e duration and termina tion provisions of your collaboration and supply agreement with Sigma-Tau Pharmaceuticals, Inc. Joe Warusz Soligenix, Inc. December 5, 2011 Page 2 BioDefense Overview, page 10 3. We note that in January 2011, you entered into a definitive license agreement with the University of Colorado. Please describe the ma terial terms of this agreement, including, but not limited to any payment provisions, r oyalty rates, aggregate milestones, usage restrictions, exclusivity provisi ons, obligations/rights to de fend, other rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions. Also, please file the agreement as an exhibit pursuant to Item 601(b)(10) of Regulation S-K. orBec License Agreement, page 15 4. We note that in November 1998, you entered into an exclusive, worldwide, royalty bearing license agreement with Dr. George B. McDonald for the rights to the intellectual property and know-how relating to orBec. Pl ease describe the material terms of this agreement, including, but not limited to, any payment provisions, roya lty rates, aggregate milestones, obligations/rights to defend, othe r rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions. 5. We note that you also executed an exclusive license to patent applications for “Use of Anti-Inflammatories to Treat Irritable Bowe l Syndrome” from the University of Texas Medical Branch-Galveston. Please describe the material terms of these license agreements, including, but not limited to any payment provisions, roya lty rates, aggregate milestones, usage restrictions, obligations/r ights to defend, other rights obtained and material obligations that must be met to keep the agreements in place, duration and termination provisions. Also, please file the license agreements as exhibits pursuant to Item 601(b)(10) of Regulation S-K. RiVax Intellectual Property, page 15 6. We note that in June 2004, you entered into a license agreement with UTSW for the injectable rights to the ricin vaccine, a nd in October 2004, you negotiated the remaining oral rights to the ricin vaccine. Please de scribe the material terms of the license agreement, including, but not limited to r oyalty rates, aggregate milestones, usage restrictions, exclusivity provi sions, obligations, rights to defend, other rights obtained and material obligations that must be met to keep the agreement in place, duration and termination provisions. Also, please file the license agreemen t as an exhibit pursuant to Item 601(b)(10) of Regulation S-K. 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. Joe Warusz Soligenix, Inc. December 5, 2011 Page 3 In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy an d 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 Johnny Gharib at (202) 551-3170, Daniel Greenspan at (202) 551-3623 or me at (202) 551-3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey Riedler Assistant Director
2010-09-07 - UPLOAD - SOLIGENIX, INC.
September 2, 2010
Christopher J. Schaber, Ph.D. President and Chief Executive Officer (Principal Executive Officer) Soligenix, Inc. 29 Emmons Drive Suite C-10 Princeton, NJ
Re: Soligenix, Inc. Form 8-K
Filed August 20, 2010 File No. 000-16929
Dear Mr. Schaber:
We have completed our review of your Form 8-K and have no further comments at this
time.
S i n c e r e l y ,
T a b a t h a A k i n s
Staff Accountant
2010-09-02 - CORRESP - SOLIGENIX, INC.
CORRESP
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, New Jersey 08540
Phone: (609) 538-8200
September 2, 2010
VIA EDGAR AND FAX (202-772-9198)
Ms. Tabatha Atkins, Staff Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Form 8-K
Filed August 20, 2010
File No. 000-16929
Dear Ms. Atkins:
We are responding to your August 30, 2010 comment letter. For your reference, we have included the comments from your letter followed by our responses.
Item 4.01. Changes in Registrant's Certifying Accountant.
1.
The letter provided by your former accountants, Amper, Politziner & Mattia, LLP, references the Form 8-K filed on August 20, 2010. As the amended Form 8-K filed on August 25, 2010 contains revised disclosure, please have Amper, Politziner & Mattia, LLP update their letter.
Response:
We will amend the Form 8-K to attach an updated letter from Amper, Politziner & Mattia to reference the amended Form 8-K filed on August 25, 2010.
* * * * *
In connection with responding to the comment letter, we acknowledge 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.
If you require any additional information, kindly contact our outside legal counsel, Leslie J. Croland with Edwards Angell Palmer & Dodge LLP at (561) 833-7700.
Sincerely,
/s/ Christopher P. Schnittker
Christopher P. Schnittker
Vice President of Administration and Controller
Cc: Christopher J. Schaber, Chief Executive Officer and President
Leslie J. Croland, P.A.
2010-08-30 - UPLOAD - SOLIGENIX, INC.
August 30, 2010
Christopher J. Schaber, Ph.D. President and Chief Executive Officer (Principal Executive Officer) Soligenix, Inc. 29 Emmons Drive Suite C-10 Princeton, NJ
Re: Soligenix, Inc. Amended Form 8-K
Filed August 25, 2010 File No. 000-16929
Dear Mr. Schaber:
We have reviewed your amended filing and have the following comment.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comment applies to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to this comment, we may have additional comments.
Item 4.01. Changes in Registra nt’s Certifying Accountant.
1. The letter provided by your former accountants, Amper, Politziner & Mattia, LLP references the Form 8-K filed on August 20, 2010. As the amended Form 8-K filed on August 25, 2010 contains revised disclosures, please have Amper, Politziner & Mattia,
LLP update their letter. Refer to Item 304(a)(3) of Regulation S-K.
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 comment, please provide a written statement from the company
acknowledging that:
Christopher J. Schaber, Ph.D. Soligenix, Inc. August 30, 2010 Page 2
• the company is responsible for the adequacy and accuracy of the disclo sure in the filing;
• staff comment 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 comment 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 call me at (202) 551-3658.
S i n c e r e l y , T a b a t h a A k i n s S t a f f A c c o u n t a n t
2010-08-25 - CORRESP - SOLIGENIX, INC.
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, New Jersey 08540
Phone: (609) 538-8200
August 25, 2010
VIA EDGAR AND FAX (202-772-9198)
Ms. Tabatha Atkins, Staff Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
RE:
Soligenix, Inc.
Form 8-K
Filed August 20, 2010
File No. 000-16929
Dear Ms. Atkins:
We are responding to your August 24, 2010 comment letter. For your reference, we have included the comments from your letter followed by our responses.
Item 4.01. Changes in Registrant's Certifying Accountant.
1.
Please amend your filing to specify whether, during your past two fiscal years through August 16, 2010, you consulted Eisner LLP regarding any of the matters outlined in Item 304(a)(2) of Regulation S-K. The current disclosure is silent with respect to the year ended December 31, 2008.
Response:
We will amend the Form 8-K to indicate that we have not, during our past two fiscal years through August 16, 2010, consulted Eisner LLP regarding any of the matters outlined in Item 304(a)(2) of Regulation S-K.
2.
Upon amending your filing, please include, as Exhibit 16, a letter from your former accountants, Amper, Politziner & Mattia, LLP, as required by Item 304(a)(3) of Regulation S-K. Please ensure that your former accountants date their letter.
Response:
We will include with the amended Form 8-K, as Exhibit 16, a dated letter from our former accountants, Amper, Politziner & Mattia, LLP, as required by Item 304(a)(3) of Regulation S-K.
* * * * *
In connection with responding to the comment letter, we acknowledge 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.
If you require any additional information, kindly contact our outside legal counsel, Leslie J. Croland with Edwards Angell Palmer & Dodge LLP at (561) 833-7700.
Sincerely,
/s/ Christopher P. Schnittker
Christopher P. Schnittker
Vice President of Administration and Controller
Cc:
Christopher J. Schaber, Chief Executive Officer and President
Leslie J. Croland, P.A.
2010-08-24 - UPLOAD - SOLIGENIX, INC.
August 24, 2010
Christopher J. Schaber, Ph.D.
President and Chief Executive Officer
(Principal Executive O fficer)
Soligenix, Inc.
29 Emmons Drive
Suite C -10
Princeton, NJ
Re: Soligenix, Inc.
Form 8-K
Filed August 20, 2010
File No. 000-16929
Dear Mr. Schaber :
We have reviewed your filing an d 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 amending your filing, by
providing the requested information, or by advising us when you will pr ovide the requested
response. 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 filing and the information you provide in
response to these comments, we may have additional comments.
Item 4.01. Changes in Regis trant’s Certifying Accountant.
1. Please amend your filing to specify whether, during your p ast two fiscal years through
August 16, 2010 , you consulted Eisner LLP regarding any of the matters outlined in Item
304(a)(2) of Regulation S -K. The current disclosure is silent with respect to the year
ended December 31, 2008.
2. Upon amending your filing, please include, as Exhibit 16, a letter from your former
accountants, Amper, Politziner & Mattia, LLP , as required by Item 304(a)(3) of
Regulation S -K. Please ensure that your former accountants date their letter.
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 Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
Christopher J. Schaber, Ph.D.
Soligenix, Inc.
August 24, 2010
Page 2
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of t he disclosures they have made.
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 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.
If you have any questions, please do not hesitate to call me at (202) 551 -3658.
Sincerely,
Tabatha Akins
Staff Accountant
2010-07-12 - CORRESP - SOLIGENIX, INC.
CORRESP
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Soligenix, Inc. 29 Emmons Drive, Suite C-10, Princeton, New Jersey 08540
July 12, 2010
Via EDGAR and Facsimile (202) 772-9198
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jeffrey P. Riedler, Assistant Director
Re:
Soligenix, Inc.
Pre-Effective Amendment No. 1 to Form S-1 Registration Statement
Filed July 9, 2010
File No. 333-167792
Ladies and Gentlemen:
The undersigned hereby respectfully requests, pursuant to Rule 461 of the Securities Act of 1933, as amended, that Pre-Effective Amendment No. 1 to Form S-1 Registration Statement filed by Soligenix, Inc. (the “Company”) with the United States Securities and Exchange Commission (the “Commission”) on July 9, 2010 (File No. 333-167792) be declared effective as of 4:00 p.m., Eastern Daylight Time, on Tuesday, July 13, 2010, or as soon thereafter as possible.
