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Letter Text
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2026-07-07
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2026-05-12
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-01-17
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-07-15
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Company responded
2024-08-16
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: July 15, 2024
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Company responded
2024-08-26
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
Generating summary...
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-08-26
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2024-07-24
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Company responded
2024-07-30
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: July 24, 2024
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-07-07
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2023-07-07
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-05-07
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: November 12,
2019
Summary
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Company responded
2020-05-15
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: May 7, 2020 | November 12, 2019
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2019-11-08
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2019-11-12
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: November 7, 2019
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2019-11-13
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2019-11-13
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2019-11-21
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-11
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-04-24
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2018-04-25
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: April 24, 2018
Summary
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Company responded
2018-04-26
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2018-04-26
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-01-18
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2018-01-30
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: January 18, 2018
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-12-04
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2016-06-14
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2016-07-05
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-11-02
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
↓
Company responded
2015-11-02
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2016-04-25
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
References: April 20, 2016
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2016-04-20
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2013-07-22
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Company responded
2013-07-23
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
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Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-07-15
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
Generating summary...
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-06-28
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-05-30
Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | Newtown, PA | 333-297195 | Read Filing View |
| 2026-07-07 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | Newtown, PA | N/A | Read Filing View |
| 2026-05-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2026-05-12 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-295727 | Read Filing View |
| 2025-01-17 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-284285 | Read Filing View |
| 2025-01-17 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-08-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 001-36020 | Read Filing View |
| 2024-08-16 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-07-24 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 001-36020 | Read Filing View |
| 2024-07-15 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-280642 | Read Filing View |
| 2023-07-07 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2023-07-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-15 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-15 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-21 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-21 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-20 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-20 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-12 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-05-17 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-04-11 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-25 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-24 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-02-06 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-02-06 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-01-30 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-01-18 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2017-12-27 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2017-12-04 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-07-05 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-06-14 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-04-25 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-04-20 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2015-11-02 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2015-11-02 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-23 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-23 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-22 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-15 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-06-28 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-05-30 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | Newtown, PA | 333-297195 | Read Filing View |
| 2026-05-12 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-295727 | Read Filing View |
| 2025-01-17 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-284285 | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 001-36020 | Read Filing View |
| 2024-07-24 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 001-36020 | Read Filing View |
| 2024-07-15 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | 333-280642 | Read Filing View |
| 2023-07-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-07 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-08 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-04-11 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-24 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-01-18 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2017-12-04 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-06-14 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-04-20 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2015-11-02 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-22 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-15 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-06-28 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-05-30 | SEC Comment Letter | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-07 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | Newtown, PA | N/A | Read Filing View |
| 2026-05-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2025-01-17 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-08-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-08-16 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2024-07-30 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2023-07-07 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-15 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2020-05-15 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-21 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-21 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-20 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-20 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-13 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-11-12 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2019-05-17 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-26 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-04-25 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-02-06 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-02-06 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2018-01-30 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2017-12-27 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-07-05 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2016-04-25 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2015-11-02 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-23 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
| 2013-07-23 | Company Response | Traws Pharma, Inc. (TRAW) (CIK 0001130598) | DE | N/A | Read Filing View |
2026-07-07 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 333-297195
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
July 7, 2026
Iain Dukes
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re: Traws Pharma, Inc.
Registration Statement on Form S-3
Filed July 1, 2026
File No. 333-297195
Dear Iain Dukes:
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: Bardia Moayedi, Esq.
</TEXT>
</DOCUMENT>
2026-07-07 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
1
filename1.htm
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
(267) 759-3680
July 7, 2026
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, D.C. 20549
Re: Traws Pharma, Inc.
Registration Statement on Form S-3
File No. 333-297195
REQUEST FOR ACCELERATION OF EFFECTIVENESS
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Traws Pharma, Inc., a Delaware corporation (the “Registrant”), hereby respectfully
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. 333-297195), to become effective on Thursday, July 9, 2026, at 5:00 p.m.,
Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that 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, Christopher L. Tinen, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please
contact Mr. Tinen at (858) 910-4809 with any questions you may have concerning this request, and please notify him when this request for
acceleration has been granted.
Very truly yours,
Traws Pharma, Inc.
By:
/s/ Charles Parker
Name:
Charles Parker
Title:
Chief Financial Officer
cc: Christopher L. Tinen, Snell & Wilmer L.L.P.
2026-05-13 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Traws Pharma, Inc. 12 Penns Trail Newtown, PA 18940 (267) 759-3680 May 13, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Traws Pharma, Inc. Registration Statement on Form S-3 Filed May 8, 2026 File No. 333-295727 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), Traws Pharma, Inc., a Delaware corporation (the "Registrant"), hereby respectfully 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. 333-295727) to become effective on Friday, May 15, 2026, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a 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, Christopher L. Tinen, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 910-4809 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Traws Pharma, Inc. By: /s/ Charles Parker Name: Charles Parker Title: Chief Financial Officer
2026-05-12 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 333-295727
May 12, 2026 Iain Dukes Chief Executive Officer Traws Pharma, Inc. 12 Penns Trail Newton, PA 18940 Re: Traws Pharma, Inc. Registration Statement on Form S-3 Filed May 8, 2026 File No. 333-295727 Dear Iain Dukes: 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: Bardia Moayedi, Esq.
2025-01-17 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 333-284285
January 17, 2025
Werner Cautreels
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re:Traws Pharma, Inc.
Registration Statement on Form S-3
Filed January 15, 2025
File No. 333-284285
Dear Werner Cautreels:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Christopher L. Tinen, Esq.
2025-01-17 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
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Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
(267) 759-3680
January 17, 2025
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Re:
Traws Pharma, Inc.
Registration Statement on Form S-3
Filed January 15, 2025
File No. 333-284285
REQUEST FOR ACCELERATION OF EFFECTIVENESS
Ladies and Gentleman:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Securities Act”), Traws Pharma, Inc., a Delaware corporation (the
“Registrant”), hereby respectfully 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. 333-284285) to become effective
on Wednesday, January 22, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Commission will consider this request as a 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, Christopher L. Tinen, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration.
Please contact Mr. Tinen at (858) 910-4809 with any questions you may have concerning this request, and please notify him when this
request for acceleration has been granted.
Very Truly Yours,
Traws Pharma, Inc.
By:
/s/ Werner Cautreels
Name: Werner Cautreels
Title: Chief Executive Officer
2024-08-26 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Traws Pharma, Inc. 12 Penns Trail Newtown, PA 18940 August 26, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Doris Gama and Laura Crotty Re: Traws Pharma, Inc. Registration Statement on Form S-3 Filed July 1, 2024 File No. 333-280642 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Traws Pharma, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended, so that such registration statement may become effective at 4:30 p.m. (Washington, D.C. time) on August 28, 2024, or as soon as practicable thereafter. TRAWS PHARMA, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2024-08-26 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 001-36020
August 26, 2024
Werner Cautreels
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re:Traws Pharma, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed June 27, 2024
File No. 001-36020
Dear Werner Cautreels:
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 of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joanne R. Soslow
2024-08-16 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
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August 16, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE.
Washington, D.C. 20549
Attention: Doris Stacey Gama and Laura Crotty
Re:
Traws Pharma, Inc.
Registration Statement
on Form S-3
Filed July 1, 2024
File No. 333-280642
Ladies and Gentlemen:
Set forth below are the responses of Traws Pharma, Inc.
(“we” or the “Company”) to a comment received from the staff of the Division of Corporation Finance (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) by letter dated July 15, 2024, with respect to the
Registration Statement on Form S-3 (the “Registration Statement”). For your convenience, we have restated the Staff's
comment from the July 15, 2024 letter below in its entirety in bold font, followed by the response from the Company.
Registration Statement on Form S-3
General
1. We note that on April 1,
2024 you acquired Trawsfynydd Therapeutics, Inc. As part of the merger transaction,
the company distributed to Traws Pharma, Inc. stockholders of record a non-transferrable
contingent value right relating to the disposition or monetization of Traws Pharma, Inc.’s
legacy business assets. Given these circumstances, please tell us your basis for concluding
that you are eligible to use Form S-3. For guidance in responding, please see Use of
Form S-8, Form 8-K, and Form 20-F by Shell Companies, Release No. 33-8587
(July 15, 2005) at n. 32 and Release No. 33-11265 (Jan. 24, 2024) at n. 943
in the Shell Company Business Combinations and the Securities Act of 1933, as well as Compliance
Disclosure Interpretations, Securities Act Forms, Question 115.18.
Response and Current Legal Standard
In response to the Staff’s comment, the
Company respectfully submits that it has not been and is not a shell company. A shell company, as defined in Rule 12b-2 under the
Securities Exchange Act of 1934 (the “Exchange Act”), is a company that has (1) no or nominal operations; and (2) either:
(i) no or nominal assets; (ii) assets consisting solely of cash and cash equivalents; or (iii) assets consisting of any
amount of cash and cash equivalents and nominal other assets.
Page 2
No or Nominal Operations
The Company has had operations at all times since
its IPO in July 2013. Prior to the merger (the “Merger””) with Trawsfynydd Therapeutics, Inc. (“Trawsfynydd”)
on April 1, 2024, the Company operated as a clinical-stage biopharmaceutical company focused on discovering and developing products
for patients with cancer. Release Nos. 33-8587 (addressing what constitutes a shell company) states that shell companies “do not
operate businesses and, hence, rarely have employees.” In contrast, the Company spent approximately $9.3 million on the development
of its product candidates during the 12 months prior to the Merger, including $1.9 million during the three months ended March 31,
2024. Employee compensation expense during the 12 months ended March 31, 2024 was approximately $6.8 million. At the time of the
Merger, the Company employed 17 persons.
For the three months ended March 31, 2023
and March 31, 2024 (the day before the merger with Trawsfynydd closed), the Company’s operating expenses associated with these
operating activities (i.e., research and development expenses, plus general and administrative expenses) totaled approximately $6.2 million
and $5.3 million, respectively. In light of these operating activities and corresponding expenses, we would respectfully submit that
the Company’s operations at all times through the Merger were substantial and do not qualify as “nominal” in order
for the Company to be deemed a shell company. In addition, after the Merger, the Company continued and continues to develop products
for patients with cancer.
As
disclosed in the Company’s definitive proxy statement filed with the Commission on August 9, 2024 (the “Proxy Statement”),
following the Merger, “the Company will primarily pursue the development of four compounds
that are all at the clinical stage. Two compounds represent the assets that were acquired from Trawsfynydd in the Merger: tivoxavir marboxil
(TRX100) and ratutrelvir (TRX01); and two compounds are legacy assets from the Company: narazaciclib and rigosertib.
