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SEC Comment Letters
Company Responses
Letter Text
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
↓
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
↓
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-11-14
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2024-11-14
Generating summary...
↓
Company responded
2024-11-14
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2024-11-14
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
↓
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2024-05-02
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2024-05-02
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-06-20
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2023-06-20
Generating summary...
↓
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-01-05
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2023-01-05
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2021-12-28
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2021-12-28
Generating summary...
↓
Company responded
2021-12-30
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2021-12-30
Generating summary...
↓
Company responded
2022-01-03
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2022-01-03
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-11-18
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2020-11-18
Generating summary...
↓
Company responded
2020-11-30
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2020-11-30
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-06-11
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2020-06-11
Generating summary...
↓
Company responded
2020-06-12
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2020-06-12
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-04-02
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2020-04-02
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
8 company response(s)
High - file number match
SEC wrote to company
2019-11-14
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2019-11-14
Generating summary...
↓
Company responded
2019-12-10
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-10
Generating summary...
↓
Company responded
2019-12-10
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-10
Generating summary...
↓
Company responded
2019-12-12
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-12
Generating summary...
↓
Company responded
2019-12-16
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-16
Generating summary...
↓
Company responded
2019-12-16
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-16
Generating summary...
↓
Company responded
2019-12-16
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-16
Generating summary...
↓
Company responded
2019-12-17
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-17
Generating summary...
↓
Company responded
2019-12-17
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-12-17
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-07-31
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2019-07-31
Generating summary...
↓
Company responded
2019-08-05
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-08-05
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
Company responded
2019-02-07
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2019-02-07
Generating summary...
↓
SEC wrote to company
2019-02-08
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2019-02-08
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-12-04
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2018-12-04
Generating summary...
↓
Company responded
2018-12-04
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2018-12-04
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-06-13
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2018-06-13
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-06-13
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2018-06-13
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2017-04-24
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2017-04-24
Generating summary...
↓
Company responded
2017-05-03
ACHIEVE LIFE SCIENCES, INC.
References: April 24, 2017
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2017-05-03
Generating summary...
↓
Company responded
2017-05-24
ACHIEVE LIFE SCIENCES, INC.
References: May 17, 2017
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2017-05-24
Generating summary...
↓
Company responded
2017-06-06
ACHIEVE LIFE SCIENCES, INC.
References: June 1, 2017
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2017-06-06
Generating summary...
↓
Company responded
2017-06-09
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2017-06-09
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-06-01
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2017-06-01
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-05-17
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2017-05-17
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2016-04-11
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2016-04-11
Generating summary...
↓
Company responded
2016-04-13
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2016-04-13
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-11-05
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2015-11-05
Generating summary...
↓
Company responded
2015-11-19
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2015-11-19
Generating summary...
↓
Company responded
2015-11-19
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2015-11-19
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-04-15
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2013-04-15
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2013-04-09
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2013-04-09
Generating summary...
↓
Company responded
2013-04-10
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2013-04-10
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2010-03-12
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2010-03-12
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2010-03-03
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2010-03-03
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2009-12-10
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2009-12-10
Generating summary...
↓
Company responded
2009-12-23
ACHIEVE LIFE SCIENCES, INC.
References: December 10, 2009
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2009-12-23
Generating summary...
↓
Company responded
2010-01-28
ACHIEVE LIFE SCIENCES, INC.
References: December 10, 2009
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2010-01-28
Generating summary...
↓
Company responded
2010-01-28
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2010-01-28
Generating summary...
ACHIEVE LIFE SCIENCES, INC.
Response Received
3 company response(s)
High - file number match
Company responded
2009-06-26
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2009-06-26
Generating summary...
↓
SEC wrote to company
2009-07-09
ACHIEVE LIFE SCIENCES, INC.
Filing - SEC Comment Letter to ACHIEVE LIFE SCIENCES, INC.
UPLOAD · 2009-07-09
Generating summary...
↓
Company responded
2009-07-13
ACHIEVE LIFE SCIENCES, INC.
References: July
9, 2009
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2009-07-13
Generating summary...
↓
Company responded
2009-07-15
ACHIEVE LIFE SCIENCES, INC.
Filing - Correspondence from ACHIEVE LIFE SCIENCES, INC.
CORRESP · 2009-07-15
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2026-05-18 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-295798 | Read Filing View |
| 2026-01-27 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2026-01-27 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-292918 | Read Filing View |
| 2024-11-14 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2024-11-14 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-283070 | Read Filing View |
| 2024-07-03 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-280585 | Read Filing View |
| 2024-07-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2024-05-02 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-278961 | Read Filing View |
| 2024-05-02 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-06-21 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-06-20 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-01-05 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-01-04 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2022-01-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2021-12-30 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2021-12-28 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-11-30 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-11-18 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-06-12 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-06-11 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-04-02 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-12 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-11-14 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-08-05 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-02-07 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-09 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-06 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-01 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-24 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-04-24 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2016-04-11 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-05 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-15 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-09 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-03-12 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-03-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-01-28 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-01-28 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-12-23 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-12-10 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-15 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-09 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-06-26 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-18 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-295798 | Read Filing View |
| 2026-01-27 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-292918 | Read Filing View |
| 2024-11-14 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-283070 | Read Filing View |
| 2024-07-03 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-280585 | Read Filing View |
| 2024-05-02 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | 333-278961 | Read Filing View |
| 2023-06-20 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-01-04 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2021-12-28 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-11-18 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-06-11 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-04-02 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-11-14 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-01 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-04-24 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2016-04-11 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-05 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-15 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-09 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-03-12 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-12-10 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-09 | SEC Comment Letter | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2026-01-27 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2024-11-14 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2024-07-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2024-05-02 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-06-21 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2023-01-05 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2022-01-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2021-12-30 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-11-30 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2020-06-12 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-12 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-12-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-08-05 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2019-02-07 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-12-04 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-09 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-06-06 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-24 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2017-05-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2016-04-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2015-11-19 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2013-04-10 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-03-03 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-01-28 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2010-01-28 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-12-23 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-15 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-07-13 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
| 2009-06-26 | Company Response | ACHIEVE LIFE SCIENCES, INC. | DE | N/A | Read Filing View |
2026-05-19 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 May 19, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Alan Campbell Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-295798) Requested Date: May 21, 2026 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, to Ms. Anderson at (206) 389-4516. * * * Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ Andrew D. Goldberg Andrew D. Goldberg C hief Executive Officer cc: Amanda L. Rose, Esq. Chelsea Anderson, Esq. Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2026-05-18 - UPLOAD - ACHIEVE LIFE SCIENCES, INC. File: 333-295798
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 18, 2026 Andrew Goldberg Chief Executive Officer and President Achieve Life Sciences, Inc. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 Filed May 12, 2026 File No. 333-295798 Dear Andrew Goldberg: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Alan Campbell at 202-551-4224 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Chelsea Anderson, Esq. </TEXT> </DOCUMENT>
2026-01-27 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 January 27, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Daniel Crawford Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-292918) Requested Date: January 29, 2026 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to declare the above-captioned Registration Statement on Form S - 3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, to Ms. Anderson at (206) 389-4516. * * * Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ Richard Stewart Richard Stewart President and Chief Executive Officer cc: Amanda L. Rose, Esq. Chelsea Anderson, Esq. Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2026-01-27 - UPLOAD - ACHIEVE LIFE SCIENCES, INC. File: 333-292918
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 26, 2026 Richard Stewart President and Chief Executive Officer Achieve Life Sciences, Inc. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 Filed January 23, 2026 File No. 333-292918 Dear Richard Stewart: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Chelsea Anderson, Esq. </TEXT> </DOCUMENT>
2024-11-14 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
CORRESP
ACHIEVE LIFE SCIENCES, INC.
22722 29th Drive SE, Suite 100
Bothell, WA 98021
November 14, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Alan Campbell
Re:
Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-283070)
Requested Date: November 18, 2024
Requested Time: 4:00 PM Eastern Time
Ladies and Gentlemen:
Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission.
The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, to Ms. Rose at (206) 389-4553.
* * *
Sincerely,
ACHIEVE LIFE SCIENCES, INC.
By: /s/ Jerry Wan
Jerry Wan
Senior Director of Accounting Operations
cc: Amanda L. Rose, Esq.
Chelsea Anderson, Esq.
Fenwick & West LLP
[Signature Page to Company Acceleration Request Letter]
2024-11-14 - UPLOAD - ACHIEVE LIFE SCIENCES, INC. File: 333-283070
November 14, 2024
Richard Stewart
Chief Executive Officer
Achieve Life Sciences, Inc.
2722 29th Drive SE, Suite 100
Bothell, WA 98021
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-3
Filed November 7, 2024
File No. 333-283070
Dear Richard Stewart:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Amanda Rose, Esq.
2024-07-03 - UPLOAD - ACHIEVE LIFE SCIENCES, INC. File: 333-280585
July 3, 2024
Jon Bencich
Chief Executive Officer
Achieve Life Sciences, Inc.
22722 29th Drive SE, Suite 100
Bothell, WA 98021
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-3
Filed June 28, 2024
File No. 333-280585
Dear Jon Bencich:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Arielle Trapp
2024-07-03 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
CORRESP
ACHIEVE LIFE SCIENCES, INC.
22722 29th Drive SE, Suite 100
Bothell, WA 98021
July 3, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Tamika N. Sheppard
Re:
Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-280585)
Requested Date: July 8, 2024
Requested Time: 4:00 PM Eastern Time
Ladies and Gentlemen:
Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission.
The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, to Ms. Rose at (206) 389-4553.
* * *
Sincerely,
ACHIEVE LIFE SCIENCES, INC.
By: /s/ John Bencich
John Bencich
Chief Executive Officer
cc: Amanda L. Rose, Esq.
Chelsea Anderson, Esq.
Fenwick & West LLP
[Signature Page to Company Acceleration Request Letter]
2024-05-02 - UPLOAD - ACHIEVE LIFE SCIENCES, INC. File: 333-278961
United States securities and exchange commission logo
May 2, 2024
John Bencich
Chief Executive Officer
Achieve Life Sciences, Inc.
22722 29th Drive SE, Suite 100
Bothell, WA 98021
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-3
Filed April 26, 2024
File No. 333-278961
Dear John Bencich:
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: Chelsea Anderson
2024-05-02 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 May 2, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Lauren Hamill Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-278961) Requested Date: May 6, 2024 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, to Ms. Rose at (206) 389-4553. * * * Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Executive Officer cc: Amanda L. Rose, Esq. Chelsea Anderson, Esq. Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2023-06-21 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 22722 29th Drive SE, Suite 100 Bothell, WA 98021 June 21, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Arzhang Navai Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-272641) Requested Date: June 23, 2023 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, to Ms. Rose at (206) 389-4553. * * * Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Executive Officer cc: Amanda L. Rose, Esq. Chelsea Anderson, Esq. Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2023-06-20 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
United States securities and exchange commission logo
June 20, 2023
John Bencich
Chief Executive Officer
ACHIEVE LIFE SCIENCES, INC.
22722 29th Drive SE, Suite 100
Bothell, WA 98021
Re:ACHIEVE LIFE SCIENCES, INC.
Registration Statement on Form S-3
Filed June 14, 2023
File No. 333-272641
Dear John Bencich:
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 Arzhang Navai at 202-551-4676 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Chelsea Anderson
2023-01-05 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm Acceleration Request ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, BC V6E 4H1 January 5, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Ada D. Sarmento Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-269059). Requested Date: January 9, 2023 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Amanda L. Rose and Steven Jean, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, to Mr. Jean at (212) 430-2634. * * * Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Executive Officer cc: Amanda L. Rose, Esq. Steven Jean, Esq. Fenwick & West LLP
2023-01-04 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
United States securities and exchange commission logo
January 4, 2023
John Bencich
Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia Street, Suite 1030
Vancouver, BC V6E 4H1
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-3
Filed December 29, 2022
File No. 333-269059
Dear John Bencich:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Amanda Rose, Esq.
2022-01-03 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
achv-corresp.htm
ACHIEVE LIFE SCIENCES, INC.
1040 West Georgia Street, Suite 1030
Vancouver, BC V6E 4H1
January 3, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Christine Westbrook
Re:
Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-261811) filed December 21, 2021.
Requested Date: January 5, 2022
Requested Time: 4:00 PM Eastern Time
Ladies and Gentlemen:
Achieve Life Sciences (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission.
The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, to Ms. Anderson at (206) 389-4516.
* * *
Sincerely,
ACHIEVE LIFE SCIENCES, INC.
By:
/s/ John Bencich
John Bencich
Chief Executive Officer
cc:Amanda L. Rose, Esq.
Chelsea Anderson, Esq.
Fenwick & West LLP
2021-12-30 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
achv-corresp.htm
ACHIEVE LIFE SCIENCES, INC.
1040 West Georgia Street, Suite 1030
Vancouver, BC V6E 4H1
December 30, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Christine Westbrook
Re:
Achieve Life Sciences, Inc. Registration Statement on Form S-3 (File No. 333-261811) filed December 21, 2021.
Requested Date: January 5, 2022
Requested Time: 4:00 PM Pacific Time
Ladies and Gentlemen:
Achieve Life Sciences (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission.
The Registrant hereby authorizes Amanda L. Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, to Ms. Anderson at (206) 389-4516.
* * *
Sincerely,
ACHIEVE LIFE SCIENCES, INC.
By:
/s/ John Bencich
John Bencich
Chief Executive Officer
cc:Amanda L. Rose, Esq.
Chelsea Anderson, Esq.
Fenwick & West LLP
2021-12-28 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
United States securities and exchange commission logo
December 28, 2021
John Bencich
Chief Executive Officer
ACHIEVE LIFE SCIENCES, INC.
1040 West Georgia Street, Suite 1030
Vancouver, BC V6E 4H1
Re:ACHIEVE LIFE SCIENCES, INC.
Registration Statement on Form S-3
Filed December 21, 2021
File No. 333-261811
Dear Mr. Bencich:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Amanda Rose, Esq.
2020-11-30 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm achv-corresp.htm ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 November 30, 2020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-250074) originally filed November 13, 2020, as amended. Requested Date: December 2, 2020 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statements on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Amanda Rose and Steven Jean, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Mr. Jean at (212) 430-2634 or, in his absence, Ms. Rose at (206) 389-4553. *** Sincerely, Achieve Life Sciences, Inc. By: /s/ John Bencich John Bencich Chief Executive Officer cc:Amanda Rose Steven Jean Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2020-11-18 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
United States securities and exchange commission logo
November 18, 2020
John Bencich
Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia, Suite 1030,
Vancouver, British Columbia, V6E 4H1
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-1
Filed November 13, 2020
File No. 333-250074
Dear Mr. Bencich:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Amanda Rose, Esq.
