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Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Hepion Pharmaceuticals, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2025-01-02
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2025-01-14
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2025-01-14
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2025-01-15
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2025-01-15
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2025-01-17
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2025-01-17
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-12
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2024-07-12
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-11-03
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2023-11-06
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-04-07
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2021-11-22
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-11-05
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2020-11-20
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2020-11-20
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2019-05-28
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2019-06-05
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2019-06-05
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2019-06-12
Hepion Pharmaceuticals, Inc.
Summary
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Company responded
2019-06-13
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2019-06-14
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-02-11
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2019-04-22
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-02-11
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2019-02-13
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-05-29
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
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Company responded
2018-05-30
Hepion Pharmaceuticals, Inc.
References: May 25, 2018
Summary
Generating summary...
↓
Company responded
2018-06-13
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-03-12
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
↓
Company responded
2015-03-16
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-10-27
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2014-10-23
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2013-09-20
Hepion Pharmaceuticals, Inc.
References: August 24, 2012 | September 5, 2013
Summary
Generating summary...
↓
SEC wrote to company
2014-02-03
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-12-11
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-11-04
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-10-10
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Hepion Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-09-05
Hepion Pharmaceuticals, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-24 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 001-36856 | Read Filing View |
| 2025-01-17 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-17 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-15 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-15 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-02 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 333-284052 | Read Filing View |
| 2024-07-12 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 333-280752 | Read Filing View |
| 2024-07-12 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2023-11-06 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2023-11-03 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2021-11-22 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2021-04-07 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-05 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-12 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-05 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-05 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-05-28 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-04-22 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-05-30 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-05-29 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2015-03-16 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2015-03-12 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-10-27 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-10-23 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-02-03 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-12-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-11-04 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-10-10 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-09-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-09-05 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-24 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 001-36856 | Read Filing View |
| 2025-01-02 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 333-284052 | Read Filing View |
| 2024-07-12 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | 333-280752 | Read Filing View |
| 2023-11-03 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2021-04-07 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-05 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-05-28 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-05-29 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2015-03-12 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-10-27 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-10-23 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2014-02-03 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-12-11 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-11-04 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-10-10 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-09-05 | SEC Comment Letter | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-01-17 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-17 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-15 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-15 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2024-07-12 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2023-11-06 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2021-11-22 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-12 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-05 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-06-05 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-04-22 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2019-02-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-06-13 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2018-05-30 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2015-03-16 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2013-09-20 | Company Response | Hepion Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
2025-04-24 - UPLOAD - Hepion Pharmaceuticals, Inc. File: 001-36856
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 24, 2025 John Brancaccio Interim Chief Executive Officer Hepion Pharmaceuticals, Inc. 55 Madison Ave., Suite 400 - PMB# 4362 Morristown, NJ 07960 Re: Hepion Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14A Filed April 16, 2025 Dear John Brancaccio: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jeffrey Fessler, Esq. </TEXT> </DOCUMENT>
2025-01-17 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Laidlaw
& Company (UK) Ltd.
521
5th Ave,
New
York, NY 10175
January
17, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hepion
Pharmaceuticals, Inc.
Registration
Statement on Form S-1, as amended
File
No: 333-284052
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), Laidlaw & Company (UK) Ltd.
as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will
become effective at 5:00pm Eastern Time on January 21, 2025 or as soon thereafter as practicable.
Very
truly yours,
Laidlaw
& Company (UK) Ltd.
By:
/s/
Hugh Regan
Name:
Hugh
Regan
Title:
Executive
Director
2025-01-17 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion
Pharmaceuticals, Inc.
c/o
Clementi Associates
919
Conestoga Road
Building
3, Suite 115
Rosemont,
PA 19010
January
17, 2025
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jason Drory
Re:
Hepion
Pharmaceuticals, Inc.
Form S-1
Registration Statement, as amended
Filed
December 26, 2024
File
No. 333-284052
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Hepion Pharmaceuticals, Inc.
(the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 5:00 p.m., Eastern Standard Time, on Tuesday, January 21, 2025, or as soon thereafter as practicable.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
HEPION
PHARMACEUTICALS, INC.
By:
/s/
John Brancaccio
Name:
John
Brancaccio
Title:
Interim
Chief Executive Officer
2025-01-15 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Laidlaw
& Company (UK) Ltd.
521
5th Ave,
New
York, NY 10175
January
15, 2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hepion
Pharmaceuticals, Inc. (the “Company”)
Registration
Statement on Form S-1, as amended
File
No: 333-284052 (the “Registration Statement”)
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence via EDGAR on January 14, 2025, in which Laidlaw & Company (UK) Ltd., as the Placement
Agent, joined the Company’s request for acceleration of the effective date of the above-referenced Registration Statement for 5:00
pm Eastern Time on January 15, 2025, or as soon thereafter as practicable, in accordance with Rule 461 under the Securities Act of 1933,
as amended. The Company is no longer requesting that such Registration Statement be declared effective at this time and we hereby formally
withdraw our request for acceleration of the effective date.
Very
truly yours,
Laidlaw
& Company (UK) Ltd.
By:
/s/
Hugh Regan
Name:
Hugh
Regan
Title:
Executive
Director
2025-01-15 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion Pharmaceuticals, Inc.
c/o Clementi Associates
919 Conestoga Road
Building 3, Suite 115
Rosemont, PA 19010
January 15, 2025
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jason Drory
Re:
Hepion Pharmaceuticals, Inc.
Form S-1 Registration Statement, as amended
Filed December 26, 2024
File No. 333-284052
Ladies and Gentlemen:
Reference is made to our
letter, filed as correspondence via EDGAR on January 14, 2025, in which we requested acceleration of the effective date of the above-referenced
Registration Statement to January 15, 2025, at 5:00 p.m., Eastern Standard Time. We hereby formally withdraw our previous request for
acceleration.
HEPION PHARMACEUTICALS, INC.
By:
/s/ John Brancaccio
Name:
John Brancaccio
Title:
Interim Chief Executive Officer
-1-
2025-01-14 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Laidlaw
& Company (UK) Ltd.
521
5th Ave,
New
York, NY 10175
January 14,
2025
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Hepion
Pharmaceuticals, Inc.
Registration
Statement on Form S-1, as amended
File
No: 333-284052
Ladies
and Gentlemen:
Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), Laidlaw & Company (UK) Ltd.
as Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that
it will become effective at 5:00pm Eastern Time on January 15, 2025 or as soon thereafter as practicable.
Very
truly yours,
Laidlaw
& Company (UK) Ltd.