The Company expects to use the
proceeds from the [contemporaneous private placement], along with the Company’s existing cash before the [Merger], as follows:
· Approximately
$6 million for the completion of the Phase 1 clinical trial in Australia of TRX100;
· Approximately
$6 million for the completion of the Phase 1 clinical trial in Australia of TRX01;
· Approximately
$3 million for two investigator-initiated studies in the United States of narazaciclib; and
· Approximately
$1 million for the ongoing development of rigosertib.”
In addition, as disclosed in
the Proxy Statement, one of the reasons for the Merger was that the combined company “would have significantly greater financial
resources and additional funding opportunities to fund in the near-term development of the combined company’s anti-viral and oncology
product candidates.” The Company’s expectation is that the combined company with four product candidates being developed
would have additional near term milestones, particularly in the anti-viral programs, that will help fund the continuing development of
the anti-viral programs and the longer term oncology clinical programs.
Page 3
Before considering the second prong of the shell
company test (i.e., no/nominal assets), we would note that the prongs are conjunctive, such that both prongs must be met for a company
to be deemed a shell company. Accordingly, we would respectfully submit that solely on the basis of its operations through the closing
of the Merger (and since that time), the Company should not be deemed to be a shell company. However, we would submit that the Company
also fails the asset test for shell company status, as described below.
No or Nominal Assets
As of March 31, 2024 and March 31,
2023, the Company had total assets (excluding cash, cash equivalents, marketable securities and restricted cash) of approximately $1.8
million and $0.8 million, respectively. Moreover, we would note that the book value of the Company’s assets reflected on the balance
sheet do not reflect the fair value of the Company’s drug development programs, which had been expensed as incurred as in-process
research and development in accordance with GAAP.
As
referenced above, prior to the Merger, the Company operated as a clinical-stage biopharmaceutical company focused on discovering and
developing products for patients with cancer. These activities were being conducted prior to the Merger and continue after the Merger
closed. As the Company states in the Registration Statement, following the Merger, the Company now, in addition to aiming to address
unmet medical needs in cancer, also works to address unmet medical needs in respiratory viral diseases. The viral respiratory
disease program includes a single oral dose CAP dependent inhibitor candidate for influenza, and an oral antiviral candidate designed
to target mPro protease without the need for a CYP inhibitor for SARS-CoV-2, both of which were acquired as part of the Merger. In the
cancer program, the Company is developing the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib for refractory endometrial
cancer and potentially for other cancers, which was in development prior to the Merger.
Narazaciclib is a product candidate in the
field of oncology with potential for use in multiple solid tumors In Q2 2024, the Company completed Phase 1/2 dose escalation
studies for narazaciclib, evaluated both as a monotherapy and in combination with letrozole in patients with recurrent metastatic
low-grade endometrioid endometrial cancer and other gynecologic malignancies. The studies were designed to define the dose limiting
toxicity and maximally tolerated dose that should result in the recommended Phase 2 dose for further clinical trials. The next steps
for narazaciclib will utilize an investigator sponsored trial (“IST”) strategy.
Upcoming milestones include:
· Release
of topline data from the recently completed Phase 1/2 dose escalation studies at an upcoming
medical meeting, and
· Identify
the recommended Phase 2 dose and initiation of ISTs in multiple myeloma, breast cancer and
other indications in H2 2024 and beyond.
Rigosertib in the field of oncology has potential
for use in the ultra-rare disease, advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated
SCC, or RDEB).
Page 4
The Company been utilizing an IST strategy to
develop rigosertib in this ultra rare disease. Data from these studies have been presented at international medical meetings including
the Society for Investigative Dermatology held in July, 2024 which highlighted ongoing studies conducted at the University Hospital in
Salzburg, Austria and Thomas Jefferson University, Philadelphia, PA. The Company has been encouraged by the ongoing investigator interest
for rigosertib and support the IST-led RDEB program, including compassionate use filings in both the USA and other countries.
As indicated in a letter to the Nasdaq Listing
Qualifications Department regarding the nonoccurrence of a change of control of Onconova Therapeutics, Inc. (“Onconova”,
now known as Traws Pharma, Inc.) under Nasdaq Marketplace Rule 5110(a), the combined Company has always intended to work on
developing both the Company’s and Trawsfynydd’s product candidates. The Nasdaq Listing Qualifications Department concurred
with the Company’s determination that the Merger would not constitute a change of control of the Company under Nasdaq Rule 5110(a).
CVRs and Referenced Releases
At the time of the Merger on April 1, 2024,
the Company entered into a CVR agreement with its legacy stockholders in order to distribute proceeds relating to any disposition or
monetization of the legacy cancer products, narazaciclib and rigosertib, following the closing of the Merger. While the contingent value
rights (“CVRs”) provide potential upside for the legacy stockholders, the Company intends to continue to develop narazaciclib
and rigosertib, along with tivoxavir marboxil (TRX100) and ratutrelvir (TRX01), the two assets acquired in the merger from Trawsfynydd,
and has no current plans to dispose of either legacy asset.
CVRs have the potential to capture benefits of
pre-merger assets for the pre-merger stockholders and are commonly used in merger transactions as a tool to capture as much value as
possible for pre-merger stockholders and to simplify negotiations by avoiding the need to mutually agree on an asset value. In this case,
the use of a CVR is not a sham transaction intended to temporarily park assets in a company to avoid shell company status only to revert
them back to promoters at a later date (e.g., the abusive transaction highlighted in note 32 of Release Nos. 33-8587). The Company respectfully
submits that it did not and has not entered into any agreement to materially dispose of such legacy assets as highlighted in note 943
of Release Nos. 33-11265 and that the Company has always intended to pursue its legacy business.
Totality of the Transactions
In looking at the totality of the transactions,
we also wanted to note that following the Merger, Dr. Steven M. Fruchtman, the Company’s prior Chief Executive Officer, remained
with the Company as Chief Scientific Officer, Oncology, the Company’s Chief Medical Officer, Dr. Victor Moyo, remained with
the Company as Chief Medical Officer, Oncology, and Mark Guerin remained with the Company in his role of Chief Financial Officer, although
Dr. Fruchtman subsequently resigned. The Company’s new Chief Executive Officer, Werner Cautreels, was not previously affiliated
with either the Company or Trawsfynydd.
Page 5
We also note that Onconova is deemed to be the
accounting acquirer of Trawsfynydd for GAAP purposes. Accordingly, Onconova’s historical financial statements will continue to
be the financial statements for the combined business on a going-forward basis. Furthermore, Trawsfynydd’s audited financial statements
and accompanying notes of Trawsfynydd as of and for the years ended December 31, 2023 and 2022, and their unaudited financial statements
and accompanying notes as of and for the three months ended March 31, 2024 and 2023, were all provided in Form 8-K/A, filed
with the SEC on June 17, 2024.
Based on the above facts, we do not believe that
the Company is a shell company as defined in the Exchange Act nor was it a shell company at any relevant time for determining its eligibility
to register its securities on Form S-3.
If you require any additional information on
these issues, or if we can provide you with any other information that will facilitate your review, please contact me at 617-610-4711.
Sincerely,
/s/
Werner Cautreels
Werner Cautreels
Chief Executive Officer
Cc: Joanne
R. Soslow
2024-07-30 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
1
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July 30, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE.
Washington, D.C. 20549
Attention: Doris Stacey Gama and Laura Crotty
Re: Traws Pharma, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed June 27, 2024
File No. 000-36020
Ladies and Gentlemen:
Set forth below are the responses of Traws Pharma, Inc.
(“we” or the “Company”) to comments received from the staff of the Division of Corporation Finance (the “Staff”)
of the U.S. Securities and Exchange Commission (the “Commission”) by letter dated July 24, 2024, with respect to the
Preliminary Proxy Statement on Schedule 14A (the “Proxy Statement”). For your convenience, we have restated the Staff's comments
from the July 24, 2024 letter below in their entirety in bold font, followed by the corresponding responses from the Company.
Preliminary Proxy Statement on Schedule
14A
Description of the Transactions
Acquisition of Trawsfynydd, page 11
1. Please revise this section,
where appropriate, to disclose the operating plan for the business in the near term as well
as the intended uses of the proceeds raised through the merger and concurrent financing.
State the principal purposes and the approximate amount intended to be used for each such
purpose.
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to now state:
“The Company expects to use the proceeds
from the Financing, along with the Company’s existing cash before the Transactions, as follows:
· Approximately
$6 million for the completion of the Phase 1 clinical trial in Australia of TRX100;
Page 2
· Approximately
$6 million for the completion of the Phase 1 clinical trial in Australia of TRX01;
· Approximately
$3 million for two investigator-initiated studies in the United States of narazaciclib; and
· Approximately
$1 million for the ongoing development of rigosertib.”
2. You state that in connection
with the merger you issued non-transferrable contingent value rights (CVRs) to your stockholders
of record as of the close of business of April 15, 2024 who will be entitled to receive
certain stock and/or cash payments from proceeds received by you, if any, related to the
disposition or monetization of your legacy assets. Please identify the legacy assets referenced,
as you do on page 16, and discuss any plan to dispose of or monetize each asset.
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to now state:
“Following the transaction, the
Company will primarily pursue the development of four compounds that are all at the clinical stage. Two compounds represent the assets
that were acquired from Trawsfynydd in the Merger: tivoxavir marboxil (TRX100) and ratutrelvir (TRX01); and two compounds are legacy
assets from the Company: narazaciclib and rigosertib.”
3. We note you discuss the merger
consideration that was issued and delivered by the company to stockholders of Trawsfynydd.
Please also include a discussion, where appropriate, to identify all assets acquired by you
from Trawsfynydd as part of the acquisition. In this regard, we note you plan to advance
development of tivoxavir marboxil (TRX100) and ratutrelvir (TRX01), which were acquired as
part of the merger.
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to now state:
“Following the transaction, the
Company will primarily pursue the development of four compounds that are all at the clinical stage. Two compounds represent the assets
that were acquired from Trawsfynydd in the Merger: tivoxavir marboxil (TRX100) and ratutrelvir (TRX01); and two compounds are legacy
assets from the Company: narazaciclib and rigosertib.”
Opinion of Onconova Therapeutics, Inc.’s
Financial Advisor, page 25
4. We note that Onconova Therapeutics, Inc.
retained H.C. Wainwright & Co. to render an opinion to the Onconova board of directors
as to the fairness, from a financial point of view, to Onconova of the exchange ratio pursuant
to the merger agreement. Please include, where appropriate, any conclusions Wainwright &
Co. reached as to the exchange ratio.
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to include the following disclosure:
Page 3
“Based upon and subject to the
assumptions, factors, qualifications and limitations set forth in the written opinion described herein and the results of the application
by Wainwright of each of the valuation methodologies utilized in connection with its fairness opinion as summarized above, taken as a
whole, Wainwright concluded that the Exchange Ratio was fair, from a financial point of view, to Onconova.”
