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ADIAL PHARMACEUTICALS, INC.
Response Received
4 company response(s)
Medium - date proximity
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
High
ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
↓
ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
↓
ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
↓
ADIAL PHARMACEUTICALS, INC.
Response Received
2 company response(s)
High - file number match
↓
Company responded
2023-07-13
ADIAL PHARMACEUTICALS, INC.
References: July 7, 2023
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ADIAL PHARMACEUTICALS, INC.
Response Received
2 company response(s)
High - file number match
↓
Company responded
2022-03-09
ADIAL PHARMACEUTICALS, INC.
References: March 7, 2022
Summary
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Company responded
2022-04-06
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-04-27
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2020-04-28
ADIAL PHARMACEUTICALS, INC.
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Company responded
2022-03-31
ADIAL PHARMACEUTICALS, INC.
References: March 22, 2022
Summary
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-03-22
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-12-13
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2021-12-14
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-07-23
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2021-07-27
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-06-04
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2021-06-08
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-04-26
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2021-05-24
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
Company responded
2020-12-14
ADIAL PHARMACEUTICALS, INC.
Summary
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SEC wrote to company
2020-12-15
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-08
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2020-07-08
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-03-28
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2019-03-28
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2019-02-08
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2019-02-12
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2019-02-13
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2019-02-19
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2019-02-19
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
8 company response(s)
High - file number match
Company responded
2017-09-25
ADIAL PHARMACEUTICALS, INC.
Summary
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SEC wrote to company
2017-10-05
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2017-10-25
ADIAL PHARMACEUTICALS, INC.
References: October 5, 2017
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Company responded
2017-12-15
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2017-12-15
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2017-12-19
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2018-07-03
ADIAL PHARMACEUTICALS, INC.
References: July 2, 2018
Summary
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Company responded
2018-07-24
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2018-07-24
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-07-03
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2018-06-21
ADIAL PHARMACEUTICALS, INC.
Summary
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Company responded
2018-06-25
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-09-21
ADIAL PHARMACEUTICALS, INC.
Summary
Generating summary...
ADIAL PHARMACEUTICALS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2017-09-19
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-07-03
ADIAL PHARMACEUTICALS, INC.
Summary
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ADIAL PHARMACEUTICALS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-06-12
ADIAL PHARMACEUTICALS, INC.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-06 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-05 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-04 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-287679 | Read Filing View |
| 2025-04-01 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 377-07825 | Read Filing View |
| 2024-12-26 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-12-26 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-283968 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-278652 | Read Filing View |
| 2024-04-17 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-01-22 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-01-19 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-276496 | Read Filing View |
| 2023-11-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-11-14 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-13 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-07 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-04-06 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-31 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-22 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-09 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-07 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-12-14 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-12-13 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-07-23 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-06-08 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-06-04 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-04-26 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-12-15 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-12-14 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-07-08 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-07-08 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-04-28 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-03-28 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-03-28 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-03 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-03 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-06-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-06-21 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-10-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-21 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-07-03 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-06-12 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-04 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-287679 | Read Filing View |
| 2025-04-01 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 377-07825 | Read Filing View |
| 2024-12-26 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-283968 | Read Filing View |
| 2024-04-17 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-278652 | Read Filing View |
| 2024-01-19 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | 333-276496 | Read Filing View |
| 2023-11-14 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-07 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-22 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-07 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-12-13 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-07-23 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-06-04 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-04-26 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-12-15 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-07-08 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-03-28 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-03 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-06-21 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-10-05 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-21 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-07-03 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-06-12 | SEC Comment Letter | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-06 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2025-06-05 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-12-26 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-04-17 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2024-01-22 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-11-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2023-07-13 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-04-06 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-31 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2022-03-09 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-12-14 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-06-08 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2021-05-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-12-14 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-07-08 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2020-04-28 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-03-28 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2019-02-12 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-24 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-07-03 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2018-06-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-12-15 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-10-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-25 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
| 2017-09-19 | Company Response | ADIAL PHARMACEUTICALS, INC. | DE | N/A | Read Filing View |
2025-06-12 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP 1 filename1.htm June 12, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Doris Stacy Gama Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 6, 2025 File No: 333-287826 Dear Ms. Gama: Adial Pharmaceuticals, Inc. (the " Registrant ") hereby requests that the effective date of the above-referenced Registration Statement on Form S-1, as amended (File No. 333-287826), be accelerated by the U.S. Securities and Exchange Commission (the " Commission ") to become effective on Monday, June 16, 2025 , at 9:15 a.m ., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238 with any questions you may have concerning this request, and please notify either of them when this request for acceleration has been granted. Very truly yours, ADIAL PHARMACEUITCALS, INC. By: /s/ Cary Claiborne Name: Cary Claiborne Title: Chief Executive Officer cc: Leslie Marlow, Blank Rome LLP
2025-06-12 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP 1 filename1.htm June 12, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Doris Stacy Gama Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 6, 2025 File No: 333-287826 Dear Ms. Gama: Reference is made to our letter, filed as correspondence via EDGAR on June 6, 2025, requesting acceleration of effectiveness of the above-referenced Registration Statement for Tuesday, June 10, 2025 at 9:00 a.m. Eastern Time, which was amended via telephone and email to Wednesday , June 12, 2025 at 5:00 p.m. We are no longer requesting that such Registration Statement be declared effective at the time mentioned above, and we hereby formally withdraw our request for acceleration of the above referenced effective date. Very truly yours, ADIAL PHARMACEUITCALS, INC. By: /s/ Cary Claiborne Name: Cary Claiborne Title: Chief Executive Officer cc: Leslie Marlow, Blank Rome LLP
2025-06-06 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP 1 filename1.htm June 6, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Doris Stacy Gama Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 6, 2025 File No: 333-287826 Dear Ms. Gama: Adial Pharmaceuticals, Inc. (the " Registrant ") hereby requests that the effective date of the above-referenced Registration Statement on Form S-1, as amended (File No. 333-287826), be accelerated by the U.S. Securities and Exchange Commission (the " Commission ") to become effective on Tuesday, June 10, 2025 , at 9:00 a.m ., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238 with any questions you may have concerning this request, and please notify either of them when this request for acceleration has been granted. Very truly yours, ADIAL PHARMACEUITCALS, INC. By: /s/ Cary Claiborne Name: Cary Claiborne Title: Chief Executive Officer cc: Leslie Marlow, Blank Rome LLP
2025-06-05 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP 1 filename1.htm June 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 30, 2025 File No: 333-287679 Dear Mr. Howes: Adial Pharmaceuticals, Inc. (the " Registrant ") hereby requests that the effective date of the above-referenced Registration Statement on Form S-3, as amended (File No. 333-287679), be accelerated by the U.S. Securities and Exchange Commission (the " Commission ") to become effective on Monday, June 9, 2025 , at 9:00 a.m ., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes Leslie Marlow of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 457-4238 with any questions you may have concerning this request, and please notify either of them when this request for acceleration has been granted. Very truly yours, ADIAL PHARMACEUITCALS, INC. By: /s/ Cary Claiborne Name: Cary Claiborne Title: Chief Executive Officer cc: Leslie Marlow, Blank Rome LLP
2025-06-04 - UPLOAD - ADIAL PHARMACEUTICALS, INC. File: 333-287679
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 4, 2025 Cary Claiborne Chief Executive Officer Adial Pharmaceuticals, Inc. 4870 Sadler Road, Suite 300 Glen Allen, VA 23060 Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 30, 2025 File No. 333-287679 Dear Cary Claiborne: 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: Leslie Marlow, Esq. </TEXT> </DOCUMENT>
2025-04-01 - UPLOAD - ADIAL PHARMACEUTICALS, INC. File: 377-07825
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Vinay Shah Chief Financial Officer Adial Pharmaceuticals, Inc. 4870 Sadler Road, Ste 300 Glen Allen, VA 23060 Re: Adial Pharmaceuticals, Inc. Draft Registration Statement on Form S-1 Submitted March 27, 2025 CIK No. 0001513525 Dear Vinay Shah: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement no later than 48 hours prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Doris Stacey Gama at 202-551-3188 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Leslie Marlow, Esq. </TEXT> </DOCUMENT>
2024-12-26 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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December 26, 2024
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Daniel Crawford
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 20, 2024
File No: 333-283968
Dear Mr. Crawford:
Adial Pharmaceuticals, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1
(File No. 333-283968), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to become effective
on Monday, December 30, 2024, at 4:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Hank Gracin of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Mr. Gracin at (561) 926-7995 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUITCALS, INC.
By:
/s/ Cary Claiborne
Name:
Cary Claiborne
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Hank Gracin, Blank Rome LLP
2024-12-26 - UPLOAD - ADIAL PHARMACEUTICALS, INC. File: 333-283968
December 26, 2024
Cary Claiborne
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
4870 Sadler Road, Ste 300
Glen Allen, VA 23060
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 20, 2024
File No. 333-283968
Dear Cary Claiborne:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Leslie Marlow, Esq.
2024-04-17 - UPLOAD - ADIAL PHARMACEUTICALS, INC. File: 333-278652
United States securities and exchange commission logo
April 17, 2024
Cary Claiborne
Chief Executive Officer
Adial Pharmaceuticals, Inc.
4870 Sadler Road, Suite 300
Glen Allen, VA 23060
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 12, 2024
File No. 333-278652
Dear Cary Claiborne:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Hank Gracin
2024-04-17 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
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April 17, 2024
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Lauren Hamill
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 12, 2024
File No: 333-278652
Dear Ms. Hamill:
Adial Pharmaceuticals, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-3,
as amended (File No. 333-278652), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”)
to become effective on Friday, April 19, 2024, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Hank Gracin of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Mr. Gracin at (561) 926-7995 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUITCALS, INC.
By:
/s/ Cary Claiborne
Name:
Cary Claiborne
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Hank Gracin, Blank Rome LLP
2024-01-22 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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January 22, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed January 12, 2024
File No: 333-276496
Dear Sir or Madam:
Adial Pharmaceuticals, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-3,
as amended (File No. 333-276496), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”)
to become effective on Wednesday, January 24, 2024, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Hank Gracin of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Mr. Gracin at (561) 926-7995 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUITCALS, INC.
