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SEC Comment Letters
Company Responses
Letter Text
NANOVIRICIDES, INC.
Response Received
1 company response(s)
High - file number match
↓
NANOVIRICIDES, INC.
Response Received
1 company response(s)
High - file number match
↓
NANOVIRICIDES, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
NANOVIRICIDES, INC.
Response Received
2 company response(s)
High - file number match
↓
Company responded
2024-04-09
NANOVIRICIDES, INC.
References: February 13, 2024
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2024-04-09
Generating summary...
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Company responded
2024-05-08
NANOVIRICIDES, INC.
References: April 22, 2024
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
NANOVIRICIDES, INC.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-05-17
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2023-05-17
Generating summary...
NANOVIRICIDES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-03-26
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2020-03-26
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Company responded
2020-03-31
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2020-03-31
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NANOVIRICIDES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-12-09
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2019-12-09
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Company responded
2020-01-08
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2020-01-08
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Company responded
2020-01-09
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2020-01-09
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NANOVIRICIDES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2017-03-15
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2017-03-15
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Company responded
2017-04-18
NANOVIRICIDES, INC.
References: March 15, 2017
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2017-04-18
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Company responded
2017-04-20
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2017-04-20
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NANOVIRICIDES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2014-11-06
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2014-11-06
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Company responded
2014-11-07
NANOVIRICIDES, INC.
References: November 6, 2014
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2014-11-07
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Company responded
2014-11-13
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2014-11-13
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NANOVIRICIDES, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2012-11-05
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2012-11-05
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Company responded
2012-12-20
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-12-20
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Company responded
2012-12-20
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-12-20
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-07-10
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2012-07-10
Generating summary...
NANOVIRICIDES, INC.
Response Received
7 company response(s)
High - file number match
SEC wrote to company
2009-04-16
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2009-04-16
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Company responded
2009-04-23
NANOVIRICIDES, INC.
References: April 16, 2009
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2009-04-23
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Company responded
2010-03-22
NANOVIRICIDES, INC.
References: March 10, 2010
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-03-22
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Company responded
2010-04-06
NANOVIRICIDES, INC.
References: March 30, 2010
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-04-06
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Company responded
2012-04-10
NANOVIRICIDES, INC.
References: March 31, 2012
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-04-10
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Company responded
2012-04-26
NANOVIRICIDES, INC.
References: March
31, 2012
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-04-26
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Company responded
2012-05-30
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-05-30
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Company responded
2012-06-11
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2012-06-11
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-29
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2012-03-29
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-06-03
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2010-06-03
Generating summary...
NANOVIRICIDES, INC.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2010-03-11
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2010-03-11
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Company responded
2010-03-15
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-03-15
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Company responded
2010-03-17
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-03-17
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Company responded
2010-04-27
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-04-27
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Company responded
2010-04-28
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2010-04-28
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-04-26
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2010-04-26
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-03-15
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2010-03-15
Generating summary...
NANOVIRICIDES, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2008-01-11
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2008-01-11
Generating summary...
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Company responded
2008-04-09
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2008-04-09
Generating summary...
NANOVIRICIDES, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-03-31
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2008-03-31
Generating summary...
NANOVIRICIDES, INC.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2007-02-27
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2007-02-27
Generating summary...
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Company responded
2007-04-03
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2007-04-03
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Company responded
2007-04-05
NANOVIRICIDES, INC.
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2007-04-05
Generating summary...
NANOVIRICIDES, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2007-02-02
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2007-02-02
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Company responded
2007-02-14
NANOVIRICIDES, INC.
References: February 2, 2007
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2007-02-14
Generating summary...
NANOVIRICIDES, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2006-12-12
NANOVIRICIDES, INC.
Filing - SEC Comment Letter to NANOVIRICIDES, INC.
UPLOAD · 2006-12-12
Generating summary...
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Company responded
2007-01-17
NANOVIRICIDES, INC.
References: December 11, 2006
Filing - Correspondence from NANOVIRICIDES, INC.
CORRESP · 2007-01-17
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-23 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2026-06-18 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 333-296790 | Read Filing View |
| 2026-06-11 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2026-06-10 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 333-296550 | Read Filing View |
| 2025-12-18 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2024-05-13 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2024-05-08 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2024-04-22 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2024-04-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2024-02-13 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2023-05-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2023-05-12 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-03-31 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-03-26 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-01-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-01-08 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2019-12-09 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-04-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-03-15 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-13 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-07 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-06 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-11-05 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-07-10 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-06-11 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-05-30 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-04-26 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-04-10 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-03-29 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-06-03 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-28 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-27 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-26 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-06 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-22 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-15 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-15 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-11 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2009-04-23 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2009-04-16 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-04-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-03-31 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-01-11 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-04-05 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-04-03 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-27 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-14 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-02 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-01-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2006-12-12 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-18 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 333-296790 | Read Filing View |
| 2026-06-10 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 333-296550 | Read Filing View |
| 2024-05-13 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2024-04-22 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2024-02-13 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | 001-36081 | Read Filing View |
| 2023-05-12 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-03-26 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2019-12-09 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-03-15 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-06 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-11-05 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-07-10 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-03-29 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-06-03 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-26 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-15 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-11 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2009-04-16 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-03-31 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-01-11 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-27 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-02 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2006-12-12 | SEC Comment Letter | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-23 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2026-06-11 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2025-12-18 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2024-04-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2023-05-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-03-31 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-01-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2020-01-08 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-04-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2017-04-18 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-13 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2014-11-07 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-12-20 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-06-11 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-05-30 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-04-26 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2012-04-10 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-28 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-27 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-04-06 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-22 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2010-03-15 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2009-04-23 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2008-04-09 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-04-05 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-04-03 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-02-14 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
| 2007-01-17 | Company Response | NANOVIRICIDES, INC. | DE | N/A | Read Filing View |
2026-06-23 - CORRESP - NANOVIRICIDES, INC.
CORRESP 1 filename1.htm NANOVIRICIDES, INC. 1 Controls Drive Shelton, Connecticut 06484 June 23, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Trade and Services 100 F Street, N.E. Washington, D.C. 20549 Re: NanoViricides, Inc. Registration Statement on Form S-3 Filed June 15, 2026 File No. 333-296790 REQUEST FOR ACCELERATION OF EFFECTIVENESS Requested Date: Friday, June 26, 2026 Requested Time: 9:30 a.m.., Eastern Time Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended, NanoViricides, Inc. (the "Company"), hereby requests acceleration of effectiveness of the above referenced Registration Statement on Form S-3 (File Number 333-296790), as amended so that it will become effective at 9:30 a.m., Eastern Time, on Friday, June 26, 2026, or as soon as practicable thereafter. Please contact our counsel, Peter Campitiello, Esq. of Lucosky Brookman LLP at (732) 395-4517 with any questions you may have regarding this request. In addition, the Company requests that you kindly notify Mr. Campitiello by telephone when this request for acceleration has been granted Very truly yours, /s/ Anil Diwan Anil Diwan President, Chief Executive Officer, and Chairman
2026-06-18 - UPLOAD - NANOVIRICIDES, INC. File: 333-296790
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 18, 2026 Anil Diwan Chief Executive Officer NANOVIRICIDES, INC. 1 Controls Drive Shelton, CT 06484 Re: NANOVIRICIDES, INC. Registration Statement on Form S-3 Filed June 15, 2026 File No. 333-296790 Dear Anil Diwan: 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 </TEXT> </DOCUMENT>
2026-06-11 - CORRESP - NANOVIRICIDES, INC.
CORRESP 1 filename1.htm NANOVIRICIDES, INC. 1 Controls Drive Shelton, Connecticut 06484 June 11, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Trade and Services 100 F Street, N.E. Washington, D.C. 20549 Re: NanoViricides, Inc. Registration Statement on Form S-3 Filed June 5, 2026 File No. 333-296550 REQUEST FOR ACCELERATION OF EFFECTIVENESS Requested Date: Monday, June 15, 2026 Requested Time: 4:30 p.m., Eastern Time Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended, NanoViricides, Inc. (the "Company"), hereby requests acceleration of effectiveness of the above referenced Registration Statement on Form S-3 (File Number 333-296550), as amended so that it will become effective at 4:30 p.m., Eastern Time, on Monday, June 15, 2026, or as soon as practicable thereafter. Please contact our counsel, Peter Campitiello, Esq. of Lucosky Brookman LLP at (646) 242-7536 with any questions you may have regarding this request. In addition, the Company requests that you kindly notify Mr. Campitiello by telephone when this request for acceleration has been granted Very truly yours, /s/ Anil Diwan Anil Diwan President, Chief Executive Officer, and Chairman
2026-06-10 - UPLOAD - NANOVIRICIDES, INC. File: 333-296550
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 10, 2026 Anil Diwan Chief Executive Officer NANOVIRICIDES, INC. 1 Controls Drive Shelton, CT 06484 Re: NANOVIRICIDES, INC. Registration Statement on Form S-3 Filed June 5, 2026 File No. 333-296550 Dear Anil Diwan: 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: Peter Campitiello </TEXT> </DOCUMENT>
2025-12-18 - CORRESP - NANOVIRICIDES, INC.
CORRESP 1 filename1.htm December 18, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Crypto Assets 100 F Street, N.E. Washington, DC 20549 Re: NanoViricides, Inc. Registration Statement on Form S-3, File No. 333-292142 REQUEST FOR ACCELERATION OF EFFECTIVENESS Requested Date: December 19, 2025 Requested Time: 4:30 pm, Eastern Time Ladies and Gentlemen: NanoViricides, Inc. (the "Company") hereby requests that the effective date of the Company's Registration Statement on Form S-3, as amended (File No. 333-292142), be accelerated pursuant to Rule 461 under the Securities Act of 1933, as amended, so that it is declared and becomes effective at 4:30 pm Eastern Time on December 19, 2025, or as soon thereafter as possible. Please contact our counsel Peter Campitiello of Lucosky Brookman LLP at (732) 395-4517 with any questions you may have regarding this request. In addition, the Company requests that you kindly notify Mr. Campitiello by telephone when this request for acceleration has been granted. Sincerely yours, NANOVIRICIDES, INC. /s/ Anil Diwan Anil Diwan President
2024-05-13 - UPLOAD - NANOVIRICIDES, INC. File: 001-36081
United States securities and exchange commission logo
May 13, 2024
Meeta Vyas
Chief Financial Officer
NanoViricides, Inc
1 Controls Drive
Shelton, CT 06484
Re:NanoViricides, Inc
Form 10-K for Fiscal Year Ended June 30, 2023
File No. 001-36081
Dear Meeta Vyas:
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
2024-05-08 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
“Nanotechnology-Enabled
Targeted Viricides”
A Publicly Traded Issuer,
“NNVC”
www.nanoviricides.com
May 8, 2024
Division of Corporation Finance, Office
of Life Sciences
United States Securities and Exchange
Commission
Washington, D.C. 20549
Re:
NanoViricides, Inc.
Form 10-K for Fiscal Year Ended June 30, 2023 Filed October 13, 2023
Response
dated April 9, 2024
File No. 001-36081
Ladies and Gentlemen:
Please
be advised that the undersigned is the duly-appointed Chief Financial Officer of NanoViricides, Inc., the above-referenced issuer (the
“Issuer”). This letter is in response to the comments of the staff (“Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) with respect to the Issuer’s Annual Report on Form 10-K, filed on October 13, 2023 (the
“Form 10-K”) and the Issuer’s response dated April 9, 2024 (the “Response”), provided in your letter dated
April 22, 2024 (the “Comment Letter”).
The
purpose of this correspondence is to provide a response to the Comment Letter and provide explanation, where necessary of the Form 10-K
filed on October 13, 2023. Our response follows the text of the Comment Letter, which we have reproduced below for your convenience.
Form 10-K for Fiscal
Year Ended June 30, 2023
Item 1: Business
The NanoViricide
Platform Technology in Brief, page 5
1.
We note your response to prior comment 1 and reissue. Statements that conclude your clinical trials
demonstrated the “safety” or “efficacy” of your product candidates are improper without regulatory approval,
as conclusions related to safety and efficacy are within the sole authority of the FDA and comparable foreign regulators. In future filings,
please discuss the objective results of your pre-clinical and clinical trials without concluding that such results demonstrate that your
product candidates are safe or effective.
Page 1 of 2
1
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
“Nanotechnology-Enabled
Targeted Viricides”
A Publicly Traded Issuer,
“NNVC”
www.nanoviricides.com
The
Issuer respectfully acknowledges the Staff’s comment and will revise future filings to discuss the objective results of our pre-clinical
and clinical trials without concluding that such results demonstrate that our product candidates are safe or effective unless so evaluated
by applicable regulatory authority.
If
you should have any questions about this letter or require any further information, please do not hesitate to contact the undersigned
or the Issuer’s counsel, Peter Campitiello, Esq. at (732) 867-9741.
Sincerely,
/s/ Meeta Vyas, CFO
Meeta Vyas, CFO
Page
2 of 2
1
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
2024-04-22 - UPLOAD - NANOVIRICIDES, INC. File: 001-36081
United States securities and exchange commission logo
April 22, 2024
Meeta Vyas
Chief Financial Officer
NanoViricides, Inc
1 Controls Drive
Shelton, CT 06484
Re:NanoViricides, Inc
Form 10-K for Fiscal Year Ended June 30, 2023
Response dated April 9, 2024
File No. 001-36081
Dear Meeta Vyas:
We have reviewed your April 9, 2024 response to our comment letter and have the
following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended June 30, 2023
Item 1: Business
The NanoViricide Platform Technology in Brief, page 5
1.We note your response to prior comment 1 and reissue. Statements that conclude your
clinical trials demonstrated the "safety" or "efficacy" of your product candidates are
improper without regulatory approval, as conclusions related to safety and efficacy are
within the sole authority of the FDA and comparable foreign regulators. In future filings,
please discuss the objective results of your pre-clinical and clinical trials without
concluding that such results demonstrate that your product candidates are safe or effective.
Please contact Li Xiao at 202-551-4391 or Daniel Gordon at 202-551-3486 if you have
questions regarding comments on the financial statements and related matters. Please contact
Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other questions.
FirstName LastNameMeeta Vyas
Comapany NameNanoViricides, Inc
April 22, 2024 Page 2
FirstName LastName
Meeta Vyas
NanoViricides, Inc
April 22, 2024
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-04-09 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
“Nanotechnology-Enabled
Targeted Viricides”
A Publicly Traded Issuer,
“NNVC”
www.nanoviricides.com
April 9 2024
Division of Corporation Finance, Office of Life Sciences
United States Securities and Exchange Commission
Washington DC 20549
Re: NanoViricides, Inc.
Form 10-K for Fiscal Year Ended June 30, 2023 Filed October 13, 2023
File No. 001-36081
Ladies and Gentlemen:
Please be advised that the
undersigned is the duly-appointed Chief Financial Officer of NanoViricides, Inc., the above-referenced issuer (the “Issuer”).
This letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the Issuer’s Annual Report on Form 10-K, filed on October 13, 2023 (the “Form 10-K”) provided in your
letter dated February 13, 2024 (the “Comment Letter”).
The purpose of this correspondence
is to provide responses to the Comment Letter and provide explanation, where necessary of the Form 10-K filed on October 13, 2023. Our
responses follow the text of each comment, which we have reproduced below for your convenience.
Form 10-K for Fiscal Year Ended June 30, 2023
Item 1: Business – The NanoViricide Platform
Technology in Brief, page 5
1. We note disclosure throughout your annual report claiming your product candidates are "safe"
or "effective." Please revise future filings to remove any statements implying that your candidates are or will be safe or effective,
as such conclusions are within the sole authority of the FDA and comparable foreign regulators. For example, on page 8 you state that
NV-387 was "highly effective" against a lethal RSV infection and you state on page 11 that NV-387 was found to be "statistically
effective" in multiple unrelated coronaviruses in cell culture studies. Disclosure on page 25 also claims that NV-387 was found to
be "safe" in preclinical studies. These examples are not intended to be exhaustive. In future filings, please remove these statements,
and any others like them. You may present the objective data resulting from your preclinical studies and clinical trials without concluding
as to safety or efficacy.
Page 1 of 11
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Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
The process of drug development goes through a long stage of drug discovery
and optimization followed by entry into regulatory studies.
Until recently, NanoViricides has been engaged
in the drug discovery and optimization stages. In 2019 we had completed what we believe was sufficient preclinical non-GLP (US FDA’s
Good Laboratory Practice requirement) and GLP regulatory safety toxicology studies information for our first regulatory drug candidate,
NV-HHV-101 (now labeled NV-HHV-1). In 2020 we undertook and completed drug discovery and optimization of our now regulatory-stage COVID
treatment drug candidate, NV-CoV-2. Subsequently, we completed the required regulatory safety toxicology studies for NV-CoV-2 to enter
clinical trials.
The preclinical package of safety and tolerability
as well as preclinical pharmacodynamics and pharmacokinetics including effectiveness in limiting coronavirus infection in cell cultures
and animal models was submitted by our collaborator, licensee, and drug sponsor in India, Karveer Meditech Pvt. Ltd., to the Central Drugs
Standard Control Organization (“CDSCO”), a regulatory body in India, in a Clinical Trial Application (“CTA”) in
October 2022. Upon evaluation of the CTA, CDSCO approved our Phase 1a/1b clinical trial plan and provided us approval to proceed to execute
the clinical trial at the end of January 2023. The clinical trial started in India around June 2023.
The very fact that a reputable regulatory body
such as CDSCO allowed us to enter into a clinical trial is indicative that the drug candidate was deemed to be sufficiently safe and effective
for humans. Of note, India follows the ICH process for harmonizing clinical trials and regulatory approvals. It is noteworthy that different
regulatory authorities have differences in data requirements, data formatting, data handling, and details of information required.
The fact that NV-CoV-2 was permitted to enter
clinical trials does not mean that the safety and efficacy of the drugs has passed the post-clinical review of the regulatory authority,
and we have made no statements to that effect.
All of our other candidates are preclinical stage,
which is clearly indicated throughout our report. At preclinical stage, it is customary of research scientists and research reports such
as peer-reviewed publications to evaluate and comment on the safety and effectiveness of a drug candidate based on non-clinical data.
The statements of safety and/or efficacy are qualified in these reports by the models and methods employed. Our disclosures, while of
a summarizing nature of necessity, clearly disclose when we make statements regarding safety or efficacy regarding what model or study
the conclusion is based on.
In all of our disclosures throughout our reports
with the Commission, including the Form 10-K, it is clearly disclosed that we are reporting about such experiments. We have not made any
reference that this data has been evaluated by any regulatory agency. As noted above, NV-CoV-2 is in a clinical trial after relevant evaluation
by CDSCO for preclinical demonstration of safety and effectiveness that it agreed with.
Page 2 of 11
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Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
We believe that our disclosures are scientifically
accurate and that they are not misleading. We believe that we have clearly defined what our preclinical studies were and what conclusions
we have drawn from them. Where we believe that the data is sufficiently strong to enable regulatory development of a candidate, we have
stated such drug product candidates to be ready for regulatory studies (“IND-enabled” as in NV-HHV-1). Where we have demonstrated
that our drug candidates showed superior safety and/or efficacy in direct comparison with existing drugs in our models or studies, we
have reported the same.
We respectfully note that the final determination
of safety and efficacy of a product candidate for commercial use in an authorized domain is the sole authority of the drug regulatory
authority in that domain, such as the FDA, CDSCO India, EMA Europe, MHRA UK, PMDA Japan, and others.
We respectfully note that as described above,
our use of the phrases related to safety or efficacy were appropriately qualified in the reported filing and did not imply an evaluation
by or finding by a regulatory authority.
Nevertheless, the Issuer respectfully acknowledges
the Staff’s comment and will revise future filings to ensure that it does not make statements implying that our candidates are or
will be safe or effective for commercial use in any unspecified authority domain(s) unless so evaluated by applicable regulatory authority.
Licenses from TheraCour, page 15
2. In future filings, please clearly and prominently disclose the royalty rates, or royalty ranges not
exceeding ten percentage points, for the licensing agreements you have entered into with TheraCour Pharma, Inc. Please also clearly and
prominently disclose the aggregate amounts paid to TheraCour under these agreements as well as the amount and nature of any potential
future milestone payments.
The Issuer respectfully acknowledges
the Staff’s comment and in future filings we will clearly and prominently disclose the royalty rates, or royalty ranges not exceeding
ten percentage points, for the licensing agreements we have entered into with TheraCour Pharma, Inc. (“TheraCour”). We will
also clearly and prominently disclose the aggregate amounts paid to TheraCour under these agreements as well as the amount and nature
of any potential future milestone payments. Please note as of the date hereof, no royalty payments were due, and none have been paid
to TheraCour.
Page 3 of 11
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Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
Out-Licensing to Karveer Meditech Private Limited,
India, page 18
3. Please further discuss the material terms of your collaboration agreement with Karveer Meditech Private
Limited for your NV-CoV-2 candidate in future filings. Your revisions should include a discussion of any upfront payments paid or received,
aggregate amounts paid or received to date under this agreement and any term and termination provisions.
