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Theriva Biologics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-12-01
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2024-12-16
Theriva Biologics, Inc.
Summary
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Company responded
2025-01-21
Theriva Biologics, Inc.
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Company responded
2025-01-21
Theriva Biologics, Inc.
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Company responded
2025-01-23
Theriva Biologics, Inc.
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Company responded
2025-01-23
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-08
Theriva Biologics, Inc.
Summary
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Company responded
2024-09-23
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-09-16
Theriva Biologics, Inc.
Summary
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Company responded
2024-09-20
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-09-09
Theriva Biologics, Inc.
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Company responded
2022-09-12
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-10-29
Theriva Biologics, Inc.
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Company responded
2021-10-29
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-05-07
Theriva Biologics, Inc.
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Company responded
2021-05-07
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-09-25
Theriva Biologics, Inc.
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Company responded
2018-10-04
Theriva Biologics, Inc.
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Company responded
2018-10-04
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-08-15
Theriva Biologics, Inc.
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Company responded
2018-08-16
Theriva Biologics, Inc.
References: August 15, 2018
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Company responded
2018-08-20
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2018-05-14
Theriva Biologics, Inc.
Summary
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SEC wrote to company
2018-05-15
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-09-20
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2008-04-25
Theriva Biologics, Inc.
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Company responded
2008-04-28
Theriva Biologics, Inc.
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Company responded
2008-04-29
Theriva Biologics, Inc.
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Company responded
2010-12-22
Theriva Biologics, Inc.
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Company responded
2010-12-22
Theriva Biologics, Inc.
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Company responded
2011-02-08
Theriva Biologics, Inc.
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Company responded
2012-05-30
Theriva Biologics, Inc.
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Company responded
2017-08-24
Theriva Biologics, Inc.
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-08-18
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-10-14
Theriva Biologics, Inc.
Summary
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Company responded
2015-10-14
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2015-08-14
Theriva Biologics, Inc.
Summary
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Company responded
2015-08-14
Theriva Biologics, Inc.
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Company responded
2015-08-14
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-08-14
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-31
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-22
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-03-01
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-01-31
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2010-12-15
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2010-05-21
Theriva Biologics, Inc.
Summary
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Company responded
2010-06-10
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-10-22
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-08-26
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-05-07
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Response Received
3 company response(s)
High - file number match
Company responded
2007-01-05
Theriva Biologics, Inc.
Summary
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SEC wrote to company
2007-01-24
Theriva Biologics, Inc.
Summary
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Company responded
2007-01-25
Theriva Biologics, Inc.
Summary
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Company responded
2007-02-09
Theriva Biologics, Inc.
Summary
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Theriva Biologics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2007-01-24
Theriva Biologics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-01 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-05-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-05-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-21 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-21 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-283722 | Read Filing View |
| 2024-09-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2024-09-20 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-282024 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-279077 | Read Filing View |
| 2022-09-12 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2022-09-09 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-10-29 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-10-29 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-05-07 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-05-07 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-10-04 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-10-04 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-09-25 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-20 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-16 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-05-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-05-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-09-20 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-08-24 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-08-18 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-10-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-10-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-31 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-30 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-03-01 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-02-08 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-01-31 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-22 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-22 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-06-10 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-05-21 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-10-22 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-08-26 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-05-07 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-29 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-28 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-25 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-02-09 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-25 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-24 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-24 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2024-12-16 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-283722 | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-282024 | Read Filing View |
| 2024-05-08 | SEC Comment Letter | Theriva Biologics, Inc. | NV | 333-279077 | Read Filing View |
| 2022-09-09 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-10-29 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-05-07 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-09-25 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-05-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-09-20 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-08-18 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-10-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-31 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-22 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-03-01 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-01-31 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-15 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-05-21 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-10-22 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-08-26 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-05-07 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-25 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-24 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-24 | SEC Comment Letter | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-01 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-05-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-05-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-21 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2025-01-21 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2024-09-23 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2024-09-20 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2022-09-12 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-10-29 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2021-05-07 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-10-04 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-10-04 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-20 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-08-16 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2018-05-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2017-08-24 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-10-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2015-08-14 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2012-05-30 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2011-02-08 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-22 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-12-22 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2010-06-10 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-29 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2008-04-28 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-02-09 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-25 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
| 2007-01-05 | Company Response | Theriva Biologics, Inc. | NV | N/A | Read Filing View |
2025-05-05 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm May 5, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 File No. 333-283722 Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the "Act"), A.G.P./ALLIANCE GLOBAL PARTNERS, as Sole Placement Agent, hereby joins Theriva Biologics, Inc. (the "Company") in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1, as amended (the "Registration Statement"), to become effective as of 9:00 a.m., Eastern Time, on May 7, 2025, or as soon thereafter as is practicable, or at such other time as the Company or its outside counsel, Blank Rome LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 of the General Rules and Regulations under the Act, the undersigned advises that copies of the Preliminary Prospectus, dated March 21, 2025, are expected to be distributed to prospective dealers, institutional investors, retail investors and others as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus. The Placement Agent is aware of its obligations under, and confirm that it is complying with, the provisions of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, including the delivery requirement contained in such Rule. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-05-05 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm May 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 Filed December 10, 2024, as amended File No: 333-283722 Dear Ms. Sheppard: Theriva Biologics, Inc. (the " Registrant ") hereby requests that the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-283722), as amended, be accelerated by the U.S. Securities and Exchange Commission (the " Commission ") to become effective on Wednesday, May 7, 2025 , at 9:00 a.m ., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238 with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted. Very truly yours, THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer cc: Leslie Marlow, Blank Rome LLP
2025-01-23 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
January 23, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tamika Sheppard
Re:
Theriva Biologics, Inc.
Registration Statement
on Form S-1
File No. 333-283722
Ladies and Gentlemen:
Reference is made
to our letter, filed as correspondence via EDGAR on January 21, 2025, in which we, as Sole Placement Agent for the proposed offering by
Theriva Biologics, Inc. (the “Company”), joined the Company’s request for acceleration of the effective date
of the above-referenced registration statement (the “Registration Statement”) for January 23, 2025 5:00 p.m., Eastern
Time. 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 of the Registration Statement.
Very truly yours,
A.G.P./ALLIANCE GLOBAL PARTNERS
By:
/s/ Thomas J. Higgins
Name:
Thomas J. Higgins
Title:
Managing Director
2025-01-23 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
January 23, 2025
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tamika Sheppard
Re:
Theriva Biologics, Inc.
Registration Statement on Form S-1
Filed December 10, 2024, as amended
File No: 333-283722
Dear Ms. Sheppard:
Reference is made to our letter, filed as correspondence via EDGAR
on January 21, 2025, in which Theriva Biologics, Inc. (the “Company”) requested the acceleration of the effective date
of the above-referenced Registration Statement for Thursday, January 23, 2025, at 5:00 p.m. Eastern Time.
The Company no longer requesting that such Registration Statement be
declared effective at this time, and the Company hereby formally withdraw its request for acceleration of the above referenced effective
date.
Very truly yours,
THERIVA BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Chief Executive Officer and Chief Financial Officer
cc: Leslie Marlow, Blank Rome LLP
2025-01-21 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm January 21, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 Filed December 10, 2024, as amended File No: 333-283722 Dear Ms. Sheppard: Theriva Biologics, Inc. (the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-283722), as amended, be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to become effective on Thursday, January 23, 2025, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238 with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted. Very truly yours, THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer cc: Leslie Marlow, Blank Rome LLP
2025-01-21 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm January 21, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 File No. 333-283722 Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the “Act”), A.G.P./ALLIANCE GLOBAL PARTNERS, as Sole Placement Agent, hereby joins Theriva Biologics, Inc. (the “Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1, as amended (the “Registration Statement”), to become effective as of 5:00 p.m., Eastern Time, on January 23, 2025, or as soon thereafter as is practicable, or at such other time as the Company or its outside counsel, Blank Rome LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 of the General Rules and Regulations under the Act, the undersigned advises that copies of the Preliminary Prospectus, dated January 21, 2025, are expected to be distributed to prospective dealers, institutional investors, retail investors and others as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus. The Placement Agent is aware of its obligations under, and confirm that it is complying with, the provisions of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, including the delivery requirement contained in such Rule. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2024-12-16 - UPLOAD - Theriva Biologics, Inc. File: 333-283722
December 16, 2024
Steven Shallcross
Chief Executive Officer
Theriva Biologics, Inc.
9605 Medical Center, Suite 270
Rockville, MD 20850
Re:Theriva Biologics, Inc.
Registration Statement on Form S-1
Filed December 10, 2024
File No. 333-283722
Dear Steven Shallcross:
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 Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Leslie Marlow
2024-09-23 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
September 23, 2024
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tamika Sheppard
Re:
Theriva Biologics, Inc.
Registration Statement on Form S-3
Filed May 2, 2024
File No: 333-279077
Dear Ms. Sheppard:
Theriva Biologics, Inc. (the
“Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-3 (File
No. 333-279077), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to become effective
on Wednesday, September 25, 2024, at 9:00 a.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238
with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
THERIVA BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Chief Executive Officer and Chief Financial Officer
cc: Leslie Marlow, Blank Rome LLP
2024-09-20 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
September 20, 2024
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jessica Dickerson
Re:
Theriva Biologics, Inc.
Registration Statement on Form S-1
Filed September 10, 2024
File No: 333-282024
Dear Ms. Dickerson:
Theriva Biologics, Inc. (the
“Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1 (File
No. 333-282024), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to become effective
on Monday, September 23, 2024, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238
with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
THERIVA BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Chief Executive Officer and Chief Financial Officer
cc: Leslie Marlow, Blank Rome LLP
2024-09-16 - UPLOAD - Theriva Biologics, Inc. File: 333-282024
September 16, 2024
Steven Shallcross
Chief Executive Officer
Theriva Biologics, Inc.
9605 Medical Center, Suite 270
Rockville, MD 20850
Re:Theriva Biologics, Inc.
Registration Statement on Form S-1
Filed September 10, 2024
File No. 333-282024
Dear Steven Shallcross:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Leslie Marlow, Esq.
2024-05-08 - UPLOAD - Theriva Biologics, Inc. File: 333-279077
United States securities and exchange commission logo
May 8, 2024
Steven Shallcross
Chief Executive Officer and Chief Financial Officer
Theriva Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re:Theriva Biologics, Inc.
Registration Statement on Form S-3
Filed May 2, 2024
File No. 333-279077
Dear Steven Shallcross:
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 Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2022-09-12 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
September 12, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Synthetic Biologics, Inc.