By:
/s/ Cary Claiborne
Name:
Cary Claiborne
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Hank Gracin, Blank Rome LLP
2024-01-19 - UPLOAD - ADIAL PHARMACEUTICALS, INC. File: 333-276496
United States securities and exchange commission logo
January 19, 2024
Joseph Truluck
Chief Financial Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed January 12, 2024
File No. 333-276496
Dear Joseph Truluck:
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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2023-11-15 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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November 15, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed November 8, 2023
File No: 333-275397
Dear Sir or Madam:
Adial Pharmaceuticals, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1,
as amended (File No. 333-275397), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”)
to become effective on Thursday, November 16, 2023, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Hank Gracin of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Mr. Gracin at (561) 926-7995 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUITCALS, INC.
By:
/s/ Cary Claiborne
Name:
Cary Claiborne
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Hank Gracin, Blank Rome LLP
2023-11-14 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
November 14, 2023
Cary Claiborne
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, Virginia 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed November 8, 2023
File No. 333-275397
Dear Cary Claiborne:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2023-07-25 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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July 25, 2023
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1 (as amended)
Filed June 23, 2023
File No: 333-272846
Dear Sir or Madam:
Adial Pharmaceuticals, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1,
as amended (File No. 333-272846), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”)
to become effective on Thursday, July 27, 2023, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Hank Gracin of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Mr. Gracin at (561) 926-7995 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUITCALS, INC.
By:
/s/ Cary Claiborne
Name:
Cary Claiborne
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Hank Gracin, Blank Rome LLP
2023-07-13 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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1271 Avenue of the Americas | New York, New York 10020
Blankrome.com
July 13, 2023
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Cindy Polynice
Re: Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed June 23, 2023
File No. 333-272846
Dear Ms. Polynice:
On behalf of our client, Adial
Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated July 7, 2023 (the “Comment
Letter”), relating to the above-referenced filings.
Set forth below in bold are
comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds to the numbered comment in the
Staff’s Comment Letter and includes the caption used in the Comment Letter. Immediately following each comment is the Company’s
response to that comment.
Registration Statement on Form S-1
filed June 23, 2023
Cover Page
1. We note that you are seeking to register 10,199,620 shares of common stock for resale, but you disclose
on page 4 that you only may issue 5,916,575 shares to Alumni Capital under the Purchase Agreement before obtaining shareholder approval
and you disclose on page 7 that “only 1,541,370 shares of common stock remain issuable at this time.” More specifically, we
note that all of the common shares you are seeking to register will not be duly authorized at the time of registration. Please revise
your registration statement so that the volume of common shares registered does not exceed the number of common shares that remain available
for issuance or otherwise advise.
Response: We have revised the registration
statement to register only 1,740,990 shares of common stock, consisting of the 1,541,370 shares issuable at this time and the 199,620
commitment shares already issued.
The Alumni Capital Transaction,
page 4
2. We note your disclosure that under your Purchase Agreement with Alumni Capital dated May 31, 2023, “[u]nder
the applicable rules of the Nasdaq, in no event may [you] issue more than 5,916,575 Shares... unless [you] obtain stockholder approval
to issue shares of Common Stock in excess of the Exchange Cap, provided further that the Exchange Cap does not apply to the extent the
purchase price is equal to or exceeds the Minimum Price (as defined in the Purchase Agreement).” Please revise your disclosure to
disclose the “Minimum Price” or otherwise advise.
Response: We have revised our
disclosure to disclose the Minimum Price.
United States Securities
and Exchange Commission
July 13, 2023
Page 2
Exhibits
3. Please revise the legal opinion filed as Exhibit 5.1. The opinion should not assume material facts underlying
the opinion. In this regard, we note that the opinion assumes that “there will be sufficient shares of Common Stock authorized but
unissued under the Certificate of Incorporation and not otherwise reserved for issuance.” However, this assumption goes to whether
the shares will be validly issued. See Item II.B.3.a. of Staff Legal Bulletin No. 19.
Response: We have revised the
legal opinion filed as Exhibit 5.1.
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 me at (516)
457-4238 with any questions or further comments regarding the response to the Staff’s comments.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
2023-07-07 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
July 7, 2023
Cary Claiborne
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed June 23, 2023
File No. 333-272846
Dear Cary Claiborne:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed June 23, 2023
Cover Page
1.We note that you are seeking to register 10,199,620 shares of common stock for resale,
but you disclose on page 4 that you only may issue 5,916,575 shares to Alumni Capital
under the Purchase Agreement before obtaining shareholder approval and you disclose on
page 7 that "only 1,541,370 shares of common stock remain issuable at this time." More
specifically, we note that all of the common shares you are seeking to register will not be
duly authorized at the time of registration. Please revise your registration statement so that
the volume of common shares registered does not exceed the number of common shares
that remain available for issuance or otherwise advise.
FirstName LastNameCary Claiborne
Comapany NameAdial Pharmaceuticals, Inc.
July 7, 2023 Page 2
FirstName LastName
Cary Claiborne
Adial Pharmaceuticals, Inc.
July 7, 2023
Page 2
The Alumni Capital Transaction, page 4
2.We note your disclosure that under your Purchase Agreement with Alumni Capital dated
May 31, 2023, "[u]nder the applicable rules of the Nasdaq, in no event may [you] issue
more than 5,916,575 Shares... unless [you] obtain stockholder approval to issue shares of
Common Stock in excess of the Exchange Cap, provided further that the Exchange Cap
does not apply to the extent the purchase price is equal to or exceeds the Minimum Price
(as defined in the Purchase Agreement)." Please revise your disclosure to disclose the
"Minimum Price" or otherwise advise.
Exhibits
3.Please revise the legal opinion filed as Exhibit 5.1. The opinion should not assume
material facts underlying the opinion. In this regard, we note that the opinion assumes that
“there will be sufficient shares of Common Stock authorized but unissued under the
Certificate of Incorporation and not otherwise reserved for issuance.” However, this
assumption goes to whether the shares will be validly issued. See Item II.B.3.a. of Staff
Legal Bulletin No. 19.
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 Cindy Polynice at 202-551-8707 or Jason Drory at 202-551-8342 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Patrick Egan, Esq.
2022-04-06 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800
April 6, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
File No: 333-263037
Request for Acceleration
Ladies and Gentlemen:
Adial Pharmaceuticals, Inc. (the
“Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-3, as amended (File No. 333-263037), to become
effective on Friday, April 8, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Blank Rome LLP, to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (212) 885-5358 or Mr. Egan at (212) 885-5346 with any questions you may have concerning this request, and
please notify either Ms. Marlow or Mr. Egan when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name: William B. Stilley III
Title: Chief Executive Officer
cc:
Leslie Marlow, Esq., Blank Rome LLP
Patrick J. Egan, Esq., Blank Rome LLP
2022-03-31 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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1271 Avenue of the Americas | New York, New York 10020
Blankrome.com
Phone:
(212) 885-5358
Fax:
(917) 332-3832
Email:
Leslie.marlow@blankrome.com
March 31, 2022
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed February 25, 2022
File No. 333-263037
Dear Ms. Westbrook:
On behalf of our client, Adial
Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to: (i) a written comment from the staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated
March 22, 2022 (the “Comment Letter”), and (ii) an oral comment received from the Staff on March 31, 2022 (the “Oral
Comment”), relating to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”).
Set forth below in bold is
the comment from the Comment Letter. For your convenience, the numbered paragraph below corresponds to the numbered comment in the Staff’s
Comment Letter and includes the caption used in the Comment Letter. Immediately following the comment is the Company’s response
to that comment. In addition, the response below responds to the Staff’s Oral Comment.
Correspondence dated March 9, 2022
General 1
1. We note your response to comment 1, which we reissue. Because the aggregate
number of shares sold by you to the selling stockholder in the registered direct offering and the private placement exceeds the limitation
in General Instruction I.B.6, it does not appear you are eligible to rely on Instruction I.B.3 to Form S-3 to register the resale of the
common stock underlying the warrants. We note you have provided information related to the calculation of public float on dates in September
2021. Please provide your analysis supporting your eligibility to conduct the offering that closed on February 15, 2022 pursuant to Instruction
I.B.1 of Form S-3 given that you updated your Form S-3 (333-237793) for purposes of Securities Act Section 10(a)(3) when you filed your
annual report on Form 10-K for fiscal year ended December 31, 2020 on March 22, 2021. For guidance, refer to Securities Act Forms Compliance
and Disclosure Interpretations Questions 114.02, 114.04 and 116.07.
Response: We respectfully submit
that the Company was eligible to use and relied on General Instruction I.B.1 to Form S-3 (and not General Instruction I.B.6 to
Form S-3) to conduct the offering that closed on February 15, 2022.
United States Securities
and Exchange Commission
March 31, 2022
Page 2
On August 23, 2021, the Company
filed a definitive proxy statement on Schedule 14A in connection with the Company’s 2021 Annual Meeting of Stockholders (the “Definitive
Proxy Statement”), which included, among other things, a section entitled “Security Ownership of Certain Beneficial Owners
and Management.” The table discloses the shares of the Company’s common stock, par value $0.001 per share (the “Common
Stock”), beneficially owned by each director, named executive officer, all directors and executives as a group and each person
known to the Company to own more than 5% of its outstanding Common Stock. Beneficial ownership is determined in accordance with the rules
of the Commission. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power
or investment power with respect to those securities. In addition, the rules include shares of Common Stock issuable pursuant to the exercise
of profits interest units, warrants or other rights that are either immediately exercisable or exercisable within 60 days.
The Company’s “Security
Ownership of Certain Beneficial Owners and Management” table in the Definitive Proxy Statement discloses that all current executive
officers and directors as a group (8 people) beneficially own an aggregate of 6,057,914 shares; however, as disclosed in the footnotes
to the table, of these 6,057,914 shares a significant portion (3,536,305 shares) are actually held in the form of warrants and options
that provide the directors and officers with the right to acquire shares within 60 days, and the remaining 2,521,609 shares are shares
actually owned by the directors and officers. The table also disclosed that there is one beneficial owner of more than 5% of the outstanding
Common Stockholder, Mark Peikin, who owned 1,134,935 shares of Common Stock (plus options to acquire 211,806 shares of Common Stock).
