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Nuvectis Pharma, Inc.
Response Received
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Nuvectis Pharma, Inc.
Response Received
1 company response(s)
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Nuvectis Pharma, Inc.
Response Received
1 company response(s)
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Nuvectis Pharma, Inc.
Response Received
7 company response(s)
High - file number match
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Company responded
2021-10-20
Nuvectis Pharma, Inc.
References: October 19, 2021
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Company responded
2021-11-26
Nuvectis Pharma, Inc.
Summary
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Company responded
2021-11-30
Nuvectis Pharma, Inc.
Summary
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Company responded
2021-11-30
Nuvectis Pharma, Inc.
Summary
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Company responded
2022-02-02
Nuvectis Pharma, Inc.
Summary
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Company responded
2022-02-02
Nuvectis Pharma, Inc.
Summary
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Nuvectis Pharma, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-10-01
Nuvectis Pharma, Inc.
Summary
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Company responded
2021-10-06
Nuvectis Pharma, Inc.
References: October 1, 2021
Summary
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Nuvectis Pharma, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-08-26
Nuvectis Pharma, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-18 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2026-02-18 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | 333-293459 | Read Filing View |
| 2023-03-27 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2023-03-21 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-08-19 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-02-02 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-02-02 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-26 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-26 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-19 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-01 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-08-26 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-18 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | 333-293459 | Read Filing View |
| 2023-03-21 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-08-19 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-19 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-01 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-08-26 | SEC Comment Letter | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-18 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2023-03-27 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-08-23 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-02-02 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2022-02-02 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-26 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-11-26 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-20 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Nuvectis Pharma, Inc. | DE | N/A | Read Filing View |
2026-02-18 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
February 18, 2026
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-3
File No. 333-293459
Ladies and Gentlemen:
Nuvectis Pharma, Inc. (the
“Company”) hereby requests, pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as
amended, that the effective date of the above-referenced Registration Statement be accelerated so as to permit it to become effective
at 4:30 p.m. EST on February 20, 2026, or as soon thereafter as practicable.
Please contact Matt Mamak
of Alston & Bird LLP, the Company’s counsel, at (212) 210-1256, as soon as the Registration Statement has been declared effective,
or if you have any other questions or concerns regarding this matter.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name:
Ron Bentsur
Title:
Chairman, Chief Executive Officer and President
2026-02-18 - UPLOAD - Nuvectis Pharma, Inc. File: 333-293459
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
February 18, 2026
Ron Bentsur
Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza
Suite 275
Fort Lee, NJ 07024
Re: Nuvectis Pharma, Inc.
Registration Statement on Form S-3
Filed February 13, 2026
File No. 333-293459
Dear Ron Bentsur:
This is to advise you that we have not reviewed and will not review your
registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Matthew Mamak, Esq.
</TEXT>
</DOCUMENT>
2023-03-27 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
March 27, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-3
File No. 333-270657
Ladies and Gentlemen:
Nuvectis Pharma, Inc. (the
“Company”) hereby requests, pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as
amended, that the effective date of the above-referenced Registration Statement be accelerated so as to permit it to become effective
at 9:00 a.m. EST on March 29, 2023, or as soon thereafter as practicable.
Please contact Matt Mamak
of Alston & Bird LLP, the Company’s counsel, at (212) 210-1256, as soon as the Registration Statement has been declared effective,
or if you have any other questions or concerns regarding this matter.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name: Ron Bentsur
Title: Chairman, Chief Executive Officer and President
2023-03-21 - UPLOAD - Nuvectis Pharma, Inc.
United States securities and exchange commission logo
March 21, 2023
Ron Bentsur, M.B.A.
Chairman, President and Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza
Suite 275
Fort Lee, NJ 07024
Re:Nuvectis Pharma, Inc.
Registration Statement on Form S-3
Filed March 17, 2023
File No. 333-270657
Dear Ron Bentsur:
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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew W. Mamak, Esq.
2022-08-23 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
August 23, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1
File No. 333-266857
Ladies and Gentlemen:
Nuvectis Pharma, Inc. (the “Company”)
hereby requests, pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, that the effective
date of the above-referenced Registration Statement be accelerated so as to permit it to become effective at 5:00 p.m. EST on August 24,
2022, or as soon thereafter as practicable.
