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SEC Comment Letters
Company Responses
Letter Text
CytoDyn Inc.
Response Received
2 company response(s)
High - file number match
↓
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-09-17
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2024-06-10
CytoDyn Inc.
Summary
Generating summary...
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Company responded
2024-06-12
CytoDyn Inc.
References: June 7, 2024
Summary
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Company responded
2024-06-20
CytoDyn Inc.
References: June 7, 2024
Summary
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CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-13
CytoDyn Inc.
Summary
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CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-06-26
CytoDyn Inc.
Summary
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CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-09-21
CytoDyn Inc.
Summary
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CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-29
CytoDyn Inc.
Summary
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CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-14
CytoDyn Inc.
References: August 24, 2021
Summary
Generating summary...
CytoDyn Inc.
Response Received
12 company response(s)
High - file number match
SEC wrote to company
2006-09-06
CytoDyn Inc.
Summary
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↓
Company responded
2006-11-02
CytoDyn Inc.
References: June 30, 2006 | October 10, 2006
Summary
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Company responded
2011-02-04
CytoDyn Inc.
References: January 25, 2011
Summary
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Company responded
2014-07-14
CytoDyn Inc.
References: July 10, 2014
Summary
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Company responded
2014-07-14
CytoDyn Inc.
References: July 10, 2014 | July 11, 2014
Summary
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Company responded
2021-03-23
CytoDyn Inc.
References: February 18, 2021
Summary
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Company responded
2021-05-07
CytoDyn Inc.
References: April 16, 2021 | February 18, 2021
Summary
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Company responded
2021-05-21
CytoDyn Inc.
References: February 18, 2021 | May 19, 2021
Summary
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Company responded
2021-05-24
CytoDyn Inc.
References: May 24, 2021
Summary
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Company responded
2021-10-05
CytoDyn Inc.
References: September 14, 2021 | September 3, 2021
Summary
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CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-10-06
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-08-31
CytoDyn Inc.
Summary
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CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-09-14
CytoDyn Inc.
References: September 3, 2021
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-08-24
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-08-03
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-06-08
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-05-24
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-05-19
CytoDyn Inc.
References: February 18, 2021
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-04-16
CytoDyn Inc.
References: February 18,
2021
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-02-18
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-01-21
CytoDyn Inc.
Summary
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↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-12-29
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-09-23
CytoDyn Inc.
Summary
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CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-02-04
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2019-09-13
CytoDyn Inc.
Summary
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↓
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CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-09-26
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-02-05
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-10-11
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-10-05
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-09-17
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-05-08
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-03-30
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-03-19
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-03-02
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2018-02-06
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2016-09-07
CytoDyn Inc.
Summary
Generating summary...
↓
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-10-11
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-02-12
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-09-21
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2015-09-03
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-06-16
CytoDyn Inc.
Summary
Generating summary...
↓
CytoDyn Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-07-14
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-07-11
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2013-11-22
CytoDyn Inc.
Summary
Generating summary...
↓
↓
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-02-16
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-01-25
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-10-23
CytoDyn Inc.
Summary
Generating summary...
CytoDyn Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-10-10
CytoDyn Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-19 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2025-08-18 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2025-07-31 | SEC Comment Letter | CytoDyn Inc. | DE | 333-288970 | Read Filing View |
| 2024-09-26 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-09-17 | SEC Comment Letter | CytoDyn Inc. | DE | 333-282000 | Read Filing View |
| 2024-06-28 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-12 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-10 | SEC Comment Letter | CytoDyn Inc. | DE | 005-79349 | Read Filing View |
| 2024-02-15 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-02-13 | SEC Comment Letter | CytoDyn Inc. | DE | 333-276912 | Read Filing View |
| 2023-07-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2023-06-26 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-09-28 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-08-29 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-09-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-31 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-24 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-03 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-06-08 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-19 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-07 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-04-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-02-18 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-01-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-01-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-12-29 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-12-29 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-05-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-02-04 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-27 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-13 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-10-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-10-05 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-09-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-09-17 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-05-08 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-30 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-19 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-02 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-02-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-02-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-10-19 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-10-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-09-08 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-09-07 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-02-12 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-02-12 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-10-01 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-08 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-03 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-01 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-06-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-02-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-02-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2013-11-22 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-02-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-01-25 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-11-02 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-10-23 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-10-10 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-09-07 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-09-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-31 | SEC Comment Letter | CytoDyn Inc. | DE | 333-288970 | Read Filing View |
| 2024-09-17 | SEC Comment Letter | CytoDyn Inc. | DE | 333-282000 | Read Filing View |
| 2024-06-10 | SEC Comment Letter | CytoDyn Inc. | DE | 005-79349 | Read Filing View |
| 2024-02-13 | SEC Comment Letter | CytoDyn Inc. | DE | 333-276912 | Read Filing View |
| 2023-06-26 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-09-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-08-29 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-09-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-31 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-24 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-08-03 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-06-08 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-19 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-04-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-02-18 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-01-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-12-29 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-02-04 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-13 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-02-05 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-10-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-10-05 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-09-17 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-05-08 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-30 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-19 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-02 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-02-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-10-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-09-07 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-02-12 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-21 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-03 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-06-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-11 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2013-11-22 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-02-16 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-01-25 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-10-23 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-10-10 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-09-06 | SEC Comment Letter | CytoDyn Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-19 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2025-08-18 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-09-26 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-28 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-06-12 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2024-02-15 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2023-07-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-09-28 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-05-07 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2021-01-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-12-29 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2020-05-06 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-27 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-26 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-09-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-09-24 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-21 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-03-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2018-02-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-10-19 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-09-08 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2016-02-12 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-10-01 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-08 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2015-09-01 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-07-14 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-02-05 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2014-02-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-11-02 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
| 2006-09-07 | Company Response | CytoDyn Inc. | DE | N/A | Read Filing View |
2025-08-19 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm August 19, 2025 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Alan Campbell Re: CytoDyn Inc. Registration Statement on Form S-3 File No. 333-288970 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-3 filed on July 25, 2025 (Registration No. 333-288970) (the “Registration Statement”) so that the Registration Statement shall become effective at 9 am Eastern Time on August 21, 2025, or as soon as possible thereafter. The Company also requests that its letter requesting effectiveness at 8 am submitted on August 18, 2025, be withdrawn. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, /s/ Robert Hoffman Robert E. Hoffman Chief Financial Officer
2025-08-18 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm August 18, 2025 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Alan Campbell Re: CytoDyn Inc. Registration Statement on Form S-3 File No. 333-288970 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-3 filed on July 25, 2025 (Registration No. 333-288970) (the “Registration Statement”) so that the Registration Statement shall become effective at 8 am Eastern Time on August 21, 2025, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, /s/ Robert Hoffman Robert E. Hoffman Chief Financial Officer
2025-07-31 - UPLOAD - CytoDyn Inc. File: 333-288970
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 31, 2025 Robert Hoffman Chief Financial Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, WA 98660 Re: CytoDyn Inc. Registration Statement on Form S-3 Filed July 25, 2025 File No. 333-288970 Dear Robert Hoffman: 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: Mary Ann Frantz </TEXT> </DOCUMENT>
2024-09-26 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CYTODYN INC. September 26, 2024 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Chris Edwards Re:CytoDyn Inc. Registration Statement on Form S-1 File No. 333-282000 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-1 filed on September 9, 2024 (File No. 333-282000) (the “Registration Statement”) so that the Registration Statement shall become effective at noon Eastern Time on October 1, 2024, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, CYTODYN INC. By: /s/ Mitchell Cohen____ Mitchell Cohen Interim Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2024-09-17 - UPLOAD - CytoDyn Inc. File: 333-282000
September 17, 2024
Mitchell Cohen
Interim Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-1
Filed September 9, 2024
File No. 333-282000
Dear Mitchell Cohen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Mary Ann Frantz
2024-06-28 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Mary Ann Frantz maryann.frantz@millernash.com 503.205.2552 (direct) June 28, 2024 Via EDGAR Office of Mergers & Acquisitions Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Perry Hindin Subject: CytoDyn Inc. Schedule TO-I/A filed June 20, 2024 File No. 005-79349 Ladies and Gentlemen: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the oral comments received on June 21, 2024 (the “Oral Comments”), from Perry Hindin with the Office of Mergers & Acquisitions of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Schedule TO-I filed on June 3, 2024, as amended by Amendment No. 1 to Schedule TO filed on June 20, 2024 (together, the “Schedule TO”), in connection with the Company’s offer to amend and exercise certain warrants of the Company (the “Exercise Offer”). For ease of reference, set forth below in bold are a summary of the comments of the staff of the Commission (the “Staff”) with respect to the Schedule TO, as stated in the Oral Comments. The Company’s response is set forth below each comment. Concurrently with the filing of this response letter to the Commission as CORRESP on EDGAR, the Company is filing Amendment No. 2 to the Schedule TO (“Amendment No. 2”) and has caused the dissemination of a copy of Amendment No. 2 to holders of all Original Warrants. In addition to addressing comments raised by the Commission in the Oral Comments, the Company, as described in Amendment No. 2, has revised the Exercise Offer to incorporate by reference the Company’s Current Report on Form 8-K filed with the Commission on June 28, 2024. The Company has authorized us to respond to the Oral Comments as follows: US Bancorp Tower | 111 SW Fifth Ave, Ste 3400 | Portland, OR 97204 2 Division of Corporation Finance June 28, 2024 Page 2 Schedule TO-I/A filed June 20, 2024 1.We note that the disclosure in the section entitled “Description of the Exercise Offer” includes the following statement: “The Original Warrants represent 75% of our outstanding warrants. The balance of our outstanding warrants generally have different, and primarily lower, exercise prices.” Given the use of the word “generally,” we refer the Registrant to Exchange Act Rule 13e-4(f)(8)(i), which states that no issuer or affiliate shall make a tender offer unless the tender offer is open to all security holders of the class of securities subject to the tender offer. Please confirm via written response that the balance of warrants referred to therein represents different classes of warrants than the classes currently subject to the Exercise Offer. Response to Comment #1 The Company confirms that the outstanding warrants that are not subject to the Exercise Offer represent classes of warrants with different exercise prices than the classes currently subject to the Exercise Offer. 2.We note that the disclosure in the section entitled “Conditions to the Exercise Offer” includes the following condition: “There will have been threatened or instituted or be pending any action, proceeding or litigation seeking to enjoin, make illegal or delay completion of the Exercise Offer or otherwise relating in any manner, to the Exercise Offer”. We refer the Registrant to Compliance and Disclosure Interpretation 101.01 of the Commission’s Tender Offer Rules and Schedules, which states that a tender offer may be subject to conditions only where the conditions are based upon objective criteria and otherwise not within the offeror’s control, and whether or not each condition has been triggered should be objectively verifiable. Please revise the condition in the referenced disclosure so that it is objectively determinable. Response to Comment #2 The referenced disclosure has been revised in Amendment No. 2 as follows (with new language in bold): “There will have been threatened in writing or instituted or be pending any action, proceeding or litigation seeking to enjoin, make illegal or delay completion of the Exercise Offer or otherwise relating in any manner, to the Exercise Offer”. 3 Division of Corporation Finance June 28, 2024 Page 3 3.We note that the disclosure in the section entitled “Conditions to the Exercise Offer” includes the following condition: “any general suspension of trading in, or limitation on prices for, our shares of common stock in an over the-counter market in the United States”. We refer the Registrant again to Compliance and Disclosure Interpretation 101.01 of the Commission’s Tender Offer Rules and Schedules. Please revise the condition to include an explanation of what is considered a limitation on prices for securities in an over-the-counter market in the United States. Response to Comment #3 The referenced disclosure has been revised in Amendment No. 2 as follows (with deleted language in strike-through): “any general suspension of trading in, or limitation on prices for, our shares of common stock in an over the-counter market in the United States”. If you have any questions with respect to the foregoing responses, please feel free to call me at (503) 205-2552. Very truly yours, /s/ Mary Ann Frantz
2024-06-20 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Mary Ann Frantz maryann.frantz@millernash.com 503.205.2552 (direct) June 20, 2024 Via EDGAR Office of Mergers & Acquisitions Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Perry Hindin Subject: CytoDyn Inc. Schedule TO-I filed June 3, 2024 File No. 005-79349 Ladies and Gentlemen: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter dated June 7, 2024 (the “Comment Letter”), from Perry Hindin with the Office of Mergers & Acquisitions of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Schedule TO-I filed on June 3, 2024 (the “Schedule TO”), in connection with the Company’s offer to amend and exercise certain warrants of the Company (the “Exercise Offer”). For ease of reference, set forth below in bold are the comments of the staff of the Commission (the “Staff”) with respect to the Schedule TO, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Concurrently with the filing of this response letter to the Commission as CORRESP on EDGAR, the Company is filing Amendment No. 1 to the Schedule TO (“Amendment No. 1”). Also concurrently with the submission of this response letter, the Company has distributed revised materials for the Exercise Offer to holders of all Original Warrants listed in Amendment No. 1, including a copy of Amendment No. 1 and Exhibits (a)(1)(E), (a(1)(F) (including the Acceptance and Exercise Documents referenced in Comment #5 below), and (a)(1)(G). In addition to addressing comments raised by the Commission in the Comment Letter, the Company, as described in Amendment No. 1, has revised the Exercise Offer to, among other things: (i) include three additional tranches of outstanding warrants to purchase shares of the Company’s common stock at exercise prices of $0.21, $0.35, and $0.37 per share, respectively; (ii) to provide for an exercise price for the Amended Warrants of $0.09387 per share; and (iii) as US Bancorp Tower | 111 SW Fifth Ave, Ste 3400 | Portland, OR 97204 2 Division of Corporation Finance June 20, 2024 Page 2 a further inducement to holders to participate in the Exercise Offer and exercise the Amended Warrants, to provide for participating holders to receive shares of common stock equal to an additional 20% of the number of shares issuable upon exercise of the tendered warrants (the “Additional Shares”), without the payment of any additional consideration. Amendment No. 1 also reflects the addition of two risk factors related to the Additional Shares. With the inclusion of the three additional tranches of warrants, the Exercise Offer has been revised to provide for an Expiration Time of 12:01 a.m. Eastern Time on July 19, 2024, which is 20 full business days from the filing of Amendment No. 1. All holders of Original Warrants, other than the holder of Original Warrants with an exercise price of $0.37 per share, previously received, on June 3, 2024, copies of Exhibits (a)(1)(A), (a)(1)(B), (a)(1)(C), and (a)(1)(D) to the Schedule TO, together with the Acceptance and Exercise Documents referenced in Comment #5 below. Following the filing of the Schedule TO, the holder of Original Warrants with an exercise price of $0.37 per share asked to be allowed to participate in the Exercise Offer, and the Company agreed to accommodate his request. Accordingly, concurrently with the submission of this response letter, copies of the documents listed in the third paragraph of this letter, as well as a copy of the original offer document filed as Exhibit (a)(1)(B) to the Schedule TO, were distributed to the additional holder. The Company has authorized us to respond to the Comment Letter as follows: Schedule TO-I filed June 3, 2024 General 1.We note that the Exercise Offer commenced on June 3, and is currently set to expire at 5:00 P.M. eastern time on June 28, 2024. Please revise to ensure that the Exercise Offer is open for a full twenty business days. Please note that June 19, 2024, is a federal holiday. In addition, please note the definition of “business day” in Exchange Act Rule 13e-4(f)(3) when establishing the specific time of day that the Exercise Offer will expire. Refer to Exchange Act Rule 14e-1(a) and Rule 13e-4(f)(i). Response to Comment #1 3 Division of Corporation Finance June 20, 2024 Page 3 As noted above, the Exercise Offer has been revised to provide for an Expiration Time of 12:01 a.m. Eastern Time on July 19, 2024, which is 20 full business days from the filing of Amendment No. 1. 2.Refer to the current pricing mechanism of the Exercise Offer. It appears that holders of Original Warrants will not know the exercise price of the Amended Warrants prior to the Expiration Date in contravention of Exchange Act Rule 14e-1(b) and Rule 13e- 4(f)(1)(ii). Please revise the pricing disclosure accordingly. Response to Comment #2 As noted above, the terms of the Exercise Offer have been revised to provide for an exercise price for the Amended Warrants of $0.09387 per share, which is 70% of the closing price of the Company’s common stock on June 14, 2024. 3.Please revise the disclosure to include a definition of the term “VWAP.” Response to Comment #3 Following the amendment of the exercise price of the Amended Warrants as discussed in the Company’s response to Comment #2, the concept of VWAP is no longer used in the Exercise Offer. 4.Please revise the pricing disclosure to quantify “the closing price on May 31, 2024.” Response to Comment #4 As noted in the response to comment #2, the exercise price has been revised to be $0.09387 per share. Important Procedures, page i 5.Disclosure references “Acceptance and Exercise Documents” but no such documents are included as exhibits to the Exercise Offer. Please amend to include such documents for staff review and confirm that such documents were disseminated to holders of Original Warrants on June 3, 2024. Also describe in your response how such documents were disseminated. Please provide evidence of such dissemination. 4 Division of Corporation Finance June 20, 2024 Page 4 Response to Comment #5 As noted above, the Acceptance and Exercise Documents were distributed by email by Paulson Investment Company, LLC, the Soliciting Agent for the Exercise Offer, with Exhibit (a)(1)(C) to all holders of the Original Warrants, other than the holder of warrants with an exercise price of $0.37 per share. Exhibits (a)(1)(A), (a)(1)(C), and (a)(1)(D), revised to reflect the amended terms of the Exercise Offer, have been filed as Exhibits (a)(1)(E) (Letter to Holders of Original Warrants), (a)(1)(F) (Form of Election to Participate and Exercise, together with the Acceptance and Exercise Documents as revised to reflect the amended terms of the Exercise Offer), and (a)(1)(G) (Form of Notice of Withdrawal) to Amendment No. 1, and copies have been distributed by email to all holders of Original Warrants concurrently with the filing of Amendment No. 1. Section 6. Conditions to the Exercise Offer, page 28 6.Disclosure in this section indicates that “[i]f you are unable to establish that you are an accredited investor, you will not be able to participate in the Exercise Offer.” While the Company may establish conditions to the Exercise Offer as a whole and terminate the Exercise Offer if such conditions are not satisfied, the above requirement appears to serve to exclude a particular holder or subset of holders in contravention of Exchange Act Rule 13e-4(f)(8)(i). Please revise. Response to Comment #6 In response to the Staff’s comment, the Company has revised Section 6. “Conditions to the Exercise Offer” of the Offer to Amend and Exercise, as set forth in Amendment No. 1, to clarify that, while the Company requires holders of Original Warrants to complete an Accredited Investor Questionnaire, holders of Original Warrants will not be required to be accredited investors in order to participate in the Exercise Offer. The clarification also provides that, in the event that the Company receives a completed Accredited Investor Questionnaire from any holder of Original Warrants that desires to participate in the Exercise Offer indicating that such holder is no longer an accredited investor, the Company will file (as part of a subsequent amendment to its Schedule TO) and distribute to all holders of Original Warrants supplemental disclosure, which will include all of the information required by Rule 502 of Regulation D. In such a circumstance, the Company will extend the Expiration Time of the Exercise Offer to the extent required under the Securities Exchange Act of 1934, and the rules of the Commission thereunder. 5 Division of Corporation Finance June 20, 2024 Page 5 It should be noted that, based on prior representations, the Company anticipates that each of the holders of the Original Warrants are currently accredited investors, and that the Exercise Offer will qualify for an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506(b) of Regulation D promulgated thereunder. 7.Disclosure in this section indicates that “…if we determine, after reviewing the representations and warranties and Accredited Investor Questionnaires of all participating warrant holders, that a valid exemption is not available from the registration requirements of applicable federal and/or state securities laws, then we may determine that it is necessary to cancel the Exercise Offer in its entirety, and not to consummate any of the contemplated transactions.” A tender offer may be conditioned on a variety of events and circumstances provided that they are not within the direct or indirect control of the offeror. The conditions also must be drafted with sufficient specificity to allow for objective verification that the conditions have been satisfied. Refer to Question 101.01 of the Tender Offer Rules and Schedules Compliance and Disclosure Interpretations (March 17, 2023). Please revise to provide additional detail as to what factors the Company will consider in making its determination to ensure that the condition is objectively determinable. Response to Comment #7 We have revised the language in Section 6. “Conditions to the Exercise Offer”, as set forth in Amendment No. 1, to read as follows: “If we determine, after reviewing the representations and warranties and Accredited Investor Questionnaires of all participating warrant holders and consulting with knowledgeable counsel, that a valid exemption is not available from the registration requirements of applicable federal and/or state securities laws and that it is necessary to cancel the Exercise Offer in order to comply with the requirements of applicable securities laws, we will cancel the Exercise Offer in its entirety, and not consummate any of the contemplated transactions. In that case, all exercise payments previously received would be promptly returned to participating warrant holders, along with all Original Warrants, unexercised and outstanding pursuant to their original terms.” Thus, the only factor that the Company will consider in making its determination that the Exercise Offer must be canceled is whether the cancellation is required in order to comply with applicable securities laws, in consultation with knowledgeable counsel. 6 Division of Corporation Finance June 20, 2024 Page 6 Section 7. Extension of the Exercise Offer Period, page 29 8.Disclosure in this section states that “[w]e also may terminate the Exercise Offer in our sole discretion if the closing price of the common stock is below $0.16 on June 28, 2024.” Refer to the pricing disclosure on page 26. As currently written, it appears that the pricing is formulated to provide holders with warrants having an exercise price of $0.16 or lower (“…but in no event higher than the closing price on May 31, 2024…). Refer to our preceding comment regarding the direct or indirect control of the offeror. Such condition gives rise to illusory offer concerns under Section 14(e) of the Exchange Act and Regulation 14E thereunder. Please revise. Response to Comment #8 As noted in the Company’s response to Comment #2 above, the exercise price of the Amended Warrants has been fixed at $0.09387 per share. The Company has no discretion to terminate the Exercise Offer based on the exercise price of the Amended Warrants. If you have any questions with respect to the foregoing responses, please feel free to call me at (503) 205-2552. Very truly yours, /s/ Mary Ann Frantz
2024-06-12 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Mary Ann Frantz maryann.frantz@millernash.com 503.205.2552 (direct) June 12, 2024 VIA EDGAR Office of Mergers & Acquisitions Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Perry Hindin Subject: CytoDyn Inc. Schedule TO-I filed June 3, 2024 File No. 005-79349 Ladies and Gentlemen: On behalf of CytoDyn Inc. (the “Company”), we are providing certain additional information discussed with Perry Hindin with the Office of Mergers & Acquisitions (the “Office”) of the Division of Corporation Finance (the “Division”) of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Schedule TO-I filed on June 3, 2024 (the “Schedule TO-I”), in connection with the Company’s offer to amend and exercise certain warrants to purchase shares of the Company’s common stock (the “Tender Offer”). As discussed with Mr. Hindin, the Company plans to respond early next week to the comments set forth in the Office’s letter dated June 7, 2024 (the “Letter”), regarding the Tender Offer and to file an Amendment No. 1 to Schedule TO-I (the “Amendment”) making certain revisions that will be described in the responses. Before filing the Amendment, the Company wishes to advise the Office of the Company’s plans to amend the Tender Offer to include two additional tranches of outstanding warrants to purchase shares of the Company’s common stock. Specifically, the original terms of the Tender Offer in the Schedule TO-I related to four tranches of outstanding warrants with exercise prices of $0.306, $0.45, $0.50, and $1.00 per share (the “Original Warrants”). The two additional tranches of outstanding warrants have exercise prices of $0.21 and $0.35 per share (the “Additional Warrants”). In response to certain comments in the Letter, the Company also intends to amend the exercise price of Original Warrants and Additional Warrants tendered in the Tender Offer to be equal to 70% of the closing price for the Company’s common stock on June 14, 2024 (the “Amended Exercise Price”). As a further inducement to holders of Original and Additional Warrants to participate in the Tender Offer, participating holders will also receive shares of common stock US Bancorp Tower | 111 SW Fifth Ave, Ste 3400 | Portland, OR 97204 2 Division of Corporation Finance June 12, 2024 Page 2 equal to an additional 20% of the number of shares issuable upon exercise of the tendered warrants, without the payment of any consideration other than the Amended Exercise Price. In light of the changes in the tranches of warrants that will be accepted in the Tender Offer and in the exercise price to be applied to both the Original and Additional Warrants, as well as the additional shares of common stock to be issued to holders of Original and Additional Warrants who choose to participate in the Tender Offer, the Company intends to extend the expiration date of the Tender Offer such that it will remain open for at least 10 business days from the date that the material changes in the tender offer materials are distributed to the holders of Original and Additional Warrants. It is important to note that every holder of Additional Warrants, as well as every holder of Original Warrants, previously received copies of the documents comprising the Tender Offer on June 3, 2024. The documents were distributed by email, and in some cases also by U.S. First Class Mail. The amendments to the Tender Offer materials will also be distributed by email to every holder of Original Warrants or Additional Warrants. It should also be noted that Paulson Investment Company, LLC, is acting as Soliciting Agent in the Tender Offer and will receive a fee equal to 13% of the total cash exercise price paid by holders of Original and Additional Warrants who participate in the Tender Offer, and is thereby motivated to assure that every holder of Original or Additional Warrants is fully apprised of the revised terms for the Tender Offer. If the Office has any concerns regarding the information provided in this letter, we respectfully request the opportunity to discuss those concerns at your earliest convenience. Very truly yours, /s/ Mary Ann Frantz
2024-06-10 - UPLOAD - CytoDyn Inc. File: 005-79349
United States securities and exchange commission logo
June 7, 2024
Tyler Blok, Esq.