By:
/s/
Hugh Regan
Name:
Hugh
Regan
Title:
Executive
Director
2025-01-14 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion
Pharmaceuticals, Inc.
c/o
Clementi Associates
919
Conestoga Road
Building
3, Suite 115
Rosemont,
PA 19010
January
14, 2025
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jason Drory
Re:
Hepion
Pharmaceuticals, Inc.
Form S-1
Registration Statement, as amended
Filed
December 26, 2024
File
No. 333-284052
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Hepion Pharmaceuticals, Inc.
(the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 5:00 p.m., Eastern Standard Time, on Wednesday, January 15, 2025, or as soon thereafter
as practicable.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
HEPION
PHARMACEUTICALS, INC.
By:
/s/
John Brancaccio
Name:
John
Brancaccio
Title:
Interim
Chief Executive Officer
2025-01-02 - UPLOAD - Hepion Pharmaceuticals, Inc. File: 333-284052
January 2, 2025
John Brancaccio
Interim Chief Executive Officer
Hepion Pharmaceuticals, Inc.
c/o Clementi Associates
919 Conestoga Road
Building 3, Suite 115
Rosemont, PA 19010
Re:Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 26, 2024
File No. 333-284052
Dear John Brancaccio:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeffrey Fessler
2024-07-12 - UPLOAD - Hepion Pharmaceuticals, Inc. File: 333-280752
July 12, 2024
John Cavan
Interim Chief Executive Officer
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed July 11, 2024
File No. 333-280752
Dear John Cavan:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Sean Reid
2024-07-12 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion
Pharmaceuticals, Inc.
399
Thornall Street, First Floor
Edison,
NJ 08837
July
12, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jimmy McNamara
Re:
Hepion
Pharmaceuticals, Inc.
Form
S-1 Registration Statement
Filed
July 11, 2024
File
No. 333-280752
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Hepion Pharmaceuticals, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 4:30 p.m., Eastern Standard Time, on Monday, July 15, 2024, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
HEPION
PHARMACEUTICALS, INC.
By:
/s/
John Cavan
Name:
John
Cavan
Title:
Interim
Chief Executive Officer
2023-11-06 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
November 6, 2023
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
Re:
Hepion Pharmaceuticals, Inc.
Form S-1 Registration Statement
Filed October 31, 2023
File No. 333-275231
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Hepion Pharmaceuticals, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 4:00 p.m., Eastern Standard Time, on Wednesday, November 8, 2023, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
HEPION PHARMACEUTICALS, INC.
By:
/s/ Robert Foster
Name:
Robert Foster
Title:
Chief Executive Officer
-1-
2023-11-03 - UPLOAD - Hepion Pharmaceuticals, Inc.
United States securities and exchange commission logo
November 3, 2023
Robert Foster, Ph.D.
Chief Executive Officer
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed October 31, 2023
File No. 333-275231
Dear Robert Foster:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey J. Fessler, Esq.
2021-11-22 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
November 22, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
Re:
Hepion Pharmaceuticals, Inc.
Amendment No. 1 to Form S-3 Registration Statement
Filed November 19, 2021
File No. 333-254996
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Hepion Pharmaceuticals, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 4:00 p.m., Eastern Standard Time, on Wednesday, November 24, 2021, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
HEPION PHARMACEUTICALS, INC.
By:
/s/ Robert Foster
Name:
Robert Foster
Title:
Chief Executive Officer
-1-
2021-04-07 - UPLOAD - Hepion Pharmaceuticals, Inc.
United States securities and exchange commission logo
April 7, 2021
Robert Foster, Ph.D.
Chief Executive Officer
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 2, 2021
File No. 333-254996
Dear Dr. Foster:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-36735 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey J. Fessler, Esq.
2020-11-20 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
November 20, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-1, as amended
File No. 333-249724
Acceleration Request
Requested Date: November 24, 2020
Requested Time: 5:00 p.m. Eastern Time (US)
Ladies and Gentlemen:
In connection with the above-referenced
Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative
of the underwriters, hereby join in the request of Hepion Pharmaceuticals, Inc. that the effective date of the Registration Statement
be accelerated so that it will be declared effective at 5:00 p.m., Eastern Time (US), on November 24, 2020, or as soon thereafter
as practicable.
Pursuant to Rule 460 under the Act, we wish
to advise you that the underwriters have distributed as many copies of the preliminary prospectus to underwriters, dealers, institutions
and others as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned, as representative of the
underwriters, has complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
THINKEQUITY
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name: Eric Lord
Title: Head of Investment Banking
ThinkEquity
17 State Street, 22nd Floor
A division of Fordham Financial Management, Inc.
New York, NY 10004
Member FINRA – SIPC
Tel: 646-968-9355
2020-11-20 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
HEPION PHARMACEUTICALS, INC.
399 Thornall
Street, First Floor
Edison, NJ 08837
November 20, 2020
VIA EDGAR
United States Securities and Exchange Commission
100 F. Street, NE
Washington, DC 20549
Attention: Deanna Virginio
Re: Hepion Pharmaceuticals, Inc.
Registration Statement
on Form S-1, as amended
File No. 333-249724
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Hepion Pharmaceuticals, Inc.
(the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 5:00 p.m.., Eastern Standard Time, on Tuesday, November 24, 2020, or as soon thereafter
as possible.
Please notify Jeffrey
Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
Thank you,
HEPION PHARMACEUTICALS, INC.
By:
/s/ Robert Foster
Name: Robert Foster
Title: Chief Executive Officer
2020-11-05 - UPLOAD - Hepion Pharmaceuticals, Inc.
United States securities and exchange commission logo
November 4, 2020
Robert Foster
Chief Executive Officer
Hepion Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:Hepion Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed October 29, 2020
File No. 333-249724
Dear Mr. Foster:
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: Jeffrey Fessler, Esq.
2019-06-14 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 June 14, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: ContraVir Pharmaceuticals, Inc. Form S-1, as amended File No. 333-231604 Dear Ms. Yale: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Standard Time, on Monday, June 17, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-06-13 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 June 13, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: ContraVir Pharmaceuticals, Inc. Form S-1, as amended File No. 333-231604 Dear Ms. Yale: ContraVir Pharmaceuticals, Inc. (the “Company”) hereby respectfully withdraws its request, dated June 12, 2019, that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Time, on Thursday, June 13, 2019. The Company intends to submit a revised acceleration request at a later date. Please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 if there are any questions with respect to this request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-06-12 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 June 12, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: ContraVir Pharmaceuticals, Inc. Form S-1, as amended File No. 333-231604 Dear Ms. Yale: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Standard Time, on Thursday, June 13, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-06-05 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 June 5, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: ContraVir Pharmaceuticals, Inc. Form S-1 File No. 333-231604 Dear Ms. Yale: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Standard Time, on Thursday, June 6, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-06-05 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 June 5, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: ContraVir Pharmaceuticals, Inc. Form S-1 File No. 333-231604 Dear Ms. Yale: ContraVir Pharmaceuticals, Inc. (the “Company”) hereby respectfully withdraws its request, dated June 5, 2019, that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:30 p.m., Eastern Time, on Thursday, June 5, 2019. The Company intends to submit a revised acceleration request at a later date. Please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 if there are any questions with respect to this request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-05-28 - UPLOAD - Hepion Pharmaceuticals, Inc.