Please contact Matt Mamak of Alston & Bird
LLP, the Company’s counsel, at (212) 210-1256, as soon as the Registration Statement has been declared effective, or if you have
any other questions or concerns regarding this matter.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name: Ron Bentsur
Title: Chairman, President, and Chief Executive Officer
2022-08-19 - UPLOAD - Nuvectis Pharma, Inc.
United States securities and exchange commission logo
August 19, 2022
Ron Bentsur
Chairman and Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza, Suite 275
Fort Lee, NJ, 07024
Re:Nuvectis Pharma, Inc.
Registration Statement on Form S-1
Filed August 15, 2022
File No. 333-266857
Dear Mr. Bentsur:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jordan Nimitz at 202-551-5831 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-02-02 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
February 2, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Nuvectis Pharma, Inc.
Registration Statement on Form S-1
File No. 333-260099
Ladies and Gentlemen:
In accordance with the above-referenced
Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and Exchange Commission
under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative of the several
underwriters (the “Representative”), hereby joins in the request of Nuvectis Pharma, Inc. that the effective date of
the above-referenced Registration Statement be accelerated so that it will be declared effective at 9:00 a.m., Eastern Time, on Friday,
February 4, 2022, or as soon thereafter as practicable.
Pursuant to Rule 460
under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated
to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears
to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned, as the representative
of the several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.
Very truly yours,
H.C. Wainwright & Co., LLC
As representative of the
several Underwriters
H.C. WAINWRIGHT & CO., LLC
By:
/s/ Edward D. Silvera
Name:
Edward D. Silvera
Title:
Chief Operating Officer
430 Park Avenue | New York, NY 10022 | 212.356.0500 | www.hcwco.com
Member: FINRA/SIPC
2022-02-02 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
February 2, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1, as amended
File No. 333-260099
Ladies and Gentlemen:
Nuvectis Pharma, Inc. (the “Company”)
hereby requests, pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, that the effective
date of the above-referenced Registration Statement be accelerated so as to permit it to become effective at 9:00 a.m. EST on February
4, 2022, or as soon thereafter as practicable.
Please contact Matt Mamak of Alston & Bird
LLP, the Company’s counsel, at (212) 210-1256, as soon as the Registration Statement has been declared effective, or if you have
any other questions or concerns regarding this matter.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name: Ron Bentsur
Title: Chairman, President, and Chief Executive Officer
2021-11-30 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
November 30, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1, as amended (File No. 333-260099)
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on November 26, 2021, in which we requested acceleration of the effective date of the above-referenced Registration Statement
for Tuesday, November 30, 2021, at 5:00 p.m. Eastern Time. We are no longer requesting that such Registration Statement be declared effective
at this time and we hereby formally withdraw our request for acceleration of the effective date.
Please feel free to contact Matt Mamak of Alston
& Bird LLP, legal counsel to the Company, at (212) 210-1256 or via email at matthew.mamak@alston.com if you have any questions.
Nuvectis Pharma, Inc.
By:
/s/ Ron Bentsur
Name: Ron Bentsur
Title: Chairman, President, and Chief Executive Officer
2021-11-30 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
November 30, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1
File No. 333-260099
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on November 26, 2021, in which we, as representative of the several underwriters of Nuvectis Pharma, Inc.’s proposed initial
public offering of common stock, joined Nuvectis Pharma, Inc.’s request for acceleration of the effective date of the above-referenced
Registration Statement for Tuesday, November 30, 2021, at 5:00 p.m. Eastern Time. Nuvectis Pharma, Inc. is no longer requesting that such
Registration Statement be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective
date.
Very truly yours,
ThinkEquity LLC
As representative of the
several Underwriters
THINKEQUITY LLC
By:
/s/ Kevin Mangan
Name: Kevin Mangan
Title: Managing Director, Head of Equity
2021-11-26 - CORRESP - Nuvectis Pharma, Inc.