Registration Statement on Form S-3
File No: 333-267294
Request For Acceleration
Ladies and Gentlemen:
Synthetic
Biologics, Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission
(the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No.
333-267294), to become effective on Wednesday, September 14, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is
practicable.
The
Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Blank Rome LLP, to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (212) 885-5358 or Mr. Egan at (212) 885-5346 with any questions you may have concerning this request, and
please notify either Ms. Marlow or Mr. Egan when this request for acceleration has been granted.
Very truly yours,
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Name: Steven A. Shallcross
Title: Chief Executive Officer and Chief Financial Officer
cc:
Leslie Marlow, Esq., Blank Rome LLP
Patrick J. Egan, Esq., Blank Rome LLP
2022-09-09 - UPLOAD - Theriva Biologics, Inc.
United States securities and exchange commission logo
September 9, 2022
Steven A. Shallcross
Chief Executive Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed September 6, 2022
File No. 333-267294
Dear Mr. Shallcross:
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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2021-10-29 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
October 29, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Synthetic
Biologics, Inc.
Registration Statement on Form S-3
File No: 333-260449
Request For Acceleration
Ladies and Gentlemen:
Synthetic
Biologics, Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission
(the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No.
333-260449), to become effective on Tuesday, November 2, 2021, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 or (212) 907-6457 with any questions you may
have concerning this request, and please notify her or him when this request for acceleration has been granted.
Very truly yours,
Synthetic Biologics, Inc.
By:
/s/ Steven A. Shallcross
Name: Steven A. Shallcross
Title: Chief Executive Officer and Chief Financial Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick J. Egan, Esq., Gracin & Marlow, LLP
2021-10-29 - UPLOAD - Theriva Biologics, Inc.
United States securities and exchange commission logo
October 29, 2021
Steven A. Shallcross
Chief Executive Officer and Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed October 22, 2021
File No. 333-260449
Dear Mr. Shallcross:
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 Davis at 202-551-4385 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2021-05-07 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
May 7, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Dillon Hagius
Re: Synthetic Biologics, Inc.
Registration Statement on Form
S-3
File No. 333-255726
Ladies & Gentlemen:
Synthetic Biologics, Inc.
(the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3
(File No. 333-255726), be accelerated by the U.S. Securities and Exchange Commission to Tuesday, May 11, 2021 at 5:00 pm,
New York City Time, or as soon as reasonably practicable thereafter.
The Company hereby authorizes
Leslie Marlow and/or Patrick Egan of Gracin & Marlow, LLP to orally modify or withdraw this request for acceleration. Please contact
Ms. Marlow at (516) 496-2223 or (212) 907-6457, or Mr. Egan at (914) 557-5574 with any questions you may have concerning this request,
and please notify either of them when this request for acceleration has been granted.
Very truly yours,
Synthetic Biologics, Inc.
By:
/s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Chief Executive Officer and Chief Financial Officer
cc: Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick Egan, Esq., Gracin & Marlow, LLP
2021-05-07 - UPLOAD - Theriva Biologics, Inc.
United States securities and exchange commission logo
May 7, 2021
Steven Shallcross
Chief Executive Officer and Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed May 3, 2021
File No. 333-255726
Dear Mr. Shallcross:
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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2018-10-04 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
October 4, 2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook
Re: Synthetic Biologics,
Inc.
Registration Statement
on Form S-1
File No. 333-227400
Dear Ms. Westbrook:
Synthetic Biologics,
Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on
Form S-1, as amended (File No. 333-227400), be accelerated by the U.S. Securities and Exchange Commission to Tuesday,
October 9, 2018 at 5:00 pm, New York City Time, or as soon as reasonably practicable thereafter.
The Company hereby
authorizes Leslie Marlow and/or Patrick Egan of Gracin & Marlow, LLP to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457, or Mr. Egan at (914) 557-5574 with any questions you may have
concerning this request, and please notify either of them when this request for acceleration has been granted.
Very truly yours,
Synthetic Biologics, Inc.
By:
/s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Interim Chief Executive Officer and Chief Financial Officer
2018-10-04 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm A.G.P./Alliance Global Partners 590 Madison Avenue New York, New York 10022 October 4, 2018 VIA EDGAR U.S. Securities and Exchange Commission 100 F St., NE Washington, D.C. 20549 RE: Synthetic Biologics, Inc. (the “Company”) File No. 333-227400 Registration Statement on Form S-1 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, A.G.P./Alliance Global Partners, as representative of the underwriters, hereby joins the request of the Company that the effective date of the above-referenced Registration Statement be accelerated so that it will become effective at 5:00 p.m. Eastern Time on October 9, 2018, or as soon thereafter as practicable. Pursuant to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies of the proposed form of preliminary prospectus 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, A.G.P./Alliance Global Partners By: Thomas Higgins /s/ Thomas Higgins Name: Thomas Higgins Title: Managing Director
2018-09-25 - UPLOAD - Theriva Biologics, Inc.
September 25, 2018
Steven A. Shallcross
Interim Chief Executive Officer and Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, MD 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-1
Filed September 18, 2018
File No. 333-227400
Dear Mr. Shallcross:
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,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Leslie Marlow, Esq.
2018-08-20 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
August 20, 2018
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, NE
Washington, D.C. 20549
Attention: Ms. Irene Paik
Ms.
Christine Westbrook
Re: Synthetic Biologics, Inc.
Registration
Statement on Form S-3
Filed
August 1, 2018
File
No. 333-226500
Dear Mss. Paik and Westbrook:
Synthetic Biologics,
Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement
on Form S-3 so that it may become effective at 5:00 p.m. (New York City Time) on Wednesday, August 22, 2018,
or as soon thereafter as reasonably practicable.
The Company hereby
authorizes its legal counsel, Leslie Marlow and/or Patrick Egan of Gracin & Marlow, LLP, to orally modify or withdraw this
request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457, or Mr. Egan at (914) 557-5574 with
any questions you may have concerning this request, and please notify either of them when this request for acceleration has been
granted.
Very truly yours,
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Name:
Title:
Steven A. Shallcross
Interim Chief Executive
Officer and Chief Financial Officer
2018-08-16 - CORRESP - Theriva Biologics, Inc.
CORRESP 1 filename1.htm The Chrysler Building 405 Lexington Avenue, 26th Floor New York, New York 10174 Telephone (212) 907-6457 www.gracinmarlow.com August 16, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, D.C. 20549 Attention: Ms. Irene Paik Ms. Christine Westbrook Re: Synthetic Biologics, Inc. Registration Statement on Form S-3 Filed August 1, 2018 File No. 333-226500 Dear Mss. Paik and Westbrook: Thank you for your letter dated August 15, 2018 (the “Comment Letter”) regarding the Synthetic Biologics, Inc. (the “Company”) Registration Statement on Form S-3 (File No. 333-226500) filed with the Securities and Exchange Commission (the “Commission”) on August 1, 2018 (the “Registration Statement on Form S-3”). In order to assist the Staff in its review, we hereby submit this letter responding to the comment in the Comment Letter. For your convenience, we have set forth below the Staff’s comment in its entirety in bold and italicized text followed by our response thereto. Registration Statement on Form S-3 filed August 1, 2018 General 1. Please tell us how you are eligible to conduct your offering on Form S-3. We note that the aggregate market value of your voting and non-voting common equity held by nonaffiliates appears to be less than $75 million during the 60 days prior to filing the registration statement, so that you would not meet the requirement of General Instruction I.B.1 to use Form S-3. If you are relying on General Instruction I.B.4 to use Form S-3, please tell us how you have met the informational requirements to warrant holders required by General Instruction I.B.4(b) and (c). If you are relying on General Instruction I.B.6 to use Form S-3, please include the information on your prospectus cover page that is required by Instruction 7 to General Instruction I.B.6 of Form S-3. United States Securities and Exchange Commission August 16, 2018 Page 2 Response: The Company acknowledges that it is not eligible to conduct this offering on a Form S-3 registration statement under General Instruction I.B.1 of Form S-3 as the aggregate market value of the voting and non-voting common equity held by non-affiliates of the Company, computed by use of the price at which the Company’s common stock was last sold on the NYSE American, LLC as of a date within 60 days prior to the filing of the Registration Statement on Form S-3, did not equal or exceed $75 million. In addition, the Company is not relying on General Instruction I.B.6 to use the Registration Statement on Form S-3. However, the Company is eligible to conduct this offering on a Form S-3 registration statement since, as discussed in greater detail below, it has complied with General Instruction I.B.4 of Form S-3. General Instruction I.B.4 permits registrants meeting the registrant requirements specified in General Instruction I.A to register on Form S-3 securities to be offered upon the exercise of outstanding warrants issued by the issuer of the securities to be offered, provided that (i) the issuer has sent, within the twelve calendar months immediately before the registration statement is filed, material containing the information required by Rule 14a-3(b) (the “Annual Report Information”) under the Securities Exchange Act of 1934, as amended, to all record holders of the warrants, and (ii) the issuer has provided, within the twelve calendar months immediately before the Form S-3 registration statement is filed, the applicable information required by Items 401, 402, 403 and 407(c)(3), (d)(4), (d)(5) and (e)(4) of Regulation S-K (collectively, the “Regulation S-K Information”) to all holders of the warrants. The Company confirms that, during 2018 and prior to the filing of the Registration Statement on Form S-3, it distributed to all record holders and holders of the outstanding warrants a copy of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (the “Form 10-K”) via e-mails sent directly by the Company and by engaging Broadridge Financial Solutions to conduct a mailing of hard copies. The Form 10-K contained all of the Annual Report Information and the Regulation S-K Information that is required of the Company under General Instruction I.B.4 of Form S-3. Based upon the foregoing, we respectfully submit that the Company is eligible to conduct this offering on a Form S-3 registration statement. * * * United States Securities and Exchange Commission August 16, 2018 Page 3 If you have any questions or need additional information regarding the Form S-3 or our response to the Comment Letter, please do not hesitate to contact the undersigned at (516) 496-2223 or (212) 907-6457, or Patrick J. Egan at (914) 557-5574. Sincerely, /s/ Leslie Marlow Leslie Marlow Enclosure cc: Steven A. Shallcross Interim Chief Executive Officer and Chief Financial Officer, Synthetic Biologics, Inc.
2018-08-15 - UPLOAD - Theriva Biologics, Inc.