Executive Vice President of Legal Affairs
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Schedule TO-I filed June 3, 2024
File No. 005-79349
Dear Tyler Blok:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Schedule TO-I filed June 3, 2024
General
1.We note that the Exercise Offer commenced on June 3, and is currently set to expire at
5:00 P.M. eastern time on June 28, 2024. Please revise to ensure that the Exercise Offer
is open for a full twenty business days. Please note that June 19, 2024, is a federal
holiday. In addition, please note the definition of “business day” in Exchange Act Rule
13e-4(f)(3) when establishing the specific time of day that the Exercise Offer will expire.
Refer to Exchange Act Rule 14e-1(a) and Rule 13e-4(f)(i).
2.Refer to the current pricing mechanism of the Exercise Offer. It appears that holders of
Original Warrants will not know the exercise price of the Amended Warrants prior to the
Expiration Date in contravention of Exchange Act Rule 14e-1(b) and Rule 13e-
4(f)(1)(ii). Please revise the pricing disclosure accordingly.
3.Please revise the disclosure to include a definition of the term “VWAP.”
4.Please revise the pricing disclosure to quantify “the closing price on May 31, 2024.”
FirstName LastNameTyler Blok, Esq.
Comapany NameCytoDyn Inc.
June 7, 2024 Page 2
FirstName LastNameTyler Blok, Esq.
CytoDyn Inc.
June 7, 2024
Page 2
Important Procedures, page i
5.Disclosure references “Acceptance and Exercise Documents” but no such documents are
included as exhibits to the Exercise Offer. Please amend to include such documents for
staff review and confirm that such documents were disseminated to holders of Original
Warrants on June 3, 2024. Also describe in your response how such documents were
disseminated. Please provide evidence of such dissemination.
Section 6. Conditions to the Exercise Offer, page 28
6.Disclosure in this section indicates that “[i]f you are unable to establish that you are an
accredited investor, you will not be able to participate in the Exercise Offer.” While the
Company may establish conditions to the Exercise Offer as a whole and terminate the
Exercise Offer if such conditions are not satisfied, the above requirement appears to serve
to exclude a particular holder or subset of holders in contravention of Exchange Act Rule
13e-4(f)(8)(i). Please revise.
7.Disclosure in this section indicates that “…if we determine, after reviewing the
representations and warranties and Accredited Investor Questionnaires of all participating
warrant holders, that a valid exemption is not available from the registration requirements
of applicable federal and/or state securities laws, then we may determine that it is
necessary to cancel the Exercise Offer in its entirety, and not to consummate any of the
contemplated transactions.” A tender offer may be conditioned on a variety of events and
circumstances provided that they are not within the direct or indirect control of the offeror.
The conditions also must be drafted with sufficient specificity to allow for objective
verification that the conditions have been satisfied. Refer to Question 101.01 of the
Tender Offer Rules and Schedules Compliance and Disclosure Interpretations (March 17,
2023). Please revise to provide additional detail as to what factors the Company will
consider in making its determination to ensure that the condition is objectively
determinable.
Section 7. Extension of the Exercise Offer Period, page 29
8.Disclosure in this section states that “[w]e also may terminate the Exercise Offer in our
sole discretion if the closing price of the common stock is below $0.16 on June 28,
2024.” Refer to the pricing disclosure on page 26. As currently written, it appears that
the pricing is formulated to provide holders with warrants having an exercise price of
$0.16 or lower (“…but in no event higher than the closing price on May 31, 2024…).
Refer to our preceding comment regarding the direct or indirect control of the offeror.
Such condition gives rise to illusory offer concerns under Section 14(e) of the Exchange
Act and Regulation 14E thereunder. Please revise.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
FirstName LastNameTyler Blok, Esq.
Comapany NameCytoDyn Inc.
June 7, 2024 Page 3
FirstName LastName
Tyler Blok, Esq.
CytoDyn Inc.
June 7, 2024
Page 3
Please direct any questions to Perry Hindin at 202-551-3444.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
cc: Mary Ann Frantz
2024-02-15 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CYTODYN INC. February 15, 2024 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Alan Campbell Re:CytoDyn Inc. Registration Statement on Form S-1 File No. 333-276912 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-1 filed on February 7, 2024 (File No. 333-276912) (the “Registration Statement”) so that the Registration Statement shall become effective at noon Eastern Time on February 21, 2024, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, CYTODYN INC. By: /s/ Mitchell Cohen____ Mitchell Cohen Interim Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2024-02-13 - UPLOAD - CytoDyn Inc. File: 333-276912
United States securities and exchange commission logo
February 13, 2024
Mitchell Cohen
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-1
Filed February 7, 2024
File No. 333-276912
Dear Mitchell Cohen:
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: Mary Ann Frantz
2023-07-06 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CYTODYN INC. July 6, 2023 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Tim Buchmiller Re:CytoDyn Inc. Registration Statement on Form S-1 File No. 333-272815 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-1 filed on June 21, 2023 (File No. 333-272815) (the “Registration Statement”) so that the Registration Statement shall become effective at 5 pm Eastern Time on July 10, 2023, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, CYTODYN INC. By: /s/ Antonio Migliarese____ Antonio Migliarese Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2023-06-26 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
June 26, 2023
Antonio Migliarese
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-1
Filed June 21, 2023
File No. 333-272815
Dear Antonio Migliarese:
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: Mary Ann Frantz, Esq.
2022-09-28 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CYTODYN INC. September 28, 2022 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Tyler Howes Re: CytoDyn Inc. Registration Statement on Form S-3 File No. 333-267426 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-3 filed on September 14, 2022 (File No. 333-267426) (the “Registration Statement”) so that the Registration Statement shall become effective at 5 pm Eastern Time on September 30, 2022, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 205-2552, or the undersigned at (360) 980-8524. Thank you. Very truly yours, CYTODYN INC. By: /s/ Antonio Migliarese Antonio Migliarese Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2022-09-21 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
September 21, 2022
Antonio Migliarese
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed September 14, 2022
File No. 333-267426
Dear Mr. Migliarese:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Mary Ann Frantz, Esq.
2022-08-30 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CYTODYN INC. August 30, 2022 VIA EDGAR Office of Life Sciences Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Alan Campbell Re: CytoDyn Inc. Registration Statement on Form S-3 File No. 333-267030 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-3 filed on August 23, 2022 (File No. 333-267030) (the “Registration Statement”) so that the Registration Statement shall become effective at 9 am Eastern Time on September 2, 2022, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 880-0278, or the undersigned at (360) 980-8524. Thank you. Very truly yours, CYTODYN INC. By: /s/ Antonio Migliarese Antonio Migliarese Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2022-08-29 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
August 29, 2022
Antonio Migliarese
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed August 23, 2022
File No. 333-267030
Dear Mr. Migliarese:
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: Mary Ann Frantz
2021-12-14 - UPLOAD - CytoDyn Inc.
SIDLEY AUSTIN LLP
787 SEVENTH AVENUE
1501 K STREET, N.W.
WASHINGTON, D.C. 20005
PHONE:+1 202 736 8000
FAX:+1 202 736 8711
+1 202 736 8715
AMERICA • ASIA PACIFIC • EUROPE SVONALTHANN@SIDLEY.COM
September 3, 2021
Via EDGAR
Daniel F. Duchovny
Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549- 3561
Re: CytoDyn Inc.
Soliciting Materials filed pursuant to Rule 14a-12 on August 19, 2021
File No. 000-49908
Dear Mr. Duchovny:
On behalf of our client, CytoDyn Inc. (the “ Company ” or “ CytoDyn ”), set forth below are our responses to
comments received from the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and
Exchange Commission (the “ Commission ”) by letter dated August 24, 2021, with respect to the soliciting materials
filed pursuant to Rule 14a-12 on August 19, 2021, File No. 000-49908 (the “ Soliciting Materials ”).
For your convenience, each response is prefaced by the exact text of the Staff’s corresponding comment in
bold, italicized text.
1. You must avoid issuing statements that directly or indirectly impu gn the character, integrity or personal
reputation or make charges of illegal, improper or immoral conduct without factual foundation. Provide us
supplementally, or disclose, the factual foundation for the statements listed below. In this regard, note that
the factual foundation for such assertion must be reasonable. Refer to Rule 14a-9.
• “…the continued efforts of an activist group led by Paul Rosenbaum and Bruce Patterson …to mislead
shareholders and engage in an unlawful proxy contest to replace a majority of the Company’s Board”
and “its attempt to unlawfully effectuate a hostile takeov er of CytoDyn’s Board.” In this respect, we
note your public statements regarding the purported deficiencies in the dissidents’ submission to the
company: to the extent your reference to an unlawful proxy contest refers to your allegations under
state law, please clarify this in future disclosure.
Daniel F. Duchovny, Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United States Securities and Exchange Commission
September 3, 2021
Page 2
Response :
To the extent we make statements in future filings relating to our allegations under state law, we will
characterize them as such. The reference to “an unlawful proxy contest” set forth above refers to the
totality of violations by the activist group led by Paul Rosenbaum and Bruce Patterson (the “ Activist
Group ”). In addition to its state law violations, we believe the Activist Group has engaged in
numerous violations of federal law ( i.e., the Securities Exchange Act of 1934, as amended (the
“Exchange Act ”), and Regulation 14A promulgated thereunder). These federal law violations are at
issue in the pending litigation brought by CytoDyn in the U.S. District Court for the District of
Delaware (the “District Court ”) in CytoDyn Inc. v. Rosenbaum et al. , 1:21- cv-01139- UNA (D. Del.),
filed August 6, 2021 (the “ Federal Court Litigation”). Please find attached as Exhibit A the
Company’s complaint, dated August 6, 2021 (the “ Complaint ”), and attached as Exhibit B the
Company’s answering brief in opposition to the Activist Group’s motion to dismiss, dated August 19,
2021 (the “ Answering Brief ”); the Complaint and Answering Brief explain in detail the allegations
against the Activist Group. We also attached as Exhibit C the Memorandum Order issued by the
District Court on August 24, 2021 (the “ Court Order”), in which the Court ruled that, even with the
new disclosures made in the Activist Group’s amended preliminary proxy statement, expedited
discovery is nonetheless warranted in the Federal Court Litigation because the Activist Group h as “not
amended their Schedule 13D filing and [the Company] has identified additional purported deficiencies in the revised preliminary proxy statement,” and as Exhibit D , the Stipulated Order entered by the
District Court on September 1, 2021 (the “ Stipul ated Order ”), in which the Activist Group agreed that
prior solicitations were required by Rule 14a-6 to be filed with the SEC and the Court ordered the
Activist Group to comply with the federal securities laws with respect to such solicitations. The Activ ist Group agreed to the Stipulated Order only after the Company informed the group that it
intended to seek a temporary restraining order from the Court regarding email solicitations that had not been filed with the SEC as required.
• the dissidents’ “… filings continue the pattern of selective disclosures, misrepresentations and
falsehoods that have characterized the Group’s efforts to date. The Group’s new disclosures were
intended to retroactively rectify certain violations and omission s we have previously raised – indicating
a tacit admission that the Group previously willfully failed to properly disclose material information to
shareholders.”
Response :
The Federal Court Litigation highlights myriad selective disclosures, misrepresenta tions and
falsehoods contained in the Activist Group’s proxy statement, Schedule 13D filings, and solicitation materials, including but not limited to: (i) Bruce Patterson’s statements on Twitter, in violation of
Rule 14a-12 of the Exchange Act, (ii) Jeffrey Beaty’s anonymous statements as “u/superchet” on
Reddit, in violation of Rule 14a-12 of the Exchange Act, (iii) the failure to disclose
Daniel F. Duchovny, Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United State s Securities and Exchange Commission
September 3, 2021
Page 3
IncellDx’s proposal to be purchased by CytoDyn for $350 million (the “$350M Proposal ”), in
violation of Rule 14a-9 of the Exchange Act, (iv) the failure to disclose Dr. Patterson’s application to
patent certain uses of the Company’s drug Leronlimab as his own (the “ Patterson Patent
Application”), in violation of Rule 14a-9 of the Exchange Act, (v) the failure to disclose
the involvement of former CytoDyn directors, Anthony D. Caracciolo and Richard G. Pestell, M.D., in
the proxy contest, in violation of Rule 14a-9 of the Exchange Act, and (vi) the failure to disclose the
financial backers of CCTV Proxy Group, LLC (“ CCTV”), in violation of Rule 14a-9 of the Exchange
Act. We refer the Staff to the Complaint and the Answering Brief for more details.
On August 13, 2021, several days after CytoDyn filed its complaint in the Federal Court Litigation, the
Activist Group filed a Form DFAN14A disclosing Dr. Patterson’s tweets and Mr. Beaty’s Reddit posts
as soliciting material under Rule 14a-12 of the Exchange Act, as well as an amended preliminary
proxy statement, disclosing the $350M Proposal, the Patterson Patent Application, the involvement of
Messrs. Caracciolo and Pestell in the proxy contest, and the financial backers of CCTV. The Activist Group was clearly aware of this material information prior to filing its initial proxy statement, but chose not to disclose it. In this context, we also refer the Staff to the Court Order and the Stipu lated
Order.
• “Shareholders should be asking themselves what else the Rosenbaum/Patterson Group is seeking to
hide, and what other critical facts they could be withholding that they simply haven’t been forced to
publicly reveal yet?”
Response :
The Company respectfully submits that this statement does not impugn the character, integrity or
personal reputation of the Activist Group without a reasonable factual foundation. Given the Activist Group’s track record of failing to disclose material informat ion to shareholders until an issue is
publicly raised by CytoDyn —including but not limited to the five examples cited in the above
Response —the Company has a reasonable basis for concern that there are further material facts and
disclosures being withheld by the Activist Group, which shareholders have a right to know prior to deciding how to vote in the proxy contest. Again, we refer the Staff to the Complaint and the Answering Brief for more details.
• “The Group indirectly admitted that its initial proxy statement was materially misleading to investors.
As evidence of this, the Group’s proxy filings include over a dozen pages with corrective and new
disclosures.” In this respect, please be sure to provide support for your assertion that the dissident s’
initial proxy statement filing was “materially” misleading.
Daniel F. Duchovny, Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United States Securities and Exchange Commission
September 3, 2021
Page 4
Response :
The Company respectfully submits that the Activist Group’s initial proxy statement was “materially” misleading due to the myriad selective disclosures, misrepresentations and falsehoods that are currently at issue in the Federal Court Litigation. The Compa ny reasonably believes that these alleged
selective disclosures, misrepresentations and falsehoods are materially misleading on an individual
basis and in the aggregate.
We refer the Staff to the Complaint and the Answering Brief for more details as well as the Court
Order and the Stipulated Order.
• “ The Group’s new disclosures reveal the “dark money” funding its hostile takeover attempt.”
Response :
Prior to the start of the Federal Court Litigation, the Activist Group only disclosed that the proxy
contest solicitation expenses will be financed by CCTV, an entity about which nothing was publicly known. Following the filing of the Complaint, the Activist Group amended its preliminary proxy
statement to name the Company shareholders that gifted money to CCTV (the “Gifting Persons ”).
Even in this updated disclosure, certain of the Gifting Persons that are named are non -public entities
whose owners and financial backers remain unknown.
The term “dark money” is commonly utilized to refer to anonymous election campaign contributions
made by donors whose individual identities are not disclosed. This is directly applicable to the
anonymous financial contributions made to CCTV for the purpose of financing the Activist Group’s
director election contest. We believe shareholders deserve to know which individuals are the Activist
Group’s campaign, so that they can properly assess such individuals’ motivations in the context of the
upcoming director election.
We refer the Staff to the Complaint and the Answering Brief for more details as well as the Court Order and the Stipulated Order.
• that “…the Group is implicitly acknowledging that these posts violated federal securities laws.”
Response :
On August 13, 2021, in response to the Federal Court Litigation, th e Activist Group filed a Form
DFAN14A disclosing Dr. Patterson’s tweets and Mr. Beaty’s Reddit posts as soliciting material under
Rule 14a-12 of the Exchange Act. In the DFAN14A filing, the Activist Group stated:
Daniel F. Duchovny, Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United States Securities and Exchange Commission
September 3, 2021
Page 5
“[W]hile the Participants believe that such social media statements do not constitute
solicitations under the Exchange Act and the rules promulgated thereunder and otherwise comply fully with applicable law, in order to moot certain of the Company’s claims, avoid
nuisance and possible expense and delay, and provide additional information to the Company’s
stockholders, the Participants have determined to file certain of Dr. Patterson’s and Mr. Beaty’s
social media statements below as soliciting material under Rule 14a-12 of the Exchange Act.”
Despite this disclaimer, it should be clear to the Activist Group and its legal counsel that the social media posts filed by the Activist Group constituted “solicitations,” which is broadly defined to include communications “rea sonably calculated to result in the procurement, withholding or revocation of a
proxy.” For example, in his tweets, Dr. Patterson directly interacts with shareholders of the Company,
thanking them for their support of the proxy campaign, implying that he w ill be CEO of both CytoDyn
and IncellDx in the future, accusing the Company’s management team of lying, etc. In his Reddit posts, Mr. Beaty refers to the management team as “incompetent and less than truthful,” expresses his
belief that Dr. Patterson shoul d be running the Company’s long hauler trial and that management
needs to be replaced, echoes the sentiments of other Reddit users who support the Activist Group, etc.
Not only are these statements clearly intended to influence the votes of CytoDyn shareho lders, but
many of these statements were made in July and August —well after Messrs. Patterson and Beaty
became Schedule 13D filers associated with the public proxy campaign of the Activist Group.
Moreover, if the Activist Group actually believed in its stated position that the “social media
statements do not constitute solicitations under the Exchange Act and the rules promulgated thereunder,” it likely would not have made the DFAN14A filing, which forced the Activist Group to
reveal the anonymous Reddit pe rsona of Mr. Beaty, who is a moderator of the CYDY Reddit page, and
the twitter handle of Dr. Patterson, who has since stopped tweeting about CytoDyn and the ongoing
proxy contest.
We refer the Staff to the Complaint and the Answering Brief for more detail s as well as the Court
Order and the Stipulated Order.
• that the dissidents are “hiding behind the smokescreen of misleading communications and selective
disclosures.”
Response :
As stated above, the Federal Court Litigation highlights myriad select ive disclosures,
misrepresentations and falsehoods contained in the Activist Group’s proxy statement, Schedule 13D
filings and solicitation materials. Many of these have yet to be resolved despite being brought to the
Activist Group’s attention, and the Co mpany has a reasonable basis for concern that there are
additional misstatements and omissions that have not come to light yet, which means that shareholders do not have all the facts necessary to make informed voting decisions. As such, the Company respectfully submits that it has a reasonable factual basis to alert shareholders that the Activist Group is hiding behind a “smokescreen.” We refer the Staff to the Complaint and the Answering Brief for more details as well as the Court Order and the Stipulated Order.
Daniel F. Duchovny, Special Counsel
Division of Corporation Finance
Office of Mergers and Acquisitions
United States Securities and Exchange Commission
September 3, 2021
Page 6
2. Refer to your statement about the dissidents’ actions being an unlawful attempt to “effectuate a hostile
takeover.” Given that the only apparent way for the dissidents to obtain seats on the board of directors is by
way of a shareholder vote, please revise your disclosure to explain your characterization of the proxy contest
as a “hostile takeover.”
Response :
The term “hostile takeover” is commonly utilized to refer to the merger or acquisition of a company over the objections of such company’s board of directors. In this context, Messrs. Patterson and Beaty have prev iously
attempted to effectuate a merger of IncellDx with CytoDyn, but their $350M Proposal was rejected by the Board. To overcome the objections of the Board, they and their colleagues in the Activist Group have launched a proxy contest to replace the Board. Both Messrs. Patterson and Beaty have also publicly made
statements on Twitter and Reddit, respectively, indicating an intent in replacing the management team of the
Company with Dr. Patterson and likeminded others, who would presumably approve a merger with IncellDx.
3. Please provide us support for your association of “dark money” and (i) a law firm called the Greenan Law
Firm and (ii) a fu
2021-10-06 - UPLOAD - CytoDyn Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
October 1, 2021
By E-Mail
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
787 Seventh Avenue
New York, NY 10019
Re: CytoDyn Inc.
Preliminary Proxy Statement on Schedule 14A
Filed September 24 , 2021
File No. 000 -49908
Dear Mr . Liekefett :
We have reviewed the above -captioned filing, and have the following comments. Some
of our comments may ask for additional information so that we may better understand the
disclosure.
Preliminary Proxy Statement
Background to the Solicitation, page 9
1. Please revise this section to describe the results of the litigation involving Mr. Pestell and
Mr. Caracciolo .
2. Refer to the events of May 22, 2020. This disclosure and disclosure you have made
elsewhere suggest that the dissidents are interested in acquiring the company or hav ing
the company acquire IncellDx . Please balance this disclosure with a reference to the
dissidents ’ own disclosure in their proxy statement that “there is no intention on the part
of the Nominees to pursue any such or similar acquisition transaction with IncellDx if
elected to the Board.”
Payments upon Termination of Employment, Death or Disability, or Change of Control , page 37
3. Please revise this section to c larify whether the election of the dissidents’ nominees
would constitute a change of control under the Employment Agreements and, if so,
quantify the potential payments due to each of Dr. Pourhassan, Dr. Kelly and Dr. Ray .
4. On a related note, disclose wheth er any other company obligations would arise or be
triggered by the election of the dissidents’ nominees and the costs associated with the
satisfaction of those obligations.
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
October 1 , 2021
Page 2
Annex B
5. We note your reference to Mr. Lonsford and your discussion of his status as a participant
in your solicitation . It has also come to our attention that Mr. Lonsford appears to be
acting as a moderator in an online forum relating to the company and that, in this capacity,
he has made soliciting statements. Please provide us wit h a description of Mr. Lonsford’s
soliciting activities, to the extent you are aware of them, and your analysis s upporting your
conclusion that M r. Lonsford is not a participant in your solicitation .
Form of Proxy
6. Please mark your form of proxy as prel iminary.
Please direct any questions to me at (202) 551 -3619.