2020-06-12 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm achv-corresp.htm ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 June 12, 2020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-238970) originally filed June 5, 2020. Requested Date: June 16, 2020 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Amanda Rose and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, Ms. Rose at (206) 389-4553. *** Sincerely, Achieve Life Sciences, Inc. By: /s/ John Bencich John Bencich Chief Financial Officer cc:Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Amanda Rose Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2020-06-11 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
United States securities and exchange commission logo
June 11, 2020
Richard Stewart
Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia Street, Suite 1030
Vancouver, British Columbia, V6E 4H1
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-1
Filed June 5, 2020
File No. 333-238970
Dear Mr. Stewart:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Chelsea Anderson, Esq.
2020-04-02 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
April 2, 2020
Richard Stewart
Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia, Suite 1030
Vancouver, British Columbia, V6E 4H1
Re:Achieve Life Sciences, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed March 30, 2020
File No. 033-80623
Dear Mr. Stewart:
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: Chelsea Anderson, Esq.
2019-12-17 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP LADENBURG THALMANN & CO. INC. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 December 17, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 17, 2019 Requested Time: 12 PM Eastern Time Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request of Achieve Life Sciences, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 12 p.m.., Eastern Time (US), on December 17, 2019, or at such later time as the Company or its outside counsel, Fenwick & West LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated December 2, 2019 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. *** Sincerely, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Nicholas Stergis Managing Director [Signature Page to Underwriter Acceleration Request Letter]
2019-12-17 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 December 17, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 17, 2019 Requested Time: 12 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Alan Smith and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, Mr. Smith at (206) 389-4530. *** Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-12-16 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 December 16, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Withdrawal of Request for Acceleration of Effectiveness of Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby withdraws its request, dated December 16, 2019, that the Registration Statement on Form S-1 (File No. 333-234530), as amended (the “Registration Statement”) become effective on December 16, 2019 at 4:30 PM, orally amended to 5:30 PM, or as soon thereafter as practicable. If you have any questions regarding the foregoing, please contact our counsel, Chelsea Anderson at (206) 389-4516 or, in her absence, Alan Smith at (206) 389-4530, of Fenwick & West LLP. *** Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-12-16 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP LADENBURG THALMANN & CO. INC. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 December 16, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 16, 2019 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request of Achieve Life Sciences, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time (US), on December 16, 2019, or at such later time as the Company or its outside counsel, Fenwick & West LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated December 2, 2019 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. *** Sincerely, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Nicholas Stergis Managing Director [Signature Page to Underwriter Acceleration Request Letter]
2019-12-16 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 December 16, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 16, 2019 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Alan Smith and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, Mr. Smith at (206) 389-4530. *** Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-12-12 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 December 12, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Withdrawal of Request for Acceleration of Effectiveness of Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby withdraws its request, date December 10, 2019, that the Registration Statement on Form S-1 (File No. 333-234530), as amended (the “Registration Statement”) become effective on December 12, 2019 at 4:30 PM or as soon thereafter as practicable. If you have any questions regarding the foregoing, please contact our counsel, Chelsea Anderson at (206) 389-4516 or, in her absence, Alan Smith at (206) 389-4530, of Fenwick & West LLP. *** Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-12-10 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, V6E 4H1 December 10, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 12, 2019 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Alan Smith and Chelsea Anderson, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Anderson at (206) 389-4516 or, in her absence, Mr. Smith at (206) 389-4530. *** Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Chelsea Anderson Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-12-10 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP LADENBURG THALMANN & CO. INC. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 December 10, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gregory Dundas Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-234530) originally filed November 6, 2019, as amended. Requested Date: December 12, 2019 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request of Achieve Life Sciences, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time (US), on December 12, 2019, or at such later time as the Company or its outside counsel, Fenwick & West LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated December 2, 2019 to underwriters, dealers, institutions and others as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. *** Sincerely, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Nicholas Stergis Managing Director [Signature Page to Underwriter Acceleration Request Letter]
2019-11-14 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
November 14, 2019
Richard Stewart
Chairman and Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia, Suite 1030,
Vancouver, British Columbia, V6E 4H1
Re:Achieve Life Sciences Inc.
Registration Statement on Form S-1
Filed November 6, 2019
File No. 333-234530
Dear Mr. Stewart:
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 Gregory Dundas, Attorney Adviser, at (202) 551-3436 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Chelsea Anderson, Esq.
2019-08-05 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
CORRESP
ACHIEVE LIFE SCIENCES, INC.
1040 West Georgia Street, Suite 1030
Vancouver, British Columbia, Canada V6E 4H1
August 5, 2019
VIA EDGAR
U.S. Securities and Exchange Commission
Division
of Corporation Finance
100 F Street, N.E.
Washington, D.C.
20549
Attn: Ada D. Sarmento
Re:
Achieve Life Sciences, Inc. Registration Statement on Form
S-1 (File No. 333-232817)
originally filed July 25, 2019, as amended
Requested Date: August 7, 2019
Requested Time: 4:00 PM Eastern Time
Ladies and Gentlemen:
Achieve
Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable.
The Registrant hereby authorizes Alan Smith or Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick &
West LLP, to orally modify or withdraw this request for acceleration.
The Registrant requests that it be notified of such effectiveness by a telephone
call to Ms. Rose at (206) 389-4553, or in her absence, Mr. Smith at (206) 389-4530.
Sincerely,
ACHIEVE LIFE SCIENCES, INC.
By:
/s/ John Bencich
John Bencich
Chief Financial Officer
2019-07-31 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
July 31, 2019
Richard Stewart
Chief Executive Officer
Achieve Life Sciences, Inc.
1040 West Georgia Street, Suite 1030
Vancouver, British Columbia, V6E 4H1
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-1
Filed July 25, 2019
File No. 333-232817
Dear Mr. Stewart:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Amanda Rose, Esq.
2019-02-08 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
February 7, 2019
John Bencich
Chief Financial Officer
ACHIEVE LIFE SCIENCES, INC.
1001 W. Broadway, Suite 400
Vancouver, British Columbia, V6H 4B1
Re:ACHIEVE LIFE SCIENCES, INC.
Registration Statement on Form S-3
Filed December 26, 2018
File No. 333-229019
Dear Mr. Bencich:
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 Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-02-07 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ACHIEVE LIFE SCIENCES, INC. 1040 West Georgia Street, Suite 1030 Vancouver, British Columbia, Canada V6E 4H1 February 7, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Robert Errett Re: Achieve Life Sciences, Inc. Registration Statement on Form S-3 Filed December 26, 2018 (File No. 333-229019) Requested Date: February 11, 2019 Requested Time: 4:30 p.m. Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Alan Smith or Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553, or in her absence, Mr. Smith at (206) 389-4530. Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial Officer
2018-12-04 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
December 4, 2018
Richard Stewart
Chairman and Chief Executive Officer
Achieve Life Sciences, Inc.
1001 W. Broadway, Suite 400
Vancouver, British Columbia, V6H 4B1
Re:Achieve Life Sciences, Inc.
Registration Statement on Form S-1
Filed November 29, 2018
File No. 333-228596
Dear Mr. Stewart:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Amanda Rose, Esq.
2018-12-04 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP Achieve Life Sciences, Inc. 1001 W. Broadway, Suite 400 Vancouver, British Columbia, V6H 4B1 December 4, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Christine Westbrook Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-228596) originally filed November 29, 2018, as amended. Requested Date: December 7, 2018 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statements on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Alan Smith and Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, Mr. Smith at (206) 389-4530. Sincerely, ACHIEVE LIFE SCIENCES, INC. By: /s/ John Bencich John Bencich Chief Financial and Operating Officer cc: Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Robert Freedman Amanda Rose Fenwick & West LLP
2018-06-13 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm achv-corresp.htm Achieve Life Sciences, Inc. 1001 W. Broadway, Suite 400, Vancouver, British Columbia, V6H 4B1 June 13, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Christine Westbrook Re: Achieve Life Sciences, Inc. Registration Statement on Form S-1 (File No. 333-224840) originally filed May 10, 2018, as amended. Requested Date: June 14, 2018 Requested Time: 4:30 PM Eastern Time Ladies and Gentlemen: Achieve Life Sciences, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statements on Form S-1 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert Freedman and Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant hereby acknowledges that: • should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert the Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553 or, in her absence, Mr. Freedman at (650) 335-7292. Sincerely, Achieve Life Sciences, Inc. By: /s/ John Bencich John Bencich Chief Financial and Operating Officer cc:Richard Stewart, Chairman and Chief Executive Officer Achieve Life Sciences, Inc. Alan C. Smith Robert Freedman Amanda Rose Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2018-06-13 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm achv-corresp.htm Ladenburg Thalmann & Co. Inc. 999 Vanderbilt Beach Road, Suite 200 Naples, Florida 34108 June 13, 2018 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, DC 20549 Re:ACHIEVE LIFE SCIENCES, INC. Registration Statement on Form S-1 (Registration No. 333-224840) Concurrence in Acceleration Request Ladies and Gentlemen: Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as representative of the underwriters for the above-referenced offering, hereby concurs in the request by Achieve Life Sciences, 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 June 14, 2018, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering. Very truly yours, LADENBURG THALMANN & CO. INC. By: /s/ Nicholas Stergis Name: Nicholas Stergis Title: Managing Director
2017-06-09 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ONCOGENEX PHARMACEUTICALS, INC. 19820 North Creek Parkway Bothell, Washington 98011 June 9, 2017 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Ada D. Sarmento Erin Jaskot Rolf Sundwall Mark Brunhofer Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S-4 File No. 333-216961 Originally filed March 27, 2017, as amended Requested Date: June 13, 2017 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: OncoGenex Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to declare the above-captioned Registration Statement on Form S-4 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Robert Freedman or Amanda Rose, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Rose at (206) 389-4553, or in her absence, Mr. Freedman at (650) 335-7292. [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] Sincerely, ONCOGENEX PHARMACEUTICALS, INC. By: /s/ John Bencich John Bencich Chief Financial Officer cc: Scott Cormack, Chief Executive Officer John Bencich, Chief Financial Officer OncoGenex Pharmaceuticals, Inc. Alan Smith, Esq. Robert Freedman, Esq. Kee Kim, Esq. Amanda Rose, Esq. Fenwick & West LLP Robert Carlson, Esq. Nicholas DeAngelis, Esq. Paul Hastings LLP
2017-06-06 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP June 6, 2017 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Ada D. Sarmento Erin Jaskot Rolf Sundwall Mark Brunhofer Re: OncoGenex Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S-4 Filed May 24, 2017 File No. 333-216961 Ladies and Gentlemen: We are submitting this letter on behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated June 1, 2017 relating to Amendment No. 2 to the Company’s Registration Statement on Form S-4 (File No. 333-216961) filed with the Commission on May 24, 2017 (the “Registration Statement”). The numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery five copies of Amendment No. 3 to the Registration Statement (“Amendment No. 3”) in paper format, which have been marked to show changes from Amendment No. 2 to the Registration Statement as filed on May 24, 2017. Competition, page 180 Prescription Treatments, page 181 1. We note your response to our prior comment 5. Please revise to disclose that “no apparent difference in efficacy between cytisine and Chantix” means that the review found that the risk ratio for cytisine and Chantix was found to be in the same order of magnitude. Please also clearly disclose that only two studies were used to calculate the risk ratio for cytisine versus 27 trials for varenicline, and that evidence for varenicline U.S. Securities and Exchange Commission June 6, 2017 Page 2 was considered of high and moderate quality while the evidence for cytisine was considered low quality. In response to the Staff’s comment, the Company has revised the disclosure on page 181 of Amendment No. 3. 2. We note your response to our prior comment 6. Please revise the disclosure of the Cochrane Group review to provide the year of the first trial included in the review. In response to the Staff’s comment, the Company has revised the disclosure on page 181 of Amendment No. 3. *** Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (650) 335-7292. Sincerely, /s/ Robert Freedman Robert Freedman cc: Scott Cormack, Chief Executive Officer John Bencich, Chief Financial Officer OncoGenex Pharmaceuticals, Inc. Alan Smith, Esq. Kee Kim, Esq. Amanda Rose, Esq. Fenwick & West LLP Robert Carlson, Esq. Nicholas DeAngelis, Esq. Paul Hastings LLP
2017-06-01 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Mail Stop 4546 June 1, 201 7 Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway Bothell, Washington 98011 Re: OncoGenex Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S -4 Filed May 24, 2017 File No. 333-216961 Dear Mr. Cormack : We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply t o your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our May 17, 2017 letter . Compe tition, page 180 Prescription Treatments, page 181 1. We note your response to our prior comment 5. Please revise to disclos e that “no apparent difference in efficacy between cytisine and Chantix ” means that the review found that the risk ratio for cytisine and Chantix was found to be in the same order of magnitude . Please also clearly disclose that only two studies were used to calculate the risk ratio for cytisine versus 27 trials for varenicline , and that evidence for varenicline Scott Cormack OncoGenex Pharmaceuticals, Inc. June 1, 201 7 Page 2 was considered of high and moderate quality while the evidence for cytisine was considered low quality. 2. We note your response to our prior comment 6. Please revise the disclosure of the Cochrane Group review to provide the year of the first trial included in the review. You may contact Rolf Sundwall at (202) 551 -3105 or Mark Brunhofer at (202) 551 -3494 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special Counsel, at (202) 551 - 3442 with any other questions . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Robert Free dman Fenwick & West LLP
2017-05-24 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
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CORRESP
1191 SECOND AVENUE, 10TH FLOOR SEATTLE, WA 98101
TEL 206.389.4510 FAX 206.389.4511 WWW.FENWICK.COM
May 24, 2017
VIA EDGAR AND OVERNIGHT
DELIVERY
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Suzanne
Hayes
Ada D. Sarmento
Erin Jaskot
Rolf Sundwall
Mark Brunhofer
Re: OncoGenex Pharmaceuticals, Inc.