August 15, 2018
Steven A. Shallcross
Interim Chief Executive Officer and Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed August 1, 2018
File No. 333-226500
Dear Mr. Shallcross:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-3 filed August 1, 2018
General
1.Please tell us how you are eligible to conduct your offering on Form S-3. We note that the
aggregate market value of your voting and non-voting common equity held by non-
affiliates appears to be less than $75 million during the 60 days prior to filing the
registration statement, so that you would not meet the requirement of General Instruction
I.B.1 to use Form S-3. If you are relying on General Instruction I.B.4 to use Form S-3,
please tell us how you have met the informational requirements to warrant holders
required by General Instruction I.B.4(b) and (c). If you are relying on General Instruction
I.B.6 to use Form S-3, please include the information on your prospectus cover page that
is required by Instruction 7 to General Instruction I.B.6 of Form S-3.
FirstName LastNameSteven A. Shallcross
Comapany NameSynthetic Biologics, Inc.
August 15, 2018 Page 2
FirstName LastName
Steven A. Shallcross
Synthetic Biologics, Inc.
August 15, 2018
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 Irene Paik at 202-551-6553 or Christine Westbrook at 202-551-5019 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Patrick J. Egan - Gracin & Marlow LLP
2018-05-15 - UPLOAD - Theriva Biologics, Inc.
May 14, 2018
Steven Shallcross
Interim Chief Executive Officer and Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, MD 20850
Re:Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed May 7, 2018
File No. 333-224728
Dear Mr. Shallcross:
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 Dorrie Yale at 202-551-8776 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Leslie Marlow
2018-05-14 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
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Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
May 14, 2018
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ms. Dorrie Yale
Re:
Synthetic Biologics, Inc.
Registration Statement on Form S-3
File No: 333-224728
Ladies and Gentlemen:
Synthetic Biologics,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-22478), to become effective
on Tuesday, May 15, 2018, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby authorizes its counsel, Leslie Marlow, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this
request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 with any questions you may have concerning
this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
Synthetic Biologics, Inc.
By: /s/ Steven A. Shallcross
Name:
Steven A. Shallcross
Title:
Interim Chief Executive Officer and
Chief Financial Officer
cc: Leslie
Marlow, Esq., Gracin & Marlow, LLP
2017-09-20 - UPLOAD - Theriva Biologics, Inc.
September 20, 2017 Steven A. Shallcross Chief Financial Officer Synthetic Biologics, Inc. 9605 Medical Center Drive, Ste. 270 Rockville, MD 20850 Synthetic Biologics, Inc. Form 10-K for the Fiscal Year Ended December 31, 2016 Filed March 2, 2017 File No. 001-12584Re: Dear Mr. Shallcross: We have completed our review of your filing. 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 by the staff. Division of Corporation Finance Office of Healthcare & Insurance cc: Leslie Marlow, Esq. - Gracin & Marlow, LLP
2017-08-24 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
August 24, 2017
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Division of Corporation Finance
Re: Synthetic Biologics, Inc.
Form 10-K filed on March 2,
2017
File No. 001-12584
Dear Ms. Paik:
Thank you for your August
18, 2017 letter regarding Synthetic Biologics, Inc. (“Synthetic”). Enclosed are responses to the comments in your letter.
For your convenience, we have set forth below the staff’s numbered comments in their entirety followed by our responses thereto.
Form 10-K for the Fiscal Year Ended December
31, 2016
Item 1. Business
Intellectual Property, page 11
1. Please
expand your disclosure in future filings regarding your intellectual property portfolio to (i) clarify which patents are owned
and which ones are licensed, (ii) identify the product candidate to which your patents and patent applications apply, and (iii)
disclose the foreign jurisdictions where you have issued patents or pending patent applications, and the corresponding expiration
dates (or expected expiration dates).
Response: In our
Annual Report on 10-K for the year ended December 31, 2017, we will: (i) clarify which patents are owned and which ones are licensed;
(ii) identify the product candidate to which the patents and patent applications apply; and (iii) disclose by region (e.g. Europe)
the number of countries in each region for which we have foreign issued patents or pending patent applications, and a range of
the corresponding expiration dates (or expected expiration dates) with regard to our intellectual property portfolio.
United States Securities and
Exchange Commission
August 22, 2017
Page 2
Our Collaborations, page 11
2. In
future filings, please expand the description of your various collaboration agreements
to disclose:
• the royalty
rates (or a range of royalty rates within a 10% range) that are payable under these agreements, to the extent not already provided;
• the aggregate
future potential milestone payments that are payable under the CSMC License Agreement and the Prev Agreement;
• the term
of your collaboration and license agreements (and with respect to the Texas License Agreement, please clarify when the patent rights
expire so that investors understand the term of the agreement); and
• the termination
provisions under the PKU ECC and Prev Agreement.
Response: In our
Annual Report on Form 10-K for the year ended December 31, 2017, we will provide the requested information regarding our various
collaboration agreements.
Item 7. Management's Discussion and Analysis
of Financial Condition and Results of Operations
Liquidity and Capital Resources, page 42
3. We
note your disclosure on page 43 that based on your current plans, your cash and cash equivalents will not be sufficient to enable
you to meet your near term expected plans. In future filings, please expand your disclosure to describe how your cash position
will affect your operations. To this end, we refer to your statements in recent earnings calls that you intend to initiate your
Phase 2b/3 pivotal study for SYN-010 only once you have the clinical financial infrastructure necessary for its completion and
to that end you are evaluating the option of a partnership with another pharmaceutical company.
Response: In our
future filings, including our Annual Report on Form 10-K for the year ended December 31, 2017, we will further disclose how our
cash position affects our operations. We respectfully also submit that in our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2017 we had sought to provide disclosure addressing this issue in under the subtitles “Phase 3 Planning” and
“Current and Future Financing Needs” in Management's Discussion and Analysis of Financial Condition and Results of
Operations. Please see below:
Phase 3 Planning
On July 20, 2016, we participated
in an End of Phase 2 meeting with the FDA. Following a review of data from the two Phase 2 clinical trials of SYN-010 conducted
by us, a collaborative and positive discussion ensued with the FDA to determine the optimal pathway to advance SYN-010 into Phase
3 development. On January 18, 2017, and in accordance with guidance from the FDA, we confirmed our plan to conduct a Phase 2b/3
adaptive design study for our first pivotal trial intended to further evaluate the efficacy and safety of SYN-010, which we plan
to initiate subject to our successful pursuit of opportunities that will allow us to establish the clinical infrastructure and
financial resources necessary to successfully initiate and complete this plan.
United States Securities and
Exchange Commission
August 22, 2017
Page 3
Current and Future Financing Needs
Based on our current plans, our cash
and cash equivalents will not be sufficient to enable us to meet our near term expected plans. Our notes to the condensed
consolidated financial statements contain an explanatory paragraph referring to our recurring and continuing losses from operations
and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available. In
order to continue the development of our current product candidates as currently planned, including commencing our planned Phase
2b/3 and Phase 3 clinical trials, and to continue to fund operations at the current cash expenditure levels, we are required to
obtain additional funding, although we do not currently have commitments from any third parties to provide us with capital. Potential
sources of financing that we are pursuing include strategic relationships, public or private sales of our equity (including through
the FBR Sales Agreement that we entered into with FBR Capital Markets & Co. in August 2016) or debt and other sources. We cannot
assure that we will meet the requirements for use of the FBR Sales Agreement or that additional funding will be available on favorable
terms, or at all. If we fail to obtain additional funding in the next few months we will be forced to delay the initiation of our
planned clinical trials until such time as we obtain adequate financing and if we fail to obtain additional funding otherwise in
the future when needed, we may not be able to execute our business plan as planned and we may be forced to cease certain development
activities until funding is received and our business will suffer, which would have a material adverse effect on our financial
position, results of operations and cash flows.
We acknowledge that the
adequacy and accuracy of the disclosure in our filings is our responsibility. We acknowledge that the staff comments or changes
to disclosure do not foreclose the Commission from taking any action with respect to the filings. We acknowledge that the company
may not assert staff comments as a defense in any proceedings initiated by the Commission or any person under the federal securities
laws of the United States.
United States Securities and
Exchange Commission
August 22, 2017
Page 4
If you have any questions
or need additional information, please contact the undersigned at (301) 417-4359.
Sincerely,
Steven Shallcross
2017-08-18 - UPLOAD - Theriva Biologics, Inc.
August 18, 2017
Steven A. Shallcross
Chief Financial Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Ste. 270
Rockville, MD 20850
Synthetic Biologics, Inc.
Form 10-K
Filed March 2, 2017
File No. 001-12584Re:
Dear Mr. Shallcross:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2016
Item 1. Business
Intellectual Property, page 11
1. Please expand your disclosure in future filings regarding your intellectual property
portfolio to (i) clarify which patents are owned and which ones are licensed, (ii) identify
the product candidate to which your patents and patent applications apply, and (iii)
disclose the foreign jurisdictions where you have issued patents or pending patent
applications, and the corresponding expiration dates (or expected expiration dates).
Our Collaborations, page 11
2. In future filings, please expand the description of your various collaboration agreements
to disclose:
Steven A. Shallcross
Synthetic Biologics, Inc.
August 18, 2017
Page 2
• the royalty rates (or a range of royalty rates within a 10% range) that are payable
under these agreements, to the extent not already provided;
• the aggregate future potential milestone payments that are payable under the CSMC
License Agreement and the Prev Agreement;
• the term of your collaboration and license agreements (and with respect to the Texas
License Agreement, please clarify when the patent rights expire so that investors
understand the term of the agreement); and
• the termination provisions under the PKU ECC and Prev Agreement.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources, page 42
3. We note your disclosure on page 43 that based on your current plans, your cash and cash
equivalents will not be sufficient to enable you to meet your near term expected plans. In
future filings, please expand your disclosure to describe how your cash position will
affect your operations. To this end, we refer to your statements in recent earnings calls
that you intend to initiate your Phase 2b/3 pivotal study for SYN-010 only once you have
the clinical financial infrastructure necessary for its completion and to that end you are
evaluating the option of a partnership with another pharmaceutical company.
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 Dorrie Yale at 202-551-8776 or Irene Paik at 202-551-6553 with any
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Leslie Marlow, Esq. - Gracin & Marlow, LLP
2015-10-14 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
October 14, 2015
VIA EDGAR
United States Securities
and
Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director
Re: Synthetic Biologics, Inc.
Registration Statement
on Form S-3
Filed October 7, 2015
File No. 333-207327
Dear Ms. Hayes:
Synthetic Biologics,
Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement
so that it may become effective by 5:00 p.m. Eastern Daylight Time on October 15, 2015 or as soon thereafter as reasonably practicable.