The Issuer respectfully acknowledges
the Staff’s comment and in future filings we will further discuss the material terms of our collaboration agreement with Karveer
Meditech Private Limited for our NV-CoV-2 candidate. Our revisions will include a discussion of any upfront payments paid or received,
aggregate amounts paid or received to date under this agreement and any term and termination provisions.
Financial Statements
Note 4. Related Party Transactions, page
F-13
4. You disclosed multiple related party transactions with TheraCour Pharma, Inc.
(TheraCour) here and elsewhere in the filing. Please address the following:
· Provide your analysis under ASC 810-10 in determining whether TheraCour is a variable interest entity
(VIE), including whether the entity has sufficient equity at risk to finance its activities without additional subordinated financial
support.
· To the extent that TheraCour is determined to be a VIE, provide your analysis
under ASC 810-10 supporting your determination that you do not have a controlling financial interest in the VIE. Address the following
as part of your response:
o Identify the activities of TheraCour that most significantly impact its economic
performance and explain how you determined that you do not have the power to direct such activities and therefore do not hold a controlling
financial interest.
o With respect to the 90% TheraCour capital stock held by your CEO, provide an
analysis under ASC 810-10-25-42 and 25-43.
· Confirm that you will revise your future filings to provide the VIE-specific
disclosures required by ASC 810-10-50, to the extent applicable.
The Issuer evaluated the guidance in ASC 810-10
and based on that guidance, understands that the Issuer would first assess if it has a variable interest in TheraCour before assessing
if TheraCour is a variable interest entity (VIE). If the Issuer does not have a variable interest in TheraCour, then there is no need
to assess if TheraCour is a variable interest entity and the VIE-specific consolidation and disclosure provisions of ASC 810-10 do not
apply. Based on this evaluation, the Issuer has arrived at the conclusion that it does not have a variable interest in TheraCour and therefore
does not need to determine whether TheraCour is a variable interest entity or provide VIE-specific disclosures.
Page 4 of 11
1
Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
The Issuer evaluates whether it has a variable
interest in TheraCour on a quarterly basis. Since we have continued to arrive at the same conclusion, that the Issuer does not have a
variable interest in TheraCour, no further analysis is required, and no VIE-specific disclosure is required.
Background
The Issuer (as Licensee) entered into license
agreements with TheraCour (as Licensor) whereby the Issuer was granted exclusive licenses for technologies developed by TheraCour as related
to various virus types. Under these license agreements, the Issuer pays to TheraCour research and development fees charged by TheraCour
for services performed on behalf of the Issuer, milestone payments, and royalty payments. There were no royalty payments due or paid through
the date of this response.
The Issuer has no debt or equity investment in
TheraCour since inception of the license agreements through the date of this response.
Dr. Anil Diwan, Chairman, President, CEO and Director
of the Issuer also serves as the CEO and Director of TheraCour, owning approximately 90% of the capital stock of TheraCour.
As of the date hereof, TheraCour owns 470,959
shares of the Issuer’s outstanding Common Stock (approximately 4.0% of the Issuer’s Common Stock) and 681,859 shares of the
Issuer’s Series A Preferred Stock, which votes at the rate of 9.0 shares of Common Stock per each share of Series A Preferred Stock
and is convertible into 3.5 shares of Common Stock only upon a change in control of the Issuer.
Dr. Diwan owns 106,479 shares of the Issuer’s
Series A Preferred Stock, which votes at the rate of 9.0 shares of Common Stock per each share of Series A Preferred Stock and is convertible
into 3.5 shares of Common Stock only upon a change in control of the Issuer. Dr. Diwan has no direct ownership interest in the Issuer’s
Common Stock.
On July 19, 2023, the Issuer issued a convertible
note to TheraCour as payment for a milestone award which TheraCour converted into shares of the Issuer’s Series A Preferred Stock
on October 27, 2023. At time of conversion, TheraCour relieved the Issuer of its obligation to pay interest due of approximately $50,000
on the convertible note with no additional compensation.
On November 13, 2023, Dr. Diwan entered into a
line of credit agreement whereby Dr. Diwan agreed to provide a standby line of credit to the Issuer in the maximum amount of $2,000,000.
The Issuer has not drawn against the facility as of the date of this response.
ASC 810-10 Assessment
Page 5 of 11
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Controls Drive, Shelton, CT 06484. Email: info@nanoviricides.com
Is TheraCour a legal entity? Do the scope exceptions to consolidation
guidance apply?
ASC 810-10-15-3 provides that all reporting entities
should apply the guidance under ASC 810–Consolidation to determine whether and how to consolidate another entity. The
Issuer concluded that TheraCour, a Connecticut corporation, is a legal entity, and that none of the scope exceptions to the consolidation
guidance listed in ASC 810-10-15-12 or ASC 810-10-15-17 are applicable.
Does the Issuer have a variable interest in TheraCour?
A variable interest is a contractual, ownership,
or other monetary interest in an entity whose value changes with changes in the fair value of the entity’s net assets. ASC 810-10-20
defines a Variable Interest (“VI”) as:
“The investments or other interests that
will absorb portions of a variable interest entity's (VIE's) expected losses or receive portions of the entity's expected residual returns
are called variable interests. Variable interests in a VIE are contractual, ownership, or other pecuniary interests in a VIE that
change with changes in the fair value of the VIE's net assets exclusive of variable interests. Equity interests with or without voting
rights are considered variable interests if the legal entity is a VIE and to the extent that the investment is at risk as described in
paragraph 810-10-15-14. Paragraph 810-10-25-55 explains how to determine whether a variable interest in specified assets
of a legal entity is a variable interest in the entity. Paragraphs 810-10-55-16 through 55-41 describe various types of variable
interests and explain in general how they may affect the determination of the primary beneficiary of a VIE.”
PwC’s Guide – Consolidation (December
2023) (the “PwC Consolidation Guide”) provides the following examples in Section 3.3 of common arrangements that may be
variable interests (based on the guidance in ASC 810-10-55-16 through 55-41). We considered the guidance in ASC 810-10-55-16 through 55-41
and these examples in our determination of whether the Issuer has a variable interest in TheraCour:
·
Equity securities – The Issuer does not own any equity securities issued by TheraCour.
·
Beneficial interests – TheraCour is not a securitization special purpose entity and does not issue any beneficial
interests.
·
Debt instruments – The Issuer does not hold any debt instruments issued by TheraCour.
·
Guarantees – The Issuer has not guaranteed any obligations of TheraCour or provided indemnifications to Th
2024-02-13 - UPLOAD - NANOVIRICIDES, INC. File: 001-36081
United States securities and exchange commission logo
February 13, 2024
Meeta Vyas
Chief Financial Officer
NANOVIRICIDES, INC.
1 Controls Drive
Shelton , Connecticut 06484
Re:NANOVIRICIDES, INC.
Form 10-K for Fiscal Year Ended June 30, 2023
Filed October 13, 2023
File No. 001-36081
Dear Meeta Vyas:
We have reviewed your filing and have the following comments.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended June 30, 2023
Item 1: Business
The Nanoviricide Platform Technology in Brief, page 5
1.We note disclosure throughout your annual report claiming your product candidates are
"safe" or "effective." Please revise future filings to remove any statements implying that
your candidates are or will be safe or effective, as such conclusions are within the sole
authority of the FDA and comparable foreign regulators. For example, on page 8 you state
that NV-387 was "highly effective" against a lethal RSV infection and you state on page
11 that NV-387 was found to be "statistically effective" in multiple unrelated
coronaviruses in cell culture studies. Disclosure on page 25 also claims that NV-387 was
found to be "safe" in preclinical studies. These examples are not intended to be
exhaustive. In future filings, please remove these statements, and any others like them.
You may present the objective data resulting from your preclinical studies and clinical
trials without concluding as to safety or efficacy.
FirstName LastNameMeeta Vyas
Comapany NameNANOVIRICIDES, INC.
February 13, 2024 Page 2
FirstName LastName
Meeta Vyas
NANOVIRICIDES, INC.
February 13, 2024
Page 2
Licenses from TheraCour, page 15
2.In future filings, please clearly and prominently disclose the royalty rates, or royalty
ranges not exceeding ten percentage points, for the licensing agreements you have entered
into with TheraCour Pharma, Inc. Please also clearly and prominently disclose the
aggregate amounts paid to TheraCour under these agreements as well as the amount and
nature of any potential future milestone payments.
Out-Licensing to Karveer Meditech Private Limited, India, page 18
3.Please further discuss the material terms of your collaboration agreement with Karveer
Meditech Private Limited for your NV-CoV-2 candidate in future filings. Your revisions
should include a discussion of any upfront payments paid or received, aggregate amounts
paid or received to date under this agreement and any term and termination provisions.
Financial Statement
Note 4. Related Party Transactions, page F-13
4.You disclosed multiple related party transactions with TheraCour Pharma, Inc.
(TheraCour) here and elsewhere in the filing. Please address the following:
•Provide your analysis under ASC 810-10 in determining whether TheraCour is a
variable interest entity (VIE), including whether the entity has sufficient equity at risk
to finance its activities without additional subordinated financial support.
•To the extent that TheraCour is determined to be a VIE, provide your analysis under
ASC 810-10 supporting your determination that you do not have a controlling
financial interest in the VIE. Address the following as part of your response:oIdentify the activities of TheraCour that most significantly impact its economic
performance and explain how you determined that you do not have the power to
direct such activities and therefore do not hold a controlling financial interest.
oWith respect to the 90% TheraCour capital stock held by your CEO, provide an
analysis under ASC 810-10-25-42 and 25-43.
•Confirm that you will revise your future filings to provide the VIE-specific
disclosures required by ASC 810-10-50, to the extent applicable.
Note 9. Equity Transactions, page F-16
5.Please expand your future filings to provide a detailed description of the key terms for
your Series A preferred stock, including but not limited to their liquidation preferences, if
applicable, as required under ASC 505-10-50.
FirstName LastNameMeeta Vyas
Comapany NameNANOVIRICIDES, INC.
February 13, 2024 Page 3
FirstName LastName
Meeta Vyas
NANOVIRICIDES, INC.
February 13, 2024
Page 3
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Please contact Li Xiao at 202-551-4391 or Daniel Gordon at 202-551-3486 if you have
questions regarding comments on the financial statements and related matters. Please contact
Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-05-17 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
May 17, 2023
Via Edgar Only
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nanoviricides, Inc.
Registration Statement on Form S-3
Filed on May 5, 2023 (as amended on May 8, 2023)
File No. 333-271706
To Whom It May Concern:
Please be advised that the
undersigned is the duly elected President and Chairman of Nanoviricides Solutions, Inc. (the "Registrant").
Having been advised that the
Commission has no further comments to the Registrant's Registration Statement on Form S-3 (File No. 333-271706) originally filed on May
5, 2023, as amended (the “Registration Statement”), the Registrant hereby requests acceleration of the effective date of the
Registration Statement to Monday, May 22, 2023 at 1:00 p.m., or as soon thereafter as practicable.
Please contact Peter Campitiello,
Esq. at McCarter & English, LLP at (732) 867-9741 with any questions you may have regarding this request. In addition, please notify
Mr. Campitiello by telephone when this request for acceleration has been granted.
Very truly yours,
/s/ Anil Diwan
Anil Diwan
President and Chairman
2023-05-12 - UPLOAD - NANOVIRICIDES, INC.
United States securities and exchange commission logo
May 12, 2023
Dr. Anil Diwan
President and Chairman
NANOVIRICIDES, INC.
1 Controls Drive
Shelton, Connecticut 06484
Re:NANOVIRICIDES, INC.
Registration Statement on Form S-3
Filed May 5, 2023
File No. 333-271706
Dear Dr. Anil Diwan:
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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Peter Campitiello, Esq.
2020-03-31 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
March 31, 2020
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 24, 2020
File No. 333-237370
To Whom It May Concern:
Please be advised that
the undersigned is the duly elected President and Chairman of NanoViricides, Inc. (the "Registrant").
Having been advised
that the Commission has no comments to the Registrant's Registration Statement on Form S-3 (File No. 333-237370) filed on March
24, 2020, the Registrant hereby requests acceleration of the effective date of the Registration Statement to Thursday, April 2,
2020 at 4:00 p.m., or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
· should the Commission or
the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking
any action with respect to the filing;
·
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
·
the 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.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me or the Registrant’s counsel Peter Campitiello, Esq. at 732-867-9741.
Very truly yours,
Anil Diwan, PhD
President, Chairman
1 Controls Drive, Shelton, CT 06484. Tel./Fax: 203-937-6137.
2020-03-26 - UPLOAD - NANOVIRICIDES, INC.
March 26, 2020
Anil Diwan
President
NanoViricdes, Inc.
1 Controls Drive
Shelton, Connecticut 06484
Re:NanoViricides, Inc.
Registration Statement on Form S-3
Filed March 24, 2020
File No. 333-237370
Dear Dr. Diwan:
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 Jacqueline Kaufman at 202-551-3797 with any questions.
Sincerely,
Division of Corporation Finance
Office of Trade & Services
2020-01-09 - CORRESP - NANOVIRICIDES, INC.
CORRESP 1 filename1.htm January 9, 2020 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: NanoViricides, Inc. Registration Statement on Form S-1, as amended File No. 333-235306 Ladies and Gentlemen: As representative of the underwriters of the proposed public offering of common stock of NanoViricides, Inc. (the “Company”), we hereby join the Company’s request that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:00 p.m., Eastern time, on Thursday, January 9, 2020, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise you that we intend to effect the following distribution of the Company’s Preliminary Prospectus dated January 8, 2020, through the time of effectiveness: Preliminary Prospectus dated January 6, 2020: 200 copies to prospective underwriters, institutional investors, dealers and others The undersigned advise that they have complied and will continue to comply, and that they have been informed by the participating underwriters and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, AEGIS CAPITAL CORP. By: /s/ Joseph T. Rallo Name: Joseph T. Rallo Title: Co-Head of Investment Banking
2020-01-08 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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Publicly Traded Company, “NNVC”
www.nanoviricides.com
January 8, 2020
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on November 29, 2019
File No. 333-235306
To Whom It May Concern:
Please be advised that
the undersigned is the duly elected President and Chairman of NanoViricides, Inc. (the "Registrant").
Having been advised
that the Commission has no comments to the Registrant's Registration Statement on Form S-1 (File No. 333-235306) filed on November
29, 2019, and subsequently amended, the Registrant hereby requests acceleration of the effective date of the Registration Statement
to Thursday, January 9, 2020 at 4:00 p.m., or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
· should the Commission
or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from
taking any action with respect to the filing;
· the action of the Commission
or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its
full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the 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.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me.
Very truly yours,
/s/ Anil Diwan, PhD
Anil Diwan, PhD
President, Chairman
1 Controls Drive, Shelton,
CT 06484. Tel./Fax: 203-937-6137.
2019-12-09 - UPLOAD - NANOVIRICIDES, INC.
December 9, 2019
Anil Diwan
President
NanoViricides, Inc.
1 Controls Drive
Shelton, CT 06484
Re:NANOVIRICIDES, INC.
Registration Statement on Form S-1
Filed November 29, 2019
File No. 333-235306
Dear Dr. Diwan:
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 Jennifer López at 202-551-3792 with any questions.
Sincerely,
Division of Corporation Finance
Office of Trade & Services
2017-04-20 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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Nanotechnology-Enabled
Targeted Viricides
Publicly
Traded Company, “NNVC”
www.nanoviricides.com
April 20,
2017
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 1, 2017
File No. 333-216345
To Whom It May Concern:
Please be advised that
the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant").
Having been
advised that the Commission has no comments to the Registrant's Registration Statement on Form S-3 (File No. 333-216345)
filed on March 1, 2017, and subsequently amended, the Registrant hereby requests acceleration of the effective date of the
Registration Statement to Tuesday, April 25, 2017 at 10:00 a.m., or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
· should
the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission
from taking any action with respect to the filing;
· the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve
the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the
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.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me.
Very truly yours,
/s/ Eugene Seymour, MD, MPH
Eugene Seymour, MD, MPH
1 Controls Drive, Shelton,
CT 06484. Tel./Fax: 203-937-6137.
2017-04-18 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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April 18, 2017
VIA EDGAR ONLY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention:
John Reynolds
Assistant Director
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed March 1, 2017
File No. 333-216345
Dear Mr. Reynolds:
Please be advised that
the undersigned is the duly-appointed Chief Executive Officer of NanoViricides, Inc., the above-referenced issuer (the “Issuer”).
This letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the Issuer’s registration statement on Form S-3, filed on March 1, 2017 (the “Registration Statement”)
provided in your letter dated March 15, 2017 (the “Comment Letter”).
The purpose of this
correspondence is to provide responses to the Comment Letter to the Commission and provide explanation, where necessary. Our responses
follow the text of each Staff comment reproduced consecutively for your convenience.
General
1. It appears that you are relying on General Instruction I.B.6 to Form S-3 for your offering. Please revise your prospectus in
accordance with Instruction 7 to Form S-3 or advise.
Please note the Registration Statement
was revised to include the following disclosure regarding General Instruction I.B.6. of Form S-3:
As of April 18,
2017, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float, was $57,211,329,
which was calculated based on 50,629,495 shares of outstanding common stock held by non-affiliates at a price of $1.13 per share,
the closing price of our common stock on April 17, 2017. Pursuant to General Instruction I.B.6.
of Form S-3, in no event will we sell securities in a public primary offering with a value exceeding more than one-third of our
“Public Float” (the market value of our common stock held by our non-affiliates) in any 12-month period so long as
our Public Float remains below $75,000. We have not sold any of our common stock or securities convertible into our common stock
during the 12 calendar months prior to and including the date of this prospectus pursuant to Instruction I.B.6.
The Issuer hereby acknowledges that:
● should the Commission or the staff, acting pursuant
to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;
● the action of the Commission or the staff, acting pursuant
to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy
and accuracy of the disclosure in the filing; and
● the 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.
If you should have
any questions about this letter or require any further information, please do not hesitate to contact the undersigned or the Issuer’s
counsel Peter Campitiello, Esq. at (212) 519-5109.
Very truly yours,
/s/ Eugene Seymour, MD
Eugene Seymour, MD
Chief Executive Officer
2017-03-15 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 3561 March 15 , 2017 Via E -mail Eugene Seymour , MD Chief Executive Officer NanoViricides, Inc . 1 Controls Drive Shelton, C T 06484 Re: NanoViricides, Inc . Registration Statement on Form S-3 Filed March 1, 2017 File No. 333-216345 Dear Dr. Seymour : We have limited our review of your registration statement to those issues w e have addressed in our comment . In our comment , we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our com ment applies to your facts and circumstances or do not be lieve an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. General 1. It appears that you are relying on General Instruction I.B. 6 to Form S -3 for your offering. Please revise your prospectus in accord ance with Instruction 7 to Form S -3 or advise . We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration . Please allow adequate time for us to review any amendment prior to the r equested effective date of the registration statement. Eugene Seymour, MD NanoViricides, Inc. March 15 , 2017 Page 2 Please contact Jonathan Burr at (202) 551 -5833 or Brigitte Lippmann at (202) 551 -3713 with any questions. Sincerely, /s/ Brigitte Lippmann (for) John Reynolds Assistant Director Office of Beverages, Apparel, and Mining cc: Peter Campitiello, Esq. Kane Kessler, P.C.
2014-11-13 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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Nanotechnology-Enabled Targeted
Viricides”
Publicly
Traded Company, “NNVC”
www.nanoviricides.com
November 13, 2014
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention: Jeffrey P. Riedler,
Assistant Director
Re: NanoViricides, Inc.
Registration Statement on Form S-3
Filed on October 31, 2014
File No. 333-199757
Dear Mr. Riedler:
Please be advised that
the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant").
Having been advised
that the Commission has no comments to the Registrant's Form S-3 Registration Statement (File No. 333-199757), the Registrant hereby
requests acceleration of the effective date of the Registration Statement on Monday, November 17, 2014 at 10:00 a.m., or as soon
thereafter as practicable.
The Registrant hereby acknowledges that:
· should the Commission
or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking
any action with respect to the filing;
· the action of the
Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company
from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the 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.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me.
Very truly yours,
/s/ Eugene Seymour, MD, MPH
Eugene Seymour, MD, MPH
135 Wood Street, Ste. 205,
West Haven, CT 06516. Tel./Fax: 203-937-6137.
2014-11-07 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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November 7, 2014
VIA EDGAR ONLY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention: Jeffrey P. Riedler
Assistant Director
Re: NanoViricides, Inc.
Registration Statement on Form S-3
Filed October 31, 2014
File No. 333-199757
Dear Mr. Riedler:
Please be advised that
the undersigned is the duly-appointed Chief Executive Officer of NanoViricides, Inc., the above-referenced issuer (the “Issuer”).
This letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the Issuer’s registration statement on Form S-3, filed on October 31, 2014 (the “Registration Statement”)
provided in your letter dated November 6, 2014 (the “Comment Letter”).
The purpose of this
correspondence is to provide responses to the Comment Letter to the Commission and provide explanation, where necessary. Our responses
follow the text of each Staff comment reproduced consecutively for your convenience.
General
1. Please amend the fee table on the cover page of the Registration Statement to include “units” as a type of security
that you are registering.
We have filed an amended registration
statement to include “units” as a type of security we are registering
The Issuer hereby acknowledges
that:
· should the Commission or the staff, acting
pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with
respect to the filing;
· the action of the Commission or the staff,
acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Issuer from its full responsibility
for the adequacy and accuracy of the disclosure in the filing; and
· the Issuer 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.
If you should have
any questions about this letter or require any further information, please do not hesitate to contact the undersigned or the Issuer’s
counsel Peter Campitiello, Esq. at (212) 519-5109.
Very truly yours,
/s/ Eugene Seymour, MD
Eugene Seymour, MD
Chief Executive Officer
2014-11-06 - UPLOAD - NANOVIRICIDES, INC.
November 6, 2014 Via E -mail Dr. Eugene Seymour Chief Executive Officer Nanoviricides, Inc. 135 Wood Street Suite 205 West Haven, Connecticut Re: Nanoviricides, Inc. Registration Statement on Form S-3 Filed October 31, 2014 File No. 333-199757 Dear Dr. Seymour : We have limited our review of your registration statement to the issue we have address ed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After revi ewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. General 1. Please amend the fee table on the cover page of the registration statement to include “units ” as a type of security that you are registering. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securitie s 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. Dr. Eugene Seymour Nanoviricides, Inc. November 6, 2014 Page 2 Notwithstanding our comments, in the ev ent you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; 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 responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please cont act Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Peter Campitiello, Esq. Kane Kessler, P.C. 1350 Avenue of the Americas New York, New York 10019
2012-12-20 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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Nanotechnology-Enabled Targeted Viricides”
Publicly Traded Company, “NNVC”
www.nanoviricides.com
December 20, 2012
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention: Jeffrey P. Riedler,
Assistant Director
Re: NanoViricides, Inc.
Registration Statement on Form S-3
Filed on October 26, 2012
File No. 333-184626
Dear Mr. Riedler:
Please be advised that
the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant").
Having been advised
that the Commission has no further comments to the Registrant's Form S-3 Registration Statement, the Registrant hereby requests
acceleration of the effective date of the Registration Statement to Friday, December 21, 2012 at 3:00 p.m., or as soon thereafter
as practicable. Please disregard the Registrant’s earlier request for acceleration of Wednesday, December 26, 2012 at 9:00
a.m.
The Registrant hereby acknowledges that:
· should the Commission
or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking
any action with respect to the filing;
· the action of the
Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company
from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the 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.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me.
Very truly yours,
/s/ Eugene Seymour, MD, MPH
Eugene Seymour, MD, MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2012-12-20 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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Nanotechnology-Enabled Targeted Viricides”
Publicly Traded Company, “NNVC”
www.nanoviricides.com
December 20, 2012
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention: Jeffrey P. Riedler,
Assistant
Director
Re: NanoViricides, Inc.
Registration
Statement on Form S-3
Filed
on October 26, 2012
File
No. 333-184626
Dear Mr. Riedler:
Please be advised that
the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the “Registrant”). Having been advised
that the Commission has no further comments to the Registrant’s Form S-3 Registration Statement, the Registrant hereby requests
acceleration of the effective date of the Registration Statement to Wednesday, December 26, 2012 at 9:00 a.m., or as soon thereafter
as practicable.
The Registrant hereby acknowledges that:
· should
the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission
from taking any action with respect to the filing;
· the
action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve
the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the
Registrant may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission
or any person under the federal securities laws of the United States.
Should you have any
questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate
to contact me.
Very truly yours,
/s/ Eugene Seymour, MD, MPH
Eugene Seymour, MD, MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2012-11-05 - UPLOAD - NANOVIRICIDES, INC.
November 5, 2012 Via E -mail Dr. Eugene Seymour Chief Executive Officer, Acting Financial Officer and Director Nanoviricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516 Re: Nanoviricides, Inc. Registration Statement on Form S-3 Filed October 26, 2012 File No. 333-184626 Dear Dr. Seymour : We have limited our review of your registration statement to the issue w e have addressed in our comment below . Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comment appl ies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why i n your response. After reviewing any amendment to your registration statement and the information you provide in response to our comment, we may have additional comments. Item 16. Exhibits 1. In order to qualify your indenture under the T rust Indenture Act of 1939 you must have a form of indenture on file at time of ef fectiveness of the registration statement. Please file by pre -effective amendment a form of indenture as an exhibit to your registration statement. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to b e 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 comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledgi ng that: Dr. Eugene Seymour Nanoviricides, Inc. November 5, 2012 Page 2 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding reques ts for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Karen Ubell at (202) 551 -3873 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Peter Campitiello, Esq. Kane Kessler, P.C.
2012-07-10 - UPLOAD - NANOVIRICIDES, INC.
July 10 , 201 2 Via E -mail Eugene Seymour, M.D. Chief Executive Officer and Interim Chief Financial Officer and Director Nanoviricides , Inc. 135 Wood Street, Suite 205 West Haven, CT 06516 Re: Nanoviricides , Inc . Form 10-K for the Fiscal Year Ended June 30 , 201 1 Filed October 13 , 2011 File No. 000-52318 Dear Dr. Seymour : 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 asse rt 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/ Joel Parker Joel Parker Accounting Branch Chief
2012-06-11 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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June 11, 2012
VIA EDGAR
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention:
Jim B. Rosenberg,
Senior Assistant Chief Accountant
Re:
NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2011
Filed October 13, 2011
File No. 000-52318
Dear Mr. Rosenberg,
This
letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the above-referenced filings of NanoViricides, Inc. (the “Company”) provided in our phone conversation
on May 11, 2012 (the “Comments”). The purpose of this correspondence is to illustrate these changes to the Commission
and provide explanation, where necessary. Our responses follow the text of each Staff comment reproduced consecutively for your
convenience.
Item 9A(T). Controls and Procedures
Evaluation of Disclosure Controls and Procedures, page 95
1. Please amended the Form 10-K
for fiscal year ended June 30, 2011 to include the revised language provided in your response to comment 2 to state disclosure
controls and procedures were not effective. Please also amend your Forms 10-Q for September 30, 2011 and December 30, 2011 to state
that disclosure controls and procedures were not effective. Please file updated certifications.
We will revise our Form 10-K for fiscal
year ended June 30, 2011, Forms 10-Q for September 30, 2011 and December 30, 2011 to include our revised language from our response
to state that disclosure controls and procedures were not effective; and will update the certifications therein.
Management’s Report on Internal Control Over Financial
Reporting, page 96
3. Please refer to your response
to Comments 3 and 4. Please amend the Form 10-K for the fiscal year ended June 30, 2011 to include revised language in responses
for management’s internal controls in financial reporting.
We will revise our Form 10-K for fiscal
year ended June 30, 2011 to include our revised language from our response to for management’s internal controls in financial
reporting.
Notes to Financial Statements
Note 4 – Related Party Transactions, page F-52
3. Please refer to your response
to Comment 5. Please provide a more robust analysis on how you determined that TheraCour Pharma is not a variable interest entity,
refer to ASC 810-10-15-14.
The Company performed a variable interest
entity (VIE) assessment of TheraCour Pharma, Inc. (“TheraCour”) and determined that TheraCour is not a VIE under ASC
810 — Consolidation.
Under the terms and conditions of the formative
documents, including the Certificate of Incorporation, and the Bylaws of TheraCour dated September 29, 2004, all fundamental aspects
of TheraCour were designed for this entity to operate as an independent business entity to exploit certain inventions encompassing
the use of polymer chains to encapsulate a virus and/or deliver antiviral compounds to the viruses.
NanoViricides’ predecessor, NanoViricide,
Inc., was formed May 12, 2005 and entered into arm’s length licensing agreements with TheraCour that granted it exclusive
rights for the development of drugs for various viral diseases, in perpetuity, from this novel technology.
ASC 810-10-15-14 establishes the evaluation
criteria for determining whether an entity is a VIE. Following is a discussion of each of the evaluation criteria, along with our
analyses and conclusions:
A. Sufficiency
of Equity — An entity is a VIE if the total equity at risk is not sufficient to permit the entity to finance its activities
without additional subordinated financial support. The equity investment at risk must be large enough to absorb the potential
downside variability of the entity’s activities in order to be sufficient.
Analysis — We determined that
this criterion is not met because: (1) the fair value of the total equity investment at risk of TheraCour is considered significant
at the level of approximately 50% of the fair value of total assets, (2) TheraCour has no debt or other forms of subordinated financial
support, and (3) TheraCour’s governing documents allow additional equity contributions on a pro rata basis from the equity
holders as called for by the TheraCour board of directors. Furthermore, we performed both a qualitative and quantitative analysis
along the guidelines set forth in ASC 810-10-25-45 and determined:
· That TheraCour has demonstrated that it can finance its activities without additional subordinated
financial support ( no such support now exists)
· TheraCour has at least as much equity invested as other entities that hold only similar assets
of similar quality in similar amounts and operate with no additional subordinated financial support; and
· The amount of equity invested in TheraCour exceeds the estimate of TheraCour’s expected losses
based on quantitative evidence.
B. Lack
of a Controlling Financial Interest — An entity is a VIE if, as a group, the equity investors lack any one of the following
three characteristics of control:
· The ability to control the entity through voting rights,
· If the group of equity holders do not have the ability to make decisions about the entity’s
activities, the entity is a VIE with respect to this characteristic
· Equity investors are deemed to lack this criterion if voting rights are not proportional to economic
interests and substantially all of the entity’s activities either involve or are conducted on behalf of an investor with
disproportionately fewer voting rights
· The obligation to absorb expected losses, or
· The rights to receive expected residual returns.
Analysis — We determined that
this criterion is not met because all of the above characteristics are present in the structure of the TheraCour entity. TheraCour’s
By Laws state that each equity holder has the right to vote its shares for election of applicants to the board of directors of
TheraCour through which they jointly control all activities of the entity. All material decisions are subject to voting control
proportional to the economic interests of the equity holders;
All material business decisions of TheraCour
must be approved by unanimous consent of all the directors. Key business decisions include:
· Adoption of the Annual Budget, and Strategic Plan;
· Entry into any contract ;
· Making distributions to the equity holders;
· Any change to the organization, governance; or
· Any incurrence of indebtedness
Further, each investor is at risk for its
share of expected losses and each investor has the right to its pro rata share of TheraCour’s residual returns.
We also determined that other agreements
between us and TheraCour, as described below, are not variable interests. Accordingly, the equity holders as a group have the ability
to make decisions that have a significant impact on the success of the entity through the equity ownership interests and corresponding
board authorities. Nanoviricides does not have the 1) the power to direct the activities of TheraCour that most significantly affect
TheraCour’s economic performance, nor 2) the obligation to absorb the losses of TheraCour, ASC 810-10-15-14(b)(2) or the
right to receive benefits from TheraCour that could potentially be significant to TheraCour ASC 810-10-15-14(b)(3). NanoViricides,
therefore, does not have a variable or controlling financial interest in TheraCour and is thus not the Primary Beneficiary of TheraCour.
See, ASC 810-10-25-38 through 25-38G.
In conjunction with our licensing agreements
from TheraCour of certain proprietary technology, we executed two licensing agreements with TheraCour. We evaluated these licensing
agreements for possible variable interest classification and determined that the licensing agreements did not constitute a variable
interest for the following reasons:
· The licensing agreements do not create risks that cause variability ASC 810-10-25-24;
· The terms contained in the licensing agreements are fixed and limited to development work undertaken
at the Companies specific request and;
· These licensing agreements were negotiated at arm’s length terms between Nanoviricides and
TheraCour and, except for proprietary technology, include services that could be contracted from third parties;
· Nanoviricides has independently contracted with independent laboratories for studies designed to
test the efficacy of its drug candidates;
· The payment of liabilities that arise from these licensing agreements have the same level of seniority
as other trade payables; and
· Nanoviricides does not guarantee, nor is it at risk, for the obligations of TheraCour.
In conclusion, we believe
that TheraCour would not be considered a VIE as it otherwise does not meet the specified criteria to be considered a VIE, and that
Nanoviricides cannot , therefore, be the primary beneficiary of TheraCour.
Should you have any questions or require
any further information, please do not hesitate to contact us.
Very truly yours,
/s/ Eugene Seymour
Eugene Seymour, MD, MPH,
Chief Executive Officer
2012-05-30 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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May 30, 2012
VIA EDGAR
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention: Jim B. Rosenberg,
Senior Assistant
Chief Accountant
Re:
NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2011
Filed October 13, 2011
File No. 000-52318
Dear Mr. Rosenberg,
The purpose of this
correspondence is to respectfully request an additional ten day extension to reply to the comments of the staff of the U.S. Securities
and Exchange Commission (the “Commission”) provided in a telephone conversation with the
Commission on May 11, 2012.
Should you have any
questions or require any further information, please do not hesitate to contact us.
Very truly yours,
/s/ Eugene Seymour
Eugene Seymour, MD, MPH,
Chief Executive Officer
PC/mm
2012-04-26 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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April 26, 2012
VIA EDGAR AND OVERNIGHT DELIVERY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention:
Jim B. Rosenberg,
Senior Assistant Chief Accountant
Re:
NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2011
Filed October 13, 2011
File No. 000-52318
Dear Mr. Rosenberg,
This
letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the above-referenced filings of NanoViricides, Inc. (the “Company”) provided in your letter dated March
31, 2012 (the “Comment Letter”). The purpose of this correspondence is to illustrate these changes to the Commission
and provide explanation, where necessary. Our responses follow the text of each Staff comment reproduced consecutively for your
convenience.
General
1. Based on the information included
in the cover page of the June 30, 2011 Form 10-K it appears that you no longer qualify as a smaller reporting company. Please explain
why you have continued to report as a smaller reporting company for the quarterly periods ended September 30, 2011 and December
31, 2011. Please confirm to us, if true, that there are no material omissions as a result of reporting as a smaller reporting company
rather than not reporting as a smaller company in your Forms 10-Q for each of these two quarters. Further, confirm to us that you
will no longer report as a smaller reporting company in future filings.
The Company confirms that it no longer
qualifies as a smaller reporting company and that it will no longer report as a smaller reporting company in future filings. The
Company has reviewed its Forms 10-Q for the periods ending September 30, 2011 and December 30, 2011 and confirms that there are
no material omissions as a result of the Company’s reporting as a smaller reporting company for these periods.
-1-
Item 9A(T). Controls and Procedures
Evaluation of Disclosure Controls and Procedures, page 95
2. Please revise your disclosure
to clarify the basis for management concluding that your disclosure controls and procedures were effective in light of the conclusion
that internal control over financial reporting was not effective.
We intend to revise our disclosure regarding
Controls and Procedures as follows (proposed text underlined):
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and
Procedures
We maintain disclosure controls and procedures
that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized
and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such
information is accumulated and communicated to our management, including our chief executive and chief financial officer, as appropriate,
to allow for timely decisions regarding required disclosure. Disclosure controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply
its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Management has designed our disclosure
controls and procedures to provide reasonable assurance of achieving the desired control objectives.
As required by Exchange Act Rule 13a-15(b),
we have carried out an evaluation, under the supervision and with the participation of our management, including our principal
executive and principal financial officer, of the effectiveness of the design and operation of our management, including our principal
executive and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of June 30, 2011.
a) Based upon an evaluation of the effectiveness
of disclosure controls and procedures, our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO")
have concluded that as of the end of the period covered by this Annual Report on Form 10-K, as amended, our disclosure controls
and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) were not effective to provide reasonable
assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported
within the time periods specified by the rules and forms of the SEC and is accumulated and communicated to management, including
the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.
b) Changes in internal control over financial
reporting. Since the Company is not listed on a national exchange or on an automated interdealer quotation system, it is not required
to have an audit committee or independent directors. We consider this to be a material weakness. The Company is in the process
of addressing this issue by establishing an Audit Committee, appointing independent directors with at least one having financial
expertise.
Management’s Report on Internal
Control Over Financial Reporting
Management is responsible for establishing
and maintaining adequate internal control over financial reporting as defined in Rules 13a- 15(f) under the Securities Exchange
Act of 1934, as amended. Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles in the United States of America (“GAAP”). We recognize that because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies and procedures may deteriorate.
-2-
Management conducted an evaluation of
the effectiveness of our internal control over financial reporting as of June 30, 2011. To evaluate the effectiveness of our internal
control over financial reporting, management used the criteria described in Internal Control — Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO Framework”). Based on its evaluation
under the Internal Control - Evaluation Framework, due to the material weakness described above, management concluded that
our internal control over financial reporting was not effective as of June 30, 2011. A material weakness is a control deficiency,
or combination of control deficiencies, such that there is a reasonable possibility that a material misstatement of the financial
statements will not be prevented or detected on a timely basis by the Board in the normal course of their duties. See,
AUDITOR’S OPINION PARAGRAPH BELOW.
Based on its evaluation under the Internal
Control - Evaluation Framework, due to the material weakness described above, management concluded that our internal control over
financial reporting was not effective as of June 30, 2011.
The material weakness relates to a lack
of a functioning audit committee and a lack of outside directors on the Company’s Board. We intend to initiate measures to
remediate the identified material weakness by establishing a formal audit committee and the appointment of additional outside directors,
one or more of whom may be appointed to a fully functioning audit committee.
During the period ended June 30, 2009,
the Company implemented additional segregation of responsibilities and authorizations for initiating, authorizing and recording
transactions. In addition the Company has engaged the services of a financial consultant to assist in reviewing significant transactions
and the Company’s quarterly and annual financial statements.
Changes in Internal Control Over Financial
Reporting
Other than as described above, there were
no material changes in our internal control over financial reporting (as defined in Rule 13a- 15(f) under the Exchange Act) that
occurred as of June 30, 2011, that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Attestation Report of the Independent
Registered Public Accounting Firm
This annual report includes an attestation
report of our registered public accounting firm regarding internal control over financial reporting. The final paragraph of the
Auditor’s Report states:
“Also in our opinion, the financial
statements referred to above present fairly, in all material respects, the financial position of the Company as of June 30, 2011
and 2010 and the results of its operations and its cash flows for the fiscal years then ended and for the period from May 12, 2005
(inception) through June 30, 2011 in conformity with accounting principles generally accepted in the United States of America.”
Management’s Report on Internal Control Over Financial
Reporting, page 96
3. Please clarify the statement
in this section that “we determined that there were no material weaknesses in our internal control over financial reporting
as of June 30, 2011” since you reference a material weakness under the section ‘Changes in Internal Control Over Financial
Reporting’.
Please refer to the Response to Comment
#2 above.
-3-
4. Please include management’s
conclusion regarding the effectiveness of the company’s internal control over financial reporting in this section rather
than under the section ‘Changes in Internal Control over Financial Reporting’ as required under Item 308 of Regulation
S-K.
Please refer to the Response to Comment
#2 above.
Notes to Financial Statements
Note 4 – Related Party Transactions, page F-52
5. We note that your disclosure
on page F-35 of the Form 10-K for the fiscal year ended June 30, 2010 states “the Company evaluated its relationship with
TheraCour Pharma, Inc. for purposes of Section 810-10 of the FASB Accounting Standards Codification, and concluded that TheraCour
Pharma, Inc. is not a variable interest entity that is subject to consolidation in the Company’s financial statements under
Section 810-10”. It appears your conclusion did not change at June 30, 2011. Please provide us your analysis supporting your
conclusion that TheraCour Pharma, Inc. is not a variable interest entity subject to consolidation in compliance with ASC 810-10.
The Company evaluated its relationship
with TheraCour, Pharma, Inc. (“TheraCour”) for purposes of ASC 810-10 and concluded that it does not have a direct
or indirect variable interest in TheraCour and has further determined that it does not have exposure to losses or rights to residual
returns of TheraCour and is ,therefore, not the primary beneficiary of TheraCour Pharma, Inc. Accordingly, the Company concluded
that it is not required to provide the variable interest entity disclosures for TheraCour under ASC 810-10-50.
Further, the Company hereby advises the Commission that:
· The Company is responsible for the adequacy
and accuracy of the disclosure in the filings;
· Staff comments or changes to disclosure
in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
· The Company may not assert staff comments
as a defense in any proceedings initiated by the Commission or any person under the federal securities laws of the United States.
Should you have any
questions or require any further information, please do not hesitate to contact us.
Very truly yours,
/s/ Eugene
Seymour
Eugene Seymour, MD, MPH,
Chief Executive Officer
PC/mm
-4-
2012-04-10 - CORRESP - NANOVIRICIDES, INC.