CORRESP 1 filename1.htm ThinkEquity LLC 17 State Street, 22nd Floor New York, New York 10004 November 26, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Nuvectis Pharma, Inc. Registration Statement on Form S-1 File No. 333-260099 Ladies and Gentlemen: In accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative of the several underwriters (the “Representative”), hereby joins in the request of Nuvectis Pharma, Inc. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 5:00 p.m., Eastern Time, on Tuesday, November 30, 2021, or as soon thereafter as practicable. Pursuant to Rule 460 under the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the security, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned, as the representative of the several underwriters, represents that the several underwriters have and will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, ThinkEquity LLC As representative of the several Underwriters THINKEQUITY LLC By: /s/ Kevin Mangan Name: Kevin Mangan Title: Managing Director, Head of Equity
2021-11-26 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
November 26, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1, as amended
File No. 333-260099
Ladies and Gentlemen:
Nuvectis Pharma, Inc. (the “Company”)
hereby requests, pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, that the effective
date of the above-referenced Registration Statement be accelerated so as to permit it to become effective at 5:00 p.m. EST on November
30, 2021, or as soon thereafter as practicable.
Please contact Matt Mamak of Alston & Bird
LLP, the Company’s counsel, at (212) 210-1256, as soon as the Registration Statement has been declared effective, or if you have
any other questions or concerns regarding this matter.
Nuvectis
Pharma, Inc.
By:
/s/ Ron Bentsur
Name:
Ron Bentsur
Title:
Chairman, President, and Chief Executive Officer
2021-10-20 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
90 Park Avenue
New York, NY 10016
212-210-9400 | Fax: 212-210-9444
Matthew W. Mamak
Direct Dial: 212-210-1256
Email: matthew.mamak@alston.com
October 20, 2021
VIA: ELECTRONIC MAIL
Margaret Schwartz
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Registration Statement on Form S-1
Filed October 6, 2021
CIK No. 0001875558
Dear Ms. Schwartz:
On behalf of Nuvectis Pharma,
Inc., a Delaware corporation (the “Company”), we hereby respond to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received in a letter dated October 19, 2021, relating
to the Company’s Registration Statement on Form S-1 submitted on October 19, 2021.
Comment 1:
We note that you have added graphics after the
cover page. We note that the information is repeated in the Prospectus Summary and Business sections but is shown without the context
of those sections. Please remove this page as its prominence is not appropriate. For guidance, refer to Securities Act Form Compliance
and Disclosure Interpretation 101.02.
Response:
In response to the Staff’s comment, the
Company has removed the page containing graphics that followed the cover page.
Comment 2:
We note your response to our prior comment number
3. Please revise to state whether the comparison in table 5 on page 74 is a head-to-head comparison. To the extent it is not a head-to-head
comparison, please remove the table. To the extent is a head-to-head comparison, please revise to state such and remove the term “selectivity”
from the header of the table.
Response:
In response to the Staff’s comment, the
Company has removed Table 5 and all in-text references to Table 5.
October 20, 2021
Page
2
Comment 3:
We note your response to our prior comment number
2. On page 61 you state “[t]hese compounds were further optimized to demonstrate in vivo efficacy in mouse zenografts.” Please
remove this reference to efficacy.
Response:
In response to the Staff’s comment, the
Company has revised the statement on page 61 to remove the reference to efficacy.
Comment 4:
We note you present historical net tangible book
value of $6.8 million as of June 30, 2021, which seems to improperly include the convertible preferred stock A that is classified outside
of permanent equity. Please revise or advise. Please also revise to start with your historical net tangible book value to provide a full
dilution to your investors.
Response:
In response to the Staff’s comment, the
Company has revised the historical net tangible book value to not include the convertible preferred stock A. The Company has also revised
the table illustrating dilution on page 50 to start with the historical net tangible book value (deficit) as of June 30, 2021 and the
increase in pro forma net tangible book value.
Comment 5:
We note your Form of Amended and Restated Certificate
of Incorporation filed as Exhibit 3.1 says that the federal district courts of the United States of America shall be the exclusive forum
for the resolution of any complain asserting a cause of action arising under the Securities Act of 1933, as amended, and/or the Securities
Exchange Act of 1934, as amended. However, your disclosure on page 118 of the prospectus states that “this forum provision will
not apply to any causes of action arising under the Exchange Act or the Securities Act” and does not mention a requirement for a
federal forum for Securities Act and Exchange Act claims. Please reconcile.
Response:
In response to the Staff’s comment, the
Company has revised the disclosure on page 118 of the prospectus to include the federal forum requirement for causes of action arising
under the Securities Act or the Exchange Act.
October 20, 2021
Page
3
Comment 6:
We note the Executive Employment Agreement with
Uri Ben-Or was removed from the Exhibit Index. Please file this agreement or advise.