Description of Business
Our Portfolio/Product Candidates/Compounds,
page 38
5. We note the following statements
in relation to tivoxavir marboxil and ratutrelvir, both of which were acquired in the merger:
· “Tivoxavir
marboxil has completed a first Phase 1 study that generally demonstrated safety and tolerability
in healthy volunteers.”
· “We
believe ratutrelvir may be effective against the original, delta, and omicron variants of
SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer’s Mpro inhibitor,
PAXLOVID™).”
Please revise these statements to
remove the implications of safety and efficacy, as such determinations are within the sole purview of the FDA. You may present clinical
trial end points and objective data resulting from trials without concluding safety and efficacy, and you may state that your product
candidates are well tolerated, if accurate. In addition, to the extent head-to-head trials have not been conducted, please remove comparisons
to other approved products.
Response: In response to the Staff’s comment, those statements have been
removed.
6. You state that you have completed
a first Phase 1 study of tivoxavir marboxil that also provided pharmacokinetics and pharmacodynamics
data. Please expand your description of this trial to provide specific details, parameters
and results, including, to the extent applicable:
· dates
of the trial and location(s);
· identity
of trial sponsor(s);
· trial
design;
· patient
information (e.g., number of patients enrolled and treated and the criteria for participation
in the study);
· duration
of treatment and dosage information;
· primary
and secondary endpoints; and
· discussion
of results, including adverse events and serious adverse events, if any.
Page 4
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to include the following disclosure:
“The first-in-man clinical study
of TRX100 (designated AV5124 in a previous study) was performed from May to September of 2023 in Russia. The study sponsor
was Pharmasyntez, JSC. Traws Pharma has the right to use the data resulting from the study outside of Russia and the Eurasian Economic
Community countries. The trial was a single ascending dose study, and, as such, each study participant only received one dose of TRX100.
The study consisted of four dose cohorts that received 20, 40, 80 or 120 mg TRX100 delivered as 20 mg strength tablets, or placebo. The
study enrolled 28 healthy males ages 18-45 years who received either the study drug or placebo. The primary study endpoint was measurement
of the safety and tolerability of single drug doses in healthy volunteers. The secondary endpoint was the measurement of pharmacokinetic
parameters of single drug doses in healthy volunteers on an empty stomach or after a meal. The study demonstrated a favorable safety
profile for TRX100, with only one subject, that had received a single 40 mg dose of the study drug, experiencing two adverse events (AEs).
This subject experienced hyperglycemia, which was deemed to be mild and we believe probably related to TRX100 and erosive gastritis with
complications in the form of severe iron deficiency anemia which was considered to be a serious adverse event (SAE) and we believe unlikely
to be related (doubtful per the protocol) to the study drug. There were no other AEs in the trial, including at higher doses. The pharmacokinetic
measurements indicated a food effect for TRX100, with increased exposure when drug was taken after a meal, but otherwise showed increasing
exposure with increasing dose.”
7. We note your statement that
trivoxavir marboxil is a “cap-dependent endonuclease inhibitor” intended to inhibit
influenza virus replications. We also note your disclosure that ratutrelvir is an “Mpro
protease inhibitor” intended for the treatment of COVID19. Where appropriate, please
explain “cap-dependent endonuclease inhibitors” and “Mpro protease inhibitors”
in plain English.
Response: In response to the Staff’s
comment, the Company proposes to revise the language referenced above to now state:
“Tivoxavir
marboxil (TRX100), which we acquired as part of the Merger, is a small molecule cap-dependent endonuclease inhibitor. Cap-dependent
endonuclease (CEN) is an enzyme that is important for viral replication. TRX100 is intended to inhibit CEN and, thus, is intended to
impede influenza virus replication including, the influenza A and B viral strains and bird flu viral strains. It is Traws Pharma’s
intention to develop TRX100 as a single oral dose for treatment and prophylaxis of seasonal influenza and bird flu.”
“Ratutrelvir
(TRX01), which we acquired as part of the Merger and is an inhibitor of the main protease (also known as 3CL protease) of
the SAR-CoV-2 virus, the virus that causes COVID19. The main protease is an essential component in the mechanism for SARS-CoV-2 replication.
TRX01 is intended to inhibit this protease and, thus SAR-CoV-2 viral replication.”
8. You state that you plan to
develop Ratutrelvir (TRX01) which does not require co- administration with a human cytochrome
P450 (CYP) inhibitor such as ritonavir, avoiding potential significant drug-on-drug interactions,
with the opportunity to expand the number of eligible patients. Please discuss the basis
for such claims and if you have conducted any studies or clinical trials to date.
Page 5
Response: In response to the Staff’s
comment, the Company proposes to revise the section referenced above to include the following disclosure:
“Based on preclinical animal
studies, we intend to develop TRX01 without co-administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir.”
Information Incorporated by Reference,
page 58
9. The pro forma financial information
included as Exhibit 99.3 to your amended Form 8-K dated June 17, 2024 indicates
that Traws Pharma was determined to be the accounting acquirer in the share exchange agreement
with Trawsfynydd and that the merger was accounted for as an asset acquisition as the primary
assets acquired consisted of cash and in-process research and development (IPR&D) and
the assets acquired did not include any processes, such as an organized workforce. Please
provide us with a detailed analysis explaining how you determined the accounting acquirer
in this transaction, considering the guidance in ASC 805-10-55-10 through 55-15. In this
regard, your disclosure on page 26 indicates that the stockholders of Trawsfynydd immediately
prior to the merger will own 75.3% of the outstanding equity of Traws Pharma (formerly Onconova)
on a fully diluted basis immediately following the closing and after giving effect to the
concurrent financing transaction. Further, the inclusion of contingent value rights (CVRs)
in the transaction raises the question as to whether you plan to dispose of or monetize your
legacy assets. Please explain how this factored into your analysis.
Response: The Company acknowledges
the Staff’s comment and respectfully advises the Staff that it concluded that Trawsfynydd is a Variable Interest Entity (“VIE”)
and the Company is the primary beneficiary. Under paragraph 805-10-25-5, the primary beneficiary is always the accounting acquirer. As
such, the factors within ASC 805-10-55-11 through 55-15 were not relevant to the determination.
The Company concluded that
Trawsfynydd is a VIE because it has insufficient equity at risk. ASC 810-10-15-14(a) indicates that an entity is a VIE if its
total equity at risk is insufficient for it to finance its activities without additional subordinated financial support. The Company
evaluated whether Trawsfynydd had sufficient equity at risk by assessing whether it could fund its operations to the next
development stage without obtaining additional subordinated financial support. In reaching this conclusion, the Company considered
the current stage of development for Trawsfynydd’s two main programs, Tivoxavir marboxil (“TRX100”) and
Ratutrelvir (“TRX01”).
· TRX100
will be a Phase 2 ready asset after the Company completes a Phase 1 dose extension to evaluate
additional, higher doses of TRX100 prior to the initiation of a Phase 2 study which cannot
be commenced until additional capital is raised. Completion of the Phase 2 study is esti
2024-07-24 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 001-36020
July 24, 2024
Werner Cautreels
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re:Traws Pharma, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed June 27, 2024
File No. 001-36020
Dear Werner Cautreels:
We have reviewed your filing and have the following comments.
Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A
Description of the Transactions
Acquisition of Trawsfynydd, page 11
1.Please revise this section, where appropriate, to disclose the operating plan for the
business in the near term as well as the intended uses of the proceeds raised through the
merger and concurrent financing. State the principal purposes and the approximate
amount intended to be used for each such purpose.
2.You state that in connection with the merger you issued non-transferrable contingent
value rights (CVRs) to your stockholders of record as of the close of business of April 15,
2024 who will be entitled to receive certain stock and/or cash payments from proceeds
received by you, if any, related to the disposition or monetization of your legacy assets.
Please identify the legacy assets referenced, as you do on page 16, and discuss any plan to
dispose of or monetize each asset.
We note you discuss the merger consideration that was issued and delivered by the
company to stockholders of Trawsfynydd. Please also include a discussion, where
appropriate, to identify all assets acquired by you from Trawsfyndd as part of the 3.
July 24, 2024
Page 2
acquisition. In this regard, we note you plan to advance development of tivoxavir
marboxil (TRX100) and ratutrelvir (TRX01), which were acquired as part of the merger.
Opinion of Onconova Therapeutics, Inc.'s Financial Advisor, page 25
4.We note that Onconova Therapeutics, Inc. retained H.C. Wainwright & Co. to render an
opinion to the Onconova board of directors as to the fairness, from a financial point of
view, to Onconova of the exchange ratio pursuant to the merger agreement. Please
include, where appropriate, any conclusions Wainwright & Co. reached as to the
exchange ratio.
Description of Business
Our Portfolio/ Product Candidates/ Compounds, page 38
5.We note the following statements in relation to tivoxavir marboxil and ratutrelvir, both of
which were acquired in the merger:
•"Tivoxavir marboxil has completed a first Phase 1 study that generally demonstrated
safety and tolerability in healthy volunteers."
•"We believe ratutrelvir may be effective against the original, delta, and omicron
variants of SARS-CoV-2, with potentially superior properties to nirmatrelvir (Pfizer’s
Mpro inhibitor, PAXLOVID™)."
Please revise these statements to remove the implications of safety and efficacy, as such
determinations are within the sole purview of the FDA. You may present clinical trial end
points and objective data resulting from trials without concluding safety and efficacy, and
you may state that your product candidates are well tolerated, if accurate. In addition, to
the extent head-to-head trials have not been conducted, please remove comparisons to
other approved products.
6.You state that you have completed a first Phase 1 study of tivoxavir marboxil that also
provided pharmacokinetics and pharmacodynamics data. Please expand your description
of this trial to provide specific details, parameters and results, including, to the extent
applicable:
•dates of the trial and location(s);
•identity of trial sponsor(s);
•trial design;
•patient information (e.g., number of patients enrolled and treated and the criteria for
participation in the study);
•duration of treatment and dosage information;
•primary and secondary endpoints; and
•discussion of results, including adverse events and serious adverse events, if any.
7.We note your statement that trivoxavir marboxil is a "cap-dependent endonuclease
inhibitor" intended to inhibit influenza virus replications. We also note your disclosure
that ratutrelvir is an "Mpro protease inhibitor" intended for the treatment of COVID19.
Where appropriate, please explain "cap-dependent endonuclease inhibitors" and "Mpro
protease inhibitors" in plain English.
You state that you plan to develop Ratutrelvir (TRX01) which does not require co-8.
July 24, 2024
Page 3
administration with a human cytochrome P450 (CYP) inhibitor such as ritonavir, avoiding
potential significant drug-on-drug interactions, with the opportunity to expand the number
of eligible patients. Please discuss the basis for such claims and if you have conducted any
studies or clinical trials to date.