CORRESP
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April 9, 2012
VIA EDGAR ONLY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention:
Jim B. Rosenberg,
Senior Assistant Chief Accountant
Re: NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2011
Filed October 13, 2011
File No. 000-52318
Dear Mr. Rosenberg,
The purpose of this
correspondence is to respectfully request an additional ten day extension to reply to the comments of the staff of the U.S. Securities
and Exchange Commission with respect to the above-referenced filings provided in your letter dated March 31, 2012.
Should you have any
questions or require any further information, please do not hesitate to contact us.
Very truly yours,
/s/ Eugene Seymour, M.D., MPH
Chief Executive Officer
2012-03-29 - UPLOAD - NANOVIRICIDES, INC.
March 29, 2012 Via E-mail Eugene Seymour, M.D. Chief Executive Officer and Interim Chief Financial Officer and Director Nanoviricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516 Re: Nanoviricides, Inc. Form 10-K for the Fiscal Year Ended June 30, 2011 Filed October 13, 2011 File No. 000-52318 Dear Dr. Seymour: We have reviewed your filing and have the following comments. Please respond to this letter within 10 business days by providing us the requested information and amending your filing or by advi sing us when you will provide the requested response. If you do not believe that a comment a pplies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. General 1. Based on the information included in the c over page of the June 30, 2011 Form 10-K it appears that you no longer qualify as a sma ller reporting company. Please explain why you have continued to report as a smaller reporting compan y for the quarterly periods ended September 30, 2011 and December 31, 2011. Please confirm to us, if true, that there are no material omissions as a result of reporting as a sma ller reporting company rather than not reporting as a smaller comp any in your Forms 10-Q for each of these two quarters. Further, confirm to us that you will no longer report as a smaller reporting company in future filings. Item 9A(T). Controls and Procedures Evaluation of Disclosure Cont rols and Procedures, page 95 2. Please revise your disclosure to clarify the basis for management concluding that your disclosure controls and procedur es were effective in light of the conclusion that internal Eugene Seymour, M.D. Nanoviricides, Inc. March 29, 2012 Page 2 control over financial repo rting was not effective. Management’s Report on Internal Cont rol Over Financial Reporting, page 96 3. Please clarify the statement in this secti on that “we determined that there were no material weaknesses in our in ternal control over financial reporting as of June 30, 2011” since you reference a material weakness under the section ‘Changes in Internal Control Over Financial Reporting’. 4. Please include management’s conclusion rega rding the effectiveness of the company’s internal control over financia l reporting in this section ra ther than under the section ‘Changes in Internal Control over Financia l Reporting’ as requir ed under Item 308 of Regulation S-K. Notes to Financial Statements Note 4 – Related Party Transactions, page F-52 5. We note that your disclosure on page F-35 of the Form 10-K for the fiscal year ended June 30, 2010 states “the Company evaluated its relationship with TheraCour Pharma, Inc. for purposes of Section 810-10 of the FASB Accounting Standards Codification, and concluded that TheraCour Pharma, Inc. is not a variable interest entity that is subject to consolidation in the Company’ s financial statements under S ection 810-10”. It appears your conclusion did not cha nge at June 30, 2011. Please provide us your analysis supporting your conclusion that TheraCour Pharma , Inc. is not a variable interest entity subject to consolidation in compliance with ASC 810-10. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Eugene Seymour, M.D. Nanoviricides, Inc. March 29, 2012 Page 3 You may contact Vanessa Robe rtson, Staff Accountant, at (202) 551-3649 or Lisa Vanjoske, Assistant Chief Accountant, at (202) 551-3614 if you have any questions regarding the comments. In this regard, do not he sitate to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2010-06-03 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 4720
March 30, 2010
Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, Connecticut 06506
Re: NanoViricides, Inc.
Form 10-K for Fiscal Year Ended June 30, 2009 Form 10-Q for the quarterly period ended December 31, 2009
Supplemental Response filed March 22, 2010 File No. 000-52318
Dear Dr. Seymour:
We have reviewed your filing and have the following comments. Where the comments
request you to revise disclosure, the informati on you provide should show us what the revised
disclosure will look like and identify the annual or quarterly filing, as applicable, in which you
intend to first include it. If you do not believe that revised disc losure is necessary, explain the
reason in your response. After reviewing the information provided, we may raise additional
comments and/or request that you amend your filing.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filing. We look forward to working with you in these respects. We welcome any questions
you may have about our comment or on any other aspect of our review. Feel free to call us at the
telephone numbers listed at th e end of this letter.
General
1. We note your response to our prior comment 1. However, your conclusion that none of
the referenced agreements is material a ppears to be at odds with your acknowledged
dependence on third party collaborators for scientific input and experimentation to
minimize your capital requirements. Because you have not provided sufficient details
about the various collaborations, it is difficult for us to assess your conclusion that none
of the agreements is material. Therefore, for each of the agreements referenced in prior comment 1, please provide us with an analysis , supported by a descript ion of the parties’
mutual obligations and the stat us of the activities undertaken by your collaborators, that
the agreement is not material. In your analys is, please make sure to address whether any
Eugene Seymour, M.D.
NanoViricides, Inc.
March 30, 2010
Page 2 of 3
of these agreements requires any financial ob ligation of the collaborator(s) that could be
material to the Company.
2. Given that your development model is base d on collaborations with outside laboratories
and third party service providers, a more robus t description of these arrangements in your
document appears warranted. Please revise the disclosure of your collaboration
agreements to include a descri ption of the parties’ mutual obligations, the status of the
development activities undertaken by your collaborators, potentia l payments under the
agreements, and any other material terms. Notwithstanding whether you are required to
file these agreements exhibits to your report under Item 601 of Regulation S-K, sufficient
disclosure of the principal rights and obliga tions of the parties unde r these contracts is
required.
3. In addition, we reissue the porti on of our prior comment 1 that asked that you to disclose
the material terms of your February 25, 2009 Ma terial Transfer Agreement, including the
other party to that agreement, and that you f ile a copy of the agreem ent as an exhibit to
the extent that it is material to your company. In the altern ative, please pr ovide us with
your analysis why this agreement need not be filed.
Requirement for Additional Capital, page 67
4. We note the revisions you have made to your disclosure here and in the risk factor
discussion on page 41 in response to our pr ior comment 2. Howeve r, these disclosures
still do not appear to correspond. On page 41, you state that you have sufficient
resources to fund your operations for the next eighteen months , but at the top of page 67
you state you have sufficient cash reserves to achieve all of your budgeted plans for the
next twelve months. Furthermore, on page 67 you indicate that your company will need an additional $10-$15 million to accomplish your business plan for th e next eighteen months, while on page 41
you indicate that you will need the same $10-$15 million in the upcoming twenty-four
months in accordance with your business plans.
Please revise your disclosure in these two s ections to rectify th ese inconsistencies.
* * *
Please respond to these comments within 10 business days or tell us when you will
provide us with responses. Please furnish a letter that keys your response to our comments and
provide the requested information. Detailed letters greatly facilita te our review. Please furnish
your letter on EDGAR under the form type label CORRESP.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing in cludes all information re quired under the Securities
Exchange Act of 1934 and that they have provi ded all information investors require for an
informed investment decision. Since the compa ny and its management are in possession of all
Eugene Seymour, M.D.
NanoViricides, Inc.
March 30, 2010
Page 3 of 3
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
• staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
• the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the sta ff of the Division of Corporati on Finance in our review of your
filing or in response to our comment on your filing.
Please contact Michael Rosent hall at (202) 551-3674 or me at (202) 551-3715 with any
questions.
Sincerely,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2010-04-28 - CORRESP - NANOVIRICIDES, INC.
CORRESP
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formcorresp.htm
Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Company, “NNVC”
www.nanoviricides.com
April 27, 2010
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention:
Jeffrey P. Riedler,
Assistant Director
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 4, 2010
File No. 333-165221
Dear Mr. Riedler:
Please be advised that the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission has no further comments to the Registrant's Form S-3 Registration Statement, the Registrant hereby requests acceleration of the effective date of the Registration Statement to Thursday, April 29, 2010 at 9:00 a.m., or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
●
The Registrant is responsible for the adequacy and accuracy of the disclosure in the filings;
●
Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
●
The Registrant may not assert staff comments as a defense in any proceedings initiated by the Commission or any person under the federal securities laws of the United States.
Should you have any questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate to contact me.
Very truly yours,
/s/ Eugene Seymour
Eugene Seymour, MD MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2010-04-27 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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formcorresp.htm
Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Company, “NNVC”
www.nanoviricides.com
April 27, 2010
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention:
Jeffrey P. Riedler,
Assistant Director
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 4, 2010
File No. 333-165221
Dear Mr. Riedler:
Please be advised that the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission has no further comments to the Registrant's Form S-3 Registration Statement, the Registrant hereby requests acceleration of the effective date of the Registration Statement to Thursday, April 29, 2010 at 4:00 p.m., or as soon thereafter as practicable.
Should you have any questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate to contact me.
Very truly yours,
/s/ Eugene Seymour
Eugene Seymour, MD MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2010-04-26 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 4720
April 26, 2010
Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, Connecticut 06506
Re: NanoViricides, Inc.
Form 10-K for Fiscal Year Ended June 30, 2009 File No. 000-52318
Dear Dr. Seymour: We have completed our review of your Form 10-K and related filings and have no
further comments at this time. S i n c e r e l y ,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2010-04-06 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
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TARTER
KRINSKY
& DROGIN LLP
April 5, 2010
VIA EDGAR AND OVERNIGHT DELIVERY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention: Jim B. Rosenberg,
Senior Assistant Chief Accountant
Re: NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2009
Form 10-Q for the quarterly period ended December 31, 2009
Supplemental Response filed March 22, 2010
File No. 000-52318
Dear Mr. Riedler:
Please be advised that this firm is special securities counsel to NanoViricides, Inc., the above-referenced issuer (the “Issuer”). This letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-referenced filings provided in your letter dated March 30, 2010 (the “Comment Letter”).
The purpose of this correspondence is to illustrate the changes the Issuer proposes in response to the Commission and provide explanation, where necessary. Our responses follow the text of each Staff comment reproduced consecutively for your convenience.
General
1.
We note your response to our prior comment 1. However, your conclusion that none of the referenced agreements is material appears to be at odds with your acknowledged dependence on third party collaborators for scientific input and experimentation to minimize your capital requirements. Because you have not provided sufficient details about the various collaborations, it is difficult for us to assess your conclusion that none of the agreements is material. Therefore, for each of the agreements referenced in prior comment 1, please provide us with an analysis, supported by a description of the parties’ mutual obligations and the status of the activities undertaken by your collaborators, that the agreement is not material. In your analysis, please make sure to address whether any of these agreements requires any financial obligation of the collaborator(s) that could be material to the Company.
General Comment:
All of our agreements provide for the evaluation of Nanoviricides® substances created and provided by the Issuer to the Laboratory. In general, the Laboratory is compensated for certain material and personnel costs for these evaluations. The evaluations involve in vitro and in vivo scientific studies at the Laboratory using their established protocols. In some cases, the Issuer provides scientific input regarding certain modifications to their protocols as may be needed. The Laboratory returns the results and data to the Issuer. The Laboratory is allowed to publish the results after allowing time for the Issuer to protect intellectual property (IP) as needed. The Issuer sends nanoviricides as well as positive control (i.e. known therapeutics) and negative control (i.e. known not to work) compounds as needed in a fully formulated, ready to use form, to the Laboratory. All IP related to the nanoviricide materials, their formulations and reformulations, and their usage, rests with the Issuer. Any IP developed by the Laboratory regarding their own know-how, such as laboratory tests, their modifications, etc. rests with the Laboratory. Joint inventions are treated as per applicable US Laws.
The Issuer tries to choose the scientific laboratories with the most appropriate facilities and know-how relating to a particular field for the evaluation of an antiviral agent developed by the Issuer. The Issuer also tries to work with more than one laboratory for a given group of viruses whenever possible. We seek to improve confidence by obtaining independent datasets for corroboration of the efficacy and safety of the nanoviricides we develop. In addition, the Issuer is not dependent on a particular Laboratory for the development of any specific drug candidate in our product pipeline.
To date, the Issuer has engaged in non-GLP Efficacy and Safety evaluations in both in vitro (cell culture models) and in vivo (animal models) of our different Nanoviricides® at different laboratories.
Cooperative Research and Development Agreement NanoViricides, Inc. (the “Issuer”) and Armed Forces Institute of Pathology (“Laboratory”) and American Registry of Pathology (“ARP”).
The term of this agreement is two years from the effective date. The Issuer shall supply novel anti-viral agents as formulation suitable for animal injectables, for testing as candidate antivirals against certain viruses, and provide sufficient information for safe and effective handling and disposal of the provided materials. The Laboratory shall test the candidate antiviral agents in animal studies and in-vitro studies against certain viruses, and provide written reports of the data generated to the Issuer. The Issuer shall pay an amount equal to $122,844 for the direct costs associated with therewith; provided if costs exceed that amount, the Issuer shall reimburse the laboratory for reimbursable costs not to exceed $250,000 without the prior approval of the Issuer.
The Laboratory was to evaluate the materials to be supplied by the Issuer against H5N1 “Bird Flu”, Common Influenza viruses, and a separate set of materials against HIV. Since execution of the agreement, the Laboratory has informed us that they are unable to engage into any studies on any forms of influenza due to programmatic changes in their prerogatives. No work was conducted as of date. No monies were paid by the Issuer. The agreement has lapsed.
Cooperative Research and Development Agreement between NanoViricides, Inc. (the “Issuer”) and Walter Reed Army Institute of Research (“Laboratory”).
The term of this agreement is two years from the effective date. The Issuer shall fragment, test, isolate, modify, and attach the anti-Dengue antibodies of interest to WRAIR to the base nanomicelle to generate novel substances called anti-Dengue nanoviricides. The Laboratory shall provide the monoclonal antibodies to Issuer and test the resulting antiviral compounds for inhibition of the virus by the Nanoviricide®, both in vitro, and in vivo. The Laboratory is to provide results from any in vitro and in vivo studies to the Issuer (which data may be used to design potentially more effective antivirals).
Each Party is responsible for funding its own respective researchers and expenses related to their respective researchers, including laboratory facilities, salaries, overhead and indirect costs. The Issuer shall pay up to $10,000 for the costs of supplies such as antibodies for this project that need to be obtained from outside sources.
The Issuer has since purchased the antibodies that were of interest to WRAIR from sources selected by WRAIR. The Issuer has proceeded to develop chemistries and technologies and novel materials based on these antibodies and their attachment to nanoviricide base polymeric micelle.
Cooperative Research and Development Agreement for Material Transfer, dated October 15, 2007, between NanoViricides, Inc. (the “Issuer”) and United States Army Medical Research Institute of Infectious Disease (“Laboratory”).
The term of the agreement was for one year initially and extended for an additional year. It has been extended again, based on positive results. The Issuer shall invent, develop, and provide to the laboratory, Nanoviricides® that are expected to be capable of attacking a multiplicity of different Ebola and Marburg viruses. The Laboratory shall assess in vitro and in vivo activity of the anti-Ebola Nanoviricides® provided against the virus.
There is no payment by the Issuer to the Laboratory, nor from the Laboratory to the Issuer. USAMRIID has federal funding to support their part of the work.
Clinical Study Agreement, dated May 6, 2009, between NanoViricides, Inc. (the “Issuer”) and Thevac, LLC. (“Laboratory”).
From May 1, 2009 through October 31, 2009, the Laboratory performed pre-clinical studies on various antiviral activities of up to eleven different formulations and assessed the potential of six nanoviricides manufactured by the Issuer. The Issuer paid the Laboratory the amount of $55,000 for the studies.
Master Services Agreement, dated August 31, 2009, by and between Southern Research Institute (“Southern”) and NanoViricides, Inc. (the “Issuer”).
The term of this agreement is three years from its execution. The Issuer agrees to supply necessary quantities of its products in order for Southern to complete specific studies as to the efficacy and safety of the Issuer’s compounds. The Issuer shall pay charges associated with each task order and provide payment in the amount and as indicated therein. It is anticipated the Issuer will pay approximately $9,530 for such services. SRI is a general contract research organization (CRO). As per the first Task Order, SRI is evaluating the in vitro activity of a set of Nanoviricides® against HIV. These nanoviricides were created, produced, formulated and sent to SRI in a ready to use form by the Issuer. Under this agreement, SRI will estimate the work load and invoices for additional task orders, subject to the Issuer’s agreement on costs.
Technical Testing Agreement, dated December 15, 2007, between The Feinstein Institute for Medical Research (“Feinstein”) and NanoViricides, Inc. (the “Issuer”).
The term of this agreement runs from December 17, 2007 through December 31, 2010. Feinstein performed animal studies testing services on epidemic kerato-conjunctivitis and related viral diseases of the cornea and conjunctiva. All test results and inventions resulting from the tests remained property of the Issuer. Inventions resulting from the testing services would be determined by an independent patent counsel with the Issuer retaining a commercial license on such inventions. The Issuer paid Feinstein an amount equal to $40,090.19 for the costs associated with the research.
Materials Cooperative Research and Development Agreement between NanoViricides, Inc. (the “Issuer”) and Centers for Disease Control and Prevention.
The CRADA provided that the CDC would test the efficacy of the Issuer’s drug candidates against rabies. The nanoviricides provided by the Issuer remained its proprietary information. The CDC retains rights to certain inventions that may be conceived during testing. The Issuer paid the CDC an amount equal to approximately $10,000 for the costs associated with the research.
2.
Given that your development model is based on collaborations with outside laboratories and third party service providers, a more robust description of these arrangements in your document appears warranted. Please revise the disclosure of your collaboration agreements to include a description of the parties’ mutual obligations, the status of the development activities undertaken by your collaborators, potential payments under the agreements, and any other material terms. Notwithstanding whether you are required to file these agreements exhibits to your report under Item 601 of Regulation S-K, sufficient disclosure of the principal rights and obligations of the parties under these contracts is required.
Please refer to responses in Comment 1.
3.
In addition, we reissue the portion of our prior comment 1 that asked that you to disclose the material terms of your February 25, 2009 Material Transfer Agreement, including the other party to that agreement, and that you file a copy of the agreement as an exhibit to the extent that it is material to your company. In the alternative, please provide us with your analysis why this agreement need not be filed.
The Material Transfer Agreement (“MTA”) provided for the in vitro and in vivo testing of the Issuer’s drug candidate EKC-Cide™ against adenovirus-caused corneal and conjunctival infections, and HSV-1 serotypes associated with ocular infections by a major pharmaceutical manufacturer (the “PharmaCo”) at a Laboratory of the PharmaCo’s choosing (the “Laboratory”) that has been engaged in service contract relationship with the PharmaCo. The testing was supervised by a physician-scientist who is an authority on adenovirus and herpesvirus infections of the eye. The Issuer retained all rights to the materials provided and the PharmaCo used them solely for evaluation on a non-exclusive basis. The Costs of the work at the Laboratory were paid by the PharmaCo, as the evaluations were required by the PharmaCo. The Issuer did not make any payments to the Laboratory or the PharmaCo. The Issuer did not receive any payments from the PharmaCo.
Upon successful completion of the studies, each company will independently decide whether to enter into negotiations for a licensing agreement. The Issuer is not required to license the products to the PharmaCo.
Given the foregoing, the Issuer believes that the MTA would not be defined as “material” under any of the Commission’s criteria for materiality in either Regulation S-K or the Instruction to Form 8-K.
Requirement for Additional Capital, page 67
4.
We note the revisions you have made to your disclosure here and in the risk factor discussion on page 41 in response to our prior comment 2. However, these disclosures still do not appear to correspond. On age 41, you state that you have sufficient resources to fund your operations for the next eighteen months, but at the top of page 67 you state you have sufficient cash reserves to achieve all of your budgeted plans for the next twelve months.
Furthermore, on page 67 you indicate that your company will need an additional $10-$15 million to accomplish your business plan for the next eighteen months, while on page 41 you indicate that you will need the same $10-$15 million in the upcoming twenty-four months in accordance with your business plans.
The Issuer proposes to amend the disclosure on page 41 of the Form of the Form 10-K/A as follows:
As of June 30, 2009 we have a cash and cash equivalent balance of $1,689,422 which combined with the $3,217,400 obtained through the sale of the Company’s common stock, after the close of the Company’s year end, will be sufficient to fund our currently budgeted operations for the next twelve months at the Company’s current rate of expense.
We estimate that we will need approximately an additional $10M to $15M over the next 18 months for further development of our pipeline. These additional funds, if raised, will enable us to perform Toxicology Package Studies and additional efficacy studies necessary to prepare the full dataset required for filing our first Investigational New Drug Application (“IND”) with the US FDA on one of our drug candidates. The additional funds will also be needed to pay additional personnel, increased subcontract costs related to the expansion and further development of our drug pipeline, and for additional capital and operational expenditures required to fie our first IND.
Further, we anticipate incurring additional costs of approximately $10 to 15 million dollars in the upcoming twenty-four months to construct or obtain facilities to support an initial new drug application filing with the FDA in accordance with our business plans.