Amendment No. 1 to
Registration Statement on Form S-4
Filed May 3, 2017
File No. 333-216961
Ladies and Gentlemen:
We are submitting this letter on behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”) in response to comments from
the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated May 17, 2017 relating to Amendment No. 1 to the Company’s
Registration Statement on Form S-4 (File No. 333-216961) filed with the Commission on May 3, 2017 (the “Registration Statement”). The
numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery
five copies of Amendment No. 2 to the Registration Statement (“Amendment No. 2”) in paper format, which have been marked to show changes from the Registration Statement as filed on
May 3, 2017.
General
1.
We note your disclosure that Achieve is pursuing a financing in which it would issue securities in exchange for up to $5 million and that the shares issued in such a financing
would cause an adjustment to the exchange ratio. Please disclose a range of possible adjustments to the exchange ratio based on potential financing amounts.
In response to the Staff’s comment, the Company has revised the disclosure on pages 3 and 14 of Amendment No. 2 to indicate that
Achieve Life Science, Inc. (“Achieve”) expects the
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exchange ratio to be reduced to between 3,772.7640 and 4,177.8154 based on a financing of up to $5 million, should it occur. As further described in the table below, Achieve expects that the
amount raised in any financing would be between $1 million and $5 million, and would be at a discount of between 20-50%, based on the aggregate valuation of the combined company of $107 million
provided in the section entitled “The Merger Agreement — Exchange Ratio.” However, Achieve has not yet entered into any term sheet, definitive agreement, or other arrangement with any investor, and therefore, the actual amounts raised
and discount rate could fall outside such range, resulting in a different exchange ratio.
Amount Raised
Discount
Per Share Price
Shares Issued
Exchange Ratio
$1,000,000
20%
$
3,024.02
330.69
4,177.8154
$1,000,000
50%
$
1,890.01
529.10
4,139.7198
$5,000,000
20%
$
3,024.02
1,653.43
3,936.3232
$5,000,000
50%
$
1,890.01
2,645.48
3,772.7640
Background of the Merger, page 81
2.
We note that the board presentation dated December 16, 2016 indicates that the company decided to move into more detailed and economic discussions with one party while keeping
Achieve and another party as potential backup. Please revise the disclosure in this section to reflect this information or advise.
The Company advises the Staff that text referenced in the December 16, 2016 board presentation is a high-level summary and lacks the
nuances and context that were discussed by the board of directors of the Company. The Company has revised the disclosure on page 89 of Amendment No. 2 to provide the context and details around the board’s October 28, 2016 meeting and
the actions taken following that meeting.
[Important Information About the OncoGenex Financial Forecasts, page 103
3.
We note the inclusion of cautionary language that reads in relevant part, “[n]either OncoGenex, Achieve nor, after completion of the Merger, the combined company undertakes any obligation, except as required
by law, to update or otherwise revise the OncoGenex financial forecasts…even in the event that any or all of the underlying assumptions are shown to be in error.” While you can include appropriate limiting
language on the reliability of the forecasted information, it is inappropriate to disclaim any responsibility to update material disclosure. Please revise here and the similar language with respect to the Achieve financial forecasts.
In response to the Staff’s comment, the Company has revised the disclosure on pages 104 and 106 of Amendment
No. 2.
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Material U.S. Federal Income Tax Consequences of the Merger, page 120
4.
We note your statement on page 120 that it is the opinion of legal counsel that “the following is a discussion of the material U.S. federal income tax consequences,” and your statement on page 123 that
it is the opinion of legal counsel that “the statements set forth herein correctly describe the general U.S. federal income tax consequences.” These statements fail to identify the specific tax issue on which counsel is opinion. Counsel
must opine on the tax consequences of the offering, not the manner in which they are described in the prospectus. See Staff Legal Bulletin No. 19 (2011). Please remove or revise these statements as appropriate. To
the extent that you retain any portion of the statement on page 123, please refer to “material” U.S. federal income tax consequences instead of “general.”
In response to the Staff’s comment, the Company has revised the disclosure on pages 120 and 123 of Amendment No. 2.
Achieve Business, page 175
The
Global Smoking Cessation Market, page 176
5.
We note your response to our prior comment 24 and reissue in part. Please supplementally explain how overlapping risk ratios indicate similar efficacy for cytisine and Chantix.
In response to the Staff’s comment, the Company advises the Staff that the risk ratio is a statistical method to compare two treatments.
Using a risk ratio, the efficacy of the treatment is expressed as a fraction of the efficacy of the control treatment (placebo in this case). If the treatment and placebo have the same efficacy, the risk ratio would be 1. If the efficacy of the
treatment is better than placebo, the risk ratio is greater than 1; the higher the risk ratio, the greater the efficacy of the treatment. For example, a risk ratio of 2 means that the treatment was twice as effective as placebo. The risk ratio
calculated from the results of a trial is an estimate of the “true” risk ratio (a theoretical value that would be obtained if an infinite number of patients had been treated). It follows that studies with larger numbers of patients
have more reliable estimates of the true risk ratio than smaller studies.
An estimate of the reliability of the calculated risk
ratio can be made by calculation of the 95% confidence interval for the ratio. This confidence interval measures how reliable the estimated risk ratio is. Therefore, for a given risk ratio it can be stated that the analysis indicates that we are 95%
sure (confident) that the “true” risk ratio lies within the bounds of the lower and upper limits. If the 95% confidence interval is all positive (i.e. the range does not include zero), it can be further concluded that
the treatment was significantly more effective than placebo.
The Cochrane analysis included studies where cytisine was
compared with placebo, and varenicline (Chantix) was compared with placebo. Studies included in Cochrane analyses were carefully screened for reliability according to established and robust methods, in order that they may be reliably combined
and compared. Risk ratios were used to compare the drug with placebo in each case, but also included meta-analyses where cytisine versus placebo studies were combined and varenicline versus placebo studies were combined. This combination increases
the number of patients included in the analyses and increases the statistical power of the analyses.
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The results of the Cochrane meta-analyses were expressed as risk ratios and 95% confidence
intervals. It was shown that the risk ratio for cytisine versus placebo was 3.98 (95% confidence interval, 2.01 - 7.87) and for varenicline versus placebo 2.24 (95% confidence interval, 2.06 - 2.43). This indicates that both treatments were
significantly more effective than placebo. However, although the risk ratio for cytisine was higher than that for varenicline, the confidence interval was also larger and there is a considerable overlap with that of varenicline. This data indicates
further that, although the two drugs have not been compared directly in the same clinical trial, the estimated efficacy for both drugs is about the same, i.e. the “true” risk ratio for cytisine and for varenicline are both
in the same order of magnitude.
Competition, page 180 Prescription Treatments, page 180
6.
Please revise the disclosure of the Cochrane Group review to provide further details regarding the mechanics of the study, including that the data used to compare cytisine and Chantix is from separate trials done
on each of the drugs at various times going back to 1971. Please also disclose that the Cochrane Group review judged the evidence form the cytisine trials to be of low quality, meaning that there was limited confidence in the evidence.
In response to the Staff’s comment, the Company has revised the disclosure on page 181 of Amendment No. 2.
7.
Please supplementally provide the report by the National Institute of Health Research in the United Kingdom referred to in this section.
In response to the Staff’s comment, the Company has provided to the Staff on a supplemental basis under separate cover a copy of the
report by the National Institute of Health Research.
Achieve Executive Compensation, page 224
8.
We note your disclosure that Mr. Stewart and Dr. Clarke have historically waived all rights to receive compensation pursuant to their employment
agreements. Please note that an executive’s decision to not accept compensation does not change the disclosure requirements with respect to any compensation that was earned for services performed during the applicable fiscal year. Please tell
us why you believe you are not required to disclose any compensation information for Mr. Stewart and Dr. Clarke. For guidance, please refer to Question 119.25 of the Regulation S-K Compliance and Disclosure Interpretations.
In response to the Staff’s
comment, the Company has revised the disclosure on page 230 of Amendment No. 2.
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Achieve Related-Party Transactions, page 240
9.
We note your response to our prior comment 19 that you intend to enter into employment agreements with the executive officers of the combined company after the consummation of the merger and your disclosure on
page 208 that Mr. Stewart and Dr. Clarke will provide services to the company as employees rather than pursuant to a consulting agreement with Ricanto Limited. Please disclose when
you intend to terminate the consulting agreement with Ricanto Limited.
The Company advises the Staff that Achieve
intends to terminate the consulting agreement with Ricanto Limited prior to the closing of the merger. The Company has revised the disclosure on page 212 of Amendment No. 2 to reflect this fact.
Achieve Life Science, Inc.
Notes
to Consolidated Financial Statements
8. Commitments and Contingencies, page F-55
10.
Please tell us whether the financing milestone under your license agreement with the University of Bristol will be achieved with the completion of the merger with OncoGenex Pharmaceuticals, Inc. or the potential
$5 million financing disclosed on page 13. If so, revise your disclosure and the pro forma financial statements, as appropriate, to disclose the amount of the liability that will be incurred.
The Company advises the Staff that the financing milestone under Achieve’s license agreement with the University of
Bristol will not be achieved upon either the completion of the merger with the Company or a potential financing of up to $5 million.
***
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Should the Staff have additional questions or comments regarding the foregoing, please do not
hesitate to contact the undersigned at (650) 335-7292.
Sincerely,
/s/ Robert Freedman
Robert Freedman
cc:
Scott Cormack, Chief Executive Officer
John Bencich, Chief
Financial Officer
OncoGenex Pharmaceuticals, Inc.
Alan Smith, Esq.
Kee Kim, Esq.
Amanda Rose, Esq.
Fenwick & West LLP
Robert Carlson, Esq.
Nicholas DeAngelis, Esq.
Paul Hastings LLP
2017-05-17 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Mail Stop 4546 May 17, 201 7 Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway Bothell, Washington 98011 Re: OncoGenex Pharmaceuticals, Inc. Amendment No. 1 to Registration Statement on Form S -4 Filed May 3, 2017 File No. 333-216961 Dear Mr. Cormack : We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our April 24, 2014 letter . General 1. We note your disclosure that Achieve is pursuing a financing in which it wou ld issue securities in exchange for up to $5 million and that the shares issued in such a financing would cause an adjustment to the exchange ratio. Please disclose a range of possible adjustments to the exchange ratio based on potential financing amounts . Scott Cormack OncoGenex Pharmaceuticals, Inc. May 17, 201 7 Page 2 Background of the Merger, page 81 2. We note that the board presentation dated December 16, 2016 indicates that the company decided to move into more detailed and economic discussions with one party while keeping Achieve and another party as potential backup . Please revise the disclosure in this section to reflect this information or advise. [Important Information About the OncoGenex Financial Forecasts , page 103 3. We note the inclusion of cautionary language that reads in relevant part, “ [n]either OncoGenex, Achieve nor, after completion of the Merger, the combined company undertakes any obligation, except as required by law, to update or otherwise revise the OncoGenex financial forecasts …even in the event that any or all of the underlying assumpti ons are shown to be in error .” While you can include appropriate limiting language on the reliability of the forecasted information, it is inappropriate to disclaim any responsibility to update material disclosure. Please revise here and the similar langua ge with respect to the Achieve financial forecasts . Material U.S. Federal Income Tax Consequences of the Merger , page 120 4. We note your statement on page 120 that it is the opinion of legal counsel that “the following is a discussion of the material U.S. federal income tax consequences,” and your statement on page 123 that it is the opinion of legal counsel that “the statements set forth herein correctly describe the general U.S. federal income tax consequences.” These statements fail to identify the spe cific tax issue on which counsel is opinion. Counsel must opine on the tax consequences of the offering, not the manner in which they are described in the prospectus. See Staff Legal Bulletin No. 19 (2011). Please remove or revise these statements as ap propriate. To the extent that you retain any portion of the statement on page 123, please refer to “material” U.S. federal income tax consequences instead of “general.” Achieve Business, page 175 The Global Smoking Cessation Market, page 176 5. We note y our response to our prior comment 24 and reissue in part . Please supplementally explain how overlappi ng risk ratios indicate similar efficacy for cytisine and Chantix. Scott Cormack OncoGenex Pharmaceuticals, Inc. May 17, 201 7 Page 3 Compe tition, page 180 Prescription Treatments, page 180 6. Please revise the disclosure of the Cochrane Group review to provide further details regarding the mechanics of the study, including that the data used to compare cytisine and Chantix is from separate trials done on each of the drugs at various times going back to 1971. Please also disclose that the Cochrane Group review judged the eviden ce form the cytisine trials to be of low quality, meaning that there was limited confidence in the evidence. 7. Please supplementally provide the report by the National Institute of Health Research in the United Kingdom referred to in this section. Achieve Executive Compensation, page 224 8. We note your disclosure that Mr. Stewart and Dr. Clarke have historically waived all rights to receive compensation pursuant to their employment agreements. Please note that an executive’s decision to not accept c ompensation does not change the disclosure requirements with respect to any compensation that was earned for services performed during the applicable fiscal year. Please tell us why you believe y ou are not required to disclos e any compensation informatio n for Mr. Stewart and Dr. Clarke. For guidance, please refer to Question 119.25 of the Regulation S -K Compliance and Disclosure Interpretations. Achieve Related -Party Transactions, page 240 9. We note your response to our prior comment 19 that you intend t o enter into employment agreements with the executive officers of the combined company after the consummation of the merger and your disclosure on page 208 that Mr. Stewart and Dr. Clarke will provide services to the company as employees rather than pursua nt to a consulting agreement with Ricanto Limited . Please disclose when you intend to terminate the consulting agreement with Ricanto Limited. Achieve Life Science, Inc. Notes to Consolidated Financial Statements 8. Commitments and Contingencies, page F -55 10. Please tell us whether the financing milestone under your license agreement with the University of Bristol will be achieved with the completion of the merger with OncoGenex Pharmaceuticals, Inc. or the potential $5 million financing disclosed on page 13. If so, revise your disclosure and the pro forma financial statements, as appropriate, to disclose the amount of the liability that will be incurred. Scott Cormack OncoGenex Pharmaceuticals, Inc. May 17, 201 7 Page 4 You may contact Rolf Sundwall at (202) 551 -3105 or Mark Brunhofer at (202) 551 -3494 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special Counsel, at (202) 551 - 3442 with any other questions . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Robert Free dman Fenwick & West LLP