May 24, 2019
Robert Foster
President and Chief Executive Officer
ContraVir Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:ContraVir Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed May 20, 2019
File No. 333-231604
Dear Dr. Foster:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Dorrie Yale at 202-551-8776 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey J. Fessler, Esq.
2019-04-22 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm April 22, 2019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, DC 20549 Attention: Todd Schiffman Re: ContraVir Pharmaceuticals, Inc. Registration Statement on Form S-1, as amended File No. 333-229416 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m. (EDT) on Wednesday April 24, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at 212-634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer 1
2019-02-13 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street Edison, NJ 08837 February 13, 2019 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Todd Schiffman Re: ContraVir Pharmaceuticals, Inc. Form S-3 File No. 333-229534 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 p.m., Eastern Standard Time, on Thursday, February 14, 2019, or as soon thereafter as possible. Please notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Thank you, CONTRAVIR PHARMACEUTICALS, INC. By: /s/ Robert Foster Name: Robert Foster Title: Chief Executive Officer
2019-02-11 - UPLOAD - Hepion Pharmaceuticals, Inc.
February 11, 2019
Robert Foster
Chief Executive Officer
ContraVir Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:ContraVir Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed on January 29, 2019
File No. 333-229416
Dear Mr. Foster:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-06-13 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street, First Floor Edison, New Jersey 08837 June 13, 2018 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Ms. Ada D. Sarmento Re: ContraVir Pharmaceuticals, Inc. Registration Statement on Form S-1, as amended File No. 333-225041 Dear Ms. Sarmento: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 4:00 P.M., Eastern Daylight Time, on Thursday, June 14, 2018, or as soon thereafter as possible. The Company acknowledges that: 1) should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; 2) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and 3) the Company may not assert the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP with any questions or comments at (212) 653-8700. Thank you for your assistance with this filing. CONTRAVIR PHARMACEUTICALS, INC. By: /s/ James R. Sapirstein Name: James R. Sapirstein Title: Chief Executive Officer
2018-05-30 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street, First Floor Edison, NJ 08837 May 30, 2018 Ms. Ada D. Sarmento Ms. Mary Beth Breslin Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F. Street, NE Washington, DC 20549 Re: ContraVir Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed May 18, 2018 File No. 333-225041 Dear Ms. Sarmento and Ms. Breslin: This letter sets forth the response of ContraVir Pharmaceuticals, Inc., a Delaware corporation (the “Company” or “we”), to the comment received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated May 25, 2018 (“Comment Letter”) concerning the Company’s registration statement on Form S-1. In conjunction with this letter, the Company is submitting an amended draft registration statement on Form S-1 (the “Registration Statement”) to the Commission. For convenient reference, we have set forth below in bold each of the Staff’s comments set forth in the Comment Letter and have set forth our responses to the numbering of the comments and the headings used in the Comment Letter. Registration Statement on Form S-1 Information Incorporate by Reference, page 60 1. Please incorporate by reference your Current Reports on Form 8-K filed on August 3, 2017 and September 11, 2017 or provide us your analysis explaining why incorporating these two filings is not required. Refer to Item 12(a)(2) of Form S-1. Response: We have added the Current Reports on Form 8-K filed on August 3, 2017 and September 11, 2017 to the Incorporation by Reference section in Amendment No. 1 to Form S-1. **** 1 If you have any further comments and/or questions, please contact the undersigned at (212) 634-3067. Very truly yours, /s/ Jeffrey Fessler Jeffrey Fessler cc: James Sapirstein, CEO 2
2018-05-29 - UPLOAD - Hepion Pharmaceuticals, Inc.
May 25, 2018
James R. Sapirstein
Chief Executive Officer
ContraVir Pharmaceuticals, Inc.
399 Thornall Street, First Floor
Edison, NJ 08837
Re:ContraVir Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed May 18, 2018
File No. 333-225041
Dear Mr. Sapirstein:
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
Information Incorporated by Reference, page 60
1.Please incorporate by reference your Current Reports on Form 8-K filed on August 3,
2017 and September 11, 2017 or provide us your analysis explaining why incorporating
these two filings is not required. Refer to Item 12(a)(2) of Form S-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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
FirstName LastNameJames R. Sapirstein
Comapany NameContraVir Pharmaceuticals, Inc.
May 25, 2018 Page 2
FirstName LastName
James R. Sapirstein
ContraVir Pharmaceuticals, Inc.
May 25, 2018
Page 2
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625
with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Jeffrey J. Fessler, Esq.
2015-03-16 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm ContraVir Pharmaceuticals, Inc. 399 Thornall Street, First Floor Edison, New Jersey 08837 March 16, 2015 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Ms. Alla Berenshteyn Re: ContraVir Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-202625 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), ContraVir Pharmaceuticals, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 9 a.m., Eastern Daylight Time, on Wednesday, March 18, 2015, or as soon thereafter as possible. The Company acknowledges that: 1) should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; 2) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and 3) the Company may not assert the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. CONTRAVIR PHARMACEUTICALS, INC. By: /s/ James R. Sapirstein Name: James R. Sapirstein Title: Chief Executive Officer
2015-03-12 - UPLOAD - Hepion Pharmaceuticals, Inc.
March 12 , 2015 Via E -mail Jame s R. Sapirstein Chief Executive Officer ContraVir Pharmaceuticals, Inc . 399 Thornall Street, First Floor Edison, New Jersey 08837 Re: ContraVir Pharmaceuticals, Inc. Registration Statement on Form S -3 Filed March 9 , 2015 File No. 333-202625 Dear Mr. Sapirstein : We have limited our review of you r registration statement to the issue we have addressed in our comment . After reviewing any amendment to your registration statement and the information you provide in response to our comment , we may have additional comments. General 1. We note that you have a pending co nfidential treatment request. Please be advised that we will not be in a position to accelerate the effectiveness of your registration statement until we have completed processing your confidential treatment request. We urge all persons who a re responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; James R. Sapirstein ContraVir Pharma ceuticals, Inc. March 12 , 2015 Page 2 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilit ies under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Alla Berenshteyn at (202) 551 -4325 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Jeffrey J. Fessler, Esq. Stephen A. Cohen , Esq. Sichenzia Ross Friedman Ference LLP
2014-10-27 - UPLOAD - Hepion Pharmaceuticals, Inc.