In making this request,
the Company acknowledges that: (i) should the Securities and Exchange Commission or the staff, acting pursuant to delegated authority,
declare the filing effective, it will 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.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Steven A. Shallcross, Chief Financial Officer
2015-10-14 - UPLOAD - Theriva Biologics, Inc.
October 13, 2015 Via E -mail Jeffrey Riley Chief Executive Officer and President Synthetic Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, Maryland 20850 Re: Synthetic Biologics, Inc. Registration Statement on Form S-3 Filed October 7, 2015 File No. 333-207327 Dear Mr. Riley : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Jeffrey Riley Synthetic Biologics, Inc. October 13, 2015 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 Scot Foley at (202) 551 -3383 or me at (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP The Chrysler Building 405 Lexington Avenue, 26th Floor New York, New York 10174
2015-08-14 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
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August 14, 2015
VIA EDGAR
United States Securities
and
Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Assistant
Director
Re: Synthetic Biologics, Inc.
Registration Statement
on Form S-3
Filed August 10, 2015
File No. 333-206266
To whom it may concern:
Synthetic Biologics,
Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement
so that it may become effective by 5:00 p.m. Eastern Daylight Time on
August 18, 2015 or as soon thereafter as reasonably practicable.
In making this request,
the Company acknowledges that: (i) should the Securities and Exchange Commission (the “Commission”) or the staff, acting
pursuant to delegated authority, declare the filing effective, it will 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.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Steven A. Shallcross, Chief Financial Officer
2015-08-14 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
August 14, 2015
VIA EDGAR
United States Securities
and
Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Assistant
Director
Re: Synthetic Biologics, Inc.
Registration Statement
on Form S-3
Filed August 10, 2015
File No. 333-206267
To whom it may concern:
Synthetic Biologics,
Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement
so that it may become effective by 5:00 p.m. Eastern Daylight Time on
August 18, 2015 or as soon thereafter as reasonably practicable.
In making this request,
the Company acknowledges that: (i) should the Securities and Exchange Commission (the “Commission”) or the staff, acting
pursuant to delegated authority, declare the filing effective, it will 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.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ Steven A. Shallcross
Steven A. Shallcross, Chief Financial Officer
2015-08-14 - UPLOAD - Theriva Biologics, Inc.
Mail Stop 4720
August 14 , 2015
Via E -mail
Jeffrey Riley
Chief Executive Officer and President
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
Re: Synthetic Biologics, Inc.
Registration Statement on Form S-3
Filed August 10 , 2015
File No. 333-206266
Dear Mr. Riley :
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.
Jeffrey Riley
Synthetic Biologics, Inc.
August 14 , 2015
Page 2
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 registered securities .
Please contact Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3715 with any
other questions.
Sincerely,
/s/ Bryan J. Pitko for
Jeffrey P. Riedler
Assistant Director
Office of Healthcare and Insurance
cc: Via E -mail
Leslie Marlow, Esq.
Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
2012-05-31 - UPLOAD - Theriva Biologics, Inc.
May 31, 2012
Via E -mail
Mr. C. Evan Ballantyne
Chief Financial Officer
Synthetic Biologics, Inc.
3985 Research P ark Drive
Suite 200
Ann Arbor, MI 48108
Re: Synthetic Biologic , Inc.
Item 4.0 2 Form 8 -K
Filed May 3, 2012
File No. 001-12584
Dear Mr. Ballantyne :
We have completed our review of your filing . We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States. We urge all persons who are re sponsible for the
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 rules require.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assis tant Chief Accountant
2012-05-30 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
May 30, 2012
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Jim Rosenberg
Senior Assistant Chief
Accountant
Re: Synthetic Biologics, Inc. (the “Company”)
Form 8-K filed on May 3,
2012 and Form 8-K/A filed on May 30, 2012
Item 4.02
File
No. 001-12584
Dear Mr. Rosenberg:
Reference is made to
the above-captioned filings.
We acknowledge that
the adequacy and accuracy of the disclosure in our filings is our responsibility. We acknowledge that the staff comments or changes
to disclosure do not foreclose the Commission from taking any action with respect to the filings. We further acknowledge that the
Company may not assert staff comments as a defense in any proceedings initiated by the Commission or any person under the federal
securities laws of the United States.
Thank you.
SYNTHETIC BIOLOGICS, INC.
By:
/s/ C. Evan Ballantyne
C. Evan Ballantyne
Chief Financial Officer
Synthetic Biologics, Inc.
3985 Research Park Drive, Suite 200, Ann Arbor, MI 48108 (t): 734-332-7800 (f): 734-332-7878
2012-05-22 - UPLOAD - Theriva Biologics, Inc.
May 22, 2012
Via E -mail
Mr. C. Evan Ballantyne
Chief Financial Officer
Synthetic Biologics, Inc.
3985 Research P ark Drive
Suite 200
Ann Arbor, MI 48108
Re: Synthetic Biologic , Inc.
Item 4.0 2 Form 8 -K Dated May 1, 2012
Filed May 3, 2012
File No. 001-12584
Dear Mr. Ballantyne :
We have reviewed your filing and have the following comment . In our comment , we
may ask you to provide us with information so we may better understand your disclosure.
Please r espond to this letter within five business days by amending your filing or by
advising us when you will provide the requested response . 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 your response. Please furnish us a letter on EDGAR under the form type label
CORRESP that key s your response to our comment .
After reviewing any amendm ent to your filing and any information you provide in
response to the comment, we may have additional comments.
Item 4.0 2. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or
Completed Interim Review
You filed your Form 8-K under Item 4.02 of 8 -K and refer therein to an audit opinion included in
the Company’s Annual Report on Form 10 -K for the year ended December 31, 2011 that was
issued by a partner at Berman & Company who was not authorized under the PCAOB rules to
issue the opinion or act as the Company’s named engagement partner with respect to the Form
10-K audit or subsequent interim reviews. Your disclosure under this item, however, does not
specifically state that the audit report nor any annual and subsequent int erim financial statements
should not be relied upon. Please revise your disclosure to identify the previously issued audit
report and annual and subsequent interim financial statements , as applicable that should no
longer be relied upon. Refer to requir ements of Item 4.02(b) of Form 8 -K.
Mr. C. Evan Ballantyne
Synthetic Biologics, Inc.
May 22, 2012
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 Exchange Act of
1934 and all applicable Excha nge Act rules require. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comment, please pr ovide 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.
You may contact Christine Allen, Staff Accountant, at (202) 551 -3652 if you have
questions regarding the comment . In this regard, do not hesitate to contact me, at (202) 551 -
3679.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
2011-03-01 - UPLOAD - Theriva Biologics, Inc.
February 24, 2011 Mr. James S. Kuo, M.D., M.B.A President and Chief Executive Officer Adeona Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108 Re: Adeona Pharmaceuticals, Inc. Form 10- K for the Year Ended December 31, 2009 Form 10- Q for the Interim Period Ended June 30, 2010 File No. 001 -12584 Dear Mr. Kuo : We have completed our review of the above referenced filings and have no further comments at this time. Sincerely, Melissa N. Rocha Branch Chief
2011-02-08 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
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Unassociated Document
February 8,
2011
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100 F
Street, NE
Mail Stop
4270
Washington,
D.C. 20549
Attention:
Jim
Rosenberg
Senior Assistant Chief
Accountant
Re:
Adeona
Pharmaceuticals, Inc.
Form
10-K for the Year Ended December 31, 2009
Form
10-Q for the Interim Period Ended June 30, 2010
File No.
001-12584
Dear Mr.
Rosenberg:
Thank you
for your January 31, 2011 letter regarding Adeona Pharmaceuticals, Inc.
(“Adeona”). We hereby submit a letter responding to the
comments. For your convenience, we have set forth below the staff’s
numbered comment followed by our response thereto.
Form 10-Q
for the Interim Period Ended June 30, 2010
Note 2.
Basis of Presentation
Revenue
Recognition" page 7
1.
We acknowledge your response to
comment 8. Please revise your draft disclosures to include how revenue
will be recognized to the extent contracts have continuing obligations or
additional deliverables. Additionally; revise your draft disclosure to
include your revenue recognition policy for royalty payments, including
how royalty revenue will be calculated and
recognized.
Response: Complied with. We
have revised our disclosures to include how revenue will be
recognized. We have also revised our disclosure to include our
revenue recognition policy for royalty payments.
United
States Securities and
Exchange
Commission
February
8, 2011
Page
2
The
Company records revenue when all of the following have occurred: (1) persuasive
evidence of an arrangement exists, (2) the service is completed without further
obligation, (3) the sales price to the customer is fixed or determinable, and
(4) collectability is reasonably assured. The Company recognizes
milestone payments or upfront payments that have no contingencies as revenue
when payment is received. The Company has two streams of revenue,
license revenue and laboratory revenue.
Licensing
agreements:
The
Company’s licensing agreements may contain multiple elements, such as
non-refundable up-front fees, payments related to the achievement of particular
milestones and royalties. Fees
associated with substantive at risk performance-based milestones are recognized
as revenue upon completion of the scientific or regulatory event specified in
the agreement. When the
Company has substantive continuing performance obligations under an arrangement,
revenue is recognized over the performance period of the obligations using a
time-based proportional performance approach. Under the time-based method,
revenue is recognized over the arrangement’s estimated performance period based
on the elapsed time compared to the total estimated performance period. Revenue
recognized at any point in time is limited to the amount of non-contingent
payments received or due. When the Company has no substantive continuing
performance obligations under an arrangement, it recognizes revenue as the
related fees become due.
Revenues from royalties on third-party sales of licensed
technologies are generally recognized in accordance with the contract terms when
the royalties can be reliably determined and collectibility is reasonably
assured. To date, the Company has not received any royalty
revenues.
On
May 6, 2010, the Company entered into a Sublicense Agreement (the “Meda
Agreement”) with Meda AB of Sweden (“Meda”) for the development and
commercialization of Effirma (flupirtine) for fibromyalgia. As
consideration for the sublicense, the Company received an up-front payment of
$2.5 million upon execution of the Meda Agreement. This payment was recorded as
license revenue in June 2010. Pursuant to the Company’s license agreement with
McLean Hospital, the Company paid 15% of the $2.5 million payment ($375,000) to
McLean Hospital. The payment to McLean Hospital was netted against
the revenues received from Meda AB for financial statement
purposes. The Company is also entitled to additional milestone
payments of $5 million upon filing of a New Drug Application with the United
States Food and Drug Administration for flupirtine for fibromyalgia and $10
million upon marketing approval. The Meda Agreement also provides that the
Company is entitled to receive net royalties of 7% of net sales of flupirtine
approved for the treatment of fibromyalgia covered by issued patent claims in
the United States and Japan. The Meda Agreement provides that Meda AB
will assume all future development costs for the commercialization of flupirtine
for fibromyalgia. Pursuant to the terms of the Company’s agreement with McLean
Hospital, the Company is obligated to pay them half of the royalties the Company
receives. Future milestone payments will be recorded as revenue when
payment is received as there are no future deliverables, and it is
non-refundable. We will make similar disclosure for any future license
agreements.
