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NeuroSense Therapeutics Ltd.
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NeuroSense Therapeutics Ltd.
Response Received
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NeuroSense Therapeutics Ltd.
Response Received
1 company response(s)
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NeuroSense Therapeutics Ltd.
Response Received
1 company response(s)
High - file number match
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NeuroSense Therapeutics Ltd.
Response Received
1 company response(s)
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NeuroSense Therapeutics Ltd.
Response Received
5 company response(s)
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SEC wrote to company
2021-11-16
NeuroSense Therapeutics Ltd.
Filing - SEC Comment Letter to NeuroSense Therapeutics Ltd.
UPLOAD · 2021-11-16
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Company responded
2021-11-19
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2021-11-19
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Company responded
2021-12-06
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2021-12-06
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Company responded
2021-12-06
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2021-12-06
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Company responded
2023-12-04
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2023-12-04
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NeuroSense Therapeutics Ltd.
Response Received
2 company response(s)
High - file number match
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Company responded
2023-08-14
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2023-08-14
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Company responded
2023-08-31
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2023-08-31
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NeuroSense Therapeutics Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-01-26
NeuroSense Therapeutics Ltd.
Filing - SEC Comment Letter to NeuroSense Therapeutics Ltd.
UPLOAD · 2023-01-26
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NeuroSense Therapeutics Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-10-15
NeuroSense Therapeutics Ltd.
Filing - SEC Comment Letter to NeuroSense Therapeutics Ltd.
UPLOAD · 2021-10-15
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Company responded
2021-10-18
NeuroSense Therapeutics Ltd.
Filing - Correspondence from NeuroSense Therapeutics Ltd.
CORRESP · 2021-10-18
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NeuroSense Therapeutics Ltd.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-10-01
NeuroSense Therapeutics Ltd.
Filing - SEC Comment Letter to NeuroSense Therapeutics Ltd.
UPLOAD · 2021-10-01
Generating summary...
NeuroSense Therapeutics Ltd.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-09-03
NeuroSense Therapeutics Ltd.
Filing - SEC Comment Letter to NeuroSense Therapeutics Ltd.
UPLOAD · 2021-09-03
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-24 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-01-16 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-01-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-01-03 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-284051 | Read Filing View |
| 2024-12-12 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-12-12 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-283656 | Read Filing View |
| 2024-11-21 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-283338 | Read Filing View |
| 2024-11-21 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-05-21 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-05-14 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-279324 | Read Filing View |
| 2023-12-04 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-31 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-14 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-01 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-01-26 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-01-26 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-12-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-12-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-19 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-16 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-04 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-18 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-15 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-01 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-09-03 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-01-03 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-284051 | Read Filing View |
| 2024-12-12 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-283656 | Read Filing View |
| 2024-11-21 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-283338 | Read Filing View |
| 2024-05-14 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | 333-279324 | Read Filing View |
| 2023-08-01 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-01-26 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-16 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-15 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-01 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-09-03 | SEC Comment Letter | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-24 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-01-16 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2025-01-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-12-12 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-11-21 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2024-05-21 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-12-04 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-31 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-08-14 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2023-01-26 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-12-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-12-06 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-19 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-11-04 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
| 2021-10-18 | Company Response | NeuroSense Therapeutics Ltd. | Israel | N/A | Read Filing View |
2025-11-24 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP 1 filename1.htm NeuroSense Theapeutics Ltd. 11 HaMenofim Street, Building B Herzliya 4672562 November 24, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: NeuroSense Therapeutics Ltd. (CIK 0001875091) Registration Statement No. 333-291122 on Form F-3 (the "Registration Statement") Ladies and Gentlemen: NeuroSense Therapeutics Ltd. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Securities Act "), so that it may become effective on November 25, 2025 at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A., by calling Gary Emmanuel at + 972 (0) 3.636.6033. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request for acceleration. Very truly yours, NEUROSENSE THERAPEUTICS LTD. By: /s/ Or Eisenberg Or Eisenberg Chief Financial Officer
2025-01-16 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
January 16, 2025
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NeuroSense Therapeutics Ltd. (CIK 0001875091)
Registration Statement No. 333-284051 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
NeuroSense Therapeutics Ltd.
(the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on January 16, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A.,
by calling Gary Emmanuel at 212-801-9337. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request for acceleration.
Very truly yours,
NEUROSENSE THERAPEUTICS LTD.
By:
/s/ Alon Ben-Noon
Alon Ben-Noon
Chief Executive Officer
2025-01-06 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
January 6, 2025
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance, Office of Life
Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Joshua Gorsky
Re:
NeuroSense Therapeutics Ltd.
Registration Statement on Form F-3
Filed December 26, 2024
File No. 333-284051
Dear Mr. Gorsky:
On behalf of NeuroSense Therapeutics
Ltd. (the “Company”), we are writing to submit the response of the Company to the comment of the staff (the “Staff”)
of the Division of Corporation Finance Office of Life Sciences of the Securities and Exchange Commission (the “Commission”)
dated January 3, 2025, relating to the above Registration Statement on Form F-3 (File No. 333-284051) filed by the Company on December
26, 2024 (the “Form F-3”).
For ease of review, we have
set forth below the comment of your letter and the Company’s response thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in the Form F-3.
Registration Statement on Form F-3
General
1.
We note the press release filed as Exhibit 99.1 to your Report on Form 6-K, filed December 23, 2024, stating that you “entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC[.]” Please revise your registration statement where appropriate to disclose the material terms of this binding term sheet as well as the identity of the counterparty. Additionally, please file the binding term sheet as an exhibit to this registration statement or, alternatively, please tell us why you are not required to do so. Refer to Item 601(b)(10) of Regulation S-K for guidance.
Response: In response to
the Staff’s comment, the Company has determined that the term sheet is not a material contract under Item 601(b)(10) of
Regulation S-K. The term sheet does not contain final definitive terms and provides that it is not intended to contain all final
contract terms. Furthermore, as disclosed in the press release filed as Exhibit 99.1 to the Company’s report on Form 6-K,
filed December 23, 2024 and as provided for in the term sheet, the transaction is subject to the finalization of a definitive
agreement. Therefore, the Company does not believe that it is required to provide further disclosure with respect the terms of the
term sheet or to file the term sheet itself as an exhibit.