Additionally, the Company proposes deleting the following portion of the 3rd paragraph on page 41:
As a result of the above sale of the Company’s stock and warrant conversions, the Company has reserves in excess of $3,000,000. This will permit us to continue our operations and research and development for the next fifteen months, but not to fully execute the first phase of the Company’s business plan.
Rule 12b-4 Supplemental Information
In addition, please be advised that the Issuer has authorized this firm to provide the Supplemental Information requested in accordance with Rule 12b-4 of the Securities Act of 1933, as amended, solely with the hard copy of this correspondence. Upon completion of its review, the Issuer requests the Commission discard these materials.
In addition, we have been authorized by the Issuer to advise the
2010-03-22 - CORRESP - NANOVIRICIDES, INC.
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TARTER
KRINSKY
& DROGIN LLP
March 19, 2010
VIA EDGAR ONLY
United States Securities and Exchange Commission
Mail Stop 4720
Washington, D.C. 20549
Attention: Jim B. Rosenberg,
Senior Assistant Chief Accountant
Re: NanoViricides, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2009
Form 10-Q for the quarterly period ended December 31, 2009
File No. 000-52318
Dear Mr. Rosenberg:
Please be advised that this firm is special securities counsel to NanoViricides, Inc., the above-referenced issuer (the “Issuer”). This letter is in response to the comments of the staff of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-referenced filings provided in your letter dated March 10, 2010 (the “Comment Letter”). In response to these comments, the Issuer has caused to be filed Form 10-K/A for the Fiscal Year Ended June 30, 2009 and Form 10-Q/A for the quarterly period ended December 31, 2009. The purpose of this correspondence is to illustrate these changes to the Commission and provide explanation, where necessary. Our responses follow the text of each Staff comment reproduced consecutively for your convenience.
Form 10-K For The Fiscal Year Ended June 30, 2009
General
1.
We note your discussion throughout your Form 10-K of your company’s collaboration agreements, including pages 6, 24 and 64. In these sections, you address a number of agreements but do not disclose the material terms of such agreements. Nor have you filed these agreements as exhibits to your 10-K, as required by Item 601(b)(10) of Regulation S-K. With respect to each of these agreements that are material to your company, please discuss the material terms, whether financial terms or otherwise, and file the agreement as an exhibit. This includes your collaborations and contracts with the following parties:
·
the Centers for Disease Control and Prevention (CDC)
·
the Walter Reed Army Institutes of Research (WRAIR);
·
the United States Army Medical Research Institute of Infectious Disease (USAMRIID);
Jim B. Rosenberg
March 15, 2010
Page 2 of 5
·
the United States Armed Forces Institute of Pathology (USAFIP);
·
THEVAC, LLC;
·
the Southern Research Institute, Infectious Diseases Division, Frederick, MD (SRI-F);
·
the Long Island Jewish Medical System, Feinstein Institute of Medical Research;
·
KARD Scientific, Inc; and
·
the pharmaceutical company with which you signed a Material Transfer Agreement on February 25, 2009
With respect to the February 25, 2009 Material Transfer Agreement, you are required to disclose the material terms of this agreement and file a copy as an exhibit to the extent it is material to your company, regardless of whether the parties have signed a confidentiality agreement. If there are provisions of this agreement that would cause potential commercial harm to your company if released publicly, you may make a request for confidential treatment under Rule 24b-2 of the Exchange Act. Note, however, that the identity of the counterparty cannot be kept confidential.
The Issuer has not disclosed the material terms of these collaborative agreements, nor filed them as exhibits to any of its filings with the Commission, since they are not material definitive agreements as that term is defined in Item 601 of Regulation S-K. The agreements ordinarily accompany the kind of businesses conducted by the Issuer, the Issuer’s business is not substantially dependent on any of these collaborative agreements, do not propose the acquisition or sale of any of the Issuer’s property and do not require any material financial obligation on the part of the Issuer. Moreover, there is no adverse economic event if either party does not perform in accordance with the terms of these agreements.
Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operation, page 63
Requirement for Additional Capital, page 67
2.
We note that you state here that you currently have sufficient cash reserves to achieve all of your budgeted plans for the next twelve months. However, earlier in your Risk Factor discussion, on page 41, you note that you have enough resources to fund operations for fifteen months. Finally, in the penultimate paragraph on page 67 you state that you can support current operations through the next six quarters, which would be eighteen months. Please revise your disclosure to clarify this inconsistency.
The Issuer has revised the relevant provisions in the Form 10-K/A to disclose its capital requirements for the next twelve (12) months.
Jim B. Rosenberg
March 15, 2010
Page 3 of 5
Item 9A(T) Controls and Procedures
Management’s Report on Internal Control over Financial Reporting, page 79
3.
While it appears that you have conducted an evaluation of internal controls over financial reporting, it does not appear that you have disclosed your conclusion as of June 30, 2009 as required by Item 308T(a)(3) of Regulation S-K. Please amend your filing within 10 business days to provide management’s conclusion as to the effectiveness of your internal control over financial reporting.
The Issuer has revised the disclosure to include the following conclusion as to its internal controls as of June 30, 2009 in the Form 10-K/A:
Management conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2009. Our management’s evaluation of our internal control was based on the framework in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “COSO Framework”). Based on this evaluation under the COSO Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2009.
Item 11, Executive Compensation, page 81
4.
It appears that your disclosure of executive compensation, including your Summary Compensation Table on page 82, is not in compliance with the current requirements of Item 402 of Regulation S-K for smaller reporting companies. Please revise your executive compensation disclosure in accordance with Items 402(m) through 402(r) of Regulation S-K. This includes providing the Outstanding Equity Awards at Fiscal Year-End Table, as applicable.
The Issuer has revised its executive compensation disclosure in accordance with the current requirements of Items 402(m) through 402(r) of Regulation S-K and included the following tables as specified therein:
Stock Award(s) ($)
Option Awards(#)
All Other Compensation ($)
Name and Principal Position
Year
Salary
Bonus ($)
Total ($)
Eugene Seymour,
2009
$
250,000
$
—
—
—
$
—
$
250,000
CEO, Director
2008
$
237,500
$
—
2,035
125,000
$
—
$
239,535
2007
$
200,000
$
—
6,208
125,000
$
—
$
206,208
Anil Diwan,
2009
$
252,000
$
—
-
-
$
—
$
252,000
President, Director
2008
$
243,107
$
—
5,009
333,334
$
1,500
$
249,616
2007
$
200,000
$
—
17,197
333,333
$
—
$
217,197
Leo Ehrlich,
2009
$
—
$
—
—
—
$
—
$
—
Former CFO*
2008
$
91,666
$
—
—
—
$
—
$
91,666
2007
$
150,000
$
—
3,657
125,000
$
—
$
153,657
* Deferred compensation paid in 2008, accrued in 2007.
Jim B. Rosenberg
March 15, 2010
Page 4 of 5
Outstanding Equity Awards at Fiscal Year-End
The following table sets forth for each named executive officer certain information concerning the outstanding equity awards as of June 30, 2009.
Option awards
Stock awards
Name and Principal Position
Number of Securities Underlying Unexercised
Options Exercisable
Number of Securities Underlying Unexercised Options Unexercisable
Option Exercise Price ($)
Option Expiration Date
Number of Shares or Units of Stock that Have Not Vested
Market Value of Shares or Units of Stock that Have Not Vested
Equity Incentive
Plan Awards :
Number of Unearned Shares,
Units or Other Rights that Have Not Vested
Equity Incentive Plan Awards: Market or Payout Value of Unearned
Shares, Units or Other Rights that Have Not Vested
Eugene Seymour
CEO and Director
500,000
—
$
0.10
September 26, 2015
—
—
—
Anil Diwan
President and Director
1,000,000
—
$
0.10
September 26, 2015
—
—
—
Form 10-Q for the six months ending December 31, 2009
Exhibit 31.1
5.
We note that you filed your Principal Executive Officer and Principal Financial Officer certification under Item 601(b)(31) of Regulation S-K. Please revise the certification to include the introductory language of paragraph 4 of Item 601(b)(31) of Regulation S-K to include reference to internal controls.
The certification in the Form 10-Q/A was revised to include the following, new introductory paragraph 4:
4.
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13A-15(f)) for the registrant and have:
Jim B. Rosenberg
March 15, 2010
Page 5 of 5
In addition, we have been authorized by the Issuer to advise the Commission:
·
The company is responsible for the adequacy and accuracy of the disclosure in the filings;
·
Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and
·
The company may not assert staff comments as a defense in any proceedings initiated by the Commission or any person under the federal securities laws of the United States.
Should you have any questions or require any further information, please do not hesitate to contact us.
Very truly yours,
Tarter Krinsky & Drogin LLP
Tarter Krinsky & Drogin LLP
PC/mm
2010-03-17 - CORRESP - NANOVIRICIDES, INC.
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Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Company, “NNVC”
www.nanoviricides.com
March 17, 2010
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention:
Jeffrey P. Riedler,
Assistant Director
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 4, 2010
File No. 333-165221
Dear Mr. Riedler:
Please be advised that the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission has delivered comments to the Registrant's Form 10-K for the Fiscal Year Ended June 30, 2009 and the Form 10-Q for the six months ended June 30, 2009, the Registrant hereby withdraws its request for acceleration of the effective date of the Registration Statement, effective immediately.
Should you have any questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate to contact me.
Very truly yours,
/s/ Eugene Seymour
Eugene Seymour, MD MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2010-03-15 - CORRESP - NANOVIRICIDES, INC.
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Nanotechnology-Enabled Targeted Viricides”
A Publicly Traded Company, “NNVC”
www.nanoviricides.com
March 15, 2010
Via Edgar Only
United States Securities and Exchange Commission
Mail Stop 6010
Washington, D.C. 20549
Attention:
Jeffrey P. Riedler,
Assistant Director
Re:
NanoViricides, Inc.
Registration Statement on Form S-3
Filed on March 4, 2010
File No. 333-165221
Dear Mr. Riedler:
Please be advised that the undersigned is the duly elected Chief Executive Officer of NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission has no further comments to the Registrant's Form S-3 Registration Statement, the Registrant hereby requests acceleration of the effective date of the Registration Statement to Wednesday, March 17, 2010 at 9:00 a.m., or as soon thereafter as practicable.
Should you have any questions in regard to this correspondence or any other matter relating to this Registrant’s filing, please do not hesitate to contact me.
Very truly yours,
Eugene Seymour, MD MPH
135 Wood Street, Ste. 205, West Haven, CT 06516. Tel./Fax: 203-937-6137.
2010-03-15 - UPLOAD - NANOVIRICIDES, INC.
Via Facsimile and U.S. Mail Mail Stop 4720 March 10, 2010 Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, Connecticut 06506 Re: NanoViricides, Inc. Form 10-K for Fiscal Year Ended June 30, 2009 Form 10-Q for the quarterly period ended December 31, 2009 File No. 000-52318 Dear Dr. Seymour: We have reviewed your filings and have the following comments. We think you should revise your documents in response to these comments. If you disagree, we will consider your explanation as to why our co mments are inapplicable or a revision is unnecessary. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filings. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form 10-K For The Fiscal Year Ended June 30, 2009 General 1. We note your discussion throughout your Form 10-K of your company’s collaboration agreements, including pa ges 6, 24 and 64. In these sections, you address a number of agreements but do not disclose the material terms of such agreements. Nor have you filed these agr eements as exhibits to your 10-K, as required by Item 601(b)(10) of Regulation S-K. With respect to each of these agreements that are material to your co mpany, please discuss the material terms, whether financial terms or otherwise, and f ile the agreement as an exhibit. This includes your collaborations and cont racts with the following parties: Eugene Seymour, M.D. NanoViricides, Inc. March 10, 2010 Page 2 • the Centers for Disease Control and Prevention (CDC) • the Walter Reed Army Institutes of Research (WRAIR); • the United States Army Medical Research Institute of Infectious Diseases (USAMRIID); • the United States Armed Forces Institute of Pathology (USAFIP); • THEVAC, LLC; • the Southern Research Institute, Inf ectious Diseases Division, Frederick, MD (SRI-F); • the Long Island Jewish Medical System , Feinstein Institute of Medical Research; • KARD Scientific, Inc.; and • The pharmaceutical company with which you signed a Material Transfer Agreement on February 25, 2009. With respect to the February 25, 2009 Material Transfer Agreement, you are required to disclose the material terms of this agreement and file a copy as an exhibit to the extent it is material to your company, regardless of whether the parties have signed a confidentiality agreem ent. If there are provisions of this agreement that would cause potential commercial harm to your company if released publicly, you may make a request for confidential treatment under Rule 24b-2 of the Exchange Act. Note, however , that the identity of the counterparty cannot be kept confidential. Item 7. Management’s Discussion and Analys is of Financial Condition and Results of Operations, page 63 Requirement for Additional Capital, page 67 2. We note that you state here that you curre ntly have sufficient cash reserves to achieve all of your budgeted plans for the ne xt twelve months. However, earlier in your Risk Factor discussion, on pa ge 41, you note that you have enough resources to fund operations for fifteen months. Finally, in the penultimate paragraph on page 67 you state that you can support current operations through the next six quarters, wh ich would be eighteen months. Please revise your disclosure to clarify this inconsistency. Item 9A(T) Controls and Procedures Management’s Report on Internal Control over Financial Reporting, page 79 3. While it appears that you ha ve conducted an evaluation of internal controls over financial reporting, it does not appear th at you have disclosed your conclusion as of June 30, 2009 as required by Item 308T(a)(3) of Regulation S-K. Please amend your filing within 10 business days to provide management’s conclusion as to the effectiveness of your intern al control over financial reporting. Eugene Seymour, M.D. NanoViricides, Inc. March 10, 2010 Page 3 Item 11. Executive Compensation, page 81 4. It appears that your disclosure of executive compensation, including your Summary Compensation Table on page 82, is not in compliance with the current requirements of Item 402 of Regulation S-K for smaller reporting companies. Please revise your executive compensation disclosure in accordance with Items 402(m) through 402(r) of Regulation S-K. This includes providing the Outstanding Equity Awards at Fiscal Year-End Table, as applicable. Form 10-Q for the six months ending December 31, 2009 Exhibit 31.1 5. We note that you filed your Principal Ex ecutive Officer and Principal Financial Officer certification under Item 601(b)(31) of Regulation S-K. Please revise the certification to include the introductory language of paragraph 4 of Item 601(b)(31) of Regulation S-K to include reference to internal controls. * * * As appropriate, please amend your Form 10- K for the fiscal year ended June 30, 2009 and subsequent Forms 10-Q and respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a cover letter with your amendments that keys your res ponses to our comments. Detailed letters greatly facilitate our review. Please furnis h the cover letter to us via EDGAR under the form type label CORRESP. We may have additional comments after reviewing your amendment and responses to our comments. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include all information required under the Securities Exchange Act of 1934 and that they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in the filings; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; and Eugene Seymour, M.D. NanoViricides, Inc. March 10, 2010 Page 4 • the company may not assert staff comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filings or in response to our comments on your filings. Please contact James Peklenk, Staff Account ant, at (202) 551-3661 or Mary Mast, Senior Accountant, at (202) 551-3613 if you have any questi ons regarding the processing of your response as well as any questions re garding comments on the financial statements and related matters. You may contact Michael Rosenthall, Staff A ttorney, at (202) 551- 3674 or Daniel Greenspan, Special Counsel, at (202) 551-3623 with questions on any of the other comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2010-03-11 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 4720 March 11, 2010 Eugene Seymour Chief Executive Officer and Acting Financial Officer Nanoviricides, Inc. 135 Wood Street Suite 205 West Haven, Connecticut 06516 Re: Nanoviricides, Inc. Registration Statement on Form S-3 Filed March 4, 2010 File No. 333-165221 Dear Mr. Seymour: We have limited our review of the above referenced registration statement to only those issues identified herein. Where indicated, we think you should provide additional disclosure in response to these comment. If you disagree, we will consider your explanation as to why our comments are in applicable or additi onal disclosure is unnecessary. Please be as detailed as necessary in your explanation. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone number listed at the end of this letter. Form S-3 filed March 4, 2010 Incorporation of Certain Docu ments by Reference, page 19 1. We note that the list of documents to be incorporated by reference into the filing does not incorporate by re ference the following: • Form 8-K (Items 1.01, 3.02 and 9.01) filed July 10, 2009; and • Form 8-K (Items 1.01, 3.02 and 9.01) filed October 5, 2009. Please revise the list of documents to be incorporated by reference on page 19 to include these filings. Eugene Seymour Nanoviricides, Inc. March 11, 2010 Page 2 Signatures, page 25 2. We note that you, as chief executive offi cer and acting chief financial officer, have signed the Form S-3 on behalf of the registrant and in each of those capacities, but that the filing has not b een signed by the company’s controller or principal accounting officer as required by Form S-3. Please amend your filing to include the signature of the company’s c ontroller or principa l accounting officer. If you are also the company’s controlle r or principal accounting officer, please indicate beneath your signature that you are also si gning the Form S-3 in the capacity of controller or principal accounti ng officer. See Instructions 1 and 2 to the Signatures section of Form S-3 for further information. Exhibit Index, page 26 3. We note that you have not indicated where th e form of indenture listed as Exhibit 4.2 is filed. If the form of indenture has previously been filed by the company, please revise your exhibit index to inco rporate the document by reference from a previous filing. If the document has not ye t been filed, please file a copy with your amendment to the Form S-3. * * * As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendm ent and response to our comments. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Act of 1933 and that they have provided all information investors require for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the ev ent the company requests acceleration of the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; Eugene Seymour Nanoviricides, Inc. March 11, 2010 Page 3 • 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 comment s and the declaration of effectiveness as a defense in any proceeding initiat ed by the Commission or any person under the federal securities laws of the United States. In addition, please be advi sed that the Division of En forcement has access to all information you provide to the staff of the Di vision of Corporation Finance in connection with our review of your filing or in response to our comments on your filing. We will consider a written request for acceleration of the effective date of the registration statement as conf irmation of the fact that t hose requesting acceleration are aware of their respective re sponsibilities under the S ecurities Act of 1933 and the Securities Exchange Act of 1934 as they rela te to the proposed public offering of the securities specified in the above registration statement. We will act on the request and, pursuant to delegated authority, grant acce leration of the effective date. We direct your attention to Rules 46 0 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. Please contact Laura Crotty at (202) 551-3563 or myself at (202) 551-3715 with any questions. S i n c e r e l y , J e f f r e y P . R i e d l e r Assistant Director cc: Peter Campitiello, Esq. Tarter Krinsky & Drogin LLP 1350 Broadway New York, New York 10018
2009-04-23 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
formcorresp.htm
April
21, 2009
VIA
EDGAR
Mr.
Jeffrey Riedler
U.S.
Securities and Exchange Commission
100 F
Street, NE
Washington,
DC 20549
Re:
NanoViricides,
Inc.
Preliminary
Information Statement on Schedule
14C
Filed
April 8, 2009
File
No. 000-52318
Dear Mr.
Riedler:
Please be
advised that the undersigned is the duly elected Chief Executive Officer of
NanoViricides, Inc., the above-referenced issuer (the “Issuer”). This
letter is in response to the comments of the Staff of the U.S. Securities and
Exchange Commission (the “Commission”) with respect to the above-referenced
filings provided in your letter dated April 16, 2009 (the “Comment Letter”), and
to illustrate the amendments made to the filing of the Preliminary Information
Statement on Schedule 14C, filed concurrently herewith. Our responses
follow the text of each Staff comment and are reproduced consecutively for your
convenience.
Preliminary Information
Statement on Schedule 14C
General
1.
Please
revise your disclosure to include a discussion of your plans to issue
blank check preferred stock. If you have no such plans for the foreseeable
future, please revise to include a statement saying this. Please also
include a discussion of the potential ramifications of authorizing blank
check preferred stock on the rights and economic interests of holders of
your common stock.
The
Preliminary Information Statement was revised to provide the
following:
The
Charter Amendment authorizes the issuance of ‘blank check” preferred stock with
such designations, rights and preferences as may be determined from time to time
by the board of directors. Accordingly, the board is empowered, without
stockholder approval, to issue preferred stock with whatever rates of
dividends, redemption provisions, liquidation preferences, voting rights,
conversion privileges and other characteristics as it may deem necessary.
If any preferred stock is issued, it may adversely affect the holders
of the common stock. For example, in a liquidation, the holders of the
preferred stock may be entitled to receive a certain amount per share of
Preferred Stock before the holders of the common stock receive any
distribution. In addition, the holders of Preferred Stock may be
entitled to a certain number of votes per share of preferred stock and such
votes may dilute the voting rights of the holders of common stock when the
Company seeks to take corporate action. Furthermore, preferred stock
may be issued with certain preferences over the holders of common stock with
respect to dividends or the power to approve the declaration of a
dividend. These are only examples of how shares of Preferred Stock,
if issued, may dilute the interests of the holders of common
stock. The Company has no present intention to issue any shares of
preferred stock, we cannot assure you that we will not do so in the
future.