The undersigned hereby acknowledges that (i) 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; (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 any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
Soligenix, Inc.
By:
/s/ Evan Myrianthopoulos
Evan Myrianthopoulos
Chief Financial Officer
cc: Rose Zukin, Division of Corporation Finance
Christopher J. Schaber, Chief Executive Officer and President
Leslie J. Croland, Esq.
2010-07-09 - CORRESP - SOLIGENIX, INC.
CORRESP
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SOLIGENIX, INC.
29 Emmons Drive, Suite C-10
Princeton, New Jersey 08540
Phone: (609) 538-8200
July 8, 2010
VIA EDGAR AND FAX (202-772-9198)
Mr. Jeffrey P. Riedler, Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-0405
RE:
Soligenix, Inc.
Registration Statement on Form S-1
Filed June 25, 2010
File No. 333-167792
Dear Mr. Riedler:
We are responding to your July 2, 2010 comment letter. For your reference, we included the comment from your letter followed by our response.
Form S-1 filed June 25, 2010
Selling Stockholders, page 43
1.
We note that certain members of your Board of Directors are listed as selling shareholders, as well as Sigma Tau Pharmaceuticals, Inc. Please revise your registration statement to identify these board members and Sigma Tau Pharmaceuticals as underwriters, or provide us with a detailed legal analysis supporting your position that these selling shareholders are not underwriters. Please refer to Securities Act Rules, Compliance and Disclosure Interpretation 612.09.
Response:
Sigma Tau Pharmaceuticals, Inc., Gregg A. Lapointe and Robert J. Rubin have waived their rights under the Registration Rights Agreement dated June 15, 2010 to have the resale of their shares of common stock and shares of common stock issuable upon exercise of warrants registered in the Registration Statement on Form S-1. Accordingly, we will file a Pre-Effective Amendment to the Registration Statement on Form S-1 to remove the shares to be registered on behalf of Sigma Tau Pharmaceuticals, Inc., Gregg A. Lapointe and Robert J. Rubin and to remove them as selling stockholders.
If you require any additional information, kindly contact our outside legal counsel, Leslie J. Croland with Edwards Angell Palmer & Dodge LLP at (561) 833-7700.
Sincerely,
/s/ Evan Myrianthopoulos
Evan Myrianthopoulos
Chief Financial Officer
Cc:
Rose Zukin, Staff Attorney
Christopher J. Schaber, Chief Executive Officer and President
Leslie J. Croland, P.A.
2010-07-02 - UPLOAD - SOLIGENIX, INC.
July 2, 2010 Christopher J. Schaber, Ph.D. President and Chief Executive Officer Soligenix, Inc. 29 Emmons Drive, Suite C-10 Princeton, NJ 08540 Re: Soligenix, Inc. Registration Statement on Form S-1 Filed June 25, 2010 File No. 333-167792 Dear Dr. Schaber: We have limited our review of your registra tion 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. 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 re gistration statement and the information you provide in response to these comments, we may have additional comments. Form S-1 filed June 25, 2010 Selling Stockholders, page 43 1. We note that certain members of your Bo ard of Directors are listed as selling shareholders, as well as Sigma Tau Pharmaceuti cals, Inc. Please revise your registration statement to identify these board members and Sigma Tau Pharmaceuticals as underwriters, or provide us with a detailed legal analysis supporting your position that these selling shareholders are not underwrite rs. Please refer to Securities Act Rules, Compliance and Disclosure Interpretation 612.09. 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 incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in Christopher J. Schaber, Ph.D. Soligenix, Inc. July 2, 2010 Page 2 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 event you request acceleration of the effective date of the pending registration statement please pr ovide a written statement from the company acknowledging that: • should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission 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 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. Please refer to Rules 460 and 461 regarding re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Rose Zukin at (202) 551-3239 or me at (202) 551-3710 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director cc: Leslie J. Croland, Esq. Edwards Angell Palmer & Dodge LLP 525 Okeechobee Blvd., Suite 1600 West Palm Beach, FL 33401
2009-04-15 - CORRESP - SOLIGENIX, INC.
CORRESP
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DOR
BioPharma, Inc. 29 Emmons Drive, Suite C-10, Princeton, New Jersey
08540
April 15,
2009
Via EDGAR and Facsimile
(202) 772-9217
Division
of Corporation Finance
United
States Securities and Exchange Commission
100 F
Street, N.E.
Washington,
D.C. 20549-4561
Attn: Jeffrey
P. Riedler
Re: DOR
BioPharma, Inc.
Pre-Effective Amendment No. 1 to Form
S-1 Registration Statement
Filed April 14, 2009
File No. 333-157322
Ladies
and Gentlemen:
The
undersigned hereby respectfully requests, pursuant to Rule 461 of the Securities
Act of 1933, as amended, that Pre-Effective Amendment No. 1 to Form S-1
Registration Statement filed by DOR BioPharma, Inc. (the “Company”) with the
United States Securities and Exchange Commission (the “Commission”) on April 14,
2009 (File No. 333-157322) be declared effective as of 4:00 p.m., Eastern Time,
on Friday, April 17, 2008, or as soon thereafter as possible.
The
undersigned hereby acknowledges that (i) 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;
(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 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,
DOR
BioPharma, Inc.
By: /s/ Christopher J.
Schaber
Christopher
J. Schaber, Ph.D.
President
and Chief Executive Officer
cc: Leslie
J. Croland, Esq.
2009-04-15 - CORRESP - SOLIGENIX, INC.
CORRESP
1
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Leslie
J. Croland, P.A.
561.820.0212
fax
561.655.8719
lcroland@eapdlaw.com
April 14,
2009
Via EDGAR and Facsimile
(202) 772-9217
Division
of Corporation Finance
United
States Securities and Exchange Commission
100 F
Street, N.E.
Washington,
D.C. 20549-4561
Attn: Jeffrey
P. Riedler
Re: DOR
BioPharma, Inc.
Registration Statement on Form S-1 (the
"Registration Statement")
Filed February 13, 2009
File No. 333-157322
Ladies
and Gentlemen:
On behalf
of DOR BioPharma, Inc., we are filing Pre-Effective Amendment No. 1 to the
Registration Statement (the “Amendment”) in order to address the comment set
forth in the letter dated February 25, 2009 from the staff (the “Staff”) of the
United States Securities and Exchange Commission. The Amendment
provides updated financial statements and financial information throughout the
filing pursuant to Rule 8-08 of Regulation S-X. The Amendment also is
being filed to register additional shares.
If the
Staff has any questions or comments, please contact the undersigned at (561)
820-0212.
Sincerely,
/s/
Leslie J. Croland
Leslie J.
Croland, P.A.
2009-02-25 - UPLOAD - SOLIGENIX, INC.
Mail Stop 6010 February 25, 2009 Christopher J. Schaber, Ph.D. President and Chief Executive Officer DOR BioPharma, Inc. 850 Bear Tavern Road, Suite 201 Ewing, New Jersey 08628 Re: DOR BioPharma, Inc. Registration Statement on Form S-1 Filed February 13, 2009 File No. 333-157322 Dear Mr. Schaber: We have limited our review of your filing to those issues we have addressed in our comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we w ill consider your explanation as to why our comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary in your explanation. In some of our comme nts, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this 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. Please provide updated financial statemen ts and financial information throughout the filing pursuant to Rule 8-08 of Regulation S-X. Pending Confidential Tr eatment Application 2. It appears that the Company has a pendi ng request for confidential treatment in connection with an application filed February 13, 2009 (Control No. 23161). We Christopher J. Schaber, Ph.D. DOR BioPharma, Inc. February 25, 2009 Page 2 are currently processing this request and will issue comments, if any, to you in a separate letter that will be forthcoming. Please be advised that we will not be in a position to consider a request for acceleration of effec tiveness of the registration statement until we resolve all issues con cerning the confidential treatment request. * * * 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 ev ent 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; • 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. Christopher J. Schaber, Ph.D. DOR BioPharma, Inc. February 25, 2009 Page 3 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 460 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 Ac harya 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: Leslie J. Croland, Esq. Edwards Angell Palmer & Dodge LLP One North Clematis Street, Suite 400 West Palm Beach, Florida 33401-5552
2008-04-02 - CORRESP - SOLIGENIX, INC.
CORRESP
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s1accelerationfusion.htm
DOR BioPharma, Inc. 850 Bear
Tavern Road, Suite 201, Ewing, New Jersey 08628
April 2,
2008
Via EDGAR and Facsimile
(202) 772-9217
United
States Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, N.E.
Washington,
D.C. 20549-4561
Attn: Jeffrey
P. Riedler
Re: DOR
BioPharma, Inc.
Registration Statement on Form S-1 (the
"Registration Statement")
Initially Filed February 14,
2008
File No. 333-149239
Ladies
and Gentlemen:
The
undersigned hereby respectfully requests, pursuant to Rule 461 of the Securities
Act of 1933, as amended, that the Registration Statement on Form S-1 originally
filed by DOR BioPharma, Inc. (the “Company”) with the United States Securities
and Exchange Commission (the “Commission”) on February 14, 2008 (File No.
333-149239), as amended, be declared effective as of 4:00 p.m., Eastern Time, on
Friday, April 4, 2008, or as soon thereafter as possible.
The
undersigned hereby acknowledges that (i) 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;
(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 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,
DOR
BioPharma, Inc.
By: /s/ Christopher J,
Schaber
Christopher
J. Schaber
President
and Chief Executive Officer
cc: Leslie
J. Croland, Esq.
2008-03-31 - CORRESP - SOLIGENIX, INC.
CORRESP
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secletterons1amend.htm
EDWARDS
ANGELL PALMER & DODGE LLP
One North
Clematis Street, Suite 400
West Palm
Beach, FL 33417
March 31,
2008
Via EDGAR and Facsimile
(202) 772-9217
United
States Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, N.E.