Please contact me at +1 212
801 9337 if you have any questions or require any additional information in connection with this letter.
Sincerely,
/s/ Gary Emmanuel
Gary Emmanuel
Greenberg Traurig, P.A.
cc:
Alon Ben-Noon, Chief Executive Officer
Or Eisenberg, Chief Financial Officer
2025-01-03 - UPLOAD - NeuroSense Therapeutics Ltd. File: 333-284051
January 3, 2025
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-3
Filed December 26, 2024
File No. 333-284051
Dear Alon Ben-Noon:
We have conducted a limited review of your registration statement and have the
following comment.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe the comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Registration Statement on Form F-3
General
1.We note the press release filed as Exhibit 99.1 to your Report on Form 6-K, filed
December 23, 2024, stating that you "entered into a binding term sheet with a leading
global pharmaceutical company to advance the development and commercialization
of PrimeC[.]" Please revise your registration statement where appropriate to disclose
the material terms of this binding term sheet as well as the identity of the
counterparty. Additionally, please file the binding term sheet as an exhibit to this
registration statement or, alternatively, please tell us why you are not required to do
so. Refer to Item 601(b)(10) of Regulation S-K for guidance.
January 3, 2025
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Joshua Gorsky at 202-551-7836 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gary Emmanuel, Esq.
2024-12-12 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
December 12, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NeuroSense Therapeutics Ltd. (CIK 0001875091)
Registration Statement No. 333-283656 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
NeuroSense Therapeutics Ltd.
(the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on December 12, 2024, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A.,
by calling Gary Emmanuel at +972 (0) 3-636-6033. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly yours,
NEUROSENSE THERAPEUTICS LTD.
By:
/s/ Alon Ben-Noon
Alon Ben-Noon
Chief Executive Officer
2024-12-12 - UPLOAD - NeuroSense Therapeutics Ltd. File: 333-283656
December 12, 2024
Or Eisenberg
Chief Financial Officer
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-3
Filed December 6, 2024
File No. 333-283656
Dear Or Eisenberg:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Gary M. Emmanuel, Esq.
2024-11-21 - UPLOAD - NeuroSense Therapeutics Ltd. File: 333-283338
November 21, 2024
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-1
Filed November 19, 2024
File No. 333-283338
Dear Alon Ben-Noon:
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:Gary Emmanuel, Esq.
2024-11-21 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
November 21, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NeuroSense Therapeutics Ltd. (CIK 0001875091)
Registration Statement No. 333-283338 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
NeuroSense Therapeutics Ltd.
(the “Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on November 22, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A.,
by calling Gary Emmanuel at +972 (0) 3-636-6033. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request
for acceleration.
Very truly yours,
NEUROSENSE THERAPEUTICS LTD.
By:
/s/ Alon Ben-Noon
Alon Ben-Noon
Chief Executive Officer
2024-05-21 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
May 21, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NeuroSense Therapeutics Ltd. (CIK 0001875091)
Registration Statement No. 333-279324 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
NeuroSense Therapeutics Ltd. (the
“Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on
May 22, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig,
P.A., by calling Gary Emmanuel at +972 (0) 3-636-6033. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this
request for acceleration.
Very truly yours,
NEUROSENSE THERAPEUTICS LTD.
By:
/s/ Alon Ben-Noon
Alon Ben-Noon
Chief Executive Officer
2024-05-14 - UPLOAD - NeuroSense Therapeutics Ltd. File: 333-279324
United States securities and exchange commission logo
May 14, 2024
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-1
Filed May 10, 2024
File No. 333-279324
Dear Alon Ben-Noon:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Gary Emmanuel, Esq.
2023-12-04 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
December 4, 2023
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-3561
Attn: Lauren Hamill
Re:
NeuroSense Therapeutics Ltd.
Post-Effective Amendment No. 3 to Registration Statement on Form
F-1
Filed December 4, 2023
File No. 333-260338
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Securities Act”), NeuroSense Therapeutics Ltd. (the “Company”) hereby respectfully requests that the effective
date of the above-referenced Registration Statement on Form F-1 (the “Registration Statement”) be accelerated by the Securities
and Exchange Commission so that the Registration Statement, as then amended, will be declared effective under the Securities Act at 4:00
p.m. Eastern Time on December 4, 2023, or as soon thereafter as is practicable, or such other time as the Company or its counsel, Covington
& Burling LLP, may request by telephone that such Registration Statement be declared effective.
We respectfully request that we be notified of such effectiveness by
a telephone call to Brian K. Rosenzweig of Covington & Burling LLP at (212) 841-1108 and that such effectiveness also be confirmed
in writing.
Respectfully,
NeuroSense Therapeutics Ltd.
By:
/s/ Alon Ben-Noon
Name:
Alon Ben-Noon
Title:
Chief Executive Officer and Director
cc: Brian K. Rosenzweig, Covington & Burling LLP
2023-08-31 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
August 31, 2023
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-3561
Attn:
Cindy Polynice
Laura Crotty
Re:
NeuroSense Therapeutics Ltd.
Amendment No. 2 to the
Registration Statement on Form F-1
Filed August 31, 2023
File No. 333-273375
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Securities Act”), NeuroSense Therapeutics Ltd. (the “Company”) hereby respectfully requests that the effective
date of the above-referenced Registration Statement on Form F-1 (the “Registration Statement”) be accelerated by the Securities
and Exchange Commission so that the Registration Statement, as then amended, will be declared effective under the Securities Act at 4:00
p.m. Eastern Time on September 5, 2023, or as soon thereafter as is practicable, or such other time as the Company or its counsel, Covington
& Burling LLP, may request by telephone that such Registration Statement be declared effective.
We respectfully request that we be notified of such effectiveness by a
telephone call to Sarah C. Griffiths of Covington & Burling LLP at (212) 841-1013 and that such effectiveness also be confirmed in
writing.
Respectfully,
NeuroSense Therapeutics Ltd.
By:
/s/ Alon Ben-Noon
Name: Alon Ben-Noon
Title: Chief Executive Officer and Director
cc: Sarah C. Griffiths, Covington & Burling LLP
2023-08-14 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
Covington & Burling LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
T +12128411000
August 14, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Office of Technology
100 F Street, N.E.
Washington, D.C. 20549
Attn: Cindy Polynice
Laura Crotty
Re: NeuroSense Therapeutics Ltd.