In
addition, the issuance of preferred stock may discourage, delay or prevent
a takeover of the Company. When, in the judgment of the Board of
Directors, this action will be in the best interest of the stockholders and the
Company, such shares may be used to create voting or other impediments or to
discourage persons seeking to gain control of the Company. Such
shares also could be privately sold to purchasers favorable to the Board of
Directors in opposing such action. In addition, the Board of
Directors may authorize holders of a series of common or preferred stock to vote
either separately as a class or with the holders of the Company's common stock,
on any merger, sale or exchange of assets by the Company or any other
extraordinary corporate transaction. The existence of the additional
authorized shares may have the effect of discouraging unsolicited takeover
attempts. The issuance of new shares also may be used to dilute the
stock ownership of a person or entity seeking to obtain control of the Company
should the Board of Directors consider the action of such entity or person not
to be in the best interest of the stockholders of the Company. The
issuance of new shares also may be used to entrench current management or deter
an attempt to replace the Board of Directors by diluting the number or rights of
shares held by individuals seeking to control the Company by obtaining a certain
number of seats on the Board of Directors.
The
Issuer acknowledges the following statements:
1.
The
Issuer is responsible for the adequacy and accuracy of the disclosure in
the filings;
2.
The
staff comments or changes to disclosure in response to staff comments in
the filings reviewed by the staff do not foreclose the Commission from
taking any action with respect to the filing;
and
3.
The
Issuer may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal securities
laws of the United States.
Should
you have any questions or require any further information please do not hesitate
to contact the undersigned.
Very
truly yours,
/s/ Eugene Seymour
Eugene
Seymour
2009-04-16 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 6010 April 16, 2009 Via Facsimile and U.S. Mail Eugene Seymour Chief Executive Officer NanoViricides, Inc. 131 Wood Street, Suite 205 West Haven, CT 06516 Re: NanoViricides, Inc. Preliminary Information Statement on Schedule 14C Filed April 8, 2009 File No. 000-52318 Dear Mr. Seymour: This is to advise you that we have limited our review of the above information statement to the issues identified below. We will make no further review of this filing. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necess ary in your explanation. After reviewing this information, we ma y or may not raise additional comments. General 1. Please revise your disclosure to include a di scussion of your plans to issue blank check preferred stock. If you have no such plans for the foreseeable future, please revise to include a statement saying this. Please al so include a discussi on of the potential ramifications of authorizing blank check preferred stock on the rights and economic interests of holders of your common stock. * * * As appropriate, please revise your information statement in response to these comments. You may wish to provide us with marked copies of the revised document to expedite our review. Please furnish a response letter th at keys your responses to our co mments. Detailed cover letters greatly facilitate our review. Please file your cover letter on EDGAR under the form type label Eugene Seymour NanoViricides, Inc. April 16, 2009 Page 2 CORRESP. Please understand th at we may have additional comments after reviewing your amendment and response to our comment. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings reviewed by the staff to be certain that they have provided all information investors 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 acc uracy and adequacy of the disclosures they have made. In connection with responding to our comme nts, please provide, in writing, a statement from the company acknowledging that • the company is responsible for the adequacy and accuracy of the disclo sure in the filings; • staff comments or changes to disclosure in response to staff comments in the filings reviewed by the staff do not foreclose th e Commission from taking any action with respect to the filing; and • the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. In addition, please be advi sed that the Division of En forcement has access to all information you provide to the sta ff of the Division of Corporati on Finance in our review of your filing or in response to our comments on your filing. Please contact Scot Foley at (202) 5 51-3383 or me at (202) 551-3715 with any questions. S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r
2008-04-09 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
corresp.htm
Nanotechnology-Enabled
Targeted Viricides”
A
Publicly Traded Company, “NNVC”
www.nanoviricides.com
April
8, 2008
VIA
EDGAR AND OVERNIGHT DELIVERY
United
States Securities and Exchange Commission
Mail Stop
6010
Washington,
D.C. 20549
Attention:
Jeffrey
P. Riedler,
Assistant
Director
Re:
NanoViricides,
Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed on
March 24, 2008
File No.
333-148471
Dear Mr.
Riedler:
Please be
advised that the undersigned is the duly elected Chief Executive Officer of
NanoViricides, Inc. (the "Registrant"). Having been advised that the
Commission has no further comments to the Registrant's Form S-1 Registration
Statement, the Registrant hereby requests acceleration of the effective date of
the Registration Statement to Friday, April 11, 2008 at 9:30 a.m., or as soon
thereafter as practicable.
The
Registrant is in receipt of your comment letter of March 31, 2008, as it relates
to the Registrant’s Form S-1 filing. In accordance therewith, the
Registrant acknowledges that staff comments or changes in response to staff
comments in the proposed disclosure in the registration statement do not
foreclose the Commission from taking any action with respect to the filing. The
Registrant also acknowledges that the adequacy and accuracy of the disclosure in
the above-referenced filing is the responsibility of the
Registrant. The Registrant represents to the Commission that staff
comments will not be asserted as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United
States.
Should
you have any questions in regard to this correspondence or any other matter
relating to this Registrant’s filing, please do not hesitate to contact
me.
Very
truly yours,
/s/ Eugene Seymour
Eugene
Seymour, MD MPH
135 Wood
Street, Ste. 205, West Haven, CT 06516. Tel./Fax:
203-937-6137.
2008-03-31 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 6010 March 31, 2008 Dr. Eugene Seymour Chief Executive and Financial Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516
Re: NanoViricides, Inc.
Amendment No. 1 to Registra tion Statement on Form S-1
Filed March 24, 2008 File Number 333-148471
Dear Dr. Seymour:
We have reviewed your filing and have th e following comments. Where indicated, we
think you should revise your document in response to these comments. If you disagree, we will
consider your explanation as to why our comments are inapplicable or a revision is unnecessary.
Please be as detailed as nece ssary in your explanation.
Amendment No. 1 to Registration Statement on Form S-1
General
1. Please explain the discrepancy between the numbe r of shares you seek to register in your
“Calculation of Registration Fee” table and the number of shares you seek to register in
your “Selling Security Holders” table. We note that your “Calcu lation of Registration
Fee” table seeks to register 3,225,000 shares of common stock, while your “Selling
Security Holders” table seeks to regi ster 4,750,000 shares of common stock.
Signatures, page 67
2. We note your response to Comment 6 and reis sue the comment in part. We note that
your chief executive officer and chief financ ial officer have signed this Form S-1 on
behalf of the registrant and in his own capacit y, but that the Form S-1 has not been signed
Dr. Eugene Seymour
NanoViricides, Inc. March 31, 2008 Page 2
by your controller or principal accounting officer in those capacities as required by Form
S-1. Please revise your filing to include th e signature of your controller or principal
accounting officer. If either Dr. Seymore or Dr. Diwan is also your controller or
principal accounting officer, please indicate bene ath his signature that he is signing the
Form S-1 in the capacity of contro ller or principal accounting officer.
* * *
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filings reviewed by the staff to be certain that they have provided all information investors
require for an informed decision. Since the comp any and its management are in possession of all
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made. Notwithstanding our comments, in the even t the company requests acceleration of the
effective date of the pending registration statement, it should furnish a letter, at the time of such
request, acknowledging that:
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose the Co mmission from taking any action with respect
to the filing;
• the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and
• the company may not assert this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divisi on of Corporation Finance in connection with
our review of your filing or in re sponse to our comments on your filing.
We will consider a written request for acceleration of the effective date of the registration statement as a confirmation of the fact that those requesting accelerat ion are aware of their
respective responsibilitie s under the Securities Act of 1933 and the Securities Exchange Act of
1934 as they relate to the proposed public offeri ng of the securities specified in the above
registration statement. We w ill act on the request and, pursuant to delegated authority, grant
acceleration of the effective date. Please contact Rose Zukin at (202) 551-3239 or me at (202) 551-3710 with any
questions.
Dr. Eugene Seymour
NanoViricides, Inc. March 31, 2008 Page 3
S i n c e r e l y ,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Peter Campitiello, Esq. Tarter Krinsky & Drogin LLP 1350 Broadway New York, NY 10018
2008-01-11 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 6010 January 11, 2008 Dr. Eugene Seymour Chief Executive and Financial Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516
Re: NanoViricides, Inc.
Registration Statement on Form SB-2 Filed January 4, 2008 File Number 333-148471
Dear Dr. Seymour:
We have reviewed your filing and have the fo llowing comments. Where indicated, we think
you should revise your document in response to thes e comments. If you disagree, we will consider
your explanation as to why our comments are inapp licable or a revision is unnecessary. Please be as
detailed as necessary in your explanation. Form SB-2
1. In an appropriate place in your prospectus, please provide descriptions of the private
placement transactions pursuant to which you sold securities to the selling shareholders listed
in the filing.
2. We note that it appears that one of the selling shareholders, DKR Saturn Event Driven
Holding Fund Ltd., is an affiliate of a broker-d ealer. Please confirm to us that you have
determined for each selling stockholder whether th at selling stockholder is a broker-dealer or
an affiliate of a broker-dealer.
3. For each selling stockholder who is a broker-dealer , please revise the prospectus to state that
such selling stockholder is an underwriter with respect to these securities. An exception to
this requirement is recognized wh en the broker-dealer receives the securities as compensation
for underwriting activities.
Dr. Eugene Seymour
NanoViricides, Inc. January 11, 2008 Page 2
4. For each selling stockholder who is an affiliate of a broker-dealer, please revise the prospectus
to state that:
• such selling stockholder purchased or will purchase the securities in the ordinary
course of business, and
• at the time of purchase of such securities, the selling stockholder had or will have no
agreement or understandings, directly or indi rectly, with any person to distribute such
securities or any securities issu able upon conversion or exercise.
In the alternative, for each such broke r-dealer affiliate who cannot make these
representations, please state that they are underwriters within the meaning of the Securities
Act of 1933.
5. Please revise your filing to provide executive co mpensation disclosure for the fiscal year
ended December 31, 2007.
6. Please revise your filing to reflect that Dr. E ugene Seymour is signing in his capacity as the
Chief Executive and Financial Officer, the c ontroller or principal accounting officer, and
director. The Form SB-2 requires the small busin ess issuer, its principal executive officer, its
principal financial officer, its controller or principal accoun ting officer and at least the
majority of the board of directors to sign the registration statement. Any person who occupies
more than one of the positions required to sign the filing shall indicate each capacity in which
he or she signs the registration statement.
* * *
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in
the filings reviewed by the staff to be certain that they have provided all information investors require for an informed decision. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are re sponsible for the accuracy and adequacy of the
disclosures they have made. Notwithstanding our comments, in the even t the company requests acceleration of the
effective date of the pending registration statement, it should furnish a letter, at the time of such
request, acknowledging that:
• should the Commission or the staff, acting pursua nt to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to the
filing;
Dr. Eugene Seymour
NanoViricides, Inc. January 11, 2008 Page 3
• the action of the Commission or the staff, acting pursuant to delegated authority, in declaring
the filing effective, does not re lieve the company from its full responsibility for the adequacy
and accuracy of the disclosure in the filing; and
• the company may not assert this action as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
In addition, please be advised th at the Division of Enforcement has access to all information
you provide to the staff of the Divi sion of Corporation Finance in c onnection with our review of your
filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the registration
statement as a confirmation of the fact that those requesting acceleration are aw are of their respective
responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they
relate to the proposed public offeri ng of the securities sp ecified in the above registration statement.
We will act on the request and, pursuant to delegate d authority, grant acceleration of the effective
date. Please contact Rose Zukin at (202) 551-3239 or me at (202) 551-3710 with any questions.
S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Peter Campitiello, Esq. Tarter Krinsky & Drogin LLP 1350 Broadway New York, NY 10018
2007-04-05 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
Nanoviricides Correspondence 4-5-2007
NANOVIRICIDES,
INC.
135
Wood
Street
Suite
205
West
Haven, Connecticut 06516
April
5, 2007
VIA
EDGAR ONLY
Securities
and Exchange Commission
100
F
Street, N.E.
Mail
Stop
6010
Washington,
D.C. 20549
Attention:
Suzanne Hayes, Esq.
Re:
NanoViricides, Inc.
Form 10-SB, filed November 14,
2006
File No.
0-52318
Dear
Ms.
Hayes:
Please
be
advised that the undersigned is the duly elected Chief Executive Officer of
NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission
has no further comments to the Registrant's Form 10-SB Registration Statement,
the Registrant hereby requests acceleration of the effective date of the
Registration Statement to Monday, April 8, 2007 at 9:30 a.m., or as soon
thereafter as practicable.
Additionally,
please note that the Registrant acknowledges the following:
·
should
the Commission or the staff, acting pursuant to delegated authority,
declare the Registration Statement effective, it does not foreclose
the
Commission from taking any action with respect to the filing;
·
the
action of the Commission or the staff, acting pursuant to delegated
authority, in declaring the filing effective, does not relieve
the
Registrant from its full responsibility for the adequacy and
accuracy of
the disclosure in the filing;
and
·
the
Registrant may not assert staff comments and the declaration
of
effectiveness as a defense in any proceeding initiated by the
Commission
or any person under the federal securities laws of the United
States
Should
you have any questions in regard to this correspondence or any other matter
relating to this Registrant=s
filing,
please do not hesitate to contact the undersigned or the Registrant's counsel
Peter Campitiello, Esq. at (212) 413-7427.
Very truly yours,
/s/ Eugene Seymour,
M.D.
Eugene Seymour,
M.D.
2007-04-03 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
Nanoviricides Correspondence 4-3-2007
NANOVIRICIDES,
INC.
135
Wood
Street
Suite
205
West
Haven, Connecticut 06516
April
3, 2007
VIA
EDGAR
AND
FACSIMILE
Securities
and Exchange Commission
100
F
Street, N.E.
Mail
Stop
6010
Washington,
D.C. 20549
Attention:
Suzanne Hayes, Esq.
Re:
NanoViricides,
Inc.
Form
10-SB, filed November 14, 2006
File
No. 0-52318
Dear
Ms.
Hayes:
Please
be
advised that the undersigned is the duly elected Chief Executive Officer of
NanoViricides, Inc. (the "Registrant"). Having been advised that the Commission
has no further comments to the Registrant's Form 10-SB Registration Statement,
the Registrant hereby requests acceleration of the effective date of the
Registration Statement to Monday, April 8, 2007 at 9:30 a.m., or as soon
thereafter as practicable.
Should
you have any questions in regard to this correspondence or any other matter
relating to this Registrant's filing, please do not hesitate to contact
me.
Very
truly yours,
/s/
Eugene Seymour, M.D.
Eugene
Seymour, M.D.
2007-02-27 - UPLOAD - NANOVIRICIDES, INC.
1
Mail Stop 6010 February 27, 2007 Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516
Re: NanoViricides, Inc.
Amendment No. 2to the Form 10-SB12G
Filed on February 14, 2007
File No. 0-52318
Dear Dr. Seymour:
We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your documents in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to pr ovide us with supplemental information so
we may better understand your disclosure. Af ter reviewing this information, we may or
may not raise additional comments. Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-SB12G/Amendment No. 2
Preliminary Efficacy Study, page 7
1. We note your response to comment 3 a nd your revised disclosure. In your
discussion of the preclinical animal testi ng related to the H1N1 influenza strain,
you reference a statistical test and more specifically you provid e that your initial
animal findings could be considered stat istically significant. Please disclose how
you determine your initial animal findings were statistically significant and also
indicate what statistical analysis you conducted to test your findings.
2Avian Influenza, page 11
2. We note your response to comment 7 and your supplemental response. However,
the materials you provided do not appear to support your statement “Of the avian influenza viruses that have crossed the sp ecies barrier to infect humans, the H5N1
has caused the largest number of detected cases of severe disease and death in
humans.” Please provide us with supplem ental copy of the article that supports
your statement and note that such material should be marked to illustrate what
portion of the article suppor ts your statement. In the alternative, revise your
document to identify the source of the information that you relied on in making
the statement.
“With our limited resources, we may be unable to effectively manage growth, pages 29
and 32
3. We note your responses to comments 12 and 13 and your revised disclosure.
Please combine the risk factors on pages 29 and 32 with the above referenced risk factor heading as both discussions appear to be discussing risk factors related to
your future hiring needs. Additionally, we note that the risk factor discussion on
page 29 appears to suggest that you intend to expand your operations and staff in
a material amount whereas the risk fact or on page 32 appears to suggest your
plans to grow your operations and sta ff is heavily dependent on the positive
progression of your preclinical studies. Please reconcile the two statements.
“There are conflicts of interest among our o fficers, directors and stockholders, page 34”
4. We note your response to comment 16. To th e extent that any of your officers or
directors are affiliated with any companie s that have an economic interest in
companies that invest in you or do busine ss with you, please identify them here.
Additionally, identify transactions that may not be at arm’s length.
Management Discussion and Analysis of Plan of Operation, page 42
5. We note your response to comment 19 and your revised disclosure. Your revised
disclosure indicates that you have not yet discussed a final agreement with NIHE
despite having entered into a memorandum of understanding on December 23, 2005. Please disclose the current terms of the financial obligations and
responsibilities of each party pursuant to the memorandum of understanding.
6. Please revise your disclosure provided in response to our previous comment 21 to
clearly indicate the basis you used to a llocate costs to each of your development
projects. Although you now provide an indi cation of the level of effort expended
on each project through your allocations, pleas e revise your disclosure to clarify
why you do not maintain and evaluate your research and development costs by project and disclose whether you have any plans to implement a system to track
your costs by project. In addition, as pr eviously requested, please represent to us
3in your letter that you will continue to in clude your allocated costs by project in
any future filings under the Exchange Act.
Exhibit List
7. We note your response to comment 28 and reissue the comment. Our comment
sought for you to add disclosure to your e xhibit table to indica te that portions of
your exhibit have been omitted pursuant to confidential treatmen t request and that
this information has been filed or will be filed separately with the Commission. Your current disclosure to the exhibit table indicating “**Con fidential Treatment
Requested” does not satisfy our comm ent. Please revise accordingly.
8. Additionally, it appears that your confidential treatment request has not yet been
filed. We will not be able to clear your filing until the confidential treatment request has been filed and all comments rela ting to the request ha ve been cleared.
Please file it as soon as possible.
* * *
You may wish to provide us with marked copies of the amendment to expedite
our review. Please furnish a cover letter with you r amendment that keys your responses
to our comments and provides any requested supplemental information. Detailed cover
letters greatly facilitate our review. Pl ease furnish your cover letter on EDGAR under the
form type label CORRESP. Please understand that we may have additional comments
after reviewing your amendment and responses to our comments.
You may contact Mark Brunhof er at (202) 551- 3638 or Donald Abbott at (202)
551-3608 if you have questions regarding comm ents on the financial statements and
related matters. Please contact Song Brandon at (202) 551-3621, Suzanne Hayes, Legal
Branch Chief at (202) 551-3675 or me at (202) 551-3710 with any other questions.
S i n c e r e l y , J e f f r e y R i e d l e r A s s i s t a n t D i r e c t o r cc: Peter Campitiello, Esq. Levy & Boonshoft, P.C. 477 Madison Avenue New York, NY 10022
2007-02-14 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
NanoViricides, Inc. Corresp 02-14-2007
LEVY
& BOONSHOFT, P.C.
ATTORNEYS
AT LAW
477
Madison
Avenue
New
York,
New York 10022
(212)
751-1414
Facsimile:
(212) 751-6943
February
14, 2006
Via
EDGAR and OVERNIGHT DELIVERY
Mr.
Jeffrey Riedler
Assistant
Director
Securities
and Exchange Commission
Division
of Corporate Finance
100
F
Street, N.E.
Mail
Stop
6010
Washington
DC 20549
Re:
NanoViricides,
Inc.
Amendment
No. 1 to the Form 10-SB12G filed on January 17, 2007
File
No
0-52318
Dear
Mr.
Riedler:
Please
be
advised that this firm is special securities counsel to NanoViricides, Inc.,
the
above-referenced issuer (the “Issuer”). This letter is in response to the
comments of the Staff of the U.S. Securities and Exchange Commission (the
“Commission”) with respect to the above-referenced filing provided in your
letter dated February 2, 2007 (the “Comment Letter”). The purpose of this
correspondence is to illustrate these changes to the Commission and provide
explanation, where necessary. Revisions and additions to the Registration
Statement will be shown in strikethrough and underlined format for convenience.
Our responses follow the text of each Staff comment reproduced consecutively
for
your convenience.
Form
10-SB12G / Amendment No. 1
General
1. In
your
response letter, please state our comment and then explain each change that
has
been made in response to a comment. In addition, you should also reference
each
page number in which disclosure has been revised in response to a comment
so
that we can easily place your revised disclosure in its proper
context.
The
Issuer will indicate the appropriate revisions within this
correspondence.