October 2 7, 2014 Via E -mail Gary S. Jacob Chief Executive Officer and Director ContraVir Pharmaceuticals, Inc. 399 Thornall Street, First Floor Edison, New Jersey 08837 Re: ContraVir Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14 A Filed October 17, 2014 File No. 000-55020 Dear Mr. Jacob : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with r espect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing ] to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Jeffrey Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2014-10-23 - UPLOAD - Hepion Pharmaceuticals, Inc.
October 22, 2014 Via E -mail Gary S. Jacob Chief Executive Officer and Director ContraVir Pharmaceuticals, Inc. 399 Thornall Street, First Floor Edison, New Jersey 08837 Re: ContraVir Pharmaceuticals, Inc. Preliminary Proxy Statement on Schedule 14 A Filed October 17, 2014 File No. 000-55020 Dear Mr. Jacob : We have limited our review of your proxy statement to the issue s we have addressed in our comment s. Please respond to this letter by amending your proxy statement as requested . If you do not believe these comment s apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in a response. After reviewing any amendment to your proxy statement or your response to these comment s, we may have addition al comment s. Proposal 6: Amendment to our Certificate of Incorporation to Authorize a Reverse Stock Split, page 18 1. Please amend your disclosure to state the number of authorized shares that will become available for issuance as a result of the reverse stock split at each of the possible ratios. 2. Please amend your disclosure to state whether or not you have any current plans, agreements, understandings, etc. with respect to the authorized shares that will be come available for issuance after the reverse stock split has been implemented . If you have any such plans, agreements, understandings, etc., please describe them. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have mad e. Gary S. Jacob ContraVir Pharmaceuticals, Inc. October 22, 2014 Page 2 In responding to our comment s, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response t o staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact S cot Foley at (202) 551 -3383 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Jeffrey Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2014-02-03 - UPLOAD - Hepion Pharmaceuticals, Inc.
February 3, 2014 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170 Re: ContraVir Pharmaceuticals, Inc. Form 10 -12G Filed August 8, 2013 File No. 000-55020 Dear Mr. Denoyer : We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We u rge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedle r Assistant Director cc: Via E -mail Jeffrey Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2013-12-11 - UPLOAD - Hepion Pharmaceuticals, Inc.
December 11 , 2013 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170 Re: ContraVir Pharmaceuticals, Inc. Amendment No. 3 to Form 10 Filed November 21 , 2013 File No. 000 -55020 Dear Mr. Denoyer: We have reviewed your amended filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, w e may have additional comments. Form 10 -12G/A 1. Please file the amendment, dated March 27, 2007, to the Patent and Technology License Agreement between Cardiff and Contravir Research Incorporated (the Cardiff Agreement) as an exhibit to your Form 10 -12G. Exhibit 99.1 Information Statement Business, page 46 2. In your description of the BMS Agreement, please expand your disclosure to provide: the total remaining amount of milestones payments that could be payable to BMS, if less than the $9 million figure disclosed on page 46; the duration of milestone and royalty obligations owed to BMS; and Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. December 11 , 2013 Page 2 the respective rights of the parties to terminate the agreement and remaining obligations thereunder. 3. In your description of the Cardiff Agreement, please expand yo ur disclosure to provide: the precise nature and scope of the intellectual property licensed; the duration of the agreement and royalty term; the respective rights of the parties to terminate the agreement; and any material performance or financial obligations that must be satisfied in order to maintain the license. FV-100, page 46 4. We note your response to our prior comment 2 and associated revisions to pages 47 and 49 of the Information Statement. Please revise your description of the prior FV -100 studies to include all of the information from your response. In particular, you sho uld include mention that the FDA has not officially recognized “numerically favorable treatment difference” or “relative treatment difference” as standards and that the FDA does not expect statistical significance in Phase 2 clinical trials. Intellectual Property, page 50 5. It appears that Cardiff and Rega Foundation were the joint owners of the patent rights and technology rights sub -licensed to Contravir Research Incorporated in 2005 under the terms of the Patent and Technology License Agreement between Cardiff and Contravir Research Incorporated. Please revise your disclosure of this license agreement to state that Cardiff and Rega were joint owners and discuss the nature of this joint ownership as it exists today and any rights retained in the intellec tual property by Rega, a successor in interest, or a licensee thereof. 6. In addition, please disclose the history of the conveyance of rights to the intellectual property covered by the Cardiff agreement beginning with its original owners and including the license to Contravir Research Incorporated and subsequent transfers to Inhibitex, BMS, Synergy and ContraVir. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes t he information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. December 11 , 2013 Page 3 the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under th e federal securities laws of the United States. Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspan at (202) 551 -3623 or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Jeffre y Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2013-11-04 - UPLOAD - Hepion Pharmaceuticals, Inc.
November 4 , 2013 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170 Re: ContraVir Pharmaceuticals, Inc. Amendment No. 2 to Form 10 Filed October 22, 2013 File No. 000 -55020 Dear Mr. Denoyer: We have reviewed your amended filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, w e may have additional comments. Business, page 43 FV-100, page 44 1. We note your response to our prior Comment 5. Please expand your disclosure to include the maximum total milestone payments you could potentially owe to Bristol -Meyers Squibb Company (B MS), a description of the potential royalties within 10%, such as single -digits, teens, twenties, etc., and the termination provisions of your Asset Purchase Agreement with BMS. 2. We note your response to our prior Comment 6. Please disclose whether “numeri cally favorable treatment difference” or “relative treatment difference” are standards recognized by the FDA or any comparable regulatory agency. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. November 4, 2013 Page 2 3. We note your response to our prior Comment 10. Please define the following abbreviations used in the tables o n page 47: “S.E.;” “AE;” and “SAE.” Intellectual Property, page 48 4. We note your response to our prior Comment 11. Please revise your disclosure to state clearly whether your foreign granted patents related to FV -100 are licensed or owned. If licensed, pl ease identify the licensor. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the compa ny and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the com pany acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect t o the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. November 4, 2013 Page 3 Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspa n at (202) 551 -3623 or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Jeffrey Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2013-10-10 - UPLOAD - Hepion Pharmaceuticals, Inc.