Response:
In response to the Staff’s comment, the
Company has added Uri Ben-Or’s employment agreement back onto the Exhibit Index and filed this agreement as an exhibit.
Sincerely,
ALSTON & BIRD LLP
/s/ Matthew W. Mamak
Matthew W. Mamak, Esq.
cc: Ron Bentsur, Chief Executive Officer
2021-10-19 - UPLOAD - Nuvectis Pharma, Inc.
United States securities and exchange commission logo
October 19, 2021
Ron Bentsur, M.B.A.
Chairman and Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza
Suite 275
Fort Lee, NJ 07024
Re:Nuvectis Pharma, Inc.
Registration Statement on Form S-1
Filed October 6, 2021
File No. 333-260099
Dear Mr. Bentsur:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1, Filed October 6, 2021
Cover Page
1.We note that you have added graphics after the cover page. We note that the information
is repeated in the Prospectus Summary and Business sections but is shown without the
context of those sections. Please remove this page as its prominence is not appropriate.
For guidance, refer to Securities Act Forms Compliance and Disclosure
Interpretation 101.02.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
October 19, 2021 Page 2
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
October 19, 2021
Page 2
Prospectus Summary, page 1
2.We note your response to our prior comment number 3. Please revise to state whether the
comparison in table 5 on page 74 is a head-to-head comparison. To the extent it is not a
head-to-head comparison, please remove the table. To the extent is a head-to-head
comparison, please revise to state such and remove the term "selectivity" from the header
of the table.
3.We note your response to our prior comment number 2. On page 61 you state “[t]hese
compounds were further optimized to demonstrate in vivo efficacy in mouse xenografts.”
Please remove this reference to efficacy.
Dilution, page 50
4.We note you present historical net tangible book value of $6.8 million as of June 30, 2021,
which seems to improperly include the convertible preferred stock A that is classified
outside of permanent equity. Please revise or advise. Please also revise to start with your
historical net tangible book value to provide a full dilution to your investors.
Exhibits
5.We note your Form of Amended and Restated Certificate of Incorporation filed as Exhibit
3.1 says that the federal district courts of the United States of America shall be the
exclusive forum for the resolution of any complaint asserting a cause of action arising
under the Securities Act of 1933, as amended, and/or the Securities Exchange Act of
1934, as amended. However, your disclosure on page 118 of the prospectus states that
“this forum provision will not apply to any causes of action arising under the Exchange
Act or the Securities Act” and does not mention a requirement for a federal forum for
Securities Act and Exchange Act claims. Please reconcile.
6.We note the Executive Employment Agreement with Uri Ben-Or was removed from the
Exhibit Index. Please file this agreement 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 requested effective date of the registration
statement.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
October 19, 2021 Page 3
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
October 19, 2021
Page 3
You may contact Li Xiao at 202-551-4391 or Brian Cascio at 202-551-3676 if you have
questions regarding comments on the financial statements and related matters. Please contact
Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew W. Mamak, Esq.
2021-10-06 - CORRESP - Nuvectis Pharma, Inc.
CORRESP
1
filename1.htm
90 Park
Avenue
New York,
NY 10016
212-210-9400
| Fax: 212-210-9444
Matthew
W. Mamak
Direct
Dial: 212-210-1256
Email:
matthew.mamak@alston.com
October
6, 2021
VIA: ELECTRONIC MAIL
Margaret Schwartz
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Nuvectis Pharma, Inc.
Amendment No. 1 to Draft
Registration Statement on Form S-1
Submitted September 20,
2021
CIK No. 0001875558
Dear Ms. Schwartz:
On
behalf of Nuvectis Pharma, Inc., a Delaware corporation (the “Company”), we hereby respond to comments
from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
received in a letter dated October 1, 2021, relating to the Company’s Draft Registration Statement on Form S-1 submitted
on July 30, 2021.
Comment
1:
We note
the pipeline table added to page 2. Please revise to include a column for Phase 3 clinical trials.
Response:
In response
to the Staff’s comment, the Company has added a Phase 3 clinical trial column to Figure 1 and Figure 6 on pages 2 and 58,
respectively.