Securities
and Exchange Commission
February
14, 2007
Page
2
of
21
2. We
note your response to comment 43 relating to your intention to submit a
confidential treatment application for Exhibit A pursuant to Rule 406. Please
note that because you have filed Exhibit A as part of an Exchange Act document,
you should seek confidential treatment under Rule 24b-2 of the Exchange Act.
Additionally, please note that comments related to your request for confidential
treatment will be delivered under separate cover. Please be advised that
we will
not be in a position to consider notifying you that we have no further comments
on your Form 10-SB until we resolve all issues concerning the confidential
treatment request.
The
Issuer has sought confidential treatment under separate cover.
Preliminary
Efficacy Study, page 7
3. We
note your response to comment 11 and your revised disclosure and reissue
the
comment in part. Our comment also sought for you to quantify the results
to the
extent possible for studies where you indicate that preclinical testing has
shown efficacy. For example, in this section, we note you provide the efficacy
results related to a drug related to common influenza. Please revise your
disclosure to provide quantified disclosure such as the number of test subjects
you used as well as p value or other statistical analysis you conducted to
determine the efficacy of the particular study. Similarly, we note your
discussion in the section entitled “Preliminary Cell Culture Studies against
H5N1 Avian Influenza,” on page 7 where you discuss your preclinical testing of
various nanoviricides related to the treatment of H5N1. You do not provide
any
quantified disclosure in terms of the number of subjects you used or whether
you
used any statistical analysis. Please revise the above referenced sections
as
well as throughout the document where you discuss preclinical testing showing
efficacy to disclose the results of the preclinical studies, including the
number of test subjects, what your test group comprised of and whether your
results were subject to any statistical analysis.
Preliminary
Efficacy Study
A
nanoviricide drug was made using a well-known compound that has known efficacy
against common influenza. This nanoviricide and the free compound were tested
along with appropriate controls in mice infected with very high levels of
a
common influenza virus called H1N1. The results indicated that the efficacy
of
the nanoviricide was approximately 50 Times (5,000%) better than that of
the
free compound.
This
study indicated that the efficacy of a known virus-binding compound can be
enhanced to extremely high levels by using the nanoviricides technology.
We had
predicted such strong efficacy improvements theoretically. Further work will
be
necessary to substantiate that such an effect is seen across a wide range
of
compounds.
Securities
and Exchange Commission
February
14, 2007
Page 3
of
21
The
preclinical animal testing, done to study the efficacy (effectiveness) of
the
test nanoviricide (anti-human influenza, H1N1) compound, revealed potential
for
development for the reasons delineated below. Three separate and distinct
sets of experiments were performed to address different questions regarding
efficacy.
The
first
set of experiments was conducted in five different groups of ten mice to
test
efficacy of the nanoviricide compounds against H1N1 strain influenza with
ten
animals per group for statistical significance. All animals were given known
lethal doses of H1N1 human influenza virus. In all of these groups, at
least 60% or more of the animals survived when treated with the active
anti-H1N1 nanoviricide compound compared to those animals which
were administered only a saline (non-therapeutic, inert)
solution.
The next
set of experiments was conducted to determine the destruction/protection
of the
animal organs. There were also ten animals in each of five groups. Lethal
doses
of H1N1 were also administered. The active compound protected the organs so
that there were no histological (microscopic tissue) changes to the internal
organs of the treated animals. Highly significant tissue damage was found
in the
internal organs of the unprotected groups.
A
third
set of experiments was performed, again on five separate groups each containing
ten animals where the viral load was determined in the animals. The findings
revealed that the viral load (number of viral particles per cubic millimeter)
in
the treated animals was significantly lower than that found in the control
animals.
These
initial animal findings suggested that the test nanoviricide compound was
an
effective treatment for human influenza in mice and that the concept of using
a
nanoviricide as a treatment for certain viral illnesses was a valid one and
was
deserving of further study. In more scientific terms, the statistical test
was
met for validity of the findings and these findings could be considered
statistically significant. Thus, in statistical terms, one could say that
the
null hypothesis, that is the statistical likelihood that the observed results
were not due to chance but to the effect of the drug, was proven.
The
section entitled “Preliminary Cell Culture Studies Against H5N1 Avian Influenza”
on page 8 was amended to quantify the number of subjects used and statistical
analysis, as follows:
The
pre-clinical, laboratory testing of various test nanoviricides against H5N1
in
Vietnam was conducted in the following manner. Five "plates" each containing
96
culture wells were utilized. Different amounts of virus were placed in the
wells
along with differing concentrations of the 12 test compounds and their
positive and negative controls.
Securities
and Exchange Commission
February
14, 2007
Page 4
of
21
As
a test case, we have developed and evaluated the safety and efficacy of
nanoviricides against common influenza and H5N1, one of the highly pathogenic
avian influenzas and a current pandemic threat.
In vitro
(laboratory)
evaluation of 14 substances, including controls, was performed to evaluate
protection of mammalian cells against infection by the H5N1 subtype. These
assays were conducted in Vietnam under the auspices of the National Institute
of
Hygiene and Epidemiology, Hanoi (NIHE) under the Vietnam Ministry of Health.
We
identified four different nanoviricides as being highly effective against
H5N1
using two different assays, both involving cell culture, one using the
plaque
reduction method and the other involving microscopic examination, to determine
the extent of cytopathic events (CPE) reduction. All of these nanoviricides
were
effective at extremely low concentrations and many of them are considered
drug
candidates.
The
four different nanoviricides were selected on the basis of the statistical
test
called the p-value.(explained below). The p-values for these four compounds
were
p<.003 which meant that there was a high statistical probability that these
results were due to the effect of the test nanoviricides and not to chance.
Thus
the "null hypothesis" is proven and the results can be considered statistically
significant
The
most
successful of these was a nanoviricide based on an antibody fragment as
the
targeting ligand, which led to substantial suppression of CPE at an
extraordinarily low concentration level. This is being developed as
AviFluCide-I™, a drug highly specific to H5N1 that is being developed against
the Vietnam strain. We currently believe that it is very likely to work
against
the Indonesian strain although further studies will be required to determine
its
efficacy against various highly pathogenic strains of influenza. If it fails to
work against the Indonesia 2006 strain, further development may become
necessary.
Another
nanoviricide which is based on a ligand that we designed in-house to be
specific
to the group of all or a majority of highly pathogenic avian influenza
(HPAI)
viruses, also showed a very high efficacy. This is being developed as
“AviFluCide-HP™”, a drug designed to be group-specific against emergent and
existing highly pathogenic influenza viruses (including H5N1, H7N3 and
others).
Non-H5N1 HPAI (non-pathogenic avian influenza) strains could also become
a
pandemic threat as can all influenza A viruses since they all have the
ability
to mutate. It is well known that influenza strains drift constantly due
to
mutation, ressortment or recombination events leading to failure of
vaccines.
Preliminary
analysis of the H5N1 preclinical in vitro studies completed in Vietnam
showed
that many nanoviricide™ candidates were effective at as low as 5-nanomolar
concentration levels in cell culture experiments. Typically, an early
developmental drug that proves effective at concentrations less than 500
nanomolars is considered a strong candidate for FDA approval as an
“Investigational New Drug (IND)” applicant.
A
third
nanoviricide is based on a ligand that we designed for attacking all influenza
A
viruses (type-level specificity) has shown strong efficacy against H5N1
as well.
This is being developed as “FluCide-I™”, a drug designed primarily for use
against serious cases of human influenza.
Securities
and Exchange Commission
February
14, 2007
Page 5
of
21
Preliminary
Efficacy Studies in Vivo, page 8
4. We
note your
response to comment 12 and your revised disclosure to this section where
you
disclose the p value related to common influenza strain H1N1 and your reference
to the wikipedia.org website where investors may obtain the definition of
the p
value. The definition of what a p value measures should be discussed in the
text
of your document. Additionally, please further explain what it means to have
p
value less than .003. Please revise your disclosure
accordingly.
The
Registration Statement was revised to include the definition of “p-value” in the
Glossary on page 4 as follows:
P-Value:
In
statistical hypothesis testing, the p-value
is
the
probability of obtaining a result at least as extreme as that obtained, assuming
the truth of the null hypothesis that the finding was the result of chance
alone. The
fact that p-values are based on this assumption is crucial to their correct
interpretation.
More
technically, the p-value of an observed value observed of some random variable
T
used as a test statistic is the probability that, given that the null hypothesis
true, T will assume a value as or more unfavorable to the null hypothesis
as the
observed value observed. “More unfavorable to the null hypothesis can in some
cases mean greater than, in some cases less than and in some cases further
away
from a specified center.
Additionally,
the Registration Statement was revised to describe the significance of a
p-Value
of less than .003, on page 8 Preliminary Efficacy Studies in Vivo, as
follows:
In
statistics, a result is called significant if it is unlikely to have occurred
by
chance. "A statistically significant difference" simply means there is
statistical evidence that there is a difference; it does not mean the difference
is necessarily large, important or significant in the usual sense of the
word.
In
traditional frequentist statistical hypothesis testing, the significance
level
of a test is the maximum probability, assuming the null hypothesis, that
the
statistic would be observed. Hence, the significance level
2007-02-02 - UPLOAD - NANOVIRICIDES, INC.
1 Mail Stop 6010 February 2, 2007 Eugene Seymour, M.D. Chief Executive Officer NanoViricides, Inc. 135 Wood Street, Suite 205 West Haven, CT 06516 Re: NanoViricides, Inc. Amendment No. 1 to the Form 10-SB12G Filed on January 17, 2007 File No. 0-52318 Dear Dr. Seymour: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your documents in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to pr ovide us with supplemental information so we may better understand your disclosure. Af ter reviewing this information, we may or may not raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form 10-SB12G/Amendment No. 1 General 1. In your response lette r, please state our comment a nd then explain each change that has been made in response to a comment. In addition, you should also reference each page number in which disclo sure has been revised in response to a comment so that we can easily place your re vised disclosure in its proper context. 2. We note your response to comment 43 re lating to your intention to submit a confidential treatment applic ation for Exhibit A pursuant to Rule 406. Please note that because you have filed Exhibit A as part of an Exchange Act document, you 2should seek confidential treatment under Rule 24b-2 of the Exchange Act. Additionally, please no te that comments related to your request for confidential treatment will be delivered under separate cover. Please be advised that we will not be in a position to consider notif ying you that we have no further comments on your Form 10-SB until we resolve a ll issues concerning the confidential treatment request. Preliminary Efficacy Study, page 7 3. We note your response to comment 11 and your revised disclosure and reissue the comment in part. Our comment also sought for you to quantify the results to the extent possible for studies where you indi cate that preclinical testing has shown efficacy. For example, in this section, we note you provide the efficacy results related to a drug related to common influe nza. Please revise your disclosure to provide quantified disclosure such as the number of test subjects you used as well as what p value or other statistical analysis you conducted to determine the efficacy of the particular study. Similarl y, we note your discussion in the section entitled “Preliminary Cell Culture Studies Against H5N1 Avian Influenza,” on page 7 where you discuss your preclinical testing of various nanoviricides related to the treatment of H5N1. You do not pr ovide any quantified di sclosure in terms of the number of subjects you used or wh ether you used any statistical analysis. Please revise the above referenced sec tions as well as throughout the document where you discuss preclinical testing showi ng efficacy to disclose the results of the preclinical studie s, including the number of test subjects, what your test group comprised of and whether your results were subject to any statis tical analysis. Preliminary Efficacy Studies In Vivo, page 8 4. We note your response to comment 12 and your revised disclosure to this section where you disclose the p value related to common influenza strain H1N1 and your reference to the wikipedia.org website where investors may obtain the definition of the p value. The definition of what a p value measures should be discussed in the text of your document. Additionally, please further explain what it means to have p value less than .003. Please re vise your disclosure accordingly. Arrangement with KARD Scientific, Inc., page 9 5. We note your response to comment 20 and your revised disclosure. Please revise your disclosure to also indicate whether you retain all intellectual property rights resulting from the services provided by KARD. Other Collaborations, page 9 6. We note your responses to comments 23 and 27 and your supplemental response. Our previous comment sought for you to disclose in your document the “significant efforts” you made in the past year with regard to obtaining valuable 3collaborations with agencies, institutions and commercial enterprises. In that regard, please revise your disclosure to disclose the material contents of the information you have set forth in Exhib it A that would let your investors know what significant efforts you are referri ng to as well as the status of your arrangements with the various agencies, institutions and commercial enterprises you indicate that you have made significan t efforts with. We also note that the contents of the information set forth in Exhibit A do not appear to explain any possible collaborations or di scussions you have held with commercial enterprises. Please revise your disclosure to identif y and discuss the commercial enterprises with whom you have made significan t efforts in obtaining valuable collaborations. With respect to the specifi c identities of the parties in Exhibit A for whom you indicate you intend to file a confidential treatment application, you may refer to such entities generally, such as a division of the U.S. Military and Civilian Research until we have an oppor tunity to review your confidential treatment application, which we note we have not yet received. Avian Influenza, page 12 7. We note your response to comment 9 and the inclusion of a web link in your supplemental response to our comment s eeking third party documentation for the statement “Of the avian influenza viruses th at have crossed the species barrier to infect humans, the H5N1 has caused the largest number of detected cases of severe disease and death in humans.” However, when we access the web link you provide, we are unable to determine whic h article or link you would like us to review in support of your statement. Pleas e either provide us with a supplemental hard copy of the article or material that supports the above referenced statement or revise your document to identify the s ource of the information that you relied on in making the statement referenced above. Inhibiting Influenza Neuraminidase, page 12 8. We note your response to comment 34 and your supplemental response where you state that “any combination of words neuraminidase, Tamiflu, limitations, and efficacy on Google would list numerous studies.” Additionally, we note you have provided web links as part of your re sponse. We are unable to access the web links you have provided. Additionally, while we note your supplemental statement that “[t]o mention a single study would not be representative of the extent of the literature,” our comment s ought for you to revise your disclosure to identify the studies discussing the topics of neuraminidase in hibitor drugs, the effectiveness of Tamiflu, and the limitati ons of oseltamivir in safety profile in humans as well as a brief discussion of who conducted the studi es and when such studies were completed. Rather than describing several studies, you may choose to disclose one or two studies discussing these topics and add further disclosure that there are other studies that have tested similar t opics and include a reference to sites or literatures wher e an investor may go to obtain additional information. Please revise your disclosure accordingly. 4 “Our company is a development stage company that has no products approved for commercial sale, never generated any reve nues and may never achieve revenues or profitability,” page 22 9. We note your response to comment 25 and your revised disclosure. Our comment also sought for you to include in the risk fact or disclosure that, if true, it would be several years until you could have a co mmercial drug product, if ever. Please revise this risk factor to include th is information, or if you do not believe inclusion of such language is applicab le, please explain to us why you do not believe is it applicable to you. “The report of our independent register ed public accounting firm includes a going concern qualification, and we have incurred significant oper ating losses and may not be profitable in the future, if ever,” page 23 10. We note your response to comment 48 a nd your revised disclosure, including your statement that “[i]t is uncertain at this time how the going concern qualification by our independent registered public accounting firm will effect our ability to raise capital.” Please revise your disclosure to state why you believe it is uncertain at this time how the goi ng concern qualification will impact your ability to raise additional capital. In many cases a going concern opinion makes raising capital more difficult and often results in terms less favorable than if the company did not have a going concern opi nion. If you believe the going concern opinion may not have this effect, please explain the basis for your belief. “We have limited experience in drug developm ent and may not be able to successfully develop any drugs,” page 24 11. We note your response to comment 46 and your revised disclosure. Please revise this risk factor to discuss how your experience in pharmaceutical drug development is limited. “Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprie tary information. Disclosure of our trade secrets or proprietary information could co mpromise any competitive advantage that we have,” page 28 12. We note your response to comment 61 and your response that the risk factor formerly entitled “With our limited res ources, we may be unable to effectively manage . . . .” was eliminated. Please explain why you believe you do not face this risk or restore th e deleted risk factor. 13. Additionally, our comment 61 sought for you to disclose how many consultants and contractors you currently have, in wh at capacity you use these individuals and how frequently you use them. We also sought for you to include in an appropriate 5section of your document, the material terms of any agreements you might have with your consultants and contractor s if you substantially rely on these individuals. We are unable to locate disc losure in your amended filing addressing our comment. In that regard, the co mment is reissued. Please revise your document or advise us accordingly. “We license our core technology from TheraC our Pharma Inc. and we are dependent upon them as they have exclusive development ri ghts. If we lose the right to utilize any of the proprietary information that is the subj ect of this license agreement, we may incur substantial delays and costs in develo pment of our drug candidates,” page 31 14. We note your response to comment 57 and your revised disclosure and reissue the comment in part. Our comment sought fo r you to also quantify the “progress payments” owed to TheraCour. Rather than providing a cross-reference to Item 7 of your document, please disclose the amount of progress payments you have paid to date as well as what payments you owe to TheraCour. “There are conflicts of interest among our o fficers, directors and stockholders.” page 34 15. We note your statements: • “Our officers and directors or their affiliates my have an economic interest in, or other business relationship with, pa rtner companies that invest in us.” • “Our officers, directors or their affiliates have interests in entities that provide products or services to us.” Please revise to identify all officers, direct ors and affiliates that have conflicts of interests, including relationships with partner companies and interests in companies that provide you w ith products and services. 16. Additionally, you state: • “Our executive officers or directors may have a c onflict between our current interests and their personal financial and other interests in another business venture. • “Our executive officers or directors may have conf licting fiduciary duties to us and the other entity.” • “The term of transactions may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations.” Please describe all such conf licts including transactions that were not subject to arm’s length negotiations. If the last two paragraphs of the risk factor discussion are the only conflicts that currently exist, please revise the risk factor to clarify these are the only current conflicts. 6 “We may enter into contracts with various U. S. government agencies which have special contracting requirements that give the government agency various rights or impose on the other party various obligations that can make the contract s less favorable to the non- government party. Consequently, if a large portion of our revenue is attributable to these contracts, our business may be adversely affected should the governmental parties exercise any of these additional rights or impose any of these additional obligations,” page 34. 17. We note your response to comment 67 and your revised disclosure that you have revised this risk factor to state that substantially all of your revenues will result from government contracts. Our comment in part previously sought for you to disclose why all of your revenues would result from government contracts and therefore our comment is reissued. Please revise your disclosure to indicate why you expect substantially all of your revenues will result from government contracts? For example, do you anticipat e primarily marketing to government agencies? If so, please revi se your disclosure to make this intention clear. “Because our common stock is traded on the ‘pin k sheets,’ your ability to . . . .,” page 38 “Because our shares are ‘penny stocks,’ you ma y have difficulty selling . . . .,” page 39 “Because our common stock is traded only on the pinks sheets your ability . . . .,” page 40 18. We note your response to comment 69 a nd reissue the comment. The above referenced risk factors still continue to contain language that your common stock “trades” on the pink sheets. As previous ly noted, because the pink sheets is a quotation medium, you should delete the reference to “trade.” Management’s Plan of Operation, page 42 19. We note your responses to comments 21 and 76 and your revised disclosure. Please revise your disclosure in this sect ion to indicate the da te you entered into this agreement and also that you will reta in all intellectual pr operty rights with respect to any resulting product. Th e memorandum of understanding with the Health Ministry of Vietnam also provide s that among other things that financial costs related to this joint project will be set forth in a “final agreement.” Please revise your disclosure to also indicate the status of when you expect to enter into a “final agreement” since the memorandum of understanding appears to have been entered into in December 2005. Management Discussion and Analysis of Plan of Operation, page 41 20. We are unable to locate any disclosu re indicating that you control the development program and associated costs with TheraCour as represented in your response to our previous comment 78. Pl ease specifically reference for us where you have made this disclosure or revise your discussion of the development fee obligation to clearly indi cate that you control the development program and 7det
2007-01-17 - CORRESP - NANOVIRICIDES, INC.
CORRESP
1
filename1.htm
NanoViricides Corresp 01-16-2007
LEVY
& BOONSHOFT, P.C.
ATTORNEYS
AT LAW
477
MADISON AVENUE
NEW
YORK,
NEW YORK 10022
(212)
751-1414
FACSIMILE:
(212) 751-6943
January
16, 2007
Via
EDGAR and OVERNIGHT DELIVERY
Mr.
Jeffrey Riedler
Assistant
Director
Securities
and Exchange Commission
Division
of Corporate Finance
100
F
Street, N.E.
Mail
Stop
6010
Washington
DC 20549
Re:
NanoViricides,
Inc.
Form
10-SB12G Filed on November 14, 2006
File
No. 0-52318
Dear
Mr.
Riedler:
Please
be
advised that this firm is special securities counsel to NanoViricides, Inc.,
the
above-referenced issuer (the “Issuer”). This letter is in response to the
comments of the Staff of the U.S. Securities and Exchange Commission (the
“Commission”) with respect to the above-referenced filing provided in your
letter dated December 11, 2006 (the “Comment Letter”). In response to these
comments, the Issuer has caused to be filed Amendment No. 1 to the Form 10-SB,
a
redlined version of which is enclosed with the original of this letter. The
purpose of this correspondence is to illustrate these changes to the Commission
and provide explanation, where necessary. Our responses follow the text of
each
Staff comment reproduced consecutively for your convenience.