October 10 , 2013 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170 Re: ContraVir Pharmaceuticals, Inc. Amendment No. 1 to Form 10 Filed September 20, 2013 File No. 000 -55020 Dear Mr. Denoyer: We have reviewed your amended filing and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, w e may have additional comments. Exhibit 99.1 Information Statement 1. We note your discussion on page 50 concerning the need for an Investigational New Drug application (IND), which must be reviewed by the FDA and become effective before the commencement of human clinical trials. Throughout the Information Statement where you discuss your clinical development program for FV -100 and contemplated future clinical studies, please disclose whether you have an active IND allowing you to conduct such studies. If so, please indicate when the IND was filed and identify the trial sponsor. If not, please state when you expect to file any necessary INDs. 2. We note your response to our prior Comment 6. Please disclose the requirements for quotation on the OTCBB. Pleas e also clarify what you mean by “shortly” after the distribution. Bernard F. Denoyer Synergy Pharmaceuticals Inc. October 10, 2013 Page 2 Information Statement Summary, page 9 3. We note your response to our prior Comment 7. Please provide an explanation of the following scientific terms the first time they are used in the Info rmation Statement: “prodromal;” “PCR ( -);” “PCR (+);” and “moiety” Risk Factors “We have limited capacity for recruiting and managing trials…,” page 16 4. We note your response to our prior Comment 12. Please conform your disclosure in this risk factor to reflect the information disclosed under “If our product candidate is unable to compete…” on page 21 that specifies your knowledge of a potential competing product, valomaciclovir, being developed by Epiphany Pharmaceuticals. Business, page 44 5. We note your response to our prior Comment 17. Please expand your disclosure to include the material obligations to BMS that you assumed from Synergy pursuant to the Contribution Agreement, as amended and restated. This includes, for example, a description of material liabilities under the BMS Agreement, the aggregate remaining milestone payments and royalties on net sales that may be due to BMS. Please also disclose the duration of any ongoing obligations that will be owed by ContraVir to BMS and provisions relating to their termination. 6. We note your response to our prior Comment 20. Please specify what numerically favorable treatment differences were observed with respect to the primary endpoint in the Phase 2 study conducted by Inhibtex. Please also disclose whether “numerically favorable treatment difference” or “relative treatment difference” are standards recognized by the FDA or any comparable regulatory agenc y. Overview, page 44 7. We note your response to our prior Comment 22. Please identify the preclinical studies you reference that demonstrated the “significant” comparative potency of FV -100 against existing approved drugs for the treatment of shingles and specify the sponsor of these trials. Bernard F. Denoyer Synergy Pharmaceuticals Inc. October 10, 2013 Page 3 FV-100, page 44 FV-100 Efficacy Summary, page 46 8. We note your response to our prior Comment 24. Please explain the concept of “statistical significance” as used throughout the filing. 9. We note your response to our pri or Comment 25. Please clarify, either in the narrative or in explanatory footnotes to your tables, what the information in each of the columns means. A lay reader may have difficulty interpreting the data provided. For example, in the first column of the first table, the meaning of “Score AUC ± S.E.” may be unclear, which obscures the meaning and significance of the numerical data in the column. 10. We note your response to our prior Comment 26. Please define abbreviations used in the tables. Intellectual Pr operty, page 48 11. We note your response to our prior Comment 27. Please revise your disclosure to state clearly whether your patents related to FV -100 are licensed or owned. If licensed, please identify the licensor. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the compa ny and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the com pany acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect t o the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Bernard F. Denoyer Synergy Pharmaceuticals Inc. October 10, 2013 Page 4 Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspa n at (202) 551 -3623 or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Jeffrey Fessler Sichenzia Ross Friedman Ference LLP 61 Broadway, 32nd Floor New York, NY 10006
2013-09-20 - CORRESP - Hepion Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CONTRAVIR PHARMAECUTICALS, INC. 420 LEXINGTON AVENUE, SUITE 2012 NEW YORK, NEW YORK 10170 September 20, 2013 Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey P. Riedler, Assistant Director Dan Greenspan Christina DeRosa Re: ContraVir Pharmaceuticals, Inc. Form 10-12G Filed August 8, 2013 File No. 000-55020 Ladies and Gentlemen: The following responses address the comments of the reviewing Staff of the Securities and Exchange Commission (“Commission”) as set forth in a comment letter dated September 5, 2013 (the “Comment Letter”) relating to the Registration Statement on Form 10 (the “Form 10”) of ContraVir Pharmaceuticals, Inc. (the “Company”). The answers set forth herein refer to each of the Staff’s comments by number. General 1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law 60 days after the date filed, at which time you will be required to begin filing all of the reports mandated by Section 12(g) of the Securities Exchange Act of 1934. Response The Company acknowledges the Staff’s comment and understands it will be a reporting company beginning on the 60th day after the filing of the Form 10. 2. Unless otherwise indicated, references to page references and captions in this letter are to the information statement filed as exhibit 99.1. Response The Company acknowledges the Staff’s comment. 3. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not exhaustive lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. Response The Company acknowledges the Staff’s comment. Securities and Exchange Commission Page 2 of 9 September 20, 2013 4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose in the beginning of your registration statement that you are an emerging growth company and revise your registration statement to: · Describe how and when a company may lose emerging growth company status; · Briefly describe the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes-Oxley Act of 2002 and Section 14A(a) and (b) of the Securities Exchange Act of 1934; and · State your election under Section 107(b) of the JOBS Act: o If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b), include a statement that the election is irrevocable; or o If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(I), provide a risk factor explaining that this election allows you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. In addition, consider describing the extent to which any of these exemptions are available to you as a Smaller Reporting Company. Response The Company acknowledges the Staff’s comment and has updated pages 1, 12, 39 and 42 of the Form 10 in accordance with the Staff’s comment. 