The percentages of beneficial ownership in the table were calculated using 20,448,156 total shares of Common Stock outstanding as August
18, 2021.
On September 7, 2021, due to an
increased closing price of the Common Stock, the Company determined that the aggregate market value of the voting and non-voting common
equity held by non-affiliates of the Company exceeded $75 million. Specifically, the closing price of the Common Stock on The Nasdaq Capital
Market on September 7, 2021 was $4.55 per share and the total voting and non-voting Common Stock held by non-affiliates of the Company
was 16,791,612 shares, which equals an aggregate market value of shares held by non-affiliates of $76,401,834.
The total voting and non-voting
shares of Common Stock held by non-affiliates of the Company (16,791,612 shares) was calculated as follows: 20,448,156 total shares outstanding
on September 7, 2021 less an aggregate of 3,656,544 shares held by deemed affiliates (2,521,609 shares held by directors and officers
of the Company and 1,134,935 shares held by Mr. Peikin) equaled 16,791,612 shares. The Company included Mr. Peikin as an affiliate
solely for the purposes of these calculations.
You will note that the share amounts
used by the Company in calculating the aggregate market value of the voting and non-voting common equity held by non-affiliates of the
Company are the same as those disclosed in the Definitive Proxy Statement. The only variable is the closing price of the Common Stock
on The Nasdaq Capital Market on September 7, 2021, which was $4.55.
As a result, on September 7, 2021,
the Company became eligible to issue securities pursuant to the Registration Statement under General Instruction I.B.1 to Form S-3 and
could have registered all of the securities on the prospectus supplement to the Registration Statement (the “Prospectus Supplement”),
filed with the Commission on February 14, 2022, but elected to issue the warrants in a concurrent private placement with a subsequent
resale registration statement in order to preserve capacity under the Registration Statement.
As a result of the foregoing, the
Company was eligible to rely on General Instruction I.B.3 to Form S-3 to register the resale of the shares of Common Stock underlying
the warrants issued in the concurrent placement on Form S-3 since it could have registered the warrants under the initial Prospectus Supplement
under General Instruction I.B.1 to Form S-3. Lastly, the Company also satisfies the registration requirements specified in General Instruction
I.A. Eligibility Requirements for Use of Form S-3.
* * *
United States Securities
and Exchange Commission
March 31, 2022
Page 3
If you have any questions
or need additional information, please contact the undersigned at (212) 885-5358 or Patrick J. Egan at (212) 885-5346.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc:
William B. Stilley
Chief Executive Officer, Adial Pharmaceuticals, Inc.
2022-03-22 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
March 22, 2022
William B. Stilley
Chief Executive Officer
ADIAL PHARMACEUTICALS, INC.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:ADIAL PHARMACEUTICALS, INC.
Registration Statement on Form S-3
Response dated March 9, 2022
File No. 333-263037
Dear Mr. Stilley:
We have reviewed your response dated March 9, 2022 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 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 the comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our March 7, 2022 letter.
Correspondence dated March 9, 2022
General
1.We note your response to comment 1, which we reissue. Because the aggregate number of
shares sold by you to the selling stockholder in the registered direct offering and the
private placement exceeds the limitation in General Instruction I.B.6, it does not appear
you are eligible to rely on Instruction I.B.3 to Form S-3 to register the resale of the
common stock underlying the warrants. We note you have provided information related to
the calculation of public float on dates in September 2021. Please provide your analysis
supporting your eligibility to conduct the offering that closed on February 15, 2022
pursuant to Instruction I.B.1 of Form S-3 given that you updated your Form S-3 (333-
237793) for purposes of Securities Act Section 10(a)(3) when you filed your annual report
FirstName LastNameWilliam B. Stilley
Comapany NameADIAL PHARMACEUTICALS, INC.
March 22, 2022 Page 2
FirstName LastName
William B. Stilley
ADIAL PHARMACEUTICALS, INC.
March 22, 2022
Page 2
on Form 10-K for fiscal year ended December 31, 2020 on March 22, 2021. For guidance,
refer to Securities Act Forms Compliance and Disclosure Interpretations Questions
114.02, 114.04 and 116.07.
Please contact Christine Westbrook at 202-551-5019 or Celeste Murphy at 202-551-
3257 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2022-03-09 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1271 Avenue of the Americas | New York, New York 10020
Blankrome.com
Phone:
(212) 885-5358
Fax:
(917) 332-3832
Email:
Leslie.marlow@blankrome.com
March 9, 2022
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed February 25, 2022
File No. 333-263037
Dear Ms. Westbrook:
On behalf of our client,
Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated March 7, 2022 (the “Comment
Letter”), relating to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”).
Set forth below in bold
are comments from the Comment Letter. For your convenience, each of the numbered paragraphs below corresponds to the numbered comments
in the Staff’s Comment Letter and includes the caption used in the Comment Letter. Immediately following each comment is the Company’s
response to that comment
Registration Statement on Form S-3 filed
February 25, 2022
General
1. We note you appear to have relied in General Instruction I.B.6 to Form S-3 to
conduct your registered direct offering in February 2022. Because the aggregate number of shares sold by you to the selling stockholder
in the registered direct offering and the private placement exceeds the limitation in General Instruction I.B.6, it does not appear you
are eligible to rely on Instruction I.B.3 to Form S-3 to register the resale of the common stock underlying the warrants. Refer to Securities
Act Forms Compliance and Disclosure Interpretations Question 116.25. Accordingly, please amend your registration statement to a form on
which you are eligible to register to conduct a primary offering of securities with a market value of the securities you have attempted
to register on Form S-3. Alternatively, please provide us with a detailed analysis supporting your eligibility to use Form S-3 to register
the resale of common stock underlying the warrants.
Response: We respectfully submit
that the Company was eligible to use and relied on General Instruction I.B.1 to Form S-3 (and not General Instruction I.B.6 to
Form S-3) to conduct the offering that closed on February 15, 2022.
On September 7, 2021, the aggregate
market value of the voting and non-voting common equity held by non-affiliates of the Company exceeded $75 million. Specifically, the
closing price of the Company’s common stock, par value $0.001 per share (the “Common Stock”), on The Nasdaq Capital
Market on September 7, 2021 was $4.55 per share and the total voting and non-voting Common Stock held by non-affiliates of the Company
was 16,791,612 shares, which equals an aggregate market value of shares held by non-affiliates of $76,401,834. In addition, on September
27, 2021, the closing price of the Common Stock, on The Nasdaq Capital Market was $4.67 per share and the total voting and non-voting
Common Stock held by non-affiliates of the Company was 16,791,612 shares, which equals an aggregate market value of shares held by non-affiliates
of $78,416,828. As a result, on September 7, 2021, the Company became eligible to issue securities pursuant to the Registration Statement
under General Instruction I.B.1 to Form S-3 and could have registered all of the securities on the prospectus supplement to the Registration
Statement (the “Prospectus Supplement”), filed with the Commission on February 14, 2022, but elected to issue the warrants
in a concurrent private placement with a subsequent resale registration statement in order to preserve capacity under the Registration
Statement.
As a result of the foregoing, the
Company was eligible to rely on General Instruction I.B.3 to Form S-3 to register the resale of the shares of Common Stock underlying
the warrants issued in the concurrent placement on Form S-3 since it could have registered the warrants under the initial Prospectus Supplement
under General Instruction I.B.1 to Form S-3. Lastly, the Company also satisfies the registration requirements specified in General Instruction
I.A. Eligibility Requirements for Use of Form S-3.
United States Securities
and Exchange Commission
March 9, 2022
Page 2
2. Please provide updated financial statements for the most recently completed
fiscal year. Refer to Rule 8-08(b) of Regulation S-X.
Response: The Company will not
seek to have the Registration Statement declared effective until the Company’s Form 10-K for the fiscal year ended December 31,
2021 has been filed with the Commission, which the Company anticipates filing no later than March 30, 2022. The Form 10-K, which will
be incorporated by reference into the Registration Statement, will include the financial statements that satisfy Rule 8-08(b) of Regulation
S-X. We understand that an amendment to the Registration Statement will be required once the Form 10-K has been filed with the Commission
to include an updated Exhibit 23.1 (auditor’s consent) and we will endeavor to file Amendment No. 1 to the Form S-3 Registration
Statement as soon as practicable after the Form 10-K has been filed.
* * *
If you have any questions
or need additional information, please contact the undersigned at (212) 885-5358 or Patrick Egan at (212) 885-5346.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc: William B. Stilley
Chief Executive Officer, Adial Pharmaceuticals,
Inc.
2022-03-07 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
March 7, 2022
William B. Stilley
Chief Executive Officer
ADIAL PHARMACEUTICALS, INC.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:ADIAL PHARMACEUTICALS, INC.
Registration Statement on Form S-3
Filed February 25, 2022
File No. 333-263037
Dear Mr. Stilley:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3 filed February 25, 2022
General
1.We note you appear to have relied in General Instruction I.B.6 to Form S-3 to conduct
your registered direct offering in February 2022. Because the aggregate number of shares
sold by you to the selling stockholder in the registered direct offering and the private
placement exceeds the limitation in General Instruction I.B.6, it does not appear you are
eligible to rely on Instruction I.B.3 to Form S-3 to register the resale of the common stock
underlying the warrants. Refer to Securities Act Forms Compliance and Disclosure
Interpretations Question 116.25. Accordingly, please amend your registration statement to
a form on which you are eligible to register to conduct a primary offering of securities
with a market value of the securities you have attempted to register on Form S-3.
Alternatively, please provide us with a detailed analysis supporting your eligibility to use
FirstName LastNameWilliam B. Stilley
Comapany NameADIAL PHARMACEUTICALS, INC.
March 7, 2022 Page 2
FirstName LastName
William B. Stilley
ADIAL PHARMACEUTICALS, INC.