Comment
2:
We note
your statement on page 6 and elsewhere that NXP900 has demonstrated high potency and selectivity, and on page 72 you state
that treatment with NXP900 results in increased antitumor efficacy and tolerability in vivo in syngeneic murine cancer models and xenografts.
Please remove all statements that present your conclusions regarding the efficacy of your product candidate as this is a determination
within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies.
October 6, 2021
Page 2
Response:
In response
to the Staff’s comment, the Company has revised its statements throughout the document relating to NXP900’s potency, selectivity,
tolerability and antitumor efficacy.
Comment
3:
On page 7
you state that treatment with NXP900 resulted in increased anti-tumor efficacy and tolerability in both syngeneic murine cancer models
and xenografts, demonstrating significant therapeutic advantages over dasatinib, including improved tumor growth inhibition, survival
and duration of response. We also note on page 73 that at least one mouse model reflected a head-to-head study of dasatinib. Please
revise to state whether each of the comparisons to dasatinib reflects the results of a head-to-head comparison. If not, please remove
such comparison as comparisons to available products and other product candidates are not appropriate unless you have conducted head-to-head
trials.
Response:
In response
to the Staff’s comment, the Company has removed comparative statements relating to the activity of NXP900 versus dasatinib.
Comment
4:
We note
your response to our prior comment 10 and reissue in part. Please revise to also include the conversion of the preferred A shares
as part of the pro forma balance, rather than as part of the pro forma as adjusted balance as you currently present, to properly reflect
the offering effect in the capitalization table here, and also to properly reflect the dilution to new investors participating in this
offering in the dilution table at page 50.
Response:
In
response to the Staff’s comment, the Company has revised its disclosures on pages 15 and 48-50 to include the conversion of
the preferred A shares as part of the pro forma balance.
Comment
5:
We note
your response to prior comment 18. Please revise to clarify the scope, size, and design of each preclinical study referenced in this
section; whether the studies were powered to show statistical significance; and revise your characterizations of the preclinical trials
to discuss the data, rather than drawing conclusions from the results.
Response:
The Company
has interpreted this comment as a request for a description in the pharmacology studies section of the experiments conducted to evaluate
NXP800’s antitumor effect. In response to the Staff’s comment, the Company has revised this section to include the scope,
size and design of the preclinical studies. Studies performed in vitro systems, or the safety pharmacology, pharmacokinetics and toxicology
studies, are not applicable, as they are not designed for prospective statistical analysis and any effects of the test article is provided
descriptively.
October 6, 2021
Page 3
Comment
6:
We note
your response to our prior comment number 21, where you state you do not plan to enter indemnification agreements with your directors
and officers. Given this response and that references to an indemnification agreement remain on pages F-15 and F-16, please clarify
whether any such agreements are already in place.
Response:
The Company
has removed any references to an indemnification agreement with the Company’s directors and officers, as there are no such agreements
in place.
Sincerely,
ALSTON &
BIRD LLP
/s/
Matthew W. Mamak
Matthew
W. Mamak, Esq.
cc:
Ron Bentsur, Chief Executive Officer
Nuvectis Pharma, Inc.
2021-10-01 - UPLOAD - Nuvectis Pharma, Inc.
United States securities and exchange commission logo
October 1, 2021
Ron Bentsur, M.B.A.
Chairman and Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza
Suite 275
Fort Lee, NJ 07024
Re:Nuvectis Pharma, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted September 20, 2021
CIK No. 0001875558
Dear Mr. Bentsur:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1, Submitted September 20, 2021
Prospectus Summary, page 1
1.We note the pipeline table added to page 2. Please revise to include a column for Phase 3
clinical trials.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
October 1, 2021 Page 2
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
October 1, 2021
Page 2
2.We note your statement on page 6 and elsewhere that NXP900 has demonstrated high
potency and selectivity, and on page 72 you state that treatment with NXP900 results in
increased antitumor efficacy and tolerability in vivo in syngeneic murine cancer models
and xenografts. Please remove all statements that present your conclusions regarding the
efficacy of your product candidate as this is a determination within the authority of the
U.S. Food and Drug Administration and comparable regulatory bodies.