Washington,
D.C. 20549-4561
Attn: Jeffrey
P. Riedler
Re: DOR
BioPharma, Inc.
Registration Statement on Form S-1 (the
"Registration Statement")
Initially Filed February 14,
2008
File No. 333-149239
Ladies
and Gentlemen:
On behalf
of DOR BioPharma, Inc. (the “Company”), we are filing Amendment No. 1 to the
Registration Statement in order to address the comment set forth in the letter
dated February 15, 2008 from the staff of the United States Securities and
Exchange Commission. The updated financial information includes the
audited financial statements of the Company for the fiscal year ended December
31, 2007. The Amendment also is being filed to register additional
shares.
If you
have any questions, please contact the undersigned at (954)
667-6129.
Sincerely,
/s/
Leslie J. Croland
Leslie J.
Croland, P.A.
2008-02-15 - UPLOAD - SOLIGENIX, INC.
Mail Stop 6010 February 15, 2008 Christopher J. Schaber President and Chief Executive Officer DOR BioPharma, Inc. 850 Bear Tavern Road, Suite 201 Ewing, NJ 08628
Re: DOR BioPharma, Inc.
Registration Statement on Form S-1 Filed February 14, 2008 File Number 333- 149239
Dear Mr. Schaber:
We have reviewed your filing and have the fo llowing comment. Where indicated, we think
you should revise your document in response to this comment. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed
as necessary in your explanation.
Form S-1
1. Please note that as of February 15, 2008, the financial statements incl uded in your filing are
no longer timely. Please provide the company’s audited financial statements for the fiscal
year ended December 31, 2007.
* * *
We urge all persons who are responsible for th e 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 re sponsible for the accuracy and adequacy of the
disclosures they have made.
Christopher J. Schaber
DOR BioPharma, Inc. February 15, 2008 Page 2
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 pursua nt 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 re lieve the company from its full responsibility for the adequacy
and accuracy of the disclosure in the filing; and
• the company may not assert this action 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 advised th at the Division of Enforcement has access to all information
you provide to the staff of the Divi sion of Corporation Finance in c onnection 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 a confirmation of the fact that those requesting acceleration are aw are of their respective
responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they
relate to the proposed public offeri ng of the securities sp ecified in the above registration statement.
We will act on the request and, pursuant to delegate d authority, grant acceleration of the effective
date. Please contact Rose Zukin at (202) 551-3239 or me at (202) 551-3710 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: Leslie J. Croland, Esq.
Edwards Angell Palmer & Dodge LLP 350 East Las Olas Blvd., Suite 1150 Fort Lauderdale, FL 33334-3607
2007-04-17 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR
BioPharma,
Inc.
1101
Brickell Avenue, Suite 701-S
Miami,
Florida 33131
April
16,
2007
VIA
FACSIMILE AND EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F
Street, NE
Washington,
D.C. 20549
Attention:
John Krug
Re: DOR
BioPharma, Inc.
Registration
Statement on Form SB-2
Pre-Effective
Amendment No. 1
Filed
April 13, 2007
File
No. 333-141209
Ladies
and Gentlemen:
The
undersigned hereby respectfully requests, pursuant to Rule 461 of the Securities
Act of 1933, as amended, that the Registration Statement on Form SB-2 originally
filed with the Securities and Exchange Commission (the “Commission”) on March 9,
2007 (File No. 333-141209), as amended by the Pre-Effective Amendment No. 1
to
the Registration Statement on Form SB-2, by DOR BioPharma, Inc. (the “Company”)
be declared effective as of 3:00 p.m. Eastern Time on Wednesday, April 18,
2007,
or as soon thereafter as possible.
The
undersigned hereby acknowledges that (i) 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;
(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 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,
DOR
BIOPHARMA, INC.
By:/s/
Christopher J. Schaber
Christopher
J. Schaber
President
and Chief Executive Officer
cc: Leslie
J.
Croland, Esq.
2007-03-13 - UPLOAD - SOLIGENIX, INC.
Mail Stop 6010
March 13, 2007
Mr. Christopher J. Schaber
President and Chief Executive Officer
DOR BioPharma, Inc.
1101 Brickell Avenue, Suite 701-S
Miami, Florida 33131
Re: DOR BioPharma, Inc.
Registration Statement on Form SB-2
Filed March 9, 2007
File No. 333-141209
Dear Mr. Schaber:
We have limited our review of your filing to those issues we have addressed in
our comments pertaining to signatures. 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 inappl icable or a revision is unnecessary. Please
be as detailed as necessary in your explanat ion. In some of our comments, we may ask
you to provide us with information so we may better understand your disclosure. After
reviewing this 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.
Signatures
1. The registration statement should also be si gned by the registrant’s controller or
principal accounting officer . Any person who occupies more than one of the
specified positions required to sign the registration statement should indicate each
capacity in which the registra tion statement is signed. S ee instructions 1 and 2 to
Signatures to Form SB-2.
* * * * *
Mr. Christopher J. Schaber
Dor BioPharma, Inc.
March 13, 2007
Page 2
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;
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.
Mr. Christopher J. Schaber
DOR BioPharma, Inc.
March 13, 2007
Page 3
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.
If you have any questions, please call J ohn L. Krug, Senior Counsel, at (202) 551-
3862, or me at (202) 551-3715.
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: Leslie J. Croland, Esq.
2007-02-05 - UPLOAD - SOLIGENIX, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 January 30, 2007 Mr. Evan Myrianthopoulos Chief Financial Officer DOR Biopharma, Inc. 1101 Brickell Avenue, 701-S Miami, FL 33131 Re: DOR Biopharma, Inc. Form 10-KSB for the Fiscal Year Ended December 31, 2005 Filed March 31, 2006 File No. 000-16929 Dear Mr. Myrianthopoulos: We have completed our review of your Form 10-KSB and have no further comments at this time. S i n c e r e l y , J i m B . R o s e n b e r g Senior Assistant Chief Accountant
2007-01-25 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR
BioPharma, Inc.
1101
Brickell Avenue
701-S
Miami,
FL
33131
January
25, 2007
SENT
VIA EDGAR
Amy
C. Bruckner
Staff
Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
RE:
Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended
December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.
Dear
Ms.
Buckner:
This
letter is in response to the conference call we had on January 16, 2007 at
11:45
am concerning comment 5 of your letter dated December 5, 2006.
We
acknowledge that the variable accounting treatment of the stock options issued
in December 2004 may have been misapplied and that the $285,000 expense taken
in
2004 should not have been recorded. With respect to FIN 28 we conclude that
since the options were not available at the time they were granted a grant
date
did not exist so it was not necessary to record this expense. We will ensure
that all future applications of FIN 28 and accounting policies with respect
to
stock options and grant dates will be accurately reflected. Our accounting
policy in all future financial statements will reflect this treatment of stock
options.
In
connection with our responses to your comments, we acknowledge
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 utilize staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal securities
laws of the United States.
If
you
should have any further questions please do not hesitate to call me at
786-425-3848.
Sincerely,
/s/Evan
Myrianthopoulos
Evan
Myrianthopoulos
Chief
Financial Officer
DOR
BioPharma, Inc.
MD/SEC/2Comment
2006-12-18 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR SEC Comment Letter 2nd Response for Letter of 12-5-06
DOR
BioPharma, Inc.
1101
Brickell Avenue
701-S
Miami,
FL
33131
December
18, 2006
SENT
VIA EDGAR
Amy
C. Buckner
Staff
Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
RE:
Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended
December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.
Dear
Ms.
Buckner:
Thank
you
for the opportunity to work with you and discuss the disclosure requirements.
This letter is in response to your letter dated December 5, 2006. Below please
find our responses to your inquiries and comments.
Form
10-KSB for the Fiscal Year Ended December 31,
2005
Management’s
Discussion and Analysis or Plan of Operation
Material
Changes in Results of Operations
1.
We
acknowledge your response to comment 2. Please provide us with additional
information, in a disclosure-type format, that reconciles the total research
and
development expense presented in your proposed disclosure for each project
to
the total research and development expense on the face of your statement of
operations for the year ended December 31, 2005. More specifically, the
aggregate 2005 expense per proposed disclosure appears to be $5,766,478, which
does not reconcile to the face of your 2005 statement of operations. Please
either reconcile the individual project information to the aggregate 2005
expense or tell us why the amounts per your proposed disclosure do not reconcile
to the 2005 statement.
RESPONSE
for 1.:
We
hereby
supplement the information previously supplied to you for comment 2..
The
table
below details our costs for 2005 and 2006 by project.
2005
Projects-Research
& Development Expenses
orBec®
$
2,209,770
RiVax™
480,120
BT-VACC™
979,247
Oraprine™
8,100
LPMTM-Leuprolide
3,900
Research
& Development Expense
$
3,681,137
Projects-Reimbursed
under Grant
orBec®
$
124,958
RiVax™
1,942,076
BT-VACC™
-
Oraprine™
-
LPMTM-Leuprolide
-
Reimbursed
under Grant
$
2,067,034
TOTAL
$
5,748,171
In
addition, from previous response to 2.A, that read:
“Since
2000, we have incurred expenses of $13,925,498 in the development of
orBec®.
Research and development costs for orBec®
totaled $2,209,770 in 2005 and $1,940,052 in the second quarter of 2006. Since
June 30th
2006, we anticipate that the remaining R&D costs for orBec®
will
approximate $2 million. If orBec®
is
approved by the FDA in the first quarter of 2007, we expect
orBec®
to
begin generating revenues by the third quarter of 2007. If the FDA rejects
the
NDA or does not approve orBec®
in a
timely manner, our financial condition, liquidity, and ability to raise
additional equity financing could be impaired.”
Correction
to read:
Since
2000, we have incurred expenses of $13,925,498 in the development of
orBec®.