2017-05-03 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP May 3, 2017 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Ada D. Sarmento Erin Jaskot Rolf Sundwall Mark Brunhofer Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S-4 Filed March 27, 2017 File No. 333-216961 Ladies and Gentlemen: We are submitting this letter on behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated April 24, 2017 relating to the Company’s Registration Statement on Form S-4 (File No. 333-216961) filed with the Commission on March 27, 2017 (the “Registration Statement”). The numbered paragraph below corresponds to the numbered comment in the Staff’s letter and the Staff’s comment is presented in bold italics. We have also enclosed with the copy of this letter that is being transmitted via overnight delivery five copies of Amendment No. 1 to the Registration Statement (“Amendment No. 1”) in paper format, which have been marked to show changes from the Registration Statement as filed on March 27, 2017. Prospectus Summary Merger Consideration, page 11 1. Please disclose the market value of the OncoGenex shares that will be issued for each share of Achieve common stock as of the latest practicable date. In response to the Staff’s comment, the Company has revised the disclosure on page 13 of Amendment No. 1. U.S. Securities and Exchange Commission May 3, 2017 Page 2 Contingent Value Rights, page 13 2. Please clearly state here, and elsewhere as appropriate, that you have not identified a third party for the development and/or commercialization of apatorsen and you have not set any milestones at this time and it is uncertain whether you will do so. Please also clearly state that OncoGenex shareholders will not be able to determine the value of the CVRs, if any, prior to voting in the merger since a portion of the consideration will be contingent upon the occurrence of future events. In response to the Staff’s comment, the Company has revised the disclosure on pages 4, 15, 144, 145, 158, 189 and 210 of Amendment No. 1. Questions and Answers About the Merger Why are the two companies proposing to merge?, page 2 3. We note your statements here and elsewhere, including in the Business section, that certain third-party trials have demonstrated “good efficacy” and a “favorable comparative safety profile” as well as “promising efficacy and safety results” for cytisine. Please remove statements suggesting that cytisine is safe and effective as approval by the FDA and other regulatory agencies is dependent on such agencies making this determination. It is premature to suggest that a non-approved product is safe or effective. Please also make clear in this section and elsewhere as appropriate that you have not yet submitted an IND to the FDA for cytisine or started clinical trials for cytisine with any other regulatory agency. In response to the Staff’s comment, the Company has revised the disclosure on pages 2, 10, 175 and 206 of Amendment No. 1. 4. Where you discuss the positive Phase 2 results for apatorsen, please balance your disclosure to reflect that all but one of the Phase 2 clinical trials failed to meet their clinical endpoints. In response to the Staff’s comment, the Company has revised the disclosure on pages 2 and 10 of Amendment No. 1. Risk Factors Related to the Merger, page 25 5. Please add a risk factor regarding the uncertainty of the tax treatment of the CVRs. In response to the Staff’s comment, the Company has revised the disclosure on page 29 of Amendment No. 1. Apatorsen may cause undesirable and potentially serious side effects…, page 37 6. Please revise your risk factor to disclose that serious adverse events were reported for half of patients in the phase 1 clinical trial for solid tumors. U.S. Securities and Exchange Commission May 3, 2017 Page 3 In response to the Staff’s comment, the Company has revised the disclosure on page 38 of Amendment No. 1. The illegal distribution and sale by third parties…, page 65 7. Please revise your disclosure to explain the meaning and significance of Cytisine being labeled a “New Chemical Entity.” In response to the Staff’s comment, the Company has revised the disclosure on page 67 of Amendment No. 1. Cytisine’s status as a “New Chemical Entity” means that no active moiety contained in cytisine has been previously approved by the U.S. Food and Drug Administration (“FDA”). This means that cytisine is potentially eligible for market exclusivity upon approval and also means that until cytisine is approved by the FDA, it is illegal to sell cytisine in the United States. To avoid potential confusion related to the term, the Company has removed references to cytisine’s status as a “New Chemical Entity.” Third-party claims of intellectual property infringement…, page 68 8. We note that you are aware of U.S. and foreign patents and pending patent applications owned by third parties that cover therapeutic uses of cytisine. We also note that you may challenge the validity of these patents and patent applications and may also seek to negotiate a license of rights to technology covered by such patents. Please explain whether your ability to manufacture or market your product candidates is dependent upon your ability to challenge the validity of these patents and/or obtain a license to the technology covered by the patents. In response to the Staff’s comment, the Company has revised the disclosure on pages 69 and 70 of Amendment No. 1. Background of the Merger, page 79 9. Please supplementally provide us with copies of all materials prepared by MTS Health Partners or MTS Securities and shared with your board of directors and their representatives, including copies of all board books and all transcripts and summaries, that were material to the board’s decision to approve the merger agreement and the transactions contemplated thereby. In response to the Staff’s comment, the Company has provided to the Staff on a supplemental basis under separate cover copies of all materials prepared by MTS Health Partners or MTS Securities that were shared with the Company’s board of directors and their representatives. 10. Please identify who Ms. Griffin is the first time that she is mentioned in this section and disclose what role she played in the process. In response to the Staff’s comment, the Company has revised the disclosure on page 81 of Amendment No. 1. U.S. Securities and Exchange Commission May 3, 2017 Page 4 11. We note your disclosure on page 87 that the board of directors considered the proposed terms offered by each of Achieve, Company A and Company D before deciding to inform Company D that it would no longer be part of the process. Please describe the material differences in the proposed terms by each of Achieve, Company A and Company D at that time. In response to the Staff’s comment, the Company has revised the disclosure on page 89 of Amendment No. 1. 12. We note on page 88 that Achieve and Sopharma were willing to enter into an amended and restated supply agreement to clarify certain “ambiguities.” Please disclose the material ambiguities. We further note the disclosure on page 91 that the parties have agreed to a letter agreement outlining the key terms of the amended and restated supply agreement, and that this agreement will be signed by Achieve and Sopharma prior to closing of the transaction. Please revise your disclosure here and in your description of the Sopharma supply agreement to disclose the key terms of the amended and restated supply agreement. Please also tell us whether you intend to file a copy of the agreement as an exhibit to the registration statement. In response to the Staff’s comment, the Company has revised the disclosure on pages 90, 184 and 208 of Amendment No. 1. The Company advises the Staff that Achieve Life Science, Inc. does not intend to enter into the amended and restated supply agreement with Sopharma until shortly before the completion of the merger, but the Company has filed the letter agreement describing the agreed upon terms for the amended and restated supply agreement as Exhibit 10.28 to Amendment No. 1. 13. We note your disclosure on page 89 that Company B decided to withdraw from the process. Please revise to disclose the reasons why Company B was no longer interested in a transaction. The Company advises the Staff that Company B did not provide to the Company any reasons for withdrawing from consideration in the transaction. 14. We note your disclosure on pages 90 and 92 regarding various discussions with Achieve regarding the transaction terms. Please disclose in greater detail any material developments in such discussions with respect to the amount or form of consideration, the determination of the exchange ratio, the size of the termination and reverse termination fees or other materials terms of the merger agreement. In response to the Staff’s comment, the Company has revised the disclosure on pages 92, 94 and 95 of Amendment No. 1. U.S. Securities and Exchange Commission May 3, 2017 Page 5 Opinion of the Financial Advisor to OncoGenex’s Board of Directors, page 100 15. We note your disclosure that MTS Securities received certain financial projections prepared by OncoGenex relating to OncoGenex’s and Achieve’s business and that such projections were utilized per OncoGenex’s instruction in the OncoGenex valuation analysis and the Achieve valuation analysis. Please disclose the projections used by the financial advisor for the relevant analyses. In response to the Staff’s comment, the Company has revised the disclosure beginning on page 102 of Amendment No. 1. Public Trading Comparable Companies Analysis, page 106 16. Please disclose the relevant selection criteria for each of the companies used in the public trading comparable companies analysis, including the underlying data for the companies such as the number of products, the pipeline, and the clinical stage of products. Please also disclose whether any of these companies have products in commercial stage. Finally, please disclose whether any companies that met the selection criteria were excluded from the analysis and why. In response to the Staff’s comment, the Company has revised the disclosure on page 113 of Amendment No. 1. General Overview of Analyses; Other Considerations, page 107 17. Please revise the disclaimer stating that MTS securities has not assumed any responsibility for the form or content of this proxy statement/prospectus/information statement to clarify that MTS is not disclaiming responsibility for the description of the MTS Opinion contained in the proxy statement/prospectus/information statement. In response to the Staff’s comment, the Company has revised the disclosure on page 114 of Amendment No. 1. Tax Treatment of the Merger, page 113 18. We note your statements here and elsewhere in the prospectus that the parties intend the first and second merger, taken together, to qualify as a reorganization with the result that Achieve stockholders will not recognize taxable gain or loss for U.S. federal income tax purposes. Please provide a firm conclusion regarding the material federal income tax consequences to investors and file a tax opinion as required by Item 601(b)(8) of Regulation S-K. Additionally, revise the discussion of the tax consequences to clarify that the discussion is counsel’s opinion and revise the related disclosure elsewhere in the prospectus, such as in the “Questions and Answers About the Merger”, to provide a firm conclusion. Please also delete the word “certain” in the phrase “certain material U.S. Federal State tax consequences of the Merger” from the heading in this section. U.S. Securities and Exchange Commission May 3, 2017 Page 6 In response to the Staff’s comment, the Company has revised the disclosure on pages 120, 121, 122 and 123 of Amendment No. 1. Directors and Executive Officers of OncoGenex Following the Merger, page 123 19. We note that certain officers and directors of both OncoGenex and Achieve will become directors and executive officers of the combined company. Please disclosure whether you have entered into employment agreements with any of these individuals and disclosure the material agreements of those agreements. Please also file the agreements as exhibits to your Form S-4, as applicable. The Company advises the Staff that the Company has entered into employment agreements with existing OncoGenex executive officers, including John Bencich and Cindy Jacobs, each of whom will also serve as an executive officer of the combined company. These employment agreements are described on pages 236 through 239 of Amendment No. 1. The Company has not entered into employment agreements with the existing directors of Achieve who will serve as executive officers of the combined company. The Company anticipates that it will negotiate and enter into a new form of employment agreement with all of the executive officers of the combined company after the consummation of the merger, and after receiving input from the combined company’s compensation committee and board of directors, as described on pages 117 and 118 of Amendment No. 1. If and when such employment agreements are approved by the combined company’s board of directors, the combined company intends to file an 8-K disclosing the material terms. The Company does not intend to enter into any employment agreements with the directors of the combined company, other than directors who also serve as executive officers of the combined company. Tax Treatment of CVRs, page 138 20. We note your statement that the issuance and distribution of CVRs could be treated in a variety of ways, including as a taxable dividend, a non-taxable return on capital, or as a distribution of equity in which case holders should not recognize gain or loss. Please tell us your consideration as to whether the issuance and distribution of the CVRs as part of the consideration in the transaction involves material tax consequences that should be opined upon. To the extent you do not believe an opinion is required, please tell us why. If you do provide an opinion, please expand the disclosure under this caption to describe counsel’s opinion and the assumptions upon which the opinion is based, or, if counsel is unable to opine on this issue, please so state and explain why it is not able to opine and the possible outcomes and risks to investors. For reference see Staff Legal Bulletin No. 19 (2011). In response to the Staff’s comment, the Company has revised the disclosure on pages 145, 146 and 147 of Amendment No. 1. U.S. Securities and Exchange Commission May 3, 2017 Page 7 Summary of Completed Apatorsen Clinical Trials Summary of Borealis-1 Results—The Randomized Phase 2 Clinical Trial in Patients with Metastatic Bladder Cancer, page 154 21. We note your disclosure regarding increased adverse events at 1000mg dosage of apatorsen in this trial. Please expand your disclosure to list all serious adverse events reported to date and the number of patients who have reported such events. In response to the Staff’s comment, the Company has revised the disclosure on page 163 of Amendment No. 1. Summary of Results of Apatorsen Phase 1 Clinical Trial in Patients with Solid Tumors, page 157 22. We note your disclosure regarding certain adverse and serious adverse events reported. Please expand your disclosure to list all such adverse and serious adverse events and the number of patients who have reported such events to the extent not already disclosed. In response to the Staff’s comment, the Company has revised th
2017-04-24 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Mail Stop 4546 April 24, 201 7 Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway Bothell, Washington 98011 Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S -4 Filed March 27 , 2017 File No. 333-216961 Dear Mr. Cormack : We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in yo ur response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments . Prospectus Summary Merger Consideration, page 11 1. Please disclose the market value of the OncoGenex shares that will be issued for each share of Achieve common stock as of the latest pract icable date. Contingent Value Rights, page 13 2. Please clearly state here, and elsewhere as appropriate, that you have not i dentified a third party for the development and/or commercialization of apatorsen and you have not set any milestones at this time and it is uncertain whether you wi ll do so. Please also clearly Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 2 state that OncoGenex shareholders will not be able to determine the value of the CVRs, if any, prior to voting in the merger since a portion of the consideration will be contingent upon the occurrence of future events. Questions and Answers About the Merger Why are the t wo companies proposing to merge ?, page 2 3. We note you r statements here and elsewhere , including in the Business section, that certain third -party trials have demonstrated “good efficacy” and a “favorable comparative safety profile” as well as “promising efficacy and safety results ” for cytisine. Please remove statements suggesting that cytisine is safe and effective as approval by the FDA and other regulatory agencies is depende nt on such agencies making this determination. It is premature to suggest that a non -approved product is safe or effective. Please also make clear in this section and elsewhere as appropriate that you have not yet submitted an IND to the FDA for cytisine or started clinical trials for cytisine with any other regulatory agency. 4. Where you discuss the positive Phase 2 results for apatorsen, please balance your disclosure to reflect that all but one of the Phase 2 clinical trials failed to meet their clinical endpoints. Risk Factors Related to the Merger , page 25 5. Please add a risk factor regarding the uncertainty of the tax treatment of the CVRs. Apatorsen may cause undesirable and potentially serious side effects . . ., page 37 6. Please revise your risk factor to disclose that serious adverse events were reported for half of patients in the phase 1 clinical trial for solid tumors. The illegal distribution and s ale by third parties . . , page 65 7. Please revise your disclosure to explain the meaning and significance of Cytisine being labeled a “New Chemical Entity.” Third -party claims of intellectual property infringement . . ., page 68 8. We note that you are aware of U.S. and foreign patents and pending patent applications owned by third parties that cover therapeutic uses of cytisine. We also note that you may challenge the validity of these patents and patent applications and may also s eek to negotiate a license of rights to technology covered by such patents. Please explain whether your ability to manufacture or market your product candidates is dependent upon your ability to challenge the validity of these patents and/or obtain a lice nse to the technology covered by the patents. Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 3 Background of the Merger, page 79 9. Please supplementally provide us with copies of all materials prepared by MTS Health Partners or MTS Securities and shared with your board of directors and their representatives, including copies of all board books and all transcripts and summaries, that were material to the board’s decision to approve the merger agreement and the transactions contemplated thereby. 10. Please identify who Ms. Griffin is the first time that she is mentioned in this section and disclose what role she played in the process . 11. We note your disclosure on page 87 th at the board of directors considered the proposed terms offered by each of Achieve, Company A and Company D before deciding to inform Company D that it would no longer be part of the process. Please describe the material differences in the proposed terms by each of Achieve, Company A and Company D at that time. 12. We note on page 88 that Achieve and Sopharma were willing to enter into an amended and restated supply agreement to clarify certain “ambiguities.” Please disclose the material ambiguities . We further note the disclosure on page 91 that the parties have agreed to a letter agreement outlining the key terms of the amended and restated supply agreement, and that this agreemen t will be signed by Achieve and Sopharma prior to closing of the transaction. Please revise your disclosure here and in your description of the Sopharma supply agreement to disclose the key terms of the amended and restated supply agreement. Please also tell us whether you intend to file a copy of the agreement as an exhibit to the registration statement. 