Amendment No. 1 to the Registration Statement on
Form F-1
Filed July 21, 2023
File No. 333-273375
Ladies and Gentlemen:
On behalf of NeuroSense Therapeutics
Ltd. (“NeuroSense” or the “Company”), we are submitting this letter in response to a letter, dated
August 1, 2023, from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
with respect to the Company’s Registration Statement on Form F-1 filed with the Commission on July 21, 2023 (the “Registration
Statement”). The Company is concurrently filing Amendment No. 1 to the Registration Statement (the “Amended Registration
Statement”), which includes changes to reflect responses to the Staff’s comments and other updates.
The numbering of the paragraphs
below corresponds to the numbering of the comments in the letter from the Staff. For the Staff’s convenience, we have incorporated
the text of the Staff’s comments into this response letter in italics. Unless otherwise indicated, page references in the responses
correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in
the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in
the Amended Registration Statement.
The responses provided herein
are based upon information provided to Covington & Burling LLP by the Company.
Registration Statement on Form F-1 filed July 21, 2023
Cover Page
1. Please revise the heading on your cover page to quantify the number of warrants to be registered.
Response to Comment 1: The Company
respectfully acknowledges the Staff’s comment and has revised the cover page of the Amended Registration Statement to quantify the
number of warrants to be registered.
General
2. In relation to the 3,000,000 ordinary shares of common stock issuable upon exercise of the ordinary warrants issued in the June
22, 2023, private placement, please tell us your basis for registering the offering of these shares on a primary basis. In this regard,
we note that these shares and warrants were issued pursuant to the exemptions provided in Section 4(a)(2) of the Securities Act and Regulation
D promulgated thereunder, and are exercisable within one year. Please consider the rationale set out in Securities Act Sections C&DI
Questions 139.08, 239.15, and 103.04.
Response to Comment 2: The
Company respectfully acknowledges the Staff’s comment and has revised the Amended Registration Statement on the cover page of
the prospectus and at pages 5, 12, 13 and 28 to remove the primary issuance of the 3,000,000 Ordinary Shares issuable upon exercise of the
Ordinary Warrants issued in the June 22, 2023 private placement.
*****
Please contact me at (212)
841-1108 with any questions or further comments regarding our responses to the Staff’s comments.
Sincerely,
/s/ Brian K. Rosenzweig
Brian K. Rosenzweig
Covington & Burling LLP
cc: Alon Ben-Noon, NeuroSense Therapeutics Ltd.
Sarah C. Griffiths, Covington & Burling
LLP
2023-08-01 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
August 1, 2023
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-1
Filed July 21, 2023
File No. 333-273375
Dear Alon Ben-Noon:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1 filed July 21, 2023
Cover Page
1.Please revise the heading on your cover page to quantify the number of warrants to be
registered.
General
2.In relation to the 3,000,000 ordinary shares of common stock issuable upon exercise of the
ordinary warrants issued in the June 22, 2023, private placement, please tell us your basis
for registering the offering of these shares on a primary basis. In this regard, we note that
these shares and warrants were issued pursuant to the exemptions provided in Section
4(a)(2) of the Securities Act and Regulation D promulgated thereunder, and are
exercisable within one year. Please consider the rationale set out in Securities Act
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
August 1, 2023 Page 2
FirstName LastName
Alon Ben-Noon
NeuroSense Therapeutics Ltd.
August 1, 2023
Page 2
Sections C&DI Questions 139.08, 239.15, and 103.04.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Cindy Polynice at 202-551-8707 or Laura Crotty at 202-551-7614 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Rosenzweig, Esq.
2023-01-26 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
January 26, 2023
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
11 Ha-Menofim Street, Building B
Herzliya 4672562 Israel
Re:NeuroSense Therapeutics Ltd.
Registration Statement on Form F-3
Filed January 19, 2023
File No. 333-269306
Dear Alon Ben-Noon:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sarah C. Griffiths
2023-01-26 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
NeuroSense Therapeutics
Ltd.
11 Ha-Menofim Street,
Building B
Herzliya 4672562 Israel
January
26, 2023
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-3561
Attn: Alan Campbell
Re:
NeuroSense Therapeutics
Ltd.
Registration Statement on Form
F-3
Filed January 19, 2023
File No. 333-269306
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), NeuroSense Therapeutics Ltd. (the “Company”) hereby respectfully
requests that the effective date of the above-referenced Registration Statement on Form F-3 (the “Registration Statement”)
be accelerated by the Securities and Exchange Commission so that the Registration Statement will be declared effective under the Securities
Act at 4:00 p.m. Eastern Time on January 30, 2023, or as soon thereafter as is practicable, or such other time as the Company or its
counsel, Covington & Burling LLP, may request by telephone that such Registration Statement be declared effective.
We respectfully request that we be notified
of such effectiveness by a telephone call to Sarah C. Griffiths of Covington & Burling LLP at (212) 841-1013 and that such effectiveness
also be confirmed in writing.
Respectfully,
NeuroSense Therapeutics Ltd.
By:
/s/ Alon Ben-Noon
Name:
Alon Ben-Noon
Title:
Chief Executive Officer and Director
cc: Sarah C. Griffiths, Covington &
Burling LLP
2021-12-06 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
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Maxim Group LLC
300 Park Ave, 16th Floor
New York, NY 10022
December 6, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3561
Attn: Tracie Mariner, Vanessa Robertson, Jane Park, Celeste Murphy
Re:
NeuroSense Therapeutics Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed December 6, 2021
File No. 333-260338
Ladies and Gentlemen:
Pursuant to Rule 461, as amended,
the undersigned, as the representative of the prospective underwriters of the proposed offering by NeuroSense Therapeutics Ltd. (the “Company”),
hereby join the Company’s request that the effectiveness of the above-referenced Registration Statement (the “Registration
Statement”) be accelerated so that the Registration Statement will become effective at 5:00 p.m., Eastern Time, on Wednesday, December
8, 2021, or as soon thereafter as is practicable, or at such other time as the Company or its counsel, Covington & Burling LLP, may
request by telephone that such Registration Statement be declared effective.