Research and development costs for orBec®
totaled
$2,209,770 in 2005 of which $124,958 are for costs reimbursed under the FDA
orphan products grant and $1,940,052 in the second quarter of 2006. Since June
30th
2006, we
anticipate that the remaining R&D costs for orBec®
will
approximate $2 million. If orBec®
is
approved by the FDA in the third quarter of 2007, we expect orBec®
to begin
generating revenues by the fourth quarter of 2007. If the FDA rejects the NDA
or
does not approve orBec®
in a
timely manner (or in accordance with anticipated and established timelines),
our
financial condition, liquidity, and ability to raise additional equity financing
could be impaired.
In
addition, from previous response to 2.B, that read:
“The
costs that we have incurred to develop RiVax™
since
2002 to date total $6,360,523. R&D costs for RiVax™
totaled $2,565,461 in 2005 and $2,130,516 in the second quarter of 2006”
Correction
to read:
The
costs
that we have incurred to develop RiVax™ since 2002 to date total $6,360,523.
R&D costs for RiVax™ totaled $2,422,196 in 2005 of which $1,942,076 are for
costs reimbursed under the NIH grant, and $2,130,516 in the second quarter
of
2006, of which $1,128,257 are for costs reimbursed under this grant.
Notes
to Consolidated Financial Statements
Note
2. Summary of Significant Accounting Policies
Intangible
Asset
2.
We
acknowledge your response to comment 4. Please provide us with further
detail regarding the “alternative future use” associated with both the
UTSW RiVax vaccine license ($425k) and the SRI Brookwood license fee
($600k), as contemplated under paragraph 11c. of SFAS No. 2. Specifically,
please tell us whether you could have used the RiVax vaccine and the
SRI/Brookwood platform technology, in their current condition at the
time
of purchase, in other identifiable research and development projects
that
you had identified to be commenced at a future date and whether you
could
reasonably believe that any such future projects would generate economic
benefit for your company. Finally, please clarify for us the financial
reporting period during which you capitalized each of these license
fees
and tell us what the unamortized balance was related to each as of
December 31, 2005.
RESPONSE
for 2.:
We
hereby
supplement the information previously supplied to you for comment 4. As
explained most of our intangible assets have alternative future uses; this
is
common in the pharmaceutical development industry. Of the intangible asset
balance, $1,025,000 is for up-front license costs. We purchased a license from
the University of Texas Southwestern (“UTSW”), for the license to the
RiVaxTM
vaccine
for $425,000. We also purchased a license from a “pharmaceutical company” namely
Southern Research Institute/Brookwood Pharmaceuticals, for a license of
microsphere technology for $600,000. We capitalize license costs because they
have alternative future use as referred to in paragraph
11 c. of SFAS No.2.
We
believe that both of these intangible assets purchased have alternative future
uses. With respect to UTSW, we believe that arising out of the development
of
the vaccine RiVaxTM,
our
vaccine against ricin toxin, could potentially be a therapeutic antibody product
to treat patients exposed to ricin toxin; this product would be purified
antibodies from the serum of vaccinated animals or humans. In addition, the
technology addresses specific methods to create vaccines from toxins that have
similar structure, so that it is possible that a series of related vaccines
can
be developed. The technology is also applicable to distinctly different forms
of
vaccines which can be utilized by different patient populations based on route
of delivery. Specifically, we envision future uses of the ricin vaccine for
oral
and nasal administration. Such uses also demand the introduction of
complementary technology. With respect to SRI/Brookwood, at the time we
purchased the license in 1998, we were aware that this technology was a platform
technology for oral and nasal delivery of vaccines. This technology was also
a
key element of the business model of Innovaccines Corporation, a joint venture
that we formed with Elan Corporation. In 2002, we and Elan dissolved
Innovaccines, but we purchased the Elan rights to the microsphere technology,
with a view toward developing its applications in biodefense and emerging
infectious disease vaccines. This included the application to anthrax, plague,
ricin, and other biowarfare toxins and pathogens. The value to us at the time
was certainly in the knowledge that it could be applied to the development
of
any and all subunit vaccines that could be administered orally, as well as
specific biodefense applications. Specifically, we engaged in product
development for an orally administered ricin vaccine based on the SRI/Brookwood
microspheres, but found that the technology did not have sufficient potency
for
commercial development. Consequently, due to its cost and reduced development
prospects we decided to terminate the SRI/Brookwood agreement and have
subsequently impaired the asset in the second quarter of 2006.
3.
We
acknowledge your response to comment 5. It remains unclear, based on
your
response, how you concluded that it is appropriate to capitalize costs
related to the protection/maintenance of your patent rights. Please
tell
us the basis for future accounting policy, referring to applicable
authoritative accounting literature. Please also quantify for us the
amount of such costs that you capitalized for the financial statement
periods presented in your 2005 Form 10-KSB and tell us where you
classified those cost on the related balance
sheets
RESPONSE
for 3.:
We
hereby
supplement the information previously supplied to you for comment 5. We
capitalize legal costs associated with the protection and maintenance of our
patents. For a development stage company with drug and vaccine products in
an
often lengthy basic and clinical research process, we believe that patent rights
form one of our most valuable assets. Patents and patent applications are a
key
currency of intellectual property, especially in the early stage of product
development, as their purchase and maintenance gives us access to key product
development rights from our academic and industrial partners. These rights
can
also be sold or sub-licensed as part of our strategy to partner our products
at
each stage of development. The legal costs incurred for these patents consist
of
work designed to protect, preserve, maintain and perhaps extend the lives of
the
patents. Therefore, our policy is to capitalize these costs and amortize them
over the remaining useful life of the patents. We
maintain that we capitalize this based on intangible assets and the alternative
future use as referred to in SFAS
No.142 and
in
paragraph 11 c. of SFAS No. 2 as
well
as in the response to 2.
During
2005, we capitalized $250,570 in patent related costs. This amount is
represented in the Cash Flow statement, in the section for investing activities
presented in the 2005 10-KSB financial statements. On the balance sheet this
amount is presented on the line intangible
assets, net
in the
amount of $1,803,020. We also explain this amount in note 5 of the 2005 10-KSB.
Attached is the excerpt from note 5.
5.
Intangible Assets
The
following is a summary of intangible assets which consists of licenses and
patents:
Weighted
Average Amortization period
(years)
Cost
Accumulated
Amortization
Net
Book Value
December
31, 2005
10.2
$
2,605,472
$
802,452
$
1,803,020
December
31, 2004
10.6
$
2,611,195
$
728,741
$
1,882,454
Amortization
expense was $168,841 and $302,449 for 2005 and 2004, respectively.
Revenue
Recognition
4.
We
acknowledge your response to comment 6. Please confirm that you will
include the expanded disclosure provided in your September 8, 2006
response letter in your next periodic report to be filed with the
Commission, presumably your December 31, 2006 Form 10-KSB.
RESPONSE
for 4.:
We
will
include the following disclosure in future filings:
All
of
our revenues are from government grants which are based upon subcontractor
costs
and internal costs covered by the grant, plus a facilities and administrative
rate that provides funding for overhead expenses. Revenues are recognized when
expenses have been incurred by subcontractors or when we incur internal expenses
that are related to the grant.
Note
7. Shareholders’ Equity
Common
Stock
Stock
Compensation to
Non-Employees
5.
We
acknowledge your response to comment 8. Pursuant to Question 18 of FIN 44, it
does not appear that a “grant date” existed for the 2004 employee/director
options in question until your board/shareholders approved your 2005 Equity
Incentive Plan. As a result, it remains unclear why you believe variable
accounting was appropriate for these stock options in December 2004. Giving
consideration to Question 18 of FIN 44, please clarify your accounting position
for us. Additionally, please provide us with a materiality analysis under
provisions of SAB No. 99 with respect to the $285,000 that you recorded as
expense in fiscal 2004 and subsequently reversed to income in fiscal
2005.
RESPONSE
for 5.:
We
believe that the answer provided in our previous response is adequate
notwithstanding question 18 of FIN 44, that concludes that if a grant is not
approved a measurement date does not exist and that in December of 2004, our
authorized number of options under the then current 1995 stock option plan
was
insufficient to grant the options described above. The options were 1,764,339
in
excess of the authorized number. Therefore, determination of a measurement
date
was not possible until the new plan was approved by the shareholders. According
to FIN28, Footnote 1, “Plans for which the number of shares of stock that may be
acquired by or awarded to an employee or the price or both are not specified
or
determinable until after the date of grant
2006-12-11 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
EDWARDS
ANGELL PALMER & DODGE LLP
350
E.
Las Olas Boulevard, Suite 1150
Fort
Lauderdale, FL 33301
December
11, 2006
By
EDGAR and Fax (202-772-9217)
Jeffrey
Riedler
Assistant
Director
United
States Securities and Exchange Commission
Division
of Corporation Finance
450
Fifth
Street, N.W.
Washington,
D.C. 20549-0405
Re: DOR
BioPharma, Inc.
Preliminary
Proxy Statement filed December 1, 2006
Dear
Mr.
Riedler:
On
behalf
of DOR BioPharma, Inc. (the “Company”), we are providing the staff with this
letter responding to the comments in the staff’s letter dated December 7, 2006
(the “Letter”) with respect to the captioned matter. For your reference, we have
reproduced the comment from the Letter, followed by the response.
Proposal
2. Amendment to the amended and restated certificate of incorporation to
increase the number of authorized shares
We
note
your planned use for the additional authorized shares and the fact you have
in
excess of 30 million shares currently available. Please expand the discussion
to
address your liquidity needs and timing. In addition, please provide more
information relative to the specific nature of the transactions under
negotiation to enable shareholders to understand the likelihood and the number
of additional shares that may be issued in connection with the transactions
and
future financings currently under consideration.
Company
Response
The
Company has expanded the disclosure in the “Purpose of Charter Amendment”
section of the proxy statement in response to this comment. Such language is
marked on the attached and will be included in the Company’s definitive proxy
statement.