March 7, 2022
Page 2
Form S-3 to register the resale of common stock underlying the warrants.
2.Please provide updated financial statements for the most recently completed fiscal year.
Refer to Rule 8-08(b) of Regulation S-X.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Christine Westbrook at 202-551-5019 or Celeste Murphy at 202-551-
3257 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-12-14 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180
Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800
December
14, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington, D.C. 20549
Re:
Adial
Pharmaceuticals, Inc.
Registration
Statement on Form S-3
File
No: 333-261509
Request
for Acceleration
Ladies
and Gentlemen:
Adial
Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission
(the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File
No. 333-261509), to become effective on Thursday, December 16, 2021, at 9:00 a.m., Eastern Time, or as soon thereafter as
is practicable.
The
Registrant hereby authorizes its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify
or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574
or (212) 907-6457 with any questions you may have concerning this request, and please notify her when this request for acceleration has
been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name:
William B. Stilley III
Title:
Chief Executive Officer
cc:
Leslie
Marlow, Esq., Gracin & Marlow, LLP
Patrick
J. Egan, Esq., Gracin & Marlow, LLP
2021-12-13 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
December 13, 2021
William B. Stilley, III
President and Chief Executive Officer
ADIAL PHARMACEUTICALS, INC.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:ADIAL PHARMACEUTICALS, INC.
Registration Statement on Form S-3
Filed on December 6, 2021
File No. 333-261509
Dear Mr. Stilley:
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 Jordan Nimitz at 202-551-5831 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2021-07-27 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22902
(434) 422-9800
July 27, 2021
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
File No: 333-258048
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Adial Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the
United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced
Registration Statement on Form S-3 (File No. 333-258048), to become effective on Thursday, July 29, 2021, at 5:00 p.m., Eastern
Time, or as soon thereafter as is practicable.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby
authorizes its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this
request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 or (212)
907-6457 with any questions you may have concerning this request, and please notify her when this request for acceleration has been
granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ Willian B. Stilley III
Name:
William B. Stilley III
Title:
Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick J. Egan, Esq., Gracin & Marlow, LLP
2021-07-23 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
July 23, 2021
William Stilley
President and Chief Executive Officer
ADIAL PHARMACEUTICALS, INC.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:ADIAL PHARMACEUTICALS, INC.
Registration Statement on Form S-3
Filed July 20, 2021
File No. 333-258048
Dear Mr. Stilley:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2021-06-08 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800
June 9, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
File No: 333-256621
Request for Acceleration
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Adial Pharmaceuticals, Inc. (the “Registrant”)
hereby requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-3 (File No. 333-256621), to become effective on Friday, June 11,
2021, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The
Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 or (212) 907-6457 with any questions you may
have concerning this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name: William B. Stilley III
Title: Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick J. Egan, Esq., Gracin & Marlow, LLP
2021-06-04 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
June 4, 2021
William B. Stilley
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 28, 2021
File No. 333-256621
Dear Mr. Stilley:
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
cc: Patrick J. Egan, Esq.
2021-05-24 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22902
(434) 422-9800
May 24, 2021
VIA
EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street,
N.E.
Washington, D.C. 20549
Re: Adial
Pharmaceuticals, Inc.
Inc. Registration
Statement on Form S-3
File No:
333-255352
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-255352), to become effective on
Wednesday, May 26, 2021, at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby
authorizes its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of
Gracin & Marlow, LLP, to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or
(212) 907-6457 or Mr. Egan at (914) 557-5574 or (212) 907-6457 with any questions you may have concerning this request, and please notify
her when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By: /s/ Willian B. Stilley III
Name:
William B. Stilley III
Title:
Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
2021-04-26 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
April 26, 2021
Joseph Truluck
Chief Financial Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 20, 2021
File No. 333-255352
Dear Mr. Truluck:
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 Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2020-12-15 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
December 11, 2020
William B. Stilley, III
Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 4, 2020
File No. 333-251122
Dear Mr. Stilley:
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: Patrick J. Egan, Esq.
2020-12-14 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800
December 14, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
File No: 333-251122
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-251122), to become effective
on Tuesday, December 15, 2020, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this request
for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 or (212) 907-6457
with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name: William B. Stilley III
Title: Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick J. Egan, Esq., Gracin & Marlow, LLP
2020-07-08 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
(434) 422-9800
July 8, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Deanna Virginio
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
File No: 333-239678
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-239678), to become effective
on Friday, July 10, 2020, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant hereby authorizes
its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this request
for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 or (212) 907-6457
with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name: William B. Stilley III
Title: Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
Patrick J. Egan, Esq., Gracin & Marlow, LLP
2020-07-08 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
July 8, 2020
William B. Stilley, III
Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, Virginia 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed July 2, 2020
File No. 333-239678
Dear Mr. Stilley:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Patrick J. Egan, Esq.
2020-04-28 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
1180 Seminole Trail, Suite 495
Charlottesville, VA 22902
(434) 422-9800
April 28, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Mr. Todd Schiffman
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
File No: 333-237793
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-237793), to become effective
on Thursday, April 30, 2020, at 10:00 a.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant
hereby authorizes its counsel, Leslie Marlow, Esq. or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify or
withdraw this request for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914)
557-5574 or (212) 907-6457 with any questions you may have concerning this request, and please notify her when this request
for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley III
Name: William B. Stilley III
Title: Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
2020-04-27 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
United States securities and exchange commission logo
April 27, 2020
William B. Stilley, III
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 22, 2020
File No. 333-237793
Dear Mr. Stilley:
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: Leslie Marlow, Esq.
2019-03-28 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
March 28, 2019
William B. Stilley, III
President and Chief Executive Officer
Adial Pharmaceuticals, Inc.
1001 Research Park Blvd., Suite 100
Charlottesville, VA 22911
Re:Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed March 22, 2019
File No. 333-230470
Dear Mr. Stilley:
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 Healthcare & Insurance
cc: Leslie Marlow, Esq.
2019-03-28 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial Pharmaceuticals, Inc.
1001 Research Park Blvd., Suite 100
Charlottesville, Virginia 22911
March
28, 2019
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Mr. Jeffrey Gabor
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended
File No: 333-230470
Dear Mr. Gabor:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the effective date of the Registrant’s Registration Statement
on Form S-1, as amended (File No. 333-230470), be accelerated by the U.S. Securities and Exchange Commission to Monday,
April 1, 2019, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The
Registrant hereby authorizes Leslie Marlow and/or Patrick Egan of Gracin & Marlow, LLP to orally modify or withdraw this request
for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457, or Mr. Egan at (914) 557-5574 with any questions
you may have concerning this request, and please notify either of them when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley
III
Name:
Title:
William
B. Stilley III
Chief Executive Officer
cc:
Joseph
Truluck, Chief Financial Officer, Adial Pharmaceuticals, Inc.
Leslie
Marlow, Esq., Gracin & Marlow, LLP
2019-02-19 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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February
19, 2019
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
Attention:
Mr. Todd Schiffman
Re:
Adial
Pharmaceuticals, Inc.
Registration
Statement on Form S-1 File No: 333-229615
Ladies
and Gentlemen:
As
the underwriters of the proposed offering of Adial Pharmaceuticals, Inc. (the “Company”), we hereby
join the Company’s request for acceleration of the above-referenced Registration Statement, requesting effectiveness for
5:00 p.m., Eastern Time, on February 20, 2019, or as soon thereafter as is practicable.
Pursuant
to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, we wish to advise you that we have effected
the following distribution of the Company’s Preliminary Prospectuses dated February 12, 2019 and February 19, 2019 through
the date hereof:
Preliminary
Prospectuses dated February 12, 2019 and February 19, 2019:
Copies to underwriters:
2
Copies to prospective dealers:
12
Copies to prospective institutional investors:
225
Copies to prospective retail investors:
430
The
undersigned advise that they have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.
Very truly yours,
Maxim Group LLC
By:
/s/
Clifford A. Teller
Name:
Clifford A. Teller
Title: Head
of Investment Banking,
Executive Managing Director
Joseph Gunnar & Co., LLC
By:
/s/
Stephan Stein
Name:
Stephan Stein
Title: President
2019-02-19 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial Pharmaceuticals, Inc.
1001 Research Park
Blvd., Suite 100
Charlottesville, Virginia 22911
February 19, 2019
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Mr. Todd Schiffman
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended
File No: 333-229615
Ladies and
Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the effective date of the Registrant’s Registration Statement
on Form S-1, as amended (File No. 333-229615), be accelerated by the U.S. Securities and Exchange Commission to Wednesday,
February 20, 2019, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant hereby authorizes
its legal counsel, Leslie Marlow, Esq. of Gracin & Marlow, LLP, to orally modify or withdraw this request for acceleration.
Please contact Ms. Marlow at (516) 496-2223 or (516) 457-4238 with any questions you may have concerning this request, and please
notify her when this request for acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ Willian B. Stilley III
Name:
William B. Stilley III
Title:
Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
2019-02-13 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial Pharmaceuticals, Inc.
1001 Research Park Blvd., Suite 100
Charlottesville, Virginia 22911
February 13, 2019
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Mr. Todd Schiffman
Re:
Adial Pharmaceuticals, Inc.
Withdrawal of Acceleration Request
Registration Statement on Form S-1
File No: 333-229615
Dear Mr. Schiffman:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby respectfully requests withdrawal of its acceleration request letter filed as
correspondence via EDGAR on February 12, 2019, which requested that the above-referenced Registration Statement on Form S-1 (File
No. 333-229615) become effective on Thursday, February 14, 2019, at 9:00 a.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant is no longer requesting that such Registration Statement be declared effective at this time and the Registrant hereby
formally withdraws its request for acceleration of the effective date.
If you have any
questions regarding the foregoing, please contact our counsel, Leslie Marlow of Gracin & Marlow, LLP, at (516) 496-2223 or
(212) 907-6457.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ Willian B. Stilley III
Name:
William B. Stilley III
Title:
Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow, LLP
2019-02-12 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial Pharmaceuticals, Inc.