Pursuant to Rule 460 of the General
Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, acting on behalf
of the several underwriters, wish to advise you that, through December 6, 2021, we distributed approximately 375 copies of the Company’s
preliminary prospectus dated December 6, 2021, including a copy to each underwriter or dealer, who is reasonably anticipated to be invited
to participate in the distribution of the security.
The undersigned, as the representative
of the prospective underwriters of the proposed offering, advise on behalf of the underwriters that the underwriters have complied and
will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Maxim Group LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Head of Investment Banking, Executive Managing Director
2021-12-06 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
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NeuroSense Therapeutics Ltd.
Medinat ha-Yehudim Street 85
Herzliya 4676670
Israel
December 6, 2021
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3561
Attn: Tracie Mariner, Vanessa Robertson, Jane Park, Celeste Murphy
Re:
NeuroSense Therapeutics Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed December 6, 2021
File No. 333-260338
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended (the
“Securities Act”), NeuroSense Therapeutics Ltd. (the “Company”) hereby respectfully requests that the effective
date of the above-referenced Registration Statement on Form F-1 (the “Registration Statement”) be accelerated by the Securities
and Exchange Commission so that the Registration Statement, as then amended, will be declared effective under the Securities Act at 5:00
p.m. Eastern Standard Time on December 8, 2021, or as soon thereafter as is practicable, or such other time as the Company or its counsel,
Covington & Burling LLP, may request by telephone that such Registration Statement be declared effective.
We respectfully request that we be notified of such effectiveness by a
telephone call to Brian K. Rosenzweig of Covington & Burling LLP at (212) 841-1108 and that such effectiveness also be confirmed in
writing.
Respectfully,
NeuroSense Therapeutics Ltd.
By:
/s/ Alon Ben-Noon
Name:
Alon Ben-Noon
Title:
Chief Executive Officer
cc: Brian K. Rosenzweig, Covington & Burling LLP
2021-11-19 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
November 19, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Tracie Mariner
Vanessa Robertson
Jane Park
Irene Paik
Re:
NeuroSense Therapeutics Ltd.
Registration Statement on Form F-1
Submitted August 10, 2021
CIK No. 0001875091
Ladies and Gentlemen:
On behalf of NeuroSense Therapeutics Ltd. (the
“Company”), we are submitting this letter in response to a letter, dated November 16, 2021, from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amended Registration
Statement on Form F-1, File No. 333-260338 that was filed with the Commission on November 10, 2021 (the “Registration Statement”).
The Company is concurrently publicly submitting this third amended Registration Statement on Form F-1 (the “Amended Registration
Statement”), which includes changes to reflect responses to the Staff’s comment and other updates.
The numbering of the paragraph below corresponds
to the numbering of the comment in the letter from the Staff. For the Staff’s convenience, we have incorporated the text of the
Staff’s comment into this response letter in italics. The page reference in the response corresponds to the page numbers in the
Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized
terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement.
The responses provided herein are based upon information
provided to Covington & Burling LLP by the Company. In addition to submitting this letter via EDGAR, we are sending you supplementally
the Amended Registration Statement (marked to show changes from the Registration Statement).
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
November 19, 2021
Page 2
Amendment No. 3 to the Registration Statement on Form F-1
Capitalization, page 57
1. Please
add a note to the table to explain how you will account for the warrants to be issued in connection with the offering.
Response to Comment No. 1: The Company respectfully
advises the Staff that it has revised the disclosure on page 57 of the Registration Statement in response to the Staff’s comment.
*****
Please contact me at (212) 841-1108 or Sarah C.
Griffiths at (212) 841-1013 with any questions or further comments regarding our responses to the Staff’s comments.
Sincerely,
/s/ Brian K. Rosenzweig
Brian K. Rosenzweig
Covington & Burling LLP
cc:
Alon Ben-Noon, NeuroSense Therapeutics Ltd.
Or Eisenberg, NeuroSense Therapeutics Ltd.
Sarah C. Griffiths, Covington & Burling LLP
Perry Wildes, Gross & Co.
Sarah E. Williams, Ellenoff Grossman & Schole LLP
Aaron M. Lampert, Goldfarb Seligman & Co
2021-11-16 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
November 16, 2021
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
Medinat ha-Yehudim Street 85
Herzliya 4676670 Israel
Re:NeuroSense Therapeutics Ltd.
Amendment No. 2 to Registration Statement on Form F-1
Filed November 10, 2021
File No. 333-260338
Dear Mr. Ben-Noon:
We have reviewed your amended 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.
Amendment No. 2 to Registration Statement on Form F-1
Capitalization, page 57
1.Please add a note to the table to explain how you will account for the warrants to be issued
in connection with the offering.
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
November 16, 2021 Page 2
FirstName LastName
Alon Ben-Noon
NeuroSense Therapeutics Ltd.
November 16, 2021
Page 2
You may contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at 202-551-
3649 if you have questions regarding comments on the financial statements and related
matters. Please contact Jane Park at 202-551-7439 or Celeste Murphy at 202-551-3257 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian K. Rosenzweig, Esq.
2021-11-04 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
1
filename1.htm
FOIA
CONFIDENTIAL TREATMENT REQUEST
Certain
confidential information in this letter has been omitted and provided separately to the Securities and Exchange Commission. Confidential
treatment has been requested by NeuroSense Therapeutics Ltd. with respect to the omitted portions, which are identified in this letter
by the mark “[***].”
November
4, 2021
VIA
EDGAR AND HAND DELIVERY
U.S.
Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
100
F Street, N.E.
Washington, D.C. 20549
Attn:
Tracie
Marner
Vanessa
Robertson
Jane
Park
Irene
Paik
Re:
NeuroSense
Therapeutics Ltd.
Registration Statement on Form F-1
Filed October 18, 2021
File No. 333-260338
Ladies
and Gentlemen:
On
behalf of NeuroSense Therapeutics Ltd. (“NeuroSense” or the “Company”), set forth below is additional
information to supplement the Company’s prior response to comment 19 contained in the letter, dated September 3, 2021, from the
staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to
the Company’s Confidential Draft Registration Statement on Form F-1 submitted to the Commission on August 10, 2021 (the “Draft
Registration Statement”). Such Draft Registration Statement has been updated by the Company as reflected in the registration
statement referenced above (File No. 333-260338), which was publicly filed by the Company on October 18, 2021 and amended in a pre-effective
amendment on November 1, 2021 (the “Registration Statement”).