Sincerely,
/s/ Daniel F. Duchovny
Daniel F. Duchovny
Special Counsel
Office of Mergers and Acquisitions
2021-10-06 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP SIDLEY AUSTIN LLP 787 SEVENTH AVENUE 1501 K STREET, N.W. WASHINGTON, D.C. 20005 PHONE:+1 202 736 8000 FAX:+1 202 736 8711 AMERICA • ASIA PACIFIC • EUROPE +1 202 736 8715 SVONALTHANN@SIDLEY.COM October 6, 2021 Via EDGAR Daniel F. Duchovny Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-3561 Re: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed September 24, 2021 File No. 000-49908 Dear Mr. Duchovny: On behalf of our client, CytoDyn Inc. (the “Company” or “CytoDyn”), set forth below are our responses to comments received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter, dated October 1, 2021, on the preliminary proxy statement (the “Preliminary Proxy Statement”) filed on September 24, 2021, File No. 000-49908. Please note that we have filed an amended preliminary proxy statement today (the “Revised Preliminary Proxy Statement”). For your convenience, each response is prefaced by the exact text of the Staff’s corresponding comment in bold, italicized text. Terms not defined herein shall have the meanings set forth in the Preliminary Proxy Statement. 1. Please revise this section to describe the results of the litigation involving Mr. Pestell and Mr. Caracciolo. Response: The Company acknowledges the Staff’s comment and has included language describing the results of such litigation in the Preliminary Proxy Statement. Please refer to pp. 9-10 of the Revised Preliminary Proxy Statement. Daniel F. Duchovny, Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission October 6, 2021 Page 2 2. Refer to the events of May 22, 2020. This disclosure and disclosure you have made elsewhere suggest that the dissidents are interested in acquiring the company or having the company acquire IncellDx. Please balance this disclosure with a reference to the dissidents’ own disclosure in their proxy statement that “there is no intention on the part of the Nominees to pursue any such or similar acquisition transaction with IncellDx if elected to the Board.” Response: The Company acknowledges the Staff’s comment but respectfully disagrees with the need to add such a reference. During the discovery for the Chancery Court Litigation, the Company discovered substantial evidence indicating the continued interest of IncellDx and its representatives in the proxy contest. As disclosed in today’s hearing of the Chancery Court, this evidence showed IncellDx’s funding of the drafting of the Nomination Notice; the involvement of IncellDx’s chairman in the selection of the director slate; and the financial support of the proxy contest by holders of millions of dollars of IncellDx’s convertible debt. In fact, Messrs. Beaty and Dr. Patterson admitted that IncellDx retained and paid the attorneys that prepared the dissidents’ nomination notice in their recent depositions, which would clearly amount to corporate waste unless IncellDx had an interest in the Nomination Notice and resulting proxy contest. Moreover, in an email exchange sent 10 days after the Nomination Notice was submitted and a mere 39 days before publicly claiming in the dissidents’ definitive proxy statement that “there is no intention on the part of the Nominees to pursue any . . . acquisition transaction with IncellDx,” Dr. Patterson privately stated in an email exchange with other stockholders that the acquisition of IncellDx by the Company “HAS to happen,” further explaining that such a business combination would present the opportunity for “1+1=3”. If desired, we can provide the Staff with a formal transcript of the hearing of the Chancery Court once it becomes available. 3. Please revise this section to clarify whether the election of the dissidents’ nominees would constitute a change of control under the Employment Agreements and, if so, quantify the potential payments due to each of Dr. Pourhassan, Dr. Kelly and Dr. Ray. Response: The Company acknowledges the Staff’s comment and has revised the Preliminary Proxy Statement accordingly. Please refer to pp. 38 of the Revised Preliminary Proxy Statement. 4. On a related note, disclose whether any other company obligations would arise or be triggered by the election of the dissidents’ nominees and the costs associated with the satisfaction of those obligations. Response: The Company acknowledges the Staff’s comment and has revised the Preliminary Proxy Statement to reflect that no additional obligations would arise or be triggered by the election of the dissidents’ nominees. Please refer to pp. 37 of the Revised Preliminary Proxy Statement. Daniel F. Duchovny, Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission October 6, 2021 Page 3 5. We note your reference to Mr. Lonsford and your discussion of his status as a participant in your solicitation. It has also come to our attention that Mr. Lonsford appears to be acting as a moderator in an online forum relating to the company and that, in this capacity, he has made soliciting statements. Please provide us with a description of Mr. Lonsford’s soliciting activities, to the extent you are aware of them, and your analysis supporting your conclusion that Mr. Lonsford is not a participant in your solicitation. Response: Mr. Lonsford is not a participant in the solicitation of proxies for the Company. His work consists of moderating the Company’s Facebook page and disseminating news related to the Company’s business, operations, and results. His posts are unrelated to the proxy contest and amount to nothing more than ordinary course of business public relations work. To the extent any posts shared by Mr. Lonsford may constitute solicitation materials, such posts were made or shared on his own accord without authority from the Company. In fact, the Chief Executive Officer of the Company expressly and repeatedly instructed Mr. Lonsford – in writing – not to make any public statements related to the proxy contest, Schedule 13D group or any related matter. Moreover, the Board never explicitly or implicitly authorized Lonsford to solicit proxies on the company’s behalf. 6. Please mark your form of proxy as preliminary. Response: The Company acknowledges the Staff’s comment and has revised the form of proxy accordingly. * * * * * Please direct any questions that you may have with respect to the foregoing or any requests for supplemental information to me at (212) 839-8744. Very truly yours, /s/ Sara von Althann Sara von Althann
2021-10-05 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP SIDLEY AUSTIN LLP 787 SEVENTH AVENUE 1501 K STREET, N.W. WASHINGTON, D.C. 20005 PHONE:+1 202 736 8000 FAX:+1 202 736 8711 AMERICA • ASIA PACIFIC • EUROPE +1 202 736 8715 SVONALTHANN@SIDLEY.COM October 5, 2021 Via EDGAR Daniel F. Duchovny Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-3561 Re: CytoDyn Inc. Response letter dated September 3, 2021 to comments issued on Soliciting Materials filed pursuant to Rule 14a-12 on August 19, 2021 File No. 000-49908 Dear Mr. Duchovny: On behalf of our client, CytoDyn Inc. (the “Company” or “CytoDyn”), set forth below are our responses to comments received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated September 14, 2021, with respect to the response letter dated September 3, 2021 (the “Response Letter”) to comments issued on soliciting materials filed pursuant to Rule 14a-12 on August 19, 2021, File No. 000-49908. For your convenience, each response is prefaced by the exact text of the Staff’s corresponding comment in bold, italicized text. Terms not defined herein shall have the meanings set forth in the Response Letter. 1. We reissue prior comment 1 as it related to your statement that “…the Group is implicitly acknowledging that these posts violated federal securities laws.” We do not believe you have provided sufficient support for your disclosure. Your response quoted explicit language used by the Group such that your belief as to what is being implied instead is superseded. Response: The Company acknowledges the Staff’s comment and will not use this statement in future communications. Instead, the Company will point to the statement of the Activist Group that it made the public disclosures of Dr. Patterson’s tweets and Mr. Beaty’s Reddit posts “to moot certain of the Company’s claims” in the Federal Court Litigation (as conceded by the Activist Group in its DEFAN14A filing with the Commission on August 13, 2021). Daniel F. Duchovny, Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission October 5, 2021 Page 2 2. We reissue prior comment 2. We do not believe you have provided sufficient support for your disclosure. Your use of the phrase “hostile takeover,” given your response, requires assumptions to be made that are not apparent. Response: The Company acknowledges the Staff’s comment and will not use this statement in future communications without additional support. The Company believes that discovery in the Delaware Chancery Court litigation yielded such additional support for this statement. However, such discovery information is subject to a protective order of the Court. The protective order does not permit the Company to share discovery information unless the Company receives a subpoena or other compulsory process, and then, prior to disclosure, provides notice to the Activist Group with an opportunity to be heard regarding the confidentiality designation. 3. We reissue prior comment 3. To the extent you continue referring to “dark money” as funding the dissidents’ campaign, please include disclosure clarifying whether such funding or related activities appear to violate any proxy solicitation rules. Response: The Company acknowledges the Staff’s comment and will not use this statement in future communications. Instead, the Company will explain that the Activist Group failed to comply with Article I, Section 2 of the Company’s bylaws, which required disclosure of “other stockholders (including beneficial owners) known by any of the Proposing Persons to support such nominations”. 4. We reissue prior comment 4. Similar to our comment immediately above, to the extent you continue referring to Eisenberg Investments as “secretive,” please include disclosure clarifying whether such funding or related activities appear to violate any proxy solicitation rules and describe the efforts you have made to obtain information about Eisenberg Investments. Response: The Company acknowledges the Staff’s comment and will not use this description in future communications. Daniel F. Duchovny, Special Counsel Division of Corporation Finance Office of Mergers and Acquisitions United States Securities and Exchange Commission October 5, 2021 Page 3 5. We reissue prior comment 5. Thus, your response describing a specific chronology of events and your conclusions from such events should be clarified to note that votes or proxies may be revoked until such time as they are counted. Response: The Company acknowledges the Staff’s comment and will clarify such disclosures in future communications by noting that votes or proxies may be revoked until such time as they are counted. The Company respectfully notes that the Activist Group filed an “exit” Schedule 13D on September 17, 2021, dissolving the Schedule 13D group. 6. We reissue prior comment 6. Response: The Company acknowledges the Staff’s comment and will not use this statement in future communications. Instead, the Company will point to the fact that Mr. Beaty attempted to solicit votes on Reddit without filing such solicitations on the first day of use, as legally required. * * * * * Please direct any questions that you may have with respect to the foregoing or any requests for supplemental information to me at (212) 839-8744. Very truly yours, /s/ Sara von Althann Sara von Althann
2021-10-04 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CYTODYN INC. October 4, 2021 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Attention: Jeffrey Gabor Re: CytoDyn Inc. Registration Statement on Form S-3 File No. 333-258944 Request for Acceleration Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, CytoDyn Inc. (the “Company”) hereby respectfully requests acceleration of the effectiveness of the Company’s Registration Statement on Form S-3 filed on August 19, 2021 (File No. 333-258944) (the “Registration Statement”) so that the Registration Statement shall become effective at 11 am Eastern Time on October 6, 2021, or as soon as possible thereafter. We would appreciate notification by telephone of the effective date of the Registration Statement and confirmation of such effectiveness in writing. If you have any questions about the foregoing request, please contact our counsel, Mary Ann Frantz of Miller Nash LLP at (503) 880-0278, or the undersigned at (360) 980-8524. Very truly yours, CYTODYN INC. By: /s/ Antonio Migliarese Antonio Migliarese Chief Financial Officer cc: Mary Ann Frantz, Miller Nash LLP
2021-09-14 - UPLOAD - CytoDyn Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
September 1 4, 2021
By E-Mail
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
787 Seventh Avenue
New York, NY 10019
Re: CytoDyn Inc.
Response letter dated September 3, 2021 to comments issued on Soliciting
Materials filed pursuant to Rule 14a -12 on August 19, 2021
File No. 000 -49908
Dear Mr . Liekefett :
We have reviewed the responses to our comments on the above -captioned filing, an d
have the following comments.
1. We reissue prior comment 1 as it related to your statement that “… the Group is implicitly
acknowledging that these posts violated federal securities laws .” We do not believe you
have provided sufficient support for your disclosure. Your response quoted explicit
language u sed by the Group such that your belief as to what is being implied instead is
superseded .
2. We reissue prior comment 2. We do not believe you have provided sufficient support for
your disclosure. Your use of the phrase “hostile takeover ,” given your response , requires
assumptions to be made that are not apparent.
3. We reissue prior comment 3. To the extent you continue referring to “dark money” as
funding the dissidents’ campaign, please include disclosure clarifying whether such
funding or related activities appear to violate any proxy solicitat ion rules.
4. We reissue prior comment 4. Similar to our comment immediately above, to the extent
you continue referring to Eisenberg Investment s as “secretive, ” please include disclosure
clarifying whether such funding or related activities appear to violate any proxy
solicitation rules and describe the efforts you have made to obtain informatio n about
Eisenberg Investments.
5. We reissue prior comment 5. Thus, your response describing a specific chronology of
events and your conclusions from such events should be clarified to note that votes or
proxies may be revoked until such time as they are counted .
6. We reissue prior comment 6.
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
September 14 , 2021
Page 2
Please direct any questions to me at (202) 551 -3619.
Sincerely,
/s/ Daniel F. Duchovny
Daniel F. Duchovny
Special Counsel
Office of Mergers and Acquisitions
2021-08-31 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
August 31, 2021
Nader Z. Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed August 19, 2021
File No. 333-258944
Dear Dr. Pourhassan:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-08-24 - UPLOAD - CytoDyn Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
August 24, 2021
By E-Mail
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
787 Seventh Avenue
New York, NY 10019
Re: CytoDyn Inc.
Soliciting Materials filed pursuant to Rule 14a -12 on August 19, 2021
File No. 000 -49908
Dear Mr . Liekefett :
We have reviewed the above -captioned filing , and have the following comments. Some
of our comments may ask for additional information so that we may better understand the
disclosure.
Please respond to this letter by amending the filing and/or by providing the requested
information. After revie wing any amendment to the filing and any information provided in reply
to these comments, we may have additional comments. If you do not believe our comments
apply to your facts and circumstances, and/or do not believe an amendment is appropriate, please
tell us why in a written response.
Soliciting Materials
1. You must avoid issuing statements that directly or indirectly impugn the character,
integrity or personal reputation or make charges of ill egal, improper or immoral conduct
without factual foundation. Provide us supplementally, or disclose, the factual foundation
for the statements listed below. In this regard, note that the factual foundation for such
assertion must be reasonable. Refer to R ule 14a -9.
“…the continued efforts of an activist group led by Paul Rosenbaum and Bruce
Patterson …to mislead shareholders and engage in an unlawful proxy contest to
replace a majo rity of the Company’s Board ” and “its attempt to unlawfully
effectuate a hostile takeover of CytoDyn’s Board .” In this respect, we note your
public s tatements regarding the purported deficiencies in the dissidents ’
submission to the company: to the e xtent your reference to an unlawful proxy
contest refers to your allegations under state law , please clarify this in future
disclosure.
the dissidents ’ “…filings continue the pattern of selective disclosures,
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
August 24, 2021
Page 2
misrepresentations and falsehoods that have characterized the Group’s efforts to
date. The Group’s new disclosures were intended to retroactively rectify certain
violations and omissions we have previously raised – indicating a tacit admissio n
that the Group previously willfully failed to properly disclose material
information to shareholders .”
“Shareholders should be asking themselves what else the Rosenbaum/Patterson
Group is seeking to hide, and what other critical facts they could be withhol ding
that they simply haven’t been forced to publicly reveal yet? ”
“ The Group indirectly admitted that its initial proxy statement was
materially misleading to investors. As evidence of this, the Group’s proxy
filings includ e over a dozen pages with corrective and new disclosures. ” In this
respect, please be sure to provide suppo rt for your assertion that the dissidents ’
initial proxy statement filing was “materially ” misleading.
“ The Group’s new disclosures reveal the “dark money” funding its h ostile
takeover attempt. ”
that “…the Group is implicitly ackno wledging that these posts violated federal
securities laws .”
that the dissidents are “hiding behind th e smokescreen of misleading
communications and selective disclosures .”
2. Refer to your statement about the dissident s’ actions being an unlawful attempt to
“effectuate a hostile takeover. ” Given that the only apparent way for the dissidents to
obtain seats o n the board of directors is by way of a shareholder vote, please revise your
disclosure to explain your charac terization of the proxy contest as a “hostile takeover. ”
3. Please provide u s support for your association of “dark money ” and (i) a law firm called
the G reenan Law Firm and (ii) a fund named Eisenberg Investments, LLC. Your
disclosure suggests a negative connotation without clarifying t he basis for such
suggestion.
4. On a related note, provide us support for your characterization of Eisenberg Investment s
as “secretive. ”
5. Refer to the paragraph captioned “The new filings raise further questions about the
motivations and goals of the Rosenbaum/Patterson Group. ” With a view toward
revised disclosure, please explain to us how one statement made by the dissidents ( “We
cannot be certain that the other stockholders named in the Schedule 13D will support the
Nominees ”) renders the other cited statement by dissidents ( “the Group ‘may seek
stockholder representation on the Board, as appropriate, including but not limited to
through the initiation of a proxy contest at the Issuer’s 2021 annual meeting of
stockholders. ’ ”) unclear. It appears that the dissidents are clearly stat ing that while the
Kai H. E. Liekefett , Esq.
Sidley Austin LLP
August 24, 2021
Page 3
individuals named in the Schedule 13D may support a proxy cont est, none of such
individuals have made a commitment to ultimately support the nominees presented by
such group at the annual me eting.
6. With a view toward revised disclosure, please te ll us how you are able to assign a
characterization to the actions allegedly taken by Mr. Bea tty on Reddit as “an attempt to
[illegally solicit votes ] without being identified. ”
7. Please provide us with su pport for your statement that “Dr. Patterson approached the
Company’s management team on several occasions to propose that IncellDx be acquired
by CytoD yn…”
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any r eview, comments, action or absence of action by the staff
Please direct any questions to me at (202) 551 -3619.
Sincerely,
/s/ Daniel F. Duchovny
Daniel F. Duchovny
Special Counsel
Office of Mergers and Acquisitions
2021-08-03 - UPLOAD - CytoDyn Inc.
July 26, 2021
Via E -Mail
Drew G. L. Chapman, Esq.
Baker Botts L.L.P.
30 Rockefeller Plaza
New York, NY 10112
Re: Soliciting Materials filed pursuant to Rule 14a -12
Filed July 1, 2021 by Paul A. Rosenbaum, Jeffrey Paul Beaty, Arthur L.
Wilmes, Thomas J. Errico, M.D., Bruce Patterson, M.D., Peter Staats,
M.D., and Melissa Yeager
SEC File No. 000 -49908
Preliminary Proxy Statement
Filed July 20, 2021 by Paul A. Rosenbaum, et al.
SEC File No. 000 -49908
Dear Mr. Chapman:
The Office of Mergers and Acquisitions has reviewed the filings listed above. Our
comments follow. All defined terms have the same meaning as in your filings.
Please respond to this letter promptly by revising your filings, by providing the requested
information, or by advising us when you will provide the requested response. To the extent we
direct a comment to one of your offers, please consider whether it also applies to your other
offer . Where applicable, please make corresponding changes in both offer documents.
If you do not believe a comment applies to your facts and circumstances or do not believe
amendments are appropriate, please tell us why in your response. After reviewing any
amendments to your filings and the information you provide in response to these comments, we
may have additional comments.
Soliciting Materials filed July 1, 2021
1. Each statement or assertion of opinion or belief must be clearly characterized as such,
and a reasonable factual basis must exist for each such opinion or belief. Support for
opinions or beliefs should be self -evident, disclosed in the proxy statement or provided to
Drew G. L. Chapman, Esq.
Baker Botts L.L.P.
July 26, 2021
Page 2
the staff on a supplemental basis. Provide support for your statement in Point #3 of your
letter to shareholders that the company received an “unusual public rebuke" by the FDA.
Preliminary Proxy Statement
Background to the Solicitation, page 4
2. Please describe the contents of the letters delivered to certain company board members
on April 8 and July 16, 2021.
3. We note your statement in the cover letter that you have attempted to work with company
management. Please revise this section to describe those attempts, including the name of
any current participant involved in those commun ications.
Reason for the Solicitation, page 5
4. Please revise your disclosure to describe how the board and management were
responsible for results of 2020 clinical trials. How were the trials ill -conceived? How is
the FDA’s request to restart a new trial e vidence that the “design and implementation of
CD12 was destined to failure form the start”? How has the company attempted to
circumvent the FDA trial process?
5. Similar to comment 1 above, please provide support for your statements that the FDA has
"repeate dly refused to authorize CYDY -led clinical trials or even authorize
applications…” and that stockholder value has been destroyed and that management and
operational deficiencies are responsible for any such destruction.
Proposal No. 1 Election of Directors, page 7
6. Please revise your disclosure to q uantify in detail the effects of a possible change of
control as described on pages 9 -10.
We remind you that the issuer is responsible for the accuracy and adequacy of its
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact me at (202) 551 -3619 with any questions about these comments.
Sincerely,
/s/ Daniel F. Duchovny
Drew G. L. Chapman, Esq.
Baker Botts L.L.P.
July 26, 2021
Page 3
Daniel F. Duchovny
Special Counsel
Office of Mergers and Acquisitions
2021-06-08 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
June 8, 2021
Antonio Migliarese
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Migliarese:
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
2021-05-24 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
May 24, 2021
Antonio Migliarese
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Migliarese:
We have reviewed your May 21, 2021 response to our comment letter and have the
following comment. In our comment, we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
May 19, 2021 letter.
Form 10-K for the fiscal year ended May 31, 2020
Note 2 -- Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches, page 84
1.We note statements in your proposed disclosure for Item 1 and Note 4 that you believe
leronlimab is safe and effective, as well as language implying the existence of “clinical
data that supports its safety and efficacy.” As safety and efficacy determinations are
within the authority of the U.S. Food and Drug Administration and comparable regulatory
bodies, please revise your proposed disclosure to remove language that states or implies
that you believe leronlimab is safe and effective or that leronlimab is likely to be found
safe and effective.
You may contact Jeanne Baker at 202-551-3691 or Terence O'Brien, Branch Chief, at
202-551-3355 if you have questions.
FirstName LastNameAntonio Migliarese
Comapany NameCytoDyn Inc.
May 24, 2021 Page 2
FirstName LastName
Antonio Migliarese
CytoDyn Inc.