1001 Research Park Blvd., Suite 100
Charlottesville, Virginia 22911
February 12, 2019
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Mr. Todd Schiffman
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
File No: 333-229615
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the effective date of the Registrant’s Registration Statement
on Form S-1 (File No. 333-229615), be accelerated by the U.S. Securities and Exchange Commission to Thursday, February
14, 2019, at 9:00 a.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant
hereby authorizes its legal counsel, Leslie Marlow, Esq. and/or Patrick J. Egan, Esq. of Gracin & Marlow, LLP, to orally modify
or withdraw this request for acceleration. Please contact either Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at
(914) 557-5574 with any questions you may have concerning this request, and please notify either of them when this request for
acceleration has been granted.
Very truly yours,
ADIAL PHARMACEUTICALS, INC.
By:
/s/ William B. Stilley
III
Name:
Title:
William
B. Stilley III
Chief Executive Officer
cc:
Leslie Marlow, Esq., Gracin & Marlow,
LLP
2019-02-08 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
February 7, 2019
William Stilley, III
President and Chief Executive Officer
ADIAL PHARMACEUTICALS, INC.
1001 Research Park Blvd.,
Suite 100
Charlottesville, VA 22911
Re:ADIAL PHARMACEUTICALS, INC.
Draft Registration Statement on Form S-1
Filed January 7, 2019
File No. 377-02455
Dear Mr. Stilley, III:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-24 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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JOSEPH
GUNNAR & CO., LLC
30 Broad Street, 11th Floor
New York, New York 10004
July 24, 2018
VIA EDGAR
Division of Corporation Finance
SECURITIES AND EXCHANGE COMMISSION
100 F Street, N.E.
Washington, DC 20549
Attention: Joseph McCann, Staff Attorney
Re: Adial Pharmaceuticals, Inc.
Registration Statement on Form
S-1;
(SEC File No. 333-220368)
Dear Mr. McCann:
Acting as representative
to the several underwriters, we hereby join in the request of Adial Pharmaceuticals, Inc. that the effective date of the above-captioned
Registration Statement be accelerated so that it will become effective at 5:00 p.m., Eastern Time, on July 26, 2018, or as soon
thereafter as practicable.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities and Exchange Commission under the Securities Act of 1933, as amended, we,
acting on behalf of the several underwriters, wish to advise you that, between July 10, 2018 and July 24, 2018, we distributed
to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the security “E-red”
copies of the Preliminary Prospectus dated July 10, 2018 as appears to be reasonable to secure adequate distribution of the preliminary
prospectus.
We confirm that we
are aware of our obligations under the Securities Act of 1933, as amended, and that we have and will comply with Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended, with respect to the distribution of Prospectus. We have been informed by the other
underwriters participating in the distribution of this offering that such persons have and will comply with Rule 15c2-8 with respect
to the distribution of Prospectus.
Very Truly Yours,
By:
JOSEPH GUNNAR & CO., LLC
By:
/s/ Stephan Stein
Name:
Stephan Stein
Title:
President
2018-07-24 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, Virginia 22901
July 24, 2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director
Office of Healthcare & Insurance
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended
File No. 333-220368
Dear Ms. Hayes:
Adial Pharmaceuticals,
Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on
Form S-1, as amended (File No. 333-220368), be accelerated by the U.S. Securities and Exchange Commission to Thursday,
July 26, 2018 at 5:00 p.m., New York City Time, or as soon as reasonably practicable thereafter.
The Company hereby
authorizes its legal counsel, Patrick Egan and/or Leslie Marlow of Gracin & Marlow, LLP, to orally modify or withdraw this
request for acceleration. Please contact Mr. Egan at (914) 557-5574 or Ms. Marlow at (516) 496-2223 or (212) 907-6457 with
any questions you may have concerning this request, and please notify either of them when this request for acceleration has been
granted.
Very truly yours,
Adial Pharmaceuticals, Inc.
By:
/s/ William B. Stilley, III
Name: William B. Stilley, III
Title: Chief Executive Officer
cc:
Joseph Truluck
Chief Financial Officer, Adial Pharmaceuticals, Inc.
2018-07-03 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 July 2, 2018 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 1180 Seminole Trail, Suite 495 Charlottesville, VA 22901 Re: Adial Pharmaceuticals, Inc. Amendment No. 6 to Registration Statement on Form S-1 Filed June 26 , 201 8 File No: 333-220368 Dear Mr. Stilley: We have reviewed your amended registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comment appl ies 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. Notes to Financial Statements Research and Development, page F -9 1. Please revise your accounting policy disclosure here and on page F -30 to reflect your accounti ng treatment for patent related costs. William B. Stilley Adial Pharmaceuticals, Inc. July 2, 201 8 Page 2 You may contact Rolf Sundwall at 202-551-3105 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at 202-551-2544 or Mary Beth Breslin at 202-551-3625 with any other questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP
2018-07-03 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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HANK
GRACIN†† | PARTNER
LESLIE MARLOW† | PARTNER PATRICK J. EGAN† | PARTNER
† Admitted in New York only
†† Admitted in New York, Florida & Colorado
GRACIN
& MARLOW, LLP
COUNSELLORS
AT LAW
THE CHRYSLER BUILDING
26th FLOOR
405
LEXINGTON AVENUE
NEW
YORK, NEW YORK 10174
(212)
907-6457
FAX (212) 208-4657
www.gracinmarlow.com
IN
BOCA RATON
1825 NW CORPORATE BLVD.
SUITE 110
BOCA RATON, FLORIDA 33431
(561) 237-0804
FAX
(561) 237-0803
WRITER
E-MAIL: lmarlow@gracinmarlow.com
July
3, 2018
VIA
EDGAR
United
States Securities
and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Mail Stop 4546
Washington, D.C. 20549
Attention: Suzanne
Hayes, Assistant Director
Office
of Healthcare & Insurance
Re: Adial
Pharmaceuticals, Inc.
Amendment
No. 6 to Registration Statement on Form S-1
Filed
June 26, 2018
File
No. 333-220368
Dear
Ms. Hayes:
On behalf of our client,
Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to a comment from the staff (the
“Staff”) of the United States Securities and Exchange Commission (the “Commission”) contained
in its letter dated July 2, 2018 (the “Comment Letter”), relating to the above-referenced Amendment No. 6 to
Registration Statement on Form S-1. We are concurrently submitting via EDGAR this letter and filing a revised Amendment No. 7 to
Registration Statement on Form S-1 (“Amendment No. 7 Registration Statement”).
Set forth below is the
comment from the Comment Letter, which is immediately followed by the Company’s response in bold and italics font to that
comment, including a cross-reference to the location of changes made in the Amendment No. 7 Registration Statement in response
to the Staff’s comment.
Notes
to Financial Statements
Research
and Development, page F-9
1. Please
revise your accounting policy disclosure here and on page F-30 to reflect your accounting
treatment for patent related costs.
Response:
The Company has revised the accounting policy related to research and development expenses on pages F-9 and F-30.
*
* *
If you have any questions
or need additional information, please contact the undersigned, the Company’s securities counsel, at (516) 496-2223 or (212)
907-6457.
Sincerely,
GRACIN & MARLOW, LLP
/s/ Leslie Marlow
Leslie Marlow
cc: William B. Stilley
Chief Executive Officer, Adial Pharmaceuticals,
Inc.
Joseph Truluck
Chief Financial Officer, Adial Pharmaceuticals,
Inc.
2018-06-25 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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The
Chrysler Building
405
Lexington Avenue, 26th Floor
New
York, New York 10174
Telephone
(212) 907-6457
Facsimile:
(212) 208-4657
June
25, 2018
VIA
EDGAR
United
States Securities
and
Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial
Pharmaceuticals, Inc.
Registration
Statement on Form S-1
Submitted
June 11, 2018
CIK
No. 0001513525
Dear
Ms. Hayes:
On behalf of our client,
Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to the comment the Company received
from the staff (the “Staff”) of the Securities and Exchange Commission in its June 21, 2018 letter to the Company
relating to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”).
Set
forth below in bold is the comment the Company received from the Staff in its June 21, 2018 letter and immediately following the
comment is the Company’s response to that comment.
1.
Tell
us your consideration of ASC 730-10-55-2i in recognizing costs associated with the validation of a patent within Research
and development expenses. In your response, tell us the amount you have recorded as Research and development expenses related
to patent validation.
Response:
The Company respectfully acknowledges the Staff’s comment. After giving consideration to ASC 730-10-55-2i, the Company has
revised its classification of expenses related to patent validation from Research and development expenses to General and administrative
expenses. This reclassification is reflected in Amendment No. 6 to the Registration Statement on Form S-1, submitted with this
letter. The Company will also exclude such expenses, if any, from Research and development expense classification in future filings.
Expenses
related to patent validation in the three months ended March 31, 2018 total $112,597. Such costs commenced in Quarter 1,
2018 and there were no expenses related to patent validation incurred or recorded for the years ended December 31, 2016 or
2017.
*
* *
If
you have any questions or need additional information, please contact the undersigned at (516) 496-2223 or (212) 907-6457.
Sincerely,
/s/
Leslie Marlow
Leslie
Marlow
cc:
William B.
Stilley
Chief Executive
Officer of ADial Pharmaceuticals, Inc.
Joseph Truluck
Chief Financial
Officer of ADial Pharmaceuticals, Inc.
2018-06-21 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 June 21 , 2018 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 1180 Seminole Trail, Suite 495 Charlottesville, VA 22901 Re: Adial Pharmaceuticals, Inc. Amendment No. 5 to Registration Statement on Form S-1 Filed June 11 , 201 8 File No: 333-220368 Dear Mr. Stilley: We have reviewed your amended registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comment appl ies to your facts and circumstances or do not believe an am endment 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. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of operations for the three months ended March 31, 2018 and 2017 Research and development (“R&D”) expenses, page 62 1. Tell us your consideration of ASC 730 -10-55-2i in recognizing costs associated with the validation of a patent within Research and development expenses. In your response, tell us the amount you have recorded as Research and development expenses related to patent validation. William B. Stilley Adial Pharmaceuticals, Inc. June 21 , 201 8 Page 2 You may contact Rolf Sundwall at 202-551-3105 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at 202-551-2544 or Mary Beth Breslin at 202-551-3625 with any other questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP
2017-12-19 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial
Pharmaceuticals, Inc.