13. We note your disclosure on page 89 that Company B decided to withdraw from the process. Please revise to disclose the reasons why Company B was no lon ger interested in a transaction. 14. We n ote your disclosure on page s 90 and 92 regarding various discussions with Achieve regarding the transaction terms. Please disclose in greater detail any material developments in such discussions with respect to the am ount or form of consideration, the determination of the exchange ratio, the size of the termination and reverse termination fees or other materials terms of the merger agreement. Opinion of the Financial Advisor to OncoGenex ’s Board of Directors, page 100 15. We note your disclosure that MTS Securities received certain financial projections prepared by OncoGenex relating to OncoGenex ’s and Achieve’s business and that such projections were utilized per OncoGenex ’s instruction in the OncoGenex valuation analysis and the Achieve valuation analysis . Please disclose the projections used by the financial advisor for the relevant analys es. Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 4 Public Trading Comparable Companies Analysis, page 106 16. Please disclose the relevant selection criteria for each of the companies used in the public trading comparable companies analysis, including the underlying data for the companies such as the number of products , the pipeline , and the clinical stage of product s. Please also disclose whether any of these companies have products in commercial stage. Finally, please disclose whether any companies that met the selection criteria w ere excluded from the analysi s and why . General Overview of Analyses; Other Considerations, page 107 17. Please revise the disclaime r stating that MTS securities has not assumed any responsibility for the form or content of this proxy statement/prospectus/information statement to clarify that MTS is not disclaiming responsibility for the description of the MTS Opinion contained in the proxy statement/prospectus/information statement. Tax Treatment of the Merger, page 113 18. We note your statement s here and elsewhere in the prospectus that the parties intend the first and second merger , taken together, to qualify as a reorganization with the result that Achieve stockholders will not recognize taxable gain or loss for U.S. federal income tax purposes . Please provide a firm conclusion regarding the material federal income tax consequences to investors and file a tax opinion as required by Item 601(b)(8) of Regulation S -K. Additionally, revise the discussion of the tax consequences to clarify that the di scussion is counsel’ s opinion and revise the related disclos ure elsewhere in the prospectus , such as in the “Questions and Answers About the Merger” , to provide a firm conclusion . Please also delete the word “certain” in the phrase “certain material U.S. Federal State tax consequences of the Merger” from the heading in this section. Directors and Executive Officers of OncoGenex Following the Merger, page 123 19. We note that certain officers and directors of both OncoGenex and Achieve will become directors and executive officers of the combined company. Please disclosure whether you have entered into employment agreements with any of these individuals and disclosure the material agreements of those agreements. Please also file the agreements as exhibits to your Form S -4, as applicable. Tax Treatment of CVRs, page 138 20. We note your statement that the issuance and distribution of CVRs could be treated in a variety of ways, including as a taxable dividend, a non -taxable return on capital, or as a distribution of equity in which case holders should not recognize gain or los s. Please tell us your consideration as to whether the issuance and distribution of the CVRs as part of Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 5 the consideration in th e transaction involves material tax con sequences that should be opined upon. To the extent you do not believe an opinion is req uired, please tell us why. If you do provide an opinion, please expand the disclosure under this caption to describe counsel’s opinion and the assumptions upon which the opinion is based , or, if counsel is unable to opine on this issue, please so state and explain why it is not able to opine and the possible outcomes and risks to investors. For reference see Staff Legal Bulletin No. 19 (2011). Summary of Compl eted Apator sen Clinical Trials Summary of Borealis -1 Results —The Randomized Phase 2 Clinical Trial in Patients with Metastatic Bladder Cancer, page 154 21. We note your disclosure regarding increased adverse events at 1000mg dosage of apatorsen in this trial . Please expand your disclosure to list all serious adverse events reported to date and the number of patients who h ave reported such events . Summary of Results of Apatorsen Phase 1 Clinical Trial in Patients with Solid Tumors, page 157 22. We note your disclosure regarding certain adverse and serious adverse events reported . Please expand your disclosure to list all su ch adverse and serious adverse events and the number of patients who have reported such events to the extent not already disclosed . License and Collaboration Agreements, page 158 23. Please expand your disclosure regarding the Ionis and UBC collaboration and license agreement for apatorsen to disclose the royalty term and the amount of milestone payments that the company is obligated to pay for each of the development, regulatory and commercial milestones. Achieve Business The Global Smoking Cessation Market, page 167 24. Please provide the basis for your statement s that Chantix and Zyban are associated with side effects, including abnormal dreams, insomnia and nausea , and that NRTs have been shown to be less effective than prescription drugs. Please also supplementally provide us with copies of the studies showing that there is no a pparent difference in efficacy between cytisine and Chantix. Cystisine Clinical Trials, page 168 25. We note your disclosure regarding certain adverse events reported. Please expand your disclosure to list all such adverse events and the number of patients who have reported such events. Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 6 Achieve’s License and Supply Agreements, page 173 26. Please expand your disclosure regarding the Sopharma and University of Bristol license agreement to explain the significance of the licensed patent under each agreement, including the technology or product to which the patents relate and the patent expiration dates. Please also disclose the royalty term , the amount paid under each of the agreements to date , and the amount of milestones payable under the University of Bristol agreement for each of the clinical development and commercial milestones. Management Following the Merger 2016 Achieve Executive Compensation, page 212 27. For each person who will serve as an executive officer or director of the combined company, please include the information required by Item 18(a)(7) of Form S -4. Certain Relationships and Related Party Transactions Achieve Related -Party Transactions, page 228 28. We note that Achieve agreed to pay Ricanto Limited $41,666 per month for services in 2015 and 2016, but Achieve has not made such payments. Please tell us whether Ricanto Limited has forgiven the amounts owed to him under this agreement and w hether the agreement is still in effect. Description of OncoGenex Capital Stock, page 238 29. We note your statement that the description of capital stock is subject to and qualified in its entirety by OncoGenex ’s certificate of incorporation. It is not appropriate to qualify your disclosure by reference to information that is not included in the prospectus or filed as an exhibit to the registration statement. Please revise accordingly. Comparison of Rights of Holders of OncoGenex Stock and Achieve Stock, page 242 30. We note your statement that t his discussion is qualified in its entirety by reference to the DGCL and the various documents of OncoGenex and Achieve that are referred to in the summaries. It is not appropriate to qualify your disclosure by reference to information that is not include d in the prospectus or filed as an exhibit to the registration statement. Please revise accordingly. Principal Stockholders of OncoGenex , page 246 31. Please provide this information as of the most recent practicable date prior to filing . Scott Cormack OncoGenex Pharmaceuticals, Inc. April 24, 2017 Page 7 Achieve Life Science, Inc. Notes to Consolidated Financial Statements 8. Commitments and Contingencies, page F -55 32. Please expand your disclosure regarding the University of Bristol license agreement to disclose the amount of the license fees tied to specific clinical development and commercialization milestones. Exhibit 99.2 33. We note that MTS Securities disclaims that is comes within the category of persons whose consent is required under Section 7 of the Securities Act of 1933. Please have MTS Securities revise the consent to remove this disclaimer . We remind you that the company and its management a re responsible for the accuracy and adequacy of their disclosures, notwith standing 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 Rolf Sundwall at (202) 551 -3105 or Mark Brunhofer at (202) 551 -3494 if you have questions regarding comments on the financial statements and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special Counsel, at (202) 551 - 3442 with any other questions . Sincerely , /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Robert Free dman Fenwick & West LLP
2016-04-13 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP April 13, 2016 VIA EDGAR U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Bryan J. Pitko Daniel F. Duchovny Re: OncoGenex Pharmaceuticals, Inc. Preliminary Proxy Statement filed on Schedule 14A Filed April 1, 2016 File No. 033-80623 Ladies and Gentlemen: On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), we are submitting this letter and the following information in response to a letter, dated April 8, 2016, from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Preliminary Proxy Statement on Schedule 14A (the “Proxy Statement”) filed on April 1, 2016. We have incorporated your comments into this response letter in bold italics and our responses are set forth below. PREC14A filing made on April 1, 2016 General 1. Please revise the cover page of the proxy statement and form of proxy to clearly identify it as being preliminary. See Rule 14a-6(e)(1) of Regulation 14A. In response to the Staff’s comment, the Company has revised the cover page of the Proxy Statement and form of proxy card to clearly identify them as being preliminary. 2. Please ensure that the approximate date on which the proxy statement and form of proxy are first sent or given to security holders appears on the first page of the proxy. Please refer to Item 1(b) of Schedule 14A and Rule 14a-6(d) of Regulation 14A. The Company respectfully advises the Staff that the last sentence of the second paragraph on page 1 of the Proxy Statement provides the approximate date on which the Proxy Statement and form of proxy are intended to first be sent or given to security holders. The Company has revised page 1 to make this sentence a standalone paragraph and bolded the text to ensure prominence. U.S. Securities and Exchange Commission April 13, 2016 Page 2 Background of the Stockholder Nominations, page 4 3. We note the disclosure stating that your Nominating and Governance Committee and Board of Directors determined not to include any of VCM’s nominees to the Board of Directors at the Annual Meeting “due to the lack of experience, industry knowledge, seniority and pedigree of these individuals to serve on our Board of Directors.” Rule 14a-9 under Regulation 14A requires a reasonable and factual basis for all beliefs, and such beliefs must be clearly characterized as such with the support self-evident, disclosed in proxy materials or provided to the staff as supplemental information. Please provide support for the cited assertion and characterize it and all similar statements as beliefs. In response to the Staff’s comment, the Company has revised page 4 of the Proxy Statement. Additionally, the Company respectfully advises the Staff that the Company’s Nominating and Governance Committee and Board of Directors considered the biographical information provided by VCM Group, LLC (“VCM”) with respect to each of VCM’s nominees. Such biographical information of the VCM nominees reflected no experience with life science companies and limited experience on public company boards of directors. The Company is a clinical-stage oncology company, and its Nominating and Governance Committee and Board of Directors therefore seek director candidates with experience in developing clinical-stage assets and serving on the board of directors of public life science companies. VCM provided no indication that any of their nominees had any formal education or training in biotechnology, and none of their nominees appeared to have any professional experience or training from working at a development stage biopharmaceutical company. The experience of the VCM director nominees consisted primarily of roles at technology companies and investment funds, which the Company’s Nominating and Governance Committee and Board of Directors believe are not relevant to the Company’s business, and would result in significant deficiencies in experience, especially as compared to the Company’s current directors. Additionally, VCM appeared to the Company’s Nominating and Governance Committee and Board of Directors to have purchased a nominal number of shares of the Company’s common stock (less than 0.0008%) solely to propose director nominees, and had no prior contact with the Company or its Board of Directors, nor had it showed any interest in advising the Company with respect to the development of its product candidates. 4. Please revise to indicate whether VCM was entitled to make nominations at the Company’s 2016 annual meeting. If so, please revise to provide the legal basis for excluding VCM’s shareholder nominees from the annual meeting. For example, to the extent that Oncogenex determined that VCM’s submission failed to comply with the bylaw provisions for stockholder nomination of directors as described on page 10 or other requirements under state law, please revise the proxy statement to so state and describe the specific deficiencies in VCM’s submission. The Company advises the Staff that VCM, as a stockholder of the Company, is entitled to nominate directors at the Company’s 2016 annual meeting pursuant to Section 2.12 of the Company’s Bylaws. VCM is not, however, entitled under the Company’s bylaws to include its nominees in the Company’s Proxy Statement or require the Company’s Board of Directors to nominate its nominees for election to the Board of Directors. The Company respectfully advises the Staff that it did not intend to exclude VCM’s nominees from the annual meeting, but instead decided not to nominate VCM’s director nominees itself for the reasons described in the Company’s response to Comment 3. VCM may nominate its nominees for election to the Board of Directors by soliciting proxies in accordance with the rules and regulations of the Securities and Exchange Commission. The Company has revised page 4 of the Proxy Statement to clarify its intention. U.S. Securities and Exchange Commission April 13, 2016 Page 3 Expenses, page 4 5. Please revise to include the disclosures required by Items 4(b) and 5(b) of Schedule 14A. In response to the Staff’s comment, the Company respectfully advises the Staff that it does not believe that the solicitation by its Board of Directors is subject to Rule 14a-12(c) of Regulation 14A, and therefore it has provided the disclosure required by Items 4(a) and 5(a) of Schedule 14A as opposed to Items 4(b) and 5(b) of Schedule 14A. In accordance with Rule 14a-12(c) of Regulation 14A, only “solicitations by any person or group of persons for the purpose of opposing a solicitation subject to this regulation by any other person or group of persons with respect to the election or removal of directors at any annual or special meeting of security holders” (emphasis added) are subject to 14a-12(c) of Regulation 14A. To the Company’s knowledge, VCM has not engaged in a “solicitation” as defined under Rule 14a-1(l) of Regulation 14A, and therefore, the Company’s solicitation is not for the purpose of opposing a solicitation by another person or group of persons. Should VCM engage in a “solicitation” as defined under Rule 14a-1(l) of Regulation 14A, the Company would file a revised Proxy Statement containing the information required by Items 4(b) and 5(b) of Schedule 14A. Proposal 1 – Election of Directors, page 11 6. We note the disclosure that if a nominee is unable or declines to serve as a director at the time of the Annual Meeting, the proxies will be voted for any nominee who is designated by the present Board of Directors to fill the vacancy. Please conform this disclosure to the language of Rule 14a-4(c)(5) of Regulation 14A. Please also confirm that should you lawfully identify or nominate substitute nominees before the meeting, you will file an amended proxy statement that (1) identifies the substitute nominees, (2) discloses whether such nominees have consented to being named in the revised proxy statement and to serve if elected and (3) includes the disclosure required by Items 5(b) and 7 of Schedule 14A with respect to such nominees. In response to the Staff’s comment, the Company has revised page 12 of the Proxy Statement to conform the language to Rule 14a-4(c)(5) of Regulation 14A. The Company also confirms to the Staff that should it lawfully identify or nominate substitute nominees before the annual meeting, it will file an amended proxy statement that (i) identifies the substitute nominees, (ii) discloses whether such nominees have consented to being named in the revised proxy statement and to serve if elected and (iii) includes the disclosure required by Items 5(b) and 7 of Schedule 14A with respect to such nominees. * * * In addition, in response to the Staff’s comment letter, the Company acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. U.S. Securities and Exchange Commission April 13, 2016 Page 4 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (206) 389-4559. Sincerely, /s/ James D. Evans James D. Evans cc: OncoGenex Pharmaceuticals, Inc. Scott Cormack, Chief Executive Officer John Bencich, Chief Financial Officer Fenwick & West LLP Alan Smith Amanda Rose
2016-04-11 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
April 8, 2016
Via E -mail
John Bencich
Chief Financial Officer
OncoGenex Pharmaceuticals, Inc.