Comment
No 1:
Your
Website at www.nanoviricides.com
We
make reference to the homepage of your webpage where you state that you believe
that “[i]t is possible that some HIV patients may be ‘cured’ by drugs developed
at NanoViricides Inc.” You also state that you hope to “spearhead” the efforts
to making advancements in curing many viral diseases. In contrast we note
the
statement on page 6 of your Form 10 that you do not claim to be creating
a cure
of influenza, HIV or any other viral disease. Please explain the
inconsistencies.
These
statements have been deleted from both the Registration Statement and the
Issuer’s website.
Comment
No 2:
Additionally,
given the current stages of your potential product candidates, it is
inappropriate for you to suggest that any persons may be cured by using your
products. For example:
•“Our
long term research efforts are aimed at augmenting the nanoviricides currently
in development with additional agents that together may lead to either total
long term control of or, in many cases, even cure of many diseases.” (page 6)
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
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27
•The
Company does not expect HiviCide-I and HiviCide-II to cure HIV/AIDS in most
patients.” (page 12)
•“It
is possible that since the cells that carry the virus genome with their genetic
material usually die in a normal cycle, known as apoptosis; an eventual cure
in
some patients may be possible with our HiviCide drugs.” (page
12)
Please
delete these statements.
The
Registration Statement has been revised to delete these statements
accordingly.
Comment
No 3:
We
make reference to your NanoBiotech News (Volume 4, No. 10) which was issued
on
March 8, 2006. In that newsletter, there is a statement indicating that your
Chief Regulatory Officer, Krishna Menon proposes that preliminary data conducted
in December 2005 related to the H2Nl (common influenza) strain “is sufficient to
file an investigational new drug application with the U.S. Food and Drug
Administration.” Your President, Anil Diwan is then quoted as saying that “I
don’t have the actual data yet. . . but we’re seeing magnitudes of efficacy
improvements over the ligand.” Please provide us with more details on the
results of these studies, including whether the results of these studies
were
completely analyzed and whether you intend to submit an IND in the near future
with the FDA or if you win need to conduct additional tests prior to submitting
an IND. Please note that we also note the disclosure you have in your
registration statement under the section entitled “Background: Preclinical
Safety and Efficacy Studies’; on page 7 and it does not appear you provide any
disclosure regarding the filing of an IND in the near future. Please explain
accordingly. We may have additional questions after reviewing your
response.
Please
note that the Issuer neither wrote nor had the opportunity to edit the
NanoBiotech News. However, all references to the article have been removed
from
the Issuer’s updated website. The section of the Registration Statement
“Background: Preclinical Safety and Efficacy Studies” was revised to include the
Issuer’s intentions with reference to filing an IND as follows:
The
discussions in this section and throughout this Form 10-SB registration
statement describe the tests that have been conducted which have yielded
these
results. These results do not provide enough evidence regarding efficacy
or
safety to support an application with the FDA. Additional tests will need
to be
conducted. It must be noted that subsequent results often do not corroborate
earlier results.
Comment
No 4:
Also
in the newsletter under the caption “Potential pharma partners line up,” there
is language indicating that “[i]n conjunction with an expected IND filing, you
are also positioned to begin licensing FluCide to major pharmaceutical partners
and further that potential licensees have begun making inquiries. Please
tell us
if you have or intend to being marketing your FluCide drug candidate in the
near
future as we understand based on the disclosure in your Form 10-SB that this
drug candidate is still in the early development phase. We may have additional
questions after reviewing your response.
The
Issuer has deleted all references to the article in its new website.
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
3 of
27
Comment
No 5:
General
Where
comments on one section also relate to disclosure in another section, please
make parallel changes to all affected disclosures. This will eliminate the
need
for us to repeat similar comments.
The
Registration Statement has been revised accordingly.
Comment
No 6:
Pursuant
to section 12(g)(l) of the Exchange Act, your registration statement will
become
effective by operation of law on January 16, 2007 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. If the review process has not been completed
before that date you should consider withdrawing the registration statement
prior to January 16, 2007 to prevent it from becoming effective and refiling
it
at such time as you are able to respond to any remaining issues or
comments.
The
Issuer believes its first amendment to the Registration Statement has
sufficiently responded to the Commission’s comments.
Comment
No 7:
Please
revise your filing to include updated financial statements and related
disclosures through September 30, 2006 as required by Item 310(g) of Regulation
S-B.
The
Registration Statement has been revised to provide the updated financial
statement material.
Comment
No 8:
As
a
general matter, it is inappropriate to speak about the merits of the company
without qualifying your statements in a manner that make clear to the reader
that the company is in the developmental stage and has commenced minimal
operations. Unless you have demonstrable proof of statement concerning what
the
company or its product candidates can do or are capable of, you should not
make
such statements. You may state your objectives and/or goals but you cannot
state
your beliefs or expectations unless you have a supportable basis for such
beliefs or expectations. For example, we note the following, which we note
is
not meant to be exhaustive, but rather is provided for illustrative
purposes.
•“The
Company believes that our drugs may become the major weapons in the fight
against certain viral diseases, possibly even after the other therapies have
failed.” (page 6)
•“The
Company also plans to seek regulatory approvals in several international
markets. . . and anticipates partnering with medium and large pharmaceutical
companies at various opportunities in order to advance the various drugs
into
commercialization. (page 6)
•“It
appears very likely that using the nanoviricides technology, the efficacy
of
such a drug may be enhanced by orders of magnitude.” (page 8)
•“We
anticipate that much of our work in the tropical and neglected diseases as
well
as in the areas of interest to bio-defense and emergency preparedness aspects
will be conducted in collaborations with renowned institutions” (page
9)
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
4 of
27
•We
believe that it is possible, in war-like scenario, to develop a response
to the
biological weapons attack in a manner of days or weeks. Similarly we believe
that when a new virus outbreak occurs. . . this building block technology
may
enable us to develop a new drug to fight the new threat in a minimal amount
of
time.” (page 10)
“The
Company believes that it can help contain epidemics before they can occur
in
what the company terms the ‘War-like’ scenario of response to a bio-threat,
whether due to bio-terrorism or natural events.” (page 10)
“The
Company believes that it will be able to rapidly create new drugs against
escape
mutants, should they arise, due to our building block approach.” (page
12)
•“We
believe that we have developed technologies that may significantly alter
the
field of medicine in many ways.” (page 15)
•“Our
first two HIV drugs. . . together are expected to be capable of attacking
and
neutralizing most of the existing HN strains, clades (or subtypes), and types.
The Company believes that our HiviCide drugs will enable a long-term nearly
virus-free lifestyle for most HIV/AIDS patients, beyond what is feasible
today
with HAART therapy.” (page 17).
•“[T]o
the best of our knowledge it is possible that we have the world’s most
efficacious drug to treat these viruses [human influenza and bird flu]” (page
43)
Given
the preliminary nature of the development of your product candidates, these
statements are inappropriate and should be deleted from your
document.
These
statements have been deleted from the Registration Statement.
Comment
No 9:
Please
provide us with third party documentation supporting the following statements
you make in this section:
“We
believe NanoViricides is the first company to bring this proven feature to
the
anti -viral therapy platform:’ (page 5)
Nanomedicines
against anticancer are an established goal of the NCI/NIH nanotechnology
initiative.
“Non-H5N1
HP AI strains are expected to become the next pandemic threats on the
horizon.”
(page 5)
NIH
has
funded Sanofi to develop a vaccine against H7N1. This is a non H5N1 highly
pathogenic influenza A strain.
http://www.sanofipasteur.com/sanofi-pasteur/ImageServlet?siteCode=AVPI_US&imageCode=17693&codeSite=AVPI_US.
“There
is now acceptance in the industry, the scientific community and the public
health community that injectable drugs should be developed and deployed when
they provide high efficacies,” (page 8)
“BioCryst
life threatening influenza injection fast tracked”
18th
January 2006
By
Staff
Writer
The
FDA
has granted fast track designation to BioCryst Pharmaceuticals peramivir
injection for the treatment of influenza infections, including highly virulent,
life-threatening strains of influenza such as avian flu.
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
5 of
27
Peramivir
is an influenza neuraminidase inhibitor that, in preclinical studies, has
shown
potent, broad spectrum activity against multiple strains of flu, including
the
H5N1 virus.
On
December 22, 2005, BioCryst announced that the FDA had given the company
approval to begin human clinical trials using injectable peramivir.
In
correspondence with BioCryst, the FDA said that it agrees that the use of
peramivir in the proposed indication meets the criterion of treating a serious
life-threatening condition. Based on this conclusion, the FDA designated
peramivir injection for influenza infection as a fast track product, meaning
that the drug will be the subject of a faster regulatory process.
"The
FDA's decision supports our belief in the potential of peramivir as an effective
therapy for the treatment of influenza, including highly virulent,
life-threatening strains like those associated with avian influenza," said
Dr
Charles Bugg, chairman and CEO of BioCryst.
“While
the HIV-l type is prevalent in North America, Europe, and a majority of the
World, a distinct HIV type called HIV-2 with a marked prevalence in West
Africa,
has recently been spreading worldwide.” (page 12)
Please
see the chapter on Human Retroviruses. Longo, DL and Fauci, AS “The Human
Retroviruses” in Harrison’s Principles of Internal Medicine, 16th
ed.
McGraw Hill. pp. 1071- 1076. Also, AS Fauci and H Clifford-Lane, “”HIV Disease:
AIDS and Related Disorders”, pp. 1076-1139, ibid.
“According
to the US Centers for Disease Control and Prevention (‘CDC’), an estimated 5% to
20% of the American population suffers from influenza annually, more than
200,000 people are hospitalized from flu complications, and approximately
36,000
people die from the flu in the US. The worldwide death
2006-12-12 - UPLOAD - NANOVIRICIDES, INC.
Mail Stop 6010
December 11, 2006
Eugene Seymour, M.D.
Chief Executive Officer
NanoViricides, Inc.
135 Wood Street, Suite 205
West Haven, CT 06516
Re: NanoViricides, Inc.
Form 10-SB12G Filed on November 14, 2006
File No. 0-52318
Dear Dr. Seymour:
We have reviewed your filing and have the following comments. Where indicated, we
think you should revise your documents in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.
Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Your Website at www.nanoviricides.com
1. We make reference to the homepage of your webpage where you state that you believe that “[i]t is possible that some HIV patients may be ‘cured’ by drugs developed at NanoViricides Inc.” You also state that you hope to “spearhead” the efforts to making advancements in curing many viral diseases. In contrast we note the statement on page 6
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 2
of your Form 10 that you do not claim to be creating a cure of influenza, HIV or any other viral disease. Please explain the inconsistencies.
2. Additionally, given the current stages of your potential product candidates, it is inappropriate for you to suggest that any persons may be cured by using your products. For example:
• “Our long term research efforts are aimed at augmenting the nanoviricides currently in development with additional agents that together may lead to either total long term control of or, in may cases, even cure of many diseases.” (page 6)
• “The Company does not expect HiviCide-I and HiviCide-II to cure HIV/AIDS in
most patients.” (page 12)
• “It is possible that since the cells that carry the virus genome with their genetic material usually die in a normal cycle, known as apoptosis; an eventual cure in some patients may be possible with our HiviCide drugs.” (page 12)
Please delete these statements.
3. We make reference to your NanoBiotech News (Volume 4, No. 10) which was issued on March 8, 2006. In that newsletter, there is a statement indicating that your Chief Regulatory Officer, Krishna Menon proposes that preliminary data conducted in December 2005 related to the H2N1 (common influenza) strain “is sufficient to file an investigational new drug application with the U.S. Food and Drug Administration.” Your President, Anil Diwan is then quoted as saying that “I don’t have the actual data yet. . . but we’re seeing magnitudes of efficacy improvements over the ligand.” Please provide us with more details on the results of these studies, including whether the results of these studies were completely analyzed and whether you intend to submit an IND in the near future with the FDA or if you will need to conduct additional tests prior to submitting an IND. Please note that we also note the disclosure you have in your registration statement under the section entitled “Background: Preclinical Safety and Efficacy Studies” on page 7 and it does not a ppear you provide any disclosure regarding
the filing of an IND in the near future. Please explain accordingly. We may have additional questions after reviewing your response.
4. Also in the newsletter under the caption “Potential pharma partners line up,” there is language indicating that “[i]n conjunction with an expected IND filing, you are also positioned to begin licensing FluCide to major pharmaceutical partners and further that potential licensees have begun making inquiries. Please tell us if you have or intend to being marketing your FluCide drug candidate in the near future as we understand based on the disclosure in your Form 10-SB that this drug candidate is still in the early development phase. We may have additional questions after reviewing your response.
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 3
Form 10-SB12G
General
5. Where comments on one section also relate to disclosure in another section, please make parallel changes to all affected disclosures. This will eliminate the need for us to repeat similar comments.
6. Pursuant to section 12(g)(1) of the Exchange Act, your registration statement will become effective by operation of law on January 16, 2007 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. If the review process has not been completed before that date you should consider withdrawing the registration statement prior to January 16, 2007 to prevent it from becoming effective and refiling it at such time as you are able to respond to any remaining issues or comments.
7. Please revise your filing to include updated financial statements and related disclosures through September 30, 2006 as required by Item 310(g) of Regulation S-B.
8. As a general matter, it is inappropriate to speak about the merits of the company without qualifying your statements in a manner that make clear to the reader that the company is in the developmental stage and has commenced minimal operations. Unless you have demonstrable proof of statement concerning what the company or its product candidates can do or are capable of, you should not make such statements. You may state your objectives and/or goals but you cannot state your beliefs or expectations unless you have a supportable basis for such beliefs or expectations. For example, we note the following, which we note is not meant to be exhaustive, but rather is provided for illustrative purposes.
• “The Company believes that our drugs may become the major weapons in the fight against certain viral diseases, possibly even after the other therapies have failed.” (page 6)
• “The Company also plans to seek regulatory approvals in several international markets . . . and anticipates partnering with medium and large pharmaceutical companies at various opportunities in order to advance the various drugs into commercialization. (page 6)
• “It appears very likely that using the nanoviricides technology, the efficacy of such a drug may be enhanced by orders of magnitude.” (page 8)
• “We anticipate that much of our work in the tropical and neglected diseases as well as in the areas of interest to bio-defense and emergency preparedness aspects will be conducted in collaborations with renowned institutions.” (page 9)
• “We believe that it is possible, in war-like scenario, to develop a response to the biological weapons attack in a manner of days or weeks. Similarly, we believe that when
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 4
a new virus outbreak occurs . . . this building block technology may enable us to develop a new drug to fight the new threat in a minimal amount of time.” (page 10)
• “The Company believes that it can help contain epidemics before they can occur in what the company terms the ‘War-like’ scenario of response to a bio-threat, whether due to bio-terrorism or natural events.” (page 10)
• “The Company believes that it will be able to rapidly create new drugs against escape mutants, should they arise, due to our building block approach.” (page 12)
• “We believe that we have developed technologi es that may significantly alter the field of
medicine in many ways.” (page 15)
• “Our first two HIV drugs . . . together are expected to be capable of attacking and
neutralizing most of the existing HIV strains, clades (or subtypes), and types. The Company believes that our HiviCide drugs will enable a long-term nearly virus-free lifestyle for most HIV/AIDS patients, beyond what is feasible today with HAART therapy.” (page 17).
• “[T]o the best of our knowledge it is possible that we have the world’s most efficacious
drug to treat these viruses [human influenza and bird flu].” (page 43)
Given the preliminary nature of the development of your product candidates, these statements are inappropriate and should be deleted from your document.
9. Please provide us with third party documentation supporting the following statements you make in this section:
• “We believe NanoViricides is the first company to bring this proven feature to the anti-viral therapy platform.” (page 5)
• “Non-H5N1 HPAI strains are expected to become the next pandemic threats on the horizon.” (page 5)
• “There is now acceptance in the industry, the scientific community and the public health community that injectable drugs should be developed and deployed when they provide high efficacies.” (page 8)
• “While the HIV-1 type is prevalent in North America, Europe, and a majority of the world, a distinct HIV type called HIV-2 with a marked prevalence in West Africa, has recently been spreading worldwide.” (page 12)
• “According to the US Centers for Disease Control and Prevention (‘CDC’), an estimated 5% to 20% of the American population suffers from influenza annually, more than 200,000 people are hospitalized from flu complications, and approximately 36,000 people die from the flu in the US. The worldwide death toll is estimated at upwards of 200,000 per year. (page 12)
• “Of the avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 has caused the largest number of detected cases of severe disease and death in humans” (page 13)
• “Congress has recently approved an appropriation of $3.8 billion for 2006 to support the development of various countermeasures for a flu pandemic.” (page 14)
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 5
• “We have identified several diseases as large commercially important drug development targets. These include HIV (estimated yearly sales worldwide, $20-$40 Billion), Hepatitis C (currently over $4 Billion, but expected to become over $40 Billion with the advent of effective drugs). . . .” (page 15)
10. We note your disclosure in the document where you provide the results of some of your preliminary studies. We also note you have provided some disclaimer language indicating that the results of the studies are preliminary and that you will need further testing. Please revise your discussions here and throughout your document as appropriate to describe the tests that you have conducted which have yielded these results and to also include appropriate caveats indicating that the results do not provide enough evidence regarding efficacy or safety to support an application with the FDA, that additional tests will be conducted and that subsequent results often do not corroborate earlier results.
11. In instances where you have stated that the preclinical testing has shown efficacy, please revise to describe the results which have led you to conclude the product candidate is effective. These results should be quantified to the extent possible.
12. With respect to your discussion of preliminary studies you have conducted or were conducted on your behalf by others, please also indicate whether the results of your studies have been subject to any type of statistical analysis and, if so, whether the results were statistically significant. In addition, th e degree of statistical significance or the P
value should be disclosed and explained.
Special Note on Forward-Looking Statements, page 3
13. Your references to the Securities Act and the Exchange Act should be deleted. You are not a reporting company and your forward-looking statements do not appear to be protected by the safe harbors contained in those statutes.
Corporate History, page 3
14. Please expand the last paragraph of this section to discuss the following:
• You have no revenue, customer or products, nor will you likely have any in the near future and may never have any;
• You are an early development stage company that has barely commenced operation.
• Quantify your accumulated deficit, and net and operating losses.
• Your auditors have issued a going concern qualification as part of their opinion.
Preliminary Safety Studies In Vivo, page 7
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 6
15. Please expand your disclosure of the in vivo studies to describe what type of studies these constitute and where completion of these studies will place you in the regulatory approval process, i.e., the FDA process.
16. Please explain the meaning of the term “”pendant polymeric micelles.”
Implications of the Study Results, page 8
17. Please explain what a “proof-of principle” is.
18. Please delete the statement that you can quickly develop a drug against a virus once a suitable virus-binding compound is found.
Subcontract to KARD Scientific, Inc., page 8
19. We note your statement that you do not have any direct collaborative relationships with Beth Israel or Harvard University, except through KARD Scientific. Please explain any indirect relationships with Beth Israel and Harvard. If the only relationship is that you
have a collaborative relationship with KARD and they have unrelated arrangements with Beth Israel and Harvard University, then you should delete the references to these parties.
20. Provide a further description of your agreement with KARD Scientific, including what it means to be your primary vendor for animal model study design and performance and payment provisions.
Collaboration with the Health Ministry of the Government of Vietnam, page 9
21. Please describe the material terms of your ag reement with the Health Ministry of the
Government of Vietnam, including each pa rty’s obligations, funding arrangements,
payment terms, ownership of any discoveries, the existence of royalties, duration and termination provisions and any other terms deemed material. The discussion of payment terms should include any amounts paid or received to date and the aggregate amount of any potential milestone payments.
22. Please file your agreements with the Health Ministry or explain the basis for your belief that they are not required to be filed.
Eugene Seymour
NanoViricides, Inc. December 11, 2006 Page 7
Other Collaborations, page 9
23. You indicate that you have made significant effo rts in the past year to obtain valuable
collaborations agencies, institutions and commercial enterprises. You further state that as efforts materialize into formal arrangements, you will able to announce them. Please specify what these significant efforts were in the past year. Please also indicate the status
of your arrangements with the collaboration agencies, institutions and commercial enterprises with which it appears you may enter formal arrangements.
24. Also, revise to specifically note that the efforts might not materialize into formal agreements.
25. You indicate that you anticipate that much of your work in the tropical and neglected disease areas and in the areas of bio-defense and emergency preparedness aspects will be conducted in collaborations with renowned institutions. Please explain what you mean by “tropical and neglected disease.” Please also explain the basis for your statement that you plan to conduct much of your work in the areas identified with “renowned institutions.” Do you currently have work in progress with such institutions? If you have work in progress with these institutions, please identify them and describe your arrangements. If you do not have work in progress or arrangements, then delete the reference to “renowned institutions.”
26. We note that you a
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