Information Incorporated by Reference, page 58
9.The pro forma financial information included as Exhibit 99.3 to your amended Form 8-K
dated June 17, 2024 indicates that Traws Pharma was determined to be the accounting
acquirer in the share exchange agreement with Trawsfynydd and that the merger was
accounted for as an asset acquisition as the primary assets acquired consisted of cash and
in-process research and development (IPR&D) and the assets acquired did not include any
processes, such as an organized workforce. Please provide us with a detailed analysis
explaining how you determined the accounting acquirer in this transaction, considering
the guidance in ASC 805-10-55-10 through 55-15. In this regard, your disclosure on page
26 indicates that the stockholders of Trawsfynydd immediately prior to the merger will
own 75.3% of the outstanding equity of Traws Pharma (formerly Onconova) on a fully
diluted basis immediately following the closing and after giving effect to the concurrent
financing transaction. Further, the inclusion of contingent value rights (CVRs) in the
transaction raises the question as to whether you plan to dispose of or monetize your
legacy assets. Please explain how this factored into your analysis.
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 Torney at 202-551-3652 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joanne R. Soslow
2024-07-15 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598) File: 333-280642
July 15, 2024
Werner Cautreels
Chief Executive Officer
Traws Pharma, Inc.
12 Penns Trail
Newtown, PA 18940
Re:Traws Pharma, Inc.
Registration Statement on Form S-3
Filed July 1, 2024
File No. 333-280642
Dear Werner Cautreels:
We have conducted a limited review of your registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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 letter, we may have additional comments.
Registration Statement on Form S-3
General
1.We note that on April 1, 2024 you acquired Trawsfynydd Therapeutics, Inc. As part of the
merger transaction, the company distributed to Traws Pharma, Inc. stockholders of record
a non-transferrable contingent value right relating to the disposition or monetization of
Traws Pharma, Inc.’s legacy business assets. Given these circumstances, please tell us
your basis for concluding that you are eligible to use Form S-3. For guidance in
responding, please see Use of Form S-8, Form 8-K, and Form 20-F by Shell Companies,
Release No. 33-8587 (July 15, 2005) at n. 32 and Release No. 33-11265 (Jan. 24, 2024) at
n. 943 in the Shell Company Business Combinations and the Securities Act of 1933, as
well as Compliance Disclosure Interpretations, Securities Act Forms, Question 115.18.
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
July 15, 2024
Page 2
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 Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joanne Soslow, Esq.
2023-07-07 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
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1
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Onconova Therapeutics, Inc.
12 Penns Trail
Newtown, PA 18940
July 7, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Lauren Hamill
Re: Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed June 30, 2023
File No. 333-273081
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration
statement, as amended, so that such registration statement may become effective at 4:30 p.m. (Washington, D.C. time) on July 11, 2023,
or as soon as practicable thereafter.
ONCONOVA THERAPEUTICS, INC.
By:
/s/ MARK GUERIN
Name:
Mark Guerin
Title:
Chief Operating Officer & Chief Financial
Officer
2023-07-07 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
United States securities and exchange commission logo
July 7, 2023
Mark Guerin
Chief Operating Officer & Chief Financial Officer
Onconova Therapeutics, Inc.
12 Penns Trail
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed June 30, 2023
File No. 333-273081
Dear Mark Guerin:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Maddy Anand
2020-05-15 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
1
filename1.htm
May 15, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attention:
Paul Fischer
Celeste M. Murphy
Re:
Onconova Therapeutics, Inc.
Registration Statement on Form S-3 (the “Registration
Statement”)
Filed April 24, 2020
File No. 333-237844
Dear Mr. Fischer:
On behalf of Onconova Therapeutics, Inc. (the “Company”),
we are responding to the comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in your letter dated May 7, 2020 to Steven M. Fruchtman, M.D., President and Chief Executive Officer of the Company,
with respect to the above referenced filing with the Commission by the Company. For your convenience, we have set forth below the
Staff’s comment in italics, followed by the Company’s response.
Registration Statement on Form S-3 filed on April 24, 2020
General
1. We note Onconova's representation in correspondence to the staff dated November 12, 2019 at
page 3 that the company would "add the following risk factor disclosure describing the Company’s forum selection provision
and its intent in the Company’s future Annual Reports on Form 10-K and in future registration statements," but are unable
to determine where you have done so in either your Form 10-K for the fiscal year ended December 31, 2019, or in the instant registration
statement on Form S-3. Please advise or revise.
Response: In response to the Staff’s comment,
the Company is filing Amendment No. 1 (“Amendment No. 1”) to the Registration Statement to include the following disclosure
under “Description of Capital Stock — Anti-Takeover Law and Provisions in our Certificate of Incorporation and Bylaws”
on page 9 of Amendment No. 1:
“Exclusive Forum Charter Provision
Our certificate of incorporation requires that
the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be the sole and exclusive
forum for the following:
United States Securities and Exchange Commission
May 15, 2020
Page 2
· any derivative action or proceeding brought on behalf of the corporation;
· any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other
employee of the corporation to the corporation or the corporation’s stockholders, creditors or other constituents;
· any action asserting a claim against the corporation arising pursuant to any provision of the
Delaware General Corporation Law, the corporation’s certificate of incorporation or the bylaws of the corporation; or
· any action asserting a claim against the corporation governed by the internal affairs doctrine,
in each such case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants
therein.
Provided, that, if and only if the Court of Chancery
of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions
may be brought in another state court sitting in the State of Delaware.
Because the applicability of the exclusive forum
provision is limited to the extent permitted by applicable law, we do not intend that the exclusive forum provision would apply
to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have
exclusive jurisdiction, and acknowledge that federal courts have concurrent jurisdiction over all suits brought to enforce any
duty or liability created by the Securities Act. We note that there is uncertainty as to whether a court would enforce the provision
and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although
we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits
to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.”
Additionally, the Company included the following
risk factor disclosure describing the Company’s forum selection provision and its intent in the Company’s Quarterly
Report for the fiscal quarter ended March 31, 2020 filed with the Commission on May 15, 2020, and will include this risk factor
disclosure in future registration statements:
“Our Certificate of Incorporation
designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings
that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum
for disputes with us or our directors, officers, employees or agents.
United States Securities and Exchange Commission
May 15, 2020
Page 3
Our Certificate of Incorporation requires that
the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be the sole and exclusive
forum for the following:
· any derivative action or proceeding brought on behalf of us;
· any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers
or other employees to us or our stockholders, creditors or other constituents;
· any action asserting a claim against us arising pursuant to any provision of, the Delaware General
Corporation Law, the Certificate of Incorporation or our bylaws; or
· any action asserting a claim against us governed by the internal affairs doctrine, in each such
case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein.
Provided, that, if and only if the Court of Chancery
of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions
may be brought in another state court sitting in the State of Delaware.
Because the applicability of the exclusive forum
provision is limited to the extent permitted by applicable law, we do not intend that the exclusive forum provision would apply
to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have
exclusive jurisdiction, and acknowledge that federal courts have concurrent jurisdiction over all suits brought to enforce any
duty or liability created by the Securities Act. We note that there is uncertainty as to whether a court would enforce the provision
and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although
we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits
to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.”
The Company respectfully requests the Staff’s
assistance in completing the review as soon as possible. Please advise us if we can provide any further information or assistance
to facilitate your review. Please direct any further comments or questions to the undersigned at (215) 963-5262.
Very truly yours,
/s/ Joanne R. Soslow
Joanne R. Soslow
Morgan, Lewis & Bockius LLP
United States Securities and Exchange Commission
May 15, 2020
Page 4
cc: Steven M. Fruchtman, M.D. (Onconova
Therapeutics, Inc.)
Mark Guerin (Onconova
Therapeutics, Inc.)
Avi Oler (Onconova
Therapeutics, Inc.)
2020-05-15 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP
1
filename1.htm
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18954
May 15, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Paul Fischer
Celeste M. Murphy
Re: Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 24, 2020
File No. 333-237844
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended,
Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced
registration statement, as amended, so that such registration statement may become effective at 4:30 p.m. (Washington, D.C. time)
on May 18, 2020, or as soon as practicable thereafter.
ONCONOVA
THERAPEUTICS, INC.
By:
/s/ MARK
GUERIN
Name:
Mark Guerin
Title:
Chief Financial Officer
2020-05-07 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
United States securities and exchange commission logo
May 7, 2020
Steven M. Fruchtman, M.D.
Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 24, 2020
File No. 333-237844
Dear Dr. Fruchtman:
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 on April 24, 2020
General
1.We note Onconova's representation in correspondence to the staff dated November 12,
2019 at page 3 that the company would "add the following risk factor disclosure
describing the Company’s forum selection provision and its intent in the Company’s
future Annual Reports on Form 10-K and in future registration statements," but are unable
to determine where you have done so in either your Form 10-K for the fiscal year ended
December 31, 2019, or in the instant registration statement on Form S-3. Please advise or
revise.
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
FirstName LastNameSteven M. Fruchtman, M.D.
Comapany NameOnconova Therapeutics, Inc.
May 7, 2020 Page 2
FirstName LastName
Steven M. Fruchtman, M.D.
Onconova Therapeutics, Inc.
May 7, 2020
Page 2
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Paul Fischer, Staff Attorney, at 202-551-3415 or Celeste M. Murphy,
Legal Branch Chief, at 202-551-3257 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Joanne Soslow, Esq.