U.S.
Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
November
4, 2021
Page
2
The
responses provided herein are based upon information provided to Covington & Burling LLP by the Company. Capitalized terms used in
this letter but otherwise not defined herein shall have the meanings set forth in the Registration Statement.
The
Company respectfully submits the below additional information to assist the Staff in its review of the Company’s determinations
of the fair value of the ordinary shares underlying its material equity awards and the reasons for the differences between the recent
valuations of the Company’s ordinary shares leading up to the Company’s initial public offering (“IPO”)
and the estimated offering price of the Company’s ordinary shares (the “Shares”) in the IPO. Unless otherwise
indicated, all information contained in this letter assumes a [***]-for-[***] stock split of the Shares, which will become effective
on November 7, 2021, and all conversion rates are reflected as of the date of the applicable issuance.
Determining
the Price per Ordinary Share Prior to the IPO
The
following sets forth a description of each of the Company’s recent equity issuances directly related to the fair value determinations
underlying the recognition of stock-based compensation expense in the Company's annual financial statements as at December 31, 2020 and
its interim financial statements as at June 30, 2021 in accordance with IFRS 2.
Valuation
Methodologies
In
anticipation of the Company’s potential IPO and in connection with the preparation of its audited financial statements to be included
in the Registration Statement, the Company obtained a third-party specialist (the “Specialist”) valuation of the estimated
fair value of its Shares underlying the options granted by the Company. In this letter, the Company describes the options granted as
shown in the table below on the respective grant dates. For all option grants prior to July 2020, the Company determined the fair value
of the underlying Shares by reference to contemporaneous fundraising transactions . In selecting the appropriate fundraising round to
use in valuing the Shares, the Company considered when an event which led to an increase in the Share value occurred. In cases where
the value increasing event took place prior to a grant, the Company used the most recent subsequent fundraising round. In cases where
the value increasing event took place after the grant, the Company used the most recent prior fundraising round. This approach ensured
that the Company appropriately captured the value at the time of the grant, including or excluding, as appropriate, certain value increasing
events. It should be noted that the Company has only issued ordinary shares and has never issued preferred stock. Given that the fundraising
rounds used in the valuations were only sales of ordinary shares, the Company was not required to separately value the fair value of
those ordinary shares. For awards granted on and after July 17, 2020, the Company, with the help of the Specialist, determined the estimated
fair value of the Shares by applying the income approach using a forecast prepared by management. The change in valuation methodology
was necessitated by the lack of contemporaneous fundraising rounds that reflected the positive preliminary results from the Company’s
Phase IIa clinical trial of its lead product candidate PrimeC that the Company received in July 2020 before the July 2020 Grants. The
income approach estimates value based on the expectation of future cash flows that the Company will generate. These future cash flows
were discounted to their present values using a discount rate based on the capital rates of return for comparable publicly traded companies
and were adjusted to reflect the risks inherent in the Company’s cash flows relative to those inherent in the comparable companies
utilized in the discount rate calculation (the “DCF” analysis). The risks considered by the Company and incorporated
in the Specialist’s discounted cash flow model included the probability of success of the PrimeC product candidate as well as the
Company’s preclinical product candidates, StabiliC and CogniC.
U.S.
Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
November
4, 2021
Page
3
After
determining the fair value of the Shares on a minority, marketable basis, the Company also considered that the Shares were not freely
tradable in the public markets. Therefore, the estimated fair value of the Shares at each grant date reflects a discount for lack of
marketability (“DLOM”) partially based on the anticipated likelihood of the closing of the Company’s IPO by
[***] as well as a function of the Company’s estimated volatility, derived primarily using the volatility of comparable publicly
traded companies. The DLOM applied to the Share price on each grant date ranged from [***]% to [***]%. The per Share price in the table
below represents the estimated fair value after applying the DLOM.
Since
July 1, 2019, the Company has granted options to purchase an aggregate of 210,000 Shares under its 2018 Employee Share Option Plan to
employees, non-employee directors and consultants. The Company made the option grants on the dates, and on the terms, set out below.
Ordinary
Share Valuations and Stock Option Grants
Grant
Date
Type
of
Award
Number
of
Underlying
Shares
Granted
Exercise
Price
Estimated
Fair Value
per
Underlying
Share
August 28,
2019
Options
60,000
$ 0.03
$ 1.08
January 9, 2020
Options
18,000
NIS
5
$ 1.07
March 5, 2020
Options
54,000
$ 0.03
$ 1.06
July 12, 2020
Options
12,000
NIS 5
$ 6.73
July 17, 2020
Options
12,000
$ 0.03
$ 6.73
July 20, 2020
Options
12,000
$ 0.03
$ 6.73
November 25, 2020
Options
3,000
$ 0.03
$ 6.96
December 8, 2020
Options
3,000
$ 0.03
$ 6.97
March 15, 2021
Options
15,000
$ 1.67
$ 16.80
July 1, 2021(*)
Options
21,000
$ 0.03
$ 17.00
(*) Despite
the fact that the formal grant date was after June 30, 2021, as the grantee begun to provide
services before the formal grant date, compensation expenses were recorded from the service
commencement date on June 1, 2021.
August
2019 Grant
In
determining the fair value of the August 2019 grants, the Company, with the help of the Specialist, considered recent transactions in
the Shares where investors, in an arm’s length transaction, purchased Shares at a negotiated price. The most recent fundraising
round immediately before the grant of options occurred in July 2019, where the Company sold 799,998 Shares in an arm’s length transaction
that valued the Shares at $1.43 on a pre-DLOM basis. The Company determined that on August 28, 2019, the estimated fair value of the
underlying Shares was $1.08 on a post-DLOM basis. The Company concluded the fair value of the Shares in the recent financing was the
appropriate fair value as of the date of grant given the short amount of time which had passed between the grant date and the July 2019
fundraising and the absence of any significant business developments between these dates.
U.S.
Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
November
4, 2021
Page
4
January
2020 Grant
The
Company determined the fair value of the Shares as of January 9, 2020, using the most recent fundraising round immediately following
the grant of options. The most recent fundraising round immediately following the grant of options occurred in February 2020, where the
Company sold 370,356 Shares in an arm’s length transaction that valued the Shares at $1.43 on a pre-DLOM basis. The Company determined
that on January 9, 2020, the estimated fair value of the underlying Shares was $1.07 on a post-DLOM basis. The Company concluded the
fair value of the Shares in the recent financing was the appropriate fair value as of the date of grant given the short amount of time
which had passed between the grant date and the February 2020 fundraising and the absence of any significant business developments between
these dates.