19820 North Creek Parkway, Suite 201
Bothell, Washington 98011
Re: OncoGenex Pharmaceuticals, Inc.
Preliminary Proxy Statement filed on Schedule 14A
Filed April 1 , 2016
File No. 033-80623
Dear Mr. Bencich :
We have revi ewed the above -captioned filing and have the following comments. Some
of our comments may ask for additional information to be provided so that we may better
understand the disclosure.
Please respond to this letter by amending the filing or by 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 advise us why.
After reviewing any amended filing and any information you provide in response to these
comments, we may have additi onal comments.
PREC14A filing made on April 1 , 2016
General
1. Please revise the cover page of the proxy statement and form of proxy t o clearly identify
it as being preliminary. See Rule 14a -6(e)(1) of Regulation 14 A.
2. Please ensure that the approximate date on which the proxy statement and form of proxy
are first sent or given to security holders appears on the first page of the proxy. Please
refer to Item 1(b) of Schedule 14A and Rule 14a -6(d) of Regulation 14 A.
Background of the Stockholder Nominatio ns, page 4
3. We note the disclosure stating that your Nominating and Governance Committee and
Board of Directors determined not to include any of VCM’s nominees to the Board of
Directors at the Annual Meeting “due to the lack of experience, industry knowledge,
John Bencich
OncoGenex Pharmaceuticals, Inc.
April 8, 2016
Page 2
seniority and pedigree of these individuals to serve on our Board of Directors.” Rule
14a-9 under Regulation 14A requires a reasonable and factual basis for a ll beliefs, and
such beliefs must be clearly characterized as such with the support self -evident, disclosed
in proxy materials or provided to the staff as supplemental information. Please provide
support for the cited assertion and characterize it and all similar state ments as beliefs .
4. Please revise to indicate whether VCM was entitled to make nominations at the
Company’s 2016 annual meeting. If so, please revise to provide the l egal basis for
excluding VCM’s shareholder nominees from the annual meeting . For example , to the
extent that Oncogenix determined that VCM’s submission failed to comply with the
bylaw provisions for stockholder nomination of directors as described on page 10 or
other requirements under state law, please revise the proxy statemen t to so state and
describe the specific deficiencies in VCM’s submission.
Expenses, page 4
5. Please revise to include the disclosures required by Items 4(b) and 5(b) of Schedule 14A.
Proposal 1 – Election of Directors, page 11
6. We note the disclosure that if a nominee is unable or declines to serve as a director at the
time of the Annual Meeting, the proxies will be voted for any nominee who is designated
by the present Board of Directors to fill the vacancy. Please conform this disclosure to
the lang uage of Rule 14a -4(c)(5) of Regulation 14A. Please also confirm that should you
lawfully identify or nominate substitute nominees before the meeting, you will file an
amended proxy statement that (1) identifies the substitute nominees, (2) discloses
wheth er such nominees have consented to being named in the revised proxy statement
and to serve if elected and (3) includes the disclosure required by Items 5(b) and 7 of
Schedule 14A with respect to such nominees.
We urge all persons who are responsible for t he accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the participants in the solicitation are
in possession of all facts relating to the disclosure presented in the above -captioned filing, they
are responsible for the accuracy and adequacy of the disclosures they have made.
In responding to our comments, please provide a written statement from the company
ackno wledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
John Bencich
OncoGenex Pharmaceuticals, Inc.
April 8, 2016
Page 3
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
Please contact me at (202) 551 -3203 or Daniel F. Duchovny, Special Coun sel, at (202)
551-3619 if you have any questions regarding our comments.
Sincerely,
/s/ Bryan J. Pitko
Bryan J. Pitko
Attorney Advisor
Office of Mergers and Acquisitions
cc: Alan Smith
Fenwick & West LLP
2015-11-19 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP November 19, 2015 U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Scot Foley Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed October 29, 2015 File No. 033-207670 Ladies and Gentlemen: On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), we are submitting this letter and the following information in response to a letter, dated November 5, 2015, from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-3 filed with the Commission on October 29, 2015. We have incorporated the Staff’s comment into this response letter in bold italics and our response is set forth below. General 1. We note that you have submitted an application for confidential treatment relating to an exhibit you filed with your quarterly report on Form 10-Q for the quarterly period ended June 30, 2015. Please be advised that we will not be in a position to grant effectiveness to your registration statement until such time as this application has completed processing or is withdrawn. The Company acknowledges the Staff’s comment and respectfully advises the Staff that the confidential treatment order (File No. 033-80623– CF#32888) relating to Exhibit 10.2 to the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2015 was issued on November 19, 2015. * * * U.S. Securities and Exchange Commission November 19, 2015 Page 2 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (206) 389-4559 or, in his absence, Amanda Rose at (206) 389-4553. Sincerely, FENWICK & WEST LLP /s/ James D. Evans James D. Evans cc: John Bencich, OncoGenex Pharmaceuticals, Inc. Alan Smith, Esq., Fenwick & West LLP Amanda Rose, Esq., Fenwick & West LLP
2015-11-19 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm CORRESP ONCOGENEX PHARMACEUTICALS, INC 19820 North Creek Parkway Bothell, Washington 98011 (425) 686-1500 November 19, 2015 Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Scot Foley Division of Corporation Finance Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed October 29, 2015 File No. 333-207670 Via EDGAR - Acceleration Request Requested Date: November 20, 2015 Requested Time: 4:00 p.m. EST Ladies and Gentlemen: OncoGenex Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-referenced Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, ONCOGENEX PHARMACEUTICALS, INC. By: /s/ John Bencich John Bencich Chief Financial Officer
2015-11-05 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Mail Stop 4720 November 5, 2015 Via E -mail John Bencich Chief Financial Officer OncoGenex Pharmaceuticals, Inc. 19820 North Creek Parkway, Suite 201 Bothell, Washington 98011 Re: OncoGenex Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed October 29, 2015 File No. 333-207670 Dear Mr. Bencich : We have limited our review of your registration statement to the issue addressed in our comment. If you do not believe this comment appl ies to your facts and circumstances, please tell us why in a response. After reviewing the information you provide in response to this comment, if any, we may have additional comments. General 1. We note that you ha ve submitted an application for confidential treatment relating to an exhibit you filed with your quarterly report on Form 10 -Q for the quarterly period ended June 30, 2015. Please be advised that we will not be in a position to grant effectiveness to you r registration statement until such time as this application has completed processing or is withdrawn. 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 inform ation 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. John Bencich OncoGenex Pharmaceuticals, Inc. November 5, 2015 Page 2 Notwithstanding our comment, in the event you request accelerat ion of the effective date of the pending registration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact S cot Foley at (202) 551 -3383 or me at (202) 551 -3675 with any other questions. Sincerely, /s/Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Alan Smith James Evans Amanda Rose Fenwick & West LLP 1191 Second Avenue, 10th Floor Seattle, WA 98101
2013-04-15 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
April 15 , 2013 Via E -mail Mr. Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 1522 – 217th Place S.E., Suite 100 Bothell, Washington 98021 Re: OncoGenex Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14A Filed on April 3, 2013 File No. 033-80623 Dear Mr. Cormack: We have comple ted our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal secur ities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules requ ire. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director
2013-04-10 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm SEC Response Letter April 10, 2013 U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Johnny Gharib Jeffrey Riedler Daniel Greenspan Re: OncoGenex Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14A Filed on April 3, 2013 File No. 033-80623 Ladies and Gentlemen: On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), we are submitting this letter and the following information in response to a letter, dated April 9, 2013, from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Preliminary Proxy Statement on Schedule 14A filed on April 3, 2013. We have incorporated your comment into this response letter in bold italics and our response is set forth below. We note proposal 5 where you are seeking approval to increase your number of authorized shares of common stock from 25 million to 50 million shares. Please revise your disclosure to describe any specific plans, arrangements or understandings, whether written or oral, to issue any of the shares of common stock that will be newly available. If you have no such plans, arrangement or understandings, please revise your disclosure to so state. In response to the Staff’s comment, the Company respectfully advises the Staff that it currently has no plans, arrangements or understandings, written or oral, to issue any shares that will be newly available and proposes to add disclosure in the Definitive Proxy Statement on Schedule 14A to be filed with the Commission to include the following disclosure: “At present, our Board of Directors has no immediate plans, arrangements or understandings to issue the additional shares of common stock. However, it desires to have the shares available to provide additional flexibility to use our common stock for business and financial purposes in the future as well to have sufficient shares available to provide appropriate equity incentives for our employees.” * * * U.S. Securities and Exchange Commission April 10, 2013 Page 2 In addition, in response to the Staff’s comment letter, the Company acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (206) 389-4559. Sincerely, FENWICK & WEST LLP /s/ James D. Evans James D. Evans cc: Scott Cormack, OncoGenex Pharmaceuticals, Inc. Alan Smith, Esq., Fenwick & West LLP
2013-04-09 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
April 9 , 2013 Via E -mail Mr. Scott Cormack President and Chief Executive Officer OncoGenex Pharmaceuticals, Inc. 1522 – 217th Place S.E., Suite 100 Bothell, Washington 98021 Re: OncoGenex Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14A Filed on April 3 , 2013 File No. 033-80623 Dear Mr. Cormack : We have limited our review of your preliminary proxy statement to the issue we have addressed in our comment . Please respond to this letter by revising the proxy statement . Where you do not believe our comment applies to your facts and circumstances , please tell us why in your response. After reviewing the information you provide in response to our comment , we may have additional comments. 1. We note proposal 5 where you are seeking approval to increase your number of authorized shares of common stock from 25 million to 50 million shares . Please revise your disclosure to describe any specific plans, arrang ements or understandings, whether written or oral, to issue any of the shares of common stock that will be newly available . If you have no such plans, arrangement or understandings, please revise your disclosure to so state. We urge all persons who are r esponsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and Scott Cormack OncoGenex Pharmaceuticals , Inc. April 9 , 2013 Page 2 the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. You may contac t Johnny Gharib at (202) 551 -3170 , Daniel Greenspan at (202) 551 -3623 or me at (2 02) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director
2010-03-12 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Via Facsimile and U.S. Mail
Mail Stop 4720
March 10, 2010
Stephen Anderson
Chief Financial Officer and Secretary
OncoGenex Pharmaceuticals, Inc.
1522 217
th Place SE, Suite 100
Bothell, WA 98021
Re: OncoGenex Pharmaceuticals, Inc .
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Anderson,
We have completed our review of your Form 10-K and related filings have no
further comments at this time.
Sincerely,
Gus Rodriguez
Accounting Branch Chief
2010-03-03 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
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Correspondence
March 3, 2010
Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
OncoGenex Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Rosenberg,
On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), this letter responds to the
verbal comments of the Staff of the Securities and Exchange Commission (the “Commission”) from our
telephonic correspondence on February 23, 2010 (“Verbal Comments”) relating to the above-referenced
matters. Set forth in italicized print below are the Staff’s comments, as set forth in the Verbal
Comments, followed by the Company’s responses.
Form 10-K for the Fiscal Year Ended December 31, 2008
Notes to Consolidated Financial Statement
Note 9, Income Tax, page 77
1.
Disclose how the reversal of pre-transaction income of $5,310 was determined. In addition,
quantify the amount included in other line items that offset the $5,310.
Response:
The Company will make the following additional disclosures to the Income Tax note disclosure in its
Annual Report on Form 10-K to be filed for the fiscal year ended December 31, 2009:
•
With respect to the line item “Reversal of pre transaction income”, the amount of $5,310
represents the pre-arrangement loss of Sonus of $15,617 multiplied by the US Federal
Statutory tax rate of 34%. Offsetting the $5,310 was $5,310 included in line item “Change
in valuation allowance”.
Definitive Proxy Statement filed on Schedule 14A
2.
Please refer to your response to comment three. Please confirm that you will expand your
disclosure to discuss the material factors and/or achievements that the compensation committee
considered regarding each named executive officer’s individual performance in awarding long-term
incentive awards in next year’s compensation discussion analysis.
Response:
We confirm that we will expand our disclosure in our 2010 compensation discussion and analysis to
discuss the material factors and/or achievements relating to the individual performance of our
named executive officers that were considered by the compensation committee when awarding long-term
incentive awards for each of our named executive officers.
Closing Comments
The Company hereby acknowledges to the Staff of the Commission the following:
•
The Company is responsible for the adequacy and accuracy of the disclosure in the
filing;
•
Staff comments or changes to disclosure in response to Staff comments do not
foreclose the Commission from taking any action with respect to the filings; and
•
The Company may not assert Staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
Very truly yours,
/s/ Cameron Lawrence
Cameron Lawrence,
Principle Financial Officer
cc: Christopher Doerksen, Dorsey & Whitney LLP
2
2010-01-28 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
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Correspondence
OncoGenex Pharmaceuticals, Inc.