5. Please advise us whether Synergy and ContraVir will enter into a formal separation and distribution agreement that will govern the terms of the contemplated spin-off. If there is such an agreement, please file it as an exhibit to your Form 10 and provide appropriate disclosure of the material terms of the agreement in your Information Statement. We may have further comments based on your response. Response The Company acknowledges the Staff’s comment and advises the Staff that currently there is no plan for Synergy and the Company to enter into a formal separation and distribution agreement regarding the contemplated spin-off since there is no operating business being transferred to the Company in connection with the proposed spin-off. Exhibit 99.1 Information Statement 6. We note your disclosure in several places throughout the Information Statement that you anticipate that ContraVir common stock will be quoted on the OTC Bulletin Board shortly after the distribution is completed. Please disclose the requirements for quotation on the OTCBB and the basis for your expectation that ContraVir shares will be quoted on the OTCBB within a short time following the distribution. Please also clarify what you mean by “shortly” after the distribution. Securities and Exchange Commission Page 3 of 9 September 20, 2013 Response The Company acknowledges the Staff’s comment and has updated pages 1, 6, 39, 40 and 66 of the Form 10 in accordance with the Staff’s comment. Information Statement Summary Our Company, page 5 7. To the extent practicable, please minimize the use of highly technical terminology in this section and elsewhere in the Information Statement that may be unfamiliar to lay investors. If the use of such terms is necessary, please give the meaning and significance of such terms in plain language that may be understood by a person not acquainted with this industry or scientific field. For example, an explanation of the following scientific terms and phrases should accompany their first usage in the Information Statement: · “nucleoside analogue prodrug of CF-1743;” · “post-herpetic neuralgia;” · “prodromal;” · “last observation carried forward methodology;” and · “top-line” adverse event findings Response The Company acknowledges the Staff’s comment and has updated pages 9, 10, 11, 44, 45, 46 and 47 of the Form 10 in accordance with the Staff’s comment. 8. Please revise to spell out and define any terms, such as “post-herpetic neuralgia,” that will later be abbreviated throughout the filing. Please ensure that this long-form identification and definition accompanies the first usage of each such term in your document. Response The Company acknowledges the Staff’s comment and has updated pages 9, 10 and 44 of the Form 10 in accordance with the Staff’s comment. Risk Factors 9. Please add a risk factor addressing the fact that all of your assets, including your intellectual property, have been pledged as collateral to Synergy to secure your obligations under the June 5, 2013 Loan and Security Agreement and that failure to make payment to Synergy when due could jeopardize the ownership of your assets and have a material adverse effect on your business. Response The Company acknowledges the Staff’s comment and has updated page 35 of the Form 10 in accordance with the Staff’s comment. “We have incurred significant losses since inception...,” page 10 10. Please expand your risk factor to disclose that your auditors have expressed substantial doubt about your ability to continue as a going concern. Securities and Exchange Commission Page 4 of 9 September 20, 2013 Response The Company acknowledges the Staff’s comment and has updated page 10 of the Form 10 in accordance with the Staff’s comment. “If third party vendors upon whom we rely...,” page I I 11. We note your disclosure that you rely on third parties to conduct your preclinical studies and clinical trials. Please identify the specific suppliers of the critical activities on which you rely. In addition, to the extent that you are substantially dependent on any of these relationships, please file any underlying agreement with these parties as an exhibit to your registration statement. Response The Company acknowledges the Staff’s comment and has updated page 16 of the Form 10 in accordance with the Staff’s comment. “We have limited capacity for recruiting and managing trials...,” page 11 12. We note your disclosure that you may be at a competitive disadvantage. Please disclose whether you know of any competitors who have conducted or are conducting clinical trials for products that will compete with your product candidate. Response The Company acknowledges the Staff’s comment and has updated pages 16 and 17 of the Form 10 in accordance with the Staff’s comment. “We have limited experience in the development of small molecule...,” page 12 13. We note that this risk factor, as well as the risk factors on page 18 and 26 under the respective headings “If we are unable to retain or attract key employees...” and “If we fail to attract and keep senior management...,” are substantially similar. Accordingly, please consolidate into a single risk factor your discussion of the risk of failing to attract or retain key personnel. In such risk factor, please disclose the names of any key personnel and address whether you have had difficulty attracting employees, consultants, third-party contractors, or other key personnel in the past. Response The Company acknowledges the Staff’s comment and has updated pages 17 and 18 of the Form 10 in accordance with the Staff’s comment. “The regulatory approval processes of the FDA and comparable foreign authorities...,” page 13 14. We note your disclosure that you “plan to seek regulatory approval to commercialize [your] product candidate both in the United States. the European Union and in additional foreign countries.” Please identify the countries outside of the United States and the European Union, if known, in which you intend to seek regulatory approval to commercialize your product candidate. Please revise your statements on pages 15 and 45 to conform to this expanded disclosure. Response The Company acknowledges the Staff’s comment and has updated page 20 of the Form 10 in accordance with the Staff’s comment. Securities and Exchange Commission Page 5 of 9 September 20, 2013 Risks Related to our Relationship with Synergy, page 29 15. Please include a risk factor disclosing that the separation will take effect without a shareholder vote and, consequently, a shareholder’s sole recourse will be to divest itself of your parent company’s common stock in advance of the record date. Response The Company acknowledges the Staff’s comment and has updated page 37 of the Form 10 in accordance with the Staff’s comment. Management’s Discussion and Analysis of Financial Condition and Plan of Operations, pages 34-36 Fair Value of Stock-Based Compensation Awards 16. Although you disclose in the notes to financial statements that the Company does not have any outstanding stock options or warrants as of June 30, 2013, please include an itemized chronological schedule covering any equity instruments that have been or will be issued as of the most recent date available (including stock units, options, warrants, etc.) and include the following information separately for each equity instrument issuance: · The date of the transaction; · The number of equity instruments issued or options granted; · The exercise price of equity instruments granted if applicable; · The fair value of the common stock on each grate date and how the fair value was determined; · Whether or not the valuation used to determine the fair value of the equity instruments was contemporaneous or retrospective; and · If the valuation specialist was a related party, please state that fact. Response The Company acknowledges the Staff’s comment and advises the Staff that as of June 30, 2013 there were no outstanding stock options or warrants and as such the Company respectfully believes this comment is not applicable at this time. The Company has updated pages 41 and 43 of the Form 10 to make note that there were no outstanding stock options or warrants as of June 30, 2013. Business 17. It is our understanding that Synergy acquired all of the assets related to FV-100 from Bristol-Meyers Squibb Company in 2012 pursuant to an Asset Purchase Agreement dated August 17, 2012. According to disclosure provided by Synergy in its periodic reports filed with the Commission, the terms of the Asset Purchase Agreement provided for an exclusive license to the patent portfolio in exchange for an upfront payment of $1 million, future milestone payments and a single digit royalty based on net sales. Accordingly, please advise us, and revise your disclosure as necessary, whether ContraVir will assume the obligations that Synergy owed to Bristol-Myers. If so, please disclose the material terms of this agreement and file the Asset Purchase Agreement as an exhibit to your Form 10 registration statement. Response The Company acknowledges the Staff’s comment and has updated pages 9, 44 and 48 of the Form 10 in accordance with the Staff’s comment. Securities and Exchange Commission Page 6 of 9 September 20, 2013 18. Furthermore, since it appears that the FV-100 assets acquired by Synergy from Bristol-Meyers were subject to a license, please advise us, and revise your disclosure as necessary, of the nature of this license, the identity of the licensor and licensee, and the extent to which this license will impact ContraVir. If the license will govern ContraVir’s development and eventual sale