March
2020 Grant
The
Company determined the fair value of the Shares granted on March 5, 2020 using the same methods described above and the fundraising round
in February 2020. The Company, with the help of the Specialist, determined the fair value of the Shares in the February 2020 investment
was $1.43 per Share on a pre-DLOM basis. The Company determined that on March 5, 2020, the estimated fair value of the underlying Shares
was $1.06 on a post-DLOM basis. The Company concluded the fair value of the Shares in the recent financing was the appropriate fair value
as of the date of grant given the short amount of time which had passed between the grant date and the February 2020 fundraising and
the absence of any significant business developments between these dates.
July
2020 Grants
As
noted above, due to the lack of contemporaneous third party financing activity, the significant advancements in the Company’s clinical
development program and the positive preliminary results from the Company’s Phase IIa clinical trial of its lead product candidate
PrimeC received in July 2020 before the July 2020 grants, the Company, with the help of the Specialist, performed a DCF analysis as of
September 30, 2020 to estimate the fair value of the Shares for awards granted in July 2020 and after this date. The September DCF analysis
was based on management’s projections and took into account the probability of success of the Company’s product candidates
between each phase from pre-clinical to approval and its ability to achieve certain levels of revenue by certain dates. The DCF analysis
conducted by the Company concluded that the estimated fair value of the Shares as of September 30, 2020 was $8.94 per Share on a pre-DLOM
basis. The Company determined that on each of the July grant dates, the estimated fair value of the underlying Shares was $6.73 on a
post-DLOM basis. While the DCF valuation was conducted as of September 30, 2020, the Company determined that given the lack of significant
changes in the business and the short amount of time between the July grants and the September 2020 valuation, it was appropriate to
conclude that the fair value of the Shares in July 2020 were the same as the fair value as determined as of September 30, 2020.
November
and December 2020 Grants
In
estimating the fair value of the Shares as of November 25 and December 8, 2020, the Company determined that the estimated fair value
as of September 30, 2020 was still appropriate given the lack of changes in the business and other circumstances of the Company. The
Company then applied a DLOM as of the grant dates to determine the estimated fair value specific to each of the November and December
grants. The increase in the fair value of the Shares compared to the July 2020 fair value is due to the reduced time until an anticipated
exit event.
U.S.
Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
November
4, 2021
Page
5
March
2021 Grants
In
order to properly value the Shares underlying the options granted in March 2021 in light of the completion of the Phase II PrimeC clinical
trial and the positive results received in February 2021, the Company, with the help of the Specialist, conducted an updated DCF analysis
to determine the value of the Shares as of March 31, 2021. The DCF analysis was based on management projections, which reflect various
assumptions regarding the success of the Company’s product candidates and the Company’s ability to commercialize these product
candidates, if approved. The DCF analysis reflected the increased likelihood of the Company achieving certain product development milestones
compared to the prior analysis conducted in September 2020 taking into consideration the completion of the Phase II PrimeC clinical trial.
Based on the Specialist’s analysis, the Company determined the estimated fair value of the Shares as of March 31, 2021 to be $20.16
per Share on a pre-DLOM basis. The Company determined that on March 15, 2021, the estimated fair value of the underlying Shares was $16.80
on a post-DLOM basis. The March 15, 2021 grant was valued using the estimated fair value of the Shares as determined by the Company as
of March 31, 2021. The Company determined that the DCF valuation as of March 31, 2021 was the most appropriate value to apply given that
the value increasing event, the receipt of positive data from the Company’s Phase II PrimeC clinical trial, occurred prior to the
March 15, 2021 grant but after the prior valuation.
July
2021 Grants
In
order to properly value the Shares underlying the options granted in July 2021, the Company, with the help of the Specialist, conducted
an updated DCF analysis to determine the value of the Shares as of June 30, 2021. The DCF analysis was based on the same projections
used in the March 2021 valuation since no significant business changes occurred. There was an insignificant increase in the value compared
to the March 2021 valuation due to the progress of time. Based on the Specialist’s analysis, the Company determined the estimated
fair value of the Shares as of June 30, 2021 to be $20.16 per Share on a pre-DLOM basis. The Company determined that on July 1, 2021,
the estimated fair value of the underlying Shares was $17.00 on a post-DLOM basis.
Preliminary
IPO Price Range
The
Company has taken into consideration guidance and market data from the representative of the underwriters for the IPO that have been
presented to and reviewed by the board of directors and management. To provide further information for the Staff’s consideration,
the Company advises the Staff that it currently anticipates a price range between approximately $[***] to $[***] per Share (the “Preliminary
Price Range”). The actual price range to be inclu
2021-10-18 - CORRESP - NeuroSense Therapeutics Ltd.
CORRESP
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October 18, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Tracie Mariner
Vanessa Robertson
Jane Park
Irene Paik
Re: NeuroSense Therapeutics Ltd.
Registration Statement on Form F-1
Submitted August 10, 2021
CIK No. 0001875091
Ladies and Gentlemen:
On behalf of NeuroSense Therapeutics Ltd. (the
“Company”), we are submitting this letter in response to a letter, dated October 15, 2021, from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amended Confidential
Draft Registration Statement on Form F-1 submitted to the Commission on October 7, 2021 (the “Draft Registration Statement”).
The Company is concurrently publicly submitting Registration Statement on Form F-1 (the “Registration Statement”),
which includes changes to reflect responses to the Staff’s comment and other updates.
The numbering of the paragraph below corresponds
to the numbering of the comment in the letter from the Staff. For the Staff’s convenience, we have incorporated the text of the
Staff’s comment into this response letter in italics. The page reference in the response corresponds to the page numbers in the
Registration Statement, and page references otherwise correspond to the page numbers in the Draft Registration Statement. Capitalized
terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Registration Statement.
The responses provided herein are based upon information
provided to Covington & Burling LLP by the Company. In addition to submitting this letter via EDGAR, we are sending you supplementally
the Registration Statement (marked to show changes from the Draft Registration Statement).