1522 217th Place SE, Suite 100
Bothell, WA 98021
January 28, 2010
Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
OncoGenex Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Rosenberg,
On December 23, 2009, OncoGenex Pharmaceuticals, Inc. (the “Company”) submitted a letter (“First Response Letter”)
responding to comments #1 and #3 of the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) set forth in the letter dated December 10, 2009 (“Comment Letter”) relating to the above-referenced
matters. In the First Response Letter, the Company requested an extension until January 31, 2010 to respond to comment
#2 of the Comment Letter. On behalf of the Company, this letter responds to comment #2 of the Comment Letter. Set
forth in italicized print below is comment #2 of the Staff, as set forth in the Comment Letter, followed by the
Company’s response.
Definitive Proxy Statement filed on Schedule 14A
Compensation Discussion and Analysis
2008 Named Executive Officer Compensation
Cash Incentives, page 24
2.
Your Compensation Discussion and Analysis does not provide sufficient disclosure regarding the corporate
objectives used to determine your executive officers’ short-term incentive award. Please provide us with draft
disclosure for your 2010 proxy statement which provides the following:
•
The corporate objectives; and
•
A discussion of how the level of achievement will affect the actual bonuses to be paid.
Please confirm that you will also disclose the achievement of these objectives. To the extent that the
objectives are quantified, the discussion in your proxy statement should also be quantified.
1
To the extent that you are concerned about the release of this information prior to the end of your fiscal
year, you may request confidential treatment pursuant to Rule 83. In order to do this, please file on EDGAR your supplemental response requesting confidential treatment under Rule 83, redacting the
information you argue to be confidential. Please note that only those words, numbers and phrases for which
confidentiality is necessary should be redacted. Further, an unredacted copy of your supplemental response
requesting Rule 83 treatment must be mailed directly to the Staff.
Additionally, please note that in order to keep your performance metrics confidential pursuant to Instruction
4 to Item 402(b) of Regulation S-K, you must submit an analysis supporting your conclusion that you are likely
to suffer competitive harm if the information is disclosed. We are generally only willing to grant
confidential treatment for performance goals if you can demonstrate how the disclosure of these goals will
allow your competitors to discover information about break even points, cost structures relating to specific
products or similarly sensitive information. In these instances, you must submit a detailed analysis,
identifying the competitively harmful information and demonstrating how the information could be harmful to
your company.
Response:
With respect to the Company’s 2009 corporate objectives, the draft disclosure of the Company’s 2010 proxy statement in
respect of the requested matters is as follows:
The Company’s short-term incentive awards program (“STIP”), as it applies to our Named Executive Officers, provides an
annual opportunity to receive a discretionary cash bonus based on performance related to corporate objectives
established by the Board of Directors. Annually, the Compensation Committee (“Committee”) will determine whether the
corporate objectives for that year were achieved. If corporate objectives were not achieved at a 100% level, the
Committee may determine that the corporate objectives were not achieved or, in its sole discretion, may determine that
such objectives were partially achieved. The Committee may award bonuses based on the foregoing determinations or,
after considering market conditions, the financial position of the Company or other factors, the Committee may, in its
sole discretion, determine not to award any bonuses or to award bonuses at less than maximum eligibility.
For 2009, each respective Named Executive Officer was eligible to receive a bonus under the STIP in an amount equal to
the following:
Short-term Incentive
Executive Officer
Award Eligibility
Scott Cormack,
Chief Executive Officer and President
40% of salary
Steve Anderson,
Chief Financial Officer and Secretary
25% of salary
Cindy Jacobs,
Chief Medical Officer/Executive Vice President
30% of salary
For 2009, the corporate objective adopted by the Board of Directors under the terms of the STIP was for the Company to
generate at least $25 million, either directly or through committed funding by a third party, designated to the
advancement of OGX-011. Based on the Company’s capital resources and needs at the time such corporate objective was
adopted, the Board of Directors adopted the objective to satisfy such funding requirements by September 30, 2009.
2
2
In July 2009, the Company completed a financing of common stock that provided the Company with aggregate proceeds of
approximately $9.5 million (the “July Financing”), which extended the Company’s runway and allowed the Committee to
exercise its discretion with respect to the date by which the corporate objective under the STIP needed to be
satisfied.
In December 2009, when making bonus determinations under the STIP, the Committee considered, among other things, the
following factors:
•
the initial deadline to satisfy the corporate objective had been established based on the Company’s
capital resources and needs on the date the corporate objective was established;
•
the Company’s completion of the July Financing extended the Company’s runway and the time available to
the Company to satisfy the corporate objective;
•
the Company was actively engaged in discussions regarding a potential licensing transaction that would
result in proceeds to the Company well in excess of the $25 million goal;
•
the timing of the potential licensing transaction had been affected by a competitive bidding process
for such transaction; and
•
management had presented various non-binding term sheets to the Board of Directors, some of which may
have led to a transaction by the initial deadline set forth in the corporate objective. Upon the
recommendation of management, the Board of Directors resolved to focus on securing a transaction that
would result in greater commitment to an expanded clinical development program in an effort to maximize
long-term shareholder value.
The Committee also determined that if the Company completed a licensing transaction with a third party resulting in at
least $25 million designated to the advancement of OGX-011 (“Licensing Transaction”), such transaction would result in
the satisfaction of the corporate objective established under the STIP. Based on the foregoing considerations, the
Committee ultimately determined that bonuses to the Named Executive Officers under the STIP would be paid in accordance
with the following:
•
100% if the Licensing Transaction was completed no later than the end of 2009;
•
90% if the Licensing Transaction was completed no later than January 31, 2010;
•
50% if the Licensing Transaction was completed no later than the end of the first quarter of 2010; and
•
0% if the Licensing Transaction was completed after the end of the first quarter of 2010.
Prior to the end of 2009, the Company completed a Licensing Transaction resulting in direct or indirect committed
funding designated to the advancement of OGX-011 in excess of the objective of $25 million. Accordingly, the Named
Executive Officers received 100% of the bonus for which they were eligible under the STIP, as follows:
3
3
Actual Short-term
Incentive Award
Executive Officer
(cash bonus)
Scott Cormack,
Chief Executive Officer and President
CDN $138,000
Stephen Anderson,
Chief Financial Officer and Secretary
CDN $52,500
Cindy Jacobs,
Chief Medical Officer/Executive Vice President
U.S. $108,000
Closing Comments
The Company hereby acknowledges to the Staff of the Commission the following:
•
The Company is responsible for the adequacy and accuracy of the disclosure in the filing;
•
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission
from taking any action with respect to the filings; and
•
The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission
or any person under the federal securities laws of the United States.
Very truly yours,
/s/ Stephen Anderson
Stephen Anderson,
Chief Financial Officer
cc:
Christopher Doerksen, Dorsey & Whitney LLP
4
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2010-01-28 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
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Correspondence
OncoGenex Pharmaceuticals, Inc.
1522 217th Place SE, Suite 100
Bothell, WA 98021
January 28, 2010
Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
OncoGenex Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Rosenberg,
On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), this letter responds to the verbal comments of the
Staff of the Securities and Exchange Commission (the “Commission”) from our telephonic correspondence on January 19,
2010 (“Verbal Comments”) relating to the above-referenced matters. Set forth in italicized print below are the Staff’s
comments, as set forth in the Verbal Comment, followed by the Company’s responses.
Form 10-K for the Fiscal Year Ended December 31, 2008
Notes to Consolidated Financial Statement
Note 9, Income Tax, page 77
1.
Please provide us revised disclosure which separately discloses for each period presented the impact of foreign
tax (Canadian) and impact on the DTA/DTL due to the change in statutory rate. In addition, please tell us and
disclose both the statutory tax rate and the applicable Canadian tax rate for each of the three years in the rate
reconciliation. We are still reviewing your response to the first portion of prior comment one that deals with
the line item “Reversal of pre-transaction income.”
1
Response:
The Company will make the following modifications to the Income Tax note disclosure in its Annual Report on Form 10-K
to be filed for the fiscal year ended December 31, 2009:
•
With respect to the line item “Effect of tax rate changes on deferred tax assets and liabilities”, we will
disclose separately the impact of foreign tax (Canadian) and impact on the DTA/DTL due to the change in
statutory rates separately under the line items “Effect of foreign tax (Canadian) rate changes on deferred tax
assets and liabilities” and “Effect of foreign tax rate differences on income”. We will also add the
following disclosure: “For the 2008 and 2007 periods, the Effect of foreign (Canadian) tax rate changes on
deferred tax assets and liabilities was $578,000 and $1,717,000, respectively, while the Effect of foreign tax
rate difference on income was $396,000 and $4,000, respectively.”
•
We will add the following disclosure to the opening paragraph of our rate reconciliation:
“The reconciliation of income tax attributable to operations computed at the statutory tax rate to income tax
expense, using a statutory tax rate of 34% for the year ended December 31, 2008, and 34.12% for the years
ended December 31, 2007 and December 31, 2006 is as follows : 2007 balances have been derived from the audited
financial statements of OncoGenex Technologies Inc., a Canadian corporation (“OncoGenex Technologies”), which
is subject to combined Canadian federal and provincial statutory tax rates for December 31, 2008, 2007, and
2006 of 31%, 34.12%, and 34.12%, respectively. Following the reverse takeover by OncoGenex Technologies of
Sonus Pharmaceuticals, Inc. (which subsequently changed its name to OncoGenex Pharmaceuticals, Inc.) in 2008,
OncoGenex Technologies became a wholly owned subsidiary of the Company, which is a Delaware incorporated
company subject to US Federal Statutory rates of 34% for all three years presented.
•
For the purposes of estimating the tax rate in effect at the time that deferred tax assets and liabilities
are expected to reverse, we use the furthest out available future tax rate in the applicable jurisdictions.
For the years ended December 31, 2008, 2007, and 2006 the future Canadian enacted rates we used were 26%, 27%,
and 31%, respectively, while for the US the future enacted rate we used was 34% for all three periods
presented.”
Closing Comments
The Company hereby acknowledges to the Staff of the Commission the following:
•
The Company is responsible for the adequacy and accuracy of the disclosure in the filing;
•
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission
from taking any action with respect to the filings; and
•
The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or
any person under the federal securities laws of the United States.
Very truly yours,
/s/ Stephen Anderson
Stephen Anderson,
Chief Financial Officer
cc:
Christopher Doerksen, Dorsey & Whitney LLP
2
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2009-12-23 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
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Correspondence
OncoGenex Pharmaceuticals, Inc.
1522 217th Place SE, Suite 100
Bothell, WA 98021
December 23, 2009
Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
OncoGenex Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Rosenberg,
On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), this letter responds to the
comments of the Staff of the Securities and Exchange Commission (the “Commission”) set forth in the
letter dated December 10, 2009 (“Comment Letter”) relating to the above-referenced matters. Set
forth in italicized print below are the Staff’s comments, as set forth in the Comment Letter,
followed by the Company’s responses.
Form 10-K for the Fiscal Year Ended December 31, 2008
Notes to Consolidated Financial Statement
Note 9, Income Tax, page 77
1.
Please revise your disclosure regarding the rate reconciliation to clarify what the line
items “Expenses (income) not deducted (included) for tax purposes,” “Reversal of pre
transaction income” and “Part VI.1 tax” represent and disclose the reasons for significant
fluctuations in these line items from year to year. In addition, disclose the reason for
adjustments in 2007 and 2006 for “effect of tax rate changes on deferred tax assets and
liabilities” as you have only disclosed a tax rate change for 2008 from 34.12% to 34%.
Response:
The Company will make the following modifications to the Income Tax note disclosure in its Annual
Report on Form 10-K to be filed for the fiscal year ended December 31, 2009:
•
With respect to the line item “Expenses (income) not deducted (included) for tax
purposes”, we will provide the following additional disclosure: “The increase in 2008 from 2007 was primarily attributable to amounts recognized in connection with the
reverse takeover by OncoGenex Technologies Inc. of Sonus Pharmaceuticals, Inc. (which
subsequently changed its name to OncoGenex Pharmaceuticals, Inc.) (“Sonus”) during 2008
(the “Arrangement”), including facility-related charges and the conversion of redeemable
convertible preferred shares into equity following the Arrangement.”
•
We will revise the line item description “Reversal of pre transaction income” to
read “Reversal of tax effect of income of Sonus prior to the Arrangement”. We will
also provide the following additional disclosure: “This line item represents the
adjustment required to the 2008 tax provision for amounts associated with Sonus during
the portion of the year prior to the Arrangement.”
•
We will revise the line item description “Part VI.1 tax” to read “Canadian Part VI.1
tax on redeemable convertible preferred shares”. We will also provide the following
additional disclosure: “Canadian Part VI.1 tax on redeemable convertible preferred
shares was accrued during each year such shares were outstanding. This tax would have
been payable upon retraction of redeemable convertible preferred shares. These shares
would have been retractable at any time after August 10. 2010. In 2008, subsequent to
the completion of the Arrangement, all convertible redeemable preferred shares were
converted into equity and as a result the associated aggregate tax liability was
reversed.”
•
With respect to the line item “Effect of tax rate changes on deferred tax assets and
liabilities”, we will provide the following additional disclosure: “This item also
includes the impact of Canadian tax rates and changes in those rates. The Company’s
Canadian subsidiary is subject to taxes in Canada at applicable rates in effect in that
jurisdiction.” The statutory tax rate will also be disclosed for each of the three
years in the rate reconciliation.
Definitive Proxy Statement filed on Schedule 14A
Compensation Discussion and Analysis
2008 Named Executive Officer Compensation
Cash Incentives, page 24
2.
Your Compensation Discussion and Analysis does not provide sufficient disclosure regarding
the corporate objectives used to determine your executive officers’ short-term incentive
award. Please provide us with draft disclosure for your 2010 proxy statement which provides
the following:
•
The corporate objectives; and
•
A discussion of how the level of achievement will affect the actual bonuses to be
paid.
Please confirm that you will also disclose the achievement of these objectives. To the
extent that the objectives are quantified, the discussion in your proxy statement should
also be quantified.
2
To the extent that you are concerned about the release of this information prior to the end
of your fiscal year, you may request confidential treatment pursuant to Rule 83. In order to
do this, please file on EDGAR your supplemental response requesting confidential treatment
under Rule 83, redacting the information you argue to be confidential. Please note that only
those words, numbers and phrases for which confidentiality is necessary should be redacted.