2019-11-21 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm November 21, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-234360) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as placement agent for the referenced offering, hereby concurs in the request by Onconova Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 10:30 a.m. (Eastern Time), or as soon as practicable thereafter, on November 21, 2019, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2019-11-21 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18940 November 21, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Paul Fischer Celeste M. Murphy Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-234360 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended (the “Registration Statement”), so that the Registration Statement may become effective at 10:30 a.m. (Eastern Time) on November 21, 2019, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with Joanne R. Soslow of Morgan, Lewis & Bockius LLP at (215) 963-5262. Under separate cover, you will receive today a letter from the placement agent of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2019-11-20 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18940 November 20, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Paul Fischer Celeste M. Murphy Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-234360 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended (the “Registration Statement”), so that the Registration Statement may become effective at 12:00 p.m. (Eastern Time) on November 21, 2019, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with Joanne R. Soslow of Morgan, Lewis & Bockius LLP at (215) 963-5262. Under separate cover, you will receive today a letter from the placement agent of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2019-11-20 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm November 20, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-234360) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as placement agent for the referenced offering, hereby concurs in the request by Onconova Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 12:00 noon (Eastern Time), or as soon as practicable thereafter, on November 21, 2019, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2019-11-13 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18940 November 13, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Paul Fischer Celeste M. Murphy Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-234360 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended (the “Registration Statement”), so that the Registration Statement may become effective at 12:00 p.m. (Eastern Time) on November 15, 2019, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with Joanne R. Soslow of Morgan, Lewis & Bockius LLP at (215) 963-5262. Under separate cover, you will receive today a letter from the underwriter of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2019-11-13 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm November 13, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-234360) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as placement agent for the referenced offering, hereby concurs in the request by Onconova Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 12:00 noon (Eastern Time), or as soon as practicable thereafter, on November 15, 2019, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2019-11-12 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm November 12, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attention: Paul Fischer Celeste M. Murphy Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (the “Registration Statement”) Filed October 29, 2019 File No. 333-234360 Dear Mr. Fischer: On behalf of Onconova Therapeutics, Inc. (the “Company”), we are responding to the comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in your letter dated November 7, 2019 to Steven M. Fruchtman, M.D., President and Chief Executive Officer of the Company, with respect to the above referenced filing with the Commission by the Company. For your convenience, we have set forth below the Staff’s comment in italics, followed by the Company’s response. Registration Statement on Form S-1, filed on October 29, 2019 Exhibit 3.1, Tenth Amended and Restated Certificate of Incorporation, page II-4 1. We note that your forum selection provision in the Certificate of Incorporation filed as Exhibit 3.1 to the registration statement identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Securities Act or the Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please revise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If the provision does not apply to actions arising under the Securities Act or Exchange Act, please also tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Response: The Company respectfully advises the Staff that the Company’s forum selection provision provides that the Court of Chancery of the State of Delaware has exclusive jurisdiction over only certain matters to the “fullest extent permitted by applicable law.” Accordingly, this provision is not intended to apply to claims arising under the Securities Act of 1933, as amended, for which federal and state courts have concurrent jurisdiction, and the Securities Exchange Act of 1934, as amended, for which federal courts have exclusive jurisdiction. In response to the Staff’s comment, the Company is filing Amendment No. 1 (“Amendment No. 1”) to the Registration Statement to include the following disclosure under “Description of Capital Stock — Anti-Takeover Law and Provisions in our Certificate of Incorporation and Bylaws” on page 20 of Amendment No. 1: “Exclusive Forum Charter Provision Our certificate of incorporation requires that the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be the sole and exclusive forum for the following: · any derivative action or proceeding brought on behalf of the corporation; · any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the corporation to the corporation or the corporation’s stockholders, creditors or other constituents; · any action asserting a claim against the corporation arising pursuant to any provision of the Delaware General Corporation Law, the corporation’s certificate of incorporation or the bylaws of the corporation; or · any action asserting a claim against the corporation governed by the internal affairs doctrine, in each such case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. Provided, that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware. Because the applicability of the exclusive forum provision is limited to the extent permitted by applicable law, we do not intend that the exclusive forum provision would apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction, and acknowledge that federal courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act. We 2 note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.” Additionally, the Company will add the following risk factor disclosure describing the Company’s forum selection provision and its intent in the Company’s future Annual Reports on Form 10-K and in future registration statements: “Our Certificate of Incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents. Our Certificate of Incorporation requires that the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be the sole and exclusive forum for the following: · any derivative action or proceeding brought on behalf of us; · any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents; · any action asserting a claim against us arising pursuant to any provision of, the Delaware General Corporation Law, the Certificate of Incorporation or our bylaws; or · any action asserting a claim against us governed by the internal affairs doctrine, in each such case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. Provided, that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware. Because the applicability of the exclusive forum provision is limited to the extent permitted by applicable law, we do not intend that the exclusive forum provision would apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction, and acknowledge that federal courts have concurrent jurisdiction over 3 all suits brought to enforce any duty or liability created by the Securities Act. We note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.” The Company respectfully requests the Staff’s assistance in completing the review as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions to the undersigned at (215) 963-5262. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow Morgan, Lewis & Bockius LLP cc: Steven M. Fruchtman, M.D. (Onconova Therapeutics, Inc.) Mark Guerin (Onconova Therapeutics, Inc.) Avi Oler (Onconova Therapeutics, Inc.) 4
2019-11-08 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
November 7, 2019
Steven M. Fruchtman, M.D.
President
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-1
Filed on October 29, 2019
File No. 333-234360
Dear Dr. Fruchtman:
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-1, filed on October 29, 2019
Exhibit 3.1, Tenth Amended and Restated Certificate of Incorporation, page II-4
1.We note that your forum selection provision in the Certificate of Incorporation filed as
Exhibit 3.1 to the registration statement identifies the Court of Chancery of the State of
Delaware as the exclusive forum for certain litigation, including any "derivative action."
Please disclose whether this provision applies to actions arising under the Securities Act
or the Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder, and Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state courts over all suits
brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please revise your
prospectus to state that there is uncertainty as to whether a court would enforce such
FirstName LastNameSteven M. Fruchtman, M.D.
Comapany NameOnconova Therapeutics, Inc.
November 7, 2019 Page 2
FirstName LastName
Steven M. Fruchtman, M.D.
Onconova Therapeutics, Inc.
November 7, 2019
Page 2
provision and investors cannot waive compliance with the federal securities laws and the
rules and regulations thereunder. If the provision does not apply to actions arising under
the Securities Act or Exchange Act, please also tell us how you will inform investors
in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Paul Fischer, Staff Attorney, at 202-551-3415, or Celeste M. Murphy,
Legal Branch Chief, at 202-551-3257, with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Joanne Soslow
2019-05-17 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 May 17, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tonya Aldave Re: Onconova Therapeutics, Inc. Registration Statement on Form S-3 Filed April 5, 2019 File No. 333-230744 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended, so that such registration statement may become effective at 4:00 p.m. (Washington, D.C. time) on May 21, 2019, or as soon as practicable thereafter. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2019-04-11 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
April 11, 2019
Steven M. Fruchtman, M.D.
Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 5, 2019
File No. 333-230744
Dear Dr. Fruchtman:
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 Tonya K. Aldave at (202) 551-3601 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Joanne R. Soslow, Esq.
2018-04-26 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 April 26, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Erin Jaskot Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-224315) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended (the “Registration Statement”), so that the Registration Statement may become effective at 4:30 p.m. (Eastern Time) on April 26, 2018, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with Joanne R. Soslow of Morgan, Lewis & Bockius LLP at (215) 963-5262. Under separate cover, you will receive today a letter from the underwriter of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2018-04-26 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm April 26, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-224315) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as underwriter for the referenced offering, hereby concurs in the request by Onconova Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 4:30 P.M. (Eastern Time), or as soon as practicable thereafter, on April 26, 2018, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2018-04-25 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm April 24, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attention: Dorrie Yale Erin Jaskot Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (the “Registration Statement”) Filed April 17, 2018 File No. 333-224315 Dear Ms. Yale: On behalf of Onconova Therapeutics, Inc. (the “Company”), we are responding to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in your letter dated April 24, 2018 to Ramesh Kumar, Ph.D., President and Chief Executive Officer of the Company, with respect to the above referenced filing with the Commission by the Company. For your convenience, we have set forth below the Staff’s comments in italics, followed by the Company’s responses. Registration Statement on Form S-1 Incorporation by Reference, page 42 1. Please revise this section to include the definitive proxy statement you filed on February 28, 2018, and the Current Reports on Form 8-K that you have filed since the filing of this registration statement. Refer to Item 12(a)(2) of the Form S-1. Response: The Company is filing Amendment No. 1 (“Amendment No. 1”) to the Registration Statement and has included in “Incorporation by Reference” section the definitive proxy statement the Company filed on February 28, 2018 and the Current Reports on Form 8-K that the Company has filed since the filing of the Registration Statement. General 2. We note that you incorporate by reference your Form 10-K for the fiscal year ended December 31, 2017; however, the Form 10-K incorporates by reference information from your definitive proxy statement that has not yet been filed. Please note that we will not be in a position to accelerate the effective date of your registration statement until you have amended the Form 10-K to include Part III information or filed the definitive proxy statement. Please refer to Compliance and Disclosure Interpretations, Securities Act Forms Question 123.01 and Regulation S-K Question 117.05 for guidance. Response: The Company acknowledges the Staff’s comment and intends to amend the Form 10-K to include Part III information prior to requesting acceleration of effectiveness of the Registration Statement. The Company respectfully requests the Staff’s assistance in completing the review as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions to the undersigned at (215) 963-5262. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow Morgan, Lewis & Bockius LLP cc: Ramesh Kumar, Ph.D. (Onconova Therapeutics, Inc.) Mark Guerin (Onconova Therapeutics, Inc.) 2
2018-04-24 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
April 24, 2018
Ramesh Kumar
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 17, 2018
File No. 333-224315
Dear Dr. Kumar:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Incorporation by Reference, page 42
1.Please revise this section to include the definitive proxy statement you filed on February
28, 2018, and the Current Reports on Form 8-K that you have filed since the filing of this
registration statement. Refer to Item 12(a)(2) of the Form S-1.
General
2.We note that you incorporate by reference your Form 10-K for the fiscal year
ended December 31, 2017; however, the Form 10-K incorporates by reference information
from your definitive proxy statement that has not yet been filed. Please note that we will
FirstName LastNameRamesh Kumar
Comapany NameOnconova Therapeutics, Inc.
June 16, 2017 Page 2
FirstName LastName
Ramesh Kumar
Onconova Therapeutics, Inc.
April 24, 2018
Page 2
not be in a position to accelerate the effective date of your registration statement until you
have amended the Form 10-K to include Part III information or filed the
definitive proxy statement. Please refer to Compliance and Disclosure Interpretations,
Securities Act Forms Question 123.01 and Regulation S-K Question 117.05 for guidance.