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
October 18, 2021
Page 2
Amendment No. 2 to the Draft Registration Statement on Form F-1
Efficacy Endpoints of Our PrimeC Trial versus PRO-ACT, page 75
1. We note your response to prior comment 5. Please expand your
disclosure on pages 75 and 76 to discuss the data that support your conclusion that significant changes were observed in key biomarkers
of ALS between ALS and healthy subjects (such as TDP-43 and LC3) and address the related statistical significance of your findings.
Response to Comment No. 1: The Company respectfully
advises the Staff that it has revised the disclosure on pages 77-79 of the Registration Statement in response to the Staff’s
comment.
*****
Please contact me at (212) 841-1108 or Sarah C.
Griffiths at (212) 841-1013 with any questions or further comments regarding our responses to the Staff’s comments.
Sincerely,
Brian K. Rosenzweig
Covington & Burling LLP
cc:
Alon Ben-Noon, NeuroSense Therapeutics Ltd.
Or Eisenberg, NeuroSense Therapeutics Ltd.
Sarah C. Griffiths, Covington & Burling LLP
Perry Wildes, Gross & Co.
Sarah E. Williams, Ellenoff Grossman & Schole LLP
Aaron M. Lampert, Goldfarb Seligman & Co
2021-10-15 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
October 15, 2021
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
Medinat ha-Yehudim Street 85
Herzliya 4676670 Israel
Re:NeuroSense Therapeutics Ltd.
Amendment No. 2 to
Draft Registration Statement on Form F-1
Submitted October 7, 2021
CIK No. 0001875091
Dear Mr. Ben-Noon:
We have reviewed your amended draft registration statement and have the following
comment.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this comment and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
October 1, 2021 letter.
Amendment No. 2 to Draft Registration Statement on Form F-1 submitted October 7, 2021
Efficacy Endpoints of Our PrimeC Trial versus PRO-ACT, page 75
1.We note your response to prior comment 5. Please expand your disclosure on pages 75
and 76 to discuss the data that support your conclusion that significant changes were
observed in key biomarkers of ALS between ALS and healthy subjects (such as TDP-43
and LC3) and address the related statistical significance of your findings.
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
October 15, 2021 Page 2
FirstName LastName
Alon Ben-Noon
NeuroSense Therapeutics Ltd.
October 15, 2021
Page 2
You may contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at 202-551-3649
if you have questions regarding comments on the financial statements and related
matters. Please contact Jane Park at 202-551-7439 or Irene Paik at 202-551-6553 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian K. Rosenzweig, Esq.
2021-10-01 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
October 1, 2021
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
Medinat ha-Yehudim Street 85
Herzliya 4676670 Israel
Re:NeuroSense Therapeutics Ltd.
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted September 21, 2021
CIK No. 0001875091
Dear Mr. Ben-Noon:
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 submitted September 21, 2021
Capitalization, page 55
1.The total capitalization line item should not include cash. Please remove the amount of
cash and cash equivalents from the total capitalization line item.
Dilution, page 56
2.It appears that the net tangible book value per share should be $0.48 rather than $0.000475
based on 1,940,974 ordinary shares outstanding as of June 30, 2021. Please revise or
advise to the appropriateness of your disclosure.
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
October 1, 2021 Page 2
FirstName LastName
Alon Ben-Noon
NeuroSense Therapeutics Ltd.
October 1, 2021
Page 2
Business
Clinical Results - NST002 Phase IIa Trial in ALS, page 73
3.We note your response to our prior comment 9 which includes the p-values in the table on
page 75. Please expand your disclosure to discuss the p-values and statistical significance
of the results from the PrimeC trial.
4.We note your response to our prior comment 10. Please expand your disclosure on pages
75 and 76 to clarify the size of your clinical trial and the findings that support your
conclusion that significant changes were observed relating to ALS-associated pathological
markers, target engagement effect on ALS-related pathways and levels of TDP-43
following PrimeC treatment.
Clinical Results - NST001 Phase I Trial in ALS, page 76
5.We note your response to our prior comment 11. Please revise your disclosure further to
discuss the timeline for the development of PrimeC, including an explanation of the
simultaneous start of your Phase IIa NST002 and Phase I NST001 trials of PrimeC and
pre-IND meeting with the FDA.
Preclinical Pipeline, page 76
6.We note your response to our prior comment 12. Please revise the introductory language
in this section to address your plans, if any, to discuss or meet with the FDA regarding
approval of your trial design before moving into the clinical phase and initiate Phase I/II
studies for your StabiliC and CogniC product candidates.
Notes to the Condensed Interim Financial Statements
Note 4 - Material Events During the Reporting Period, page F-30
7.Please provide us with your analysis of how you concluded that a change of control event
or an initial public offering is within the control of the Company under IAS 32.
You may contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at 202-551-
3649 if you have questions regarding comments on the financial statements and related
matters. Please contact Jane Park at 202-551-7439 or Irene Paik at 202-551-6553 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian K. Rosenzweig, Esq.
2021-09-03 - UPLOAD - NeuroSense Therapeutics Ltd.
United States securities and exchange commission logo
September 3, 2021
Alon Ben-Noon
Chief Executive Officer
NeuroSense Therapeutics Ltd.
Medinat ha-Yehudim Street 85
Herzliya 4676670 Israel
Re:NeuroSense Therapeutics Ltd.
Draft Registration Statement on Form F-1
Submitted August 10, 2021
CIK No. 0001875091
Dear Mr. Ben-Noon:
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 F-1 Submitted August 10, 2021
Prospectus Summary
Overview, page 1
1.We refer to your disclosure that your product candidates utilize a combination of FDA-
approved drugs with well-established safety and efficacy profiles, specifically
ciprofloxacin and celecoxib. Please revise to clarify in the Summary that both are generic
drugs. Where appropriate, please also provide a brief overview of the FDA approved uses
of ciproflaxacin and celecoxib.
2.Please expand your disclosure to provide a brief overview of the treatment emergent
adverse events that were observed in your Phase IIa NST002 trial of PrimeC in ALS
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
September 3, 2021 Page 2
FirstName LastNameAlon Ben-Noon
NeuroSense Therapeutics Ltd.
September 3, 2021
Page 2
patients in Israel in the Summary. We refer to your disclosure on page 70.