3.On page 7 you state that treatment with NXP900 resulted in increased anti-tumor efficacy
and tolerability in both syngeneic murine cancer models and xenografts, demonstrating
significant therapeutic advantages over dasatinib, including improved tumor growth
inhibition, survival and duration of response. We also note on page 73 that at least one
mouse model reflected a head-to-head study of dasatinib. Please revise to state whether
each of the comparisons to dasatinib reflects the results of a head-to-head comparison. If
not, please remove such comparison as comparisons to available products and other
product candidates are not appropriate unless you have conducted head-to-head trials.
Capitalization, page 48
4.We note your response to our prior comment 10 and reissue in part. Please revise to also
include the conversion of the preferred A shares as part of the pro forma balance, rather
than as part of the pro forma as adjusted balance as you currently present, to properly
reflect the offering effect in the capitalization table here, and also to properly reflect the
dilution to new investors participating in this offering in the dilution table at page 50.
Preclinical drug discovery and validation, page 69
5.We note your response to prior comment 18. Please revise to clarify the scope, size, and
design of each preclinical study referenced in this section; whether the studies were
powered to show statistical significance; and revise your characterizations of the
preclinical trials to discuss the data, rather than drawing conclusions from the results.
Exhibits
6.We note your response to our prior comment number 21, where you state you do not plan
to enter indemnification agreements with your directors and officers. Given this response
and that references to an indemnification agreement remain on pages F-15 and F-16,
please clarify whether any such agreements are already in place.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
October 1, 2021 Page 3
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
October 1, 2021
Page 3
You may contact Li Xiao at 202-551-4391 or Brian Cascio at 202-551-3676 if you have
questions regarding comments on the financial statements and related matters. Please contact
Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew W. Mamak, Esq.
2021-08-26 - UPLOAD - Nuvectis Pharma, Inc.
United States securities and exchange commission logo
August 26, 2021
Ron Bentsur, M.B.A.
Chairman and Chief Executive Officer
Nuvectis Pharma, Inc.
1 Bridge Plaza
Suite 275
Fort Lee, NJ 07024
Re:Nuvectis Pharma, Inc.
Draft Registration Statement on Form S-1
Submitted July 30, 2021
CIK No. 0001875558
Dear Mr. Bentsur:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted July 30, 2021
Prospectus Summary, page 1
1.Please revise the opening paragraph to clarify that your operations are preclinical.
2.Please balance the following statements on page 1 with disclosure highlighting the risk
that you may not obtain FDA approval for any product candidates: “The ICR’s drug
discovery unit has discovered several successful clinical drug candidates, the most notable
of which is Zytiga, a leading drug for metastatic prostate cancer” and “Our three co-
founders have a proven track record of successful drug development and capability to
raise the capital necessary to support the development of product candidates.”
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
August 26, 2021 Page 2
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
August 26, 2021
Page 2
3.We note your references to your product candidate as "first-in-class" on page 2 and
throughout the registration statement. This term suggests that the product candidate is
effective and likely to be approved. Please delete these references throughout your
registration statement. If your use of these terms was intended to convey your belief that
the product is based on a novel technology or approach and/or is further along in the
development process, you may discuss how your technology differs from technology used
by competitors and, if applicable, that you are not aware of competing products that are
further along in the development process. Statements such as these should be
accompanied by cautionary language that the statements are not intended to give any
indication that the product candidates have been proven effective or that they will receive
regulatory approval.
4.On page 4 you state that the studies required for a CTA to the MHRA have been
completed. However, on page 16, you state that NXP800 will require additional
preclinical studies. Please reconcile your disclosure or advise.
5.On page 4 you state that you plan to submit a CTA in the fourth quarter of 2021 and an
IND in the first half of 2022, and that you plan to initiate a Phase 1 dose escalation in the
fourth quarter of 2021. Please revise to state whether this is a U.K.-based trial and include
cautionary language that this timeline may be delayed as a result of MHRA review given
you have not submitted a CTA yet and plan to do so in the fourth quarter of 2021 at the
earliest.
6.On page 6 we note your disclosure that you plan to explore NXP800’s potential in several
additional tumor types, such as gastric, hepatocellular, esophageal, urothelial carcinoma
and others. Please state whether your product will require modification to treat
these other indications and whether you will need FDA approval for any other these
potential applications.
Shares Eligible for Future Sale, page 104
7.Please revise page 105 to state the number of shares that will be entitled to registration
rights and the types of registration rights afforded. To the extent this will be memorialized
in an agreement, please file such agreement pursuant to Item 601(b)(10) of Regulation S-
K.