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 Dorrie Yale at 202-551-8776 or Erin Jaskot at 202-551-3442 with any
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Joanne R. Soslow
2018-02-06 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm February 6, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-222374) Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), as underwriter for the referenced offering, hereby concurs in the request by Onconova Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:15 P.M. (Eastern Time), or as soon as practicable thereafter, on February 7, 2018, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act in connection with this offering. H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer 430 Park Avenue | New York, New York 10022 | 212.356.0500 Security services provided by H.C. Wainwright & Co., LLC | Member: FINRA/SIPC
2018-02-06 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 February 6, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Westbrook Erin Jaskot Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-222374) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended (the “Registration Statement”), so that the Registration Statement may become effective at 5:15 p.m. (Eastern Time) on February 7, 2018, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with Joanne R. Soslow of Morgan, Lewis & Bockius LLP at (215) 963-5262. Under separate cover, you will receive today a letter from the underwriter of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2018-01-30 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm January 30, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attention: Christine Westbrook Erin Jaskot Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (the “Registration Statement”) Filed December 29, 2017 File No. 333-222374 Dear Ms. Westbrook: On behalf of Onconova Therapeutics, Inc. (the “Company”), we are responding to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in your letter dated January 18, 2018 to Ramesh Kumar, Ph.D., President and Chief Executive Officer of the Company, with respect to the above referenced filing with the Commission by the Company. For your convenience, we have set forth below the Staff’s comments in italics, followed by the Company’s responses. Form S-1 filed December 29, 2017 Cover Page 1. Please tell us whether the recent market price set forth on the cover page of the prospectus will be substantially similar to the offering price. If not, please include disclosure on the cover page indicating the factors that will be used to determine the offering price. Response: The Company is filing Amendment No. 1 (“Amendment No. 1”) to the Registration Statement and has included disclosure on the prospectus cover page indicating the factors that will be used to determine the offering price. 2. Please identify the lead underwriter(s) on the prospectus cover page. Please note that we may defer further review of any amendment to your registration statement that does not include the names of the lead underwriter(s). Response: In Amendment No. 1, the Company has identified H.C. Wainwright & Co. LLC as the lead underwriter on the prospectus cover page. Exhibit 23.1 3. Please file a signed consent of your auditors as required by Section 7 of the Securities Act and Item 601(b)(23) of Regulation S-K. Response: The Company is filing a signed consent of Ernst & Young, LLP, the Company’s auditors, as Exhibit 23.1 to Amendment No. 1, as required by Section 7 of the Securities Act and Item 601(b)(23) of Regulation S-K. Exhibit 5.1 4. Please file a revised legality opinion that covers the securities included in the registration statement. For example, we note that the opinion references the offer and sale of up to $25,000,000 of shares of common stock. In addition, it is inappropriate to assume, for purposes of your opinion, that the issuance of shares will not exceed the number of shares available for issuance under the Company’s certificate of incorporation. Please revise your opinion to remove this assumption. Refer to Section II.B.3.a. of Staff Legal Bulletin No. 19. Response: The Company is filing a revised legal opinion of Morgan, Lewis & Bockius LLP as Exhibit 5.1 to Amendment No. 1 to address the Staff’s comment. Executive Compensation 5. Please update your executive compensation disclosure to include your most recently completed fiscal year. Refer to Item 402 of Regulation S-K. Response: The Company has included in Amendment No. 1 a section entitled “Executive Compensation” which includes executive compensation information for fiscal years 2017 and 2016 as required by Item 402 of Regulation S-K. Signatures 6. Please revise your signature page to the registration statement and provide the signatures required by Form S-1. We note that you have included such signatures in the power of attorney filed as Exhibit 24.1. Please include these signatures within the body of the registration statement. To the extent you use a power of attorney for future signatures, please ensure it to refers to amendments to the Form S-1, as it currently refers to a Form S-3. Response: The Company is filing Amendment No. 1 to provide the required signatures required by Form S-1 and a revised power of attorney which refers to amendments to the Form S-1. The Company respectfully requests the Staff’s assistance in completing the review as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions to the undersigned at (215) 963-5262. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow Morgan, Lewis & Bockius LLP cc: Ramesh Kumar, Ph.D. (Onconova Therapeutics, Inc.) Mark Guerin (Onconova Therapeutics, Inc.) 2
2018-01-18 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
January 18, 2018
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-1
Filed December 29, 2017
File No. 333-222374
Dear Dr. Kumar:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-1 filed December 29, 2017
Cover Page
1.Please tell us whether the recent market price set forth on the cover page of the
prospectus will be substantially similar to the offering price. If not, please include
disclosure on the cover page indicating the factors that will be used to determine the
offering price.
2.Please identify the lead underwriter(s) on the prospectus cover page. Please note that we
may defer further review of any amendment to your registration statement that does not
include the names of the lead underwriter(s).
FirstName LastNameRamesh Kumar, Ph.D.
Comapany NameOnconova Therapeutics, Inc.
June 16, 2017 Page 2
FirstName LastName
Ramesh Kumar, Ph.D.
Onconova Therapeutics, Inc.
January 18, 2018
Page 2
Exhibit 23.1
3.Please file a signed consent of your auditors as required by Section 7 of the Securities
Act and Item 601(b)(23) of Regulation S-K.
Exhibit 5.1
4.Please file a revised legality opinion that covers the securities included in the registration
statement. For example, we note that the opinion references the offer and sale of up to
$25,000,000 of shares of common stock. In addition, it is inappropriate to assume, for
purposes of your opinion, that the issuance of shares will not exceed the number of shares
available for issuance under the Company's certificate of incorporation. Please revise
your opinion to remove this assumption. Refer to Section II.B.3.a. of Staff Legal Bulletin
No. 19.
Executive Compensation
5.Please update your executive compensation disclosure to include your most recently
completed fiscal year. Refer to Item 402 of Regulation S-K.
Signatures
6.Please revise your signature page to the registration statement and provide the signatures
required by Form S-1. We note that you have included such signatures in the power of
attorney filed as Exhibit 24.1. Please include these signatures within the body of the
registration statement. To the extent you use a power of attorney for future signatures,
please ensure it to refers to amendments to the Form S-1, as it currently refers to a Form
S-3.
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 Christine Westbrook at (202) 551-5019 or Erin Jaskot at (202) 551-
3442 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Joanne R. Soslow, Esq.
2017-12-27 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 December 27, 2017 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Mary Beth Breslin Re: Onconova Therapeutics, Inc. Registration Statement on Form S-3 Filed November 20, 2017 File No. 333-221684 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of the above referenced registration statement, as amended, so that such registration statement may become effective at 9:00 a.m. (Washington, D.C. time) on December 28, 2017, or as soon as practicable thereafter. ONCONOVA THERAPEUTICS, INC. By: /s/ MARK GUERIN Name: Mark Guerin Title: Chief Financial Officer
2017-12-04 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
December 4, 2017
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18954
Re:Onconova Therapeutics, Inc.
Registration Statement on Form S-3
Filed November 20, 2017
File No. 333-221684
Dear Dr. Kumar:
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
Selling Stockholders, page 14
1.Based on your disclosure that the selling stockholders will be named in a prospectus
supplement, it appears that you intend to rely on General Instruction II.G to Form S-3 to
omit the identities of the selling stockholders and amounts of securities registered on
their behalf. Please note that General Instruction II.G. is only available to registrants
eligible to register primary offerings on Form S-3 pursuant to General Instruction I.B.1,
for which you do not appear to be eligible. Please revise your disclosure as appropriate.
For guidance, please refer to Rule 430B and Regulation S-K CD&I 140.03.
FirstName LastNameRamesh Kumar, Ph.D.
Comapany NameOnconova Therapeutics, Inc.
June 16, 2017 Page 2
FirstName LastName
Ramesh Kumar, Ph.D.
Onconova Therapeutics, Inc.
December 4, 2017
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.
You may contact Dorrie Yale at 202-551-8776 or Mary Beth Breslin at 202-551-3625
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Joanne R. Soslow
2016-07-05 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm July 5, 2016 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes, Assistant Director Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 Filed June 1, 2016, as amended Registration No. 333-211769 Dear Ms. Hayes: Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), hereby requests, pursuant to Rule 461 under the Securities Act of 1933, as amended, that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 p.m., eastern time, on July 7, 2016, or as soon as practicable thereafter. In this regard, the Company is aware of its obligations under the Securities Act as they relate to the Registration Statement referred to above and acknowledges that: (i) should the U.S. Securities and Exchange Commission (the “Commission”) or its staff (the “Staff”), acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; (ii) the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and (iii) the Company may not assert Staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Donald R. Readlinger, Esq. of Pepper Hamilton LLP with any questions or comments at (609) 951-4164. Sincerely, /s/ Mark Guerin Mark Guerin Vice President, Financial Planning & Accounting (Principal Financial and Accounting Officer) cc: Donald R. Readlinger, Esq.
2016-06-14 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Mail Stop 4720 June 1 4, 2016 Ramesh Kumar, Ph.D. President and Chief Executive Officer Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 Filed June 1 , 2016 File No. 333-2117 69 Dear Dr. Kumar : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Ramesh Kumar, Ph.D. Onconova Therapeutics, Inc. June 1 4, 2016 Page 2 Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1 933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . You may contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Jeffery P. Libson Pepper Hamilton LLP
2016-04-25 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm April 25, 2016 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes, Assistant Director Re: Onconova Therapeutics, Inc. Post-Effective Amendment No. 1 to Form S-1 Filed April 11, 2016 Registration No. 333-207533 Dear Ms. Hayes: This letter is in response to the comment letter of the staff of the United States Securities and Exchange Commission (the “Commission”) dated April 20, 2016 (the “Comment Letter”) related to the Post-Effective Amendment No. 1 to Form S-1 filed April 11, 2016 (File No. 333-207533) (“Amendment No. 1”) of Onconova Therapeutics, Inc. (“Onconova,” the “Company,” or “we”). For your convenience, we have set forth below the text of the comments contained in the Comment Letter, followed by our response. Information Incorporated by Reference, page 1 1. Please incorporate by reference your Current Report on Form 8-K filed on February 17, 2016. Response: We are filing Post-Effective Amendment No. 2 to our Registration Statement on Form S-1 (“Amendment No. 2”) and have added the Company’s Current Report on Form 8-K filed on February 17, 2016 to the documents incorporated by reference. (See page 1 of Amendment No. 2.) 375 Pheasant Run www.onconova.com Phone: 267 759 3680 Newtown, PA 18940 Fax: 267 759 3681 U.S. Securities and Exchange Commission Division of Corporate Finance Attn.: Suzanne Hayes Page 2 April 25, 2016 2. Please include your web site address, including the uniform resource locator (URL) where your incorporated reports and other documents may be accessed. Please see Item 12(b)(1)(v) of Form S-1. Response: The Company’s web site address, including the uniform resource locator (URL), is set forth on page 1 of Amendment No. 2 under the header “Where You Can Find More Information.” In responding to the Comment Letter, the Company acknowledges that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Thank you for your consideration of our responses to the Comment Letter and please do not hesitate to contact our counsel, Donald R. Readlinger, Esq., at 609.951.4164, with any questions or comments regarding any of the foregoing. Very truly yours, /s/ Mark Guerin Mark Guerin Vice President, Financial Planning & Accounting (Principal Financial and Accounting Officer) cc: Donald R. Readlinger, Esq. 375 Pheasant Run www.onconova.com Phone: 267 759 3680 Newtown, PA 18940 Fax: 267 759 3681
2016-04-20 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Mail Stop 4720 April 20, 201 6 Ramesh Kumar, Ph.D. President and Chief Executive Officer Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 Re: Onconova Therapeutics , Inc. Post-Effective Amendment No. 1 to Form S-1 Filed April 11, 2016 File No. 333-207533 Dear Dr. Kumar : We have reviewed your post -effective amendment and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not bel ieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Information Incorporated by Reference, page 1 1. Please incorporate by reference your Current Report on Form 8 -K filed on February 17, 2016 . 2. Please include your web site address, including the uniform resource locator (URL) where your incorporated reports and other documents may be accessed. Please see Item 12(b)(1)(v) of Form S -1. 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. Ramesh Kumar, Ph.D. Onconova Therapeutics, Inc. April 20, 201 6 Page 2 Notwithstanding our comments, before we can declare the amended registration statement effective, the company should provide us with a letter, acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Michael Gershon at (202) 551 -6598 or Erin Jaskot at (202) 551 -3442 with any questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Donald R. Readlinger , Esq. Pepper Hamilton LLP
2015-11-02 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
Mail Stop 4720 November 2, 2015 Via E -mail Ramesh Kumar, Ph.D. President and Chief Executive Officer Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18954 Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 Filed October 20, 2015 File No. 333-207533 Dear Dr. Kumar : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Ramesh Kumar, Ph.D. Onconova Therapeutics, Inc. November 2, 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 Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Via E -mail Donald R. Readlinger Pepper Hamilton LLP 301 Carnegie Center, Suite 400 Princeton, NJ 08540 -6227
2015-11-02 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm November 2, 2015 Via EDGAR (Correspondence) U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes, Assistant Director Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 Filed on October 20, 2015 Registration No. 333-207533 Dear Ms. Hayes: Onconova Therapeutics, Inc., a Delaware corporation (the “Company”), hereby requests, pursuant to Rule 461 under the Securities Act of 1933, as amended, that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 p.m., eastern time, on November 3, 2015, or as soon as practicable thereafter. In this regard, the Company is aware of its obligations under the Securities Act as they relate to the Registration Statement referred to above and acknowledges that: (i) should the U.S. Securities and Exchange Commission (the “Commission”) or its staff (the “Staff”), acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; (ii) the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and (iii) the Company may not assert Staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Donald R. Readlinger, Esq. of Pepper Hamilton LLP with any questions or comments at (609) 951-4164. Sincerely, /s/ Ajay Bansal Ajay Bansal Chief Financial Officer cc: Via E-Mail Pepper Hamilton LLP Donald R. Readlinger, Esq.