May 24, 2021
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-05-24 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP May 24, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549 Re: CytoDyn Inc. Form 10-K for the fiscal year ended May 31, 2020 File No. 000-49908 Division of Corporation Finance: CytoDyn Inc. (“CytoDyn” or the “Company”) has received your letter dated May 24, 2021 with respect to the limited review by the staff (“Staff”) of the Securities and Exchange Commission (the “Commission”) of the Company’s Form 10-K for the fiscal year ended May 31, 2020. CytoDyn understands the importance of providing accurate and adequate disclosures in its 1934 Act filings and appreciates this feedback from the Staff. For your convenience, the comment from your May 24, 2021 letter is repeated herein, and the Company’s response is set forth immediately following such comment. Form 10-K for the fiscal year ended May 31, 2020 Note 2 — Summary of Significant Accounting Policies Inventories Procured or Produced in Preparation for Product Launches, page 84 1. We note statements in your proposed disclosure for Item 1 and Note 4 that you believe leronlimab is safe and effective, as well as language implying the existence of “clinical data that supports its safety and efficacy.” As safety and efficacy determinations are within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies, please revise your proposed disclosure to remove language that states or implies that you believe leronlimab is safe and effective or that leronlimab is likely to be found safe and effective. RESPONSE: The Company will revise its proposed disclosure to remove language that states or implies that it believes leronlimab is safe and effective or that leronlimab is likely to be found safe and effective. We appreciate your consideration of the response provided herein and look forward to hearing from you regarding any additional comments based upon such response. Please contact me by telephone at 360-980-8524 or by e-mail at amigliarese@cytodyn.com. Very truly yours, /s/ Antonio Migliarese Antonio Migliarese Chief Financial Officer
2021-05-21 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP May 21, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549 Re: CytoDyn Inc. Form 10-K for the fiscal year ended May 31, 2020 File No. 000-49908 Division of Corporation Finance: CytoDyn Inc. (“CytoDyn” or the “Company”) has received your letter dated May 19, 2021 with respect to the limited review by the staff (“Staff”) of the Securities and Exchange Commission (the “Commission”) of the Company’s Form 10-K for the fiscal year ended May 31, 2020. CytoDyn understands the importance of providing accurate and adequate disclosures in its 1934 Act filings and appreciates this feedback from the Staff. For your convenience, the comments from your May 19, 2021 letter are repeated herein, and the Company’s responses are set forth immediately following such comments. Form 10-K for the fiscal year ended May 31, 2020 Note 2 — Summary of Significant Accounting Policies Inventories Procured or Produced in Preparation for Product Launches, page 84 1. We note your response to prior comment 1. Please expand your proposed disclosures to clarify that, due to their RTF letter, the FDA has not yet commenced their review of your BLA, including leronlimab’s safety and efficacy. Ensure you also discuss and update the risks and uncertainties surrounding market acceptance and salability of leronlimab in your future periodic reports. 2. We note your response to prior comment 4 from our letter dated February 18, 2021. Given the significant delays in resubmitting your BLA, please expand your disclosures to provide detailed disaggregated information related to the remaining shelf lives of your inventory. As of each balance sheet date, please quantify the remaining shelf life of your raw materials, finished drug product in vials and bulk drub substance. To the extent material, separately quantify raw material that has a 12 month shelf life from raw materials with longer shelf lives. Please also disclose the point at which inventory may no longer be accepted by potential customers due to limited remaining shelf life. RESPONSE: The Company will expand its future disclosures as of each balance sheet date as follows, for illustration purposes the next report filing period end date of May 31, 2021 is used: U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 2 ITEM 1. BUSINESS. The deficiencies cited by the FDA in its July 2020 Refusal to File letter consisted of administrative deficiencies, omissions, corrections to data presentation and related analyses and clarifications of manufacturing processes. While none of the deficiencies cited by the FDA related to leronlimab’s clinically proven safety and efficacy, or the Company’s ability to manufacture leronlimab at commercial scale consistent with cGMP standards, due to the deficiencies the FDA has not yet commenced their review of our BLA, including the clinical data that supports its safety and efficacy. Management believes, based on the results of our Phase 3 and Phase 2b/3 clinical trials, leronlimab is safe and effective. The Company is working with new consultants to effectively cure the BLA deficiencies and resubmit the BLA by mid-calendar year 2021 or shortly thereafter, in order to allow the FDA to perform their substantive review. ITEM 1A. RISK FACTORS. Risks Related to Our Business. We have capitalized pre-launch inventories prior to receiving FDA marketing approval. If either FDA approval or market acceptance post-approval do not occur at all or on a timely basis prior to shelf-life expiration, the Company will be required to write-off pre-launch inventories which would materially and adversely affect our business, financial condition and stock price. Pre-launch inventories consist of costs of raw materials and work-in-progress related to our product candidate leronlimab, which have been capitalized prior to the date that we anticipate that such product will receive FDA final marketing approval. The BLA resubmission will require updating the previously provided analyses which could result in significant delay in obtaining approval. If FDA approval is significantly delayed, the shelf-life of our pre-launch inventory may be limited, and the salability of our product may be affected. In addition, market acceptance of our product could fall short of our expectations, as a result of the introduction of a competing product, as a result of physicians being unwilling or unable to prescribe leronlimab to their patients, or if our target patient population is reluctant to try leronlimab as a new therapy. If any of these risks were to materialize with respect to our product, or if the launch of such product is significantly postponed, the salability of our pre-launch inventories would be adversely affected and may require write-off of the carrying value of our pre-launch inventories in amounts that could have a material adverse effect on our results of operations and financial condition. ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. Critical Accounting Policies and Estimates. For inventories capitalized prior to FDA marketing approval in preparation of product launch, anticipated future sales, shelf-lives, and expected approval date are considered when evaluating realizability of pre-launch inventories. The shelf-life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventory U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 3 the Company considers the stability data of all inventories. As inventories approach their shelf-life expiration, the Company may perform additional stability testing to determine if the inventory is still viable, which can result in an extension of its shelf-life. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration. We also consider potential delays associated with regulatory approval in determining whether pre-approval inventory remains salable. See Note 4 – Inventories for information regarding the remaining shelf-lives of our pre-launch inventory, by each category of inventory. Although we believe our product will receive market acceptance, the introduction of a competing product could negatively impact the demand for our product and affect the realizability of our inventories. In addition, if physicians are unwilling or unable to prescribe leronlimab to their patients, or the target patient population was reluctant to try leronlimab as a new therapy, the salability of our pre-launch inventory would be adversely affected. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. Note 2 – Summary of Significant Accounting Policies Inventories Procured or Produced in Preparation for Product Launches As inventories approach their shelf-life expiration the Company may perform additional stability testing to determine if the inventory is still viable, which can result in an extension of its shelf-life. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. Note 4 – Inventories The deficiencies cited by the FDA in its July 2020 Refusal to File letter consisted of administrative deficiencies, omissions, corrections to data presentation and related analyses and clarifications of manufacturing processes. While none of the deficiencies cited by the FDA related to leronlimab’s clinically proven safety and efficacy, or the Company’s ability to manufacture leronlimab at commercial scale consistent with cGMP standards, due to the deficiencies the FDA has not yet commenced their review of our BLA, including the clinical data that supports its safety and efficacy. Management believes, based on the results of our Phase 3 and Phase 2b/3 clinical trials, leronlimab is safe and effective. The Company is working with new consultants to effectively cure the BLA deficiencies and resubmit the BLA in order to allow the FDA to perform their substantive review. The Company anticipates when the FDA completes their review, leronlimab will be approved, and we will achieve market acceptance of leronlimab as a treatment for HIV, realizing the amount of pre-launch inventory on-hand, and occurring prior to shelf-life expiration. Accordingly, Management believes the Company will realize future economic benefit in excess of the carrying value of its pre-launch inventory. U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 4 The expiration of remaining shelf-life of the Company’s inventory consists of the following as of May 31, 2021: Expiration period ending May 31, Remaining Shelf-Life Raw materials Work-in-progress bulk drug product Work-in-progress finished drug product in vials Total inventory 2022 12 or less months $ — $ — $ — $ — 2023 12 to 24 months — — — — 2024 24 to 36 months — — — — 2025 36 to 48 months — — — — 2026 48 to 60 months — — — — Thereafter 60 or more months — — — — Total $ — $ — $ — $ — When the remaining shelf-life of inventory is less than xx months, it is likely that it will not be accepted by potential customers. However, as inventories approach their shelf-life expiration the Company may perform additional stability testing to determine if the inventory is still viable which can result in an extension of its shelf-life. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration, which as of May 31, 2021 and May 31, 2020 was ## and ##, respectively. If the Company determines it is not likely shelf-life will be able to be extended or the inventory cannot be sold prior to expiration, the Company will write-down the inventory to its net realizable value. For the fiscal years ended May 31,2021, May 31, 2020, and May 31, 2019, the Company recognized expense related to the write-down of obsolete inventory of ##, ##, and ##, respectively. We appreciate your consideration of the responses provided herein and look forward to hearing from you regarding any additional comments based upon such responses. Please contact me by telephone at 360-980-8524 or by e-mail at amigliarese@cytodyn.com. Very truly yours, /s/ Antonio Migliarese Antonio Migliarese Chief Financial Officer
2021-05-19 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
May 19, 2021
Michael Mulholland
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Mulholland:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the fiscal year ended May 31, 2020
Note 2 -- Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches, page 84
1.We note your response to prior comment 1. Please expand your proposed disclosures
to clarify that, due to their RTF letter, the FDA has not yet commenced their review of
your BLA, including leronlimab's safety and efficacy. Ensure you also discuss and update
the risks and uncertainties surrounding market acceptance and salability of leronlimab in
your future periodic reports.
2.We note your response to prior comment 4 from our letter dated February 18, 2021.
Given the significant delays in resubmitting your BLA, please expand your disclosures to
provide detailed disaggregated information related to the remaining shelf lives of your
inventory. As of each balance sheet date, please quantify the remaining shelf life of your
raw materials, finished drug product in vials and bulk drub substance. To the extent
material, separately quantify raw material that has a 12 month shelf life from raw
materials with longer shelf lives. Please also disclose the point at which inventory may no
FirstName LastNameMichael Mulholland
Comapany NameCytoDyn Inc.
May 19, 2021 Page 2
FirstName LastName
Michael Mulholland
CytoDyn Inc.
May 19, 2021
Page 2
longer be accepted by potential customers due to limited remaining shelf life.
In closing, 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.
You may contact Jeanne Baker at (202) 551-3691 or Terence O'Brien at (202) 551-3355
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-05-07 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP May 7, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549 Re: CytoDyn Inc. Form 10-K for the fiscal year ended May 31, 2020 File No. 000-49908 Division of Corporation Finance: CytoDyn Inc. (“CytoDyn” or the “Company”) has received your letter dated April 16, 2021 with respect to the limited review by the staff (“Staff”) of the Securities and Exchange Commission (the “Commission”) of the Company’s Form 10-K for the fiscal year ended May 31, 2020. CytoDyn understands the importance of providing accurate and adequate disclosures in its 1934 Act filings and appreciates this feedback from the Staff. For your convenience, the comments from your April 16, 2021 letter are repeated herein, and the Company’s responses are set forth immediately following such comments. Financial Statements Note 2 – Summary of Significant Accounting Policies Inventories Procured or Produced in Preparation for Product Launches, page 84 1. We do not believe your response to prior comment 2 from our letter dated February 18, 2021, provides a sufficient basis to support management’s assertion that prelaunch inventory represented an asset at each date it was capitalized. For example: • You assert that your meetings with the FDA addressed safety and efficacy of the drug. However, the FDA’s July 2020 Refusal to File letter states that your Biologics License Application omitted information necessary for the FDA to perform a substantive review of the product’s safety and effectiveness. RESPONSE: To clarify, our pre-BLA meetings with the FDA were about the presentation and analysis in the BLA of data regarding safety and efficacy, rather than the safety or efficacy of leronlimab itself. The safety and efficacy of our drug was determined solely by the results of our clinical trials. The statement in the July 2020 Refusal to File letter (“RTF Letter”) that our BLA was missing certain analyses the FDA needed for its substantive review did not question leronlimab’s clinically proven safety or efficacy or request new data, but asked only that we submit the complete data. The FDA did not request any additional trials or require any new scientific work, and we have not had any conversations or correspondence with the FDA where the FDA has questioned the drug’s clinically proven safety or efficacy. U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 2 Furthermore, in response to your comment, management believes its prelaunch inventory represented an asset at each date it was capitalized primarily for the following reasons: • The Company had successfully completed a Phase 3 clinical trial of leronlimab as a combination therapy for highly treatment experienced HIV patients with a p-value of 0.0032 based on a dosage of 350 mg; • Leronlimab had been administered to over 1,200 patients in 11 clinical trials without any drug-related serious adverse events (“SAE’s”), thus exhibiting a strong safety profile; • Leronlimab also demonstrated safety and efficacy in a concurrent Phase 2b/3 investigative monotherapy trial using up to 700 mg which served as the basis for the FDA supporting a 700 mg dose in the BLA rather than the original 350 mg dose from the Phase 3 clinical trial; • Leronlimab has been successfully manufactured in multiple batches at commercial scale consistent with cGMP standards; and • The RTF Letter focused on presentation and omitted data and did not question the science, leronlimab’s clinically proven safety or efficacy, or of the Company’s proven ability to manufacture leronlimab at commercial scale in full compliance with cGMP standards. In other words, the RTF Letter resulted from the FDA’s conclusions that the Company’s disclosures and presentations in the BLA were deficient, which was the unforeseen result of certain of the Company’s prior regulatory consultants not performing work consistent with professional standards and their representations, including a third party laboratory’s receptor occupancy analysis. In addition, and as noted in our previous letter, we are working with a new group of regulatory consultants to effectively address the deficiencies noted in the RTF Letter, which consisted of: • 57% Administrative Corrections—Approximately 57% of the total comments addressed format errors, missing but available data, inoperable hyperlinks, and missing but available analysis as identified directly in the RTF Letter; • 25% Scientific Clarifications—Approximately 25% of the total comments addressed required clarifications of analytics and assessments, including the revalidation of the receptor occupancy to assist the FDA in its substantive review of the BLA. None of those comments call into question the leronlimab’s clinically proven safety or efficacy. Moreover, the revalidation of the receptor occupancy does not affect the efficacy of the drug, which our trials have proven is effective at either dose; and • 18% Manufacturing Clarifications—Approximately 18% of the total comments addressed clarifications required by the FDA to understand the manufacturing controls used in production, container closure, media fills, labeling and packaging of leronlimab. Therefore, the RTF Letter did not affect management’s assessment of the timing of the recognition of prelaunch inventory as an asset and the Company’s ability to realize future economic benefit in excess of each of the then-current carrying values of prelaunch inventory on the Company’s reported balance sheet dates. U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 3 • You indicate that “…current scientific work being performed by the Company to complete a successful resubmission of the Company’s BLA” is ongoing and that you do not expect to resubmit your BLA until mid-calendar year 2021 or shortly thereafter. RESPONSE: Our March 23, 2021 response letter imprecisely described the receptor occupancy analysis as “current scientific work being performed…” More precisely, the work involves revalidation of previously performed analyses from already available data. This revalidation is now being performed by a leading global healthcare diagnostics company pursuant to cGLP standards. As all the deficiencies cited in the RTF Letter were curable, the Company initially anticipated it would be able to resubmit its BLA by the end of calendar year 2020. Numerous unforeseen events, however, pushed the projected resubmission date until mid-2021 or shortly thereafter. Those events include delays associated with the Company’s unexpected pivot to focus on clinical trials to evaluate leronlimab as a potential therapeutic for COVID-19 (including numerous regulatory filings with many countries) thereby causing a redirection of Company resources, the difficulty of finding and engaging new qualified consultants to assist with the resubmission, and limited availability due to the ongoing COVID-19 pandemic of diagnostics laboratory capacity to revalidate the receptor occupancy analysis pursuant to cGLP standards. Despite these unanticipated delays, as of each reporting period, management believes it appropriately concluded it was, and continues to be, probable the Company will realize future economic benefit in excess of the carrying value of the prelaunch inventory. • You assert that you manufactured leronlimab consistent with cGMP standards. However, we note that the FDA’s September 20, 2020[sic], response to your list of questions related to the Refusal to File letter continued to reference issues with your clinical and statistical data, device related issues, and chemical manufacturing and control related issues. RESPONSE: As noted above, the issues related to clinical and statistical data, and device related issues, are the result of curable presentation issues and omitted data in the submitted BLA. Indeed, many of the noted missing “device related issues” were contained in the original BLA, as confirmed by the FDA in subsequent correspondence. The “chemical, manufacturing and control related issues” were standard FDA review requests which were subsequently resolved post-BLA submission through written communications with the FDA and will be included in the BLA resubmission. These deficiencies and standard FDA review requests did not call into question the science, leronlimab’s clinically proven safety or efficacy, or the Company’s proven ability to manufacture leronlimab at commercial scale in full compliance with cGMP standards. As such, as of each reporting period, management believes it appropriately concluded it was and continues to be probable the Company will realize future economic benefit in excess of the carrying value of the prelaunch inventory. U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 4 We request that management reconsider the appropriateness of its capitalization conclusion in light of the examples above and tell us whether management believes there is any additional information bearing on these examples to support its capitalization conclusion. RESPONSE: The examples cited by the Staff in the April 16, 2021 letter were the result of the Company’s inadequate presentations and omitted data in the BLA and do not reflect any questioning by the FDA of the science, leronlimab’s clinically proven safety or efficacy, or the Company’s proven ability to manufacture leronlimab at commercial scale in full compliance with cGMP standards. The BLA deficiencies were the result of substandard work by certain prior regulatory consultants. The delays in the resubmission of the BLA are related primarily to the Company’s unexpected pivot to focus on COVID-19 clinical trials, engaging new regulatory consultants to effectively address the noted deficiencies and the limited availability of diagnostics laboratory capacity due to the ongoing COVID-19 pandemic. As noted in our previous response dated March 23, 2021, the Company relied on authoritative literature, including CON 6 R. 25 and 26, ASC 330-10-20, ASC 330-10-10-1, ASC 330-10-30-1, and ASC 330-10-35, as well as the following five elements when evaluating its determination whether to capitalize prelaunch inventories for the quarter ended February 29, 2020 and each quarter thereafter: a) the experience and history with regulatory approvals on the part of the management team and the Company’s regulatory consultants; b) the absence of any current or potential threatened or litigation challenges involving the drug; c) the absence of any concerns by regulatory authorities or data to the contrary regarding the drug’s clinically proven safety and efficacy; d) current market factors; e) the estimated timing of anticipated regulatory approval in comparison to the remaining shelf-life of pre-launch inventories. As the Company previously concluded, and giving consideration to the Staff’s examples referenced herein, capitalization was appropriate at February 29, 2020 and, as discussed herein, there have been no changes in circumstances that give reason to revise its capitalization conclusion subsequent to that date. Management’s continuing conclusion that capitalization of prelaunch Inventories is appropriate is further underscored by the Company’s extensive efforts and financial commitments (beginning in April 2019) to achieve commercial readiness upon FDA approval. Each quarter, the Company discloses, in Note 10 to its financial statements, its ongoing and increasing manufacturing commitments to Samsung BioLogics. Please also propose revised disclosure that more fully conveys the points in the examples above. U.S Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Page 5 RESPONSE: The Company proposes adding the following disclosure to convey the points more fully in the example above: The deficiencies cited by the FDA in its July 2020 Refusal to File letter consisted of administrative deficiencies, omissions, corrections to data presentation and related analyses and clarifications of manufacturing processes. None of the deficiencies cited related to the FDA’s questioning the science, leronlimab’s clinically proven safety and efficacy or the Company’s ability to manufacture leronlimab at commercial scale consistent with cGMP standards. Management is working with new regulatory consultants to effectively cure the BLA deficiencies. Accordingly, management continues to believe the Company will realize future economic benefit in excess of the carrying value of its prelaunch inventory. We appreciate your consideration of the responses provided herein and look forward to hearing from you regarding any additional comments based upon such responses. Please contact me by telephone at 360-980-8524 or by e-mail at mmulholland@cytodyn.com. Very truly yours, /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2021-04-16 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
April 16, 2021
Michael Mulholland
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Mulholland:
We have reviewed your March 23, 2021 response to our comment letter and have the
following comment. In our comment, we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
February 18, 2021 letter.
Form 10-K for the Fiscal Year ended May 31, 2020
Financial Statements
Note 2 -- Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches, page 84
1.We do not believe your response to prior comment 2 from our letter dated February 18,
2021, provides a sufficient basis to support management’s assertion that prelaunch
inventory represented an asset at each date it was capitalized. For example:
•You assert that your meetings with the FDA addressed safety and efficacy of the
drug. However, the FDA’s July 2020 Refusal to File letter states that your Biologics
License Application omitted information necessary for the FDA to perform a
substantive review of the product’s safety and effectiveness.
•You indicate that “…current scientific work being performed by the Company to
complete a successful resubmission of the Company’s BLA” is ongoing and that you
FirstName LastNameMichael Mulholland
Comapany NameCytoDyn Inc.
April 16, 2021 Page 2
FirstName LastName
Michael Mulholland
CytoDyn Inc.
April 16, 2021
Page 2
do not expect to resubmit your BLA until mid-calendar year 2021 or shortly
thereafter.
•You assert that you manufactured leronlimab consistent with cGMP standards.
However, we note that the FDA’s September 20, 2020, response to your list of
questions related to the Refusal to File letter continued to reference issues with your
clinical and statistical data, device related issues, and chemical manufacturing and
control related issues.
We request that management reconsider the appropriateness of its capitalization
conclusion in light of the examples above and tell us whether management believes there
is any additional information bearing on these examples to support its capitalization
conclusion. Please also propose revised disclosure that more fully conveys the points in
the examples above.
You may contact Jeanne Baker at 202-551-3691 or Terence O'Brien at 202-551-3355 if
you have questions regarding the comment.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-03-23 - CORRESP - CytoDyn Inc.
CORRESP
1
filename1.htm
CORRESP
March 23, 2021
U.S. Securities and Exchange Commission
Division of Corporation
Finance
Office of Life Sciences
100 F Street N.E.
Washington, DC 20549
Re:
CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31,
2020
File No. 000-49908
Division of Corporate Finance:
CytoDyn Inc.
(“CytoDyn” or the “Company”) has received your letter dated February 18, 2021 with respect to the limited review by the staff (“Staff”) of the Securities and Exchange Commission (the “Commission”) of the
Company’s Form 10-K for the fiscal year ended May 31, 2020. CytoDyn understands the importance of providing accurate and adequate disclosures in its 1934 Act filings and appreciates this feedback
from the Staff. For your convenience, the comments from your February 18, 2021 letter are repeated herein, and the Company’s responses are set forth immediately following such comments.
Form 10-K for the Fiscal Year ended May 31, 2020
Cover Page
1.
You indicated by checkmark that you are an accelerated filer pursuant to the definitions in Rule12b-2 of the Exchange Act. Pursuant to the March 12, 2020 revisions to these definitions, it appears that you are no longer an accelerated filer. Please confirm and ensure that you appropriately identify
your filing status. In this regard, we note that an accelerated filer definition triggers the external auditor attestation requirement over internal control over financial reporting (ICFR) under Section 404(b) of the Sarbanes Oxley Act and you
indicated by checkmark that you did not provide this attestation.
RESPONSE:
The Company had previously determined it was an accelerated filer under the old definition of accelerated filer in Rule
12b-2. Based upon the amendments to the definition contained in Release No. 34-88365, effective April 27, 2020, the Company has determined it is not an
accelerated filer because it is eligible to use the requirements for smaller reporting companies under the revenue test in paragraph (2) of the “smaller reporting company” definition in Rule
12b-2. The Company will correct its filing status on the cover page of subsequent filings.
CytoDyn
Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.799.5954
U.S. Securities and Exchange Commission
Division of Corporation Finance
March 23, 2021
Page
2
Financial Statements
Note 2 – Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches, page 84
2.
We note that you began capitalizing inventories procured or produced in preparation for product launches
during the quarter ended quarter ended February 29, 2020. Tell us the specific point during the FDA approval process that you determined the approval by the FDA was probable. Discuss any contingencies that need to be resolved prior to obtaining
FDA approval. Clarify the nature of any manufacturing, marketing or labeling issues outstanding. Your response should address how you are accounting for your inventory as of May 31, 2020, August 31, 2020 and November 30, 2020 complies
with ASC 330-10-30 as well as paragraph 26 of Concepts Statement 6. Ensure your response also addresses the following:
•
Tell us the dates of, and nature of the results from, meetings with the relevant regulatory authorities prior
to the filing of your regulatory applications. In this regard, we note that you filed the non-clinical portion of your BLA on March 18, 2019 and your CMC portions of the BLA in April and May of 2020, but
that you began to capitalize inventory during your quarter ended February 29, 2020;
•
Explain how the July 2020 Refusal to File Letter you received from the FDA and their refusal to schedule a
Type A meeting impacted your analysis. Explain the nature of the deficiencies raised in the letter and why those deficiencies did not create a material risk or contingency such that the related inventory should no longer qualify for capitalization;
•
Explain the nature of the written responses received from the FDA related to your September 2020 submission.
Explain the nature of additional information required by the FDA in order for you to resubmit the BLA. Address why the FDA’s request for this information did not create a material risk or contingency such that the related inventory should no
longer qualify for capitalization; and
•
Explain why your projected date for resubmitting the BLA keeps slipping. In this regard, in your Form 10-Q for the Quarter ended November 30, 2020, you disclose that you expect to resubmit the BLA in the 1st half of 2021, in your Form 10-Q for the quarter ended
August 31, 2020, you disclose that you anticipate resubmitting the BLA by the end of the 2020 and in Form 10-K for the year ended May 31, 2020, you disclose that you hope to resubmit your BLA as soon
as possible. Address whether your apparent inability to timely resubmit your BLA creates a material risk or contingency such that the related inventory should no longer qualify for capitalization.
RESPONSE:
The Company determined that FDA approval of
leronlimab was probable during the quarter ended February 29, 2020 as a result of Company management, including its regulatory team, confirming that it believed the remaining two components of the Company’s BLA (clinical and CMC) were
nearly complete and the two remaining components would be filed before fiscal year ended May 31, 2020. The Company also took into account the fact that the FDA typically approves a new biologic eight to 12 months after BLA submission; however,
the Company’s drug, leronlimab, has a “fast track” designation, which was expected to potentially accelerate the time to approval. The subsequent receipt of the July 2020 Refusal to File letter (“RTF Letter”) does not create
a material risk or contingency such that the pre-launch inventory no longer qualifies for capitalization.
U.S. Securities and Exchange Commission
Division of Corporation Finance
March 23, 2021
Page
3
Background: Understanding the initial uncharted regulatory path is integral to understanding the delay in
resubmission of the BLA and the current scientific work being performed by the Company to complete a successful resubmission of the Company’s Biologics License Application (“BLA”). The Company’s drug candidate, VyrologixTM, also known as leronlimab (PRO 140), is believed to represent the first monoclonal antibody with weekly subcutaneous dosing to successfully advance as a potential therapy for HIV patients.
Consequently, the trial’s design and the number of patients participating in the trial evolved materially in the early years of the trial as a result of the Company’s ongoing discussions with the FDA. The Phase 3 trial to evaluate
leronlimab’s safety and efficacy for highly treatment experienced HIV patients was commonly referred to as the “Murray design,” in recognition of the guidance provided by Jeffrey Murray, M.D., M.P.H., Deputy Director of the Division
of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research, at the U.S. Food and Drug Administration (“FDA”). The importance of this trial is directed for the benefit of highly treatment experienced HIV patients
because drug resistance develops after years of small molecule therapies for a number of reasons. Once an HIV patient has developed resistance to a certain number of available drug classes (of which there are primarily four available drug classes),
there are no remaining antiviral agents available for treatment, which then leads to AIDS. Due to the challenging nature of enrolling HIV patients in this trial, i.e., concurrent with a patient’s periodic visit with their treating physician to
evaluate a change in the patient’s drug regimen due to the onset of drug resistance, the treating physician offers enrollment in CytoDyn’s Phase 3 trial for leronlimab to be introduced (for one week) and then in combination with a newly
prescribed optimum background drug regimen (for 23 more weeks). The trial was initiated with the objective to enroll 300 patients. As subsequently discussed with the FDA in July 2016, due to the extreme difficulty to enroll the targeted patient, the
enrollment was reduced to 150 patients. Following continued difficulties to enroll, the patient count was reduced to 30 patients in October 2016. Upon completion of enrolling 30 patients, the Company met with the FDA to review the trial’s data.