Adeona
Pharmaceuticals, Inc.
3930
Varsity Drive
Ann
Arbor, Michigan 48108
tel:
734.332.7800
fax:
734.332.7878
We
acknowledge that the adequacy and accuracy of the disclosure in our filings is
our responsibility. We acknowledge that the staff comments or changes to
disclosure do not foreclose the Commission from taking any action with respect
to the filings. We acknowledge that the company may not assert staff
comments as a defense in any proceedings initiated by the Commission or any
person under the federal securities laws of the United
States.
Sincerely,
/s/ James S. Kuo
James S. Kuo, MD, M.B.A
Chairman and
CEO
2011-01-31 - UPLOAD - Theriva Biologics, Inc.
January 31, 2011 Mr. James S. Kuo, M.D., M.B.A President and Chief Executive Officer Adeona Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108 Re: Adeona Pharmaceuticals, Inc. Form 10- K for the Year Ended December 31, 2009 Form 10- Q for the Interim Period Ended June 30, 2010 File No. 001 -12584 Dear Mr. Kuo : We have reviewed your December 22, 2010 response to our December 15, 2010 letter and have the following comment. Please respond to this letter within ten business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe the comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response to our comment . After reviewing the information provide d, we may raise additional comments and/or request that you amend your filing . Form 10- Q for the Interim Period Ended June 30, 2010 Note 2. Basis of Presentation Revenue Recognition, page 7 1. We acknowledge your response to comment 8. Plea se revise your draft disclosures to include how revenue will be recognized to the extent contracts have continuing obligations or additional deliverables . Additionally, revise your draft disclosure to include your revenue recognition policy for royalty pa yments, including how royalty revenue will be calculated and recognized . Mr. James S. Kuo, M.D., M.B.A Adeona Pharmaceuticals, Inc. January 31, 2011 Page 2 You may contact Christine Allen, Staff Accountant, at (202) 551- 3652 or Melissa N. Rocha, Accounting Branch Chief at (202) 551 -3854 if y ou have any questions regarding the comment. In this regard, do not hesitate to contact me at (202) 551- 3679. Sincerely, Jim Rosenberg Senior Assistant Chief Accountant
2010-12-22 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Unassociated Document
December 17,
2010
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100 F
Street, NE
Mail Stop
4270
Washington,
D.C. 20549
Attention:
Jim
Rosenberg
Senior Assistant Chief
Accountant
Re:
Adeona
Pharmaceuticals, Inc.
Form
10-K for the year ended December 31, 2010
Form
10-Q for the interim period ended June 30, 2010
File No.
001-12584
Dear Mr.
Rosenberg:
We
acknowledge that the adequacy and accuracy of the disclosure in our filings is
our responsibility. We acknowledge that the staff comments or changes
to disclosure do not foreclose the Commission from taking any action with
respect to the filings. We acknowledge that the company may not
assert staff comments as a defense in any proceedings initiated by the
Commission or any person under the federal securities laws of the United
States.
Sincerely,
/s/
James
S. Kuo
James
S. Kuo
2010-12-22 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Unassociated Document
December
22, 2010
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100 F
Street, NE
Mail Stop
4270
Washington,
D.C. 20549
Attention: Jim
Rosenberg
Senior
Assistant Chief Accountant
Re: Adeona
Pharmaceuticals, Inc.
Form
10-K for the year ended December 31, 2010
Form
10-Q for the interim period ended June 30, 2010
File No.
001-12584
Dear Mr.
Rosenberg:
Thank you
for your December 15, 2010 letter regarding Adeona Pharmaceuticals, Inc.
(“Adeona”). We hereby submit a letter responding to the
comments. For your convenience, we have set forth below the staff’s
numbered comments in their entirety followed by our responses
thereto.
United
States Securities and
Exchange
Commission
December
22, 2010
Page
2
Form
10-K for the Year Ended December 31. 2009
Intellectual
Property, page 8
1. Please
confirm that in future filings you will include:
·
The
duration of each agreement and a discussion of the termination
provisions;
·
The
date of expiration of the licenses under each
agreement;
·
The
amount of the annual maintenance fees you pay under the Thomas Jefferson
University and the 2005 University of California license
agreements;
·
The
aggregate milestone payments under the 2008 University of California
license agreement; and
·
The
royalty rates you have agreed to pay under each agreement on net sales of
products covered by licensed
patents.
Response:
We confirm that in future filings we will include disclosure regarding all of
the items listed above.
2.
Please
tell us the amount in dispute under the legal action for past consulting
services filed in 2009.
Response:
The dispute for past consulting services was settled in September
2010. In accordance with the Stipulation of Settlement, the Company
issued the individual $92,000 worth of shares of its common stock in full
settlement of all claims of the individual against the subsidiary.
Notes to the Consolidated
Financial Statements. page 43
Note 2. Acquisition of Hart
Lab, LLC. page 45
3.
Please
provide us draft disclosure for future filings showing the amounts
recognized at the acquisition date for each major class of assets acquired
and liabilities assumed in accordance with ASC 805-20-50-1c Business Combinations.
Identifiable Assets and Liabilities, and any Non-controlling Interest.
Depending on the nature of assets and liabilities acquired, please
ensure your draft disclosure complies with all requirements in ASC
805-20-50-1.
United
States Securities and
Exchange
Commission
December
22, 2010
Page
3
Response:Our
review of the accounting guidance has resulted in the following draft
disclosure:
Net
Assets Acquired:
Current
Assets:
Cash
$
5,625
Accounts
Receivable – net of allowance of $4,192
$
79,657
Equipment
– net of accumulated depreciation of $25,536
$
39,464
Total
$
124,746
Current
Liabilities:
Accounts
payable
$
38,324
Accrued
liabilities
$
12,593
Capital
lease
$
31,917
Total
$
82,834
Total
Net Assets Acquired
$
41,912
All
assets acquired and liabilities assumed have a book value equivalent to fair
value. The Company did not record any fair value adjustment for
contingencies since there were none.
The
Company believes that all assets are recoverable and that no impairment or
write-down to net realizable value is required. As a result of this business
combination, there is no allocation for a non-controlling interest since the
Company acquired a 100% controlling interest in Hart Lab, LLC.
Directors. Executive
Officers, Promoters and Corporate Governance, page 62
4.
Please
provide draft disclosure for future filings which discusses the specific
experience, qualifications, attributes or skills that led to the
conclusion that each nominee should serve as a director for the
registrant.
Response: Set forth below is the draft disclosure that the
Company intends to include in its future
filings.
JAMES S. KUO, M.D., M.B.A. Dr.
Kuo has been a director since February 2007. Effective February
6, 2010, Dr. Kuo was appointed as our Chairman of the Board, Chief Executive
Officer and President. Dr Kuo was the Chairman and Chief
Executive Officer of Cordex Pharma, Inc., a public biopharmaceutical company,
from September 2007 until February 1, 2010 and remained as a director until
March 13, 2010. From 2003 to 2006, he served as founder, Chairman and Chief
Executive Officer of BioMicro Systems, Inc. a private venture-backed,
microfluidics company. Prior to that time, Dr. Kuo was a founder,
President and Chief Executive Officer of Discovery Laboratories, Inc. where he
raised over $22 million in initial private funding and was instrumental in the
company going public. Dr. Kuo was also a founder and board member of Monarch
Labs, LLC, a private medical device company. Dr. Kuo is the former Managing
Director of Venture Analysis for Healthcare Ventures, LLC, which managed $378
million in venture funds. He has also been a senior licensing and business
development executive at Pfizer, Inc., where he was directly responsible for
cardiovascular licensing and development. After studying molecular biology and
receiving his B.A. at Haverford College, Dr. Kuo simultaneously received his
M.D. from the University of Pennsylvania School of Medicine and his M.B.A. from
the Wharton School of Business. From 2004 until October 2009 Dr. Kuo
also served as a director of Soligenix, Inc.
United
States Securities and
Exchange
Commission
December
22, 2010
Page
4
Dr.
Kuo brings to the Board significant executive leadership and operational
experience. Dr. Kuo’s prior business experience and board service,
along with his tenure at Adeona, gives him a broad and extensive understanding
of our operations and the proper role and function of the Board. His
prior service on the board of other public companies has provided him with a
strong corporate governance expertise. In addition, his medical background
allows him to bring to the Board extensive knowledge about our
industry. Due to his business background, he has a broad
understanding of the operational, financial and strategic issues facing public
companies.
STEVE H. KANZER, CPA,
JD. Mr. Kanzer is a co-founder and served as our President from our
inception in February 2001 until May 2006. Mr. Kanzer
previously served as our Chief Executive Officer from September 2004 until
November 2008, Chairman of the Board until February 6, 2010 and currently serves
as a director. Mr. Kanzer has also been a director and officer of
our subsidiaries, including Solovax, Inc., Effective Pharmaceuticals, Inc.,
Putney Drug Corp. Epitope Pharmaceuticals, Inc. and CD4 Biosciences, Inc. Since
December 2000, he has served as co-founder and Chairman of Accredited Ventures
Inc. and Accredited Equities Inc., a venture capital firm and investment bank,
respectively, which both specialize in the biotechnology industry. Prior to
founding Accredited Ventures and Accredited Equities in December 2000, Mr.
Kanzer served as Senior Managing Director-Head of Venture Capital at Paramount
Capital from 1991 until December 2000. While at Paramount Capital, Mr. Kanzer
was involved in the formation and financing of a number of biotechnology
companies and held various positions in these companies. Prior to joining
Paramount Capital in 1992, Mr. Kanzer was an attorney at the law firm of
Skadden, Arps, Slate, Meagher & Flom in New York where he specialized in
mergers and acquisitions. Mr. Kanzer received his J.D. from New York University
School of Law in 1988 and a B.B.A. in Accounting from Baruch College in 1985,
where he was a Baruch Scholar. Mr. Kanzer is active in university-based
pharmaceutical technology licensing and has served as Co-Chair of the New York
Chapter of the Licensing Executives Society.
