SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Comment Letter for NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC) — Feb 2, 2007

NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: Feb. 2, 2007 · CIK: 0001379006 · Accession: 0000000000-07-005732

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
February 2, 2007
Author
Not clearly detected
Form
UPLOAD
Company
NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)

Letter

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.

“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.

“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

Show Raw Text
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