1180
Seminole Trail, Suite 495
Charlottesville, VA 22901
December
19, 2017
VIA
EDGAR
United
States Securities
and
Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington,
D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial
Pharmaceuticals, Inc.
Withdrawal
of Acceleration Request
Registration
Statement on Form S-1 (as amended)
File
No: 333-220368
Ladies
and Gentlemen:
Adial
Pharmaceuticals, Inc. (the “Registrant”) hereby respectfully requests withdrawal of its acceleration request
letter filed as correspondence via EDGAR on December 15, 2017, which requested that the above-referenced Registration Statement
on Form S-1 (File No. 333-220368) become effective on Tuesday, December 19, 2017, at 5:00 p.m., Eastern Time, or as soon thereafter
as is practicable. The Registrant is no longer requesting that such Registration Statement be declared effective at this time
and the Registrant hereby formally withdraws its request for acceleration of the effective date.
If
you have any questions regarding the foregoing, please contact our counsel, Leslie Marlow of Gracin & Marlow, LLP, at (516)
496-2223 or (212) 907-6457.
Very truly
yours,
Adial
Pharmaceuticals, Inc.
By: /s/
William B. Stilley
Name:
William
B. Stilley
Title:
Chief
Executive Officer
cc:
Joseph
Truluck, Chief Financial Officer of Adial Pharmaceuticals, Inc.
Leslie
Marlow, Esq., Gracin & Marlow, LLP
2017-12-15 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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Adial
Pharmaceuticals, Inc.
1180 Seminole Trail, Suite 495
Charlottesville, VA 22901
December 15, 2017
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1 (as amended)
File No: 333-220368
Ladies and Gentlemen:
Adial Pharmaceuticals,
Inc. (the “Registrant”) hereby requests that the United States Securities and Exchange Commission (the “Commission”)
take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-220368) to become effective
on Tuesday, December 19, 2017, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant
hereby authorizes its counsel, Leslie Marlow and Patrick Egan of Gracin & Marlow, LLP, to orally modify or withdraw this request
for acceleration. Please contact Ms. Marlow at (516) 496-2223 or (212) 907-6457 or Mr. Egan at (914) 557-5574 with any questions
you may have concerning this request, and please notify either of them when this request for acceleration has been granted.
Very truly yours,
Adial Pharmaceuticals, Inc.
By: /s/ William B. Stilley
Name:
William B. Stilley
Title:
Chief Executive Officer
cc:
Joseph Truluck, Chief Financial Officer of Adial Pharmaceuticals,
Inc.
Leslie Marlow, Esq., Gracin & Marlow, LLP
2017-12-15 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
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December 15, 2017
VIA EDGAR
Division of Corporation Finance
SECURITIES AND EXCHANGE COMMISSION
100 F Street, N.E.
Washington, DC 20549
Attention: Ms. Suzanne Hayes
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1;
(SEC File No. 333-220368)
Dear Ms. Hayes:
Acting as representatives
to the several underwriters, we hereby join in the request of Adial Pharmaceuticals, Inc. that the effective date of the above-captioned
Registration Statement be accelerated so that it will become effective at 5:00 p.m., Eastern Time, on December 19, 2017, or as
soon thereafter as practicable.
Pursuant to Rule 460 of
the General Rules and Regulations of the Securities and Exchange Commission under the Securities Act of 1933, as amended, we, acting
on behalf of the several underwriters, wish to advise you that, between November 24, 2017 and December 18, 2017, we distributed
to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the security,
as many copies, as well as “E-red” copies of the Preliminary Prospectus dated November 22, 2017 as appears to be reasonable
to secure adequate distribution of the preliminary prospectus.
We confirm that we are
aware of our obligations under the Securities Act of 1933, as amended, and that we have and will comply with Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended, with respect to the distribution of the Prospectus. We have been informed by the
other underwriters participating in the distribution of this offering that such persons have and will comply with Rule 15c2-8 with
respect to the distribution of the Prospectus.
Very Truly Yours,
By: JOSEPH
GUNNAR & CO., LLC
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking/Underwritings
Global Equity Capital Markets
2017-10-25 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
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The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
Telephone (212) 907-6457
Facsimile: (212) 208-4657
October 25, 2017
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 25, 2017
File No: 333-220368
Dear Ms. Hayes:
On behalf of our client,
Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comment 1 received from the
staff (the “Staff”) of the Securities and Exchange Commission in its letter dated October 5, 2017 addressed
to the Company relating to the above-referenced Amendment No. 1 to the Registration Statement on Form S-1 (the “Registration
Statement”). Concurrently, we have filed Amendment No. 2 to the Registration Statement on Form S-1 (“Amendment
No. 2”).
Set forth below in italics
is comment number 1 included in the October 5, 2017 letter from the Staff and immediately following the comment is the Company’s
response to that comment.
SEC Comment:
Summary Financial Information, page 12
1. Refer to your response to our prior comment 1. Your calculation of Pro forma net loss and Pro forma net loss per share includes
adjustments which appear to be nonrecurring in nature. Please explain to us your consideration of Rules 11-02(b)(5) and 11-02(b)(6)
of Regulation S-X.
United States Securities
and Exchange Commission
October 25, 2017
Page 2
Adial Reply:
The Company has revised its calculation of Pro
forma net loss to exclude the nonrecurring charges attributable to the transaction and, accordingly, the Pro forma net loss per
share as presented in the Summary Financial Information on page 12 has been revised to conform with Rule 11-02(b)(5). It has been
determined by management that although the adjustments included in the Pro forma net loss (note 2 to the Summary Financial Information)
in Amendment No. 1 to the Registration Statement on Form S-1 are (a) directly attributable to the transaction and (b) factually
supportable; they are not expected to have a continuing impact and will be included in the net loss of the Company within 12 months
following the transaction. The Pro forma net loss and Pro forma net loss per share, as well as notes 2 and 3 to the Summary Financial
Information on Page 12, have been adjusted in Amendment No.2 to the Registration Statement on Form S-1 to indicate which items
are not included in the Pro forma net loss and which items are included in the shares used to calculate the Pro forma net loss
per common share. The Pro forma net loss continues to give effect to the conversion of the convertible debt to equity which will
occur at the time of the transaction.
Please note that the Pro forma, adjusted balance
sheet and footnote 4 to the Pro forma statements on page 12 have also been revised. These changes give effect to an amendment,
dated October 23, 2017, to the outstanding bridge note, and are not in response to comment 1.
* * *
If you have any questions
or need additional information, please contact the undersigned at (516) 496-2223 or (212) 907-6457.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc:
William B. Stilley
Chief Executive Officer of Adial Pharmaceuticals, Inc.
Joseph Truluck
Chief Financial Officer of Adial Pharmaceuticals, Inc.
2017-10-05 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 October 5 , 2017 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 204 E. High Street Charlottesville, VA 22902 Re: Adial Pharmaceuticals, Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed September 25 , 2017 File No: 333-220368 Dear Mr. Stilley: We have reviewed your amended registration statement and have the following comment. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comment appl ies to your facts and circumstances or do not believe an amendment is appropr iate, 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 21, 2017 letter . Summary Financial Information, page 12 1. Refer to your response to our prior comment 1. Your calculation of Pro forma net loss and Pro forma net loss per share includes adjustments which appear to be nonrecurring in nature. Please explain to us your consideration of Rules 11 -02(b)(5) and 11 -02(b)(6) of Regulation S -X. William B. Stilley Adial Pharmaceuticals, Inc. October 5 , 2017 Page 2 You may contact Rolf Sundwall at (202) 551 -3105 or Angela Connell at (202) 551 -3426 if you have questions regarding comments o n the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or Joseph McCann at (202) 551 -6262 with any other questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP
2017-09-25 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
The
Chrysler Building
405
Lexington Avenue, 26th Floor
New
York, New York 10174
Telephone
(212) 907-6457
Facsimile:
(212) 208-4657
September
25, 2017
VIA
EDGAR
United
States Securities
and
Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial
Pharmaceuticals, Inc.
Registration
Statement on Form S-1
Filed
September 7, 2017
File
No: 333-220368
Dear
Ms. Hayes:
On
behalf of our client, Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comment
number 1 received from the staff (the “Staff”) of the Securities and Exchange Commission in its September 21,
2017 letter addressed to the Company relating to the above-referenced Registration Statement on Form S-1 (the “Registration
Statement”). Concurrently, we have filed Amendment No. 1 to the Registration Statement on Form S-1 (“Amendment
No. 1”).
Set
forth below in italics is comment number 1 from the September 21, 2017 letter from the Staff and immediately following the comment
is the Company’s response to that comment.
SEC
Comment:
Summary
Financial Information, page 12
1. Your
disclosure of the Pro forma net loss per share for the Year Ended December 31, 2016 does
not appear to be correct based on your disclosure of shares used in the calculation.
Please revise accordingly, or provide us with your calculation.
Adial
Reply:
The following sets forth an explanation
of the calculation of the Pro forma net loss per share. In addition, the Company has added a new line item, labeled “Pro
forma net loss,” to the table on page 12 to assist the reader in understanding the calculation.
United
States Securities
and Exchange Commission
September
25, 2017
Page 2
According
to footnote 2 of the tables provided on page 12, pro forma figures give effect to
“(i)
the corporate conversion/reincorporation (including the conversion of the Class B Units issued in July and August 2017); (ii)
the debt and accrued interest conversion; (iii) the issuance of 215,879 shares of our common stock to a debt holder, consultants,
and employees upon consummation of the offering; (iv) the issuance of warrants to purchase 320,352 shares of our common stock
to one consultant and one debtholder upon consummation of the offering; (v) the issuance of 47,775 shares of common stock having
a value of $477,750 upon consummation of the offering to our Chairman of the Board, Chief Executive Officer and Chief Operating
Officer/Chief Financial Officer in accordance with the terms of our Performance Bonus Plan; (vi) the receipt of $10,000 in cash
proceeds from the sale of 9,434 Series B Units (1,755 shares of common stock post-corporate conversion/reincorporation) in July
2017 and the issuance of such Class B Units; and (vii) the receipt of $10,000 in cash proceeds from the sale of 9,434 Series B
Units (1,755 shares of common stock post-corporate conversion/reincorporation) in August 2017 and the issuance of such Class B
Units.”