Mr. Kanzer
has been associated with Adeona since inception and brings to the Board
extensive knowledge about our business operations and in particular our licenses
and products. Mr. Kanzer also brings to the Board
significant executive leadership and operational experience.
Mr. Kanzer’s legal background provides him with a broad
understanding of the legal issues facing Adeona, the financial markets and the
financing opportunities available to Adeona .
United
States Securities and
Exchange
Commission
December
22, 2010
Page
5
JEFFREY J. KRAWS. Mr. Kraws
has been a director since January 2006. Mr. Kraws is Chief
Executive Officer and co-founder of Crystal Research Associates. Well known and
respected on Wall Street, Mr. Kraws has received some of the most prestigious
awards in the industry. Among other awards, he was given a 5-Star Rating” in
2001 by Zacks and was ranked the number one analyst among all pharmaceutical
analysts for stock performance in 2001 by Starmine.com. Prior to founding
Crystal Research Associates, Mr. Kraws served as co-president of The Investor
Relations Group (IRG), a firm representing primarily under-followed,
small-capitalization companies. Previously, Mr. Kraws served as a managing
director of healthcare research for Ryan Beck & Co. and as director of
research/senior pharmaceutical analyst and managing director at Gruntal &
Co., LLC (prior to its merger with Ryan Beck & Company). Mr. Kraws served as
managing director of the healthcare research group and senior pharmaceutical
analyst at First Union Securities (formerly EVEREN Securities); as senior U.S.
pharmaceutical analyst for the Swedish-Swiss conglomerate Asea Brown Boveri; and
as managing director and president of the Brokerage/Investment Banking operation
of ABB Aros Securities, Inc. He also served as senior pharmaceutical analyst at
Nationsbanc Montgomery Securities, BT Alex Brown & Sons, and Buckingham
Research. Mr. Kraws also has industry experience, having been responsible for
competitive analysis within the treasury group at Bristol-Myers-Squibb Company.
He holds an MBA from Cornell University and a B.S. degree from State University
of New York-Buffalo. During 2006 through February 2007, Mr. Kraws served as our
Vice President of Business Development, on a part-time basis.
Mr. Kraws
brings a strong business background to Adeona, having worked as a pharmaceutical
analyst for over 22 years. Mr. Kraws brings to the Board significant
strategic, business and financial experience related to the business and
financial issues facing pharmaceutical companies. Mr. Kraws has a broad
understanding of the operational, financial and strategic issues facing
pharmaceutical companies. Through his services as Adeona’s Vice President
of Business Development during 2006 and a part of 2007, he developed extensive
knowledge of Adeona’s business.
JEFF RILEY Mr. Riley has been
a director since March 16, 2010. Since November 2009, Mr. Riley has served as
the Managing Director of Black Crow Ventures, a life science-focused consulting
firm with a commercial and transactional focus. He sits on the advisory boards
of an Australia-based venture fund (Queensland Biocapital Fund) and Ruga
Corporation, a Stanford University spin-out drug discovery company focused on
endoplasmic reticulum stress targets. Mr. Riley has held senior corporate and
commercial development positions with biotech companies Amphora Discovery,
Ontogen Corporation, and AvMax. In these positions, he was responsible for
raising equity and negotiating alliances including in-licensing, out-licensing,
distribution agreements, technology acquisitions and research agreements with
large pharmaceutical companies and government agencies. Mr. Riley's
pharmaceutical experience includes commercial management and mergers and
acquisition roles for Pfizer and SmithKline Beecham. Additionally, Mr. Riley
served as CFO and VP Corporate Development for Nichols Institute Diagnostics, a
CLIA-certified molecular diagnostics and reference lab, later acquired by Quest
Diagnostics. Prior to attending university, Mr. Riley served in the U.S.
Army.
Mr.
Riley brings to the Board extensive knowledge of the pharmaceutical industry.
Having served in senior corporate positions in biotech and pharmaceutical
companies he has a vast knowledge of the industry. His business
experience provides him with a broad understanding of the operational, financial
and strategic issues facing public companies.
United
States Securities and
Exchange
Commission
December
22, 2010
Page
6
JEFF WOLF, ESQ. Mr. Wolf has
substantial experience in creating, financing, nurturing and growing new
ventures based upon breakthrough research and technology. Mr. Wolf is the
founding partner of Seed-One Ventures, LLC, a venture capital group focused on
seed-stage technology-based investments. Mr. Wolf has been a founder of Elusys
Therapeutics, Inc., an antibody-based therapeutic company, Tyrx Pharma, Inc., a
biopolymer-based company, Sensatex, Inc., a medical device company and
Generation Mobile, Inc. a telecommunications company. Prior to founding Seed-One
Ventures, Mr. Wolf served as the Managing Director of The Castle Group, Ltd., a
biomedical venture capital firm. At both organizations, Mr. Wolf was responsible
for supervising the formation and funding of new technology, biomedical, and
service oriented ventures. Mr. Wolf currently sits on the board of Elusys
Therapeutics and Netli, Inc. Mr. Wolf received his MBA from Stanford Business
School, his JD from New York University School of Law and his BA with honors in
Economics from the University of Chicago.
Mr.
Wolf also has extensive knowledge of the industry and in particular research and
development. His legal and business background provide him with a
broad understanding of the legal, operational, financial and strategic issues
facing Adeona. Having served as a board member on other public
company boards, Mr. Wolf has an extensive understanding of the operational,
financial and strategic issues facing public companies.
Certain Relationships and
Related, Transactions and Director Independence, page 68
5.
Please
provide draft disclosure for future filings that discusses your policies
and procedures for reviewing and approving the related party transactions
that you discloser as required by Item 404(b) of Regulation
S-K.
Response: The following draft disclosure will
be added to future filings: “Pursuant to its charter, the Company’s Audit
Committee, shall review on an on-going basis for potential conflicts of
interest, and approve if appropriate, all “Related Party Trans
2010-12-15 - UPLOAD - Theriva Biologics, Inc.
December 15, 2010 Mr. James S. Kuo, M.D., M.B.A President and Chief Executive Officer Adeona Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108 Re: Adeona Pharmaceuticals, Inc. Form 10- K for the Year Ended December 31, 2009 Form 10- Q for the Interim Period Ended June 30, 2010 File No. 001 -12584 Dear Mr. Kuo : We have reviewed your filing and have the following comments. In our comments, we 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, providing the requested information , or by advising us when you will provide the requested response. If you do not be lieve a comment appl ies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Form 10- K for the Year Ended December 31, 2009 Intellectual Property, page 8 1. Please confirm that in future filings you will include: • The duration of each agreement and a discussion of the termination provisions; • The date of expiration of the licenses under each agreement; • The amount of the annual maintenance fees you pay under the Thomas Jefferson University and the 2005 University of California license agreements; and • The aggregate m ilestone payments under the 2008 University of California license agreement; and • The royalty rates you have agreed to pay under each agreement on net sales of products covered by licensed patents. Mr. James S. Kuo, M.D., M.B.A Adeona Pharmaceuticals, Inc. December 13, 2010 Page 2 Legal Proceedings, page 28 2. Please tell us the amount in dispute under the legal action for past consulting services filed in 2009. Notes to the Consolidated Financial Statements, page 43 Note 2. Acquisition of Hart Lab, LLC, page 45 3. Please provide us draft disclosure for future filings showing the amounts recognized at the acquisition date for each major class of assets acquired and liabilities assumed in accordance with ASC 805- 20-50-1c Business Combinations, Identifiable Assets and Liabilities, and any Noncontrolling Interest . Depending on t he nature of assets and liabilities acquired, please ensure your draft disclosure complies with all requirements in ASC 805 -20-50-1. Directors, Executive Officers, Promoters and Corporate Governance, page 62 4. Please provide draft disclosure for future filings which discusses the specific experience, qualifications, attributes or skills that led to the conclusion that each nominee should serve as a director for the registrant. Certain Relationships and Related Transactions and Director Independence, pag e 68 5. Please provide draft disclosure for future filings that discusses your policies and procedures for reviewing and approving the related party transactions that you disclose, as required by Item 404(b) of Regulation S -K. Signatures, page 74 6. Please am end your filing to include the signature of your Principal Accounting Officer or Controller or, alternatively, please tell us if one of the persons already signing the Form 10- K was acting in that capacity and confirm that you will identify that person as such in future filings. Form 10- Q for the Interim Period Ended June 30, 2010 Note 2. Basis of Presentation Revenue Recognition, page 7 7. Please tell us why it is appropriate to immediately recognize the entire $2.125 million up - front payment received f rom Meda AB of Sweden (Meda) in the quarter ended June 30, 2010. Also, tell us what continuing involvement or obligations you have to Meda in accordance with your Sublicense Agreement and how your accounting for each of the deliverables in this agreement is in accordance with ASC 605 -10 Revenue Recognition . Mr. James S. Kuo, M.D., M.B.A Adeona Pharmaceuticals, Inc. December 13, 2010 Page 3 8. Please provide us draft disclosure for future filings of your revenue recognition policy to specifically disclose your accounting policy for each deliverable included in your license agreements, includ ing up -front fees, milestone payments, and royalties. 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 in possession of all facts relating to a company’s disclosure, they are r esponsible 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 t o 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 f ederal securities laws of the United States. You may contact Christine Allen, Staff Accountant at (202) 551- 3652 or Melissa N. Rocha, Branch Chief at (202) 551- 3854 if you have questions regarding the processing of your response as well as any questions regarding the comment s on the financial statements and related matters. Please contact Michael Rosenthall , Staff Attorney at (202) 551- 3674 or Dan Greenspan , Special Counsel at (202) 551- 3623 with questions on any of the other comments. In this regard, do not hesitate to contact me, at (202) 551- 3679. Sincerely, Jim Rosenberg Senior Assistant Chief Accountant
2010-06-10 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
s22-9783_corresp.htm
Adeona Pharmaceuticals, Inc.
3930 Varsity Drive
Ann Arbor, MI 48108
Tel: 734.332.7800
Fax: 734.332.7878
June 10, 2010
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, NE
Mail Stop 4720
Washington, D.C. 20549
Attention: Jeffrey Riedler
Re: Adeona Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 12, 2010 as amended May 26, 2010
File No. 333-166750
Dear Mr. Riedler:
Adeona Pharmaceuticals, Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it may become effective by 5:00 p.m. Eastern Daylight Time on June 14, 2010 or as soon thereafter as reasonably practicable.
In making this request, the Company acknowledges that (i) should the Securities and Exchange Commission or the staff declare the filing effective, it will not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff 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 staff’s 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.