Due to various complexities of the data from 30 patients, the Company and the FDA agreed in October 2017 to continue patient recruitment in order to reach a total of 50 patients. In February 2018, the Company announced that its Phase 3 trial had
achieved its primary endpoint with a 350 mg weekly dose of leronlimab. Of critical importance, the successful Phase 3 trial evaluated only 50 patients for safety and efficacy. Concurrent with this combination therapy trial, the Company was also
conducting a Phase 2b/3 investigative trial with leronlimab as a monotherapy based upon initial success of a much smaller monotherapy clinical trial. The Phase 2b/3 investigative trial was investigating the cause of viral load failure in certain
patients as compared to the successful viral load suppression in other patients. In the course of this evaluation, a Company key-opinion-leader (“KOL”) recommended evaluating leronlimab dosage at
higher levels of 525 mg and consequently 700 mg. During the pendency of this trial from approximately December 2016 to June 2020, the Company periodically reported the results of viral load suppression at the various dosage levels. In the later
stages of this trial, it became clear that the optimum dosage level was 700 mg, which demonstrated it was over 90% effective in suppressing viral load post-first 10 weeks (the induction period). Following the recommendations of the FDA in December
2018, the Company changed its plan for BLA submission for 350 mg to a BLA submission at 700 mg. Per the FDA’s recommendation, and recognizing the HIV patients in the Phase 3 trial were patients with a critical condition, the Company should use
the most effective dose (700 mg) rather than the 350 mg dose in its BLA. The Company incorporated the safety data from over 500 patients in the Phase 2b/3 investigative trial to augment the safety data from the 50 patients in its Phase 3 trial and
changed the dosage level in its BLA filing from 350 mg to 700 mg. As a consequence to the agreed upon change in dosage levels for the BLA filing, the Company committed to provide to the FDA empirical support for a Dose Justification Report.
U.S. Securities and Exchange Commission
Division of Corporation Finance
March 23, 2021
Page
4
The Company engaged a third-party laboratory to conduct receptor occupancy analyses to demonstrate why the higher dosage was more effective than the 350 mg dose in the successful Phase 3 trial.
This agreed change of dose also required the Company to change its vials of 175 mg to 350 mg of leronlimab, which created a significant delay in the timeline for submitting the CMC (chemistry, manufacturing and control) section of the BLA, because
the new size vials of drug require a stability analysis of at least six months. Note, the original 350 mg dose for the original 175 mg vials had already completed the six-month stability analysis. The Company
submitted the last two sections (clinical and CMC/manufacturing) of the BLA to the FDA in April 2020, and the submission was completed on May 11, 2020.
It was brought to the Company’s attention by the FDA in the RTF Letter that the third party laboratory’s receptor occupancy analysis was not
properly performed. Thereafter, the Company engaged a leading global healthcare diagnostics company, along with an expanded team of subject matter expert consultants, to conduct the receptor occupancy analysis to support the Dose Justification
Report, which is currently contributing to the additional delay in the resubmission of its BLA. Concurrently, the Company is evaluating a traditional pharmacokinetics and pharmacodynamics (“PK/PD”) approach as an alternative to the
receptor occupancy analysis.
Although the Company is required to resubmit its receptor occupancy analyses to demonstrate why the higher dosage was more
effective than the 350 mg dose in the successful Phase 3 trial, based upon the Company’s correspondence and discussions with the FDA, management’s assessment that regulatory approval was probable has not been affected. The FDA’s
requests for additional information and analyses in the RTF Letter and the correction of certain administrative submission deficiencies have been discussed orally and in writing with the FDA, and the Company has an expanded team of subject matter
experts in place working to resolve the deficiencies as quickly as possible in order to resubmit its BLA. The FDA has not requested additional trials nor has the drug’s efficacy or safety been questioned. Of particular significance, the FDA
also offered the Company the opportunity to have a special analysis of the key elements of the BLA for 30 days to ensure the submission of the BLA is successfully filed. As discussed below, the potential and still pending approval, by several
countries, of leronlimab as a therapeutic for critically ill COVID-19 patients diluted limited Company resources, thereby greatly adding to the delayed BLA resubmission.
A summary of the meetings with the FDA prior to the filing of the BLA regulatory applications follows:
Date
Type of Meeting
Purpose
Outcome
June 18, 2018
Type B, Pre-BLA meeting to discuss adequacy of Non-clinical, Clinical and CMC data in support of a planned BLA submission
Discuss adequacy of Non-clinical, Clinical and CMC data in support of a planned BLA submission
FDA reiterated potential review issues that could affect approvability of the BLA, which included, but were not limited to: the appropriateness of the patient population enrolled with respect to eligibility criteria,
the adequacy of the study sample size, the lack of available safety laboratory data during the on-treatment interval and the requirement for full validation data from all PPQ lots at the time of the BLA submission.
December 14, 2018
Teleconference (Requested from FDA)
Follow-up to the Type B, Pre-BLA
meeting held on June 18, 2018, to discuss specific and potential refuse to file issues identified to date to allow for corrective action in
advance of planned BLA submission
FDA briefly reiterated the previous advice provided to CytoDyn regarding outstanding information to be completed prior to submission of BLA, where if not submitted in completed form, would be considered Refuse to File
issues. These include final CMC information, an agreed upon iPSP and final results from a Human Factors study.
August 28, 2019
Teleconference
(Informal)
Discuss Clinical and CMC data required for dose selection
FDA clarified data to support dose selection for HTE MDR patients; CytoDyn to provide FDA with timeline for submission of CMC and Clinical modules; agreement reached on drug stability data.
U.S. Securities and Exchange Commission
Division of Corporation Finance
March 23, 2021
Page
5
We will now address each of the Staff’s questions.
We note that you began capitalizing inventories procured or produced in preparation for product launches during the quarter ended quarter ended
February 29, 2020. Tell us the specific point during the FDA approval process that you determined the approval by the FDA was probable.
RESPONSE:
As noted above, the Company’s Phase 3
trial achieved its primary endpoint in February 2018. Approximately 13 months later, in March 2019, the Company filed the non-clinical portion (the first component of a
3-component BLA). Subsequent to March 2019, the Company incurred both clinical and CMC-related delays, as described above under “Background.” During the
Company’s third fiscal quarter ended Febru
2021-02-18 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
February 18, 2021
Michael Mulholland
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Form 10-K for the Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Mulholland:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comments. In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year ended May 31, 2020
Cover Page
1.You indicated by checkmark that you are an accelerated filer pursuant to the definitions in
Rule12b-2 of the Exchange Act. Pursuant to the March 12, 2020 revisions to these
definitions, it appears that you are no longer an accelerated filer. Please confirm and
ensure that you appropriately identify your filing status. In this regard, we note that an
accelerated filer definition triggers the external auditor attestation requirement over
internal control over financial reporting (ICFR) under Section 404(b) of the Sarbanes
Oxley Act and you indicated by checkmark that you did not provide this attestation.
Financial Statements
Note 2 – Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches , page 84
2.We note that you began capitalizing inventories procured or produced in preparation for
product launches during the quarter ended quarter ended February 29, 2020. Tell us the
FirstName LastNameMichael Mulholland
Comapany NameCytoDyn Inc.
February 18, 2021 Page 2
FirstName LastNameMichael Mulholland
CytoDyn Inc.
February 18, 2021
Page 2
specific point during the FDA approval process that you determined the approval by the
FDA was probable. Discuss any contingencies that need to be resolved prior to obtaining
FDA approval. Clarify the nature of any manufacturing, marketing or labeling issues
outstanding. Your response should address how your accounting for your inventory as of
May 31, 2020, August 31, 2020 and November 30, 2020 complies with ASC 330-10-30 as
well as paragraph 26 of Concepts Statement 6. Ensure your response also addresses the
following:
•Tell us the dates of, and nature of the results from, meetings with the relevant
regulatory authorities prior to the filing of your regulatory applications. In this
regard, we note that you filed the non-clinical portion of your BLA on March 18,
2019 and your CMC portions of the BLA in April and May of 2020, but that you
began to capitalize inventory during your quarter ended February 29, 2020;
•Explain how the July 2020 Refusal to File Letter you received from the FDA and
their refusal to schedule a Type A meeting impacted your analysis. Explain the
nature of the deficiencies raised in the letter and why those deficiencies did not create
a material risk or contingency such that the related inventory should no longer qualify
for capitalization;
•Explain the nature of the written responses received from the FDA related to your
September 2020 submission. Explain the nature of additional information required
by the FDA in order for you to resubmit the BLA. Address why the FDA’s request
for this information did not create a material risk or contingency such that the related
inventory should no longer qualify for capitalization; and
•Explain why your projected date for resubmitting the BLA keeps slipping. In this
regard, in your Form 10-Q for the Quarter ended November 30, 2020, you disclose
that you expect to resubmit the BLA in the 1 st half of 2021, in your Form 10-Q for
the quarter ended August 31, 2020, you disclose that you anticipate resubmitting the
BLA by the end of the 2020 and in Form 10-K for the year ended May 31, 2020, you
disclose that you hope to resubmit your BLA as soon as possible. Address whether
your apparent inability to timely resubmit your BLA creates a material risk or
contingency such that the related inventory should no longer qualify for
capitalization.
3.Explain how you determined it is probable that this inventory will provide “some future
economic benefit” in excess of capitalized costs. In doing so, please address the
following:
•Please explain your term “some”;
•Based on the nature of your raw materials and work-in-progress, indicate whether
these inventories are salable in their current form; and
•We note that in assessing the lower of cost or net realizable value to pre-
launch inventory, the Company relies on independent analysis provided by a third-
party knowledgeable of the range of likely commercial prices comparable to current
comparable commercial product. However, we note that you currently do not have
FirstName LastNameMichael Mulholland
Comapany NameCytoDyn Inc.
February 18, 2021 Page 3
FirstName LastName
Michael Mulholland
CytoDyn Inc.
February 18, 2021
Page 3
finished goods inventory. Please provide a detailed explanation of how you
determined the future economic benefit of your raw materials and work-in-progress.
4.We note that you consider the product stability data of all of the pre-approval inventory to
determine whether it has an adequate shelf life. With reference to this data and expected
approval date for your product, address how you determined that you will be able to
realize the inventory prior to the expiration of the shelf life. Address the risks and
uncertainties surrounding market acceptance of the product once approved and how this
will effect the realization of your inventory.
In closing, 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.
You may contact Jeanne Baker 202-551-3691 or Terence O'Brien at 202-551-3355 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-01-21 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 600 Vancouver, WA 98660 January 21, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Attn: Alan Campbell Re: CytoDyn Inc. Registration Statement on Form S-3 Filed January 15, 2021 File No. 333-252154 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, CytoDyn hereby requests acceleration of the effective date of the above-referenced registration statement to 4:30 p.m., Eastern Standard Time, on January 22, 2021, or as soon thereafter as is practicable. Thank you for your assistance in this matter. Should you have any questions, please contact me at (360) 980-8524. Very truly yours, /s/ Arian Colachis Arian Colachis, General Counsel
2021-01-21 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
January 21, 2021
Nader Z. Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed January 15, 2021
File No. 333-252154
Dear Dr. Pourhassan:
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: Arian Colachis
2020-12-29 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
December 29, 2020
Nader Z. Pourhassan, Ph.D.
Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed December 18, 2020
File No. 333-251522
Dear Dr. Pourhassan:
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: Arian Colachis, Esq.
2020-12-29 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP December 29, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Attn: Ada D. Sarmento Re: CytoDyn Inc. Registration Statement on Form S-3 Filed December 18, 2020 File No. 333-251522 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, CytoDyn Inc. hereby requests acceleration of the effective date of the above-referenced registration statement to 4:00 p.m., Eastern Standard Time, on December 30, 2020, or as soon thereafter as is practicable. Thank you for your assistance in this matter. Should you have any questions, please contact me at (360) 980-8524. Very truly yours, CYTODYN INC. /s/ Arian Colachis Arian Colachis VP, General Counsel
2020-09-23 - UPLOAD - CytoDyn Inc.
United States securities and exchange commission logo
September 22, 2020
Nader Pourhassan
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed September 15, 2020
File No. 333-248823
Dear Dr. Pourhassan:
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: Arian Colachis
2020-09-23 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 September 23, 2020 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-248823 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 4:30 p.m. (Eastern time) on Friday, September 25, 2020, or as soon thereafter as practicable. The Company requests the Commission confirm the effective date and time of the Registration Statement to Arian Colchis, General Counsel of the Company, by telephone at (360) 998-3992. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer cc: Kara Tatman (Perkins Coie LLP)
2020-05-06 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 May 6, 2020 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-236198 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 4:30 p.m. (Eastern time) on Monday, May 11, 2020, or as soon thereafter as practicable. The Company requests the Commission confirm the effective date and time of the Registration Statement to Kara Tatman of Perkins Coie LLP, counsel to the Company, by telephone at (503) 727-2171. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Interim Chief Financial Officer cc: Kara Tatman (Perkins Coie LLP)
2020-02-04 - UPLOAD - CytoDyn Inc.
February 4, 2020
Craig Eastwood
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed January 31, 2020
File No. 333-236198
Dear Mr. Eastwood:
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 William Mastrianna, Attorney-Adviser, at (202) 551-3778 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Kara Tatman
2019-09-27 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 September 27, 2019 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-233526 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 9:00 a.m. (Eastern time) on Monday, September 30, 2019, or as soon thereafter as practicable. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Steven M. Skolnick of Lowenstein Sandler LLP, counsel to the Company, at (973) 597-2476, as soon as the Registration Statement has been declared effective. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2019-09-26 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP September 26, 2019 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Irene Paik Re: CytoDyn Inc. Registration Statement on Form S-3 Filed August 29, 2019 File No. 333-233526 Dear Ms. Paik: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated September 26, 2019 (the “Comment Letter”), from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Registration Statement on Form S-3, filed on August 29, 2019 (the “Registration Statement”). Concurrently with this letter, the Company is filing Pre-Effective Amendment No. 1 to the Registration Statement (“Amendment No. 1”) which reflects revisions made to the Registration Statement in response to the comments of the Staff. For ease of reference, set forth below in bold is the comment of the Staff of the Commission with respect to the Registration Statement, as reflected in the Comment Letter. The Company’s response is set forth below the comment. Unless otherwise noted, the page numbers in the bold headings and the responses below refer to pages in the Registration Statement. Capitalized terms used but not defined herein have the meaning given to such terms in the Registration Statement. The Company has authorized us to respond to the Comment Letter as follows: Registration Statement on Form S-3 filed August 29, 2019 General 1. We note that in your response to our prior comment 1 you state that the exclusive forum provision is “not intended to apply” to claims arising under the Securities Act and Exchange Act. However, we note that your proposed disclosure only states that you “believe” that the exclusive forum provision would not apply to claims arising under the Securities Act and Exchange Act. Please revise your proposed disclosure to either affirmatively state that your exclusive forum provision does not apply to Exchange Act or Securities Act claims or that you do not intend for the provision to apply to Exchange Act or Securities Act claims. Response to Comment No. 1 In response to the Staff’s comment, the Company has revised the disclosure on page 16 to state that the Company does not intend for the exclusive forum provision to apply to Exchange Act or Security Act claims. If you have any questions with respect to the foregoing, please feel free to call me at (973) 597-2476. Very truly yours, /s/ Steven M. Skolnick Steven M. Skolnick
2019-09-26 - UPLOAD - CytoDyn Inc.
September 26, 2019
Nader Z. Pourhassan, Ph.D.
Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Response dated September 24, 2019
File No. 333-233526
Dear Dr. Pourhassan:
We have reviewed your response dated September 24, 2019 and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our September 13, 2019 letter.
Response filed September 24, 2019
General
1.We note that in your response to our prior comment 1 you state that the exclusive forum
provision is “not intended to apply” to claims arising under the Securities Act and
Exchange Act. However, we note that your proposed disclosure only states that you
“believe” that the exclusive forum provision would not apply to claims arising under the
Securities Act and Exchange Act. Please revise your proposed disclosure to either
affirmatively state that your exclusive forum provision does not apply to Exchange Act or
Securities Act claims or that you do not intend for the provision to apply to Exchange Act
or Securities Act claims.
FirstName LastNameNader Z. Pourhassan, Ph.D.
Comapany NameCytoDyn Inc.
September 26, 2019 Page 2
FirstName LastName
Nader Z. Pourhassan, Ph.D.
CytoDyn Inc.
September 26, 2019
Page 2
Please contact Irene Paik at 202-551-6553 or Ada Sarmento at 202-551-3798 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: James O’Grady, Esq.
2019-09-24 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP September 24, 2019 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Irene Paik Re: CytoDyn Inc. Registration Statement on Form S-3 Filed August 29, 2019 File No. 333-233526 Dear Ms. Paik: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated September 13, 2019 (the “Comment Letter”), from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Registration Statement on Form S-3, filed on August 29, 2019 (the “Registration Statement”). For ease of reference, set forth below in bold is the comment of the Staff of the Commission with respect to the Registration Statement, as reflected in the Comment Letter. The Company’s response is set forth below the comment. Unless otherwise noted, the page numbers in the bold headings and the responses below refer to pages in the Registration Statement. Capitalized terms used but not defined herein have the meaning given to such terms in the Registration Statement. The Company has authorized us to respond to the Comment Letter as follows: Registration Statement on Form S-3 filed August 29, 2019 General 1. We note that the forum selection provision in Article X of your Amended and Restated Certificate of Incorporation identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please also revise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If this provision does not apply to actions arising under the Securities Act or Exchange Act, please tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Response to Comment No. 1 The Company respectfully advises the Staff that the Company’s forum selection provision provides that the Court of Chancery of the State of Delaware has exclusive jurisdiction over only certain matters to the “fullest extent permitted by law.” Accordingly, this provision is not intended to apply to claims arising under the Securities Act of 1933, as amended, for which federal and state courts have concurrent jurisdiction, and the Securities Exchange Act of 1934, as amended, for which federal courts have exclusive jurisdiction. In response to the Staff’s comment, the Company will amend the Registration Statement to include the following disclosure so that it appears under the heading “Anti-takeover Effects of Delaware Law and our Certificate of Incorporation, as amended” on page 15 of the Registration Statement: “Exclusive Forum Charter Provision. Our Amended and Restated Certificate of Incorporation requires that, to the fullest extent permitted by law, and unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware, will, to the fullest extent permitted by law, be the sole and exclusive forum for each of the following: • any derivative action or proceeding brought on behalf of the Company; • any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s stockholders, creditors or other constituents; • any action asserting a claim against the Company or any director or officer of the Company arising pursuant to, or a claim against the Company or any director or officer of the Company with respect to the interpretation or application of any provision of, the DGCL, the Company’s Amended and Restated Certificate of Incorporation or the bylaws of the Company; and • any action asserting a claim governed by the internal affairs doctrine in each such case subject to said court having personal jurisdiction over the indispensable parties named as defendants therein. Provided, that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware. Because the applicability of the exclusive forum provision is limited to the extent permitted by law, we believe that the exclusive forum provision would not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction, and that federal courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act. We note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.” Additionally, the Company will add the following risk factor disclosure describing the Company’s forum selection provision and its intent in the Company’s future Annual Reports on Form 10-K and in future registration statements: “Our Amended and Restated Certificate of Incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents. Our Amended and Restated Certificate of Incorporation requires that, to the fullest extent permitted by law, and unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware, will, to the fullest extent permitted by law, be the sole and exclusive forum for each of the following: • any derivative action or proceeding brought on behalf of the Company; • any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company or the Company’s stockholders, creditors or other constituents; • any action asserting a claim against the Company or any director or officer of the Company arising pursuant to, or a claim against the Company or any director or officer of the Company with respect to the interpretation or application of any provision of, the DGCL, the Company’s Amended and Restated Certificate of Incorporation or the bylaws of the Company; and • any action asserting a claim governed by the internal affairs doctrine in each such case subject to said court having personal jurisdiction over the indispensable parties named as defendants therein. Provided, that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware. Because the applicability of the exclusive forum provision is limited to the extent permitted by law, we believe that the exclusive forum provision would not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction, and that federal courts have concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act. We note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers.” If you have any questions with respect to the foregoing, please feel free to call me at (973) 597-2476. Very truly yours, /s/ Steven M. Skolnick Steven M. Skolnick
2019-09-13 - UPLOAD - CytoDyn Inc.
September 13, 2019
Nader Z. Pourhassan, Ph.D.
Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed August 29, 2019
File No. 333-233526
Dear Dr. Pourhassan:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-3 filed August 29, 2019
General
1.We note that the forum selection provision in Article X of your Amended and Restated
Certificate of Incorporation identifies the Court of Chancery of the State of Delaware as
the exclusive forum for certain litigation, including any “derivative action.” Please
disclose whether this provision applies to actions arising under the Securities Act or
Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder, and Section 22 of the
Securities Act creates concurrent jurisdiction for federal and state courts over all suits
brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please also
revise your prospectus to state that there is uncertainty as to whether a court would
FirstName LastNameNader Z. Pourhassan, Ph.D.
Comapany NameCytoDyn Inc.
September 13, 2019 Page 2
FirstName LastName
Nader Z. Pourhassan, Ph.D.
CytoDyn Inc.
September 13, 2019
Page 2
enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder. If this provision does not apply to
actions arising under the Securities Act or Exchange Act, please tell us how you will
inform investors in future filings that the provision does not apply to any actions arising
under the Securities Act or Exchange Act.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Irene Paik at 202-551-6553 or Ada Sarmento at 202-551-3798 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: James O’Grady, Esq.
2019-02-13 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 February 13, 2019 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-228991 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 9:00 a.m. (Eastern time) on Thursday, February 14, 2019, or as soon thereafter as practicable. Please notify James O’Grady of Lowenstein Sandler LLP, counsel to the Company, at (646) 414-6849 or jogrady@lowenstein.com, as soon as the Registration Statement has been declared effective. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2019-02-05 - UPLOAD - CytoDyn Inc.
February 5, 2019
Michael Mulholland
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed December 21, 2018
File No. 333-228991
Dear Mr. Mulholland:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Dorrie Yale at 202-551-8776 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: James O'Grady
2018-10-11 - UPLOAD - CytoDyn Inc.
October 11, 2018
Nader Z. Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Preliminary Proxy Statement on Schedule 14A
Filed September 7, 2018
File No. 000-49908
Dear Dr. Pourhassan:
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 Healthcare & Insurance
cc: Steven M. Skolnick - Lowenstein Sandler LLP
2018-10-05 - UPLOAD - CytoDyn Inc.
October 4, 2018
Nader Z. Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Preliminary Proxy Statement on Schedule 14A
Filed September 7, 2018
Response dated September 24, 2018
File No. 000-49908
Dear Dr. Pourhassan:
We have reviewed your response dated September 24, 2018 and have the following
comment.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Response dated September 24, 2018
General
1.As it appears you will acquire substantially all of the assets of ProstaGene, and a
presumption exists that a separate entity is a business, it appears that you will acquire a
business for purposes of Rule 3-05 of Regulation S-X. Please revise your preliminary
proxy statement to provide the disclosure required by Items 11(e), 13 and 14 of Schedule
14A pursuant to Note A of Schedule 14A.
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.
FirstName LastNameNader Z. Pourhassan, Ph.D.
Comapany NameCytoDyn Inc.
October 4, 2018 Page 2
FirstName LastName
Nader Z. Pourhassan, Ph.D.
CytoDyn Inc.