of products derived from these licensed assets, please revise your Information Statement to provide the material terms of such license, including the duration, termination provisions, payment provisions and any other material obligations between the parties to the license. Response The Company acknowledges the Staff’s comment however the Company advises the Staff that in accordance with the asset purchase agreement, dated August 24, 2012, between Synergy Pharmaceuticals, Inc. and Bristol-Meyers Squibb Company (“BMS”), Synergy acquired all the intellectual property related the FV-100 assets from BMS. All of this intellectual property was then contributed to the Company by Synergy in accordance with the contribution agreement, dated June 5, 2012, as amended, by and between the Company and Synergy. The Company advises the Staff’s that it has updated page 48 of the Form 10 to state that the Company owns the intellectual property acquired from BMS. 19. It is our understanding that the Phase 2 clinical trial for FV-100, completed in December 2010, was conducted by Inhibitex rather than Synergy. In fact, it appears that you were not involved at all in this trial and, since Synergy’s acquisition of the Inhibitex assets from Bristol-Myers in August 2012, Synergy has not engaged in any clinical study of FV-100 or materially advanced the development of the drug candidate. As such, please revise your disclosure throughout the Information Statement to make this clear. Response The Company acknowledges the Staff’s comment and has updated pages 9, 14 and 44 of the Form 10 in accordance with the Staff’s comment. 20. It is also our understanding that the Phase 2 trial for FV-100 did not meet its primary endpoint of a 25% reduction in the severity and duration of shingles-related pain as compared to Valtrex and that the results obtained from the study were not statistically significant. Please revise your disclosure throughout the Information Statement as necessary to make this clear. We note, for example, your disclosure on page 37 that “there were no statistical differences observed on the primary endpoint” but that there were “numerically favorable differences” observed. This disclosure in your Overview section is not as clear as a statement that the study failed to meet its primary endpoint and results were not statistically signifi
2013-09-05 - UPLOAD - Hepion Pharmaceuticals, Inc.
September 5, 2013 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170 Re: ContraVir Pharmaceuticals, Inc. Form 10-12G Filed August 8, 2013 File No. 000 -55020 Dear Mr. Denoyer : We have reviewed your filing an d 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 within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply t o your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. General 1. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law 60 days after the date filed , at which time you will be required to begin filing all of the reports mandated by Section 12(g) of the Securities Exchange Act of 1934. 2. Unless otherwise indicated, references to page references and captions in this letter are to the information statement filed as exhibit 99.1. 3. Please note that where we provide exampl es to illustrate what we mean by our comments, they are examples and not exhaustive lists. If our comments are applicable to portion s of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 2 4. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, please disclose in the beginning of your registration statement that you are an emerging growth company and revise your registration statement to: Describe how and when a company may lose emerging growth company status; Briefly describe the various exemptions that are available to you, such as exemptions from Section 404(b) of the Sarbanes -Oxley Act of 2002 and Section 14A(a) a nd (b) of the Securities Exchange Act of 1934; and State your election under Section 107(b) of the JOBS Act: o If you have elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b ), include a statement that the election is irrevocable; or o If you have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1), provide a risk factor explaining that this election allow s you to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. Please state in your risk factor that, as a result of this election, your financial statements may not be comparable to companies that comply with public company effective dates. Include a similar statement in your critical accounting policy disclosures. In addition, consider describing the extent to which any of these ex emptions are available to you as a Smaller Reporting Company. 5. Please advise us whether Synergy and ContraVir will enter i nto a formal separation and distribution agreement that will govern the terms of the contemplated spin -off. If there is such an agreement, please file it as an exhibit to your Form 10 and provide appropriate disclosure of the material terms of the agreeme nt in your Information Statement. We may have further comments based on your response. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 3 Exhibit 99.1 Information Statement 6. We note your disclosure in several places throughout the Information Statement that you anticipate that ContraVir commo n stock will be quoted on the OTC Bulletin Board shortly after the distribution is completed. Please disclose the requirements for quotation on the OTCBB and the basis for your expectation that ContraVir shares will be quoted on the OTCBB within a short t ime following the distribution. Please also clarify what you mean by “ shortly” after the distribution. Information Statement Su mmary Our Company, page 5 7. To the extent practicable, please minimize the use of highly technical terminology in this section and elsewhere in the Information Statement that may be unfamiliar to lay investors. If the use of such terms is necessary, please give the meaning and significance of such terms in plain language that may be understood by a person not acquainted with this industry or scientific field. For example, an explanation of the following scientific terms and phrases should accompany their f irst usage in the Information Statement : “nucleos ide analogue prodrug of CF -1743; ” “post -herpetic neuralgia ;” “prodromal ;” “last observation carried forward methodology ;” and “top-line” adverse event findings 8. Please revise to spell out and define any terms , such as “post -herpetic neuralgia ,” that will later be abbreviated throughout the filing. Please ensure that this long -form identification and definition accompanies the first usage of each such term in your document. Risk Factors 9. Please add a risk factor addressing the fact that all of your assets, including your intellectual property, have been pledged as collateral to Syne rgy to secure your obligations under the June 5, 2013 Loan and Security Agreement and that failure to make payment to Synergy when due could jeopardize the ownership of your assets and have a material adverse effect on your business . “We h ave incurred significant losses since inception …,” page 10 10. Please expand your risk factor to disclose that your auditors have expressed substantial doubt about your ability to continue as a going concern. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 4 “If third party vendors upon whom we rely…,” page 11 11. We note your disclosure that you rely on third parties to conduct your preclinical studies and clinical trials. Please identify the specific suppl iers of the critical activities on which you rely. In addition, to the extent that you a re substantially dependent on any of these relationships, please file any underlying agreement with these parties as an exhibit to your registration statement. “We have limited capacity for recruiting and managing trials… ,” page 11 12. We note your disclosure that you may be at a competitive disadvantage. Please disclose whether you know of any competitors who have conducted or are conducting clinical trials for products that will compete with your product candidate. “We have limited exp erience in the development of small molecule… ,” page 12 13. We note that this risk factor, as well as the risk factors on page 18 and 26 under the respective headings “If we are unable to retain or attract key employees…” and “If we fail to attract and keep s enior management…,” are substantially similar. Accordingly, please consolidate into a single risk factor your discussion of the risk of failing to attract or retain key personnel. In such risk factor, please disclose the names of any key personnel and ad dress whether you have had difficulty attracting employees, consultants, third -party contractors, or other key personnel in the past. “The regulatory approval processes of the FDA and comparable foreign authorities… ,” page 13 14. We note your disclosure that you “plan to seek regulatory approval to commercialize [your] product candidate both in the United States, the European Union and in additional foreign countries.” Please identify the countries outside of the Unite d States and the European Union, if known, in which you intend to seek regulatory approval to commercialize your product candidate. Please revise your statements on pages 15 and 45 to conform to this expanded disclosure. Risks Related to our Relationship with Synergy , page 29 15. Please include a risk factor disclosing that the separation will take effect withou t a shareholder vote and, consequ ently, a shareholder’s sole recourse will be to divest itself of your parent company’s common stock in advance of the record date. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 5 Management’s Discussion and Analysis of Financial Condition and Plan of Operations , pages 34 -36 Fair Value of Stock -Based Compensation Awards 16. Although you disclose in the notes to financial statements that the Company does not have any outstanding stock options or warrants as of Jun e 30, 2013, please include an itemized chronological schedule covering any equity instruments that have been or will be issued as of the most recent date available (including stock units, options, warrants, etc.) and include the following information separ ately for each equity instrument issuance: The date of the transaction; The number of equity instruments issued or options granted; The exercise price of equity instruments granted if applicable; The fair value of the common stock on each grate date and how the fair value was determined; Whether or not the valuation used to determine the fair value of the equity instruments was contem poraneous or retrospective; and If the valuation specialist was a related party, please state that fact. Business 17. It is our understanding that Synergy acquired all of the asset s related to FV -100 from Bristol -Meyers Squibb Company in 2012 pursuant to an Asset Purchase Agreement dated August 17, 2012. According to disclosure provided by Synergy in its periodic reports filed with the Commission, the terms of the Asset Purchase Ag reement provided for an exclusive license to the patent portfolio in exchange for an upfront payment of $1 million, future milestone payments and a single digit royalty based on net sales . Accordingly, please advise us, and revise your disclosure as neces sary, whether ContraVir will assume the obligations that Synergy owed to Bristol -Myers. If so, please disclose the material terms of this agreement and file the Asset Purchase Agreement as an exhibit to your Form 10 registration statement. 18. Furthermore, since it appears that the FV -100 a ssets acquired by Synergy from Bristol - Meyers were subject to a license, please advise us, and revise your disclosure as necessary, of the nature of this license, the identity of the licensor and licensee, and the extent to which this license will impact C ontraVir. If the license will govern ContraVir’s development and eventual sale of products derived from these licensed assets, please revise your Information Statement to provide the material terms of such license , including the duration, termination prov isions, payment provisions and any other material obligations between the parties to the license. Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 6 19. It is our understanding th at the Phase 2 clinical trial for FV -100, completed in December 2010, was conducted by Inhibitex rather than Synergy. In fact, it appears that you were not involved at all in this trial and, since Synergy’s acquisition of the Inhibitex assets from Bristol -Myers in August 2012, Synergy has not engaged in any clinical study of FV-100 or materially advanced the development of the drug candidate. As such, please revise your disclosure throughout the Information Statement to make this clear. 20. It is also our understanding that the Phase 2 trial for FV -100 did not meet its primary endpoint of a 25% reduction in the severity and duration of shingles -related pain as compared to Valtrex and that the results obtained from the study were not statistica lly significant. Please revise your disclosure throughout the Information Statement as necessary to make this clear. We note, for example, your disclosure on page 37 that “there were no statistical differences observed on the primary endpoint” but that t here were “numerically favorable differences” observed. This disclosure in your Overview section is not as clear as a statement that the study failed to meet its primary endpoint and results were not statistically significant. Furthermore, you should cla rify what significance , if any, a “numerically f avorable treatment difference ” or a “relative treatment difference” have to the prospect that FV -100 will receive marketing approval from regulatory authorities and whether “numerically favorable treatment di fference” or “relative treatment difference” are standard s recognized by the FDA or any comparable foreign regulatory authority. 21. Given the poor results of the 2010 Phase 2 clinical trial for FV -100, please make clear throughout your disclosur e whether additional Phase 2 trials will be necessary, which could be quite lengthy and expensive, if the company continues with the development of this product candidate. Overview, page 37 22. Please identify the preclinical studies you refe rence that demonstrated the “significant” comparative potency of FV -100 against existing approved drugs for the treatment of shingles and specify the sponsor of these trials. FV-100 Ef ficacy Summary 23. Please disclose the primary endpoint of the study and clarify what the percentages of 3%, 7%, -4% and 14% in patients treated with FV -100 and valacyclovir measured and the methodology for such measurements. 24. Please explain t he concepts of “statistical significance” and “p -values.” If available, please provide the p -values from the Phase 2 study and explain their significance. 25. Please clarify, either in the narrative or in explanatory footnotes to your tables , what the information in each of the columns means . A lay reader may have difficulty interpreting Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. September 5, 2013 Page 7 the data provided. For example, in the first column of the first table, the meaning of “Least Squares Mean” and “BO130 days AUC ± S.E.” may be unclear, whic h obscures the meaning and significance of the numerical data in the column. 26. Please define abbreviations used in the table s. Intellectual Property , page 40 27. Please disclose whether your patents related to FV -100 are licensed or owned. If licensed, please identify the licensor. Management, page 46 28. Here and in the section entitled “Our Relationship with Synergy Following the Distribution” beginning on page 59, please disclose whether any of your o fficers and directors will continue their management functions at Synergy. If so, please describe how their responsibilities will be allocated and add a risk factor addressing the potential conflicts of interest that may arise as a result of members of ma nagement having dual responsibilities to ContraVir and Synergy. In addition, your table of officers and directors should, if applicable, also identify their positions with Synergy. We note, in this regard, that Messrs. Jacob and Denoyer have current empl oyment agreements with Synergy rather than ContraVir. Executive Compensation, page 48 29. We note that you have provided historical compensation information for Synergy officers and directors who will continue as ContraVir management following the separation. Please ensure that all such information for these individuals, which also appears in Synergy’s definitive proxy statement filed August 30, 2013, has been fully and accurately disclosed in the Information Statement. 30. You s tate that your Compensation Discussion and Analysis describes certain aspects of your anticipated compensation structure following the separation, yet this discussion appears to pertain exclusively to Synergy’s historical compensation practices. Please expan