Further, an unredacted copy of your supplemental response requesting Rule 83 treatment must
be mailed directly to the Staff.
Additionally, please note that in order to keep your performance metrics confidential
pursuant to Instruction 4 to Item 402(b) of Regulation S-K, you must submit an analysis
supporting your conclusion that you are likely to suffer competitive harm if the information
is disclosed. We are generally only willing to grant confidential treatment for performance
goals if you can demonstrate how the disclosure of these goals will allow your competitors
to discover information about break even points, cost structures relating to specific
products or similarly sensitive information. In these instances, you must submit a detailed
analysis, identifying the competitively harmful information and demonstrating how the
information could be harmful to your company.
Response:
The Company’s Board of Directors (the “Board”) and Compensation Committee (“Committee”) have not
yet had sufficient time to evaluate and approve the above-referenced disclosure for the Company’s
2010 proxy statement. The Company’s management will work with the Board and the Committee to be
able to provide such draft disclosure to the Staff as soon as possible. For the foregoing reasons,
we respectfully request an extension until January 31, 2010 to provide the requested response to
question 2 of the Comment Letter.
Long-Term Incentive Awards, page 25
3.
We note your disclosure on page 25 that a component of long-term incentive award
determination is based on individual performance. Your Compensation Discussion and Analysis
does not disclose the individual objectives used to determine the amount of equity granted to
your executive officers. Please provide us with draft disclosure for your 2010 proxy statement
which provides the following:
•
The performance objectives; and
•
A discussion of how the level of achievement will affect the actual amounts of
equity granted.
To the extent that the objectives are quantified, the discussion in your proxy statement
should also be quantified. Please also confirm that you will disclose the level of
achievement of these objectives.
3
Response:
The Board and Committee do not base the determination of long-term incentive awards of the
executive officers upon any specific individual performance objectives. Rather, when evaluating
individual performance, the Board and Committee undertake a subjective determination of the
respective individual’s personal contribution to the successes of the Company and the individual’s
performance of his or her job responsibilities. Because the Board’s and Committee’s evaluations of
the individual performance of the executive officers is based upon their respective subjective
determinations, rather than upon any specific performance objectives, the Company does not believe
the requested disclosure is applicable.
In its 2010 proxy statement, the Company will clarify that the Board and Committee do not base the
determination of long-term incentive awards of the executive officers upon any specific individual
performance objectives.
Closing Comments
The Company hereby acknowledges to the Staff of the Commission the following:
•
The Company is responsible for the adequacy and accuracy of the disclosure in the
filing;
•
Staff comments or changes to disclosure in response to Staff comments do not
foreclose the Commission from taking any action with respect to the filings; and
•
The Company may not assert Staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
Very truly yours,
/s/ Stephen Anderson
Stephen Anderson,
Chief Financial Officer
cc: Christopher Doerksen, Dorsey & Whitney LLP
4
2009-12-10 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Via Facsimile and U.S. Mail
Mail Stop 4720
December 10, 2009
Stephen Anderson
Chief Financial Officer and Secretary
OncoGenex Pharmaceuticals, Inc.
1522 217th Place SE, Suite 100
Bothell, WA 98021
Re: OncoGenex Pharmaceuticals, Inc .
Form 10-K for the Fiscal Year Ended December 31, 2008
Definitive Proxy Statement filed on Schedule 14A
File Number: 033-80623
Dear Mr. Anderson:
We have reviewed your filing and have the following comments. In our
comments, we ask you to provide us with information to better understand your
disclosure. Where our comment requests you to revise disclosure, the information you
provide should show us what the revised disc losure will look like and identify the annual
or quarterly filing, as appli cable, in which you intend to fi rst include it. If you do not
believe that revised disclosure is necessary, explain the reason in your response. After
reviewing the information provided, we may raise additional comments and/or request
that you amend your filings.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-K for the Fiscal Year Ended December 31, 2008
Notes to Consolidated Financial Statement
Note 9. Income Tax, page 77
1. Please revise your disclosure regarding the ra te reconciliation to cl arify what the line
items “Expenses (income) not deducted (inc luded) for tax purpos es, “Reversal of pre
transaction income” and “Part VI.I tax” represent and disclo se the reasons for
significant fluctuations in thes e line items from year to year . In addition, disclose the
reason for adjustments in 2007 and 2006 for “effect of tax rate changes on deferred
Stephen Anderson
OncoGenex Pharmaceuticals, Inc.
December 10, 2009
Page 2
tax assets and liabilities” as you have only disclosed a tax rate change for 2008 from
34.12% to 34%.
Definitive Proxy Statement filed on Schedule 14A
Compensation Discussion and Analysis
2008 Named Executive Officer Compensation
Cash Incentives, page 24
2. Your Compensation Discussion and Analysis does not prov ide sufficient disclosure
regarding the corporate object ives used to determine your executive officers’ short-
term incentive award. Please provide us with draft disclosure for your 2010 proxy
statement which provides the following:
• The corporate objectives; and
• A discussion of how the level of achievement will affect the actual
bonuses to be paid.
Please confirm that you will also disclose th e achievement of these objectives. To the
extent that the objectives are quantifie d, the discussion in your proxy statement
should also be quantified. To the extent that you are concerned about th e release of this information prior to the
end of your fiscal year, you may request c onfidential treatment pursuant to Rule 83.
In order to do this, please file on E DGAR your supplemental response requesting
confidential treatment under Rule 83, redacting the in formation you argue to be
confidential. Please note that only th ose words, numbers and phrases for which
confidentiality is necessary s hould be redacted. Further, an unredacted copy of your
supplemental response requesting Rule 83 trea tment must be mailed directly to the
Staff. Additionally, please note that in order to keep your performance metrics confidential
pursuant to Instruction 4 to Item 402(b) of Regulation S-K you must submit an
analysis supporting your conclusion that you are likely to suffer competitive harm if the information is disclosed. We are gene rally only willing to grant confidential
treatment for performance goals if you can demonstrate how the disclosure of these
goals will allow your competitors to disc over information about break even points,
cost structures relating to specific products or similarly sensitive information. In
these instances, you must submit a detailed analysis, identifying the competitively
harmful information and demonstrating how the information could be harmful to your company.
Stephen Anderson
OncoGenex Pharmaceuticals, Inc.
December 10, 2009
Page 3 Long-Term Incentive Awards, page 25
3. We note your disclosure on page 25 that a component of long-term incentive award
determination is based on individual pe rformance. Your Compensation Discussion
and Analysis does not disclose the individua l objectives used to determine the amount
of equity granted to your executive officers. Please provide us with draft disclosure
for your 2010 proxy statement which provides the following:
• The performance objectives; and
• A discussion of how the level of achievement will affect the actual
amounts of equity granted.
To the extent that the objectives are quan tified, the discussion in your proxy statement
should also be quantified. Please also conf irm that you will disclose the level of
achievement of these objectives.
* * * *
Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response. Pl ease furnish a cover le tter with your response
that keys your response to our comments. De tailed cover letters gr eatly facilitate our
review. Please furnish your letter on EDGAR under the form type label CORRESP.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in
the filing;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filings;
and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any pers on under the federal s ecurities laws of
the United States.
Stephen Anderson
OncoGenex Pharmaceuticals, Inc.
December 10, 2009
Page 4
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact Dana Hartz, Staff Accountant, at (202) 551-3648 or Lisa
Vanjoske, Assistant Chief Accountant, at (202) 551-3614 if you have any questions
regarding the processing of your response as well as any questions regarding comments
on the financial statements and related ma tters. You may contact Rose Zukin, Staff
Attorney, at (202) 551-3239 with questions on any of the other comments. In this regard,
do not hesitate to contact me, at (202) 551-3679.
S i n c e r e l y ,
J i m B . R o s e n b e r g
Senior Assistant Chief
Accountant
2009-07-15 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP 1 filename1.htm Correspondence July 14, 2009 Jeffrey P. Riedler Assistant Director Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-7010 Re: OncoGenex Pharmaceuticals — Registration Statement on Form S-3 (File No. 333-160251) filed on June 26, 2009 Dear Mr. Riedler, OncoGenex Pharmaceuticals, Inc. hereby requests that its Registration Statement on Form S-3 (File 333-160251) be declared effective as of the date and time set forth below, or as soon thereafter as is practicable, unless you are orally notified to the contrary by us prior to such time: Requested date of effectiveness: July 17, 2009 Requested time of effectiveness: 9 A.M. Eastern Standard Time OncoGenex Pharmaceuticals, Inc. hereby acknowledges, in relation to its request for acceleration of the effective date of its pending registration statement, that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please do not hesitate to call Randal R. Jones of Dorsey & Whitney LLP at (206) 903-8800 or the undersigned at (425) 686-1500 with any questions or comments you might have. ONCOGENEX PHARMACEUTICALS, INC. /s/Scott Cormack Scott Cormack President & Chief Executive Officer cc: Randal R. Jones, Dorsey & Whitney LLP 1522 217th Place SE, Suite 100, Bothell, WA 98021 t 425.686-1500 f 425.686-1600 w www.oncogenex.com
2009-07-13 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
Correspondence
OncoGenex Pharmaceuticals, Inc.
1522 217th Place SE, Suite 100
Bothell, WA 98021
July 13, 2009
Jeffrey P. Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-7010
Re: OncoGenex Pharmaceuticals — Registration Statement on Form S-3 (File No. 333-160251)
filed on June 26, 2009
Ladies and Gentlemen,
On behalf of OncoGenex Pharmaceuticals, Inc. (the “Company”), this letter responds to the
comments of the Staff of the Securities and Exchange Commission set forth in the letter dated July
9, 2009 relating to the above-referenced registration statement (the “Form S-3”). On behalf of the
Company, we are filing herewith Amendment No. 1 to the Form S-3 (the “Amendment”).
Set forth in italicized print below are the Staff’s comments, as set forth in the July 9, 2009
comment letter, followed by the Company’s responses.
Incorporation by reference of Form 8-K filed on 06/26/09
1. We note that you have not incorporated by reference your Form 8-K filed after filing of
this registration statement on June 26, 2009. Because your Form 8-K filed during the waiting period
for your registration statement to become effective, a statement specifically incorporating this
Form 8-K was required in your disclosure on page 9. Pursuant to Securities Act Forms Compliance and
Disclosure Interpretations 123.05, “if a registration statement does not specifically incorporate
reports filed during the waiting period, a pre-effective amendment would be required to
incorporate” it. Therefore, please file a pre-effective amendment to incorporate your Form 8-K into
your registration statement.
The Company has amended the Form S-3 to incorporate by reference the above-noted Form 8-K.
Very truly yours,
/S/ Stephen Anderson
Stephen Anderson,
Chief Financial Officer
cc: Randal R. Jones, Dorsey & Whitney LLP
2009-07-09 - UPLOAD - ACHIEVE LIFE SCIENCES, INC.
Mail Stop 4720 July 9, 2009 Stephen Anderson Chief Financial Officer OncoGenex Pharmaceuticals, Inc. 1522 217
th Place SE, Suite 100
Bothell, Washington 98021
Re: OncoGenex Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed June 26, 2009
File No. 333-160251
Dear Mr. Anderson: We have limited our review of your filing to those issues we have addressed in
our comments. After any issues that arise during our examination of the request have
been satisfied, we will consider your request for acceleration of the effective date of the
registration statement. Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Incorporation by reference of Form 8-K filed on 06/26/09
1. We note that you have not incorporated by reference your Form 8-K filed after the
filing of this registrati on statement on June 26, 2009. Because your Form 8-K was
filed during the waiting period for your regi stration statement to become effective,
a statement specifically incorporating this Form 8-K was required in your
disclosure on page 9. Pursuant to Securities Act Forms Compliance and
Disclosure Interpretations 123.05, “if a regi stration statement does not specifically
incorporate reports filed during the wait ing period, a pre-effective amendment
would be required to incorporate” it. Th erefore, please file a pre-effective
amendment to incorporate your Form 8- K into your registration statement.
Stephen Anderson
OncoGenex Pharmaceuticals Inc. July 9, 2009 Page 2
* * *
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have provided all information investors require
for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the ev ent the company requests acceleration of
the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that:
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose th e Commission from taking any action with
respect to the filing;
• the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility
for the adequacy and accuracy of the disclosure in the filing; and
• the company may not assert staff comments a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing. We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement. We will act on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 460 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date.
Stephen Anderson
OncoGenex Pharmaceuticals Inc. July 9, 2009 Page 3
Please contact Michael McGowan at (202) 551-5797 or me at (202) 551-3715
with any questions.
S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Randall R. Jones & Christopher L. Doerksen Dorsey & Whitney LLP U.S. Bank Center 1420 Fifth Avenue, Suite 3400 Seattle, WA 98101-4010 (206) 903-8800
2009-06-26 - CORRESP - ACHIEVE LIFE SCIENCES, INC.
CORRESP
1
filename1.htm
Correspondence
RANDAL R. JONES
(206) 903-8814
FAX (206) 903-8820
JONES.RANDAL@DORSEY.COM
June 26, 2009
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-7010
Re: OncoGenex Pharmaceuticals — Registration Statement on Form S-3 (File No. 333-160251)
filed on June 26, 2009
Dear Sir or Madam,
In connection with the Registration Statement on Form S-3 (file no. 333-160251) filed on June
26, 2009 by OncoGenex Pharmaceuticals, Inc., we are furnishing the correspondence attached as
Exhibit A required under National Instrument 71-101.
Very truly yours,
/s/ Randal R. Jones
Randal R. Jones
EXHIBIT A
NOTICE OF FILING PURSUANT TO NATIONAL INSTRUMENT 71-101
The Multijurisdictional Disclosure System
TO:
British Columbia Securities Commission
AND TO:
The United States Securities and Exchange Commission
RE:
OncoGenex Pharmaceuticals, Inc. (the “Company”)
The Company has today filed a preliminary MJDS prospectus dated June 26, 2009, pursuant to National
Instrument 71-101, The Multijurisdictional Disclosure System (“NI 71-101”), and designates the
British Columbia as the principal jurisdiction in Canada.
DATED June 26, 2009.
ONCOGENEX PHARMACEUTICALS, INC.
/s/ Scott Cormack
Scott Cormack
President and Chief Executive Officer
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