October 4, 2018
Page 2
Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven M. Skolnick - Lowenstein Sandler LLP
2018-09-24 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP September 24, 2018 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Irene Paik Re: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed September 7, 2018 File No. 000-49908 Dear Ms. Paik: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated September 14, 2018 (the “Comment Letter”), from Irene Paik, of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Preliminary Proxy Statement on Schedule 14A, filed on September 7, 2018 (the “Preliminary Proxy Statement”) in connection with the Company’s annual meeting of its stockholders (the “Annual Meeting”). For ease of reference, set forth below in bold is the comment of the staff of the Commission (the “Staff”) with respect to the Preliminary Proxy Statement, as reflected in the Comment Letter. The Company’s response is set forth below the comment. The Company has authorized us to respond to the Comment Letter as follows: 1. We note that one of the reasons you are seeking the authorization of additional shares of common stock is to allow the company to issue shares of common stock as consideration in the ProstaGene transaction. Please revise your preliminary proxy statement to provide the disclosure required by Items 11(e), 13 and 14 of Schedule 14A, as applicable, pursuant to Note A of Schedule 14A. Alternatively, please explain why such disclosure is not required. In response to the Comment Letter, the Company has considered the application of Note A of Schedule 14A and has concluded that the proposal to approve the amendment to the Company’s charter to increase the number of authorized shares of common stock (the “Proposal”) is not also a solicitation with respect to the consummation of the ProstaGene transaction described in the Preliminary Proxy Statement (the “ProstaGene Transaction”), because the issuance of common stock in the ProstaGene Transaction is not the primary purpose of the Proposal, as set forth in Part I of this response, and also because the ProstaGene Transaction is not conditioned upon the approval of the Proposal and will close regardless of the outcome of the stockholder vote, as set forth in Part II of this response. In any event, as set forth in Part III of this response, the Company believes that the information currently disclosed in the Preliminary Proxy Statement includes all of material information stockholders may require to make an informed voting decision about the Proposal. The reasons for the Company’s conclusions are set forth in greater detail below. I. The ProstaGene Transaction is not the primary purpose of the Proposal. As stated on page 2 of the Preliminary Proxy Statement, “[t]he primary reasons for the increase in authorized shares of Common Stock are to have sufficient shares available for possible future financings, acquisition transactions, joint ventures and other general corporate purposes […].” While the ProstaGene Transaction is one example of a potential use of such authorized shares, it is not the primary reason for the Proposal. The primary reason for the Proposal is to provide for additional shares of common stock that can be issued in public and private capital raising transactions to fund the Company’s ongoing business operations. As an early stage biotechnology company whose main drug candidate has not yet been approved by the Food and Drug Administration, the capital markets are the Company’s most critical mechanism for funding its operations and clinical development. As of September 20, 2018, as illustrated in the chart below, the Company had only 19,096,436 shares of common stock authorized and available for future issuance. Shares of Common Stock As of September 20, 2018 Authorized 450,000,000 Issued and outstanding 253,610,949 Reserved for: Exercise of outstanding warrants 144,528,080 Conversion of outstanding convertible notes 15,830,809 Exercise of outstanding stock options 13,182,513 Issuance under equity incentive plans 2,428,048 Conversion of outstanding Series B Convertible Preferred Stock 921,000 Payment of undeclared dividends on outstanding Series B Convertible Preferred Stock 402,165 177,292,615 Available for future issuance 19,096,436 As explained more fully in Part II of this response, the ProstaGene Transaction is not conditioned upon the approval of the Proposal and will close regardless of the outcome of the stockholder vote.1 However, without the approval of the Proposal, the Company will be severely limited in its ability to conduct critically necessary future capital raising transactions, the proceeds of which are instrumental to the Company’s ongoing business operations, due to the 1 If the Proposal is not approved prior to the closing date of the ProstaGene Transaction, the Company will be required to close the ProstaGene Transaction by issuing shares of newly designated Series C Convertible Preferred Stock as transaction consideration. 2 limited number of authorized shares of common stock remaining. The Company will also be unable to issue warrants to consultants, or stock options to employees, executive officers and directors, which are critical means of compensating and incentivizing the Company’s business partners and management, and aligning management’s interests with those of the Company’s stockholders. The Company has put forth the Proposal primarily due to the urgent need for additional authorized shares of common stock to support its capital raising and other business initiatives. Even if the ProstaGene Transaction were not occurring at this time, the Company would have nonetheless included in the Preliminary Proxy Statement a proposal to increase the number of authorized shares of the Company’s common stock. There is a critical need for the increased authorized shares independent of the Company’s obligations in the ProstaGene Transaction, which (again) will close on its terms regardless of the outcome of the stockholder vote on the Proposal, as described in greater detail below. II. The ProstaGene Transaction is not conditioned upon approval of the Proposal and will close regardless of the outcome of the stockholder vote. Note A of Schedule 14A provides that when information with respect to any matter to be acted on which involves other matters with respect to which disclosures are called for by other items of Schedule 14A, then the disclosures required by such other items also shall be given. As a specific example, Note A provides that, when a solicitation seeking approval of additional securities is for the purpose of acquiring another company, and when the stockholders will not have a separate opportunity to vote on the transaction, then the solicitation will be considered to be a solicitation seeking approval of the acquisition as well. This guidance is not applicable to the current fact pattern, because the increase in authorized shares is not a closing condition of the ProstaGene Transaction, and the ProstaGene Transaction will close regardless of the outcome of the stockholder vote on the authorized share increase. Unlike other situations where the vote on the proposal being submitted to the stockholders could affect whether or not the transactions are consummated, the Company could and will consummate the ProstaGene Transaction even if the stockholders reject the Proposal. Because Section 251(g) of the Delaware General Corporation Law (the “DGCL”) does not require stockholder approval for the ProstaGene Transaction, and the Company’s board of directors (the “Board”) has previously unanimously approved the transaction, the only aspect of the ProstaGene Transaction which will be affected by the Proposal is the form of the transaction consideration to be paid out by the Company. If the Company’s authorized common stock is increased to at least 500,000,000 shares prior to the closing of the transaction, the Company will issue 27,000,000 shares of its common stock. If it is not increased to such a level prior to the closing of the transaction, the Company will issue newly designated shares of Series C Convertible Preferred Stock. As already disclosed in the Preliminary Proxy Statement, the Series C Convertible Preferred Stock will automatically convert into shares of the Company’s common stock upon the Company’s authorized common stock being increased to at least 500,000,000 shares, whether this be at the Annual Meeting or some other point in the future. The terms of the Series C Convertible Preferred Stock, in particular the redemption terms, which are already disclosed in the Preliminary Proxy Statement, may be material to the stockholders’ consideration of whether or not to approve the Proposal. However, the consummation of the ProstaGene Transaction is in no way dependent on stockholder approval of the Proposal. 3 The Company is aware of similar instances where the Staff has concluded that Note A disclosures are not germane to a particular stockholder proposal, because the closing of an acquisition was not conditioned on the outcome of the stockholder vote. For example, please refer to the comment response from Manhattan Pharmaceuticals, Inc., filed October 20, 2009, and the comment response from Encompass Group Affiliates, Inc., filed January 9, 2008. In light of the foregoing, because the authorization of the additional shares of common stock is not a condition or a requirement of, and will have no impact on, the completion of the ProstaGene Transaction, and such authorization is not in contemplation of an exchange, merger, consolidation, acquisition or similar transaction, the Company does not believe that Note A of Schedule 14A applies. III. The Preliminary Proxy already includes the material information that would be required to be added by Items 11(e), 13 and 14 of Schedule 14A. The Company maintains that the assets purchased in the ProstaGene Transaction do not qualify as a “business” for purposes of the reporting requirements of Item 3-05 of Regulation S-X, or otherwise constitute a material transaction that would in any way change the nature of the stockholders’ investment in the Company. As a result, the Company believes that, even if Note A of Schedule 14A were deemed to be applicable to the ProstaGene Transaction, the disclosures in the Preliminary Proxy Statement already include any material information that would be required to be added by Items 11(e), 13 and 14 of Schedule 14A. In general, Item 3-05 of Regulation S-X requires the filing of pre-acquisition historical financial statements when the acquisition of a significant “business” has occurred or is probable. The determination of what constitutes a business for reporting purposes is made by reference to the definition of “business” in Item 11-01(d) of Regulation S-X, which states: [T]he term business should be evaluated in light of the facts and circumstances involved and whether there is sufficient continuity of the acquired entity’s operations prior to and after the transactions so that disclosure of prior financial information is material to an understanding of future operations. A presumption exists that a separate entity, a subsidiary, or a division is a business. However, a lesser component of an entity may also constitute a business. Among the facts and circumstances which should be considered in evaluating whether an acquisition of a lesser component of an entity constitutes a business are the following: (1) Whether the nature of the revenue-producing activity of the component will remain generally the same as before the transaction; or (2) Whether any of the following attributes remain with the component after the transaction: (i) Physical facilities, (ii) Employee base, (iii) Market distribution system, (iv) Sales force, (v) Customer base, (vi) Operating rights, (vii) Production techniques, or (viii) Trade names. 4 According to Staff guidance, the evaluation of whether an acquisition constitutes a business “focuses primarily on whether the nature of the revenue producing activity previously associated with the acquired assets will remain generally the same after the acquisition” (see Note to Section 2010.2 of the Financial Reporting Manual). When evaluated in light of the foregoing standards, it is clear that no “business” is being acquired. No continuity of operations exists between ProstaGene, LLC (“ProstaGene”) and the post-acquisition assets purchased by the Company. ProstaGene is an extremely early-stage biotechnology company, with zero revenue producing operations for the prior four years, other than a recent immaterial single limited clinical research contract with the Company.2 ProstaGene has zero employees and only 512 square feet of leased lab space in a research lab near Philadelphia, PA. The purchased assets consist of certain patents and other intellectual property rights relating to prostate cancer diagnostics and treatments, which are in various stages of pre-clinical and clinical development, and none of which currently generates any revenue. The Company is also acquiring certain limited trademarks, trade names and other intellectual property (e.g., a web URL address) relating to the name “ProstaGene”; however the Company does not anticipate to use any such trademarks or related intellectual property going forward. As of June 30, 2018 and December 31, 2017, the purchased assets were carried on ProstaGene’s financial statements with zero aggregate book value. Rather than constituting the acquisition of any business, a principal purpose of the ProstaGene Transaction is the hiring of Dr. Pestell as Chief Medical Officer of the Company. Dr. Pestell is an extremely prominent research academic in the field of prostate cancer diagnostics and therapeutics aimed at blocking cancer metastasis by blocking CCR5. It is anticipated that the GAAP accounting treatment of the transaction will result in as much as one-third of the transaction consideration to be accounted for as compensation expense and not assets, to be amortized over the three year term of an employment agreement that Dr. Pestell is required to enter into upon closing the ProstaGene Transaction. The Company therefore believes that it is not acquiring any “business” within the meaning of Item 3-05 of Regulation S-X, as determined according to the guidelines set forth in Item 11-01(d) of Regulation S-X. Consequently, no separate financial statements of ProstaGene (or otherwise relating to any purchased assets), and no pro forma financial information of the Company, is required to be presented under Item 3-05 of Regulation S-X or would be otherwise material to its stockholders.3 2 ProstaGene in fact outsourced its obligations under this contract to a third-party research institution, with which Dr. Pestell has a very close working relationship. The Company will assume this contract and will have direct privity of contract with this third-party research institution going forward. Since this is a contract with the Company, there will be no continuing revenues to the Company pursuant to the contract following the closing of the ProstaGene Transaction. 3 The other information required by Items 11(e) and 13 of Schedule 14A is included in the Company’s annual report for the year ended May 31, 2018 (and in the Form 10-K filed with the Commission on July 27, 2018), copies of which will be mailed to stockholders along with the definitive proxy statement for the Annual Meeting, as is the Company’s standard practice. 5 For similar reasons, the Company also believes that any additional disclosure required by Item 14 of Schedule 14A would not be meaningful to its stockholders, inasmuch as the consummation of the ProstaGene Transaction does not fundamentally alter the nature of a stockholder’s investment in the Company. Following the ProstaGen
2018-09-17 - UPLOAD - CytoDyn Inc.
September 14, 2018
Nader Z. Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Preliminary Proxy Statement on Schedule 14A
Filed September 7, 2018
File No. 000-49908
Dear Dr. Pourhassan:
We have limited our review of your filing to the issues presented in the comment below.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A filed September 7, 2018
Proposal 2 - Proposal to Increase the Company's Authorized Capital to 600,000,000 Shares of
Common Stock, page 29
1.We note that one of the reasons you are seeking the authorization of additional shares of
common stock is to allow the company to issue shares of common stock as consideration
in the ProstaGene transaction. Please revise your preliminary proxy statement to provide
the disclosure required by Items 11(e), 13 and 14 of Schedule 14A, as applicable, pursuant
to Note A of Schedule 14A. Alternatively, please explain why such disclosure is not
required.
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.
FirstName LastNameNader Z. Pourhassan, Ph.D.
Comapany NameCytoDyn Inc.
September 14, 2018 Page 2
FirstName LastName
Nader Z. Pourhassan, Ph.D.
CytoDyn Inc.
September 14, 2018
Page 2
You may contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven M. Skolnick - Lowenstein Sandler LLP
2018-05-08 - UPLOAD - CytoDyn Inc.
May 8, 2018
Nader Pourhassan, Ph.D.
Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, WA 98660
Re:CytoDyn Inc.
Preliminary Proxy Statement on Schedule 14A
Filed April 26, 2018
File No. 000-49908
Dear Dr. Pourhassan:
We have completed our review of your filing on May 7, 2018. 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.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven Skolnick
2018-03-30 - UPLOAD - CytoDyn Inc.
December 5, 2017 Via E -Mail Nader Z. Pourhassan, Ph.D. President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Schedule TO -I Filed November 24, 2017 File No. 005-79349 Dear Dr. Pourhassan : We have limited our review of the above filing to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand the disclosure. Please respond to this letter by amendin g the filing or providing the requested information. If you do not believe our comments apply to the facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to the filing and the information you provide in response to these comments, we may have additional comments . Exhibit 99(a)(1)( B) Offer to Amend and Exercise 1. Condition (i) to the offer as set forth on pages 1 and 15 suggests that the offer is limited to holders of Original Warrants who are accredited investors. Since it is possible that the current holders of Original Warrants may not consist entirely of accredited investors, please revise the Offer to Amend and Exercise and accompanying Acce ptance and Exercise Documents to clarify that the offer is not limited t o accredited investors . Refer to Rule 13e -4(f)(8)(i). Exhibit 99(a)(1)(C) Acknowledgments and Repres entations and Warranties Nader Z. Pourhassan, Ph.D. CytoDyn Inc. December 5, 2017 Page 2 2. Representations and warranties (2) through (5), set forth on page 2, appear to operate as disclaimers or waivers of rights and/or to impermissibly restrict participation in the tender offer under Rule 13e -4(f)(8)(i). Please revise to eliminate these repre sentations as a requirement to tender, or provide an analysis as to how these representations do not so operate and are consistent with Rule 13e -4(f)(8)(i). 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 Bryan Hough , Staff Attorney, at (202) 551 -8625 or me at (202) 551 -3589 if you have any questions regarding our comments . Sincerely, /s/ Tiffany Piland Posil Tiffany Piland Posil Special Counsel Office of Mergers and Acquisitions cc: Via E -Mail Michael Lerner, Esq. Steven Skolnick, Esq. Lowenstein Sandler LLP
2018-03-21 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 March 21, 2018 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-223563 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 9:00 a.m. (Eastern time) on Friday, March 23, 2018, or as soon thereafter as practicable. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Steven M. Skolnick of Lowenstein Sandler LLP, counsel to the Company, at (646) 414-6947, as soon as the Registration Statement has been declared effective. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2018-03-19 - UPLOAD - CytoDyn Inc.
March 16, 2018
Nader Pourhassan, Ph.D.
Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed March 9, 2018
File No. 333-223563
Dear Dr. Pourhassan:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven M. Skolnick, Esq.
2018-03-05 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 March 5, 2018 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-223195 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 9:00 a.m. (Eastern time) on Wednesday, March 7, 2018, or as soon thereafter as practicable. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Steven M. Skolnick of Lowenstein Sandler LLP, counsel to the Company, at (646) 414-6947, as soon as the Registration Statement has been declared effective. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2018-03-02 - UPLOAD - CytoDyn Inc.
March 2, 2018
Nader Pourhassan, Ph.D.
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re:CytoDyn Inc.
Registration Statement on Form S-3
Filed February 23, 2018
File No. 333-223195
Dear Dr. Pourhassan:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at (202) 551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Steven M. Skolnick, Esq.
2018-02-13 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP Steven M. Skolnick Partner One Lowenstein Drive Roseland, New Jersey 07068 T: 973 597 2476 F: 973 597 2477 E: sskolnick@lowenstein.com February 13, 2018 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Tiffany Piland Posil Re: CytoDyn Inc. Schedule TO-I/A Filed January 31, 2018 File No. 005-79349 Dear Ms. Posil: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated February 6, 2018 (the “Comment Letter”), from Tiffany Piland Posil, Special Counsel, Office of Mergers & Acquisitions of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Schedule TO-I/A, filed on January 31, 2018 (the “Schedule TO-I Amendment”) in connection with the Company’s offer to amend certain warrants of the Company (the “Tender Offer”). For ease of reference, set forth below in bold are the comments of the staff of the Commission (the “Staff”) with respect to the Schedule TO Amendment, as reflected in the Comment Letter. The Company’s response is set forth below each comment. The Company has authorized us to respond to the Comment Letter as follows: General 1. We note that you have conducted a series of offerings, between November 30, 2017 and January 31, 2018, in which you sold shares of your common stock and warrants to purchase shares of your common stock to certain investors, including directors of the company. We also note that certain of such offerings involved the issuance of warrants to purchase common stock to Paulson Investment Company, LLC in consideration for its services as placement agent in such offerings. For instance, we note that, according to Form 4 filings made on February 2, 2018, it appears that certain directors of your company purchased common stock and warrants to purchase common stock in your January 31, 2018 offering. As another example, according to a Form 8-K filed January 23, 2018, you granted Paulson Investment Company, LLC, the solicitation agent in your current tender offer, warrants to purchase common stock. Please provide a detailed legal analysis as to your compliance with Rule 13e-4(f)(6) and Rule 14e-5 with respect to these offerings. February 13, 2018 Page 2 Response to Comment No. 1 The Company respectfully submits that the warrants issued to certain directors of the Company on January 31, 2018 (the “January 31 Warrants”) are, for purposes of Rule 13e-4(f)(6), not subject securities nor the same class of securities as the subject securities of the Company’s Tender Offer. Further, the Company respectfully submits that neither the January 31 Warrants nor the warrants issued to Paulson Investment Company, LLC on January 23, 2018 (“Paulson” and such warrants, the “Placement Agent Warrants”) are, for purposes of Rule 14e-5, subject securities or related securities. Based on the foregoing, the Company believes that its offerings of the January 31 Warrants and the Placement Agent Warrants (as well as all of the warrants issued to Paulson since the commencement of the Company’s Tender Offer) were not prohibited purchases outside of the Tender Offer and fully comply with Rule 13e-4(f)(6) and Rule 14e-5. Rule 13e-4(f)(6) and Rule 14e-5 Both Rule 13e-4(f)(6) and Rule 14e-5 are intended to prevent the purchase of certain securities by the issuer, or parties related to the issuer, during the course of an issuer tender offer, but differ slightly in their scope and reach. Rule 13e-4(f)(6) prohibits the issuer or any affiliate, until at least ten business days after the date of termination of an issuer tender offer, from purchasing (otherwise than pursuant to the issuer tender offer) “any security which is the subject of the issuer tender offer, or any security of the same class and series, or any right to purchase any such securities.” Rule 14e-5 provides that, in connection with a tender offer for equity securities, from the time of the announcement of a tender offer until it expires, no “covered person” may directly or indirectly purchase, or arrange to purchase, any “subject securities” or “related securities” except as part of the tender offer. The definition of “covered person” under paragraph (c)(3) of Rule 14e-5 encompasses both the Company’s directors and Paulson, as the solicitation agent in the Tender Offer. “Subject securities” is defined under paragraph (c)(7) by reference to Rule 1000 of Regulation M-A as “the securities or class of securities that are sought to be acquired in the transaction or that are otherwise subject of the transaction.” Neither the Placement Agent Warrants nor the January 31 Warrants qualify as “subject securities” under either Rule 13e-4(f)(6) or Rule 14e-5. Pursuant to the Company’s Schedule TO-I filed on November 24, 2017 (the “Schedule TO-I”), only the specific warrants enumerated in Exhibit (A)(1)(B) (the “Solicitation Statement”) are subject to the Company’s Tender Offer (the “Original Warrants”). The January 31 Warrants issued on January 31, 2018 are not enumerated in the Solicitation Statement, are not of the same class as the securities included in the Tender Offer and are therefore not subject securities for purposes of Rule 13e-4(f)(6) or Rule 14e-5. The same is true of the Placement Agent Warrants. In fact, with respect to the Placement Agent Warrants, the Company intentionally excluded from the Tender Offer all classes of warrants previously issued to Paulson in consideration for services as placement agent in various prior offerings, due to provisions allowing for cashless exercise.1 Thus, the Placement Agent Warrants are not subject securities for the purposes of Rule 13e-4(f)(6) or Rule 14e-5. 1 The purpose of the Tender Offer is to obtain cash proceeds by inducing investors to exercise of warrants. That purpose is not served by allowing warrants to be exercised on a cashless basis at a reduced exercise price. Therefore, all warrants owned by Paulson were excluded from the Tender Offer. February 13, 2018 Page 3 Further, the Company believes that neither the Placement Agent Warrants nor the January 31 Warrants are “related securities” under Rule 14e-5. “Related securities” is defined under paragraph (c)(6) of the rule as “securities that are immediately convertible into, exchangeable for or exercisable for subject securities.” The Placement Agent Warrants and the January 31 Warrants are not, and moreover the Company has not issued any securities that are, immediately convertible into, exchangeable for or exercisable for the Original Warrants that are subject securities in the Tender Offer. Thus, the Company does not believe the Placement Agent Warrants or the January 31 Warrants are “related securities.” Class of Securities The Company believes that neither the January 31 Warrants nor the Placement Agent Warrants are of the same class, much less the same series, as the subject securities. While the term “class” is not defined specifically for purposes of Rule 13e-4 or Rule 14e-5, it is defined for other purposes under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Section 12(g)(5) of the Exchange Act provides that, for purposes of Section 12(g) of the Exchange Act, the term “class” includes “all securities of an issuer which are of substantially similar character and the holders of which enjoy substantially similar rights and privileges.” As several commentators have noted, the Commission has issued limited guidance interpreting the meaning of the definition of “class” in Section 12(g)(5).2 With respect to what constitutes a “class” of derivative securities such as options and warrants, however, the Commission has issued clear guidance in the context of reporting requirements under Exchange Act Section 16. When reporting derivative securities on Form 4 and Form 5, the Commission has made clear that options that have different “economic characteristics (such as exercise price and expiration date) are considered different classes of options.”3 The same reporting principles apply to warrants and other derivative securities with similar characteristics to options.4 The Company submits that, in the absence of any clear guidance from the Commission to the contrary, the same principles should be applied to warrants in the context of Rules 13e-4 and 14e-5. When comparing the economic characteristics of both the Placement Agent Warrants and 2 See generally, 1 Louis Loss (late), Joel Seligman & Troy Paredes, Fundamentals of Securities Regulation, § 6.A.3.a (6th ed. 2018 & Cum. Supp. 2011); See also, Peter J. Romeo & Alan L. Dye, Romeo & Dye’s Section 16 Treatise and Reporting Guide §3.04(2)(b) (4th ed. 2012). 3 See, Exchange Act Section 16 and Related Rules and Forms Compliance and Disclosure Interpretations (“C&DI”) Question 133.06; See also, Thompson, Hine & Flory (available March 29, 1991). 4 Rule 16a-1(c) defines “derivative security” very broadly, encompassing options, warrants, convertible securities, stock appreciation rights, and similar rights that may be exercised for or converted into an equity security or the cash value thereof. February 13, 2018 Page 4 the January 31 Warrants to the Original Warrants based upon these principles, it is clear that both the Placement Agent Warrants and the January 31 Warrants should be treated as separate classes of securities from any of the classes of Original Warrants. The Original Warrants that are subject of the Tender Offer were issued in multiple disparate transactions over a period of over four years, so that the issuance dates of the Original Warrants range from September 2013 to October 2017. Correspondingly, the expiration dates of the Original Warrants range from September 25, 2018 to October 11, 2022. The issuance and exercise dates of the January 31 Warrants and Placement Warrants are different and later than this — January 23, 2018 and 2023 for the Placement Agent Warrants and January 31, 2018 and 2023 for the January 31 Warrants. The exercise prices of the Original Warrants range from $0.50 to $1.35 per share. Again, the Placement Agent Warrants and the January 31 Warrants differ from the Original Warrants, with exercise prices of $0.55 and $0.75, respectively. As a result of this diversity, each class of warrants has different economic characteristics and different fair market values. The Original Warrants represent 84 unique classes of securities.5 We have estimated fair market values of each class of such warrants according to the Black-Scholes valuation model as of February 9, 2018. 6 The Original Warrants have 84 different Black-Scholes values, which range from $0.0015 to $0.3820. No two classes of warrants within the 84 different classes of warrants comprising the Original Warrants have the exact same Black-Scholes value. These characteristics are very different from the economic characteristics and Black-Scholes values of the January 31 Warrants ($0.2795) and the Placement Agent Warrants ($0.3216). In addition, other differences in non-economic characteristics further distinguish the classes of Original Warrants from each other and from the Placement Agent Warrants and January 31 Warrants, beyond the differences in economic characteristics highlighted above and by the Commission in its guidance — for example, differences in anti-dilution protection, price adjustment provisions, limitations on transferability, notice provisions, and other non-economic rights. With such different characteristics and fair market values, each set of warrants must be considered a different class, as no investor would be indifferent as to which warrant of the 84 classes he received, and the January 31 Warrants and the Placement Agent Warrants are different from all 84. Of course, the Placement Agent Warrants (as 5 The Company respectfully advises the Commission that, on the front cover of the Solicitation Statement, it has grouped the various classes of Original Warrants together by price for ease of reading, separately disclosing the ranges of expiration dates for each exercise price category. Besides different issuance and expiration dates, the Original Warrants within any exercise price category have many other non-economic characteristics which differ, in addition to their economic characteristics, depending on the particular form of warrant used for any particular issuance of Original Warrants. Such differences include differences in anti-dilution protection, price adjustment provisions, limitations on transferability, notice provisions, and other non-economic rights. 6 The Black-Scholes valuation model values derivative securities based on factors which (other than the exercise price and expiration date) are generally consistent for the Company across all classes of warrants as of any given measurement date. The input factors are: (i) exercise price, (ii) expiration date, (iii) current stock price, (iv) current stock price volatility, (v) risk-free rates of return (based on U.S. Treasury bonds) and (vi) the stock dividend rate for the Company. February 13, 2018 Page 5 well as all of the warrants issued to Paulson since the commencement of the Company’s Tender Offer) are further distinguished as a separate class from the Original Warrants and the January 31 Warrants because the Placement Agent Warrants have a cashless exercise feature, and none of the Original Warrants nor the January 31 Warrants permit unlimited cashless exercise. As the Staff is aware from its initial review of the Schedule TO-I in December 2017, the Company determined to exclude several categories of warrants from the Tender Offer, including among others (i) warrants issued in connection with the Company’s September 15, 2016 registered direct offering to certain institutional investors, and (ii) warrants issued in certain private placement offerings occurring after November 1, 2017. Each category of excluded warrants also had clearly different economic characteristics, due principally to the differences in expiration dates. Such exclusions were only permissible under Rule 13e-4(f)(8) because the excluded warrants constitute separate classes of securities from any of the Original Warrants, on the basis of their different economic characteristics. For similar reasons, the January 31 Warrants and the Placement Agent Warrants constitute separate classes of securities from any of the Original Warrants that are subject of the Tender Offer, and are excludable from the Tender Offer under Rule 13e4-(f) (8). Based on the Commission’s interpretation of the term “class,” and because the economic characteristics (i.e. exercise price and expiration date) of the January 31 Warrants, the Placement Agent Warrants and the Original Warrants are different, the January 31 Warrants and the Placement Agent Warrants (as well as all of the warrants issued to Paulson since the commencement of the Company’s Tender Offer) should be treated as separate classes of securities from any Original Warrants for purposes of Rule 13e-4(f)(6) and Rule 14e-5. Policy Considerations In addition to the fact that the January 31 Warrants and the Placement Agent Warrants are of different classes than the Original Warrants, the Company also respectfully submits that neither the limited acquisitions of securities by the Company’s directors, as minority participants in the January 31, 2018 offering on equal terms to the Company’s other investors, nor the payment by the Company to its Placement Agent for its services, partially in warrants, was in any manner inconsistent with the policy considerations behind Exchange Act Rules 13e-4(f)(6) and 14e-5. As noted in Securities Act Release No. 6108 (the adopting release for Rule 13e-4), Section 13(e) of the Securities Act empowered the Commission to define manipulative practices with respect to an issuers’ “repurchases of their own securities, whether by tender
2018-02-06 - UPLOAD - CytoDyn Inc.