If
you
require additional information or have further comment, please contact the
undersigned at 954.667.6129.
Sincerely,
/s/
Leslie J. Croland
Leslie
J.
Croland, P.A.
PROPOSAL
2
AMENDMENT
TO THE AMENDED AND RESTATED CERTIFICATE OF
INCORPORATION
TO INCREASE THE NUMBER OF AUTHORIZED SHARES
General
Our
Amended and Restated Certificate of Incorporation currently provides for
150,000,000 shares of authorized Common Stock. On November 24, 2006, our Board
of Directors adopted a resolution to amend the Amended and Restated Certificate
of Incorporation to increase the authorized number of shares of Common Stock
to
250,000,000, subject to stockholder approval of the amendment. No changes will
be made to the number of authorized shares of our preferred stock.
The
proposed amendment to the Amended and Restated Certificate of Incorporation
will
be effected by amending the first two introductory paragraphs of Article FOURTH
thereof to read in full as follows:
"The
total number of shares of capital stock of all classes which the Corporation
shall have authority to issue is two hundred fifty five million (255,000,000)
shares, of which two hundred fifty million (250,000,000) shares, of par value
of
$.001 per share, shall be of a class designated "Common Stock," four million
six
hundred thousand (4,600,000) shares, of a par value of $.001 per share, shall
be
of a class designated "Preferred Stock," two hundred thousand (200,000) shares,
of a par value of $.05 per share, shall be of a class designated "Series B
Convertible Preferred Stock," and two hundred thousand (200,000) shares, of
a
par value of $.05 per share, shall be of a class designated "Series C
Convertible Preferred Stock."
The
designations, powers, preferences, privileges, and relative, participating,
option, or other special rights and qualifications, limitations, or restrictions
of the above classes of capital stock shall be as follows:"
A
copy of
the proposed amendment to our Amended and Restated Certificate of Incorporation
is set forth in Annex A attached hereto.
Purpose
of Charter Amendment
As
of
November 3, 2006, we had 68,778,401 shares of Common Stock outstanding. In
addition, as of such date, 36.628.789 shares were reserved for issuance upon
exercise of outstanding warrants and 11,649,339 shares were reserved for
issuance upon exercise of presently outstanding options under the 1995 Amended
and Restated Omnibus Incentive Plan and options granted under the 2005 Equity
Incentive Plan. Based upon the foregoing number of outstanding and reserved
shares of Common Stock, we have 32,943,471 shares remaining available for other
purposes. We also have 3,000,644 shares available for future option grants
under
the 2005 Equity Incentive Plan and 0 shares available for future option grants
under the 1995 Amended and Restated Omnibus Incentive Plan.
The
proposed increase in the number of shares available for issuance under
the
Certificate is intended to provide the Board of Directors with authority,
without further action of the stockholders, to issue the additional shares
of
Common Stock, from time to time in such amounts as the Board of Directors
deems
necessary. Without limitation of the foregoing, the additional shares may
be
issued in connection with (1) capital raising transactions through the
sale of
Common Stock and/or securities convertible into or exercisable for Common
Stock
in the private and/or public equity markets to support a higher level of
growth,
respond to competitive pressures, develop new products and services and
support
new strategic partnership expenditures and (2) strategic partnering or
acquisition transactions involving the issuance of our securities as
well as to meet long-term corporate
objectives.
Although
we do have near term financing needs, the need to increase the authorized
is
primarily driven by our desire to have sufficient shares available for possible
merger and acquisition activities and other corporate development objectives
that may occur over the coming years. However, we have no present plans to
engage in such activities. We are currently engaged in discussions with
potential investors with respect to several different financing transactions
ranging from $2 million to $5 million. Based on current market conditions,
we
should have enough authorized shares to complete such potential transactions.
We
would use the proceeds from such a transaction primarily to: (1) support
regulatory functions in connection with our recent New Drug Application (“NDA”)
and Marketing Authorization Application (“MAA”) filings with the Food and Drug
Administration (“FDA”) and European Medicines Evaluation Agency (“EMEA”) for
marketing approval for orBec® in the U.S. and Europe; (2) complete
the process validation in support of the orBec® NDA and MAA filings;
(3) advance our BioDefense programs; and (4) provide for general and
administrative expenses. At the present time, we have no agreements,
understandings or arrangements to issue any securities. Furthermore, we can
provide no assurances that a financing will be completed.
In
the
absence of a proportionate increase in our earnings and book value, an increase
in the aggregate number of outstanding shares of Common Stock caused by the
issuance of the additional shares would dilute the earnings per share (including
projected future earnings per share) and book value per share of all outstanding
shares of our Common Stock. If such factors were reflected in the price per
share of the Common Stock, the potential realizable value of a stockholder's
investment could be adversely affected. An issuance of additional shares of
Common Stock could therefore have an adverse effect on the potential realizable
value of a stockholder's investment. The holders of outstanding shares of Common
Stock have no preemptive rights to purchase additional shares.
The
proposed increase in the authorized number of shares of Common Stock could
have
other effects on our stockholders. The increase could deter takeovers, in that
additional shares could be issued (within the limits imposed by applicable
law)
in one or more transactions that could make a change in control or takeover
of
us more difficult. For example, additional shares could be issued by us so
as to
dilute the stock ownership or voting rights of persons seeking to obtain
control. Similarly, the issuance of additional shares to certain persons allied
with our management could have the effect of making it more difficult to remove
our current management by diluting the stock ownership or voting rights of
persons seeking to cause such removal.
Recommendation
of the Board of Directors
The
Board
of Directors recommends that you vote "FOR" the approval of the amendment to
our
Amended and Restated Certificate of Incorporation.
2006-12-07 - UPLOAD - SOLIGENIX, INC.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 0610 December 7, 2006
James Clavijo, C.P.A.
Controller, Treasurer and Secretary
DOR BioPharma, Inc.
1101 Brickell Avenue, Suite 701-S
Miami, Florida 33131
Re: DOR BioPharma, Inc.
Preliminary proxy statement filed December 1, 2006
File No. 0-16929
Dear Mr. Clavijo:
We have reviewed your filing solely with respect to proposal
number two and have the following comments. 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 revision is unnecessary. Please be
as
detailed as necessary in your explanation. In some of our
comments,
we may ask you to provide us with supplemental information so we
may
better understand your disclosure. After reviewing this
information,
we may or may not raise additional comments.
Please understand that the purpose of our review 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.
Proposal 2. Amendment to the amended and restated certificate of
incorporation to increase the number of authorized shares
We note your planned use for the additional authorized shares and
the
fact you have in excess of 30 million shares currently available.
Please expand the discussion to address your liquidity needs and
timing. In addition, please provide more information relative to
the
specific nature of the transactions under negotiation to enable
shareholders to understand the likelihood and the number of
additional shares that may be issued in connection with the
transactions and future financings currently under consideration.
* * * * *
Mr. James Clavijo
DOR BioPharma, Inc.
December 7, 2006
Page 2
As appropriate, please amend your filing and respond to
these
comments within 10 business days or tell us when you will provide
us
with a response. You may wish to provide us with marked copies of
the amendment to expedite our review. Please furnish a cover
letter
with your amendment that keys your responses to our comments and
provides any requested supplemental information. Detailed cover
letters greatly facilitate our review. Please understand that we
may
have additional comments after reviewing your amendment and
responses
to our comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filing 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.
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.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
You may contact John L. Krug at (202) 551-3862, Senior
Counsel,
or me at (202) 551-3715 if you have any questions.
Sincerely,
Jeffrey Riedler
Assistant Director
</TEXT>
</DOCUMENT>
2006-12-05 - UPLOAD - SOLIGENIX, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 December 5, 2006 Mr. Evan Myrianthopoulos Chief Financial Officer Dor Biopharma, Inc. 1101 Brickell Avenue, 701-S Miami, FL 33131
Re: Form 10-KSB for the Fiscal Year Ended December 31, 2005
Filed March 31, 2006
File No. 000-16929
Dear Mr. Myrianthopoulos:
We have reviewed your September 8, 2006 response to our August 15, 2006 letter
and have the following comments. In our co mments, we ask you to provide us with
information so we may better understand your disclosure.
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 on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-KSB for the Fiscal Year Ended December 31, 2005
Management’s Discussion and Anal ysis or Plan of Operation
Material Changes in Results of Operations
1. We acknowledge your response to comment 2. Please provide us with additional
information, in a disclosure-type format, that reconciles the total research and
development expense presented in your pr oposed disclosure for each project to
the total research and development e xpense on the face of your statement of
operations for the year ended Decem ber 31, 2005. More specifically, the
aggregate 2005 expense per your proposed disclosure appears to be $5,766,478,
which does not reconcile to the face of your 2005 statement of operations. Please
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. December 5, 2006 Page 2
either reconcile the individual project in formation to the aggregate 2005 expense
or tell us why the amounts per your propos ed disclosure do not reconcile to the
2005 statement of operations.
Notes to Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies
Intangible Assets
2. We acknowledge your response to comment 4. Please provide us with further
detail regarding the “alternative future use” associated with both the UTSW
RiVax vaccine license ($425k) and the SRI Brookwood license fee ($600k), as contemplated under paragraph 11c. of SFA S No. 2. Specifically, please tell us
whether you could have used the RiVa x vaccine and the SRI/Brookwood platform
technology, in their current c ondition at the time of purchas e, in other identifiable
research and development projects that you had identified to be commenced at a
future date and whether you could reasonably believe that any such future projects
would generate economic benefit for your company. Finally, please clarify for us
the financial reporting period during whic h you capitalized each of these license
fees and tell us what the unamortized ba lance was related to each as of December
31, 2005.
3. We acknowledge your response to comment 5. It remains unclear, based on your
response, how you concluded that it is appr opriate to capitalize co sts related to the
protection/maintenance of your patent right s. Please tell us the basis for your
accounting policy, referring to applicable authoritative acco unting literature.