ADEONA PHARMACEUTICALS, INC.
By: /s/ James S. Kuo
James S. Kuo, Chairman and
Chief Executive Officer
2010-05-21 - UPLOAD - Theriva Biologics, Inc.
Mail Stop 4720 May 21, 2010 James S. Kuo Chief Executive Officer and President Adeona Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108 Re: Adeona Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 12, 2010 File No. 333-166750 Dear Dr. Kuo: We have limited our review of the above referenced registration statement to only the issues identified herein. Where indicated, we think you should revise your document in response to these comments. If you disagr ee, we will consider your explanation as to why our comments are inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form S-3 filed May 12, 2010 General 1. We note that you have a pending confiden tial treatment request. Please be advised that we will not be in a position to consider a request for acceleration of effectiveness of the registration statemen t until we resolve all issues concerning the confidential tr eatment request. James S. Kuo Adeona Pharmaceuticals, Inc. May 21, 2010 Page 2 Incorporation of Certain Docu ments by Reference, page 16 2. Please revise your disclosure to incorpor ate by reference all reports filed pursuant to Section 13(a) or 15(d) of the Exchange Act since the end of your fiscal year 2009. Specifically, this should include your current reports on Form 8-K as filed on January 13, February 9 and March 16, as amended on March 31. * * * 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 response to our comments and provides any re quested information. De tailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendment and response to our comment. 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. James S. Kuo Adeona Pharmaceuticals, Inc. May 21, 2010 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 acceleration 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 Karen Ubell at (202) 551-3873 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 Assistant Director cc: Hank Gracin Gracin & Marlow, LLP Chrysler Building 405 Lexington Avenue, 26th Floor New York, New York 10174
2008-10-22 - UPLOAD - Theriva Biologics, Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 October 8, 2008 Steve H. Kanzer Chairman and Chief Executive Officer Pipex Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108
Re: Pipex Pharmaceuticals, Inc.
Form 10-KSB for the Year Ended December 31, 2007
File No. 001-12584
Dear Mr. Kanzer:
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 o e l P a r k e r A c c o u n t i n g B r a n c h C h i e f
2008-08-26 - UPLOAD - Theriva Biologics, Inc.
Via Facsimile and U.S. Mail
Mail Stop 6010
August 26, 2008
Steve H. Kanzer
Chairman and Chief Executive Officer
Pipex Pharmaceuticals, Inc.
3930 Varsity Drive
Ann Arbor, MI 48108
Re: Pipex Pharmaceuticals, Inc.
Form 10-KSB for the Year Ended December 31, 2007
File No. 001-12584
Dear Mr. Kanzer:
We have reviewed your filing and have the following comment. We have limited
our review to only your financia l statements and related disclosures and do not intend to
expand our review to other portions of your document. 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.
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 filings. We look forward to working with you in these respects. We
welcome any questions you may have about our comment or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Exhibit 31.1 – Certification Pursuant To Rule 13a-14(a) or Rule 15d-14(a)
1. We note that you filed your Principal Ex ecutive Officer and Principal Financial
Officer certification under Item 601(b)(31) of Regulation SB. Please revise this
certification to include the introductory language of paragraph 4 and the language
of paragraph 4(b) of Item 601(b)(31) of Regulation SB.
* * * *
As appropriate, please amend your Form 10-KSB for the year ended December
31, 2007 and respond to the comment within 10 business days or tell us when you will provide us with a response. Please furnish a letter that keys your response to our
comment and provides any requested information. Detailed cover lette rs greatly facilitate
Steve H. Kanzer
Pipex Pharmaceuticals, Inc.
August 26, 2008 Page 2
our review. Please furnish your letter on E DGAR under the form type label CORRESP.
Please understand that we may have addi tional comments after reviewing your
amendment and response to our comment.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings to be certain that the filings include 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 comment, 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
filings;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filings; and
• the company may not assert staff comme nts 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 filings or in response to our comments on your filings.
Please contact James Peklenk, Staff A ccountant, at (202) 551-3661, or Mary
Mast, Senior Accountant, at (202) 551-3613 if you have any questions regarding the
comment. In this regard, do not hesi tate to contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief Accountant
2008-05-07 - UPLOAD - Theriva Biologics, Inc.
Mail Stop 6010 April 29, 2008 Mr. Steve H. Kanzer, CPA, Esq. Chief Executive Officer Pipex Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108 Re: Pipex Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14A Filed on April 18, 2008 File Number 001-12584 Dear Mr. Kanzar: We have completed our review of your proxy statement and have no further comments at this time. Please contact Sonia Barros at (202) 551-3655 with any questions. S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Steven Pappas, Esq. Lehman & Eilen LLP
2008-04-29 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
PIPEX PHARMACEUTICALS, INC.
3930 Varsity Drive
Ann Arbor, MI 48108
Tel: (734) 332-7800
Fax: (734) 332-7878
April 29, 2008
VIA EDGAR AND
OVERNIGHT MAIL
United States Securities
and Exchange Commission
100 F Street, NE
Mail Stop 4561
Washington, D.C. 20549
Attention: Sonia Barros
Re:
Pipex Pharmaceuticals, Inc.
File No. 001-12584
Dear Ms. Barros:
Thank you for your April 25, 2008 letter regarding Pipex Pharmaceuticals, Inc.’s (the “Company”) proxy statement.
In connection with responding to your comments, the Company acknowledges that (i) the Company is responsible for the adequacy and accuracy of the disclosure in the filings; (ii) staff comments or changes to disclosure in response to staff comments in the filings reviewed by the staff do not foreclose the Commission from taking any action with respect to the filing; and (iii) the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
PIPEX PHARMACEUTICALS, INC.
By: _/s/ Steve H. Kanzer______
Steve H. Kanzer, Chief Executive Officer
2008-04-28 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
LEHMAN & EILEN LLP
50 Charles Lindbergh Blvd
Suite 505
Uniondale, NY 11553
Tel: (516) 222-0888
Fax: (516) 222-0915
April 28, 2008
VIA EDGAR AND
OVERNIGHT MAIL
United States Securities
and Exchange Commission
100 F Street, NE
Mail Stop 4561
Washington, D.C. 20549
Attention: Sonia Barros
Re:
Pipex Pharmaceuticals, Inc.
File No. 001-12584
Dear Ms. Barros:
Thank you for your April 25, 2008 letter regarding Pipex Pharmaceuticals, Inc.’s (the “Company”) proxy statement. We hereby submit a letter responding to the two comments. For your convenience, we have set forth below the comments in their entirety followed by our responses thereto.
1.
Please include the required compensation for 2006 in the summary compensation table.
Response: We will revise the summary compensation table to include the required compensation for 2006 in the Definitive Proxy Statement.
2.
Please disclose your current plans to complete a spin off. If you have any plans to complete a spin off, you must provide all information that would be required as if the shareholders were voting on a spin off. See Note A to Schedule 14A.
United States Securities
and Exchange Commission
April 28, 2008
Page 2
Response: We will disclose in the Definitive Proxy Statement that “the Company has no plans to complete a spin off at this time.”
Please call me at (516)222-0888 to let me know whether I can file the Definitive Proxy Statement.
Thank you
Sincerely,
/s/ Steven Pappas
Steven Pappas
cc: Pipex Pharmaceuticals, Inc.
2008-04-25 - UPLOAD - Theriva Biologics, Inc.
Mail Stop 6010 April 25, 2008 Mr. Steve H. Kanzer, CPA, Esq. Chief Executive Officer Pipex Pharmaceuticals, Inc. 3930 Varsity Drive Ann Arbor, MI 48108
Re: Pipex Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed on April 18, 2008 File Number 001-12584
Dear Mr. Kanzar:
This is to advise you that we have limited our review of the above proxy statement to the
issues identified below. We will make no further review of this filing.
Where indicated, we think you should revise your documents 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. Summary Compensation Table, page 12
1. Please include the required compensation for 2006 in the summary compensation table.
Proposal Three, page 22
2. Please disclose your current plans to complete a spin off. If you have any plans to
complete a spin off, you must provide all information that would be required as if the shareholders were voting on a spin off. See Note A to Schedule 14A.
As appropriate, please revise your proxy statement in response to this comment. You may wish to provide us with marked copies of the revised document to expedite our review. Please furnish a response letter that keys your responses to our comments. Detailed cover letters
Mr. Steve H. Kanzer, CPA, Esq.
Pipex Pharmaceuticals, Inc. April 25, 2008 Page 2 greatly facilitate our review. Please file your cover letter on EDGAR under the form type label CORRESP. 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 filings reviewed by the staff to be certain that they have provided all information investors 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 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 filings;
• staff comments or changes to disclosure in response to staff comments in the filings reviewed by the staff 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.
Please contact Sonia Barros at (202) 551-3655 with any questions.
S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Hank Gracin, Esq.
Lehman & Eilen LLP Mission Bay Office Plaza Suite 300 20283 State Road 7 Boca Raton, FL 33498
2007-02-09 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
PIPEX PHARMACEUTICALS, INC.
3985 Research Park Drive
Ann Arbor, Michigan 48108
Tel. (734) 332-7800
February 9, 2007
VIA FACSIMILE (202) 772-9217
AND FIRST CLASS MAIL
United States Securities
and Exchange Commission
450 Fifth Street, N.W.
Mail Stop 4561
Washington, D.C. 20549
Attention: Sonia Barros, Esq.
Re:
File No. 333-139354
Pipex Pharmaceuticals, Inc. Form SB-2
Dear Ms. Barros:
Pipex Pharmaceuticals, Inc. (the “Company”) hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it may become effective by 5:00 p.m. Eastern Daylight Time on Tuesday, February 13, 2007 or as soon thereafter as reasonably practicable.
In making this request, the Company acknowledges that (i) should the Securities and Exchange Commission or the staff declare the filing effective, it will not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff 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.
PIPEX PHARMACEUTICALS, INC.
By: /s/ Steve H. Kanzer __________
Steve H. Kanzer, Chief Executive Officer
2007-01-25 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Unassociated Document
Lehman
& Eilen LLP
Mission
Bay Office Plaza, Suite 300
20283
State Road 7
Boca
Raton, FL 33498
T:
561-483-2796
F:
561-237-0803
January
25, 2007
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100
F
Street, NE
Mail
Stop
4561
Washington,
D.C. 20549
Attention:
Sonia Barros
Re:
Pipex
Pharmaceuticals, Inc.
Registration
Statement on Form SB-2
Filed
on December 14, 2006
File
No. 333-139354
Dear
Ms.