Summary Financial Data, page 11
8.Please revise to present the pro forma as adjusted balance sheet data based on the
latest balance sheet when available. Refer to Rule 11-02(c) of Regulation S-X. In
addition, revise the December 31, 2020 financial data to agree with your financial
statements.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
August 26, 2021 Page 3
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
August 26, 2021
Page 3
Capitalization, page 44
9.Please revise to double underline cash balance to clarify that such amounts are not
included in your total capitalization.
10.Here you stated that your capitalization does not include 128,250 preferred A shares.
Please revise to present the issuance and conversion of the preferred A shares using a
separate pro forma column, and thus eventually include their effect in your pro forma as
adjusted column, to properly capture your full capitalization. The same comment applies
to your dilution table at page 46.
Business
The Nuvectis Approach, page 53
11.Given it appears you only have one product candidate in development, please revise the
following statement on page 53 and all similar statements that imply you have multiple
product candidates in development, or clarify your development program: “We analyze
clinical trial data to assess the response signals of a product candidate in development, in
order to identify candidates that show promise and favorable pharmacologic properties
based on absorption, distribution, and/or side effect profile.”
Our Leadership Team, page 53
12.On page 54 you state that you received “several Orphan Drug (U.S. and EU) and Fast
Track Designations.” Please revise to state the exact number of Orphan Drug and Fast
Track Designations and the indications for the product candidates that received such
designations.
NXP800 - Our Lead Product Candidate, page 55
13.Please clarify whether you or the ICR conducted each of the preclinical pharmacology,
pharmacokinetic, and toxicological and other safety studies described in the registration
statement, and the extent to which you depend on the ICR for running additional
preclinical or clinical trials, as referenced on pages 64 and 67, where you mention the ICR
performing additional studies.
NXP800 Patient Enrichment Strategies, page 58
14.On page 58 you state: “Tumor samples from seven different ovarian cancer xenograft
model studies were split into two groups based on their response to NXP800 treatment,
with probes required to express at least a two-fold differential in the responsive groups.”
Please clarify the portion of samples that did not respond to NXP800 treatment or did not
express at least a two-fold differential.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
August 26, 2021 Page 4
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
August 26, 2021
Page 4
Intellectual Property, page 65
15.Please revise to state whether the E.U. and Japanese patents are composition of matter
patents. With respect to the patents related to HSF1, please state the number of patents,
type of patent protection afforded and whether they are patents or patent applications. For
the patent family that has a statutory expiration in October of 2037, please provide the
jurisdiction(s) covered.
Clinical Development Plan, page 66
16.Please revise to provide more information concerning your first Phase I trial, including the
primary and secondary endpoints, how many subjects you intend to enroll and the planned
duration and dosing.
NXP800 License Agreement, page 66
17.We note your statement that the royalty term under the NXP800 License Agreement may
in part expire on a country-by-country basis as to each licensed product until expiry of the
last to expire patent in such country. Please revise to clarify when these claims are
expected to expire. Please also revise to state the term of the agreement and grounds for
termination of the agreement.
Preclinical Drug Discovery and Validation, page 66
18.Please revise page 66 or elsewhere to more fully describe each preclinical study that has
been performed with respect to NXP800, including, with respect to any animal studies, the
number of subjects, dosage, duration of the study, results and any serious adverse effects.
Please also clarify the scope of preclinical studies conducted thus far.
Executive Compensation, page 89
19.Please provide the information required by Item 402(r) of Regulation S-K concerning
director compensation.
Principal Shareholders, page 97
20.Please revise your disclosure to identify the natural person or persons who have voting
and/or investment control of the shares held by Pontifax VI LP on page 98.
Exhibits
21.We note your reference to entering indemnification agreements with your directors and
officers. Please file such agreements as exhibits pursuant to Item 601(b)(10) of Regulation
S-K.
FirstName LastNameRon Bentsur, M.B.A.
Comapany NameNuvectis Pharma, Inc.
August 26, 2021 Page 5
FirstName LastName
Ron Bentsur, M.B.A.
Nuvectis Pharma, Inc.
August 26, 2021
Page 5
General
22.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Li Xiao at 202-551-4391 or Brian Cascio at 202-551-3676 if you have
questions regarding comments on the financial statements and related matters. Please contact
Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Matthew W. Mamak, Esq.