Please also quantify for us the amount of such costs that you capitalized for the
financial statement periods presented in your 2005 Form 10-KSB and tell us
where you classified those costs on the related balance sheets.
Revenue Recognition
4. We acknowledge your response to comme nt 6. Please confirm that you will
include the expanded disclosure provid ed in your September 8, 2006 response
letter in your next periodic report to be filed with the Commission, presumably
your December 31, 2006 Form 10-KSB.
Note 7. Shareholders’ Equity
Stock Compensation to Non-Employees
5. We acknowledge your response to comment 8. Pursuant to Question 18 of FIN
44, it does not appear that a “grant dat e” existed for the 2004 employee/director
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. December 5, 2006 Page 3
options in question until your board/s hareholders approved your 2005 Equity
Incentive Plan. As a result, it remains unclear why you believe variable accounting was appropriate for these stock options in December 2004. Giving
consideration to Question 18 of FIN 44, please clarify your accounting position
for us. Additionally, please provide us with a materiality analysis under the
provisions of SAB No. 99 with respec t to the $285,000 that you recorded as
expense in fiscal 2004 and subsequently reversed to income in fiscal 2005.
* * * *
Please provide us the information requested within 10 business days of the date of
this letter or tell us when you will provide a response prior to the expiration of the 10-day
period. Please furnish a letter with your responses that keys your responses to our
comments. Detailed letters grea tly facilitate our re view. You should furnish the letter to
us via EDGAR under the form type label CORRESP. Please understand that we may have additional comments after review ing your responses to our comments.
You may contact Amy Bruckner, Staff Accountant, at (202) 551-3657 or Mary
Mast, Senior Accountant, at (202) 551-3613 if you have questions regarding comments
on the financial statements and related matters. In this regard, please do not hesitate to
contact me at (202) 551-3679.
Sincerely,
J i m B . R o s e n b e r g Senior Assistant Chief Accountant
2006-09-19 - UPLOAD - SOLIGENIX, INC.
Mail Stop 6010
February 6, 2006
Michael T. Sember
President and Chief Executive Officer
DOR BioPharma, Inc.
1691 Michigan Ave.
Miami, Florida 33139
Re: DOR BioPharma, Inc.
Form S-1 Registration Statement
File No. 333-131166
Dear Mr. Sember:
We have limited our review of your filing to those issues we have addressed in our
comments. 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 revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this information, we may raise additional comments.
Please understand that the purpose of our review 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.
Comments Applicable to the Entire Document
1. You have incorporated a number of small business documents by reference into this Form S-1 registration statement. Information incorporated by reference into a Form S-1 must satisfy the disclosure requirements of Regulation S-K and Regulation S-X, rather
than those of Regulation S-B. Please revise your registration statement to include all of
the information specified by Regulations S-K and S-X.
Michael T. Sember Dor BioPharma, Inc. February 6, 2006 Page 2
2. We note that you entered into a letter of intent to acquire Gastrotech Pharma A/S on October 28, 2005. It appears, based on the information provided, that this probable acquisition would qualify as a “significan t” business under Regulation S-X 210.3-05. As
a result, please provide the required financial statements. Additionally, please provide the related pro forma financial statements required under Article 11 of Regulation S-X.
As appropriate, please amend your registration 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 cover 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 amendment 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 information 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 event 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 pursuan t 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.
In addition, please be advised that the Division of Enforcement has access to all information you provide to the staff of the Division of Corporation Finance in connection with our review of your filing or in response to our comments on your filing.
Michael T. Sember Dor BioPharma, Inc. February 6, 2006 Page 3
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. We will act on the request and, pursuant to delegated authority, grant acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding requesting acceleration of a
registration statement. Please allow adequate 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 advance of the requested effective date.
You may contact Amy Bruckner at (202) 551-3657 or Mary Mast at (202) 551-3613 if
you have questions regarding comments on the financial statements and related matters. Please contact Mary K. Fraser at (202) 551-3609 or me at (202) 551-3710 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
Assistant Director
Cc: Leslie J. Croland, Esq.
Edwards Angell Palmer & Dodge LLP
350 East Las Olas Blvd – Suite 1150
Fort Lauderdale, Florida 33334-3607
2006-09-08 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR Letter 090806
DOR
BioPharma, Inc.
1101
Brickell Avenue
701-S
Miami,
FL
33131
September
8, 2006
SENT
VIA EDGAR
Amy
C. Buckner
Staff
Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
RE:
Review of Filings and comments related to Form 10KSB for the Fiscal Year
Ended
December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.
Dear
Ms.
Buckner:
Thank
you
for the opportunity to work with you and discuss the disclosure requirements.
This letter is in response to your letter dated August 15, 2006. Below please
find our responses to your inquiries and comments.
Form
10-KSB for the Fiscal Year Ended December 31,
2005
Management’s
Discussion and Analysis or Plan of Operation
Material
Changes in Results of Operations
1.
Please
provide us with additional information, in a disclosure-type format,
that
clarifies why you appear to have recognized $285,891 in revenue that
relates to fiscal 2004 during the year ended December 31, 2005 when
you
received the actual cash
reimbursement.
RESPONSE
for 1.:
As
explained in paragraph 1 of Material
Changes in Results of Operations, Item 6, Managements Discussion and
Analysis,
we were
awarded a grant on September 15, 2004, in the amount of $5,173,298 from the
National Institutes of Health (“NIH”) for process development for manufacturing
our genetically engineered ricin vaccine. On May 6, 2005 we were awarded
a
provisional overhead rate (Facilities & Administrative (F&A) rate). This
rate permitted us to request additional funds from the NIH and we were
subsequently awarded an additional $1,260,018 for overhead. We previously
received a small overhead allowance. The provisional overhead rate could
be
retroactively applied to costs already reimbursed by the NIH. The intent
of our
disclosure was to explain that a portion of the revenues received in 2005
pertained to overhead reimbursement for the grant period in 2004. Therefore
we
recalculated our request at the new rate to the funds already applied and
received in 2004. During the second quarter of 2005 we received a retroactive
reimbursement of $285,891 for overhead expenses. We recognized the $285,891
in
2005, and not in 2004, since we did not know we would be receiving the amounts
until the provisional overhead rate was approved in 2005. We segregated the
$285,891 in an effort to be completely transparent. For your guidance, we
expect
to receive a final overhead rate before the end of 2006. This new rate could
be
higher or lower than the current one and could potentially allow the NIH
to
increase the grant amount and allow us to draw down additional funds
retroactively for prior periods. In summary, it is our belief that since
the
provisional rate was not awarded until 2005 that the revised overhead allowance
could be recognized in 2005.
2.
We
acknowledge your table included in the section entitled “Summary of Our Products
in Development,” as well as the information included in your “Material Results
of Operations” discussion. However, we believe that your disclosures about
historical research and development expenses and estimated future expenses
related to your major research and development projects could be enhanced
for
investors. Please refer to the Division of Corporation Finance “Current Issues
and Rulemaking Projects Quarterly Update” under section VIII— Industry Specific
Issues — Accounting and Disclosure by Companies Engaged in Research and
Development Activities. You can find it at the following website address:
http://www.sec.gov/divisions/corpfln/cfcrq032001.htm#secviii.
Please
then provide us with the following information, in a disclosure-type format,
for
each of your major research and development projects:
a.
The costs incurred during each period presented and to date on the
project;
b.
The nature, timing and estimated costs of the efforts necessary to complete
the
project;
c.
The anticipated completion date;
d.
The risks and uncertainties associated with completing development on schedule
and the consequences to your operations, financial position and liquidity
if the
project is not completed timely; and, finally
e.
The period in which material net cash inflows from your significant projects
are
expected to commence.
Regarding
a., if you do not maintain research and development costs by project, please
tell us why management does not maintain and evaluate research and development
costs by project. Include other quantitative or qualitative analyses that
indicate the amount of the company’s resources being used on these
projects.
Regarding
b. and c., please provide us with the amount or range of estimated costs
and
timing to complete the phase in process and each future phase. To the extent
that information is not estimable, please tell us the facts and circumstances
indicating the uncertainties that preclude you from making a reasonable
estimate-
RESPONSE
for 2.:
Although
we enumerate all our current products in tabular format, our primary focus
is
concentrated on: orBec®,
RiVaxTM,
our
injectable vaccine against ricin toxin, and BT-VACCTM,
our
oral/nasal vaccine against botulinum toxin. We explain our costs for all
our
programs in Note
13
Segment
Table.
Details:
Research
and Development Projects
A.
orBec®
orBec® is
the
latest stage product that we have in development. orBec® is
an
oral formulation of a very well known and widely prescribed glucocorticoid
called beclomethasone dipropionate (BDP). We have developed orBec® to
treat
inflammation that occurs within the mucosal lining of the gastrointestinal
tract
as a result of bone marrow or stem cell transplants. This affliction is known
as
gastrointestinal Graft-versus-Host disease (“GI GVHD”) and is life-threatening.
It is also an unmet medical need. We believe that we have completed the
necessary research and development of orBec®
necessary for approval by the U.S.
Food
and Drug Administration (“FDA”)
for the
treatment of GI GVHD. orBec® is a unique two-pill system: one pill is formulated
to dissolve in the stomach, while the second pill is formulated to dissolve
in
the more alkaline environment of the upper small bowel. We plan to file a
new
drug application (“NDA”)
with
the
FDA in September of 2006. We
also
plan on filing a Marketing Authorization Application (“MAA”) with the European
Central Authority, European Medicine Agency (“EMEA”) later this
year.