3.We note your disclosure on page 37 that you have received initial agreement from the
FDA for your development to continue under the 505(b)(2) pathway. Please expand your
disclosure in the Summary to provide such information and specify when you received
this initial agreement from the FDA.
4.We note your disclosure that all patients who completed the NST002 trial elected to
continue into an extension study with PrimeC. Please expand your disclosure to indicate
the number of patients who completed the NST002 trial.
Risks Associated with Our Business, page 3
5.Please revise the Summary to highlight your belief that you were a PFIC in the preceding
taxable year and that you expect you will be a PFIC for the current taxable year. Please
disclose the adverse tax consequences to investors resulting from a PFIC classification in
any given tax year, including additional reporting requirements.
Risk Factors
We have not applied for regulatory approvals to market..., page 15
6.We note that you have "financed the pharmaceutical compounding of the two FDA-
approved drugs that comprise PrimeC" and provided the relevant information to two ALS
clinicians treating eight ALS patients under a CDA without discussing such provision
with the FDA. Please expand your disclosure to specify whether the patients were being
treated in the United States, describe the effects of the treatment on the patients, and
discuss the reporting requirements relevant to compassionate use and the risks resulting
from not discussing such provision with the FDA.
Cautionary Note Regarding Forward-Looking Statements, page 50
7.You state on page 51 that investors are "cautioned not to unduly rely upon"
statements that reflect your beliefs and opinions. Please note that you are responsible for
the disclosure contained in your registration statement and you may not use language that
could be interpreted as a disclaimer of information contained in your filing. Please revise.
Business
Clinical Results - NST002 Phase IIa Trial in ALS, page 70
8.We note your disclosure that most of the TEAEs were assessed as related to study drug
were gastrointestinal disorders. Please expand your disclosure to identify the TEAEs that
were assessed as related to the study drug, the number of times the TEAE was
reported, and whether they were classified as serious adverse events.
9.We refer to your discussion of PrimeC’s potential efficacy using two accepted ALS
clinical endpoints, the ALSFRS-R and FVC on pages 71 and 72. Please expand your
disclosure to address related statistical significance and/or p-values.
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
September 3, 2021 Page 3
FirstName LastNameAlon Ben-Noon
NeuroSense Therapeutics Ltd.
September 3, 2021
Page 3
10.We note your disclosure on page 72 relating to the analysis of blood samples and
additional ALS-associated pathological markers such as markers of autophagy and
lysosomal trafficking. Please expand your disclosure to include the design and scope of
your study and to discuss the data from the results to support the conclusions drawn.
Clinical Results - NST001 Phase I Trial in ALS, page 72
11.We refer to your disclosure on page 72 that the Phase I NST001 trial of PrimeC for the
treatment of ALS has not yet been completed and that you plan to complete the trial in the
third quarter of 2021. Based on clinicaltrials.gov, it appears that you are conducting these
trials in the United States, but based on your disclosure elsewhere in the prospectus, it
appears that you have not yet filed an IND for PrimeC. Please revise your disclosure to
identify the location of the NST001 trial and to explain this discrepancy. In addition,
please clarify your timeline for the development of PrimeC, including addressing your
completion of the Phase IIa NST002 trial in February 2021 prior to completion of the
Phase I NST001 trial, and how this factored into your discussions with the FDA regarding
approval of your trial design.
Preclinical Pipeline, page 73
12.We note the inclusion of your CogniC and StabiliC product candidates for the treatment of
Alzheimer’s and Parkinson’s disease in your pipeline table on pages 1 and 66. You also
disclose on page 3 that you are currently conducting a robust in-vitro study of CogniC,
with plans to conduct a patient-derived cell study and an in-vivo study thereafter. If they
are material, please expand your disclosure in this section to provide a more fulsome
discussion of these programs, including a description of preclinical studies or
development activities conducted. Alternatively, please remove any programs that are not
currently material from your pipeline tables.
Competition, page 73
13.We refer to your disclosure on pages 2 and 67 identifying Exservan as an FDA-approved
treatment for ALS that is delivered orally, which minimizes disruption to patients’ quality
of life. Please expand your disclosure to identify competition from FDA-approved
treatments. Please also disclose the types of modifying therapeutics that each of the listed
competitors are developing and where they are in the development process.
Intellectual Property, page 74
14.We note your disclosure that your patent portfolio includes a U.S. patent application that
is currently pending. Please amend your disclosure to clarify the type of patent protection
and expected expiration date. While you disclose that your U.S. provisional application is
directed to the composition of ciprofloxacin and celecoxib, please also specify the
expected expiration date.
Compensation of Executive Officers and Directors, page 87
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
September 3, 2021 Page 4
FirstName LastNameAlon Ben-Noon
NeuroSense Therapeutics Ltd.
September 3, 2021
Page 4
15.Please disclose the total amounts set aside or accrued by the company to provide pension,
retirement or similar benefits, as required by Item 6.B.2 of Form 20-F.
Management
Executive Management and Directors, page 87
16.Please tell us what consideration you gave to including information required by Item 6 of
Form 20-F for Dr. Oron Yacoby-Zeevi.
Related Party Transactions
IP Transactions, page 106
17.We refer to your disclosure relating to the assignment of the exclusive rights to an
invention related to the methods and compositions of anti-inflammatory drug and dicer
activator for treatment of neuronal diseases. Please tell us whether this invention relates
to your lead product candidate.
Principal Shareholders, page 108
18.Please revise footnote 2 to identify the natural persons who are the beneficial owners of
the shares held by E Europe Limited.
Financial Statements
Note 2- Basis of Presentation
F. Use of estimates and judgment
Share-based payment transactions, page F-9
19.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will help
facilitate our review of your accounting for equity issuances. Please discuss with the staff
how to submit your response.
General
20.Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.
FirstName LastNameAlon Ben-Noon
Comapany NameNeuroSense Therapeutics Ltd.
September 3, 2021 Page 5
FirstName LastName
Alon Ben-Noon
NeuroSense Therapeutics Ltd.
September 3, 2021
Page 5
You may contact Tracie Mariner at 202-551-3744 or Vanessa Robertson at 202-551-3649
if you have questions regarding comments on the financial statements and related
matters. Please contact Jane Park at 202-551-7439 or Irene Paik at 202-551-6553 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian K. Rosenzweig, Esq.
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