February 6, 2018 Nader Z. Pourhassan, Ph.D. President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Schedule TO -I/A Filed January 31, 2018 File No. 005-79349 Dear Dr. Pourhassan : We have limited our review of the above filing to those issues we have addressed in our comment. Please respond to this letter by amending the filing or providing the requested information. If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to the filing and the information you provide in response to our comment, we may have additional comments. General 1. We note that you have conducted a series of offerings, between November 3 0, 2017 and January 31, 201 8, in which you sold shares of your common stock and warrants to purchase shares of your common stock to certain investors , including directors of the company . We also note that certain of such offerings involve d the issuance of warrants to purchase common stock to Paulson Investment Company, LLC in consideration for its services as placement agent in such offerings. For instance, we note that, according to Form 4 filings made on February 2, 2018, it appears that certain directors of your company purchased common stock and warrants to purchase common stock in your January 31, 2018 offering. As another example, according to a Form 8 -K filed January 23, 2018, you granted Paulson Investment Company , LLC, the solicitation agent in your current tender offer, warrants to purchase common stock. Please provide a detailed legal analysis as to your compliance with Rule 13e -4(f)(6) and Rule 14e -5 with respect to these offerings. We remind you that th e 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. Nader Z. Pourhassan, Ph.D. CytoDyn Inc. February 6, 2018 Page 2 Please contact Bryan Hough , Staff Attorney, at (202) 551 -8625 or me at (202) 551-3589 if you have any questions regarding our comment . Sincerely, /s/ Tiffany Piland Posil Tiffany Piland Posil Special Counsel Office of Mergers and Acquisitions cc: Michael Lerner, Esq. Steven Skolnick, Esq. Lowenstein Sandler LLP
2017-12-13 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP December 13, 2017 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Tiffany Piland Posil Re: CytoDyn Inc. Tender Offer Statement on Schedule TO Filed November 24, 2017 File No. 005-79349 Dear Ms. Posil: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated December 5, 2017 (the “Comment Letter”) from Tiffany Piland Posil, Special Counsel, Office of Mergers and Acquisitions (the “Staff”) of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Tender Offer Statement on Schedule TO, filed on November 24, 2017 (the “Tender Offer Statement”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Tender Offer Statement, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Tender Offer Statement unless defined herein. The Company has authorized us to respond to the Comment Letter as follows: Exhibit 99(a)(1)(B) Offer to Amend and Exercise 1. Condition (i) to the offer as set forth on pages 1 and 15 suggests that the offer is limited to holders of Original Warrants who are accredited investors. Since it is possible that the current holders of Original Warrants may not consist entirely of accredited investors, please revise the Offer to Amend and Exercise and accompanying Acceptance and Exercise Documents to clarify that the offer is not limited to accredited investors. Refer to Rule 13e-4(f)(8)(i). In response to the Staff’s comment, the Company will revise the Tender Offer Statement to clarify that, while the Company requires holders of Original Warrants to complete an Accredited Investor Questionnaire, holders of Original Warrants will not be required to be accredited investors in order to participate in the tender offer. This also will be clarified in a supplemental letter mailed to the Original Warrant holders. The amended Tender Offer Statement will also provide that, in the event that the Company receives a completed Accredited Investor Questionnaire from any holder of Original Warrants that desires to participate in the tender offer indicating that such holder is no longer an accredited investor, the Company will file as part of a subsequent amendment to its Tender Offer Statement and distribute to all holders of Original Warrants supplemental disclosure, which will include all of the information required by Rule 502 of Regulation D. In such a circumstance, the Company will extend the Expiration Date of the Offer to Amend and Exercise, to the extent required under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the rules of the Commission thereunder. As stated in response to the Staff’s comment 2 below, based on prior representations, the Company anticipates that each of the holders of the Original Warrants are accredited investors, and that the Offer to Amended and Exercise will qualify for an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) of Regulation D promulgated thereunder. NEW YORK PALO ALTO NEW JERSEY UTAH WASHINGTON, D.C Lowenstein Sandler LLP Exhibit 99(a)(1)(C) Acknowledgement and Representations and Warranties 2. Representations and warranties (2) through (5), set forth on page 2, appear to operate as disclaimers or waivers of rights and/or to impermissibly restrict participation in the tender offer under Rule 13e-4(f)(8)(i). Please revise to eliminate these representations as a requirement to tender, or provide an analysis as to how these representations do not so operate and are consistent with Rule 13e-4(f)(8)(i). In response to the Staff’s comments, the Company does not view representations and warranties (2) through (5), set forth on page 2 of the Acknowledgement and Representations and Warranties, as disclaimers or waivers of rights and/or to impermissibly restrict participation in the tender offer based on the particular facts of this situation. The Company issued 42,878,749 of the Original Warrants in various private placement transactions (the “Private Placements”) in reliance on the exemption from registration provided by Rule 506 of Regulation D under the Securities Act, and the balance of 8,211,364 of the Original Warrants in various registered direct offerings (the “Registered Offerings” and, together with the Private Placements, the “Original Offerings”) made under the Company’s shelf registration statement on Form S-3 (File No. 333-213349), which was declared effective by the Commission on September 9, 2016. In connection with each of the Original Offerings, the holders of the Original Warrants previously made substantially the same representations and warranties to the Company as are contained in representations (2) through (5). In the case of the Registered Offerings, such representations and warranties were required under applicable federal and state securities laws, both to comply with the confidential marketing requirements for registered direct offerings under federal securities laws and to comply with certain exemptions from registration under applicable state securities laws. The Company maintains the warrant registers for each series of Original Warrants and is aware that there have been extremely limited transfers of the Original Warrants since their initial issuances in the Original Offerings. In the few cases where transfers have been made, as a prerequisite to recording such transfers, the Company has required substantially the same representations to be made by the transferee, so that such transfers could comply with the requirements of applicable federal and state securities laws. As a result of the foregoing, the Company anticipates that the holders of the Original Warrants will have no reservation making such representations again in connection with the offer to amend the Original Warrants. The Company intends to rely on Section 4(a)(2) of the Securities Act, and Rule 506 promulgated thereunder, and on exemptions from registration under applicable state securities laws, as applicable exemptions for its offer to amend the Original Warrants and, in the case of the Original Warrants that were originally issued in the Private Placements, for its issuance of common stock upon exercise of the amended warrants. The Company intends to rely on such representations in determining that such exemptions are available. The Company has implemented the Offer to Amend and Exercise without any form of general solicitation or general advertising. The Company acknowledges that it cannot exclude from the tender offer any holders who fail to make such representations, and that the Company may be required to cancel the tender offer if the Company determines that valid exemptions from registration for all securities to be issued in the tender offer are not available under applicable federal and state securities laws. Based on prior representations provided by holders in connection with the Original Offerings and limited subsequent transfers of any Original Warrants, the Company anticipates that each of the holders of the Original Warrants will be able to make the representations and warranties set forth on page 2 of the Acknowledgement and Representations and Warranties, and will in fact make such representations, so that the Offer to Amend and Exercise will qualify for exemptions under applicable federal and state securities laws—and, most importantly for these purposes, that no one will be excluded from participating in the tender offer by reason of the inclusion of these representations and warranties. Nevertheless, the Company will revise the Tender Offer Statement to clarify that it will not assert that representations and warranties (2) through (5), set forth on page 2 of the Acknowledgement and Representations and Warranties, constitute a waiver of any potential liability of the Company under federal securities laws if a claim is made against the Company. In addition, the Company will revise the Tender Offer Statement to clarify that the Company will not accept any Election to Participate and Exercise Warrant from or on behalf of any Original Warrant holders if the Company determines that valid exemptions from registration for all securities to be issued in the tender offer are not available under applicable federal and state securities laws. In such case, the Company acknowledges that it may not consummate the transactions contemplated by the tender offer. If you have any questions with respect to the foregoing, please feel free to call me at (973) 597-2476 or James O’Grady at (646) 414-6849. Very truly yours, /s/ Steven M. Skolnick Steven M. Skolnick
2016-10-19 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Acceleration Request CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 October 19, 2016 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-213866 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 9:00 a.m. (Eastern time) on Friday, October 21, 2016, or as soon thereafter as practicable. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Steven M. Skolnick of Lowenstein Sandler LLP, counsel to the Company, at (646) 414-6947, as soon as the Registration Statement has been declared effective. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2016-10-11 - UPLOAD - CytoDyn Inc.
Mail Stop 4546 October 7 , 2016 Nader Pourhassan, Ph.D. President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Registration Statement on Form S-3 Filed September 29, 2016 File No. 333-213866 Dear Dr. Pourhassan : 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 Jeffrey Gabor at (202) 551 -2544 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Steven Skolnick , Esq. Lowenstein Sandler, LLP
2016-09-08 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 September 8, 2016 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-3 File No. 333-213349 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 4:30 p.m. (New York time) on Friday, September 9, 2016, or as soon thereafter as practicable. The Company acknowledges that: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • 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 provide a copy of the Commission’s order declaring the Registration Statement effective to the undersigned at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2016-09-07 - UPLOAD - CytoDyn Inc.
Mail Stop 4 546 September 7, 2016 Nader Pourhassan , Ph.D. President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Registration Statement on Form S-3 Filed August 26 , 2016 File No. 333-213349 Dear Dr. Pourhassan : We have limited our review of your registration statement to those issue addressed in our comment. Please respond to this letter by amending your registration statement as requested . If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in a response. After reviewing any amendment to your regis tration statement and the information you provide in response to this comment, we may have additional comments. Incorporation of Certain Information by Reference, page 33 1. Please revise to include the current report on Form 8 -K you filed on August 24, 2016 among the documents you are incorporating by reference. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the fil ing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are respons ible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment, in the event you request acceleration of the effective date of the pending registration statement , 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; Nader Pourhassan , Ph.D. CytoDyn Inc. September 7, 2016 Page 2 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding reques ts for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Michael J. Lerner, Esq.
2016-02-12 - UPLOAD - CytoDyn Inc.
Mail Stop 4720 February 12, 2016 Nader Pourhassan , Ph.D. President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Registration Statement on Form S-1 Filed February 3, 2016 File No. 333-209350 Dear Dr. Pourhassan : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Nader Pourhassan , Ph.D. CytoDyn Inc. February 12, 2016 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . You may contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Michael J. Lerner, Esq.
2016-02-12 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 February 12, 2016 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-1 File No. 333-209350 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 8:30 a.m. (New York time) on Wednesday, February 17, 2016, or as soon thereafter as practicable. The Company acknowledges that: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • 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 provide a copy of the Commission’s order declaring the Registration Statement effective to the undersigned at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2015-10-01 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Acceleration Request CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 October 1, 2015 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-1 File No. 333-206896 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 8:30 a.m. (New York Time) on Monday, October 5, 2015, or as soon thereafter as practicable. The Company acknowledges that: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • 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 provide a copy of the Commission’s order declaring the Registration Statement effective to the undersigned at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2015-09-21 - UPLOAD - CytoDyn Inc.
Mail Stop 4720
September 21 , 2015
Via E -mail
Nader Pourhassan
President and Chief Executive Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re: CytoDyn Inc.
Registration Statement on Form S-1
Filed September 11 , 2015
File No. 333-206896
Dear Mr. Pourhassan :
This is to advise you that we have not reviewed and will not review your registration
statement .
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In the event you request acceleration of t he effective date of the pending regist ration
statement , please provide a written statement from the company acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclos e 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 ad equacy 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 Unit ed States.
Nader Pourhassan
CytoDyn Inc.
September 21 , 2015
Page 2
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are a ware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .
Please contact Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3675 with any
other questions.
Sincerely,
/s/ Bryan J. Pitko for
Suzanne Hayes
Assistant Director
cc: Via E -mail
Steven M. Skolnick, Esq.
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
2015-09-08 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP Steven M. Skolnick Partner 65 Livingston Avenue Roseland, NJ 07068 T 973 597 2476 F 973 597 2477 sskolnick@lowenstein.com September 8, 2015 Division of Corporation Finance U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attn: Mellissa Campbell Duru Re: CytoDyn Inc. Schedule TO-I Filed August 24, 2015 File No. 005-79349 Dear Ms. Duru: On behalf of CytoDyn Inc. (the “Company”), we are hereby responding to the letter, dated September 3, 2015 (the “Comment Letter”), from Mellissa Campbell Duru, Special Counsel, Office of Mergers & Acquisitions of the Securities and Exchange Commission (the “Commission”), regarding the Company’s Schedule TO-I, filed on August 24, 2015 (the “Schedule TO”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Schedule TO, as reflected in the Comment Letter. The Company’s response is set forth below each comment. The Company has authorized us to respond to the Comment Letter as follows: Offer to Purchase Will the Amended Warrants, the shares of Common Stock issued in exchange for the Eligible Notes in the offer …, page 3 1. Clarify the exemptions from registration under the Securities Act to which you refer and upon which you intend to rely on for purposes of the issuance of Amended Warrants and shares of common stock pursuant to the offer. We may have further comment. Each of the offerees will have re-confirmed that they are an “accredited investor” as that term is defined under Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, U.S. Securities and Exchange Commission September 8, 2015 Page 2 as amended (the “Securities Act”), and the Company will be relying on the exemptions provided for in Section 4(a)(2) of the Securities Act for the issuance of the Amended Warrants and the shares of common stock pursuant to the offer. 2. Please supplementally advise us of whether the composition of Eligible Securityholders (number and accredited status) is the same as at the time of the original issuance and if not, how the composition of warrant and note holders has changed. We may have further comment. Based upon representations to be made by the offerees and confirmation from the Company, the composition of Eligible Securityholders (number and accredited status) is the same as at the time of the original issuance. Election Form 3. Please refer to representation (12), which requires holders agree to execute unidentified additional documents as a precursor to Cytodyn determining the validity of the tender of their securities. We also note vague references in representation (14) to the representations and warranties contained in the prior subscription agreement. Please revise to specify what holders are consenting to. Based upon the comment from the Commission, the Company will be filing with the Commission and mailing to the offerees a revised Election Form which will delete representation (12) from the Election Form. In addition, the Company will add the specific represenations and warranties from the prior subscription agreement that the offerees will be consenting to. 4. Refer to the representation under (13). This representation requires a holder agree to a term of the offer which is seemingly outside of his/her control. Please remove the representation or advise. Note also our subsequent comment. Based upon the comment from the Commission, the Company will be filing with the Commission and mailing to the offerees a revised Election Form which will delete representation (13) from the Election Form. 5. We note the representation that the offer is not being offered to holders “in any State or other jurisdiction in which the Offer would not be in compliance with the laws of such State or other jurisdiction.” Please explain to us how limiting participation in this manner is consistent with Rule 13e-4(f)(8)(i). If the company is attempting to rely on Exchange Act Rule 13c-4(f)(9)(ii), we note that Rule 13e-4(f)(9)(ii) is restricted to state law, and that the disclosure does not appear to track the language of that rule. For guidance, refer to Exchange Act Release No. 34-58597, Section II.G.1 (September 19, 2008). U.S. Securities and Exchange Commission September 8, 2015 Page 3 As stated in our response to comment #4, based upon the comment from the Commission, the Company will be filing with the Commission and mailing to the offerees a revised Election Form which will delete representation (13) from the Election Form. The Company hereby 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. If you have any questions with respect to the foregoing, please feel free to call me at (973) 597-2476. Very truly yours, /s/ Steven M. Skolnick Steven M. Skolnick
2015-09-03 - UPLOAD - CytoDyn Inc.
September 3, 2015 Via E-mail Steven M. Skolnick , Esq. Lowenstein Sandler LLP 1251 Avenue of the Americas New York, NY 10020 Re: Cyto Dyn, Inc. Schedule TO -I Filed August 24, 2015 File No. 005 -79349 Dear Mr. Skolnick : We have reviewed the above referenced filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your filing, by providing the requested information, or by advising us of when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropria te, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. Offer to Purchase Will the Amended Warrants, the shares of Common Stock issued in exchange for the Eligi ble Notes in the Offer…, page 3 1. Clarify the exemption s from registration under the Securities Act to which you refer and upon which you intend to rely on for purposes of the issuance of Amended Warrants and shares of commo n stock pursuant to the offer. We may have further comment. 2. Please supplementally advise us of whether the composition of Eligible Securityholders (number and accredited status) is the same as at the time of the original issuance and if not, how the composition of warrant and note h olders has changed. We may have further comment. Steven Skolnick , Esq. Lowenstein Sandler, LLP September 3, 2015 Page 2 Election Form 3. Please refer to representation (12), which requires holders agree to execute unidentified additional documents as a precursor to Cytodyn determining the validity of the tender of their securities. We also note vague references in representation (14) to the representations and warranties contained in the prior subscription agreement. Please revise to specify what holders are consenting to. 4. Refer to th e representation under (13). This representation requires a holder agree to a term of the offer which is seemingly outside of his/her control. Please re move the representation or advise. Note also our subsequent comment. 5. We note the representation that the offe r is not being offered to holders “in any State or other jurisdiction in which the Offer would not be in compliance with the laws of such State or other jurisdiction.” Please explain to us how limiting participation in this manner is consistent with Rule 13e-4(f)(8)(i). If the company is attempting to rely on Exchange Act Rule 13e -4(f)(9)(ii), we note that Rule 13e -4(f)(9)(ii) is restricted to state law, and that the disclosure does not appear to track the language of that rule. For guidance, refer to Ex change Act Release No. 34 -58597, Section II.G.1 (September 19, 2008). We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Steven Skolnick , Esq. Lowenstein Sandler, LLP September 3, 2015 Page 3 In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the Uni ted States. Please contact the undersigned at (202) 551 -3757 with any questions. Sincerely, /s/ Mellissa Campbell Duru Mellissa Campbell Duru Special Counsel Office of Mergers & Acquisitions
2015-09-01 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm Acceleration Request CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 September 1, 2015 VIA EDGAR SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS CytoDyn Inc. Registration Statement on Form S-1 File No. 333-204802 Ladies and Gentlemen: CytoDyn Inc. (the “Company”) hereby respectfully requests the acceleration of the effectiveness of the above-referenced Registration Statement (the “Registration Statement”) so that the Registration Statement will become effective at 4:30 p.m. (New York Time) on Wednesday, September 2, 2015, or as soon thereafter as practicable. The Company acknowledges that: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • 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 provide a copy of the Commission’s order declaring the Registration Statement effective to the undersigned at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Very truly yours, CytoDyn Inc. /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer
2015-06-16 - UPLOAD - CytoDyn Inc.