Although
we provide guidance on the timing of our filings, this guidance is subject
to
change based on many factors. If
we are
unsuccessful in developing our products, our ability to generate revenues
will
be significantly impaired. Because of the nature of the complex work that
we do
in preparation of these filings we may not be able to maintain our current
research and development schedules. In addition, our business is subject
to
extensive governmental regulation, which can be costly, time consuming and
subjects us to unanticipated delays.
orBec® Research
and Development
orBec®
has
completed a randomized, multi-center, double-blinded, placebo-controlled
pivotal
Phase III clinical trial for the treatment of acute GI GVHD. While
orBec®
did not
achieve statistical significance in its primary endpoint, orBec®
demonstrated a statistically significant reduction in mortality during the
prospectively defined Day 200 post-transplant period and positive trends
on its
primary endpoint. orBec®
achieved
a 70% reduction in mortality compared to placebo (p-value 0.011). In addition,
and in response to a specific FDA request and as part of its process to submit
an NDA, we collected further mortality data from our Phase II and Phase III
clinical trials. The new survival analysis of patients enrolled in the earlier
Phase II trial suggests that results were similar to those from the pivotal
Phase III multi-center study. In the Phase II trial, there were reductions
in
the risk of mortality of 55% and 43% at transplant day-200 and one-year
post-randomization among patients randomized to orBec®,
respectively. The comparable survival data from the 129-patient Phase III
pivotal trial were 66% and 51% reductions in the risk of morality at transplant
day-200 and one-year post-randomization among patients randomized to
orBec®,
respectively.
Since
2000, we have incurred expenses of $13,925,498 in the development of
orBec®.
Research and development costs for orBec®
totaled
$2,209,770 in 2005 and $1,940,052 in the second quarter of 2006. Since June
30th
2006, we
anticipate that the remaining R&D costs for orBec®
will
approximate $2 million. If orBec®
is
approved by the FDA in the first quarter of 2007, we expect orBec®
to begin
generating revenues by the third quarter of 2007. If the FDA rejects the
NDA or
does not approve orBec®
in a
timely manner, our financial condition, liquidity, and ability to raise
additional equity financing could be impaired.
B.
Ricin Vaccine (RiVax™)
Our
product RiVax™ is a genetically engineered recombinant vaccine against ricin
toxin. It is being developed in anticipation of obtaining government procurement
contracts under the biodefense act Project Bioshield of 2004 and its successors.
Products that fall under potential Bioshield funding are usually vaccines
or
therapeutics that are not considered to be marketed for widespread distribution
and use on a routine basis, but rather used for special populations (such
as the
military) or in the event of use of an agent as a biological weapon. Thus,
we
began the development of RiVax™ and licensed the underlying technology with a
view towards addressing the need for biodefense products, but considered
its
development to be integral with an effort to obtain research and development
costs through successive grants and contracts from government agencies. We
have
successfully developed this vaccine through the early manufacturing stages
and
the first Phase I trials for safety and efficacy, in large part by obtaining
funding through SBIR and larger government grants. At this point, the vaccine
is
poised for further development and we recently have obtained additional NIH
funding of approximately $5 million to carry through the activities to develop
and use animal models that will be required for licensure of the product.
The
potential purchase of RiVax™ by the government under project Bioshield funding
for procurement purposes does not necessarily depend on licensure by the
FDA.
RiVax™ Research
and Development
RiVax™
is
being developed as a conventional vaccine, to be administered by injections.
We
have secondary plans to develop RiVax™ as a nasally administered vaccine for the
medical purpose of stimulating immunity in the lungs to prevent toxicity
by the
anticipated route of exposure through inhalation if ricin were to be used
as a
bio-weapon. At this point we are focusing our efforts on the development
of the
injectable vaccine, and have deferred the development of a nasal vaccine.
The
safety and immunogenicity of the vaccine has been validated in a small Phase
I
pilot trial and thus we are making plans to continue development using vaccine
formulated with a well known immunological adjuvant.
Cost
and Development analysis for RiVax™
2007
2008
2009
$
$
$
cGMP
stability
85,000
-
-
Adjuvant
characterization
210,000
-
-
Animal
model development
500,000
-
-
Vaccine/protection
Inhaled
ricin
295,000
295,000
295,000
Clinical
supply
(3000
doses)
150,000
-
-
Release
and potency testing
-
250,000
-
Human/animal
correlation
130,000
130,000
-
Phase
I/II
(dose
determination)
150,000
1,250,000
-
Pivotal
animal studies
(primates)
-
-
1,500,000
Additional
manufacture
-
-
750,000
TOTALS
1,520,000
1,925,000
2,545,000
The
costs
that we have incurred to develop RiVax™
since
2002 to date total $6,360,523. R&D costs for RiVax™
totaled
$2,565,461 in 2005 and $2,130,516 in the second quarter of 2006.
The
key
uncertainty in the development of RiVax™ is the position of the government,
including the Department of Defense (“DoD”), on the acquisition of
countermeasures for ricin toxin. Although ricin is a category B agent and
is
known to be a highly toxic agent, the government has not yet published or
made
known its intent to purchase the vaccine for civilian use under project
Bioshield. The DoD has had plans for years to develop a ri
2006-08-18 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR Extension letter
DOR
BioPharma, Inc.
August
18, 2006
SENT
VIA EDGAR
Amy
C. Buckner
Staff
Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
RE:
Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended
December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.
Dear
Ms.
Buckner,
Thank
you
for the opportunity to work with you and discuss the disclosure requirements.
This letter is in response to your letter dated August 15, 2006. We are
requesting that the response date be extended to September 8, 2006. Currently,
we are in the process of moving the offices and expect to be in the new offices
by early next week; in addition our auditors are on an audit in Boston and
will
not be fully accessible until next week.
If
you
should have any questions please call me at 305-534-3383.
Sincerely,
/s/
Evan Myrianthopoulos_
Evan
Myrianthopoulos
Chief
Financial Officer
DOR
BioPharma, Inc.
MD/AMEX/EC
2006-08-15 - UPLOAD - SOLIGENIX, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 August 15, 2006 Mr. Evan Myrianthopoulos Chief Financial Officer Dor Biopharma, Inc. 1691 Michigan Avenue, Suite 435 Miami, FL 33139
Re: Dor Biopharma, Inc.
Form 10-KSB for the Fiscal Year Ended December 31, 2005 Filed March 31, 2006
Form 10-QSB for the Fiscal Quarter Ended June 30, 2006
Filed August 14, 2006 File No. 000-16929
Dear Mr. Myrianthopoulos:
We have reviewed your filings and have the following comments. We have
limited our review to only your financial stat ements and related disclosures and do not
intend to expand our review to other portions of your docum ent. Where indicated, we
think you should revise your docum ent in response to our 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 e xplanation. In some of our
comments, we ask you to provide us with in formation so we may better understand your
disclosure.
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 on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. August 15, 2006 Page 2
Form 10-KSB for the Fiscal Year Ended December 31, 2005
Management’s Discussion and Anal ysis or Plan of Operation
Material Changes in Results of Operations
1. Please provide us with additional informa tion, in a disclosure-type format, that
clarifies why you appear to have recogni zed $285,891 in revenue that relates to
fiscal 2004 during the year ended December 31, 2005 when you received the actual cash reimbursement.
2. We acknowledge your table included in th e section entitled “Summary of Our
Products in Development,” as well as th e information included in your “Material
Results of Operations” discussion. Howeve r, we believe that your disclosures
about historical research and development expenses and estimated future
expenses related to your major research and development projects could be enhanced for investors. Please refer to the Division of Corporation Finance
“Current Issues and Rulemaking Project s Quarterly Update” under section VIII –
Industry Specific Issues – Accounting a nd Disclosure by Companies Engaged in
Research and Development Activities. You can find it at the following website
address: http://www.sec.gov/divisions/ corpfin/cfcrq032001.htm#secviii
.
Please then provide us with the follow ing information, in a disclosure-type
format, for each of your major research and development projects:
a. The costs incurred during each period presented and to date on the project;
b. The nature, timing and estimated costs of the efforts necessary to complete
the project;
c. The anticipated completion date;
d. The risks and uncertainties associated with completing development on
schedule and the consequences to yo ur operations, financial position and
liquidity if the project is not completed timely; and, finally
e. The period in which material net cash inflows from your significant
projects are expected to commence.
Regarding a., if you do not maintain res earch and development costs by project,
please tell us why management does not maintain and evaluate research and
development costs by project. Include othe r quantitative or qualitative analyses
that indicate the amount of the company’ s resources being used on these projects.
Regarding b. and c., please provide us w ith the amount or range of estimated costs
and timing to complete the phase in process and each future phase. To the extent that information is not estimable, please tell us the facts and circumstances indicating the uncertain ties that preclude you from making a reasonable estimate.
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. August 15, 2006 Page 3
Financial Condition, page 44
3. In Item 1, “Description of Business,” you discuss your various license agreements
and disclose that you are required to pa y certain annual “license royalty” and
other “maintenance” fees pursuant to those agreements. For example, you disclose
that you are obligated to pay a $50,000 a nnual fee pursuant to your agreement
with the University of Texas Southw estern Medical Center and a $60,000 fee
pursuant to your agreement with Southe rn Research Institute/University of
Alabama. Please provide us with additional information that clarifies why you did not disclose your various payment obligati ons under these license agreements in
your contractual obligations table or revi se your filing accordingly. Please refer to
Financial Reporting Release No. 67, Disclosure in Manage ment’s Discussion and
Analysis About Off-Balance Sheet Ar rangements and Aggregate Contractual
Obligations, as applicable.
Notes to Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies
Intangible Assets
4. Based on your disclosure in “Critical Accounting Policies,” it appears that you
capitalize certain license cost s. Please provide us with additional information, in a
disclosure-type format, that quantifies th e amount of your intangible asset balance
that relates to license costs as of December 31, 2005 and tell us whether you
capitalized the various payments made pur suant to the agreements discussed in
Note 5. For example, tell us whether you capitalized the $400,000 up-front fee pursuant to your UTSW agreemen t and the $175,000 payment to “a
pharmaceutical company,” both of which you made in July 2003. Additionally, clarify how your accounting policy decision to capitalize licens e costs under each
of your agreements complies with paragr aph 11 c. of SFAS No. 2. Specifically
state what, if any, alternative future use exists in each instance that you
capitalized an up-front license fee.