Among the effects of the listed events
is the recognition of expenses that materially affect the loss for the period in which they are recognized. The pro forma accumulated
deficit at June 30, 2017 (disclosed in the table on page 12 labeled “Balance Sheet Data”) is increased from the actual
accumulated deficit for June 30, 2017 for the same period by the amount of the total expenses recognized as a result of the events
listed in footnote 2. The pro forma net loss per share is calculated by adding these expenses to the actual net loss for December
31, 2016 (disclosed in the summary financial information table on page 12) then dividing the total by the pro forma number of
shares outstanding at December 31, 2016. The pro forma net loss for December 31, 2016, and pro forma net loss per share for December
31, 2016 can be derived from the figures disclosed as shown in the table below:
Actual Net Loss - Dec. 31, 2016
$ (421,000 )
Actual Accumulated Deficit - June 30, 2017
$ (10,381,000 )
Pro Forma Accumulated Deficit - June 30, 2017
$ (14,451,000 )
Added Loss to Give Effect to Pro Forma
$ (4,070,000 )
Pro Forma Net Loss - Dec. 31, 2016
$ (4,491,000 )
Pro Forma Shares Outstanding
4,062,011
Pro Forma Net Loss Per Share
$ (1.11 )
United
States Securities
and Exchange Commission
September
25, 2017
Page 3
As stated above, for clarity, the Company
modified that the “Unaudited pro forma net loss per share” table included on page 12 of the Registration Statement
to add the line “Pro forma net loss” as shown below. This change will be reflected on page 12 of Amendment No. 1 to
the Registration Statement filed herewith.
Unaudited pro forma net loss per share:
Net loss per share, basic and diluted(1)
(0.13 )
(0.25 )
(0.14 )
(0.07 )
Weighted average shares, basic and diluted(1)
3,258,002
3,216,009
3,261,112
3,251,838
Pro forma net loss(2)
(4,491,000 )
(443,000 )
Pro forma net loss per share, basic and diluted(2)
(1.11 )
(0.11 )
Shares used to calculate pro forma net loss per common share, basic and diluted(2)
4,062,011
4,065,121
*
* *
If
you have any questions or need additional information, please contact the undersigned at (516) 496-2223 or (212) 907-6457.
Sincerely,
/s/
Leslie Marlow
Leslie
Marlow
cc:
William
B. Stilley
Chief
Executive Officer of ADial Pharmaceuticals, Inc.
Joseph
Truluck
Chief
Financial Officer of ADial Pharmaceuticals, Inc.
2017-09-21 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 September 21 , 2017 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 204 E. High Street Charlottesville, VA 22902 Re: Adial Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed September 7, 2017 File No: 333 -220358 Dear Mr. Stilley: We have reviewed your registration statement and have the following comment . 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 informati on. 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 the comment , we may have additional comments. Summary Financial Information, page 12 1. Your disclosure of the Pro forma net loss per share for the Year Ended December 31, 2016 does not appear to be correct based on your disclosure of shares used in the calculation. Please revise accordingly, or provide us with your calculation. William B. Stilley Adial Pharmaceuticals, Inc. September 21 , 2017 Page 2 You may contact Rolf Sundwall at (202) 551 -3105 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or Joseph McCann at (202) 551 -6262 with any other questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP
2017-09-19 - CORRESP - ADIAL PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
Telephone (212) 907-6457
Facsimile: (212) 208-4657
September 19, 2017
VIA EDGAR
United States Securities
and Exchange
Commission
Division of Corporation Finance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Ms. Suzanne Hayes
Re:
Adial Pharmaceuticals, Inc.
Registration Statement on Form S-1
Submitted September 7, 2017
CIK No. 0001513525
Dear Ms. Hayes:
On behalf of our client,
Adial Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comment number 7 from the
staff (the “Staff”) of the Securities and Exchange Commission in its June 9, 2017 letter to the Company relating
to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”).
Set forth below in
bold is comment number 7 from the June 9, 2017 letter from the Staff and immediately following the comment is the Company’s
response to that comment.
7. You disclose on page 51 your process for estimating the fair value of your equity awards prior
to your IPO for purposes of granting equity-based compensation in the absence of a public trading market. Once you have an estimated
offering price or range and have determined the conversion ratio for your membership units, please explain to us the reasons for
any differences between the recent valuations of your membership units leading up to the IPO and the estimated offering price.
This information will help facilitate our review of your accounting for equity issuances including stock compensation.
Response: The Company
respectfully submits the below additional information to assist the Staff in its review of the Company’s position with respect
to its determination of the fair value of its common shares underlying its outstanding equity awards and the reasons for the differences
between the recent valuation of its membership units and the estimated offering price for its initial public offering (the “IPO”).
United States Securities
and Exchange Commission
September 19, 2017
Page 2
Historically, the fair value
of the units underlying the equity-based awards (options and profit interest units) has been determined on each grant date by the
Company’s board of directors (the “Board”), with input from management. All equity-based awards were intended
to be granted with an exercise price per award no less than the fair value per unit of the Company’s units underlying those
awards on the date of grant, determined in good faith and based on the information known to the Board on the date of grant. In
the absence of a public trading market for the Company’s units, on each grant date, the Board considered various objective
and subjective factors described in detail in the Registration Statement, along with input from management, to determine the fair
value of the Company’s units.
Effects of Reorganization/Reincorporation
on Unit Price to Stock Price Comparison and Preliminary IPO Range
The Company is currently organized
as a Virginia limited liability company. Prior to the consummation of the initial public offering, the Company will reorganize
into a Virginia corporation, then merge the Virginia corporation into a newly organized Delaware corporation. (This process is
described in detail in the section Corporate Conversion/Reincorporation, beginning on page 50 of the submitted S-1.) The
Virginia limited liability company has two classes of equity units outstanding, Class A and Class B. Both Class A and Class B units
shall convert to the shares of the same series of common stock in the Delaware corporation at the ratio of 0.186 shares per
unit or 5.37 units per share. In comparing the recent valuation of the units and the IPO Price Range, we believe it is necessary
that the comparison be of units to units as opposed to stock to units and that the Conversion/Reincorporation ratio be taken
into account in the value of the units.
Based on discussions with the Board,
management and upon the recommendation of Aegis Capital Corp, the lead underwriter for the offering, the anticipated price range
for this offering was determined to be within the range of $9.00 to $11.00 per share (the “IPO Price Range”),
with a midpoint of the price range of $10.00 per share (the “Assumed IPO Price”). Based upon the conversion ratio
of 0.186 shares per unit, the equivalent pricing range per unit is $1.67 to $2.05, with a midpoint of $1.86.
Factors Used to
Determine Price Range
The Company respectfully submits
to the Staff that the increase in value between the most recent valuation report issued by Doty Scott Enterprises, Inc. to support
the financial reporting of the Company’s 2016 financial statements described below, compared to the IPO Price Range, is reasonable
based upon the factors set forth below. As is typical in initial public offerings, the Price Range was not derived using a formal
determination of fair value, but was determined by negotiations between the Company and the underwriters. Among the factors that
were considered in setting the Price Range were the following:
- The general conditions of the securities market and the recent market prices of, and the demand for, publicly traded common stock of comparable companies;
United States Securities
and Exchange Commission
September 19, 2017
Page 3
- The
Company’s financial condition and prospects;
- Estimates
of business potential and earnings prospects for the Company and the industry in which it operates;
- Recent
performance of IPOs of companies in the biotechnology sector;
- Feedback
from the Company’s End of Phase 2 meeting in March, 2013 with the U.S. Food and Drug Administration related to AD04, the
Company’s lead product candidate;
-
Business developments impacting the Company;
- Input received from the lead underwriters, including discussions that took
place during the week of August 14th through 18th with senior management of the Company and its board of directors
(the “Board”).
The Price Range does not take
into account the current lack of liquidity for the Company’s common shares and assumes a successful IPO with no weighting
attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an
acquisition transaction. Prior to August 14th, 2017, the Company and underwriters had not had any specific discussions
regarding the Price Range.
Factors Supporting
the Increase in Price
The anticipated price range for
this offering was determined with reference to several quantitative and qualitative factors, each of which contributed to the
difference between the value of the recent equity awards and the Assumed IPO Price. The Company respectfully submits that the
difference between the fair value of its recent equity issuances and the midpoint of the anticipated offering price range for
this offering is primarily the result of the factors and events set forth below.
Recent Market Price
of Equity
The most recent arms-length transactions
in Company equity took place on June 28th and August 1st of 2017, with the sale of 18,868 and 9,434 Class
B units, respectively, to a single investor at a price of $1.06 per Class B unit. This investor was not affiliated with
the Company and negotiated the price solely for his own benefit; this price represents, therefore, a market price for Company equity.
In addition, on July 1, 2017, an incoming director purchased 9,434 Class B units at the same price negotiated by the outside investor.
In total, sale of equity at this price during this period raised $40,000, which increased cash on hand from $137,000 to $177,000,
or by 29%, making sale of equity at this price a significant offering of units, and an observable market price under ASC 718-10-55-10
or a potential Level 2 value measurement within the meaning of FASB ASC 820.
United States Securities
and Exchange Commission
September 19, 2017
Page 4
Around the period during which
equity was being sold at $1.06 per Class B unit, options with a strike price of $1.06 were granted as compensation on July 1st,
July 25th, and August 1st. (Please see the attached Appendix for a table of summary transactions in units,
profits interest units, and options to purchase units for the period from July 1, 2016 to present.) In each case, the cost of the
option issuance was calculated using the Black-Sholes model, with the underlying asset price set equal to $1.06.
Sources of Increased
Value in the Intervening Period
This increase in price will integrate
several value enhancing events that will have taken place after the price-setting transaction on June 28th and prior
to the offering:
- On July 1st, 2017, the Chief Operating Officer agreed
to accept the added position of Chief Financial Officer, a critical position previously vacant.