2013-07-23 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm July 23, 2013 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Jeffrey P. Riedler, Assistant Director Austin Stephenson Dan Greenspan Jim Peklenk Mark Brunhofer Re: Onconova Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-189358) Ladies and Gentlemen: In connection with the above-captioned Registration Statement, we wish to advise that between July 11, 2013 and the date hereof 1,170 copies of the Preliminary Prospectus dated July 11, 2013 were distributed as follows: 220 to prospective underwriters; 790 to institutional investors; 0 to prospective dealers; 160 to individuals; 0 to rating agencies and 0 to others. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, July 24, 2013 or as soon thereafter as practicable. [signature page follows] Very truly yours, Citigroup Global Markets Inc. Leerink Swann LLC As representatives of the Prospective Underwriters By: Citigroup Global Markets Inc. By: /s/ Brian Gleason Name: Brian Gleason Title: Director By: Leerink Swann LLC By: /s/ Daniel Dubin Name: Daniel Dubin Title: Vice Chairman Signature Page to Acceleration Request
2013-07-23 - CORRESP - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
CORRESP 1 filename1.htm July 23, 2013 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 RE: Onconova Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-189358 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Onconova Therapeutics, Inc. (the “Registrant”) hereby requests, subject to telephone confirmation, that the effectiveness of the above-captioned Registration Statement be accelerated so that it will become effective as of 4:00 p.m. EDT on July 24, 2013, or as soon thereafter as practicable. The Registrant acknowledges that: 1. should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; 2. the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and 3. the Registrant may not assert Staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, ONCONOVA THERAPEUTICS, INC. /s/ Ramesh Kumar, Ph.D. Ramesh Kumar, Ph.D. President and Chief Executive Officer
2013-07-22 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
July 22 , 2013
Via E -mail
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re: Onconova Therapeutics, Inc.
Amendment No. 2 to Registration Statement on Form S -1
Filed July 18 , 2013
File No. 333 -189358
Dear Dr. Kumar:
We have reviewed your amended registration statement and correspondence dated July
17, 2013 and have the following comments. In some of our comments, we may ask you to
provide us with infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and amending
your registration statement. If you do not believe our comments apply to your facts and
circu mstances or do not believe an amendment is a ppropriate, please tell us why in your
response.
After revie wing the infor mation you provide in response to these com ments and your
amended registrat ion state ment, we may have additio nal co mments.
Exhibit 5.1
1. We note counsel’s opinion that the securities will be validly issued, fully paid and
non-assessable is subject to the assumption that the Tenth Amended and Restated
Certificate of Incorporation will be filed with the Secretary of State of the State of
Delaware . Please either file a revised legal opinion to remove this assumption or
confirm that an appropriately unqualified opinion will be f iled by post -effective
amendment no later than the closing date of the offering. See Sections II.B.2.f. and
II.B.3.a. of Staff Legal Bulletin No. 19.
2. Please also provide a revised legal opinion to modify the statement regarding “the
legal power and authority of all persons signing on behalf of parties to all
Ramesh Kumar , Ph.D.
Onconova Therapeutics, Inc.
July 22 , 2013
Page 2
documents,” to limit this qualification to persons signing on behalf of parties other
than the r egistrant.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Please contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551-3623,
or me at (202) 551 -3715 with any questions.
Sincerely,
/s/ Daniel Greenspan for
Jeffrey P. R iedler
Assista nt Direct or
cc: Via E -mail
David S. Rosenthal, Esq.
Dechert LLP
2013-07-15 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
July 15, 2013
Via E -mail
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re: Onconova Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S -1
Filed July 11, 2013
File No. 333 -189358
Dear Dr. Kumar:
We have reviewed your amended registration statement and correspondence dated July
11, 2013 and have the following comments. In some of our comments, we may ask you to
provide us with infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and amending
your registration statement. If you do not believe our comments apply to your facts and
circu mstances or do not believe an amendment is a ppropriate, please tell us why in your
response.
After revie wing the infor mation you provide in response to these com ments and your
amended registrat ion state ment, we may have additio nal co mments.
Phase 1/2 Trial Results of Rigosertib IV in Patients with Myelodysplastic Syndromes , page 60
1. We note your discussion in this section of the length of survival of the 39 patients in
Phase 1, Phase 2, and Ph ase 1/2 studies who had previously failed treatment with
hypomethylating agents. You state that 23 patients lived for at least six months, 11
patients lived for more than one year, and 3 patients lived more than two years. This
suggests that 16 of the 39 patients did not survive for at least six months. Please
clarify if this is the case.
Report of Independent Registered Public Accounting Firm, pages F -2 and F -3
2. As a reminder, please assure that your auditors (both Ernst & Young LLP and
EisnerAmper LLP) remove the explanatory language referencing the reverse stock
Ramesh Kumar , Ph.D.
Onconova Therapeutics, Inc.
July 15 , 2013
Page 2
split and include a signed audit report in the amendment for which you will request
effectiveness. Also please file as Exhibits updated, signed consents from these
independent auditors wi th that amendment.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Sin ce 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.
You may contact Jim Peklenk at (202) 551 -3661 or Mark Brunhofer at ( 202) 551 -3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623, or me at (202)
551-3715 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Jeffrey P. R iedler
Assista nt Direct or
cc: Via E -mail
David S. Rosenthal, Esq.
Dechert LLP
2013-06-28 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
June 28 , 2013
Via E -mail
Ramesh Kumar, Ph.D.
President and Chief Executive Officer
Onconova Therapeutics, Inc.
375 Pheasant Run
Newtown, PA 18940
Re: Onconova Therapeutics, Inc.
Registration Statement on Form S -1
Filed June 14 , 2013
File No. 333 -189358
Dear Dr. Kumar:
We have r eviewed your registration statement filed June 14, 2013 and your response to
our comments to your confidential draft registration statement submitted on May 3, 2013 and
have the following comments. In some of our comments, we may ask you to provide us with
infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and amending
your registr ation statement . If you do not believe our comments apply to your facts and
circu mstances or do not believe an amendment is a ppropriate, please tell us why in your
response.
After revie wing the infor mation you provide in response to these com ments, we may
have additio nal co mments.
Management’s Discussion and Analysis, page 55
Financial Overview, page 58
1. We note your response to our prior comment 10. Please revise the tables on pages
58-9 to include the primary source of research funding for each of 2012 and 2011.
Stock -Based Compensation, page 69
2. Regarding your response to our prior comment 12, we have the following additional
comments regarding your disclosure and accounting for stock -based compensation:
As a continuing reminder, since you have not disclosed an estimated offering
price we are deferring a final evaluation of stock compensation and other costs
Ramesh Kumar , Ph.D.
Onconova Therapeutics, Inc.
June 28 , 2013
Page 2
recognized until the estimated offering price is specified. We may have
further comments in this regard when the amendment containing that
information is filed.
We acknowledge the disclosure in your response letter regarding the 13
“selected comparable companies” considered in estimating your assumed
annual volatility rates. Please explain to us why you deemed Enzon
Pharmaceuticals to be comparable to you since you state they had five
marketed products generating $116 million in annual revenue. In your
response, please tell us what your estimated annual volatility rate woul d be if
you deleted this company from your sample.
Regarding your fair value common stock valuation at March 31, 2013, please
tell us the fair value of common stock at this date inherent in your IPO
scenario assuming the IPO is 100% certain and excluding any discounts for
weighting other scenarios and lack of marketability.
Please provide in your filing containing the IPO price range, a discussion of
each significant factor contributing to the difference between the fair value as
of the date of each gran t and the estimated IPO price range. Please reconcile
and explain the differences between the mid -point of your estimated offering
price range and the fair values included in your analysis.
Recilisib – Acute Radiation Syndromes Treatment, page 99
3. We not e your response to our prior comment 17 and your disclosure that you plan to
“continue to seek support from government agencies and to develop recilisib under
the FDA Animal Efficacy Rule.” Please expand your disclosure in this section to
clarify that all agreements relating to the government funding of recilisib have expired
and that no such funding or other obligations remain outstanding.
Notes to Consolidated Financial Statements
15. License and Collaboration Agreements
Baxter Agreement, page F -34
4. We acknowledge your response to our prior comment 25. Please revise your
disclosure to elaborate on why the license deliverable has standalone value from the
research and development services deliverable consistent with your response.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its managemen t 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.
Ramesh Kumar , Ph.D.
Onconova Therapeutics, Inc.
June 28 , 2013
Page 3
You may contact Jim Peklenk at (202) 551 -3661 or Mark Brunhofer at ( 202) 551 -3638 if
you have questi ons regarding comments on the financial statements and related matters. Please
contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623 , or me at (202)
551-3715 with any other questions.
Sincerely,
/s/ Jeffrey P. Riedler
Jeffrey P. R iedler
Assista nt Direct or
cc: Via E -mail
David S. Rosenthal, Esq.