Barros:
Thank
you
for your January 24, 2007 letter regarding Pipex Pharmaceuticals, Inc. (the
“Company”). We hereby submit a letter responding to the one comment. For your
convenience, we have set forth below the comment in its entirety followed by
our
response thereto.
1.
Please
provide us your analysis as to whether you consider Ridgeback Capital
Investments Ltd. to be an “affiliate” of the Company. We may have further
comments after receiving your response.
Response:
We do not consider Ridgeback Capital Investments Ltd. (“Ridgeback Capital”) to
be an affiliate of the Company.
Ridgeback
Capital is a New York-based investment fund that makes investments in the life
sciences sector. The fund is managed by a physician having substantial
experience and sophistication in the realm of life science investing. Based
upon
public filings made by Ridgeback Capital with the Securities and Exchange
Commission (the “Commission”), it is clear that Ridgeback Capital has made
considerable investments in, and continues to hold positions in, numerous
other
United
States Securities
and
Exchange Commission
January
25, 2007
Page
2
publicly-traded
life science companies.
Ridgeback
was first introduced to the Company in 2006 by a registered representative
of an
NASD member firm that served as a selected dealer in connection with the
Company’s recently completed private placement. Ridgeback Capital’s only
relationship with the Company is therefore that of an investor. Indeed, there
are no interlocking relationships between the Company’s directors and officers
and those of Ridgeback Capital; Ridgeback Capital has no part in the management
of the Company and no one associated with the Company has a part in the
management or investment decisions of Ridgeback Capital; neither the Company
nor
anyone associated with the Company has any equity interest in Ridgeback Capital
or any of Ridgeback Capital’s affiliates; and there are no family relationships
among the individuals associated with the Company and those associated with
Ridgeback Capital.
Moreover,
Ridgeback Capital has filed a Schedule 13G with the Commission in connection
with its investment in the Company. As you are aware, Ridgeback Capital would
have been obligated to file a Schedule 13D under Regulation 13D-G of the Rules
and Regulations promulgated under the Securities Exchange Act of 1934 (the
“Exchange Act”) if it had made its investment in the Company with the purpose or
with the effect of changing or influencing the control of the
Company.
Finally,
Ridgeback Capital’s beneficial ownership of the Company’s common stock has
decreased to 10.5% since the original filing of the Company’s Form SB-2 due to
the Company’s issuance of 2,295,259 shares of its common stock on January 12,
2007 in order to acquire the minority interest in its subsidiary Effective
Pharmaceuticals, Inc. And after giving effect to the exercise of all of the
Company’s currently outstanding warrants and options, Ridgeback Capital’s
beneficial ownership is only 7.7%. Indeed, when one backs out the Company
warrants that Ridgeback Capital owns, the 3,713,129 shares of Company common
stock that Ridgeback Capital owns now represents only 7.3% of the Company’s
outstanding common stock.
While
we
recognize that beneficial ownership of 10% or more of a publicly registered
equity security mandates insider filings with the Commission pursuant to Section
16 of the Exchange Act, we believe that such ownership is not dispositive as
to
affiliate status. As you are aware, Rule 144 of the Rules and Regulations
promulgated under the Securities Act of 1933 (the “Rules and Regulations”)
provides that an affiliate of an issuer is “a person that directly, or
indirectly through one or more intermediaries, controls, or is controlled by,
or
is under common control with, such issuer.” Rule 405 of the Rules and
Regulations provides the same.
United
States Securities
and
Exchange Commission
January
25, 2007
Page
3
While
the
term “control” is not defined in either the Securities Act of 1933 or the
Securities Exchange Act of 1934, our above analysis demonstrates that none
of
the factors are present here that are consistently found to be present by the
Commission when concluding that “control” exists. See
generally
Loss
& Seligman, Fundamentals
of Securities Regulation,
Aspen
Publishers (2004), at pages 455-469 (“Control Concepts under the SEC
Statutes”).
For
all
of the above reasons, we believe that Ridgeback Capital is not an affiliate
of
the Company.
Sincerely,
/s/ Hank
Gracin
Hank
Gracin
HG:ckg
cc:
Pipex
Pharmaceuticals, Inc.
2007-01-24 - UPLOAD - Theriva Biologics, Inc.
Mail Stop 6010
January 24, 2007
Mr. Steve H. Kanzer
Chief Executive Officer Pipex Pharmaceuticals, Inc. 3985 Research Park Drive Ann Arbor, MI 48108
Re: Pipex Pharmaceuticals, Inc.
Registration Statement on Form SB-2
Filed on December 14, 2006
File Number 333-139354
Dear Mr. Kanzar:
We have received your response letter da ted January 5, 2007 and have the following
additional comment.
1. Please provide us your analysis as to whethe r you consider Ridgeback Capital Investment
Ltd. to be an “affiliate” of the Company. We may have further comments after receiving
your response.
* * *
Mr. Steve H. Kanzer
Pipex Pharmaceuticals, Inc.
January 24, 2007 Page 2
Please furnish a letter on EDGAR under the form type label CORRESP in response to
our comment. Detailed letters greatly facilitate our review. Please contact Sonia Barros at (202)
551-3655 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: Hank Gracin, Esq.
Lehman & Eilen LLP Mission Bay Office Plaza Suite 300 20283 State Road 7 Boca Raton, FL 33498
2007-01-05 - CORRESP - Theriva Biologics, Inc.
CORRESP
1
filename1.htm
Unassociated Document
Lehman
& Eilen LLP
Mission
Bay Office Plaza, Suite 300
20283
State Road 7
Boca
Raton, FL 33498
T:
561-483-2796
F:
561-237-0803
January
5, 2007
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100
F
Street, NE
Mail
Stop
4561
Washington,
D.C. 20549
Attention:
Sonia Barros
Re:
Pipex
Pharmaceuticals, Inc.
File
No. 333-139354
Dear
Ms.
Barros:
Thank
you
for your December 22, 2006 letter regarding Pipex Pharmaceuticals, Inc. (the
“Company”). We hereby submit a letter responding to the limited comment. For
your convenience, we have set forth below the comment in its entirety followed
by our response thereto.
1.
We
note that the securities you are registering on your Form SB-2
are being
made on a shelf basis under Rule 415. Given the nature and size
of the
transaction being registered, please advise the staff of the company’s
basis for determining that the transaction is appropriately characterized
as a transaction that is eligible to be made on a shelf basis under
Rule
415(a)(1)(i).
Response:
We understand the recent concern of the staff regarding the amount of shares
being registered in small-cap transactions but believe for the reasons set
forth
below that the staff’s concerns are not implicated by this offering.
We
understand the difference between a primary offering and a secondary offering
and that Rule 415(a)(1)(i) may not be utilized in the case of a primary offering
because Rule 415(a)(1)(i) by its specific terms is limited to secondary
offerings. However, this is not an instance in which the selling shareholders
consist of one large investor - whether or not a large hedge fund - that
has
such a large position in the
United
States Securities
and
Exchange Commission
January
5, 2007
Page
2
issuer
that it effectively has a controlling interest in the issuer and may be
perceived as an affiliate of the issuer or even the issuer’s alter ego. Instead,
in this registration there are a large number of investors with no single
large
stakeholder. Indeed, there are 53 separate unrelated selling shareholders
in the
Company’s registration statement, each having made a separate investment
decision over a period of six months after having independently conducted
due
diligence of the Company’s pharmaceutical products and intellectual property by
hiring third party counsel and scientific experts. And no selling shareholder
here holds a large stake in the Company: one selling shareholder holds
approximately 11% of the Company’s outstanding common stock (8% on a fully
diluted basis) while all the other selling shareholders hold less than 5%
of the
Company’s outstanding common stock, with the majority of the shareholders each
holding less than 1% of the outstanding common stock (these percentages have
been further diluted by the recent issuance by the Company of 2,990,442 common
shares in connection with the Company’s merger with Effective Pharmaceuticals,
Inc., as previously disclosed in the Form SB-2 registration statement). Under
these circumstances, the offering is more properly characterized as a secondary
offering under Rule 415(a)(1)(i). Indeed, we believe it would be unreasonable
to
saddle any investor here with the constraints of a primary offering as they
seek
to sell their shares.
Moreover,
the transaction involved here was not a typical reverse merger into a public
blank check shell. The public company that the Company merged with - Sheffield
Pharmaceuticals, Inc. - had been an operating biopharmaceutical company since
1986 with approximately 3,500 shareholders and was listed on the American
Stock
Exchange until 2003 when it no longer met the continued listing requirements.
The shares of the Company’s outstanding common stock held by the original owners
of the public shell represent a negligible percentage of the outstanding
(.6%)
and are subject to a lock-up agreement until November 2007. And none of the
selling shareholders here are Company insiders or promoters. Indeed the
Company’s insiders, including its co-founder, Chairman, Chief Executive Officer
and President, have invested approximately $4.7 million in the Company during
the years 2001 through 2006, are locked up until November 2007.
Furthermore,
the selling shareholders here invested a large amount of money relative to
the
amount of money that the Company had on hand prior to the investments. While
the
total amount invested by the 53 selling shareholders was approximately $13.9
million, the amount of money that the Company had on hand prior to the
investment was approximately $250,000 and $3 million in convertible notes
(these
notes were converted into shares of the Company’s common stock at the closing of
the offering, are not included in this registration statement and are subject
to
a lock-up agreement until November 2007).
United
States Securities
and
Exchange Commission
January
5, 2007
Page
3
Additionally,
we believe it is particularly appropriate in this instance to evaluate the
offering against the Company’s outstanding common stock on a fully diluted
basis. While no assurance can be given, since the Company’s common stock had
previously been listed on the American Stock Exchange (AMEX), the Company
has
had communications with AMEX that make it clear that its common stock is
likely
to be listed on AMEX in the near future. However, one of the initial listing
requirements of AMEX is a certain registered market capitalization, which
this
registration statement would enable the Company to satisfy. As such, it is
reasonable to expect that the Company’s 5,118,590 outstanding stock options and
15,725,153 outstanding warrants will be exercised in the near future, thereby
decreasing the percentage of outstanding shares being registered in this
offering.
Finally,
we submit that strictly applying a flat mathematical formula to small cap
companies can work an injustice. Instead, we believe the math should only
be one
tool to help the staff in determining whether a latent primary offering is
present, and that it is more just to also consider the other factors that
we
have addressed in this letter.
Sincerely,
/s/
Hank
Gracin
Hank
Gracin
HG:ckg
cc:
Pipex
Pharmaceuticals, Inc.