- On
July 1st, 2017, Tony Goodman agreed to serve as a director. Mr. Goodman is an experienced pharmaceutical executive
that was largely responsible for the development of the Suboxone®, the most successful addiction drug with peak sales of over
$1.5 billion.
- On July 25th, 2017, Dr. Tomasz Zastawny was hired to
act as Chief Development Officer, with responsibility the Company’s lead drug development program. This position is highly
specialized and finding a candidate with the qualifications of Dr. Zastawny was an important reduction of risk for the Company.
- A lease of office space was executed on August 16, 2017.
- The public filing of the S-1 registration statement was made on
September 7, 2017.
- Equity markets in the Company’s sector, biotechnology, remained
solid during the period from June 28th to September 13th (for example, the S&P Biotech ETF increased
by 5%), increasing the likelihood that the Company would consummate its offering in early October.
In
addition, it is expected that the following events will add value to the enterprise:
- Prior to an offering, members of ADial Pharmaceuticals, LLC, will
have formally approved the Company’s reorganization/reincorporation and initial public offering on the terms set forth in
the S-1.
- The
Company’s equity is presently highly illiquid because it is a private company; consummation of the IPO will reduce this
risk to equity holders.
- The Company’s present cash position raises significant doubt
as to its ability to continue as a going concern. Consummation of the offering within the expected range is expected to mitigate
a significant portion of this doubt and the related risk.
- The expected proceeds of the offering will allow the Company to
begin a Phase 3 trial of its lead product candidate, AD04.
- The expected proceeds will allow the Company to retain current
personnel and make additional hires if needed.
- The Company will have a broader base of shareholders.
United States Securities
and Exchange Commission
September 19, 2017
Page 5
Previous Valuation
of Company Equity
A valuation report for ADial
Pharmaceuticals, LLC equity and its derivatives was issued by Doty Scott Enterprises, Inc. to support the financial reporting of
the Company’s 2016 financial statements. The Doty Scott report included valuations of Profits Interests Units (“PIUs”)
valued as options using the Black-Scholes model, effective at the time of issuance. This third-party valuation was performed in
accordance with the guidance outlined the Statement of Financial Accounting Standard ASC 820– 10–35–37 Fair
Value in Financial Instruments to facilitate the accounting under ASC Topic 718 “Compensation – Stock Compensation”.
The Black-Scholes model requires
the underlying asset price as a parameter. Since the PIUs were valued as options for the purchase of Class A units, the value of
Class A units at the time of each PIU issuance was also calculated. The fair value of the Class A units in June of 2013 was determined
to be $0.46 per Class A unit, using an Options Pricing Model with a June 2013 offering of Class B units as input. There
being no further offerings of equity after June 2013 and prior to the offerings between June and August of 2017, subsequent valuation
of Class A units was determined by calculating the Weighted Average Costs of Capital for the periods and using them as reasonable
assumptions of the growth rate, given the occurrence of positive, non-inflective value enhancing events. Using this method, the
value of Class A units at April 25, 2016, the time of the most recent PIU issuance, was determined to be $0.81 per Class A unit.
For purposes of negotiation with
the outside investor that ultimately purchased Class B units in June and August of 2017, Company management extrapolated a growth
rate for Class A unit values by fitting a curve to the values given in the Doty-Scott report using the least squares method to
determine the best fit. This projected growth rate implied a value of $1.03 per Class A unit on June 28, 2017, which served
as a reasonable lower for the value of Class B units, given the latter’s enjoyment of a liquidity preference over Class A
units, albeit a liquidity preference that expires on completion of the reorganization/reincorporation. Additionally, based on our
projected share price range for the IPO at the time, we projected the increase in the value from the $1.06 per unit to be in the
range of 22%-105%, which the Board considered reasonable given the risks of the investment at that time and the lock-up and continued
reduced liquidity the investor would face after the initial public offering.
The Company respectfully submits
that the deemed per unit fair values used as the basis for determining the share-based compensation in connection with its grants
of profit interest units are reasonable and appropriate for the reasons described herein and in the Registration Statement.
United States Securities
and Exchange Commission
September 19, 2017
Page 6
Appendix
Summary Table of
Unit, Profit Interest Unit, and Unit Option Transactions
The following table sets forth
summary transactions in units, profits interest units, and options to purchase units for the period from July 1, 2016 to present.
For grants of profits interest units and options, this table represents the accounting grant dates in accordance with ASC 718,
Stock Compensation, at which all of the accounting prerequisites had been met in order to issue the stock options and profit interest
units and all terms had been communicated to the recipients.
Date
Transaction Type
Number of Units/Options
(Underlying) Unit Value
Strike Price/Distribution Reduction (if applicable)
6/28/17
Sale of Class B Units
18,868
$ 1.06
NA
7/1/17
Grants of Incentive Options
711,000
$ 1.06
$1.06
7/1/17
Sale of Class B Units (Insider)
9,434
$ 1.06
NA
7/25/17
Grant of Incentive Options
186,000
$ 1.06
$1.06
8/1/17
Sale of Class B Units
9,434
$ 1.06
NA
8/1/17
Grant of Incentive Options
40,000
$ 1.06
$1.06
9/1/17
Grant of Incentive Options*
30,000
$ 1.06
$1.06
* Grant of 9/1/17 is reissue on identical
terms of option grant made on 7/1/17 to a director on shift to role of scientific advisor.
* * *
If you have any questions
or need additional information, please contact the undersigned at (516) 496-2223 or (212) 907-6457.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc:
William B. Stilley
Chief Executive Officer of ADial Pharmaceuticals,
Inc.
Joseph Truluck
Chief Financial Officer of ADial Pharmaceuticals,
Inc.
2017-07-03 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 July 3, 2017 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 204 E. High Street Charlottesville, VA 22902 Re: Adial Pharmaceuticals, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted June 21 , 2017 CIK No. 0001513525 Dear Mr. Stilley: We have reviewed your amended draft registration statement and have the following comment. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. 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 the information you provide in response to this comment and your amended draft registration statement or filed registration statement, we may have additional comments. Exhibits 1. Please file the following agreements as exhib its to the registration statement or explain why each one is not required to be filed pursuant to Regulation S -K, Item 601: The agreement, referenced on page F -26, governing the consulting services provided to you by your Board Chairman; The April 25, 2016 consulting agreement with your Chief Operating/Chief Financial Officer, referenced on page F -31; The October 27, 2016 consulting agreement, referenced on page F -31; and Your Performance Bonus Plan, referenced on page F -30 and elsewhere in the prospectus. William B. Stilley Adial Pharmaceuticals, Inc. July 3 , 2017 Page 2 For additional guidance, as applicable, please refer to Compliance Disclosure Interpretations, Regulation S -K, Q. 146.04. You may contact Rolf Sundwall at (202) 551 -3105 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the f inancial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or Joseph McCann at (202) 551 -6262 with any other questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP
2017-06-12 - UPLOAD - ADIAL PHARMACEUTICALS, INC.
Mail Stop 4546 June 9, 2017 William B. Stilley, III President and Chief Executive Officer Adial Pharmaceuticals, Inc. 204 E. High Street Charlottesville, VA 22902 Re: Adial Pharmaceuticals, Inc. Draft Registration Statement on Form S-1 Submitted May 12, 2017 CIK No. 0001513525 Dear Mr. Stilley: We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary, page 1 Overview , page 1 1. Please tell us your basis for highlighting in the first paragraph of the Summary your focus on the developmen t of therapeutics for drug addi ctions and other addiction -like behaviors . In this regard, we note that you do not address these development efforts in your Business discussion . With respect to your disclosure on page 5 , please also revise to explain how you will be able to undertake evaluation of these addictions and disorders at minimal additional cash cost to the company . William B. Stilley Adial Pharmaceuticals, Inc. June 9, 2017 Page 2 2. Please balance your disclosure in the penultimate paragraph on page 1 concerning the safety profile of ondansetron by also discuss ing the lack of long -term use clinical data, which you identify in risk factors on page 13. Planned Phase 3 Clinical Program, page 4 3. Please revise to discuss briefly the status of your IND filing. Implications of Being an Emerging Growth Company, page 6 4. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investor s in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. All of our current data..., page 13 5. Please revise to explain the term “a priori .” We are an “emerging growth company,” and any decision on our part to comply…, page 32 6. We not e your disclosures indicating that you have elected to avail yourself of the exemption from new or revised accounting standards . Accordingly, please revise your disclosure in the final sentence of the risk factor , which indicates that you will be subject to the same new or revised standards that are applicable to non -emerging growth companies. Critical Accounting Policies and Estimates Profits Interest Units, p age 50 7. You disclose on page 51 your process for estimating the fair value of your equity awards prior to your IPO for purposes of granting equity -based compensation in the absence of a public trading market. Once you have an estimated offering price or range and have determined the conversion ratio for your membership units, please explain to us the reasons for any differences between the recent valuations of your membership units leading up to the IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation. Business, page 54 8. Please revise to discuss the manufacture and supply of your drug candidate and the attendant diagnostic biomarker blood test . William B. Stilley Adial Pharmaceuticals, Inc. June 9, 2017 Page 3 Strong Relationships with the Universities..., page 56 9. Please revise to clarify the nature of your relationship with the University of Tex as and any universities other than the University of Virginia . Companion Genetic Bio -Marker Potentially Expands the Market Opportunity, page 56 10. Please revise to explain how your pre -treatment screening with the companion diagnostic genetic test expands your market opportunity. AD-04 – Two-Stage Clinical Development Strategy ..., page 58 11. Please revise to clarify the reasons and rationale for potentially conducting a second , concurrent Phase 3 trial in the US . Signatu res 12. Please revise to indicate who is signing the registration statement in the capacity of principal financial officer. You may contact Rolf Sundwall at (202) 551 -3105 or Angela Connell at (202) 551 -3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jeffrey Gabor at (202) 551 -2544 or Joseph McCann at (202) 551 -6262 with any other questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Leslie Marlow, Esq. Gracin & Marlow, LLP