Dechert LLP
2013-05-30 - UPLOAD - Traws Pharma, Inc. (TRAW) (CIK 0001130598)
May 30, 2013 Via E -mail Ramesh Kumar, Ph.D. President and Chief Executive Officer Onconova Therapeutics, Inc. 375 Pheasant Run Newtown, PA 18940 Re: Onconova Therapeutics, Inc. Confidential Draft Registration Statement on Form S -1 Submitted May 3, 2013 CIK No. 0001130598 Dear Dr. Kumar: We have reviewed your confidential draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with infor mation so we may better understand your disclosure. Please respond to this letter by providing the requested infor mation and either submitting an a mended confidential draft re gistration state ment or publicly filing your registration s tatement on EDGAR. If you do not believe our comments apply to your facts and circu mstances or do not believe an amendment is a ppropriate, please tell us why in your response. After revie wing the infor mation you provide in response to these com ments and your amended confidential draft registration state ment or filed registration state ment, we may have additio nal co mments. General 1. Please sub mit all outstanding exhibits as soon as prac ticable. We may have further comments upon exa mination of these exhibits. 2. Please provide us proofs of all graphic, visual or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note that we may have comments regarding this material. Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 2 3. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities A ct, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 1 05(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. 4. We will deliver comments to your confidential treatment request under separate cover. 5. Please update your filing to include unaudited interim financial statements and related financial schedules for the quarterly periods ended March 31, 2013 and 2012 as required by Rule 3-12 of Regulation S -X. 6. Please provide the information required (including Exhibit 16) u nder Regulation S -K Item 304 and Item 11(i) of Form S -1 regarding the change in accountants for year 2012. Risk Factors “Our product candidates may cause undesirable side effects…,” page 16 7. Please expand the discussion in this risk factor to disclose th e extent to which you have observed undesirable side effects in your trials, including any safety or toxicity issues, and the impact, if any, on the prospects for obtaining marketing approval of your product candidates. We note, for example, your disclosu re on pages 85 -88 detailing certain drug - related adverse events occurring in your rigosertib trials. Special Note Regarding Forward -Looking Statements and Industry Data, page 46 8. Please note that it is not appropriate to state or imply that you do not ha ve liability for the statements in your registration statement. Your statement s at the bottom of page 47 that you have not independently verified market and industry data obtained from third -party sources or your own internal company research could imply t hat you are not taking liability for the statistical and other industry and market data included in your registration statement. In order to eliminate any inference that you are not liable for all of the information in your registration statement, please delete these statements or include a statement s pecifically accepting liability for these statements. Use of Proceeds, page 48 9. We note your statement that you have not yet determined the amount of proceeds to be spent on any of the areas listed in the second paragraph of this section, such as research and development and clinical trial expenditures. However, if the company has sp ecific purposes in mind for the use of proceeds, Item 504 of Regulation S -K requires disclosure Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 3 of the approximate amount intended to be used for each such purpose. This is required even if, as you note in your prospectus, management will have broad discr etion in allocating the proceeds and that the ultimate use of proceeds will depend on several contingencies and is subject to change. Management’s Discussion and Analysis of Financial Condition and Results of Operations Financial Overview, page 57 10. We note your disclosure of “research funding” for 2011 and 2012 in the table on page 57. Please clarify the amount of research funding attributable to payments from LLS. Research and Development Expenses, page 62 11. You state on page 59 that research and d evelopment activities are central to your business model and that you plan to increase your research and development expenses for the foreseeable future. While you state that you do not currently utilize a formal time allocation system to capture expenses on a project -by-project basis, please expand your disclosure to provide the following: The costs you do track by project for each period presented and to date and a reconciliation of the total of these project costs to the total expenses presented on your statement of operations and comprehensive loss. In this regard, it appears, for example, that you may track external cost by project as you are able to quantify on page 70 that $8.4 million of the increase in research and development expenses in 2012 as compared to 2011 relates to clinical trials expenses for rigosertib. Explain why management does not maintain and evaluate all research and development costs by project. Explain how you use functional area expenditures to evaluate and prioritize your R&D activities. Explain how you monitor development progress for individual projects. Absent costs by project, please provide other quantitative or qualitative disclosure that indicates the amount of the company’s resources being used on the project such as b y stage of development (i.e. discovery, pre -clinical, clinical phase I, clinical II and phase III) and/or other meaningful breakout. Stock -Based Compensation, page 63 12. We have the following comments regarding your disclosure and accounting for stock - based compensation: Since you have not disclosed an estimated offering price we are deferring a final evaluation of stock compensation and other costs recognized until the estimated offering price is specified. We may have further comments in this r egard when the amendment containing that information is filed. Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 4 In the first paragraph of your discussion about the fair value of stock option grants from January 1, 2011 to February 1, 2012 you indicate that you utilized an assumed annual volatility rate of 64.0% based on historical share price trading data for a group of 10 companies you considered comparable to yours. Please tell us the name of these 10 companies and explain to us why you deemed them to be comparable to you. In your response, for each of these companies tell us the following information at your valuation date: o annual revenues; o annual product revenues; o net income/loss; o assets; o equity; o number of products in development and their stages of development; and o number of marketed products Please provide in your filing containing the IPO price range, a discussion of each significant factor contributing to the difference between the fair value as of the date of each grant and the estimated IPO price range. Please reconcile and explain the differ ences between the mid -point of your estimated offering price range and the fair values included in your analysis. Operating and Capital Expenditure Requirements, page 73 13. To the extent practicable, please quantify the estimated costs mentioned in this sec tion that you will incur as a result of being a public company. Business, page 81 Our Product Candidates, page 79 14. Please disclose in this section whether there is an effective investigational new drug application (IND) for each of the following: Rigose rtib for treatment of higher risk MDS in intravenous formulation Rigosertib for treatment of lower risk MDS in oral formulation Rigosertib for treatment of head and neck cancer Rigosertib for treatment of pancreatic cancer ON 013105 for treatment of lymphoma Recilisib for treatment of ARS In each case, if an IND has been filed for the compound and corresponding treatment indicated, please disclose the identity of the filer and the date of filing. If an IND has not been filed, please explain why. Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 5 Treating Myelodysplastic Syndromes, page 81 15. Please explain how the mechanism of action for hypomethylating drugs differs from rigosertib. Specifically, please clarify why rigosertib does not pose the same risk of patient failure and drug resistance as azacitidine or decitabine, the current standard of care for higher risk MDS patients. Phase 1/2 Trial Results of Rigosertib in Patients with Myelodysplastic Syndromes, page 83 16. Please clarify the reason why a follow -up bone marrow biopsy was only availa ble for 30 of the 39 patients treated in these clinical trials. Please also disclose whether you expect any similar difficulties in obtaining follow -up biopsies in the ONTIME trial. If so, explain what effect, if any, this could have on the evaluation of trial results and the support of efficacy claims for rigosertib. Collaborations, page 90 17. Please clarify in this section whether your $10.2 million in government funding for recilisib was part of a formal agreement with the Department of Defense. If s o, please describe the material terms of that agreement and the parties’ respective obligations in this section and file the agreement as an exhibit to the registration statement. The Leukemia and Lymphoma Society 18. Please explain more specifically what “advancing the clinical development of rigosertib” means under the terms of the LLS agreement, as well as the process for determining that the company has failed to fulfill this obligation. Intellectual Property, page 93 19. We note your research agreement with Mount Sinai School of Medicine. Please disclose all material terms of that agreement in this section, including which, if any, of your products and patents are implicated under this research agreement. Please als o file this agreement as an exhibit to the registration statement. 20. Please disclose whether you license or own the composition -of-matter patent and the method of treatment patent for rigosertib. Manufacturing, page 96 21. Please identify the material ter ms of your manufacturing and supply agreements. Please file these agreements as exhibits to the registration statement as well. Alternat ively, if you do not believe any of these agreements is material , please advise us as to the basis of your conclusions . Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 6 Management, pages 113 -115 22. We note your discussion of consulting agreements with certain members of your clinical advisory and scientific advisory boards “covering their respective financial arrangements.” Please describe payments and other material terms of these agreements and file them as exhibits to the registration statement. If you do not believe these agreements are material, please advise us as to the basis of your conclusions. Shares El igible for Future Sale, page 144 23. Once available, please file the form of lock -up agreement as an exhibit to your registration statement. Consolidated Financial Statements Notes to Consolidated Financial Statements Report of Independent Registered Public Accounting Firm, page F -3 24. Please tell us if May 2, 2013 is the original signature date for EisnerAmper LLP’s audit of your financial statements for the year ended December 31, 2011. If not, tell us the original signature date and the reason(s) it changed. Tell us if any of the adjustments referred to on pages 68 -69 related to and were recorded in year 2011 as a restatement of those financial statements. 15. License and Collaboration Agreements Baxter Agreement, page F -34 25. In 2012, you recognized $42.4 million in revenue relating to the Baxter agreem ent. Please address the following and reference for us any authoritative literature you relied upon to support your position: Please elaborate on your assertion that the license has standalone value to Baxter. In your response, tell us how Baxter can exp loit the license without the additional development services that you are obligated to perform. Tell us: o whether and how Baxter or any other party can perform these development services given your expertise with your intellectual property; o whether Baxter has the rights and full access to past and future intellectual information in order to obtain regulatory approval of rigosertib in Europe; o whether Baxter is performing any development activities related to rigosertib; and o how the fact that you will own all marketing approvals and regulatory filings pursuant to section 6.1 of your agreement with Baxter filed as Exhibit 10.1 to your draft submission impacts Baxter’s ability to exploit the license. Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 7 Please tell us why it is appropriate to recognize the revenue allocated to the research and development services deliverable through March 31, 2014 when it appears that you are obligated to file all regulatory submissions in Europe and it appears unlikely that you will be in a position to have these submissions filed and approved by then. Please tell us why you do not believe your participation on the joint committee as disclosed in the third paragraph on page F -36 is a deliverable under your Baxter agreement. In your response, please tell us: o the composition of the committee; o the term of the committee; o your obligation to participate; o what happens if you do not participate; and o the dispute resolution provisions. 26. Please revise your filing to disclose each individual potential future milestone you could receive and it s related contingent consideration as required by ASC 605 -28-50-2b. Index to Exhibits, page II -7 27. Please file your joint venture agreement with GVK Biosciences as an exhibit to your registration statement. If you intend to respond to these comments with an amended draft registration statement, please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannounc ements/drsfilingprocedures101512.htm. Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm). If you intend t o use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. Ramesh Kumar , Ph.D. Onconova Therapeutics, Inc. May 30 , 2013 Page 8 You may contact Jim Peklenk at (202) 551 -3661 or Mark Brunhofer at ( 202) 551 -3638 if you have questions regarding comments on the financial statements and related matters.