5. Based on your disclosure herein and in “C ritical Accounting Policies,” it appears
that you recognize intangible assets for the filing/maintenance and legal defense
of your patent rights. We believe that these items should be expensed as incurred
in accordance with paragraph 10(i) of SFAS 2. Please tell us why your accounting policy is appropriate or revise your financial statements accordingly.
Revenue Recognition
6. Please provide us with additional informa tion, in a disclosure-type format, that
clarifies your revenu e recognition policy, both here in and in your “Critical
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. August 15, 2006 Page 4
Accounting Policies” discussion in the MD&A. Specifically, disclosing that you
record grant revenue in the “period when earned” is vague in that it does not
clarify whether you record grant revenue in relation to the expenses that you
incur.
Note 7. Shareholders’ Equity
Common Stock
7. Please provide us with your analysis, in a disclosure-type format, as to whether
the warrants issued in your Februa ry 2005 and March 2004 private placement
transactions qualify as a de rivative instrument within the scope of SFAS No. 133,
which would necessitate that you account fo r those warrants at fair market value
and record changes in that fair market value within earnings. Specifically, please
address if the warrants have any cashless exercise features. Additionally, please provide us with an analysis under EITF No. 00-19 that supports your
classification of these warrants as an e quity instrument. Lastly, provide similar
information for the warrants issued in your April 10, 2006 private placement transaction, as disclosed in your June 30, 2006 Form 10-QSB.
Stock Compensation to Non-Employees
8. Please provide us with additional informa tion, in a disclosure-type format, that
clarifies your accounting trea tment with respect to the 2004 option grants to non-
employees and directors for which you recorded approximately $285,000 in
expense that you subsequently reversed a nd recorded as income during the fiscal
year ended December 31, 2005. In so doi ng, please refer to the applicable
provisions of EITF No. 96- 18 or other literature to support your treatment.
Additionally, please tell us why you felt a “measurement date” did not exist at the
“approval date,” as it is unclear how approval attached to these grants if they were
contingent upon an amendment to the underlying option plan. Please also
reconcile your disclosure in Note 7 regarding the measurement date to the
disclosure under “Material Changes to Re sults of Operations” regarding variable
accounting.
Form 10-QSB for the Fiscal Quarter Ended June 30, 2006
Notes to Condensed Consolidated Financial Statements (Unaudited)
Note 7. Contingencies
9. Please provide us with additional informa tion, in a disclosure-type format, that
clarifies why you do not believe you are re quired to pay Gastrotech Pharma A/S
the $1 million break-up fee that resulted from your decision not to renew your
Mr. Evan Myrianthopoulos
Dor Biopharma, Inc. August 15, 2006 Page 5
letter of intent to acquire Gastrotech Pharma. Please correlate your explanation to
SFAS No. 5, as applicable.
* * * *
Please provide us the information requested within 10 business days of the date of
this letter or tell us when you will provide a response prior to the expiration of the 10-day
period. Please furnish a letter with your responses that keys your responses to our
comments. Detailed letters grea tly facilitate our review. You should file the letter on
EDGAR under the form type label CORRESP. Please understand that we may have
additional comments after reviewin g your 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 they have provided all information required
under the Securities Exchange Act of 1934 and that they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, 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 secu rities laws of the
United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact Amy Bruckner, Staff Accountant, at (202) 551-3657 or Mary
Mast, Senior Accountant, at (202) 551-3613 if you have questions regarding comments
on the financial statements and related matters. In this regard, please do not hesitate to
contact me at (202) 551-3679.
Sincerely,
J i m B . R o s e n b e r g Senior Assistant Chief Accountant
2005-04-05 - CORRESP - SOLIGENIX, INC.
CORRESP 1 filename1.htm DOR ACCELERATION REQUEST FOR S-3 FEB 2005 DOR BIO PHARMA, INC. April 5, 2005 BY FACSIMILE AND EDGAR United States Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Washington, D.C. 20549 Attention: Jeffrey P. Riedler Re: DOR BioPharma, Inc. Registration Statement on Form S-3 File No. 333-123281 Ladies and Gentlemen: The undersigned hereby respectfully requests, pursuant to Rule 461 of the Securities Act of 1933, as amended, that the Registration Statement on Form S-3 originally filed with the Securities and Exchange Commission (the “Commission”) on March 11, 2005 (File No. 333-123281) by DOR BioPharma, Inc. (the “Company”) be declared effective as of 5:00 p.m. (EST), or as soon as possible thereafter, on Wednesday, April 6, 2005. The undersigned hereby acknowledges that (i) 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; (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 this action 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, DOR BIOPHARMA, INC. By:/s/ Michael T.Sember Michael T. Sember President and Chief Executive Officer cc: Leslie J. Croland, Esq.
2005-03-31 - CORRESP - SOLIGENIX, INC.
CORRESP
1
filename1.htm
DOR Response to S-3 Commnet SEC
Edward & Angell LLP
350 East Las Olas Blvd.
Suite 1150
Ft Lauderdale, FL 33301
954-727-2600
March 31,
2005
BY
FACSIMILE AND EDGAR
Mr.
Jeffrey P. Riedler
Assistant
Director
United
States Securities and Exchange Commission
Division
of Corporation Finance
450 Fifth
Street, N.W.
Washington,
D.C. 20549
Re: DOR
BioPharma, Inc.
Registration
Statement on Form S-3
File
No. 333-123281
Dear Mr.
Riedler:
On behalf
of DOR BioPharma, Inc. (the “Company”), we are transmitting for filing under the
Securities Act of 1933, as amended, our response to the comment provided in your
letter dated March 28, 2005, to Michael T. Sember, President and Chief Executive
Officer, of the Company. All factual statements and information set forth below
are based on information furnished to us by the Company and its representatives.
All statements of belief are the belief of the Company.
1.
We
note from footnote 5 to your financial statements in the Form 10-KSB that
a note payable to a pharmaceutical company is currently in default. Based
on this default, it appears you may not be eligible to use Form S-3
pursuant to General Instruction I.A.5. to Form S-3. Please provide us with
a supplemental analysis justifying your use of Form S-3, or re-file the
registration statement on Form S-1.
RESPONSE
On June
29, 2002, the Company and Elan Pharma International Limited (“Elan”) entered
into an agreement for the dissolution of its joint ventures, Endorex Vaccine
Delivery Technologies, Inc. and Endorex Newco, Ltd. In connection with these
dissolutions, a portion of the capital contributions by the Company to the joint
ventures was restructured as a promissory note of three separate installments.
The Company timely made two of the three installments on June 30, 2003 and June
30, 2004, in equal amounts of $231,897. The Company currently owes the remaining
portion on the note, $115,948, which was due on December 30, 2004. As a result
of this
default, Elan would only be entitled to declare the unpaid amount of the note
immediately due and payable. The note is not collateralized.
General
Instruction I.A.5. to Form S-3 (the “General Instruction”) provides that a
registrant may not be eligible to use Form S-3 if the registrant defaulted on
any installment or installments on indebtedness for borrowed money, which
default in the aggregate is material to the financial position of the registrant
and its consolidated and unconsolidated subsidiaries, taken as a whole. As of
December 31, 2004, the Company maintained cash and cash equivalents of
$2,322,190, and subsequently raised approximately $3.5 million in net proceeds
in a February 2005 private placement. In light of the Company’s current cash
position, the Company believes that the remaining amount owed to Elan under the
note is not material to the overall financial position of the Company and its
subsidiaries. As previously stated, the note is not collateralized by any assets
of the Company. Therefore, Elan’s only remedy for the default under the note is
to seek payment of the final installment amount plus accrued but unpaid
interest.
For the
reasons set forth herein, the Company believes that it is eligible to use Form
S-3.
* * * *
Any
questions regarding this letter may be directed to the undersigned at
954.667.6129.
Very
truly yours,
/s/
Leslie J. Croland, Esq.
Leslie J.
Croland, Esq.
cc: Michael
T. Sember
Evan
Myrianthopoulos
James Clavijo
DOR
BioPharma, Inc.
Gregory S. Belliston
Securities
and Exchange Commission
2005-03-28 - UPLOAD - SOLIGENIX, INC.
<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 3-9 March 28, 2005 Michael T. Sember President and Chief Executive Officer DOR BioPharma, Inc. Lincoln Building, 1691 Michigan Avenue Miami, Florida 33139 Re: DOR BioPharma, Inc. Registration Statement on Form S-3 File Number 333-123281 Form 10-KSB for the Year Ended 3/11/05 File Number 0-16929 Dear Mr. Sember: This is to advise you that we have performed a limited review of the above registration statement and Form 10-KSB, and we have the following comment. 1. We note from footnote 5 to your financial statements in the Form 10-KSB that a note payable to a pharmaceutical company is currently in default. Based on this default, it appears you may not be eligible to use Form S-3 pursuant to General Instruction I.A.5 to Form S-3. Please provide us with a supplemental analysis justifying your use of Form S-3, or re-file the registration statement on Form S-1. * * * 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. Notwithstanding our comments, in the event 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 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 this action 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 advised that the Division of Enforcement has access to all information you provide to the staff of the Division 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 a 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. We will act on the request and, pursuant to delegated authority, grant acceleration of the effective date. Please contact Greg Belliston at (202) 824-5219 or me at (202) 942-1840 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director cc: Leslie J. Croland, Esq. Edwards & Angell, LLP 350 East Las Olas Blvd., Suite 1150 Fort Lauderdale, Florida 33334-3607 ?? ?? ?? ?? Michael T. Sember DOR BioPharma, Inc. March 28, 2005 Page 1 </TEXT> </DOCUMENT>