June 16, 2015 Via E -mail Nader Pourhassan President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc . Registration Statement on Form S-1 Filed June 8 , 2015 File No. 333-204802 Dear Mr. Pourhassan : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of t he effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the ade quacy 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 Unite d States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aw are of their respective responsibilities under Nader Pourhassan CytoDyn Inc. June 16, 2015 Page 2 the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . You may contact Tara Keating Brooks at (202) 551 -8336 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Steven M. Skolnick, Esq. Lowenstein Sandler LLP
2014-07-14 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP July 11, 2014 VIA EDGAR AND EMAIL Mr. Jeffrey P. Riedler Assistant Director Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549-3628 Subject: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed July 2, 2014 File No. 000-49908 Dear Mr. Riedler: We are in receipt of your letter dated July 10, 2014, regarding the subject filing. Set forth below is the response of CytoDyn Inc. (the “Company”) to the comment in your letter. Proposal 2—Approval of a Reverse Stock Split and an Amendment to the Company’s Articles of Incorporation to Implement the Reverse Stock Split, page 11. 1. We note that you have proposed a reverse stock split and an amendment to your Articles of Incorporation to implement the reverse stock split. We also note your statement that the board will not decrease the authorized common stock in connection with the reverse stock split, and that any additional common stock so authorized will be available for issuance for a variety of corporate purposes. Please revise to disclose whether you have any plans, arrangements, understandings, etc. with respect to the issuance of any of the shares that would be newly available for issuance as a result of the reverse split. If such plans exist, please disclose all material information. Response: The Company has no specific plans, arrangements or understandings regarding the issuance of shares of Common Stock that may become available for CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.980.8549 Jeffrey P. Riedler July 11, 2014 Page 2 issuance as a result of implementation of the reverse stock split if Proposal 2 is approved by the Company’s shareholders at the annual meeting to be held on August 20, 2014 (the “2014 Annual Meeting”). However, the Company will insert the following paragraph in the definitive proxy statement to be filed on EDGAR by the planned mailing date of July 18, 2014, immediately above the heading “Effects of the Reverse Stock Split” on page 13 of the subject filing: “As of July 10, 2014, the Company had approximately 5.5 million shares of Common Stock remaining authorized for issuance in excess of outstanding shares and shares reserved for issuance upon the exercise or conversion of stock options, warrants and convertible securities. This number may increase to up to a total of about 13 million shares (absent the exercise of certain outstanding warrants or other stock issuances) in October 2014. The Company currently anticipates that it will need to raise additional capital in the fall of 2014 to fund ongoing research and development activities. Such financing may include the issuance or reservation for issuance of additional shares of Common Stock that may become available as a result of the Reverse Stock Split. The Company has not, however, entered into any contracts, arrangements or understandings with respect to any such capital-raising efforts, including the engagement of any investment bankers, or made any specific determinations as to the amount or terms of any such financing.” Closing Comments The undersigned hereby acknowledges on behalf of each director and executive officer of the Company, who comprise the participants in the proxy solicitation relating to the 2014 Annual Meeting on behalf of the Company’s Board of Directors, that: • the participant 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 participant 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. CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.980.8549 Jeffrey P. Riedler July 11, 2014 Page 3 If you have any additional questions, please contact the undersigned at (360) 980-8524 or Mary Ann Frantz of Miller Nash LLP at (503) 205-2552. Sincerely, /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer cc: Mr. Matthew Jones CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.980.8549
2014-07-14 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP July 14, 2014 VIA EDGAR AND EMAIL Mr. Jeffrey P. Riedler Assistant Director Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549-3628 Subject: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed July 2, 2014 File No. 000-49908 Dear Mr. Riedler: In accordance with the oral request made by Matthew Jones in his telephone conversation with Mary Ann Frantz, outside counsel for CytoDyn Inc. (the “Company”), this morning, the disclosure to be inserted by the Company in its definitive proxy statement to be filed on EDGAR in response to the Staff’s letter dated July 10, 2014, has been revised as follows: “As of July 10, 2014, the Company had approximately 5.5 million shares of Common Stock remaining authorized for issuance in excess of outstanding shares and shares reserved for issuance upon the exercise or conversion of stock options, warrants and convertible securities. This number may increase to up to a total of about 13 million shares (absent the exercise of certain outstanding warrants or other stock issuances) in October 2014. The Company currently anticipates that it will need to raise additional capital in the fall of 2014 to fund ongoing research and development activities. Such financing may include the issuance or reservation for issuance of additional shares of Common Stock that may become available as a result of the Reverse Stock Split. The Company has not, however, entered into any contracts, arrangements or understandings with respect to any such capital-raising efforts, including the engagement of any investment bankers, or made any specific determinations as to the amount or terms of any such financing. Other than as disclosed in this proxy statement, the Company has no other specific plans, arrangements or understandings regarding the issuance of shares of Common Stock that may become available for issuance as a result of CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.980.8549 Jeffrey P. Riedler July 14, 2014 Page 2 implementation of the Reverse Stock Split if Proposal 2 is approved by the Company’s shareholders at the Annual Meeting.” The acknowledgments requested in the Staff’s July 10 letter were previously provided in the Company’s letter dated July 11, 2014. If you have any additional questions, please contact the undersigned at (360) 980-8524 or Mary Ann Frantz of Miller Nash LLP at (503) 205-2552. Sincerely, /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer cc: Mr. Matthew Jones CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 T 360.980.8524 F 360.980.8549
2014-07-14 - UPLOAD - CytoDyn Inc.
July 14, 2014 Via E -mail Nader Z. Pourhassan, Ph.D. President and Chief Executive Officer CytoDyn Inc . 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed July 2, 2014 File No. 000 -49908 Dear Dr. Pourhassan : We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are 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 require. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedle r Assistant Director
2014-07-11 - UPLOAD - CytoDyn Inc.
July 10, 2014 Via E -mail Nader Z. Pourhassan, Ph.D. President and Chief Executive Officer CytoDyn Inc . 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Preliminary Proxy Statement on Schedule 14A Filed July 2, 2014 File No. 000-49908 Dear Dr. Pourhassan : We have limited our review of your filing to the issues addressed in the following comment. Please respond to this letter by amending your filing and providing the requested information If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to this comment , we may have additional comments. Proposal 2 —Approval of a Reverse Stock Split and an Amendment to the Company’s Articles of Incorporation to Implement the Reverse Stock Split, page 11 1. We note th at you have proposed a reverse stock split and an amendment to your Articles of Incorporation to implement the reverse stock split . We also note your statement that the board will not decrease the authorized commo n stock in connection with the reverse stock split, and that any additional common s tock so authorized will be available for issuance for a variety of corporate pur poses. Please revise to disclose whether you have any plans, arrangements, understandings, etc. with respect to the issuance of any of the shares that would be newly available for issuance as a result of the reverse split . If such plans exist, please disclose all material information. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since th e 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. Nader Z. Pourhassan, Ph.D. CytoDyn Inc . July 10, 2014 Page 2 In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with r espect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Matthew Jones at (202) 551 -3786, Dan Greenspan at (202) 551 -3623, or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director
2014-02-05 - CORRESP - CytoDyn Inc.
CORRESP 1 filename1.htm CORRESP February 4, 2014 Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Subject: Request for Acceleration Registration Statement on Form S-1 (File No. 333-192361) Ladies and Gentlemen: Reference is made to the subject registration statement filed by CytoDyn Inc. (the “Registrant”) on November 15, 2013 and amended on January 31, 2014. The Registrant hereby requests acceleration of the effective date of said registration statement so that it becomes effective at 4:00 p.m. Eastern Standard Time on February 5, 2014, or as soon thereafter as practicable. In connection with the acceleration request, the Registrant acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please provide a copy of the Commission’s order declaring the Registration Statement effective via email to me at mmulholland@cytodyn.com, as well as to Mary Ann Frantz at maryann.frantz@millernash.com. Very truly yours, CYTODYN INC. By /s/ Michael D. Mulholland Michael D. Mulholland Chief Financial Officer, Treasurer, and Corporate Secretary CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660 Telephone (360) 980-8524
2014-02-04 - CORRESP - CytoDyn Inc.
CORRESP
1
filename1.htm
CORRESP
February 4, 2014
Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Subject:
Request for Acceleration
Registration Statement on Form S-1
(File No. 333-192361)
Reference is made to the subject registration statement filed by
CytoDyn Inc. (the “Registrant”) on November 15, 2013 and amended on January 31, 2014.
The Registrant hereby requests
acceleration of the effective date of said registration statement so that it becomes effective on February 5, 2014, or as soon thereafter as practicable.
In connection with the acceleration request, 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 Registrant from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and
•
the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please provide a copy of the Commission’s order declaring the Registration Statement effective via email to me at
mmulholland@cytodyn.com, as well as to Mary Ann Frantz at maryann.frantz@millernash.com.
Very truly yours,
CYTODYN INC.
By
/S/ Michael D. Mulholland
Michael D. Mulholland
Chief Financial Officer, Treasurer,
and Corporate Secretary
CytoDyn Inc. 1111 Main Street, Suite 660, Vancouver, Washington 98660
Telephone (360) 980-8524
2013-11-22 - UPLOAD - CytoDyn Inc.
November 22, 2013 Via E -mail Nader Pourhassan President and Chief Executive Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Registration Statement on Form S-1 Filed November 15, 2013 File No. 333-192361 Dear Dr. Pourhassan : We have limited our review of your registration statement to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments , we may have additional comments. Selling Shareholders, page 17 1. Please disclose , for each selling shareholder, the amount of shares owned by such selling shareholder , the amount to be offered for the selling shareholder’s account, and the amount and ( if one percent or more) the percentage of the shares to be owned by such selling shareholder after completion of the offering in accordance with Item 507 of Regulation S -K. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Nader Pourhassan CytoDyn Inc. November 22, 2013 Page 2 Notwithstanding our comments, in the event you request accelera tion of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility fo r the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding reques ts for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Matthew Jones at (202) 551 -3786, Dan Greenspan at (202) 551 -3623, or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Mary Ann Frantz Miller Nash LLP 111 S.W. Fifth Avenue, Suite 3400 Portland, Oregon 97204
2011-02-16 - UPLOAD - CytoDyn Inc.
February 16, 2011
Mr. Allen D. Allen President and Chief Executive Officer CytoDyn, Inc. 1511 Third Street Sante Fe, New Mexico 87505
Re: CytoDyn, Inc.
Form 10-K for the year ended May 31, 2010 Filed December 3, 2010
File No. 000-49908
Dear Mr. Allen:
We have completed our review of your form 10-K and related filings and have no further
comments at this time.
Sincerely,
Jeffrey Riedler
Assistant Director
2011-02-04 - CORRESP - CytoDyn Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
CYTODYN INC.
1511 Third Street
Santa Fe, New Mexico 87505
February 4, 2011
VIA EDGAR
---------
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: John L. Krug, Senior Counsel
Dan Greenspan, Special Counsel
Jeffrey Riedler, Assistant Director
Re: CytoDyn Inc.
Form 10-K for the fiscal year ended May 31, 2010
File No. 000-49908
Dear Mr. Krug:
On behalf of CytoDyn Inc. ("CytoDyn"), I am writing in response to the
comments set forth in your letter dated January 25, 2011 (the "Comment Letter").
For the convenience of the Staff of the Division of Corporation Finance (the
"Staff") of the Securities and Exchange Commission (the "SEC"), each of the
Staff's comments is repeated below, along with CytoDyn's response to each
comment set forth immediately following the comment.
Comment 1
---------
Form 10-K for the Year Ended May 31, 2011
-----------------------------------------
General
-------
1. We note you have not filed a proxy statement since at least 2007. Since
you are registered with the Commission pursuant to Section 12 of the
Exchange Act and, accordingly, subject to the proxy rules, please provide
an explanation why you have not filed required proxy or information
statements and your intention with respect to the future filing of such
documents. We may have additional comments.
Response to Comment 1
---------------------
CytoDyn filed its last proxy statement on April 2, 2007 for the annual
meeting of shareholders held on April 15, 2007. Since that time, CytoDyn has
experienced financial difficulties and, as a result, has lacked the financial
resources to file annual and quarterly reports with the SEC. In addition,
CytoDyn did not prepare or file its required proxy or information statements
during this time, not only because of its lack of resources, but also because it
would have not been able to furnish, among other things, an annual report,
including the necessary audited financial statements, to security holders as
required by Rule 14a-3(b) of the Securities Exchange Act of 1934.
<PAGE>
Securities and Exchange Commission
February 4, 2011
Page 2 of 3
More recently, CytoDyn's position has improved due to its August 2010
private placement offering to sell 2,000,000 shares of CytoDyn's no par common
stock to accredited investors at $1.00 per share. As of November 30, 2010,
CytoDyn has raised approximately $720,500 in this private placement.
As a result of its stronger financial position, CytoDyn recently
commenced the preparation and filing of its delinquent annual and quarterly
reports with the SEC and now believes it is current with respect to these
filings. It should be noted that, for each of the three most recently concluded
fiscal years, CytoDyn filed Form 10-Ks which included all disclosure items,
without any incorporation by reference to a to-be-filed proxy statement. In
addition to preparing and filing its delinquent annual and quarterly reports,
CytoDyn engaged Holland & Knight LLP in December of 2010 to assist CytoDyn in
complying with its future reporting obligations.
CytoDyn expects to prepare and file a proxy statement for its next annual
meeting of shareholders.
Comment 2
---------
Directors, Executive Officers and Corporate Governance, page 45
---------------------------------------------------------------
2. Please confirm that your future filings will address the following:
o Provide a discussion of Dr. Pourhassan's, Messrs. Naydenov and Van
Ness' specific work experience for at least the past five years
indicating the place and period of employment; and
o Define the term "C level management position."
Response to Comment 2
---------------------
CytoDyn confirms that it will disclose the following in its future
filings:
o A discussion of Dr. Pourhassan's, Messrs. Naydenov and Van Ness'
specific work experience for at least the past five years
indicating the place and period of employment; and
o A definition of the term "C level management position."
Comment 3
---------
Audit Committee, page 47
------------------------
3. Please confirm that your future filings will disclose where shareholders
can obtain and/or view the charter for the audit committee.
<PAGE>
Securities and Exchange Commission
February 4, 2011
Page 3 of 3
Response to Comment 3
---------------------
CytoDyn confirms that it will disclose where shareholders can obtain
and/or view the charter for the audit committee in its future filings.
* * *
CytoDyn acknowledges the following:
o CytoDyn is responsible for the adequacy and accuracy of the
disclosure in its Commission filings;
o 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
o CytoDyn 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.
CytoDyn believes that the foregoing responds fully to each of the
questions in the Staff's January 25, 2011 Comment Letter. Please let us know if
you have any questions about our responses.
Respectfully submitted,
CYTODYN INC.
By: /s/ Kenneth J. Van Ness
-------------------------------------
Kenneth J. Van Ness
President and Chief Executive Officer
cc: Allen D. Allen, CytoDyn Inc.
Bernie A. Barton, Jr., Esq., Holland & Knight LLP
Dino A. Doyle, Esq., Holland & Knight LLP
Richard Hadlow, Esq., Holland & Knight LLP
Tom Bellante, Pender Newkirk & Company, LLP
</TEXT>
</DOCUMENT>
2011-01-25 - UPLOAD - CytoDyn Inc.
January 25, 2011
Mr. Alan D. Allen President and Chief Executive Officer CytoDyn, Inc. 1511 Third Street Santa Fe, New Mexico 87505
Re: CytoDyn, Inc.
Form 10-K filed December 3, 2010
File No. 000-49908
Dear Mr. Allen:
We have reviewed your filing and have the following comments.
Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circum stances, please tell us w hy in your response.
After reviewing the information you provide in response to these comments, we may
have additional comments. Form 10-K
General
1. We note you have not filed a proxy statem ent since at least 2007. Since you are
registered with the Commission pursuant to Section 12 of the Exchange Act and, accordingly, subject to the proxy rules, pleas e provide an explanation why you have not
filed required proxy or information statemen ts and you intention w ith respect to the
future filing of such documents. We may have additional comments.
Directors, Executive Officers and Corporate Governance, page 45
2. Please confirm that your future filings will address the following:
Provide a discussion of Dr. Pourhassan ’s, Messrs. Naydenov and Van Ness’
specific work experience for at least the past five years indicating the place and
period of employment; and
Define the term “C level management position.”
Mr. Allen D. Allen CytoDyn, Inc. January 25, 2011 Page 2
Audit Committee, page 47
3. Please confirm that your future filings will di sclose where shareholders can obtain and/or
view the charter for the audit committee. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
Please contact John Krug, Senior Counsel, at (202) 551-3862, or Dan Greenspan, Special
Counsel, at (202) 551-36 23 with any questions.
Sincerely,
Jeffrey Riedler
Assistant Director
2006-11-02 - CORRESP - CytoDyn Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
CytoDyn, Inc.
227 E. Palace Ave., Suite M, Santa Fe, NM 87501
Santa Fe, NM 87501
November 2, 2006
VIA FACSIMILE (202-772-9217) AND EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Amy C. Bruckner
Re: CytoDyn, Inc.
File No. 000-49908
Responses to SEC Staff comments made by letter dated October 10, 2006
Dear Ms. Bruckner:
Set forth below are the responses of CytoDyn, Inc. (the "Company"), to
the SEC Staff comments made by letter dated October 10, 2006 (the "Comment
Letter"), in connection with the Company's Current Report on Form 8-K (File No.
000-49908), filed on October 6, 2006 (the "Form 8-K"). The Company's responses
are keyed by numbered paragraphs to correspond to the comments made by the Staff
in the Comment Letter. Each response is preceded by a reproduction of the
corresponding Staff comment as set forth in the Comment Letter.
Item 4.01 Form 8-K filed October 6, 2006
----------------------------------------
1. Please revise your filing to state explicitly whether during your two
most recent fiscal years ended May 31, 2006 and subsequent interim
period through the date of resignation there were any disagreements
with Cordovano and Honeck, LLP, as described in Item 304(a)(1)(iv)(A)
of Regulation S-B. You should specify the "interim period" as the
"interim period through October 3, 2006.
Response: The Company informs the Staff that it has revised the Form 8-K
-------- to respond to the disclosure requirements of Item
304(a)(1)(A)(iv)(A) through the end of our two most recent
fiscal years and the subsequent interim period. In addition,
the Company incorporated the specific language requested by
the Staff.
2. Please also revise your filing to state explicitly whether during your
two most recent fiscal years ended May 31, 2006 and subsequent interim
period through October 3, 2006 you consulted Pender Newkirk & Company,
LLP with respect to any of the matters described in Item 304(a)(2) of
Regulation S-B.
<PAGE>
Responses to SEC Staff comments made by letter dated June 30, 2006
November 2, 2006
Page Two
Response: The Company informs the Staff that it has revised the Form 8-K
-------- to respond to the disclosure requirements of Item 304(a)(2)
through the end of our two most recent fiscal years and the
subsequent interim period.
Please note that the belated filing of the amendment to the Form 8-K
was due in part to extenuating circumstances. Corinne Allen, the Company's Vice
President, went into pre-term labor several weeks ago and delivered her baby on
Monday. Fortunately, but mother and baby are doing quite well.
If you have any questions regarding the responses set forth herein or
require additional information, please contact me at (505) 988-5520.
Sincerely,
/s/ Allen D. Allen
--------------------------------
Allen D. Allen
President
</TEXT>
</DOCUMENT>
2006-10-23 - UPLOAD - CytoDyn Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 October 23, 2006 Mr. Allen D. Allen President Cytodyn, Inc. 227 E. Palace Avenue, Suite M Santa Fe, New Mexico 87501
Re: Cytodyn, Inc.
Item 4.02(b) Form 8-K
Filed October 20, 2006
File No. 000-49908
Dear Mr. Ewen:
We have reviewed your filing and have the following comment. Where indicated,
we think you should revise your document in response to this comment. If you disagree,
we will consider your explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your explanation.
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 comment or any other aspect of our
review. Feel free to call us at the telephone number listed at the end of this letter.
Item 4.02(b)
1. Please amend your filing and include a letter, as an exhibit, from your
independent accountant stating whether they agree with the statements made in
your filing and, if not, stati ng the respects in which they do not agree. Refer to
Item 4.02(c)
Please respond to this comment within five business days or tell us when you will
respond. Please furnish a letter that responds to our comment by providing the requested
information. Detailed letters greatly facilitate our review. Please file your letter on
EDGAR under the form type label CORRESP. Please understand that we may have
additional comments after reviewin g your response to our comment.
Mr. Allen D. Allen
Cytodyn, Inc. October 23, 2006 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 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 comments, please provide, in writing, a
statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing. If you have any questions, please call me at (202) 551-3665.
S i n c e r e l y , J. Todd Sherman S t a f f A c c o u n t a n t
2006-10-10 - UPLOAD - CytoDyn Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 October 10, 2006 Mr. Allen D. Allen President CytoDyn, Inc. 227 E. Palace Ave., Suite M Santa Fe, NM 87501
Re: CytoDyn, Inc.
Item 4.01 Form 8 -K filed September 20, 2006
File No. 001-13441
Dear Mr. Allen:
We have reviewed your filing and have the following comments. Where
indicated, we think you should revise your doc ument in response to these comments. If
you disagree, we will consider your explanation as to why our comments are inapplicable
or revisions are unnecessary. In some of our comments, we ask you to provide us with
information so we may better understand your disclosure.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our
review. Feel free to call us at the telephone number listed at the end of this letter.
Item 4.01 Form 8-K filed October 6, 2006
1. Please revise your filing to state explicitly whether during your two most recent
fiscal years ended May 31, 2006 and subse quent interim period through the date
of resignation there were any disagr eements with Cordovano and Honeck, LLP,
as described in Item 304(a)(1)(iv)(A) of Regulation S-B. You should specify the
“interim period” as the “inter im period through October 3, 2006.”
2. Please also revise your filing to state e xplicitly whether during your two most
recent fiscal years ended May 31, 2006 a nd subsequent interim period through
Mr. Allen D. Allen
CytoDyn, Inc. October 10, 2006 Page 2
October 3, 2006 you consulted Pender Newk irk & Company, LLP with respect to
any of the matters described in It em 304(a)(2) of Regulation S-B.
* * * *
Please revise your filing and provide us the information requested within 5
business days of the date of this letter or tell us when you will provide a response prior to
the expiration of the 5-day period. Please furn ish a letter with your response that keys
your response to our comments. Detailed letters greatly faci litate our review. You should
furnish the letter to us via EDGAR under the form type label CORRESP. Please
understand that we may have additional comm ents after reviewing your response to our
comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that they have provided all information required
under the Securities Exchange Act of 1934 and that they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please do not hesitate to call me at (202) 551-3657.
Sincerely,
A m y C . B r u c k n e r S t a f f A c c o u n t a n t
2006-09-07 - CORRESP - CytoDyn Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
CytoDyn, Inc
227 E. Palace Avenue, Suite M
Santa Fe, NM 87501
(505) 988-5520 voice
(800) 417-7252 fax
September 7, 2006
Securities and Exchange Commission
Mail Stop 6010
Washington D.C. 20549
Attn: Division of Corporate Finance J. Todd Sherman
Re: CytoDyn, Inc. - SEC File No. 000-49908
--------------------------------------
Dear Mr. Sherman:
Thank you for your fax of September 5, 2006 regarding our 8K filed September 1,
2006. We are pleased that you have reviewed our disclosures and have provided
advice to us to help us with compliance with Item 4.02(b) of Form 8K. Our
response is keyed to correspond to the comment in your letter and is preceded by
a reproduction of the corresponding Staff comment.
Item 4.02(b)
------------
1. Please disclose whether the audit committee, or board of directors in
the absence of an audit committee, or authorized office or officers,
discussed with the independent accountant the matters disclosed in the
filing as required by Item 4.02(b)(4).
Company's response
------------------
The company's authorized officers did discuss the matters disclosed in
the company's 8K that was filed September 1, 2006 with the independent
auditor from Cordovano & Honeck. The discussions led to the disclosures
as filed on the 8K. The authorized officers also communicated the
matters disclosed with the audit committee. The officers and audit
committee reviewed the disclosures as filed with the Commission and are
fully aware of the matters disclosed. The officers, audit committee
members and independent auditor are all in agreement with the
disclosures filed.
<PAGE>
Also in connection with the response to your fax of September 5, 2006, we
acknowledge that:
o The company is responsible for the adequacy and accuracy of the disclosure
in the filing
o 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;
o The company may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under federal securities laws of
the United States.
Thank you for your assistance with our Form 8K disclosures filed September 1,
2006. Please let us know if you have any additional comments.
Best regards,
/S/ Wellington Ewen
------------------------
Wellington Ewen,
Chief Financial Officer
CytoDyn, Inc.
</TEXT>
</DOCUMENT>
2006-09-06 - UPLOAD - CytoDyn Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 September 5, 2006 Mr. Wellington A. Ewen Chief Financial Officer Cytodyn, Inc. 227 E. Palace Avenue, Suite M Santa Fe, New Mexico 87501
Re: Cytodyn, Inc.
Item 4.02 Form 8-K
Filed September 1, 2006
File No. 000-49908
Dear Mr. Ewen:
We have reviewed your filing and have the following comment. Where indicated,
we think you should revise your document in response to this comment. If you disagree,
we will consider your explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your explanation.
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 comment or any other aspect of our
review. Feel free to call us at the telephone number listed at the end of this letter.
Item 4.02(b)
1. Please disclose whether the audit committ ee, or the board of directors in the
absence of an audit committee, or authori zed office or officers, discussed with the
independent accountant the matters disclo sed in the filing as required by Item
4.02(b)(4).
Please respond to this comment within five business days or tell us when you will
respond. Please furnish a letter that responds to our comment by providing the requested
information. Detailed letters greatly facilitate our review. Please file your letter on
EDGAR under the form type label CORRESP. Please understand that we may have
additional comments after reviewin g your response to our comment.
Mr. Wellington A. Ewen
Cytodyn, Inc. September 5, 2006 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 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 comments, please provide, in writing, a
statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing. If you have any questions, please call me at (202) 551-3665.
S i n c e r e l y , J. Todd Sherman S t a f f A c c o u n t a n t